FROM THE SHAMAN’S HUT TO THE PATENT OFFICE: IN SEARCH OF
EFFECTIVE PROTECTION FOR TRADITIONAL KNOWLEDGE
Nuno Pires de Carvalho*
He who seeks to build a better mousetrap
today has a long path to tread before
reaching the Patent Office.
Justice Clark, U.S. Supreme Court**
I.
INTRODUCTION
In 1999 I authored an article titled “From the Shaman’s Hut to the Patent Office:
How Long and Winding is the Road?.”1 In that article I submitted that it was possible to
build a road from the shaman’s hut to the patent office. For example, several features of
patent law that are commonly seen as obstacles for the use of the patent system for the
protection of indigenous knowledge2 are rather the result of misunderstandings and
misperceptions and not actual shortcomings of patent law.3 In addition, the article
proposed that, in spite of being possible to cover several elements of indigenous
knowledge by resorting to the traditional mechanisms of intellectual property, such as
copyright and related rights, patents, trademarks, geographical indications and trade
secrets, any attempt in that direction would divest indigenous knowledge from its holistic
nature, and therefore would not be entirely adequate.4 The article submitted that a sui
*
J.D., LL.M, S.J.D., Federal University of Minas Gerais, Brazil; LL.M., S.J.D., Washington University in
St. Louis, MO, USA. The author is Head of the Genetic Resources, Biotechnology and Associated
Traditional Knowledge Section, Traditional Knowledge Division, of the World Intellectual Property
Organization (WIPO), Geneva, Switzerland. All views expressed are the author’s and not necessarily those
of WIPO and/or its Member States.
**
Graham v. John Deere Co., 383 U.S. 1 (1965).
1
Nuno Pires de Carvalho, From the Shaman’s Hut to the Patent Office: How Long and Winding is the
Road?, 41 Rev. ABPI [Brazilian Association of Intellectual Property] 3 (1999).
2
In 1999 the term “indigenous knowledge” was still commonly used. Because, however, since then it has
been recognized that there are local communities that, like indigenous peoples, have maintained a close link
to the land for generations without being “indigenous” (as defined by Convention 169 of the International
Labour Conference, Convention Concerning Indigenous and Tribal Peoples in Independent Countries, of
June 27, 1989), the term “indigenous knowledge” has been replaced by “traditional knowledge.” A clear
sign of that evolution can be seen in WIPO’s agenda of meetings. In 1998, WIPO convened in Geneva a
roundtable on Intellectual Property and Indigenous Peoples (on July 23 and 24). One year later, also in
Geneva, WIPO organized a second roundtable and that time it called it “Roundtable on Intellectual
Property and Traditional Knowledge” (November 1, and 2, 1999). The documents of those roundtables, as
well as all other documents and administered treaties of WIPO cited or quoted throughout this article, can
be found on WIPO’s website, at www.wipo.int.
3
See Carvalho, supra note 1, at 5-10.
4
Id. at 10-11.
1
generis regime of protection of the contents of indigenous knowledge databases would
provide effective protection of indigenous knowledge and yet would permit their holders
to describe and register their knowledge in its entirety, without the need for
dismembering it.5 Moreover, protection granted would be based on a registration system
based on commercial novelty, as opposed to technical novelty.6 Indigenous knowledge
holders would be entitled to obtain injunctions in accordance with the specific piece of
knowledge infringed: an injunction against the unauthorized reproduction or fixation, if
the knowledge was an expression or a performance, or an injunction against the use, if
the element of knowledge had a technical content.7
The present article takes stock of what has been done since 1999 to build the road
that the shaman will walk from his hut to the patent office. The purpose of this article is
not to describe in detail the many multilateral debates held so far, in various
intergovernmental organizations such as the WTO,8 the CBD,9 UNCTAD,10 the FAO,11
but rather to look at the evolution of legal concepts and strategies aiming at providing for
an effective protection of traditional knowledge (hereinafter sometimes designated as
“TK”). Because the legal concepts around TK have been more deeply examined in the
context of the WIPO Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore (hereinafter referred to as “the
Intergovernmental Committee” or simply “the Committee”), this article will look more
attentively to that particular forum.
The next section briefly states some introductory concepts which set the tone for
the rest of the article. It opens with a working definition of TK, it goes on with a brief
reference to the discussion on the economic importance of TK, and it spells out the
“The advantage of databases, as compared to other intellectual creations, is that they cover extensive and
organized sets of information. Therefore, the multiple cultural, religious, technical and economic aspects of
indigenous knowledge can be included in databases.” Id. at 11.
6
Id. at 15.
7
Id.
8
Traditional knowledge was included in the working programme of the TRIPS Council at the fourth
session of the WTO Ministerial Conference, in Doha. See WTO document WT/MIN(01)/DEC/1, of
November 20, 2001. See infra note 209 and accompanying text. WTO documents and legal texts are
available on its website, at www.wto.org.
9
The Convention on Biological Diversity (CBD) has established several bodies to address TK-related
issues, such as the Working Group on Article 8(j) and the Ad Hoc Expert Group on Traditional Knowledge.
CBD legal texts and documents can be found on its website, at www.biodiv.org.
10
Under its Plan of Action, adopted at the tenth session, in Bangkok, on February 12 to 19, 2000, the
United Nations Conference on Trade and Development (UNCTAD) was directed by Member States,
“[t]aking into account the objectives and provisions of the Convention on Biological Diversity and the
TRIPS Agreement, [to study] ways to protect traditional knowledge, innovations and practices of local and
indigenous communities and enhance cooperation on research and development on technologies associated
with the sustainable use of biological resources.” Document TD/386, of February 18, 2000, at paragraph
147. All UNCTAD documents and references to work on TK can be found on its website, at
www.unctad.org.
11
Access to genetic resources for food and agriculture and protection of associated traditional knowledge
are dealt with in the Commission on Genetic Resources for Food and Agriculture (CGRFA) of the Food
and Agriculture Organization of the United Nations (FAO). The text of the International Treaty and
information about the work of the CGRFA can be found at www.fao.org/ag/cgrfa/default.htm.
5
2
different economic and non-economic reasons that should compel governments to look at
those issues seriously.
Section III examines the first approach possible to the protection of TK: the
“defensive” approach, that is, the legal measures that aim at preventing third parties from
unwarrantedly claiming rights to elements of TK. Those measures can be of two types.
The first possibility is the collection and organization of elements of TK in databases in a
manner so as to permit their retrieval by trademark and patent examiners to take TK into
consideration as prior art or otherwise as bars to registration when examining trademark
and patent applications. There are already some international experiences in that
direction, and section three will look at them. However, those databases may create some
legal problems themselves, and section three will also look at those as well as to the
precautionary measures that can be taken. The second possibility is the requirement of
disclosure of the origin of genetic resources and the previous informed consent of TK
holders eventually used in the making of inventions within patent applications
(hereinafter this will be designated as “the Requirement”). Section III will look at several
laws that have recently adopted the Requirement and will scrutinize its compatibility with
various international obligations.12 In addition, section III will compare the Requirement
with the apparently similar requirement to disclose the source of government funding
under 35 U.S.C. 202, and will conclude that, unlike the Requirement, the U.S. obligation
to identify the governmental funding source in patent applications is not incompatible
with international law and practice.
The article then moves on to examine the “positive” approach to the protection of
TK, that is, the legal measures aiming at asserting property rights by TK holders. Two
different paths have been taken by governments so far: some governments have used
traditional mechanisms of intellectual property (hereinafter sometimes abbreviated as
“IP”) in order to protect some elements of TK; other governments have preferred to open
a new path, that is, they have preferred to establish a legal regime adapted to the special
characteristics of TK—a sui generis regime—on the understanding that the traditional
regimes are not adequate for that purpose. Section IV looks at both perspectives and
draws a comparison of the four sui generis regimes so far notified as such to WIPO
(Brazil, Panama, Peru and Portugal), under the notification mechanism established by the
WIPO Intergovernmental Committee.13 In addition, Section IV contains a short
description of the new Thai statute on the protection of traditional medicinal knowledge.
12
The Requirement was the object of a more thorough examination in Nuno Pires de Carvalho, Requiring
Disclosure of the Origin of Genetic Resources and Prior Informed Consent in Patent Applications Without
Infringing the TRIPS Agreement: The Problem and the Solution, 2 Wash. Univ. J.L. & Pol’y 317 (2000).
See also Initial Report on the Technical Study on Disclosure Requirements Related to Genetic Resources
and Traditional Knowledge, document WIPO/GRTKG/IC/4/11, of November 20, 2002.
13
At its third session, the Committee decided to leave “open” a survey of national experiences with the use
of existing intellectual property mechanisms for the protection of TK, so that Committee Members can
continue providing updated information on recent legislative or judge-made measures. See Report of the
third session, document WIPO/GRTKF/IC/3/17, of June 21, 2002, at paragraphs 164 and 211. So far two
surveys have already been distributed to Committee Members (Review of Existing Intellectual Property
Protection of Traditional Knowledge, document WIPO/GRTKF/IC/3/7, of May 6, 2002, and Report on the
Review of Existing Intellectual Property Protection of Traditional Knowledge, document
WIPO/GRTKF/IC/4/7, of November 5, 2002) and a third one is near completion at the time of this writing
3
Section V notes that the construction works of the roads from the shaman’s huts
to the national patent office are well advanced in some places, but there are still some
major construction work to do, the most important one being the road across national
borders, thus permitting the international articulation of national sui generis regimes in
order to establish minimal international coherence. But for that to happen a decision must
be made on the type of national treatment that the current status of the works permits to
adopt. Only one type of national treatment, at this point, could be accepted, and it is the
“same treatment” principle of the Paris Convention,14 as opposed to the “no less
favourable treatment” of the TRIPS Agreement.15 Section V explains the differences
between those two principles and identifies the three essential standards that an
international treaty on the protection of TK should contain so as to achieve coherence and
yet permit contracting countries to keep a certain level of freedom at the national level:
standards concerning the acquisition of rights, standards regarding the loss of rights and
standards of enforceability. The definition of the scope of protection and the
identification of the owners could be left for national legislation to deal with. Section V
will also look briefly at the international treaties—the Convention on Biological
Diversity (CBD),16 the FAO Treaty on Plant Genetic Resources for Food and
Agriculture17 and the United Nations Convention to Combat Desertification
(UNCCD)18—that have been associated with international attempts of establishing
protection of TK. It will be shown that, contrary to the common understanding (or
misunderstanding), neither the CBD nor the FAO Treaty are about TK protection, and
therefore they cannot provide for any useful framework for discussions in that sense. In
contrast, the UNCCD actually calls for IP protection of TK. The legal breakthroughs and
shortcomings of the UNCCD (as far as IP is concerned) will be explained.
(Consolidated Survey of Intellectual Property Protection of Traditional Knowledge, document
WIPO/GRTKF/IC/5/7, of February 28, 2003 (forthcoming)).
14
Paris Convention for the Protection of Industrial Property, last revised at Stockholm, July 14, 1967
[hereinafter mentioned simply as the “Paris Convention”]. The full text of the Paris Convention, its
Membership, and explanatory texts can be found on the WIPO’s website, at www.wipo.int. On the
difference between the national treatment under the Paris Convention and the TRIPS Agreement, see infra
Section V(b).
15
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994). The
TRIPS Agreement constitutes Annex 1C of the Marrakesh Agreement Establishing the World Trade
Organization (WTO), of April 15, 1994. The full text of the TRIPS Agreement, explanatory comments, the
works of the TRIPS Council and Panel and Appellate Body Reports on TRIPS provisions can be found on
the WTO’s website, at www.wto.org.
16
Convention on Biological Diversity (CBD), opened for signature on June 5, 1992, and entered into force
on December 23, 1993. Currently it has 187 Parties. The text of the Treaty as well as an introductory guide
to its provisions can be found on the CBD secretariat website, at www.biodiv.org.
17
The International Treaty on Plant Genetic Resources for Food and Agriculture was approved by the FAO
Conference, at its thirty-first session (November 2001), through Resolution 3/2001. As of the date of this
writing the International Treaty had been signed by 78 countries and accepted (or ratified, approved or
acceded to) by 14 countries (entry into force will require the ratification, approval, acceptance or accession
by 40 countries). The text of the treaty is available at www.faor.org/legal.
18
The United Nations Convention to Combat Desertification (UNCCD) was adopted in June 1994 and
entered into force on December 26, 1996. It has 186 Contracting Parties. The text of the Treaty and an
explanatory guide prepared by the UNCCD Secretariat can be found at www.unccd.org.
4
The article concludes with a positive, yet (hopefully) realistic note on the progress
of the construction of a road that shamans will be able (and, eventually, willing) to use so
as to protect their TK, not only to their communities’ benefit, but also to the benefit of
society as a whole.
II.
TK: SOME PRELIMINARY CONCEPTS
(a)
TK: a working definition
TK, given its vast scope and vague boundaries, is a somewhat elusive concept.
The WIPO Secretariat, for example, has refused to seek a final and complete definition of
TK, and preferred to adopt the practical approach of finding an operational definition
based on the several statutory characteristics that TK must present in order to be eligible
for legal protection.19
Actually, as WIPO has said, there is no need for a complete and definitive
definition of TK in order to develop a legal system for its protection. Most patent laws,
for example, do not define “inventions.” 20 What those laws do is to identify the different
mandatory characteristics that inventions must meet in order to be patentable.21 The same
can be said of trademark law. No piece of legislation on trademarks attempts to define
what a sign is. Any attempt in that direction would be imprudent because of the
overwhelming conceptual complexity of signs. Instead, what law makers (including the
TRIPS negotiators22) have invariably done was to establish that distinctive signs should
be registrable as trademarks.23 The same approach, as WIPO has suggested, could be
applied to TK as well. What an operational definition of TK requires is the designation of
its essential elements, and not an exhaustive description of its concept, which would
prove an impossible task.24
19
See Elements of a Sui Generis System for the Protection of Traditional Knowledge, documents
WIPO/GRTKF/IC/3/8, of March 29, 2002, at paragraphs 10-17, and WIPO/GRTKF/IC/4/8, of September
30, 2002, at paragraphs 24-33. But see Traditional Knowledge—Operational Terms and Definitions, WIPO
document WIPO/GRTKF/IC/3/9, of May 20, 2002, which provides for a lengthy discussion on a possible
definition of TK. Annex II of that document contains several conceptual approaches to TK in national and
regional statutes (or draft legislation) and multilateral fora. Annex III lists some definitions suggested by
non-governmental organizations, academic literature and others.
20
As in Article 27 of the TRIPS Agreement, throughout this article the terms “non-obviousness” and
“utility” are interchangeable with the terms “inventiveness” and “susceptibility of industrial application”,
respectively. See footnote 5 to Article 27.1 of the TRIPS Agreement:
“For the purposes of this Article, the terms ‘inventive step’ and ‘capable of industrial application’
may be deemed by a Member to be synonymous with the terms ‘non-obvious’ and ‘useful’
respectively.”
21
See, for example, Article 27.1 of the TRIPS Agreement: “[...] [P]atents shall be available for any
inventions [...] provided they are new, involve an inventive step and are capable of industrial application.”
22
TRIPS Agreement, Article 15: “Any sign, or any combination of signs, capable of distinguishing the
goods or services [...].”
23
See Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 26.
24
Currently, this view is generally accepted by Committee Members. See Report of the fourth session,
document WIPO/GRTKF/IC/4/17, of December 17, 2002, at paragraphs 131-163. But when the Committee
started discussions, in 2001, a few Members feared that the development of new ideas on the protection of
TK could be blocked by an endless debate on a consensual definition. See, for example, Report of the first
5
This approach is helpful when the purpose of the exercise is a practical one, such
as the search for an appropriate legal framework for statutory protection of TK. However,
in some scenarios, it may be useful to move further toward the identification of the
conceptual boundaries of the subject matter of protection. For example, as a matter of
law, before one reaches the point of discussing when a invention is useful or not, it may
be of the essence to identify if a given creation is an invention or not. This is a discussion
that has frequently arisen in the fields of e-commerce (are business methods really
inventions or are they merely abstract ideas, notwithstanding their eventual novelty,
inventiveness and utility?) and biotechnology (are genes inventions or discoveries only,
regardless of the methods and means developed in order to identify and isolate those
genes?). The same approach may also apply in the field of TK. For the purposes of this
article, it is therefore suggested that TK comprises two main (and to some extent,
distinct) areas: on the one hand, TK consists of knowledge itself, that is, ideas developed
by traditional communities and Indigenous peoples, in a traditional and informal way, as
a response to the needs imposed by their physical and cultural environments and that
serve as means of cultural identification. This is what we may call “TK stricto sensu,”
and it contrasts with “expressions of TK,” also named “expressions of folklore” or
“expressions of traditional culture”, such as verbal expressions (tales, poetry, riddles),
musical expressions (songs and instrumental music), expressions by action or
performances (dances, plays and artistic forms or rituals), whether or not reduced to a
material form, and tangible expressions (productions of art, such as drawings, paintings,
carvings), musical instruments and architectural forms.25 Both categories constitute TK
lato sensu.26
The advantage of this definition is that it acknowledges the traditional dichotomy
between expressions and ideas that has been on the basis of the development of
international intellectual property law over more than one century. Indeed, the Paris
Convention and all its developments, including the special Unions created within the
Paris Union, correspond to ideas.27 On the other side of the spectrum, the Berne
Convention covers expressions. It is true that distinction has become more or less blurred,
particularly in technical fields like industrial designs (which may be protected by
industrial property or by copyright28) and software (which is copyright subject matter29
session, document WIPO/GRTKF/IC/1/13, of May 23, 2001, at paragraphs 27 (statement by Brazil) and 47
(Pakistan).
25
See WIPO/UNESCO Model Provisions for National Laws on the Protection of Expressions of Folklore
Against Illicit Exploitation and Other Prejudicial Actions, available at UNESCO’s website, at
www.unesco.org.
26
See Consolidated Survey, document WIPO/GRTKF/IC/5/7, supra note 13.
27
Trademarks are protected as ideas, not as expressions. The importance of trademarks lies on the idea of
relative quality they convey to consumers as compared to alternative products or services. If trademarks
were a matter of expressions, similarity or identity of signs would be irrelevant for protection purposes,
provided one could attribute them independent originality. But similar or identical trademarks cannot coexist (in principle) on the market when the similarity or identity prevents the conveyance of the message (or
idea) of relative quality, thus inhibiting the signs’ performance of their distinctive functions. However, in
those cases where similar trademarks do not cause confusion to consumers (or, eventually, dilution), they
can co-exist—those cases arise when the “relative quality” message is kept intact.
28
TRIPS Agreement, Article 25.2.
6
but in some countries it has been increasingly the subject matter of patent protection30).
However the proposed approach—a general concept, incorporating the notion of
intellectual property, divided into two subcategories, close to those of industrial property
and copyright—offers an operational basis for a further analysis of the legal mechanisms
aiming at protecting TK.
According to the working definition suggested above, the main elements of TK
stricto sensu are the following:
TK is ideas developed by traditional communities and Indigenous peoples.
In general, creation of TK is an incremental and collective process, but it does not follow
that TK is not the product of individuals. Indeed, creation is always the work of one or
more individuals, working alone or together. The general perception is that TK is
collective and should be collectively owned, but there are dissenting views, in particular
when TK is considered in the context of local communities, such as farming
communities.31 TK, for example, can be created by an Indigenous person who has left
his/her community and lives in a large city. Depending on the customary laws and
principles applicable to that particular situation, nothing stands in the way of recognizing
such individual creation as a genuine piece of TK. The reference to traditional
communities and Indigenous peoples in the definition above proposed is not concerned
with ownership, but rather with authorship, and it is linked to the definition’s fourth
element, described below. On the identification of traditional communities and
Indigenous peoples as such, the general requirement is that they must be identified as a
separate group (on linguistic, or ethnic, or religious criteria, or on a combination thereof)
and must maintain a close relationship with their geographical environment.32
Only ideas that are created in a traditional and informal way constitute
TK.33 “Traditional” means that TK is developed according to the rules, protocols and
customs of a certain community, and not that it is old.34 In other words, the adjective
“traditional” qualifies the method of making of TK and not the knowledge itself. This
idea logically misspells the myth that because TK is old, it cannot be captured by its
29
TRIPS Agreement, Article 10.1.
See e.g. John T. Soma et alii, Software Patents: A U.S. and E.U. Comparison, 8 U. BALT. INTELL. PROP.
J. 1 (1999) and Julie E. Cohen and Mark A. Lemley, Patent Scope and Innovation in the Software Industry,
89 CAL. L. REV. 1 (2001).
31
For this reason, the idea of individual TK ownership is accepted the Portuguese Decree-Law No. 118, of
2002, because in Portugal TK is more (albeit non exclusively) a matter of individual farmers’ rights. The
Thai law also provides for protection of individually created, improved or held traditional medicinal
formulae. See infra Section IV(b)(ii)(5). The sui generis laws of Panama and Peru, in contrast, do not
accept that TK be individually owned. See infra Section IV(b)(ii)(2) and (3).
32
Peru’s Law No. 27,811 defines Indigenous peoples as “aboriginal peoples that existed prior to the
formation of the Peruvian State, maintaining a culture of their own, occupying a specific territorial area and
recognizing themselves as such.” (Article 2(a)).
33
See Portuguese Decree-Law No. 118/2002, Article 3.1: “Traditional knowledge is all the intangible
elements associated to the commercial or industrial use of local varieties and other endogenous material
developed by local communities, collectively or individually, in a non-systematic manner and that are
inserted in the cultural and spiritual traditions of those communities […].”
34
See Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 27.
30
7
creators and therefore may not be the subject of intellectual property protection.35
Additionally, the notion of “tradition” eliminates the need to refer to the manner of
transmission of TK. It is a fact that TK is generally transferred in an oral manner. But
making of that an element of the definition would automatically exclude the vast amount
of TK that has been documented and/or codified. It would also severely jeopardize all the
ongoing initiatives of documenting TK with a defensive purpose. The idea that TK has an
intergenerational nature should also be rejected insofar as it implies the (wrong) notion
that TK is old and immutable. Traditional communities have not disappeared and
continue creating knowledge that, because of its manner of production, is traditional.
Besides, TK evolves: it is created, modified and improved in a gradual and incremental
way. So, it is not necessarily true that a piece of TK will necessarily last more than one
generation. TK is cumulative, indeed, and the manner for its accumulation is the transfer
(generally, but nor exclusively, in an oral manner) from one generation to the next. But
such transfer does not occur always and, therefore, it should not be an element of a
definition. The word “traditional” should be already sufficient to express the stability and
accumulation of TK (“tradition”, after all, implies a certain continuity in time36). As to
the informality of TK, it is understood that its creation does not integrate formal
processes of invention and innovation, but that it is generated through an incremental,
“trial and error” method. TK, per definition, cannot be generated in laboratories or other
places of systematic research and development. By saying this, it is not meant that TK is
neither sophisticated (there is indeed TK that is extremely sophisticated and complex) nor
systematic (several traditional communities and Indigenous peoples do possess vast and
articulated systems of knowledge).37
TK is the result of informal creation because it is developed as a response
to the needs imposed by the physical and cultural environments that dictate the lifestyles
of traditional communities and Indigenous peoples. As a consequence of this, TK is
“holistic” in the sense that both its spiritual and practical elements have the same purpose
of integrating the community with its environment.
TK is a means of cultural identification, be it TK stricto sensu or be it the
expressions of TK.38 In other words, even the technical elements of TK, because of their
particular insertion in a cultural context, are associated in an indissoluble manner with the
identity of the community.39 “This contrasts sharply”, the WIPO Secretariat explained,
“with two scientific inventions made separately by two different teams of employed
35
Id. at paragraph 47.
One of the meanings of the word “tradition” is “a long-established or inherited way of thinking or
acting.” WEBSTER’S COLLEGE DICTIONARY (Random House, 1991).
37
Therefore, where Portugal’s Decree-Law No. 118/2002 says that TK is non-systematic, it describes the
creation of TK, not TK itself. See infra Section IV(b)(ii)(4).
38
See Law No. 20, of June 26, 2000, of Panama, Article 2. See Decree-Law 118/2002, of Portugal, Article
3.1.
39
For this reason, the International Forum that WIPO organized in Oman, in January 2002 was named “TK
and Intellectual Property: Our Identity, Our Future.” See Information Note on Traditional Knowledge,
prepared by the Secretariat of WIPO for the WIPO International Forum on “Intellectual Property and
Traditional Knowledge: Our Identity, Our Future”, held in Muscat, Oman, on January, 21 and 22, 2002.
Traditions are the “thread of Ariadne” that links the future of local communities to their past and,
conversely, projects their past into their future.
36
8
inventors, with the objective of solving the same technical problem: it is not uncommon
that the two inventions turn out to be very similar, which, in patent law, may give rise to
interference proceedings or similar legal procedures which attribute ownership to one
claimant or the other.”40 41 There must be an unbreakable link that connects TK to its
creators, a sort of a subtle (but spiritually significant) thread of Ariadne that does not
permit that link to be broken and thus lost.42
For reasons of legislative technique, some national laws have narrowed even more
the scope of protection, and have accordingly designated other elements that, in addition
to all or some of those above, TK must contain in order to obtain legal protection.
One possible additional element is the identification of the communities that are
entitled to protection. Statutory protection, for example, can be reserved for Indigenous
communities43 or, more broadly, for indigenous and local communities (including
African-American communities).44
A second additional element is the limitation of the scope of protection. For
example, protection may be limited to TK that is associated to biological or genetic
resources,45 or to plant genetic resources,46 or, even more narrowly, to traditional
medicine.47 Or, conversely, the law may limit protection to hybrids of expressions of TK
and stricto sensu TK—namely, handicrafts (as Panama’s Law No. 20, does). As the
representative of the International Chamber of Commerce stated, at the fourth session of
the Intergovernmental Committee, it is not yet clear whether TK should be protected
through a general, one-size-fits-all mechanism, or whether it would require specific
mechanisms for each technical sector.48
40
Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 29.
In Traditional Knowledge—Operational Terms and Definitions, document WIPO/GRTKF/IC/3/9, supra
note 19, at paragraph 35, the WIPO Secretariat suggests that, in a definition “not aimed at prescribing
exactly what portion of knowledge is to be given legal protection and does not itself define the nature of
protection”, an additional element should be added: “some sense of the community or other group itself
identifying the knowledge as traditional knowledge.” The definition mentioned above aims at providing
conceptual subsidies for the development of a legal mechanism. Therefore, following the recommendation
of the WIPO secretariat itself, the possibility of having the community identifying the subject matter of
protection would not be useful because it would rely on subjective considerations. It is of the essence that,
for the sake of legal security, the law establishes some basic and objective features of protectable subject
matter, so that courts be able to distinguish with more or less precision what subject matter the law has
selected as deserving protection.
42
Because of this crucial aspect, handicrafts that are being “modernized” by some governments, eager to
promote small and medium enterprises, through the introduction of modern designs or modern techniques
of manufacture may still be “handicrafts” for some purposes, like tax law, customs tariffs and other
financial incentives, but they are not TK as such.
43
See Law No. 20, of Panama, Article 1.
44
See Brazil’s Provisional Measure No. 2.186-16, of August 23, 2001, Articles 7(III) and 8, and Peru’s
Law No. 27,811, of 2002, Articles 1 and 2(a).
45
Brazil’s Provisional Measure 2.186-16, Articles 1(I) and 7(I). Peru’s Law 27,811, Articles 2(e) and 3.
46
Portugal’s Decree-Law No. 118/2002, Article 3.1.
47
See Act on the Protection and Promotion of Traditional Thai Medicinal Knowledge, Section 14.
48
See Report of the fourth session, supra note 24, at paragraph 161.
41
9
A third additional element may be the susceptibility of commercial utilization of
protectable subject matter.49 The rationale of such a statutory option is that intellectual
property protection is about commercial exploitation (even when right holders do not
wish to make commercial use of their rights, as it will be explained below50). Purely
religious, spiritual or other cultural uses of TK that do not have a commercial dimension
are the subject matter of other branches of law, not of intellectual property.
Anyway, what must be taken into account in addressing those additional elements
is that they all have a reductionist impact to the extent that the result of their adoption or
application is the reduction in the width of the field of protection. Actually, if the intent
of establishing a definition of TK is to develop international standards, that may be
indeed a helpful approach, as the WIPO Secretariat has already noted.51
Of course, once it is admitted that the concept of TK cannot be dissociated from
its “holistic” nature, one could expect that only a holistic, i.e., broadly inclusive legal
approach could satisfy such a nature. This topic has been the subject of a few specific
points raised in the WIPO Committee. It has been said, for example, that a holistic
approach might constitute an obstacle to the enforcement of rights granted because
possible infringement would never occur in respect of the whole knowledge, but only of
one or few of its elements.52 To this the WIPO Secretariat has responded that the fact that
different enforcement tools that correspond to the different nature of specific elements of
TK are made available to right holders is not inconsistent with a holistic approach.53
(b)
TK: beyond the economics of knowledge protection
Panama’s Law No. 20, Article 1; Portugal’s Decree-Law No. 118/2002, Article 3.1.
See infra Section II(b).
51
Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 32: “[I]t
is a characteristic of IP systems that the actual legal protection afforded does not extend to all possible
material that may fall within a broad inclusive definition of relevant subject matter; to some extent this is
an inevitable feature of internationally agreed systems or standards, which does not rule out a broader
approach at the level of domestic law.”
52
At the third session of the Committee, the United States delegation said that:
“TK holders might wish to use several forms of IP protection in an overlapping way. As an
example, it referred to the overlapping use of copyright, trademark, trade secret and patent
protection by software designers and suggested that TK holders could take a similar approach. It
suggested that the example of a shaman’s TK quoted in […] document [WIPO/GRTKF/IC/3/8]
could refer to the usefulness of various forms of IPR currently in use. With this approach, it
suggested, one may not need to prove infringement of all the elements of the TK. Rather,
unauthorized making of a part of the TK, such as the use of the formula without the use of the
chant, may, in its view, be sufficient for a finding of infringement. While conceding that existing
forms of IP protection and other forms of protection, such as contracts or tort law, may not provide
perfect protection, it suggested that wider use of the IP system may prove useful to those seeking
to protect their TK.”
See Report of the third session, supra note 13, at paragraph 191. The example of shaman’s TK can be
found infra, note 277 and accompanying text.
53
See Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 65:
“The availability of differentiated enforcement measures should be independent of the holistic nature of the
protected knowledge, thus allowing right holders to enforce their rights in specific elements of infringed
TK.”
49
50
10
Does it make economic sense to protect TK? The reaction to this question stands
between two opposite ideas: on the one hand, it is understood that knowledge in the
public domain should remain in that state, and thus it should be publicly available
without any constraints; on the other hand, TK is knowledge subject to foreclosure and
therefore there are efficiencies in providing for intellectual property mechanisms that
keep it as such. The debate around these two extremes concerns the static dimension of
knowledge protection, this is, the effects that protection has on distribution and
dissemination of knowledge. In a much quoted speech, Joseph Stiglitz said on the
eventual effects of intellectual property protection:
“A pure public good is a good that is non-rivalrous and also cannot be excluded
from certain users. Knowledge is to some extent excludible so it might be
considered an impure public good. But efficiency in use requires that there be no
charge; yet with no charge, firms would have no incentive to produce knowledge.
For knowledge to be a [good] provided privately, there must be some form of
‘protection’—knowledge cannot simply be made publicly available. In some
instances, trade secrets will do. But in other instances, the broader protection of
intellectual property rights is acquired.
“Too often, however, the difference between intellectual property and other forms
of property rights are glossed over. Clearly, a system of government which
protects my physical property from theft is necessary if I am to have any incentive
to acquire such property, and there is almost universal agreement that
governments should strive to have the most effective protection of physical
property as possible. Reasoning by analogy, some have argued for ‘strong
intellectual property right regimes,’ failing to note the salient differences. In
particular, all ideas build on the work of others, drawing upon the common pool
of ideas. Indeed, the basic ideas, such as mathematical theorems (which provided,
for instance, the basis for the modern computer) typically are not patentable.
Strengthening intellectual property rights often means raising the price of a key
ingredient into research—knowledge—and thus it is possible that an excessively
‘strong’ intellectual property regime may actually inhibit the pace of innovation.
Issues of the breadth (scope) of a patent, the standards of novelty, and even the
duration pose difficult problems and trade-offs: not only between static and
dynamic efficiency (a point long emphasized in the literature) but also between
initiating and follow on innovations. As we move into the knowledge economy,
more thought to these vital issues must be given.”54
A similar view, commenting on the convenience of eventually developing a
regime of protection of contents of factual databases, was expressed by Reichman and
Uhlir:
54
Joseph Stiglitz, Public Policy for a Knowledge Economy, Remarks at the Department for Trade and
Industry and Center for Economic Policy Research, London, January 7, 1999, at
www.worldbank.org/html/extdr/extme/jssp012799a.htm (last visited on November 21, 2002).
11
“The success of the U.S. basic research and educational system is predicated on
the relatively unfettered access to and use of factual information; on a robust
public domain for data; and on easy re-use, recompilation, and value adding
applications of data. Practically all databases developed in the pursuit of basic
research and education are motivated by non-economic incentives such as the
desire to create knowledge, the thrill of discovery, and the enhancement of
professional status. The new database laws,55 however, place an overriding
emphasis on protecting original investments and on augmenting purportedly
necessary economic incentives to create new databases. At the same time, they
undervalue the adverse effects on scientific and technical progress, as well as the
aggregate economic and social costs inherent in restricting and discouraging the
downstream applications and transformative uses of noncopyrightable databases
in general.”56
As a matter of course, both texts are referring to information whose characteristics
do not correspond to those of TK. TK may comprise factual knowledge, but the
operational definition offered above is mostly concerned with creative ideas and
expressions. The parallel of TK with facts, which are generally purely public goods, is
that TK is generally very simple from a technical point of view and therefore it is very
easily copied.57 A shaman shows a bioprospector a plant that he uses on patients who
complain of headache. The bioprospector does not need further instructions to understand
that plant contains a potentially useful active ingredient. The vast number of books and
papers published around the world on the medicinal use of plants illustrates how simple is
to copy medicinal TK. The incorporation of indigenous crops into the mainstream market
of seeds, through breeding with standard plant varieties, also attests that agricultural TK
can be easily imitated. Intellectual property protection of TK, therefore, critics say, would
only harm the free flow of knowledge from “preliterate” societies to “modern” societies
which could indeed make better use of it without the constraints of enclosures and higher
prices.
Nor would it make any sense to protect TK from a dynamic efficiency approach,
opponents of TK protection would say, because TK has been created as a response to the
needs imposed by the natural environment, and a legal mechanism would not have the
dynamic efficiency of promoting the creation of new TK. Actually, TK has been created
for thousands of years without the need for such an incentive, as a WIPO Member
delegation stated in response to a questionnaire prepared by the Secretariat.58 Why then
55
The commentators refer to Directive 96/9/EC of the European Parliament and of the Council of 11 March
1996 on the legal protection of databases, 1996 O.J. (L 77), and to H.R. 2652, 105 th Cong. (1998), modified
as H.R. 2281, 105th Cong. (1998), modified as H.R. 354, 106 th Cong. (1999).
56
J.H. Reichman and Paul F. Uhlir, Database Protection at the Crossroads: Recent Developments and
their Impact on Science and Technology, 14 BERKELEY TECH. L. J. 551 (1999).
57
Mark C. Suchman, Invention and Ritual: Notes on the Interrelation of Magic and Intellectual Property in
Preliterate Societies, 89 Colum. L. Rev. 1264, 1274 (1989).
58
The Secretariat’s comment on such response was as follows:
“On the other hand, it is true that traditional knowledge has been developed without the need for a
formal system of intellectual property protection. In this sense, it can be said that intellectual
property is not necessary to promote its development any further. However, the purpose of
intellectual property, and in particular of patents, plant variety certificates and trade secrets, is not
12
create an expensive legal infrastructure that will not produce any significant dynamic
efficiencies, and also will generate foreclosure on something that can be obtained for free
or close to free? Indeed, intellectual property has been seen as too complicated and
expensive and thus as putting a financial burden on society which would not be
commensurate with the economic value of TK.59
All the views above may make sense on their face. But if we look attentively we
might conclude otherwise. Firstly, on the static efficiency of intellectual property
protection, it is not that clear that TK is so easily accessible and susceptible of being
copied that it may be compared to mere facts. Suchman, for example, draws a very
interesting analogy between the addition of layers of magic to TK in order to protect it
against imitation by the shaman’s competitors. To some extent, the commentator suggests
that magic operates as a substitute for the lack of formal legal structures of appropriation
in traditional communities.60 Besides magic, which might apply to knowledge owned by
the shamans only, traditional communities may recur to social structures, such as rites of
initiation, to restrain the use of some elements of TK. However, both magic and social
structures may constitute endogenous deterrents against competition within the
communities or between communities. But they do not deter a bioprospector from
collecting the knowledge.61 There is, therefore, another mechanism that Indigenous
peoples and traditional communities have increasingly resorted to, in order to avoid that
exclusively the promotion of inventive activities. If it were, intellectual property would have no
purpose whatsoever in countries of centrally planned economies or in those fields where the basic
inventive activities are carried out by the government or by private institutions with public funding
(biotechnology, for example). Transparent and secure property rights in knowledge have an
extremely important role in reducing transaction costs as far as the transfer of technology is
concerned. Patents, for example, have a crucial role to play in the biotechnology area, where the
governments or the institutions that have promoted the inventions need to transfer public-funded
inventions to the market. For that to happen in a transparent and secure way, rights and obligations
must be clearly defined and attributed. For that to happen, a private mechanism of appropriation is
of the essence. The same concept applies to traditional knowledge. Intellectual property protection
of traditional knowledge would establish clear rules on the private appropriation by traditional
communities of their own expressions of culture (including technical knowledge), thus reducing
the enormous uncertainty that today involves all activities of bioprospection by businesses and
research institutions.”
Elements of a Sui Generis System, document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 19.
59
Suchman, supra note 57, at 1272: “The structure of preliterate society renders conventional intellectual
property protections ineffective. Typically, such cultures lack both written records and formal government.
As a result, western-style patent and copyright laws, which require elaborate documentation and
bureaucratic enforcement, are not feasible.”
60
Id, at 1273-1275. Actually, “preliterate” societies are not the only social groups that have resorted to
magic to establish some mechanism of appropriation of knowledge. Historically, before patent rights were
made available to inventors, workers in the metallurgical industry would gather in secret societies. And so
did the alchemists. See EDITH AND FRANÇOIS-BERNARD HUYGHE, HISTOIRE DES SECRETS—DE LA GUERRE
DU FEU À L’INTERNET (Hazan 2000), at 33 and 57. In the absence of patent protection, and because, prior to
the XIXth century, protection of private trade secrets was not generally available, inventors would attempt
to create some ritual protection around their technology, which would be accessible to those “initiated”
(that is, trustworthy) only.
61
In his remarkable book, Tales of a Shaman’s Apprentice—An Ethnobotanist Searches for New Medicines
in the Amazon Rain Forest (Penguin Books, 1993), Mark Plotkin tells about several learning experiences
with shamans in the Amazon rainforest.
13
outsiders learn and copy their knowledge: they will simply not communicate it to
outsiders.
Intellectual property protection of TK will permit, therefore, the replacement of
magic, social barriers and secrecy as measures that establish some sort of appropriation.
Actually, IP is not only about promotion of creation, but also about promotion of its
transfer and dissemination.62
Still on the static side of IP protection efficiency, it should be noted that
“If the information is truly public domain, in other words, belonging to the global
commons, and not proprietary to any government or worldwide institution, then it
may meet with what is called the tragedy of the commons: either it will be
overused or misused, or nobody will take care of it.”63
Intellectual property foreclosure of TK will have the undeniable benefit of
generating an incentive to document and preserve it, thus protecting it from complete
loss. Of course, that benefit will depend ultimately on the particular configuration that is
given to the legal mechanisms adopted, but the different legal regimes on sui generis
protection adopted so far have insisted on the need for documentation, either as a
requisite for protection (that is, as a constitutive mechanism), either as an element of
evidence of ownership (as a declaratory instrument).64
Actually, the doubts about the economic relevance of protecting TK stem from
the wrong perception that TK, being traditional, is necessarily old—hence a matter of
public domain. It was already explained that TK is not necessarily old and it still
continues being created by Indigenous peoples and traditional communities.65 A system
that protects TK holders against free riding and misappropriation may indeed promote
allocation of resources into a more intensive creative effort by Indigenous peoples and
traditional communities. A shaman that obtains some kind of security that, in addition to
his spiritual achievements, will be able to increase material gains from his knowledge,
will probably dedicate more time to experiment new plants and new uses. However, this
argument is acceptable only after one parts from the misunderstanding that TK is old. If
one believes that TK is intrinsically a matter of public domain, then the probable benefit
of introducing intellectual property for its protection would be irrelevant as compared to
the social costs of establishing and managing such a system. To this extent, it is important
62
Article 7 of the TRIPS Agreement reads:
“The protection and enforcement of intellectual property rights should contribute to the promotion
of technological innovation and to the transfer and dissemination of technology [...].”
63
Anne Wells Branscomb, The Economics of Information—Public and Private Domains of Information:
Defining the Legal Boundaries, at www.asis.org/Bulletin/Dec-94/branscom.html (last visited on January
17, 2003).
64
Provisional-Measure 2.186-16 of Brazil makes protection informal (actually, the Brazilian regime is a
purely informal one). Law No. 27,811 of Peru provides for registration, but rights can be enforced even in
the absence of registration (Article 47(c)). In contrast, the laws of Panama, Portugal and Thailand make
registration mandatory. In those three countries, therefore, unregistered TK is not enforceable. See infra
Section IV(b)(ii).
65
See supra notes 33 et seq. and accompanying text.
14
to remind that both the Berne Convention66 and the TRIPS Agreement67 make it clear that
protection of subject matter that has fallen into the public domain is not mandatory, as
opposed, for example, to the extension of terms of protection of patents still valid at the
time of the application of the TRIPS Agreement in the WTO Member in question, as a
consequence of the immediate application of its provisions to situations that still exist on
that date.68 As a result of bilateral negotiations between WTO Members, some exceptions
have been granted to that rule, such as the “pipeline” protection for inventions that had
been patented in other countries but had not yet been commercialized (eventually,
because they were still in the “pipeline” of the marketing approval procedures of sanitary
and health authorities).69 Those exceptions, however, are the result of commercial
concessions bilaterally negotiated between trading partners. Financial gains and social
costs of protection of subject matter that otherwise would be in the public domain,
therefore, must be assessed vis-à-vis gains obtained from the facilitated market access.
However, the static efficiency of TK protection must be assessed also in terms of
reduction of transaction costs in commercial operations involving the transfer and
licensing of TK as well as its misappropriation. This raises the problem of
“biosquatting.”70
The lack of a clear legal framework of TK has given rise to a generalized
suspicion that every single attempt to approach a traditional community by a company
66
Berne Convention, Article 18 reads:
“(1) This Convention shall apply to all works which, at the moment of its coming into force, have
not yet fallen into the public domain in the country of origin through the expiry of the term of
protection.
“(2) If, however, through the expiry of the term of protection which was previously granted, a
work has fallen into the public domain of the country where protection is claimed, that work shall
not be protected anew.”
67
TRIPS Agreement, Article 70.3 states:
“There shall be no obligation to restore protection to subject matter which on the date of
application of this Agreement for the Member in question has fallen into public domain.”
68
TRIPS Agreement, Article 70.2. See Canada—Term of Patent Protection, Report of the Panel adopted
on April 7, 2000 (WT/DS114R, of March 17, 2000).
69
See, e.g., Brazilian Law No. 9.279/96, of June 14, 1996, Articles 229 to 231.
70
Actually, the word “biosquatting” is more accurate than the word “biopiracy” for qualifying the
unwarranted private claiming of TK that could be deemed in the public domain as well as the unauthorized
claiming of TK which is in control of Indigenous peoples and local communities. The reason is that the
first modality is not necessarily illegal—in many cases, actually, private parties benefit from a loophole or
a particular feature in the law, such as the one that only accepts written disclosure of prior art for the
purposes of patent novelty assessment. Such claims, which impinge on knowledge that otherwise would be
in the public domain are similar to settling “on public land in order to acquire title to the land,” that is,
squatting in the definition of the Black’s Law Dictionary (abridged 6th ed., West Publ., 1991). Squatting
also means “entering upon lands, not claiming in good faith the right to do so by virtue of any title of his
own or by virtue of some agreement with another who [one] believes to hold the title” (id.), which
corresponds to the misappropriation of TK that is in control of Indigenous and local communities. This
second meaning would be closer to “piracy”, but not the first one. Besides, under international IP law, the
word “piracy” is linked to some practices of copyright infringement (TRIPS Agreement, footnote 14 to
Article 51). Accordingly, the word “cybersquatting” has been used to designate those cases of
misappropriation of third parties’ names and brands as domain names over the Internet. The term
“biosquatting” seems, therefore, more accurate to identify illegal or otherwise illegitimate IP practices
related to genetic resources and associated TK.
15
interested in assessing the technical and commercial utility of a plant or animal the
practical use of which is known to that community is seen as a potential rip off. The
reaction to that perception (which frequently proves to be based on wrong assumptions
and a misunderstanding of basic intellectual property concepts) generally gives rise to a
general public commotion that seriously harms the public image of corporations and
research institutions. Just to mention a few cases, some years ago there was a debate
involving the British company Body Shop and its alleged unfair exploitation of Kayapo’s
TK.71 U.S. and European patents for products and processes involving natural materials
such as parts of the neem tree, turmeric and quinoa were the subject of enraged debates in
the press and over the Internet.72 More recently, the charges of biosquatting have focused
on maca and cupuaçu.73 All these debates cause a more or less lasting impact on the
public image of the company involved. This may be indeed bad news when the company
is a public one and depends on reputation to attract investors and new shareholders. A
second reaction may come from the authorities of the countries from which the
biosquatted genetic resources and TK were taken. Actually, it has happened that the
authorities of the country in question simply order to shut down its borders to foreign and
national collectors of genetic resources and associated TK.74 This is an example of a
situation in which all stakeholders only have to lose: companies looking for new active
ingredients and molecules do lose because they will have additional difficulties in
assessing natural resources and other raw materials; local scientists and research
institutions will lose because their access to foreign research facilities will be blocked;
local Indigenous peoples and traditional communities will also lose because they will not
be able to sell genetic resources they have been breeding and improving for generations
nor will they be allowed to sell or license their knowledge to bioprospectors. A clear and
effective legal regime has the advantage of solving those problems—which essentially
arise out from mistrust and lack of information—, thus reducing the enormous transaction
costs that generally arise in all sorts of business transactions in the field of biodiversity.
See, e.g., Jon Entine, When Rainforest Ice Cream Melts: The Messy Reality of ‘Socially Responsible
Business’, available at www.mngt.waikato.ac.nz/depts/sml/journal/dialogue/entine1.htm (last visited on
November 11, 2002), and Saulo Petean, Broken Promises, available at www.brazzil.com/p16dec96.htm
(last visited on November 11, 2002).
72
See e.g.European Patent Office Rejects Neem Tree Patent, available at www.greens.org/s-r/23/2322.html; Biopiracy and Patents, available at www.i-sis.org.uk/isisnews/i-sisnews9-31.php; R.V. Anuradha,
Biopiracy and Traditional Knowledge, available at www.hinduonnet.com/folio/fo0105/01050380.htm;
Biopiracy Threat to Traditional Crops, available at www.new-agri.co.uk/02-5/develop/dev03.html; Andean
Quinoa
Piracy—Forum
Discussion
Archive,
available
at
www.mtnforum.org/emaildiscuss/discuss97/jun97/062597c.htm (all sites last visited on February 19,
2003).
73
See statement of the representative of the Indigenous People Biodiversity Network (IPBN) at the fourth
session of the Committee, see Report of the fourth session, supra note 24, at paragraph 172. See also
Ethical Boundaries of Registering Patents and Trademarks on Biological Resources and Traditional
Knowledge
of
the
Amazon
Rain
Forest—The
Cupuaçu
Case,
available
at
www.amazonlink.org/biopiracy/cupuacu.htm.
74
See Andrew Pollack, Developing Nations See Biotech Payback—Angry That They Have Not Profited,
Some Countries Restrict Research, Herald Tribune, November 27-28, 1999, at 1 and 8. See also Xenofobia
na Selva—Paranóia Envolvendo Biopirataria Prejudica Pesquisas Científicas com Espécies Brasileiras
(Xenophoby in the Jungle—Paranoia involving Biopiracy Harms Scientific Research on Brazilian Species),
REV. VEJA, August 18, 1999, at 114-119.
71
16
This rationale of transaction costs reduction is, actually, behind the provisions of
the UNCCD, which provide for the IP protection and transfer of TK relevant to combat
desertification and the effects of drought.75
It is a fact that TK has economic value. Generally, resorting to TK as a guideline
for the collection of plants, animals and microorganisms provides for a tool for the study
and testing of plants used in traditional medicine or for a “prescreen” of resources that
“have a higher probability of yielding bioactive compounds.”76 The relevance of TK as a
useful source of information for researchers in the pharmaceutical field who seek to
identify new chemical and biological elements, as well as new approaches to disease
treatments, is generally undisputed.77 TK as a lead to identify plants that can be used as
raw materials for perfumes is also well documented.78 TK is also used by traditional
communities and poor populations as an alternative to non-existing or inaccessible public
health systems in developing countries.79
The economic value of TK may have been exaggerated, and expectations on its
potential value for the pharmaceutical and cosmetic industries may not correspond indeed
75
See infra Section V(a)(iii).
See James S. Miller, The Discovery of Medicines and Forest Conservation, in CONSERVATION OF PLANT
GENES (Acad. Press 1992), at 123. Miller says that there exist three strategies for collecting plants for
screening programs: random, taxonomic and ethnobotanical. Id. at 122. “Random collecting is an attempt
to sample as much taxonomic diversity as possible.” Id. One limitation of random collecting “is that it often
yields samples that are often taxonomically biased by the geographical restriction of collecting.” Id.
“Taxonomic collecting is based on the general tendency [...] for related taxa to contain related compounds.”
Id. at 123. And ethonobotanical collecting consists of selecting the plants to be collected based on their use
by traditional medicine. Id. at 123. The use of ethnobotanical data may be applied in the study of the use of
plants in traditional medicine, followed by a testing of their effectiveness. It also may be used for random
screening of plants “used in traditional medicine on the assumption that hey have a higher probability of
yielding bioactive compunds.” Id. at 123.
77
See Joel L. Swerdlow, Medicines in Nature, 197 NATIONAL GEOGRAPHIC 98 (April 2000). As an
example of a different approach to the treatment of diseases, Swerdlow describes how Indian practitioners
of Ayurvedic medicine attempt to create body immunities against the malaria parasite, instead of trying to
kill it. Id. at 110. See also Tim McGirk, Dealing in DNA—An ethical battle rages as prospectors scour the
globe to find—and profit from—organisms that could cure some of the world’s worst diseases, TIME,
November 30, 1998, 58 et seq..
78
See La Chasse aux Parfums—Des Odeurs Sauvages, 249 GEO 152 (1999), and Le Parfum, 42 AIR
FRANCE MAGAZINE 131 (October 2000).
79
“[…] [I]ndigenous communities [in Bolivia], which for so long have relied on traditional medicine, not
only for preventive purposes, but also with curative effects, would like to have it integrated into the
national system of health care. What traditional communities expect, in this context, is that citizens receive
government support when seeking assistance from traditional medicinal knowledge holders. Furthermore,
the gouvernment has been asked to promote capacity building in remote communities, so that medicinal
knowledge holders can be trained to provide efficient and safe assistance to patients. Courses on traditional
medicine should also be incorporated into the curricula of medical schools.” INTELLECTUAL PROPERTY
NEEDS AND EXPECTATIONS OF TRADITIONAL KNOWLEDGE HOLDERS—WIPO REPORT ON FACT-FINDING
MISSIONS ON INTELLECTUAL PROPERTY AND TRADITIONAL MEDICINE (1998-1999) (WIPO, 2001), at 1186187 (FFM to South America, Mission to Bolovia). See also Josephine R. Axt et alli, Biotechnology,
Indigenous Peoples and Intellectual Property Rights, CRS Report for Congress, April 16, 1993, at 6-7, and
Edna Fernandes, Ancient Cures in a Global Market, FINANCIAL TIMES, April 30, 2002, at 14.
76
17
to reality.80 But we should not attempt to patronize and attribute beforehand a certain
value to TK. We should let the market do it for itself. The interaction of competing
market forces is the best known (since Adam Smith) tool for evaluating economic
interests. And the best manner to incite economic actors to extract the highest aggregate
output from conflicting economic interests is to establish effective property rights. 81
On the other hand, the fact that the very notion of resorting to formal regimes of
intellectual property for protecting TK is a recent idea does not mean that traditional
communities have not developed their own mechanisms to prevent free riding and
misappropriation of their TK by internal competitors or outsiders. For instance, as said
above, it has been suggested that elements of magic rituals have been added to medicinal
TK as a means of providing for some exclusivity of knowledge. 82 WIPO, during its factfinding missions on the needs and expectations of TK holders, also documented some
measures aimed at keeping TK under control by traditional communities.83
The use of traditional elements of intellectual property or of a sui generis system
in protecting TK would have the advantage of overcoming the barriers to its commercial
circulation that those informal measures of control impose on knowledge. To some
extent, the same anti-secrecy rationale that applies to patents can also be valid in the field
of TK.
It seems, therefore, that it makes sense to apply intellectual property rights for the
protection of TK. However, given the particular characteristics of TK and the lack of a
clear perception of its economic value, it is crucial that any system that applies is simple
and relatively informal. In other words, the adoption of a very sophisticated regime for
protecting TK may end up being a burden to society without corresponding benefits. A
80
See Vying for Access to Natural Resources—Biological Diversity Worth Billions of Dollars Is at Stake,
LATIN AMERICAN WEEKLY REPORT, July 17, 2000, at 316. This report on the discussions around the
enactment by Brazil of a statute on access to genetic resources and associated TK does not make any
reference to the elements considered in order to reach such an estimate. But see Rick Cannell, The Value of
Biodiversity, Financial Times, July 21, 1998: “Even if we acknowledge that biodiversity has great value
can we ever put any kind of figure on its worth? It is perhaps impossible. First, we do not even know
roughly how many species there are: estimates range from about 5m to 30m. Second, we cannot even begin
to predict the ways an organism may be of use. As we learn more about diseases, we have more ways of
looking for useful chemicals. That is to say, organisms that are of no apparent use may be tomorrow’s
saviours.” This can be applied nutatis mutandis to associated TK. See also Fernandes, supra note 79, on the
economic prospects of exports of ayurvedic medicine.
81
On the application of the “Coase theorem” as a primary rationale for the establishment of patent rights,
see NUNO PIRES DE CARVALHO, THE TRIPS REGIME OF PATENT RIGHTS (Kluwer Law Int’l, 2002), at 2022.
82
See Suchman, supra note 57, at 1273-1275.
83
“Indigenous communities [in Bolivia] are not familiar with mechanisms of intellectual property
protection, but they have a sense that it is necessary to protect its economic and spiritual value by some
means of appropriation. Even from a historical perspective such sense has always existed. Indigenous
communities have had a tradition of sharing general knowledge with other communities, but specific pieces
of information, in particular those associated with religious practices and beliefs, have always been kept
confidencial. This explains why some communities have developed and maintained a higer degree of
knowledge or expertise in some specific areas.” INTELLECTUAL PROPERTY NEEDS AND EXPECTATIONS OF
TRADITIONAL KNOWLEDGE HOLDERS, supra note 79, at 186.
18
historical parallel can be provided. In the Middle Ages, when most important trades were
exclusively in the hands of intensively regulated corporations and guilds, foreign
craftsmen were motivated to come to a city through privileges (granted by open letters,
i.e., patent letters) that accorded them not only the right to carry out their trade for a
certain term, but also to bring their families into the fortified walls of the city and some
exemptions from local taxes.84 Those privileges were sometimes granted with strings
attached: if the craftsmen abandoned the city before a certain period (or during their
whole life), they could be sentenced to death by the local lord. 85 Of course, I am not
purporting a legal system that will permit judges to send biosquatters to death. The
example is that patents, at their birth, were extremely simple legal tools, if compared to
the current features of the patent system, which comprise so sophisticated rules as those
of the Patent Cooperation Treaty (PCT)86 and the Patent Law Treaty (PLT).87 The
evolution of the patent system from a simple legal regime towards a complex
internationally harmonized regime is, as a matter of course, the response to the demands
of the growing market of technology. Likewise, one can envisage a simple system for the
protection of TK and its gradual adaptation to the evolution of the respective market. If,
as time passes by, the market finds no economic utility to TK, or only a minor one, there
will be no reason for increasing the complexity of the features of a TK legal regime. But
if TK proves to be economically worthy, it is foreseeable that new features be introduced
in its legal regime so as to enhance legal security, both at the national and international
levels—as it happened with patent law.
The WIPO Secretariat has identified another economic reason for protecting TK:
some Indigenous peoples and traditional communities live in the direst poverty, and yet
they are potentially rich in intangible assets; however, assets (intangible or not) can only
be capitalized and become tools of economic development upon their formalization and
recording. So, if Indigenous peoples and traditional communities so wished (and if the
law so permitted), they could formalize their intangible assets, thus acquiring property
rights, which would permit their transformation into capital, and facilitate the
establishment of commercial ventures.88 Many traditional communities that live in
poverty are actually rich in knowledge—but their knowledge, not being the subject of
formal property titles, is prone to commercial misappropriation (biosquatting) by others.
Furthermore, once recognized through titles, TK could be used as collateral security for
giving traditional communities facilitated access to credit. This would apply in those
cases where traditional communities actively chose to commercialize selected elements
of their TK. One can easily imagine that a bank employee would give better
consideration to authorizing a loan to an Indigenous community which has recently
entered into an agreement on bioprospection and TK licensing with a pharmaceutical
company. This would also be helpful in promoting the development of self-sustaining
84
See Carvalho, supra note 81, at 10-11.
Id.
86
Patent Cooperation Treaty (PCT), done at Washington on June 19, 1970, amended on September 28,
1979, modified on February 3, 1984, and October 3, 2001. The PCT is administered by WIPO.
87
The Patent Law Treaty (PLT), adopted at Geneva, on June 1, 2000, is also administered by WIPO.
88
The relationship between the formalization of real estate belonging to poor communities and economic
development is discussed in HERNANDO DE SOTO, THE MYSTERY OF CAPITAL—WHY CAPITALISM
TRIUMPHS IN THE WEST AND FAILS EVERYWHERE ELSE (Basic Books, 2000).
85
19
enterprises based on TK-related handicrafts, where protection of TK may help both to
strengthen the enterprises’ access to markets, but also secure access to the capital needed
to build up community-based enterprises.89 While there is little commercial experience in
other aspects of TK, there are possibilities in such areas as traditional or complementary
medicine, and other useful technologies, as well as distinctive agricultural and food
products.90
Finally, legal protection of TK would allow traditional communities to preserve
their cultural identity and defend it against distortion and dilution.91 It was explained
above that one of the fundamental characteristics of TK is that it serves as an element of
cultural identification, even when it pursues a purely practical purpose. To this extent, it
should be emphasized that an intellectual property approach does not necessarily
“commodify” TK as a subject matter. It is true that WIPO has defined intellectual
property as “a set of principles and rules that discipline the acquisition, use and loss of
rights and interests in intangible assets susceptible of being used in commerce.”92 But
what really characterizes intellectual property is that, “[i]n most cases, the use IP owners
make of the protected material is irrelevant to how the right is defined: for IP what counts
is the use others may (or may not) make of those assets, whether they are seen as cultural
or commercial assets, or both. It is this specific characteristic of IP rights that makes them
important even for those who do not want to make commercial use of their assets, but
who want to prevent others from doing so. For example, authors’ moral rights—rights of
integrity and of attribution—do not have a commercial nature, and indeed are enjoyed
independently of authors’ economic rights.[citation omitted] Nonetheless, they function
as part of an IP system since exercising these rights (to restrain such acts as distortion,
mutilation or other modification of the work or other derogatory action) requires exactly
the same enforcement tools (such as injunctions and accounting for damages) as traderelated IP rights. In the same vein, as far as TK is an expression of cultural identity, IP
enforcement tools are necessary to protect it against distortion or other derogatory
actions, even for those TK holders who do not wish to put it in the channels of
commerce. IP protection, therefore, does not ‘commodify’ TK per se: to the contrary,
one immediate consequence can be to empower TK holders against the distorting use of
elements of their identity, or against unauthorized commodification of their TK. TK
holders may, if they wish so, not only to refrain from giving a commercial dimension to
their TK, but they may also prevent others from doing so. On the other hand, an IP
regime will be of crucial interest for those TK holders who have the legitimate aspiration
89
For this reason, the government of Panama has inserted the activities of promoting commercialization of
handicrafts in a program of support for the small and medium enterprises. Information is available at the
website of Panama’s Ministry of Trade and Industry, at www.mici.gob.pa/secartf.html (last visited on
February 21, 2003).
90
See document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 21.
91
Some commentators have limited the justifications of TK protection to this sort of moral arguments. See,
e.g., Michael Blakeney, The Protection of Traditional Knowledge under Intellectual Property Law, 6
E.I.P.R. 251, 252-256 (2000). Moral arguments are important, but they are not sufficient, because they may
be opposed by counterarguments. For example, one might say that, for reasons of social ethics, TK should
be kept freely accessible, rather than foreclosed behind legal barriers. Economic reasons are indeed crucial
to show that, besides the moral dimension, society has also to gain economically from converting TK into
IP assets.
92
See document WIPO/GRTKF/IC/4/8, supra note 19, at paragraph 34.
20
of ‘commodifying’ their knowledge or at least certain selected parts of it they choose to
commercialize.”93 94
III.
THE DEFENSIVE PROTECTION OF TK
One of the possible approaches to protection of TK is to take measures that make
it impossible (or more difficult) for third parties to claim and acquire formal property
rights in some of its elements. According to discussions in the Intergovernmental
Committee, those measures concern mainly the fields of patents and trademarks. Next
subsection will review activities carried out by governments in that context, as notified to
the WIPO Intergovernmental Committee.
(a)
Making information available to trademark and patent examiners
(i)
Trademarks
Several countries have informed the WIPO Intergovernmental Committee of
measures aiming at preventing third parties from appropriating signs, symbols and names
belonging to traditional communities and Indigenous peoples with a commercial or
otherwise distorting purpose. Those measures may be of two types: interested TK holders
may file for and obtain trademark registrations in order to preempt third parties’ claims;
or TK holders may inform the trademark office of vested interests in symbol, signs and
names that should prevail over third parties’ rights to register trade signs. From a legal
point of view, the second alternative is not necessarily complex. Actually, it will suffice
that protection of minorities’ cultural rights be deemed sufficient grounds of morality and
ordre public, so as to prohibit that some signs bearing a particular meaning for those
minorities (and the commercial utilization of which is offensive to them) be privately
appropriated as trademarks or trade names. On the other hand, the first alternative may
require some statutory amendments, in particular in those countries where only legitimate
businesses are entitled to obtain trademark registrations. In those countries, Indigenous
peoples not being registered as commercial businesses, it would be difficult for them to
acquire trademark rights.95 Nor would that mechanism be useful in those countries where
93
Id. at paragraphs 17 and 18.
Document WIPO/GRTKF/IC/4/8 mentions a fourth rationale for the protection of TK: because TK
creators spend time and other resources in creating and improving their knowledge on how to extract goods
from their environment, the absence of IP protection for their creations in other countries constitute nontariff barriers to the export of those goods. Indeed, foreign competitors will be able to copy TK-based
goods and services without having to internalize any costs on research and development. All other factors
being equal, TK creators will be barred from reaching those foreign markets where rights in their TK will
not be recognized. This same argument was successfully used by the big pharmaceutical and entertainment
industries to convince governments to allow intellectual property to integrate the Uruguay Round of GATT
negotiations. If the argument worked for those industrial sectors, why should it not work for TK holders?
See supra note 19, at paragraph 22. This is, however, not a rationale per se but an argument for
international negotiations in the WTO. Indeed, that would be a rationale only if the need for the expansion
of trade-related patent rights were self-evident.
95
See, e.g., Brazil’s Industrial Property Law No. 9,279, of May 14, 1996, Article 128(1), under which only
persons who own effective and legitimate businesses can apply for trademark registrations.
94
21
trademark registrations that are not used for a period of at least 3 years are subject to
lapse.96
The first alternative—obtaining trademark registrations not with the intent of
putting them to a commercial use but of preventing others from acquiring rights in the
registered signs—was the subject of information given by Canada to the Committee: in
Canada, the Snuneymuxw First Nation has registered ten petroglyph with a special
religious significance in order to stop the sale of commercial items, such as T-shirts,
jewelry and postcards.97
The second alternative was followed in Colombia, New Zealand and the United
States. A concrete example described by Colombia, where the registration of a trademark
was denied by the Trademark Office because its eventual use for commercial purposes
was deemed to be offensive to the “Tairona” culture (even if the “Tairona” culture had
already vanished).98 New Zealand informed that a new Trade Marks Bill, currently being
considered by Parliament, will if enacted allow the Commissioner of Trade Marks to
refuse to register a trade mark where its use or registration would be likely to offend a
significant section of the community, including Maori. This provision would provide
additional protection to some expressions of traditional knowledge by preventing the
inappropriate registration of marks based on Maori text or imagery.99 In a statement at the
second session of the Committee, the delegation of the United States informed that, “on
August 31, 2001 the USPTO began accepting requests for registration in the Database of
Official Insignia of Native American Tribes. The Database would be included, for
informational purposes, within the USPTO’s database of material that was not registered
but was searched to make determinations regarding the registrability of trademarks. To
[that] date, the USPTO had received only one request for inclusion in the Database of the
official insignia of the Redding Rancheria Wintu Yana Pit River tribe in Redding,
California. Notwithstanding this new Database, all trademark applications containing
tribal names, recognizable likenesses of Native Americans, symbols perceived as being
Native American in origin, and any other application that the USPTO believed suggested
an association with Native Americans, were examined by one attorney who had
developed expertise and familiarity with this area.”100
(ii)
Patents
The defensive use of the patent system also comprises two possible alternatives:
TK holders might apply for and obtain patent rights with the single purpose of avoiding
that others acquire rights in their knowledge. The delegation of Japan has noted that
where TK holders resort to “existing IP standards like patent law” they will be able to
prevent “any exclusive rights on the traditional knowledge from being obtained by
96
TRIPS Agreement, Article 19.1.
See Consolidated Survey, supra note 13, Annex II.
98
Id.
99
Id.
100
See Report of the second session, document WIPO/GRTKF/IC/2/16, of December 14, 2001, at
paragraph 27.
97
22
others.”101 The delegation of Japan refers to the practice (which is relatively common in
Japan) of applying for patents for inventions that the applicant does not intend to use, but
which he or she does not want to fall in the hands of competitors who might
independently reinvent them. A practical solution is to file a patent application, to wait
for it to be published (or “laid open for public inspection”) and refrain from requesting
the subsequent examination. Such application thereby falls into public domain and as
such it will necessarily be taken into account by patent examiners when assessing the
patentability of claims filed by competitors.102
As with trademarks, the Intellectual Property Office of New Zealand has developed
guidelines for patent examiners concerning patent applications of significance to Maori.
The guidelines target inventions relating to, using or derived from indigenous flora and
fauna, Maori individuals or groups, indigenous micro-organisms (including viruses,
bacteria, fungi, algae where any line of research resulted from any traditional or local
knowledge), and indigenous material derived from an inorganic source where research
resulted from any traditional or local knowledge.
If an application falls into one of the above criteria an examiner is required to
assess whether it is appropriate to raise an objection to registration under section 17 of
the New Zealand’s Patents Act (which allows the Commissioner of Patents to refuse an
application where the use of the invention in question would be contrary to morality). In
making this assessment, examiners are directed to consider the extent to which the
application may have special cultural or spiritual significance for Maori, and whether or
not the application is likely to be considered culturally offensive. Where an application
may reasonably be considered to fall under section 17, applicants are to be advised
accordingly and given the opportunity to obtain the consent of the competent Maori
authority.
Another defensive approach to patent law is to make TK-related information that
may constitute prior art available to patent examiners in a documented and organized
fashion. This matter, which has been the subject of much attention by the WIPO
Committee,103 attempts to address two sorts of concerns. On the one hand, in some
jurisdictions, the novelty and non-obviousness conditions of patentability of some
101
See document WIPO/GRTKF/IC/5/7, supra note 13.
See Robert J. Girouard, U.S. Trade Policy and the Japanese Patent System, Working Paper 89, August
1996, The Berkeley Roundtable on the International Economy, www.ciaonet.org/wps/gir01/#txt115 (last
visited on January 3, 2003). For a general overview of the relationship between patents and plant genetic
resources (including both the defensive approach and the positive approach), see Shakeel T. Bhatti, Patents
and Plant Genetic resources: The Bonn Guidelines on Access to Genetic Resources and the Patentability of
Plant Biotechnological Inventions under the TRIPS Agreement, in HARRY KLEE and PAUL CHRISTOU
(editors), HANDBOOK ON PLANT BIOTECHNOLOGY (John Wiley and Sons, 2003), forthcoming (manuscript
on file with the author).
103
See, e.g., Progress Report on the Status of Traditional Knowledge as Prior Art, document
WIPO/GRTKF/IC/2/6, Inventory of Existing Online Databases Containing Traditional Knowledge
Documentation Data, document WIPO/GRTKF/IC/3/6, of May 10, 2002, Inventory of Traditional
Knowledge-Related Periodicals, April 30, 2002, and Technical Proposals on Databases and Registries of
Traditional Knowledge and Biological/Genetic Resources, document WIPO/GRTKF/IC/4/14, of December
6, 2002.
102
23
inventions are assessed with reference to written prior art only. In the case of United
States, for example, the prior knowledge or use of an invention is considered prior art
only when those actions take place in U.S. territory. Prior knowledge or use of an
invention in a foreign country is not relevant for prior art purposes—only a written
description in a printed publication is.104 Because much of TK is orally preserved and
transmitted by traditional communities, patent examiners in those jurisdictions have no
means to consider it as prior art, which facilitates biosquatters’ claming and obtaining
rights in such TK.
On the other hand, even when TK is documented, its descriptions are not
generally arranged or selected in a manner so as to makes them easily retrievable by
patent examiners, particularly in technical fields where patent and other literature is
abundant and the examination of patent applications is a naturally burdensome task. One
tool that may facilitate the access of patent examiners to TK as prior art is the
International Patent Classification, which indexes patent applications according to the
technical field of claimed inventions.105
Several WIPO Members are establishing TK databases with those purely
defensive purposes. India, for example, has set up a database containing Ayurvedic
medicinal knowledge. China has established a traditional Chinese medicine patents
database.106 Peru, which recently enacted a sui generis regime of biodiversity-associated
TK, will have one registry of TK in public domain, whose documentation will be
communicated to the main patent offices in the world.107 Recently, Members of the PCT
Union gave positive consideration to the inclusion of TK periodicals and other databases
as relevant non-patent literature for the purposes of the elaboration of international search
and preliminary examination reports.108
However, the preparation of databases for defensive purposes raises several IPrelated questions. In the first place, documentation of TK implies its disclosure.
104
35 U.S.C. 102 reads:
“A person shall be entitled to a patent unless —
“(a) the invention was known or used by others in this country, or patented or described in a
printed publication in this or a foreign country, before the invention thereof by the applicant for
patent […].”
Likewise, under the Patent Cooperation Treaty (PCT) only previous written disclosure is taken into account
for the purposes of discovering relevant prior art (Article 15.2 in conjunction with Rule 33.1). The PCT
search report is not mandatory for Contracting Parties, nonetheless it is considered a primary source of
reliable information on prior art by many PCT Union Members’ patent offices. Under Rule 33.1(b),
previous oral disclosure, uses and exhibitions may also be considered, but provided the making available of
the invention to the public has taken place through a previous written disclosure.
105
Strasbourg Agreement Concerning the International Patent Classification (IPC), of March 24, 1971, as
amended on September 28, 1979. The Strasbourg Agreement and the IPC Union are administered by
WIPO. On the status of the development of special tools, under the IPC, that can apply to TK, see Report of
the Thirty-First Session of the Committee of Experts of the Special Union for the International Patent
Classification, document WIPO/GRTKF/IC/3/13, of May 24, 2002.
106
Links to the Indian and Chinese databases are available on WIPO’s website.
107
See Section IV(b)(ii)(3).
108
See PCT Minimum Documentation, Meeting of International Authorities under the PCT, Seventh
Session, Geneva, February 10 to 14, 2003, document PCT/MIA/7/3, of December 20, 2002.
24
Disclosure, under patent and trade secret laws, bars any possibility of acquiring formal
protection.109 Therefore, inclusion of TK in databases may diminish the possibility of TK
holders procuring IP protection.110 Second, databases may the product of creative
activity. Under current law, the original selection or arrangement of data contained in
databases is protected by copyright.111 But in most jurisdictions non-original contents of
databases are not.112 Therefore, TK holders are naturally reluctant in releasing
information in their control, even if for defensive purposes, because they rightfully fear
that they may be losing any possibility of acquiring rights in their intangible assets—thus,
paradoxically, facilitating biosquatting practices.
These problems can be addressed in several ways. The first way that immediately
comes to mind is providing legal assistance to the different stakeholders involved in the
preparation of defensive databases. As a matter of fact, the different issues mentioned in
the preceding paragraphs concern matters of IP management, such as precautions to be
taken so as: to avoid TK to fall into public domain; to distinguish TK that has already
been lost from TK that is still able to be legally captured; and to claim and enforce
property rights in TK included in databases. With that sort of concerns in mind, the
WIPO Secretariat has undertaken the preparation of a series of recommendations (a
“toolkit”) that may help TK holders and database makers to adequately address IP
concerns.113
One of the options of TK holders and database makers is to keep TK under
secrecy, until a system that may ensure protection of disclosed TK develops. This was the
option of the government of Venezuela, which controls a vast and complex database
concerning biodiversity and associated TK in the fields of agriculture and medicine. The
name of that database is “Biozulua”, an indigenous word that means “house of wisdom”
and “house of secrecy.” Indeed, the contents of Biozulua are not accessible to
unauthorized persons because otherwise, under current law applicable in Venezuela, they
would fall into public domain. Moreover, the adoption of a positive system of protection
of contents of TK databases would not suffice either, because TK disclosed in Venezuela
109
Patent law, however, admits some limited exceptions to this rule: under the grace period, inventions
disclosed within a certain period prior to the relevant filing date may still be patentable, if disclosure was
made by the inventor or by an unauthorized third party; the so-called “pipeline” patents (which some
countries have adopted in order to grant protection for pharmaceutical inventions already patented in
foreign countries and which had not yet been commercialized—hence, still in the “pipeline”).
110
This does not mean that disclosure will necessarily bar any kind of protection for TK. That is a matter of
statutory definition. Portuguese Decree-Law No. 118/2002, for example, adopts a “commercial novelty”
concept, as opposed to a “technical novelty” one (as Peru’s Law 27,811 did). See infra Section IV(b)(ii)(3)
and (4).
111
Berne Convention (Article 2.5, referring to collections of literary or artistic works such as encyclopedias
and anthologies), the TRIPS Agreement (Article 10.2) and the WIPO Copyright Treaty (WCT), of 1996
(Article 5).
112
The European Union is an exception. See supra note 55.
113
See Draft Outline of an Intellectual Property Management Toolkit for Documentation of Traditional
Knowledge, document WIPO/GRTKF/IC/4/5, of October 20, 2002.
25
could be appropriated and/or used in third countries. The government of Venezuela will
keep Biozulua data confidential until an effective international regime is established.114
A similar concern with secrecy was expressed by a few delegations which were
worried with the possibility of making publicly available defensive databases containing
TK in the public domain, thus facilitating the dissemination of TK and, ultimately,
facilitating, if not encouraging, biosquatting. Therefore, a number of delegations to the
Intergovernmental Committee have proposed that access to TK databases “should be
limited to patent examiners, along with an obligation of confidentiality for those who had
access to the information.”115 Of course, this does not make any sense. If the idea is to
serve patent examiners with tools that help them assess novelty and inventiveness, the
information they must receive is public information. It is true that the notion that prior art
must be easily accessible is not a legal condition for information to acquire that status.
Nonetheless, creating obstacles for public accessibility of information may mean that it
does not constitute prior art, in the first place. Therefore, the confidentiality obligation
may run counter the very objectives of the establishment of defensive databases.
Furthermore, a patent application rejected because of a conflict with previously
disclosed TK would be subject to publication (in those countries where patent
applications are made available for public inspection). However, under that proposal, the
TK that constituted prior art and led to that application’s rejection would be kept secret.
This does not seem to make logical sense.
Moreover, as it will be explained below,116 keeping TK databases secret is in
conflict with the objectives and the provisions of the UNCCD, in particular Article 18.2.
The UNCCD, as it will be explained, is the first international treaty that approaches TK
not only from a static efficiency standpoint, but also from a dynamic one, under which a
regime of proprietary protection is envisaged as a tool for promoting the continued
creation of TK.
114
Dr. Ramiro Royero, who conceived and manages Biozulua, made a presentation of the database at the
third session of the Intergovernmental Committee. See Report of the third session, supra note 13, at
paragraph 162. A detailed explanation of Biozulua, its objectives and the technical criteria used for its
making, can be found in Francisco Mejías et alii, Manual del Sistema Biozulua, April 2002, distributed
during the third session of the Committee (on file with the WIPO Secretariat). See also Ramiro Royero et
alii, Bases de Datos para la Información Agroalimentaria, de Tecnología Ancestral y Medicina Nativa
para el Desarrollo Sustentable en Diversas Etnias de Amazonas, 2 MEMORIAS DEL INSTITUTO DE BIOLOGÍA
EXPERIMENTAL 85-88 (1999). At a seminar on biodiversity and intellectual property organized by the
government of Venezuela in Tobogán de la Selva, State of Amazonas, in November 2002, the
representative of WIPO told the audience (which consisted mostly of Indigenous persons, including a
number of shamans) that Venezuela had two treasures: oil fields and Biozulua; the difference between the
two was that the oil fields would be exhausted in a few decades; and Biozulua, because of its intangible
components, would continue expanding and gain added value if appropriately managed and protected.
115
This proposal was made by Peru and had the support of Bolivia, Brazil, Panama and Venezuela. See
Report, document WIPO/GRTKF/IC/3/17, at paragraph 87. This idea seems to have received support from
at least one commentator. See Graham Dutfield, Sharing the Benefits of Biodiversity—Is There a Role for
the Patent System?, 5 J. WORLD INT. PROP. 899, 927-928 (2002).
116
See Section V(iii).
26
Given that databases are important for defensive purposes, one may wonder why
not give positive protection to the original contents of those databases. In doing so, law
makers would give TK holders the tool they need in order to oppose biosquatting as well
as a regime of legal security that would allow TK holders to commercialize and capitalize
their intangible assets. This is the view of the government of Venezuela and, to some
extent, the solution given by Peru and Portugal. As it will be explained later, the
difference is that the Portuguese regime permits TK databases to keep information secret,
if TK holders so wish (but that information will be protected by unfair competition law,
and will not give rise to exclusive rights).117
Another option, which is an extension of the previous approach, is to grant
positive protection for original contents of TK databases, but, so as to avoid a very
difficult task of identifying TK that is in public domain, establishing commercial novelty,
rather than technical novelty, as a condition of registrability of TK. Under this approach
(which the Portuguese Decree-Law No. 118/2002, inspired in some precedents of
industrial property international law, has adopted118), what separates TK that is new from
TK that is in the public domain is not the date of disclosure, but the date on which it was
first commercially exploited.
(b)
Increasing the burden of disclosure in patent applications
Another measure that some governments are taking, and which seems to count
with an increasing sympathy, is to require patent applicants to identify in their
applications the geographical origin of any genetic resources eventually used (directly or
indirectly) in the making of the claimed inventions as well as to prove that any element of
TK directly or indirectly used has been obtained with its holders’ prior informed consent
(hereinafter designated as “the Requirement”).119 This Requirement has a single
objective: to help stakeholders monitor compliance with legal or contractual obligations
of sharing benefits derived from the commercial use of the material and immaterial
resources obtained, in the light of the recommendation contained in Articles 8(j) and 15.7
of the Convention on Biological Diversity. Article 8(j) provides:
“Each Contracting Party shall, as far as possible and as appropriate:
“[...]
“(j) Subject to its national legislation, respect, preserve and maintain knowledge,
innovations and practice of indigenous and local communities embodying
traditional lifestyles relevant for the conservation and sustainable use of biological
diversity and promote their wider application with the approval and involvement
of the holders of such knowledge, innovations and practices and encourage the
Portugal’s Decree-Law No. 118/2002, Article 3.3. See infra Section IV(b)(ii)(4).
Id.
119
The following comments will focus on the intangible aspect of modified (domesticated or not) genetic
resources, that is, on TK.
117
118
27
equitable sharing of the benefits arising from the utilization of such knowledge,
innovations and practices.” (emphasis added).
Article 15.7 of the CBD provides:
“Each Contracting Party shall take legislative, administrative or policy measures,
as appropriate, and in accordance with Articles 16 and 19 and, where necessary,
through the financial mechanism established by Articles 20 and 21 with the aim of
sharing in a fair and equitable way the results of research and development and
the benefits arising from the commercial and other utilization of genetic resources
with the Contracting Party providing such resources. Such sharing shall be upon
mutually agreed terms.” (emphasis added).
It is generally accepted that, once a piece of TK has been instrumental for an
inventor to reach a new, creative and useful solution to a given technical problem, it is
predictable that same inventor will be able to put the invention on the market and extract
revenues from it. Under Article 15.7 of the CBD and the legal or contractual instruments
based thereon, the bioprospector or his/her successor is under the obligation of sharing
some of those revenues with the TK holder. As a matter of law, that obligation arises
from the making of the TK-derived creation and the obtaining of benefits from such
creation, and not from the patent. Where genetic resources were used to make an
invention but the invention did not result into a commercial product, the sharing must
stem from the inventive output itself (possible, in the form of a fixed payment). In other
words, the obligation remains when the practical applications directly or indirectly
derived from the element of TK in question are not submitted as patent applications and
are, for example, kept as trade secrets or are simply disclosed, and thus put in the public
domain. The problem with this is that it is very difficult to formally monitor other
applications of TK that are not contained in patent documents. If the obligation of the
bioprospector or his/her successor stems from a contract, there may be some contractual
means to accompany and monitor the use of the piece of TK—as any agreement on
technology transfer, a well written TK licensing agreement will contain that sort of
clauses. But the problem arises when there is no contractual relationship between the
bioprospector and the TK supplier and therefore the latter has no access to the former’s
accounting books or research records. Biosquatting then becomes a matter of breach of
statutory measures (in those countries which have enacted measures on access to genetic
resources and associated TK) or of breach of the law in general (when misappropriation
of TK can be alleged).
The practical reason for some countries’ insisting in keeping the Requirement is
that without the voluntary120 or mandatory disclosure it is extremely difficult, if not
120
Many patent applications do identify the origin of genetic resources used in making the invention,
regardless of any legal constraint in that sense. See Asha Sukhwani, PATENTES NATURISTAS (Oficina
Española de Patents y Marcas, Madrid). See also Patents Using Biological Sources Material (I) and
Mention of the Country of Origin in Patents Using Biological Source Material (II), Document submitted by
the Delegation of Spain, WIPO/GRTKF/IC/2/15, of December 13, 2001. The U.S. delegation, in its
response to the WIPO questionnaire in preparation for the technical study on the Requirement, said:
“[B]ased on experience, the USPTO is aware that patent applicants, at times, provide information about the
28
impossible, to assert with reasonable certainty that a given invention has been made
possible because of a certain hint given to the inventor on a certain use of a plant, animal
or microorganism. Where the invention consists of the very use of the plant (or of its
active component) for a practical purpose,121 the link between the final result of the
research (the invention) and its trigger (the TK element) is more visible—if they are not
the same, actually, as it turned out in the turmeric case. In that hypothesis, the TK creator
should be identified as co-inventor, because his contribution was one of clearly inventive
nature. But in those many countries in which uses are not patentable subject matter per se
situations like the turmeric patent would never arise.122 In most cases TK is the hint that
genetic resources used in their invention, including the source of origin, in order to meet the written
description, enablement or best mode requirement.” See Initial Report, supra note 12, at paragraph 60. For
example, the patent at the center of the current biosquatting debate involving cupuaçu (see supra note 73),
European Patent 1 219 698 A1, Fat Originating in Cupuassu Seed, Process for Producing the Same and
Use Thereof, does contain an explicit reference to the geographical origin of the cupuaçu fruits from which
the seeds used in the experiments described in the specifications were actually extracted: a farm in the
outskirts of Manaus, the capital of the State of Amazonas, Brazil. In some cases, such disclosure is indeed
voluntary. But in other cases disclosure may be mandatory, in spite of the absence of legislation on access
to genetic resources, where the precise geographical location of the resource in question is necessary to
enable another person with normal technical skills to reproduce the invention. Article 29.1 of the TRIPS
Agreement makes such enabling disclosure a mandatory requirement. In contrast, I have not seen a single
patent application (which does not necessarily mean that they do not exist) which identifies the person or
persons who have provided the inventor with knowledge about potential useful properties of the genetic
resource in question. For example, U.S. Reissue Patent No. 18,667 (reissued November 22, 1932), for a
“Vermifuge and Insecticide” made of an extract of cuba roots, informs that the plants had been obtained in
Peru but provides no information about the fact that the inventor, in 1917, “was a teacher in Peru where he
saw natives grind the root of a plant called cube with their feet and use the product to kill fish.” Dennis v.
Pitner, 106 F.2d 142, 147 (7th Cir. 1939). This fact was reported in the Seventh Circuit’s opinion in a case
concerning the infringement of Patent No. RE18,667. Ironically, Circuit Judge Evans, who delivered the
opinion for the majority, elaborated at length on the new and inventive nature of the claimed invention as
compared to prior art (including documentation showing that the use of cube extract as an insecticide was
known in Iquitos, Peru, as early as 1920—id. at 149), but made no reference whatsoever to the fact that if
there was an invention (and the majority decided that the extract could be of an inventive nature indeed, but
that was not the issue at stake, because the problem was one of novelty, not of inventiveness—id. at 146),
the true inventors were the Peruvian Indigenous peoples, not the patentee.
121
For example, U.S. Patent No. 5,401,504 was granted for the “Use of turmeric in wound healing” and it
was thus summarized: “Method of promoting healing of a wound by administering turmeric to a patient
afflicted with the wound.” The patent was reexamined and invalidated, on grounds of lack of novelty, but
this is a clear cut case in which a patent was granted for a traditional invention. The patent applicants had
added nothing new or creative to what they had learnt from ayurvedic traditional medicine. If it were not
for the lack of novelty, the people of Kerala might have been better off if the Indian Council of Scientific
and Industrial Research (CSIR), a government agency linked to the Indian Ministry of Science and
Technology, had requested the transfer of the title in the U.S. patent instead of pursuing its invalidation.
Information on the CSIR can be obtained at www.csir.res.in.
122
See, e.g., Andean Community Decision No. 486, of September 14, 2000:
“Article 21.- Products or processes already patented and included in the state of the art within the
meaning of Article 16 of this Decision may not be the subject of new patents on the sole ground of
having been put to a use different from that originally contemplated by the initial patent.”
Legislation and other documents of the Andean Community can be found on its website, at
www.comunidadandina.org.
In the same sense, The Patents Act (1970) of India, provides:
“Section 3 The following are not inventions within the meaning of this Act,—
29
leads bioprospectors to select plants for collection and further analysis—this is what
Miller refers to as “prescreen.”123 In these cases there is no visible link between the final
product and the initial lead. The invention consists of identifying the useful components
and assessing their efficacy (frequently the identified components are useful for purposes
other than those known to the shaman124). The shaman, who gave the hint and eventually
supplied the samples of the resources to the bioprospector, can be deemed instrumental to
the final output of the inventive activity, but he is not a co-inventor and possibly—
because of the lack of that visible link—he would have a very hard time to identify his
contribution in the claimed invention. The Requirement, accompanied with effective and
deterrent sanctions, becomes a crucial tool to obtain compensation from the unauthorized
use of TK.
Let us now look at how countries have established the requirement in national or
regional legislation. But, first, a few preliminary points on the true nature of the
Requirement are necessary.
In the first place, the Requirement is undoubtedly a formal one, as
opposed to a substantive requirement.125 Substantive requirements are those that concern
the nature of the invention itself. Substantive, therefore, are the elements of novelty, nonobviousness and utility. Those three elements are not only substantive requirements but
also substantive conditions of patentability, because the failure to meet them is
sanctioned with either the rejection of the patent application or, if a posteriori, with the
invalidity of the patent.126 Another substantive requirement—and which is not a
substantive condition—is the unity of invention. In general, the failure to meet this
requirement, if detected during the examination of the patent application, causes the
patent application to be divided, not rejected. If detected after the patent is granted, the
patent is preserved.127
In contrast, formal requirements are those that concern the form in which the
invention is submitted to prosecution. The main formal requirement—and which is
indeed a formal condition, because it is mandatory and therefore failure to comply with it
“(d) the mere discovery of any new property of new use for a known substance or of the mere use
of a known process, machine or apparatus unless such known process results in a new product or
employs at least one new reactant.”
Indian statutes on industrial property can be found on Indian patent office’s website, at
www.patentoffice.nic.in.
123
See supra note 76 and accompanying text.
124
The anticancer properties of the rose periwinkle, from Madagascar, from which vinblastine and
vincristine are produced, came as a surprise to researchers. Initially, the rose periwinkle called the attention
because of its use by people in the Philippines and the Caribbean to lower blood sugar. See Swerdlow,
supra note 77, at 104. Another example can be found in Reissue Patent No. 18,667, which covered an
extract of cube roots with vermifuge and insecticide properties. But the inventor had learned about the
active ingredient of that plant from observing Peruvian Indigenous peoples using powder made of ground
cube roots for catching fish. See supra note 120.
125
The United States delegation, at the third session of the Committee, said that the Requirement, in order
to be TRIPS-compatible, “could not be a substantive legal requirement for patentability.” This was
obviously a conceptual mistake. See Report of the third session, supra note 13, at paragraph 71.
126
35 U.S.C. 282(2).
127
35 U.S.C. 121.
30
will cause the patent application to be denied—is disclosure of the invention, which must
be enabling.128 This formal condition is, actually, a consequence of the three substantive
conditions above listed: it is by reading specifications that disclose the invention in an
enabling manner that patent examiners make decisions on whether they find the invention
new, non-obvious and useful. Other formal requirements that may constitute conditions
of patentability are those that relate to the evidence of ownership: a document assigning
the right to apply for the patent to the inventor’s employer, for example, or a statement
that the applicant is the true inventor. This formal condition is explained by the fact that
some patent laws retain the principle that patent rights are originally vested in the first
and true inventors. Assignees are only entitled to acquire patent rights as a result of a
transfer of original rights. Patent offices generally do not examine the issue of
inventorship, because their role is more a technical one, but some evidence is generally
required that identifies those upon whom the law vests the patent rights (or their
legitimate expectations).129 A third category of formal requirements is evidence of the
payment of fees to patent offices. There are two categories of fees: procurement fees, that
patent applicants must pay to patent offices for services rendered, and maintenance fees.
Procurement fees are not referred to either in the TRIPS Agreement or in the Paris
Convention, but they stem from customary administrative practices and are set as an
obligation by the Patent Cooperation Treaty (Articles 3(4)(iv) and 4(2), 39(1)) and its
Regulations (see e.g. Rules 14, 15 and 16).130 They are, therefore, authorized by Article
1.1 of the TRIPS Agreement.131 Maintenance fees, in contrast, are expressly mentioned
by Article 5bis of the Paris Convention. Article 5bis(2) even obliges Paris Union Members
“to provide for the restoration of patents which have lapsed by reason of non-payment of
fees,” which, a contrario, means that Paris Union Members (as well as WTO Members,
in the light of Article 2.1 of the TRIPS Agreement) may indeed provide for the lapse of
patents on grounds of non-payment of maintenance fees.
Evidence concerning the origin of genetic resources and prior informed consent of
TK holders is a formal requirement in the sense that it does not concern the nature of the
invention but the manner in which the application is presented to the patent office. The
128
The United States Patent and Trademark Office (USPTO) understands that the obligation to disclose
(that is, to describe) the invention and the obligation to do such disclosure in an enabling manner (that is, in
a manner that is enough to instruct a person with normal skills in the field to reproduce the invention) are
actually two formal conditions of patentability. But they are not: the “enabling” factor is a qualification of
the required disclosure. It is even possible (in narrow and exceptional circumstances) to conceive a
disclosure that is not enabling: for instance, in the life sciences field, patent laws are more tolerant with
simply “reasonable descriptions” given the practical impossibility of fully describing living beings—and
that is why in some areas of technology it is required that the description be accompanied with a sample of
the claimed living being, such as microorganisms (see the Budapest Treaty on the International Recognition
of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28,
1977, and amended on September 26, 1980; the Budapest Treaty is administered by the International
Bureau of WIPO). But an enabling disclosure that does not disclose the invention is inconceivable. For the
disclosure to be enabling, it must disclose the invention in the first place.
129
See infra note 227 and accompanying text.
130
The PCT and its Regulations are naturally concerned with fees due in the course of the international
phase of patent applications. But Article 39(1)(a) of the PCT makes explicit reference to national fees.
131
Article 1.1 of the TRIPS Agreement reads:
“[...] Members shall be free to determine the appropriate method of implementing the provisions
of this Agreement within their own legal system and practice.”
31
Requirement may assume different forms according to the specific nature of the TK
involved. When the knowledge about the origin of the genetic resource or about the TK
used in the invention is essential for understanding the working of the claimed invention,
it becomes an element of the enabling disclosure. The Requirement, in such
circumstances, is already imposed by current international and national patent law as a
formal condition of patentability.132 except for the evidence of TK holders’ prior
informed consent. TK holders’ authorization to use their knowledge and/or genetic
resources incorporating their knowledge, indeed, is not a technical element, but an
exclusively legal one. A patent application may, theoretically, describe a piece of TK
without the need for identifying its holder(s). But when TK is incorporated into the
claimed invention as an inventive concept in its own right (such as in the turmeric case),
then the identification of the TK holder(s) and evidence of their prior informed consent
become an important element for the attribution of inventorship and/or ownership. But, to
that extent, the Requirement has already been set by current patent law. However,
generally the Requirement does not fit those characteristics, and its qualification as a
condition of patentability or not does not naturally stem from existing international
standards but results from sui generis legislation that is being gradually introduced by
countries. In the next subsection we will look briefly at that legislation and its
consistency with international obligations.
In the second place, it is not certain that the costs that arise from the
implementation of the Requirement in the extended manner as described above
correspond to the benefits society is able to extract therefrom.133 On the one hand, when
biosquatting is the result of the claim of private property rights in knowledge that is in the
public domain (as in the turmeric case) in foreign countries (which may have legislation
that is more open to patentability in the biotechnology field), the losers of unwarranted
claims are not the TK holders, but the granting countries’ society at large. As a matter of
law, TK in the public domain can be used by anyone for free. The squatting of TK
permits biosquatters to put a higher price on products and services that otherwise would
be sold for less. Moreover, unduly patented TK cannot be incorporated to products and
services of squatters’ competitors, thus blocking the development of competing
derivatives. But squatting of TK in other countries does not prevent TK holders to
continue using it in their daily life. When the preparation of TK databases has no other
purpose than opposing to patent and trademark claims, and considering the high costs that
such preparation entails, it may well represent a waste of resources. On the other hand,
when biosquatters claim property rights in TK which remains under the private control of
132
Of course, this is true as far as information concerning the genetic resource or associated TK is
concerned. Evidence of prior informed consent is not relevant for enabling disclosure purposes.
133
To my best knowledge, the Requirement has never been applied in practice, that is, no patent application
has been rejected and no patent has been invalidated because of failure to comply with the requirement.
However, where the Requirement is a condition of validity of patent rights, a situation of legal insecurity
stems from its imposition because it may be alleged by third parties or the patent office ex officio at any
time. To provide for legal security of patent rights is one of the essential obligations under the TRIPS
Agreement, as the Panel and the Appellate Body held in India—Patent Protection for Pharmaceutical and
Agricultural and Chemical Products, Report of the Panel and Appellate Body adopted on January 16, 1998
(WT/DS50/R, of September 5, 1997, and WT/DS50/AB/R, of December 19, 1997). For a discussion of the
importance of legal security and predictability in the TRIPS Agreement, see Carvalho, supra note 81, at 60
and 290.
32
Indigenous peoples and traditional communities, the enactment of measures of positive
protection may be much more effective tools to correct and repress situations of
misappropriation. In that event, TK holders will be in a position of enforcing their
rights—rights which are recognized, if not formalized, by law. Enforcement of IP rights
may not be a very simple and cost-free issue, but it is always more effective than
challenging the validity of patents based on traditions (which are frequently
undocumented) and customary law.
Thirdly, an undue burden imposed on patent applications may create
serious difficulties to the management of national and international patent systems and
deviate the focus of the whole patent system from contributing to the progress of useful
arts to the acknowledgement of third parties’ stakes in claimed inventions. As explained
elsewhere, “[t]he matter is that patents are the recognition of an inventive activity, and
not of the manner in which that activity has been pursued. So, if an inventor has access to
a genetic resource in a way that contradicts the legislation and the national policy of a
given country, sanctions may be imposed upon the inventor. But the result of his mental
activity of inventing, although by using that genetic resource, should nonetheless be
entitled to the patent. The genetic resource is the raw material, the support for the
invention to spring out from the mind of the inventor. But the invention and its material
support or raw material should be clearly distinguished. An inventor steals a sample of a
steel plate that contains a new composition. He studies that composition, reverses
engineer the formula and improves it, thus obtaining a new and improved plate. Is his
invention patentable? Yes. Probably the inventor will enjoy from the benefits of his
patent, if any, in jail, but he will be nonetheless a patent owner. Under the unclean hands
doctrine, it seems that the inventor would not be able to enforce his patent rights against
infringers (including the owner of the original plate) until he sorts out matters arising out
from his illegal act. But his patent will be preserved because it simple acknowledges that
the inventor succeeded in developing an invention that is new, non-obvious and useful.
The same can be said with regard to the unauthorized use of traditional knowledge. If an
inventor makes a new invention improving on another invention that has been patented
by another person but does not include it in the claims, he is indisputably entitled to a
new patent. He may be liable for using the original invention in the process of developing
a new one, if the development caused him to practice one of the acts that are within the
exclusive rights of the patent, but he is entitled to have the output of his autonomous
inventive activity acknowledge as such by a patent. If the second patent cannot be
exploited without infringing the first, then the rules on compulsory licensing of
dependent patents may apply (Article 31(l) of the TRIPS Agreement). But the two
inventive activities are deemed independent. For this reason, patent licensing agreements
do not require that the licensees, when filing patent applications for inventions directly or
indirectly derived from the licensing contract, inform that those inventions were
developed with ‘the prior informed consent’ of the licensor. Such a clause could even be
seen as an abuse of rights by the licensor. Mutatis mutandis this applies to traditional
knowledge. The use of traditional knowledge on the use of a certain plant for a medicinal
purpose may constitute a lead for an inventor to identify and isolate a new chemical
compound, with the purpose of developing a new pharmaceutical product. The traditional
knowledge holder is not a co-inventor of the pharmaceutical product—his sole
33
contribution was to show that plant and describe its medicinal properties to some
bioprospector. The misuse of such information may not undermine the right of the
inventor to obtain a patent in the new pharmaceutical product. In a nutshell, patents are
not certificates of good behavior. Patents are certificates of inventive behavior.”134
Actually, not all costs arising from the implementation of the CBD can be
internalized by society if they are not kept at a reasonable level.135
Fourth, shamans who supply relevant, if not crucial, genetic material may
provide important support for the activities of research and development of
pharmaceutical and biotechnological companies, but they are not co-inventors of the
products and processes obtained as ultimate derivatives of those genetic resources. This
issue was already addressed by U.S. courts in at least two cases: Moore v. The Regents of
the University of California (Supreme Court of California, 1990)136 and The Regents of
the University of California v. Synbiotics Corp. (District Court for the Southern District
of California, 1994).137
In Moore, the Supreme Court of California held that the plaintiff, from whom the
spleen had been extracted and the respective cells been used for medical research, which
led to a patented cell line,138 had a cause of action against the five defendants (the
physician, the owners and operators of the University’s hospital, a researcher, a
biotechnological institute and a pharmaceutical company) for breach of the physician’s
disclosure obligations, but not for conversion.139 One of the reasons that led the Court to
refuse the allegation of conversion was that “the subject matter of the Regent’s patent—
the patented cell line and the products derived from it—cannot be Moore’s property. This
is because the patented cell line is both factually and legally distinct from the cells taken
from Moore’s body. Federal law permits the patenting of organisms that represent the
product of ‘human ingenuity,’ but not naturally occuring organisms. [citation omitted]
Human cell lines are patentable because ‘[l]ong-term adaptation and growth of human
tissues and cells in culture is difficult—often considered an art […],” and the probability
of success is low. [citation omitted] It is this inventive effort that patent law rewards, not
the discovery of naturally occurring raw materials.”140
134
Carvalho, supra note 81, at 159-160.
See Cannell, supra note 80: “Bioprospecting is not always quite as immediately lucrative as some have
been led to believe and nations (such as the Philippines) that are imposing strict costs and conditions on
those who wish to carry out bioprospecting may be rendering their biodiversity too expensive to be of any
use.” See also supra note 74 and accompanying text.
136
Moore v. The Regents of the University of California, 51 Cal. 3d 120 (Sup. Court of Cal., 1990), cert.
denied, 499 U.S. 936 (1991).
137
The Regents of the University of California v. Synbiotics Corp., 849 F.Supp. 740 (S.D.C., 1994).
138
Moore, supra note 136, at 125-127.
139
Id. at 125. Conversion is “[a]n unauthorized assumption and exercise of the right of ownership over
goods or personal chattels belonging to another, to the alteration of their condition or the exclusion of the
owner’s rights. Any unauthorized act which deprives an owner of his property permanently or for an
indefinite time. [...].” BLACK’S LAW DICTIONARY (abridged 6th ed., 1991).
140
Id. at 159-160. In his dissent, Judge Mosk acknowledged that, as a matter of law, suppliers of materials
cannot be seen as joint inventors because of the particular nature of their contributions. He suggested,
however, that as an analogy, the plaintiff could be entitled to claim inventorship. “A patent is not a license
135
34
In Synbiotics, the owner of several cats, because of some symptoms they were
showing, had taken them for being blood tested, along with the written observations of
the cats’ symptoms.141 From the blood samples, scientists were able to isolate the virus
(similar to the human AIDS virus), and subsequently filed for and obtained two patents.
The District Judge refused to see an inventive nature in the act of bringing the cats and
calling the scientists’ attention to the cats’ symptoms. Because gene and chemical-related
inventions are conceived only when the inventor “has reduced the invention to practice
through a successful experiment,” the cats owner could not be seen as an inventor. “As a
matter of law”, the District Court said, “only those persons who contributed to the acts
and events that resulted in the conception and reduction to practice are properly
considered the inventors of the […] patents.”142 And once the cats owner had not been
present and had not participated in any way in the events of identifying and isolating the
virus, she was not a co-inventor.143
The same reasoning can be applied to most (but not to all) shamans’ contributions
to patented inventions. Their contributions generally consist of indicating a specific use
of a specific resource and of samples of the material. Based on that information,
researchers will be able: to identify the bioactive ingredient that causes the positive action
identified by the shaman; to assess and describe the properties of that ingredient; to
isolate and to purify that ingredient (and, eventually to synthesize it); and to transform it
into a final product. Obviously, the shaman has not participated in any of these activities.
Therefore, he is not one of the inventors.144 The provision of resources, as crucial as they
may be for the inventive output, is not inventive per se.
to defraud,” he said. “I am aware that ‘patients and research subjects who contribute cells to research will
not be considered inventors.’ [citation omitted] Nor is such a person, strictly speaking, a ‘joint inventor’
within the meaning of the term in federal law. [citation omitted] But he does fall within the spirit of the law
[…]. Although a patient who donates cells does not fit squarely within the definition of a joint inventor, the
policy reasons that inform joint inventor patents should apply to cell donors.” Id. at 168-169. The problem
with Judge Mosk’s analogy is that patents are not certificates of fraud-free conduct. As said above, patents
have not been devised to certify that the inventor has a good character. They have been devised as
certificates that someone with an inventive character has reached an inventive outcome. Furthermore, Judge
Mosk’s analogy would create serious problems of proportionality: what proportion of the patent rights
should go to those who contributed with the materials? If it is accepted that without them the invention
would not have arisen, then they might be entitled to the whole patent (the understanding being that the
uniqueness of the invention lied in the uniqueness of the material—therefore, any other scientist might very
well, if in possession of the same material, develop a similar invention). Judge Mosk, ultimately, was
proposing a complete reformulation of the patent system, so that all sorts of contributions, in addition to the
inventive contributions, be recognized. Stretching his reasoning, where an inventor failed to pay the rent of
the premises where he did his research, the landlord might as well ask for a share in the ownership of the
invention.
141
Synbiotics, supra note 137, at 742.
142
Id.
143
Id. Because she was not a co-inventor, she had no vested rights in the patent title, and therefore she had
no standing for licensing the patents to a third part—which was actually a patent infringer, not a patent
licensee.
144
But, on the other hand, based on that same information, researchers may have tested and confirmed that
resource (or a bioactive ingredient in the resource) had effective results when used in the manner indicated
by the shaman (such as the use of a plant as an antibiotic). If a patent is applied for the use of that
ingredient, the shaman may rightfully claim that he is indeed an inventor (or a joint inventor, if the
35
Therefore, the Requirement is not relevant for detecting inventorship—and,
consequently, ownership—of the patented invention. It seeks only to establish a
contractual interest in the commercial gains of an invention derived from genetic
resources, in the event these resources have been extracted from a territory where there is
a duty to obtain formal consent in order to acquire legitimate access. The Requirement,
therefore, is not ancillary to patent law—it is ancillary to administrative and/or contract
law.
(i)
Legislative standards on the duty to disclose the origin of genetic
resources and prove TK holders’ prior informed consent in IP applications.
Several countries have taken legislative measures aiming at obliging patent
applicants to comply with the Requirement.145 We can classify those measures in two
different sort of categories: (1) measures may be classified as to the consequences of
failure of compliance: under some statutes, failure to comply will cause the rejection of
the patent application and the invalidity of the patent, if granted; under other statutes, the
Requirement is not a condition for the grant of the right; (2) measures may apply in the
field of patents or they may extend to all industrial property rights.
(1.1)
Countries that make the Requirement a formal condition of patentability
In this category, we can identify the statutes of Brazil,146 the Member States of the
Andean Community (Bolivia, Colombia, Ecuador, Peru and Venezuela), 147 Costa Rica,148
Egypt,149 and India.150
researchers have generated some additional concept to the shaman’s original invention), because in this
event he was indeed the person who conceived the technical solution for the problem. But when the shaman
is the true inventor, he should be identified as such under current patent law. The Requirement, therefore,
does not create a new obligation in this narrow sense.
145
The Requirement has invariably been applied in the field of TK stricto sensu because, as it corresponds
to the industrial property side of TK, the recognition of rights depends on a registration procedure. When it
comes to expressions of TK, protection being mostly informal, the granting of rights is not dependent on
any formal requirement. Eventually, it would be possible to impose the Requirement as a condition of
enforceability of rights in expressions of TK, as it has been previously suggested for TK stricto sensu. See
infra Section III(b)(v).
146
Provisional Measure No. 2.186-16, of August 23, 2001, Article 31:
“The grant of industrial property rights by the competent bodies for a process or product obtained
using samples of components of the genetic heritage is contingent on the observance of this
Provisional Measure, the applicant being obliged to specify the origin of the genetic material and
the associated traditional knowledge, as the case may be.”
The complete text of this statute can be found in Annex IV of document WIPO/GRTKF/IC/5/17, of
February 28, 2003.
147
Decision 391, of July 2, 1996, on the Common Regime on Access to Genetic Resources:
“Article 16. All Access procedures shall require the presentation, admittance, publication and
approval of an application, the signing of a contract, the issuing and publication of the
corresponding Resolution and the declarative registration of the acts connected with the access.
“Article 26. The procedure starts with the presentation to the Competent National Authority of an
application for access which should contain:
“(b) Identification of the supplier of the genetic and biological resources and their by-products or
of the associated intangible component.
36
“Article 35. When access is requested to genetic resources or they by-products with an intangible
component, the access contract shall incorporate, as an integral part of that contract, an annex
stipulating the fair and equitable distribution of the profits from use of that component.
“Complementary provisions.
“Second. The Member Countries shall not acknowledge rights, including intellectual property
rights, over genetic resources, by-products or synthesized products and associated intangible
components, that were obtained or developed through an access activity that does not comply
wuth the provisions of this Decision.
“Furthermore, the Member Country affected may request nullification and bring such actions as
are appropriate in countries that have conferred rights or granted protective title documents.”
Decision 486 of the Andean Community, of September 14, 2000, on the Common Intellectual Property
Regime:
“Article 3. The Member Countries shall ensure that the protection granted to intellectual property
elements shall be accorded while safeguarding and respecting their biological and genetic heritage,
together with the traditional knowledge of their indigenous, African American, or local
communities. As a result, the granting of patents on inventions that have been developed on the
basis of material obtained from that heritage or that knowledge shall be subordinated to the
acquisition of that material in accordance with international, Andean Community, and national
law.
“Article 75. The competent national authority may, either ex officio or at the request of a party,
and at any time, declare a patent null and void, where:
“(g) when pertinent, the products or processes in respect of which the patent is being filed have
been obtained and developed on the basis of genetic resources or their byproducts originating in
one of the Member Countries, if the applicant failed to submit a copy of the contract for access to
that genetic material;
“(h) when pertinent, the products or processes whose protection is being requested have been
obtained or developed on the basis of traditional knowledge belonging to Indigenous, African
American, or local communities in the Member Countries, if the applicant has failed to submit a
copy of the document certifying the existence of a license or authorization for use of that
knowledge originating in any one of the member Countries [...].”
Non-official English versions of the relevant legislation of the Andean Community are available on the
WIPO’s website, as annexes to document WIPO/GRTKF/IC/1/11, of May 1, 2001.
148
Article 81 of the Biodiversity Law of Costa Rica (Law No. 7,788, of 1988) establishes that:
“Both the National Seed Office and the Registers of Intellectual and Industrial Property shall
consult with the Technical Office of CONAGEBIO before granting intellectual or industrial
property protection to innovations involving elements of biodiversity. The certificate of origin
issued by the Technical Office of the Commission and the prior informed consent shall be
provided. Justified opposition from the Technical Office will prohibit registration of a patent or
protection for the innovation.”
149
Law No. 82/2002 (published in the Official Journal of June 2, 2002), Article 13, paragraph 3:
“If the [patent] application includes an invention whose subject matter is plants or animals, known
regular medicament, agricultural, industrial, handicraft, cultural heritage, or environmental, the
inventor must have obtained them from a legitimate source.”
150
The Patents Act, 1970, as amended by The Patents (Amendment) Act of June 25, 2002, reads:
“Section 10(4) Every complete specification shall—
“(d) be accompanied by an abstract to provide technical information on the invention.
“Provided that—
“(ii) if the applicant mentions a biological material in the specification which
may not be described [...] the application shall be completed [...] by fulfilling the
following conditions, namely:—
“(D) disclose the source and geographical origin of the biological
material in the specification, when used in an invention.
“Section 25(1) At any time within four months from the date of advertisement of the acceptance
[...] any person may give notice to the Controller of opposition to the grant of the patent on any of
the following grounds, namely:—
37
(1.2)
Countries that impose the Requirement but not as a formal condition of
patentability
In this category are the People’s Republic of China151 and the 15 Members of the
European Community.152
(2.2.) Countries that apply the Requirement in the field of patents only
Examples of countries in which the Requirement is confined to patents are
Egypt, India,154 Peru,155and the European Community.156
153
“(j) that the complete specification does not disclose or wrongly mentions the source of
geographical origin of biological material used for the invention.
“Section 64(1) Subject to the provisions contained in this Act, whether granted before or after the
commencement of this Act, may, on the petition of any person interested or of the Central
Government or on a counter-claim in a suit for infringement of the patent, be revoked by the High
Court on any of the following grounds, that is to say—
“(p) that the complete specification does not disclose or wrongly mentions the source or
geographical origin of biological material used for the invention.”
151
In its responses to a questionnaire circulated by WIPO in 1999 on Member States’ protection of
biotechnological inventions, China answered that, according to Article 4 of the Interim Measures for the
Administration of Human Genetic Resources, “the State adopts a reporting and registration system on
important pedigrees and genetic resources in specific regions.” See Information Provided by WIPO
Member States Concerning Provisions to Ensure the Recording of Some Contributions to Inventions,
document WIPO/IP/GR/00/3 Rev.1, of April 14, 2000, Addendum, at 1. The delegation of China added that
the requirement to identify the origin of human genetic material is not a condition of patentability, “[b]ut
failure in meeting the requirements concerned will be punished according to administrative laws and
regulations.” Id. at 4.
152
Recital 27 of Directive 98/44/EC of the European Parliament and the Council of July 6, 1998, on the
legal protection of biotechnological inventions:
“Whereas if an invention is based on biological material of plant or animal origin or if it uses such
material, the patent application should, where appropriate, include information on the geographical
origin of such material, if known; whereas this is without prejudice to the processing of patent
applications or the validity arising from granted patents.”
The EC explained to the WIPO Intergovernmental Committee that this recital “must be regarded as being
an encouragement to mention the geographical origin of biological material in the patent application, in the
lines indicated by Articles 16(5) and 11 of the CBD. However, the provision information is not an
obligation under EU law.” See Traditional Knowledge and Intellectual Property Rights—Document
Submitted by the European Community and its Member States, document WIPO/GRTKF/IC/3/16, of June
14, 2002, Annex, at 4.
153
See supra note 149.
154
See supra note 150.
155
As a Member of the Andean Community, Peru is also bound by supranational, regional legislation that
extends the Requirement (as a formal condition of obtaining IP rights) to fields other than patents.
156
The EC Directive on Biotechnological Inventions not only is limited to patents but it is also limited to
patents in the biotechnological sector. Because Recital 27 of the Directive’s Preamble it is not a mandatory
provision but a simple recommendation, EC Members are not obliged to follow it. However, as a
recommendation that applies to patents in a single technological field, it may be deemed not as a
straightforward violation of Article 27.1 of the TRIPS Agreement—as it would be, if instead of a
recommendation, Recital 27 established an obligation—, but, once the moratorium is lifted, it can be seen
as a non-violation that encourages EC Members to impair or nullify benefits granted by Article 27.1 of the
TRIPS Agreement to WTO Members. For an explanation of non-violations in the field of patents as well as
of the moratorium, see Carvalho, supra note 81, at 283-286.
38
(2.2.) Countries that extend the Requirement to other areas of industrial
property law
The Andean Community,157 Brazil158 and Costa Rica159 have adopted legislation
extending the Requirement to areas beyond patent law, such as plant breeders rights and,
where it applies, utility model protection.
(ii)
the Requirement as a condition of validity of IP rights and applicable
international law
(1)
The TRIPS Agreement
Three provisions in the TRIPS Agreement are relevant for assessing to what
extent WTO Members may establish formal requirements (such as the Requirement) as a
condition of patentability.160 Firstly, under Article 29.1, WTO Members are obliged to
impose on patent applicants the duty to disclose the invention. In addition, WTO
Members are authorized to impose on patent applicants the duty to identify the best mode
of carrying out the invention.161
The second provision is Article 32.162 A question may be raised whether WTO
Members may revoke patents on grounds of violation of rules on access to genetic
resources and/or failure to obtain informed authorization by TK holders. Even though
Article 32 is silent on this issue, it seems that there are sufficient elements to conclude
that the general understanding of WTO Members, with the exception of India, is that they
may not.163
The third provision is Article 62.1, which provides:
“Members may require, as a condition of the acquisition or maintenance of the
intellectual property rights provided for under Section 2 through 6 of Part II,
157
See supra note 147.
See supra note 146.
159
See supra note 148.
160
The TRIPS provisions on substantive conditions of patentability are Article 27.1 and 70.8(b).
161
Article 29.1 of the TRIPS Agreement reads:
“Members shall require that an applicant for a patent shall disclose the invention in a manner
sufficiently clear and complete for the invention to be carried out by a person skilled in the art and
may require the applicant to indicate the best mode for carrying out the invention known to the
inventor at the filing date or, where priority is claimed, at the priority date of the application.”
162
Article 32 reads:
“An opportunity for judicial review of any decision to revoke or forfeit a patent shall be
available.”
163
See Carvalho, supra note 81, at 252-256. Section 66 of the Indian Patents Act, of 1970, reads:
“Where the Central Government is of opinion that a patent or the mode in which it is exercised is
mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an
opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the
patent shall be deemed to be revoked.”
Section 66 was maintained by The Patents (Amendment) Act, 2002, of June 25, 2002.
158
39
compliance with reasonable procedures and formalities. Such procedures and
formalities shall be consistent with the provisions of this Agreement.”
Formal conditions that are not covered by Article 29 must be, therefore, a)
reasonable and b) consistent with the provisions of the TRIPS Agreement. The definition
of “reasonableness” is not self-evident. Because the TRIPS Agreement “occupies a
relatively self-contained, sui generis status in the WTO Agreement”, as the Panel in India
— Patent Protection for Pharmaceutical and Agricultural Chemical Products164 put it,
that is, as the TRIPS Agreement deals with intellectual property in its trade-related
aspects only, one might be led to the conclusion that reasonable are those formal
conditions that help patent offices assess whether the three substantive requirements of
Article 27.1 have been met.
Reasonable are also formal conditions that help patent offices and/or courts to
identify the inventors and or their successors in title. This issue comprises two different
aspects: one has to do with the identification of the inventor; the other, the identification
of the owner.165 It is generally understood that those persons who contributed with their
creative minds to the inventive solution of a given technical problem are entitled to the
patent. They are the original owners of the idea, and the patent cannot be attributed to
third persons if they do not receive it in consequence of a transfer of title. In the U.S., for
example, a patent application shall be made primarily by the inventor or by a person
authorized by the inventor. Only exceptionally may the application be filed by other than
the inventor.166 In other countries, the application may be filed by other person than the
inventor (his/her employer, for example), provided that the applicant provided evidence
of his/her legal right of succession (a labour contract, for example, or a statement by the
inventor in that sense).167 The inventor’s right to the patent is both a material and a moral
right, in the sense that the inventor has not only vested rights to acquire property in the
fruit of his/her work, but also to be publicly acknowledged as such. 35 U.S.C. 111 deals
with inventors’ material rights. But where the Paris Convention says that “[t]he inventor
shall have the right to be mentioned as such in the patent” (Article 4ter), it is recognizing
inventors’ moral rights.168
164
WTO document WT/DS50/R, of September 5, 1997, Panel Report, as modified by the Appellate Body
Report, adopted on January 16, 1998, paragraph 7.19.
165
Because there is a distinction between the owner and the inventor (although they may be the same
person), the Patent Cooperation Treaty (PCT), in its Article 4 (“The Request”) has two separate subsections
concerning the identification of the applicant (Article 4(1)(iii)) and the identification of the inventor
(Article 4(1)(v)). Subsection 1.4 states that
“Failure to indicate in the request the name and other prescribed data concerning the inventor shall
have no consequence in any designated State whose national law requires the furnishing of the
said indications but allows that they be furnished at a time later than that of the filing of a national
application. Failure to furnish the said indications in a separate notice shall have no consequence
in any designated State whose national law does not require the furnishing of the said indications.”
Significantly, there is no similar provision in the PCT as regards the applicant.
166
35 U.S.C. 111 and 118.
167
See, e.g., Article 6.2 of the Brazil’s Industrial Property Law No. 9.279, of May 14, 1996, which
authorizes those who, by means of a labor contract or a services contract, acquired the rights from the
inventor, to file for patent applications on their own behalf.
168
Article 9.1 of the TRIPS Agreement excludes protection of authors’ moral rights from the scope of the
Agreement—the reason being that moral rights are not trade-related. One might wonder then why the
40
The identification of the owner, in contrast with the identification of the inventor,
is a necessary element for providing legal security. Formally recognized property rights
must have their respective owners duly identified for the many social purposes that stem
from property such as levying taxes, establishing rights to inheritance and providing
collateral. Society at large must know which technology is available for use without the
need for seeking an authorization, so as to avoid infringement. In some cases, as is the
case of the U.S. requirement to disclose the source of government funding, a patent may
give rise to a public interest not only as far as government use is concerned, but also as
regards the possibility of compulsory licenses (march-in rights).169 The correct
identification of the patent owner is therefore essential for ensuring legal security and
predictability in legal relations involving patent rights. This is one of the most crucial
aspects of patent law (as well as of property rights in general). For that reason, the PCT,
as explained above,170 establishes that the identification of the applicant is one of the
mandatory elements of the patent request (Article 4.1(iii)). Likewise, the draft Standard
Patent Law Treaty (SPLT), in Article 4, says that the right to a patent shall belong to the
inventor or to the successor in title of the inventor.171
In view of the above, it seems to follow that requiring compliance with
procedures aiming to clearly identify the owner of the patent as well as other persons that
may have proprietary interests in the patent is within the scope of “reasonable procedures
and formalities,” under Article 62.1 of the TRIPS Agreement.
The same applies to requirements concerning the payment of procurement or
maintenance fees, provided these are consistent with the provisions of the TRIPS
Agreement—they may not discriminate, for example, against citizens of other WTO
Members. As explained above, both procurement and maintenance fees are accepted by
TRIPS Agreement has not a similar provision concerning inventors’ moral rights, because in its absence,
and under Article 2.1 of the TRIPS Agreement, WTO Members are obliged to comply with Article 4 ter of
the Paris Convention. The reason is that, as the WIPO Secretariat explained in document
WIPO/GRTKF/IC/3/7, supra note 13, “[…] patent law is not necessarily about protecting inventors, but
about appropriating inventions. Likewise, copyright, especially in a TRIPS-context, is not about protecting
authors, but rather about appropriating works. In other words, the protection of individual rights of authors
and inventors in the field of intellectual property has developed in the direction of the adoption and
operation of national standards, particularly through contractual arrangements and labour standards, rather
than through the establishment of international standards. For example, many national patent laws have
exceptionally acknowledged that where the inventor cannot be identified or he/she does not want to be
identified as such, national patent offices should not be prevented from issuing the patent letter, in spite of
the provisions of Article 4ter of the Paris Convention.” Id. at 12. As Bodenhausen explains, because
inventors have been accorded the right, and only the right, to be mentioned “as such” (that is, as inventors,
not as owners) in the patent, national law may provide for their right to waive it. G.H.C. BODENHAUSEN,
GUIDE TO THE APPLICATION OF THE PARIS CONVENTION FOR THE PROTECTION OF INDUSTRIAL PROPERTY
(WIPO, 1991, reprinted), at 64. That possibility does not exist under Article 6 bis of the Berne Convention—
hence the need for Article 9.1 of the TRIPS Agreement.
169
See infra Section III(b)(iii).
170
See supra note 164.
171
The draft Substantive Patent Law Treaty (SPLT) is the subject matter of discussions in the WIPO
Standing Committee on the Law of Patents, which held its eighth session on November 25 to 29, 2002. See,
e.g., document SCP/8/2, of October 16, 2002.
41
the TRIPS Agreement, either as elements of WTO Members’ national legal systems and
practices (Article 1.1) or as Paris Convention obligations (Article 2.1).
In conclusion, formal conditions that (a) have nothing to do with helping patent
examiners to assess novelty, inventiveness and susceptibility of industrial application, (b)
have no connection with inventorship and, consequently, ownership, and (c) are not
aimed at evidencing the payment of fees are beyond the scope of the TRIPS Agreement
and, ultimately, TRIPS inconsistent.172
It is probably because of fear to infringe TRIPS provisions that biodiversity-rich
developing countries have actively pursued in the WTO an amendment either to Article
27.3(b) or to Article 29, so as to explicitly allow for that condition to be included in
national laws.173 Actually, requiring the origin of materials or the consent of persons
whose knowledge has been directly or indirectly used in the development of the invention
would be TRIPS-consistent only if, besides being reasonable for the purposes of Article
62, the requirement extended to all fields of technology. To confine the requirement to
the area of biotechnological inventions is an act of discrimination as to the field of
technology, under Article 27.1.
The need for implementing Article 15 of the CBD is no excuse, because Article
27.1 admits no exceptions other than those it specifically identifies.174 Moreover, the
CBD not being a WTO Agreement, Article XX(d) of GATT 1994 would provide no
justification to discriminate against a field of technology in violation of the provisions of
an annex to the WTO Agreement. Actually, the WTO being an Agreement about customs
barriers, the WTO has Members that are not Contracting Parties to the CBD. It would not
be reasonable to impose on those Members an obligation they are not bound—and
eventually they wish not to be bound—to observe.175
172
The conflict between the Requirement (as a condition of patentability) and the TRIPS Agreement was
the subject of an exchange of views by WIPO Members at the Committee’s third session. The United States
expressed the view that such a Requirement does not keep with the TRIPS Agreement (Report of the third
session, supra note 13, at paragraph 71). The Dominican Republic (id. at paragraph 70), Sri Lanka (id. at
paragraph 75), Egypt and Sudan (id. at paragraph 76) expressed an opposed understanding.
173
See infra notes 207 et seq. and accompanying text.
174
As it will be explained below, actually it is CBD Contracting Parties that are under the obligation to
respect international agreements on intellectual property, and not the other way around. See infra Section
III(b)(ii)(5).
175
One commentator has expressed his dissent with this view. Dutfield wrote that “[t]here is no compelling
reason at all why the compulsory submission of a document, such as a certificate of origin, would impose
another substantive condition as long as it is not linked to determining the patentability of the invention.
After all examination and renewal fees have to be paid by patent applicants and owners, and TRIPS does
not prevent them merely because they are not mentioned in the Agreement. Similarly, the submission of
documentation attesting to the fact that the applicant had complied with the relevant ABS [access and
benefit sharing] regulations, such as a certificate of origin, would be just another administrative
requirement.” Dutfield, supra note 115, at 921. This line of reasoning is flawed on several grounds. Of
course, there are some aspects of patent law that are not mentioned in the TRIPS Agreement. But one must
distinguish between those aspects that are not mentioned because negotiators thought they were already
implied, and those that negotiators did not mention because of their incompatibility with WTO principles
and rules. As explained above (see supra note 130 and accompanying text), the requirement concerning
evidence of the timely payment of fees is not similar to the Requirement because the obligation to pay
42
In conclusion, WTO Members may adopt the Requirement if they so wish, but
only if it does not constitute a condition for obtaining IP rights which depend on
registration, and provided it is consistent with the provisions of the Agreement, including
Articles 27.1 and 27.2.176
(2)
The UPOV Convention(s)
On the other hand, for those WTO Members that are also Members of the UPOV,
the adoption of the requirement is barred as far as plant varieties are concerned. In fact,
both UPOV 1978 and 1991 texts provide that plant varieties certificates may be annulled
only when the varieties fail to meet the conditions of novelty and distinctness.
Certificates may also be cancelled but only when the varieties fail to meet the conditions
of uniformity or stability as well as the following formal requirements: the breeder failed
to provide the authority with the information, documents or materials deemed necessary
for the maintenance of the variety (namely, its stability); the breeder failed to pay
maintenance fees; the breeder did not propose a suitable denomination to replace the
denomination previously submitted and which has been cancelled after the grant of the
right. These are the cases for annulment and cancellation under the UPOV 1991, Articles
21 and 22.177 Article 10 of the 1978 version contains essentially the same provisions.178
procurement fees was already a legal practice in WTO Members before the entry of the TRIPS Agreement
into force (namely, under PCT provisions), and therefore is adopted under Article 1.1. Furthermore,
payment of maintenance fees is subject to Paris Convention provisions, which have been incorporated by
reference by the TRIPS Agreement. On the other hand, the Requirement is not a matter of “another
substantive condition”, but rather a formal one, because it does not concern the invention itself. And, as far
as formal conditions are concerned, the controlling provisions are Articles 29 and 62. In other words, a
formal condition is acceptable only when it is already covered by a provision of the Agreement (such as
Article 29) or when it is reasonable. Dutfield does not explain why it would be reasonable to adopt a
condition that aims at implementing a treaty that is not part of the WTO. Furthermore, as explained below,
it is not reasonable to adopt a formal condition of patentability that creates tension with the TRIPS
Agreement with the aim of implementing the CBD, when the CBD itself requires that all measures
concerning benefit sharing must comply with international treaties on IP (such as the UPOV Convention,
the PCT and the TRIPS Agreement itself).
176
Under Article 27.1, WTO Members may not restrict the Requirement to biotechnological inventions. It
must be applicable in all fields of technology. Following the approach of Article 27.2 of the TRIPS
Agreement, WTO Members can apply the Requirement where genetic resources have been collected within
national borders only. That is, Members may not require evidence of legitimate access to genetic resources
obtained in the territory of other Members. The same territorial confinement of measures that restrain
patent rights can be found in Article 31(f) of the TRIPS Agreement.
177
Articles 21 and 22 of UPOV 1991 read:
“Article 21 (Nullity of the Breeder’s Right)
“(1) [Reasons of nullity] Each Contracting Party shall declare a breeder’s right granted by it null
and void when it is established
“(i) that the conditions laid down in Articles 6 or 7 were not complied with at the time of
the grant of the breeder’s right,
“(ii) that, where the grant of the breeder’s right has been essentially based upon
information and documents furnished by the breeder, the conditions laid down in Articles
8 or 9 were not complied with at the time of the grant of the breeder’s right, or
“(iii) that the breeder’s right has been granted to a person who is not entitled to it, unless
it is transferred to the person who is so entitled.
43
More importantly, the grounds for annulling or canceling plant varieties certificates may
not be expanded by UPOV Members, under Article 10(4) of UPOV 1978, and Articles
21(2) and 22(2) of UPOV 1991. Which means that a breeder that develops a variety
based upon a plant genetic resource unlawfully collected shall not have the respective
certificate annulled or cancelled by any UPOV Member on the ground that he/she has
failed to comply with national laws concerning access to genetic resources. This view
was affirmed by the UPOV Secretariat in a communication addressed to the TRIPS
Council:
“[…] UPOV is not opposed to the disclosure, per se, of countries of origin or
geographical origin of genetic resources in any way that will facilitate the
examination mentioned above, but could not accept this as an additional condition
of protection.”
“Thus, if a country decides, in the frame of its overall policy, to introduce a
mechanism for the disclosure of countries of origin or geographical origin of
“(2) [Exclusion of other reasons] No breeder’s right shall be declared null and void for reasons
other than those referred to in paragraph (1).
“Article 22 (Cancellation of the Breeder’s Right”
“(1) [Reasons for cancellation]
“(a) Each Contracting Party may cancel a breeder’s right granted by it if it is established that the
conditions laid down in Articles 8 or 9 are no longer fulfilled.
“(b) Furthermore, each Contracting Party may cancel a breeder’s right granted by it if, after being
requested to do so and within a prescribed period,
“(i) the breeder does not provide the authority with the information, documents or
material deemed necessary for verifying the maintenance of the variety,
“(ii) the breeder fails to pay such fees as may be payable to keep his right in force, or
“(iii) the breeder does not propose, where the denomination of the variety is cancelled
after the grant of the right, another suitable denomination.
“(2) [Exclusion of other reasons] No breeder’s right shall be cancelled for reasons other than
those referred to in paragraph (1).”
UPOV legal texts and documents can be found on UPOV’s website, at www.upov.int.
178
Article 10 ( on “Nullity and Forfeiture of the Rights Protected”) of UPOV 1978 reads:
“(1) The right of the breeder shall be declared null and void, in accordance with the provisions of
the national law of each member State of the Union, if it is established that the conditions laid
down in Article 6(1)(a) and Article 6(1)(b) were not effectively complied with at the time when
the title of protection was issued.
“(2) The right of the breeder shall become forfeit when he is no longer in a position to provide the
competent authority with reproductive or propagating material capable of producing the variety
with its characteristics as defined when the protection was granted.
“(3) The right of the breeder may become forfeit if:
(a) after being requested to do so and within a prescribed period, he does not provide the
competent authority with the reproductive or propagating material, the documents and the
information deemed necessary for checking the variety, or he does not allow inspection
of the measures which have been taken for the maintenance of the variety; or
(b) he has failed to pay within the prescribed period such fees as may be payable to keep
his rights in force.
(4) The right of the breeder may not be annulled or become forfeit except on the grounds set out in
this Article.”
44
genetic resources, such a mechanism should not be introduced in a narrow sense,
as a condition for plant variety protection.”179
In conclusion, UPOV members may adopt the Requirement, provided it does not
constitute a condition for obtaining or maintaining plant breeders rights.
(3)
The Patent Cooperation Treaty (PCT)
Parties to the PCT may not impose the Requirement, either as a condition of
patentability or not, on international applications. Article 27 of the PCT (on “National
requirements”) provides that:
“(1) No national law shall require compliance with requirements relating to the
form or contents of the international application different from or additional to
those which are provided for in this Treaty and the Regulations.” (emphasis
added)
At the diplomatic conference of Washington, in 1970, there was a brief discussion
about the meaning of the word “contents” in Article 27.1. A Canadian delegate asked
whether the word “contents” (and its French version “contenu”) was used with “the intent
to cover everything in the application from the point of view of substance, or simply to
refer to matters that were, so to speak, treated in the application.” The Secretary General
of the Conference replied that the latter was intended.180 Indeed, a footnote to the Final
Text of Article 27.1 of the PCT explains that
“The requirements relating to form and contents are principally provided for in
Articles 3 (The International Application), 4 (The Request), 5 (The Description),
6 (The Claims), 7 (The Drawings), and 8 (Claiming Priority), and the Rules
pertaining to these Articles (mainly Rules 3 to 13). The words ‘form or contents’
are used merely to emphasize something that could go without saying, namely,
that requirements of substantive patent law (criteria of patentability, etc) are not
meant.”181
Article 27.5 of the PCT supports a contrario the understanding that no formal
requirements other than those explicitly set out in the Treaty can be established on
international applications.182
179
See Review of the Provisions of Article 27.3(b), Relationship Between the TRIPS Agreement and the
Convention on Biological Diversity and Protection of Traditional Knowledge and Folklore, Information
from Intergovernmental Organizations, Addendum, International Union for the Protection of New Varieties
of Plants (UPOV), WTO document IP/C/W/347/Add.3, of June 11, 2002, at 4.
180
See Records of the Washington Diplomatic Conference on the Patent Cooperation Treaty, 1970, at 553
(WIPO, 1972).
181
Id. at 35.
182
Article 27.5 of the PCT reads:
“Nothing in this Treaty and the Regulations is intended to be construed as prescribing anything
that would limit the freedom of each Contracting State to prescribe such substantive conditions of
patentability as it desires. In particular, any provision in this Treaty and the Regulations
concerning the definition of prior art is exclusively for the purposes of the international procedure
45
The requirement to disclose the origin of genetic resources and to give evidence
of prior informed consent being a formal requirement, to the extent that it does not speak
to the nature of the claimed invention itself but rather to aspects that have nothing to do
with the specifics of the inventive activity’s output, is therefore prohibited in the PCT
context. Paragraph 8 of Article 27 contains exceptions to the provisions of paragraph 1,183
but those do not comprise the requirement to disclose the origin of genetic resources.
Actually, Article 27.8 acknowledges some restrictions established by PCT Members
(such as the United States) imposed on their own nationals as regards the filing of patent
applications in other countries, for reasons of national security or other reasons of
national policy. Obviously, this is not a condition of patentability, but a matter of
permitting the filing of patent applications. In conclusion, international patent applicants,
under the PCT system, may not be required to add elements or documents to the patent
applications that are designated to follow the so-called “PCT route” beyond those
contained in the Treaty.184
In conclusion, the Requirement is not allowed under the PCT either as condition
of patentability or as an additional requirement, during the international phase. But
nothing in the PCT and its regulations stands in the way of PCT Members to adopt
additional formal requirements once the application enters the national phase.185
(4)
The Patent Law Treaty (PLT)
Article 10.1 of the Patent Law Treaty reads:
“Non-compliance with one or more of the formal requirements referred to in
Articles 6(1), (2), (4) and (5) and 8 (1) to (4), with respect to an application may
not be a ground for revocation or invalidation of a patent, either totally or in part,
and, consequently, any Contracting State is free to apply, when determining the patentability of an
invention claimed in an international application, the criteria of its national law in respect of prior
art and other conditions of patentability not constituting requirements as to the form and contents
of applications.”
183
Article 27.8 of the PCT reads:
“Nothing in this Treaty and the Regulations is intended to be construed as limiting the freedom of
any Contracting State to apply measures deemed necessary for the preservation of its national
security or to limit, for the protection of the general economic interests of that State, the right of its
own residents or nationals to file international applications.”
184
At its third session, the WIPO Intergovernmental Committee accepted an invitation by the Conference
of the Parties to the Convention on Biological Diversity (CBD) to ask the WIPO Secretariat to prepare a
technical study “on methods consistent with obligations in treaties administered by WIPO for requiring the
disclosure” of the origin of genetic resources and prior informed consent within patent applications. See
Certain Decisions of the Sixth Conference of the Parties to the Convention on Biological Diversity,
document WIPO/GRTKF/IC/3/12, of May 24, 2002 and Report of the third session, supra note 13, at
paragraphs 62 to 81. A preliminary report on the solicited technical study was submitted by the WIPO
Secretariat to the fourth session of the Committee. See supra note 12.
185
See, for example, 35 U.S.C. 371(c)(4), requesting an additional document containing an oath or
declaration of the inventor (or other person authorized under chapter 11 of Title 35) complying with the
requirements of section 115, once an international application enters the national phase in the United States.
46
except where the non-compliance with the formal requirement occurred as a result
of a fraudulent intention.”
According to Article 6(1) of the PLT
“Except where otherwise provided for by [the PLT], no Contracting Party shall
require compliance with any requirement relating to the form or contents of an
application different from or additional to […] the requirements relating to form
or contents which are provided for in respect of international applications under
the Patent Cooperation Treaty.”
In other words, formal conditions of patentability that are not provided either in
the PCT or in the PLT itself are not allowed by the PLT. Given that the Requirement is,
as shown, inconsistent with the PCT and that the PLT has no provision approving it,186
the Requirement is also inconsistent with the PLT. Incidentally, this was the main
argument behind the proposal made by Colombia in the SCP and that was dropped
later.187
In conclusion, because the PLT is complementary to the PCT, in the sense that it
applies to national and regional patent applications permitted under the PCT (PLT,
Article 3.1), the conclusion is that the Requirement is inconsistent with the PLT (as a
condition of patentability or not) both in the international and the national phases.
(5)
The Convention on Biological Diversity (CBD)
It is has been generally understood that the Requirement is necessary to help
Contracting Parties to the CBD monitor compliance by bioprospectors and/or their
successors with national legislation on access to genetic resources. It has also been
assumed that the Requirement stems logically from the provisions of Articles 8(j) and
15.7 of the CBD.188 However, the Requirement, when adopted as a (formal) condition of
patentability, is not only in violation of the TRIPS Agreement, the UPOV Convention
and the PLT and, eventually, if adopted in the international phase, of the PCT—the
Requirement is, actually, also in violation of the CBD itself. In fact, where Article 15.7 of
the CBD suggests that Contracting Parties should take legislative measures with the aim
of sharing benefits arising from the commercial exploitation of genetic resources, it says
that they should do so “in accordance with Articles 16 and 19.”189
186
Additionally formal conditions of patentability, under the PLT, are that the contents of an application
“which correspond to the contents of the request of an international application under the Patent
Cooperation Treaty be submitted under a special request form” (Article 6(2)); the payment of fees (Article
6(4)); evidence of priority (Article 6(5)); and the form and means of transmittal of communications
(concerning the patent application) to the Patent Offices (Article 8).
187
See infra note 194 and accompanying text.
188
The text of these two provisions can be found supra Section III(b).
189
Interestingly, Article 15.7 advises that benefits should be shared through the financial mechanism of
Articles 20 and 21, which dismisses the idea of an intellectual property contractual approach (under which
benefits could be extracted from royalties, for example).
47
The expression “in accordance with Article[s] 16” means two things. First, access
to genetic resources in developing and least-developing countries may require technology
that is in the hands of private companies in developed countries. Therefore, in order to
obtain technology that will create the means for accessing their genetic resources,
developing countries shall observe Article 16 which provides for measures that “facilitate
access for and transfer to other Contracting Parties of technologies that are relevant to the
conservation and sustainable use of biological diversity or make use of genetic resources
and do not cause significant damage to the environment.” (Article 16.1).
It has been suggested that the reference to Article 16 “expands the potential
benefits [to be shared with suppliers of genetic resources] to include: access to and
transfer of technology using the genetic resources (article 16(3)).”190 This aspect,
however, is not clear. When Article 15.7 says that measures will be taken “in accordance
with”, it seems that it is referring to procedural requirements that the measures must
obey, and not to the scope of the benefits. If the intent was to expand the nature of
benefits, the provision’s language would be different. For example, subsequent to the
mention of the results of research and development and the benefits arising from the
utilization of genetic resources, it could have been added the expression “including the
benefits referred to in Articles 16 and 19.” This view is corroborated by the fact that
Article 19 is not about concessions (access to biotechnology shall be on mutually agreed
terms), but about procedures that must be respected in order to establish joint research
ventures.
Second, the measures taken must be in accordance with paragraphs 2 and 3 of
Article 16, which contain rules on technology transfer: “such access and transfer” (and,
under Article 15.7, all measures aiming at promoting benefit sharing) “shall be provided
on terms which recognize and are consistent with the adequate and effective protection of
intellectual property rights” (Article 16.3) as well as “in accordance with international
law” (Article 16.5).
In other words, all measures aiming at implementing Article 15.7, including
measures to monitor compliance with the obligation of benefit sharing, must respect
Contracting Parties’ international obligations under intellectual property agreements—
which, as shown above, do not permit the adoption of the Requirement as a condition for
obtaining rights.191 Therefore, any measures aiming at monitoring compliance with
benefit sharing obligations that are non consistent with international intellectual property
treaties are also inconsistent with the CBD itself. It is true that Article 16.5 invites
190
Lyle Glowka et alii, A GUIDE TO THE CONVENTION ON BIOLOGICAL DIVERSITY (IUCN, Gland, 1994), at
82.
191
The UPOV Convention (1978) and the PCT were already in force when the CBD was negotiated and
agreed, in 1992. The UPOV 1991 and the TRIPS Agreement, which was signed in April 15, 1994, at
Marrakesh, as an Annex of the Agreement Establishing the World Trade Organization (WTO), had their
terms already negotiated. Between December 21, 1991, when the Director General of the GATT
communicated the results of the Uruguay Round so far reached, and April 15, 1994, only a few minor
aspects of the TRIPS Agreement were changed in subsequent negotiations. But essentially the TRIPS
Agreement remained the same, that is, CBD Contracting Parties in 1992 were already aware of those
obligations.
48
Contracting Parties to make efforts to avoid that patent and other intellectual property
rights may create obstacles for the implementation of CBD objectives. 192 However, those
efforts shall be made “subject to national legislation and international law.” This means
that, for Contracting Parties to be excused from observing current international
obligations under intellectual property treaties, they must provide for the amendment of
those treaties. But while that does not happen, they are obliged by the CBD itself to
observe those treaties. The only conclusion possible is that countries that implement
Article 15.7 through measures that are inconsistent with international treaties on
intellectual property (such as adopting the Requirement as a condition of patentability)
are in violation of the CBD itself.
It could be argued, however, that Article 15.7 of the CBD applies to genetic
resources only, in contrast with Article 8(j), which refers to knowledge, that is, to
intangible assets, and which contains no parallel obligation to comply with Article 16. In
other words, one might argue that the CBD does not require measures aiming at
monitoring compliance with contracts of TK licensing (either independently from access
to genetic resources or in combination with it) to comply with international treaties on
intellectual property. But that argument would be wrong: the CBD is about tangible
biological diversity and the intangible component is not defined as an integral part of
genetic resources. TK, for the CBD, is complementary and accessory to genetic
resources, and is not seen as an independent component, worthy of separate rules. In
other words, measures taken under Article 8(j), because they are complementary and
subordinated to those under Article 15.7, must likewise respect intellectual propertyrelated international obligations.
Another argument that could be raised is that under Article 15.5, which subjects
access to prior informed consent,193 makes no reference to international treaties on
intellectual property. Compliance with the obligation of obtaining prior informed consent,
therefore, could be monitored regardless of international obligations in the area of
intellectual property. To that extent, prior informed consent would give rise to stand
alone obligations under the CBD. Such an argument, however, would be flawed. The
reason is that Article 15.4 subjects access to “the provisions of this Article,” which
necessarily include those of paragraph 7. In other words, measures aiming to implement
the obligation of obtaining prior informed consent are, like those concerning benefit
sharing, subject to paragraphs 2 and 3 of Article 16.
(6)
Current multilateral negotiations
192
Article 16.5 reads:
“The Contracting Parties, recognizing that patents and other intellectual property rights may have
an influence on the implementation of this Convention, shall cooperate in this regard subject to
national legislation and international law in order to ensure that such rights are supportive of and
do not run counter to its objectives.”
193
Article 15.5 reads:
“Access to genetic resources shall be subject to prior informed consent of the Contracting Party
providing such resources, unless otherwise determined by that Party.”
49
There have been attempts to include the Requirement in international treaties.
Those attempts had two different purposes. One, obviously, is to produce effects in
territories other than those from which the genetic resources and TK were extracted. As a
matter of fact, although genetic resources are raw materials for all sorts on inventions in
all fields of technology, they are mostly important in the biotechnological field. And the
main markets for biotechnological processes and products are in developed countries,
where most related patent applications are filed. It follows that imposing the Requirement
in developing countries only has not much practical impact. With that in mind, during the
discussions in the WIPO Standing Committee on the Law of Patents (SCP), in September
of 1999, on the proposed Treaty on the Law of Patents (PLT), Colombia proposed the
addition of the following provision:
“1.
All industrial property protection shall guarantee the protection of the
country’s biological and genetic heritage. Consequently, the grant of patents or
registrations that relate to elements of that heritage shall be subject to their having
been acquired legally.
“2.
Every document shall specify the registration number of the contract
affording access to genetic resources and a copy thereof where the goods or
services for which protection is sought have been manufactured or developed
from genetic resources, or products thereof, of which one of the member countries
is the country of origin.”194
The SCP did not reach a consensus on this proposal,195 and WIPO Member States
subsequently revisited the issue no less than five times. In November 1999, the WIPO
Working Group on Biotechnology held informal discussions on Colombia’s proposal and
issued a questionnaire aiming at identifying the intentions of WIPO Member States as to
the eventual adoption of the Requirement at the national or regional level.196 The WIPO
Meeting on Intellectual Property and Genetic Resources, held in Geneva, on April 17 and
18, 2000, discussed the responses to that questionnaire as well as other issues concerning
TK, in preparation of the Diplomatic Conference for the adoption of the PLT. In that
venue, Colombia softened its proposal: it no longer suggested the provision to have a
mandatory nature, but rather a permissive nature, in the sense that it merely permitted
Parties to the future PLT to adopt the Requirement at the national level. Colombia’s
argument was that it was afraid that, without such permission, the Second
Complementary Provision of Andean Community Decision No. 391197 would be in
conflict with the future Treaty. The new proposal read as follows:
“When necessary, and if the invention has been obtained from genetic and/or
biological resources, any Contracting Party may demand that a copy of the
194
SCP/3/10, of September 8, 1999.
See Report of the third session of the SCP, SCP/3/11, of September 14, 1999, paragraphs 202 to 209.
196
See WIPO/IP/GR/00/3 Rev. 1, supra note 151.
197
See supra note 147.
195
50
document issued by the competent national authority attesting the legality of
access to those resources be submitted to the Office.”198
Subsequently, on the first day of the Diplomatic Conference, on May 11, 2000,
WIPO Members held negotiations on Colombia’s new proposal, the outcome of which
was the grant of a mandate to WIPO’s Director General to take necessary action to
establish a forum where Member States could exchange views on matters concerning
protection of traditional knowledge and expressions of folklore and access to genetic
resources.199
The Requirement was again submitted to discussion in WIPO through a request
from the Secretariat of the CBD, conveying to the Intergovernmental Committee the
invitation by the Conference of the Parties that the WIPO Secretariat prepare a study “on
methods consistent with obligations in treaties administered by the World Intellectual
Property Organization for requiring the disclosure within patent applications of, inter
alia: (a) Genetic resources utilized in the development of the claimed inventions; (b) The
country of origin of genetic resources utilized in the claimed inventions; (c) Associated
traditional knowledge, innovations and practices utilized in the development of the
claimed inventions; (d) The source of associated traditional knowledge, innovations and
practices; and (e) Evidence of prior informed consent.”200 At the time of this writing, the
final study was still in preparation.
More recently, and again in the SCP, which is currently having discussions on a
Draft Substantive Patent Law Treaty,201 the Dominican Republic, on behalf of a group of
countries,202 proposed to amend paragraph 2 of draft Article 2 (on “General Principles”),
which, after the change, would read:
198
WIPO/GR/00/4, of April 14, 2000, document on file with the WIPO Secretariat. Two elements in this
proposal made it optional for PLT Contracting Parties: first, it could be adopted only when Members
thought it was necessary (for example, necessary for implementing the CBD); and, second, the word “may”
expresses an authorization, not a mandatory action.
199
See Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and
Folklore, document WO/GA/26/6, of (August 7, 2000), and Report of the Twenty-Sixth (12th
Extraordinary) session of the WIPO general Assembly, document WO/GA/26/10 of October 3, 2000.
200
See supra note 184, Annex, at 3.
201
See Draft Substantive Patent Law Treaty, SCP/8/2, of October 16, 2002, and Practice Guidelines Under
the Substantive Patent Law Treaty, SCP/8/4, of October 16, 2002. The draft SPLT contrasts with the PLT
in the sense that it goes beyond merely procedural provisions, and contains really substantive rules of
patent law. However, if we take a narrow meaning of the word “substantive” which is the standards of
rights effectively granted and protected (in other words, the standards on the acquisition, use and loss of
patent rights)—as the TRIPS Agreement does in Section V of Part II—, then the SPLT, which is mostly
concerned with the harmonization of conditions of patentability, does not cover actual substantive law. It is
true that conditions of patentability do have an impact on the definition of standards of rights protected, but
they are not substantive standards themselves. The only substantive provision that the current draft of the
SPLT contains is Article 4, on inventorship/ownership (the language of which, incidentally, has been
borrowed from the draft Treaty Supplementing the Paris Convention as far as Patents Are Concerned,
Article 9. The Diplomatic Conference convened (at The Hague, on June 3 to 28, 1991) to adopt this draft
Treaty failed to reach a conclusion. Nevertheless, some of its provisions were later incorporated into
Section 5, Part II, of the TRIPS Agreement.
202
The countries are: Chili, Colombia, Cuba, The Dominican Republic, Ecuador, Honduras, Nicaragua,
Peru and Venezuela.
51
“Nothing in this Treaty and the Regulations shall limit the freedom of a
Contracting Party to take any action it deems necessary for the preservation of
essential security interests or to comply with international obligations, including
those relating to the protection of genetic resources, biological diversities,
traditional knowledge and the environment.”
Brazil has also suggested an amendment to Article 13 (on “Grounds for Refusal
of a Claimed Invention”)203 of the draft SPLT, which would read:
“[Compliance with Applicable Law on Other Matters] A Contracting Party may
also require compliance with the applicable law on […] access to genetic
resources, protection of traditional knowledge […].”204
These two proposals aim at avoiding the same conflict that exists under the PCT
and the PLT. In an explanatory note, however, the Dominican Republic justifies its
proposal with the need to fulfil international commitments under the CBD. To that extent,
therefore, the argument becomes circular: as explained above, in order to comply with the
CBD, countries must be in compliance with international agreements on IP; the violation
of the latter leads to the violation of the CBD itself. Therefore, in order to comply with
the CBD, it is necessary to include the Requirement in IP treaties. However, because the
Requirement is not established in the CBD—on the contrary, unless IP treaties are
modified, the CBD prohibits it—it makes no sense to amend the draft SPLT, or any treaty
in force, for that matter, to permit Contracting Parties to enact measures “in order to
comply with international obligations” (as proposed by the Dominican Republic) or to
impose “the applicable law on […] access to genetic resources” (as proposed by Brazil).
The two proposals are, in fact, circular. Because those obligations are not explicitly stated
in the CBD, they cannot be assumed therefore. For the proposals to make sense it would
be better to adopt the language proposed by Colombia during the negotiations that led to
the adoption of the PLT.
Anyway, the two proposals have already been the subject matter of discussions in
the SCP,205 but in view of the different opinions as to whether the SCP is the appropriate
forum to address the issue, it was decided to include the two proposals in the text of the
draft SPLT in square brackets, accompanied by the following note: “The SCP agreed at
its eighth session to include the paragraphs in square brackets, but to postpone
substantive discussions on these provisions.”206 In any event, even if the SPLT adopts the
proposals in the future, the Requirement would continue being in violation of the TRIPS
Agreement, the PCT and the PLT.
203
The Brazilian proposal impacts Article 14 too, which deals with revocation of patents.
See Proposals by the Delegations of the Dominican Republic and Brazil Concerning Articles 2, 13 and
14 of the Draft Substantive Patent Law Treaty, document SCP/8/5, of November 5, 2002, Annexes I and II.
205
See Report, Eighth Session of the SCP, document SCP/8/9 Prov., of December 18, 2002, at paragraphs
37 to 49.
206
Id. at paragraph 49. See also Summary by the Chair, document SCP/8/8, of November 29, 2002, at
paragraph 11.
204
52
Some WTO Members have addressed the Requirement several times in
discussions in the TRIPS Council—the idea would be to amend the TRIPS Agreement so
as to establish the Requirement as an additional formal condition of patentability. That
discussion was inaugurated by India, 1997, with a document submitted to the Committee
on Trade and Environment (CTE)207 but was soon transferred to the TRIPS Council in the
context of the review of Article 27.3(b) of the TRIPS Agreement. More recently, in the
preparations for the fourth session of the WTO Ministerial Conference, in Doha, several
WTO Members raised the issue again.208 The Ministerial Declaration, approved in Doha,
included the relationship between the TRIPS Agreement and the CBD, the protection of
traditional knowledge and folklore as topics of the work programme to be pursued by the
Council for TRIPS under the review of Article 27.3(b).209 However, because of the
ongoing discussions involving the implementation of paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health, 210 the attentions of biodiversityrich developing countries has been diverted and no progress has been made on the
Requirement issue.
(ii)
The duty to disclose other relevant interests in patent applications; the
government funding disclosure clause of 35 U.S.C. 202.
In 1999, the WIPO Secretariat included the following question in a questionnaire
on WIPO Member States’ practices related to the protection of biotechnological
inventions:
“Does your legislation include any special provisions to ensure the recording of
contributions to inventions (such as the source of government funding, the source
of genetic resources that originate or are employed in biotechnological inventions,
the grant of prior informed consent to have access to those resources)?”211
207
See Carvalho, supra note 12, at 389 et seq. For an overview of the debates on the Requirement and other
TK-related issues in the WTO, see The Relationship Between the TRIPS Agreement and The Convention on
Biological Diversity—Summary of Issues and Points Made, Note by the Secretariat (WTO document
IP/C/W/368, of August 8, 2002), Review of the Provisions of Article 27.3(b)—Summary of Issues Raised
and Points Made, Note by the Secretariat (WTO document IP/C/W/369, of August 8, 2002), and The
Protection of Traditional Knowledge and Folklore—Summary of Issues Raised and Points Made, Note by
the Secretariat (WTO document IP/C/W/370, of August 8, 2002).
208
See e.g., The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity
and the Protection of Traditional Knowledge, WTO document IP/C/W/356, of June 24, 2002, proposal by
Brazil, China, Cuba, Dominican Republic, Ecuador, India, Pakistan, Thailand, Venezuela, Zambia and
Zimbabwe.
209
Ministerial Declaration Adopted on14 November 2001, WTO document WT/MIN(01)/DEC/1, of
November 20, 2001, at paragraph 19. It should be noted that, according to paragraph 52 of the Ministerial
Declaration, the work programme does not necessarily entail negotiations on new standards. The TRIPS
Council may, therefore (and it probably will) keep its focus on TK (and , particularly, on stricto sensu TK)
at the level of discussions and exchange of views.
210
See WTO document WT/MIN(01)/DEC/2, of November 20, 2001.
211
Actually this question was originated by the debate in the SCP on the Colombian proposal. Because of
that proposal, Colombia was invited to attend the meeting of the WIPO Working Group on Biotechnology,
in November 1999. See Issues for Proposed Work Program on Biotechnology, document
WIPO/BIOT/WG/99/1, of October 28, 1999 (on file with the WIPO Secretariat). The responses to the
questionnaire were collected and circulated and submitted to the WIPO Meeting on Intellectual Property
53
The question was deliberately drafted so as to imply that the requirement to
identify the origin of genetic resources, then adopted only by Costa Rica and the Andean
Community, and the obligation to inform about the use of government funding, as
imposed by the United States Code, are similar. Indeed, they are similar to the extent that
both are formal requirements because they concern the manner in which the claimed
invention is described, and thus they do not regard the nature of the invention. Both
requirements are, therefore, extrinsic to the invention. But the similarity stops there. As it
will be shown, unlike the Requirement, the U.S. requirement that contractors inform
about government funding is consistent with international obligations, including those of
the TRIPS Agreement.
Contractors, under 35 U.S.C. 202,212 have actually two disclosure obligations:
they must disclose the very existence of the subject inventions to the funding agency
and Genetic Resources of April 17 and 18, 2000 (Information Provided by WIPO Member States
Concerning Special Provisions to Ensure the Recording of Some Contributions to Inventions, document
WIPO/IP/GR/00/3 Rev.1 of April 14, 2000)—meeting that was the precursor of the Intergovernmental
Committee. The same responses can also be found in document WIPO/GRTKF/IC/1/6, of April 6, 2000,
submitted to the first session of the Committee, from April 30 to May 3, 2001.
212
The relevant provisions of Chapter 18 (“Patent Rights in Inventions Made with Federal Assistance”), 35
U.S.C. 202 et seq. read:
“35 U.S.C. 202 Disposition of rights.
“(a) Each nonprofit organization or small business firm may, within a reasonable time after
disclosure as required by paragraph (c)(1) of this section, elect to retain title to any subject
invention. The rights of the nonprofit organization or small business firm shall be subject to the
provisions of paragraph (c) of this section and the other provisions of this chapter. […]
“(c) Each funding agreement with a small business firm or nonprofit organization shall contain
appropriate provisions to effectuate the following:
“(1) That the contractor disclose each subject invention to the Federal agency within a reasonable
time after it becomes known to a contractor personnel responsible for the administration of patent
matters, and that the Federal Government may receive title to any subject invention not disclosed
to it within such time. […]
“(4) With respect to any invention in which the contractor elects rights, the federal agency shall
have a nonexclusive, non-transferable, irrevocable, paid-up license to practice or have practiced
for on or behalf of the United States any subject invention throughout the world: Provided, That
the funding agreement may provide for such additional rights; including the right to assign or have
assigned foreign patent rights in the subject invention, as are determined by the agency [...].
“(6) An obligation on the part of the contractor, in the event a United States patent application is
filed by or on its behalf or by any assignee of the contractor, to include within the specification of
such application and any patent issuing thereon, a statement specifying that the invention was
made with Government support and that the Government has certain rights in the invention. […]
“35 U.S.C. 203 March-in rights.
“(1) With respect to any subject invention in which a small business firm or nonprofit organization
has acquired title under this chapter, the Federal agency under whose funding agreement the
subject invention was made shall have the right [...] to require the contractor, an assignee, or
exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive
license in any field of use to a responsible applicant or applicants, upon terms that are reasonable
under the circumstances, and if the contractor, assignee, or exclusive licensee refuses such request,
to grant such a license itself [...].
“35 U.S.C. 206 Uniform clauses and regulations.
“The Secretary of Commerce may issue regulations which may be made applicable to federal
agencies implementing the provisions of sections 202 through 204 of this chapter [...].”
54
(section 302(c)(1)); and they must inform that the subject invention was made under a
funding agreement in the patent application (section 302(c)(6)).213 If the contractor fails
to disclose the invention to the funding Agency, the Government may acquire title to the
invention. Such an acquisition, however, is not automatic—“the agency may only request
title within 60 days of learning of the failure to disclose or elect within the specified
times.” (37 CFR 401.14(a)(d)(1)). And because the provision says that the Government
Those regulations can be found in 37 CFR 401, and in particular in the following rules:
“Section 401.3 Use of standard clauses at Sec. 401.14.
“(a) Each funding agreement awarded to a small business firm or nonprofit organization [...] shall
contain the clause found in Sec. 401.14(a) [...].
“Section 401.14 Standard patent rights clauses.
“(a) The following is the standard patent rights clause to be used as specified in Sec. 401.3(a).
Patent rights (Small Business Firms and Nonprofit Organizations) […]
(b) Allocation of Principal Rights
The Contractor may retain the entire right, title, and interest throughout the world to each
subject invention subject to the provisions of this clause and 35 U.S.C. 203. With respect
to any subject invention in which the Contractor retains title, the Federal government
shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or
have practiced for on or behalf of the United States the subject invention throughout the
world.
(c) Invention Disclosure, Election of Title and Filing of Patent Application by Contractor
(1) The Contractor will disclose each subject invention to the Federal agency
within two months after the inventor discloses it in writing to Contractor
personnel responsible for patent matters. [...]
(2) The Contractor will elect in writing whether or not to retain title to any such
invention by notifying the Federal agency [...]
(d) Conditions When the Government May Obtain Title
The Contractor will convey to the Federal agency, upon written request, title to any
subject invention —
(1) If the Contractor fails to disclose or elect title to the subject invention within
the times specified in (c) above, or elects not to retain title; provided that the
agency may only request title within 60 days after learning of the failure of the
contractor to disclose or elect with the specified times. […]
(f) Contractor Action to Protect the Government’s Interest […]
(4) The Contractor agrees to include, within the specification of any United
States patent applications and any patent issuing thereon covering a subject
invention, the following statement, ‘This invention was made with government
support under (identify the contract) awarded by (identify the federal agency).
The government has certain rights in the invention.’”
The provisions of 35 U.S.C. 202 et seq. apply to all firms regardless of their size, in accordance with
Presidential Executive Order 12,591. It should be noted that, because the march-in-rights, under 35 U.S.C.
203, amount to a compulsory license, they are subject to the provisions of Article 31 of the TRIPS
Agreement. Therefore, the possibility for the U.S. government to grant “partially exclusive, or exclusive”
compulsory licenses is inconsistent with Article 31(d) of the TRIPS Agreement, which provides that
compulsory licenses “shall be non-exclusive.”
213
Section 302(c)(6) states that the funding agreement shall contain the obligation “on the part of the
contractor [...] to include within the specification of such application and any patent issuing thereon, a
statement specifying that the invention was made with Government support.” Evidently, the second aspect
of this provision is beyond the contractor’s control. Only the Unites States Patent and Trademark Office
(USPTO) can implement the obligation of including a certain language in the patent. The only thing the
patent applicant can do is to inform the USPTO of the interests of the federal government in a given patent
application and to request a correction if the patent is issued without such a note.
55
may request title, it follows that such a request depends on the discretionary authority of
the governmental agency.
The purpose of the government funding requirement (hereinafter sometimes
designated as “the U.S. requirement”) is two-fold. On the one hand, it is aimed at
informing the government itself about the existence of the invention, because the fact that
the invention was publicly funded gives the government some rights in the invention,
namely the right to a nonexclusive, nontransferable, irrevocable and paid-up license (35
U.S.C. 202(c)(4) and U.S. Executive Order 12,591, paragraph 4). On the other hand, the
requirement provides information to the public at large, because, if some circumstances
of public interest arise, the government has march-in rights in the invention, which means
that interested third parties may eventually obtain the right to use the patented invention
(35 U.S.C. 203).
However, the notice on the patent letter that the invention was made with Federal
financial assistance is “neutral” in the sense that the actual rights that the government
may have reserved are not specified thereon.214
Secondly, section 202 et seq. do not provide for any mandatory action to be taken
by Federal agencies. They contain no standards the legality of which courts can
examine.215
Another important aspect of Chapter 18 is that its provisions do not set a clear
entitlement to patent rights. “Though the indication is strong”, said the Court of Appeals
for the Eleventh Circuit in Southern Research Institute v. Griffin Corp. (1991),216 “that
the government should ordinarily grant such [patent] rights, the statute admits of no
considerations by which we could fairly gauge the propriety of a refusal to so grant such
rights.”217 In a footnote the court noted that commentators had suggested that the BayhDole Act created a presumption in favor of researchers working with a government
funding grant. The court, however, repeated: “While we may not disagree with this view,
“The only concrete evidence Duke cites is the statement on each of the patents noting that the
government has rights in the patents. This, however, is insufficient because these short notations on the
patents do not define the scope of the government’s rights.” See Madey v. Duke University, 307 F.3d 1351,
1364 (Fed. Cir. 2002).
215
“The court held that Vartanian’s complaint must be dismissed because (1) § 202 did not provide, either
explicitly or implicitly, a private right of action regarding the ownership of inventions; (2) judicial review
of the agency’s purported refusal to grant ownership rights was unavailable [...] because the underlying
statute, § 202, does not provide any standards for meaningful review of the agency’s actions; [...]. We also
agree with the court that judicial review is not available [...] because the underlying statute, § 202, provides
no standards for judging the propriety of the agency’s action. [citation omitted].” See Vartanian v. Gen.
Elec. Co., 2000 U.S. App. LEXIS 6327, at 2/3 and 6 (Fed. Cir. 2000).
216
Southern Research Institute v. Griffin Corp., 938 F.2d 1249 (11th Cir. 1991). The plaintiff alleged that
the government was under a statutory duty to assign the rights stemming from a patent covering an
invention to which SRI’s employees had contributed under a federal grant.
217
Id. at 1254.
214
56
we note that the Act leaves us without sufficient judicial standards by which to evaluate a
refusal to give away patent rights.”218
What is then the consequence of failure to comply with the government funding
disclosure requirement—or more specifically, what happens if the contractor fails to
acknowledge in the patent application that the invention was made with public financial
assistance? It seems that, according to courts, the consequence ultimately lies in the
discretionary authority of the government, and provided the deadlines established by 37
CFR 401.14 are complied with. In Gen-Probe Inc. v. Center for Neurological Study
(1993), the District Court for the Southern District of California held that setion 202
provides for no private right of action.219 The District Court added that, unlike sections
281 and 141-145 of the Patent Act, section 202 contains no mechanism for private
enforcement.220
Moreover, the transfer of title does not occur automatically where the contractor
failed to disclose the invention to the Federal agency or to the USPTO office. In Jewish
Hospital of St. Louis v. Idexx Laboratories (1997),221 the District Court of Maine stated
the law under section 202 in the following manner:
“Neither the statute nor the regulation results in the automatic transfer of
title IDEXX asserts. The statute requires funding agreements to provide that the
Government ‘may receive title’ under certain circumstances.222 [...] Rather than
automatically transferring title to the invention upon late disclosure, the Secretary has
provided in regulation 401.14(d)(1) that grant recipients like Jewish Hospital retain title
218
Id., footnote 10. 35 U.S.C. 202 et seq. were introduced in the Patents Act (Title 35) by the Bayh-Dole
Act (Sec. 6(A) at 94 Stat. 3019), of December 12, 1980.
219
Gen-Probe Inc. v. Center for Neurological Study, 853 F.Supp. 1215, 1217 (S.D.C. 1993), citing, with
approval, Platz v. Sloan-Kettering Institute, 787 F.Supp. 360 (S.D.N.Y. 1992).
220
“This conclusion [that under section 202 no private right of action exists] is supported by the fact that
elsewhere in the patent statutes, Congress did explicitly grant private causes of action. See, e.g., 35 U.S.C.
§ 281 (1988) (“a patentee shall have remedy by civil action for infringement of his patent”); 35 U.S.C. §§
141-145 (1988) (applicant whose patent is rejected by the Patent Office on appeal may pursue his claim in
the federal courts). That fact that elsewhere in the patent statutes private rights were expressly provided
indicates that ‘when Congress wished to provide a private damage remedy, it knew how to do so and did so
expressly.’ [citation omitted] Likewise, that such a right was not created under §202(c)(7)(B) suggests that
no right was intended.” Id., at 1218. This is debatable, however. True inventors are entitled to claim and
enforce in courts inventorship and ownership of the patent, and yet the Patent Statute contains no provision
explicitly recognizing such a right. That right stems from the principle that patents should be granted for
those whom the law qualifies as the rightful patent letter addressees.
221
Jewish Hospital of St. Louis v. Idexx Laboratories, Civil No. 95-290-P-H. Order on Idexx’s Motion to
file third amended answer and counterclaim (Docket Item 202), June 12, 1997, available at
www.med.uscourts.gov/site/opinions/hornby/1997/dbh_2-96cv290_jewish_hosp_v_idexx_doc10_jun.pdf
(last visited on January 29, 2003). Idexx had moved to file a third amended answer and counterclaim to
assert three affirmative defenses to patent infringement: (1) lack of standing or failure to join an
indispensable party (the Federal government); (2) patent misuse and unclean hands; and (3) inequitable
conduct. The argument of Idexx was that, because Jewish Hospital had neglected to promptly communicate
to the NIH the making of the patented invention under a NIH funding agreement (the communication was
made after the patent was issued), the government had automatically acquired title and therefore the Jewish
Hospital had no standing for enforcing rights in that patent.
222
Emphasis added by the District Court.
57
to the invention unless and until the Federal agency meets two requirements. First, the
Federal agency must make a ‘written request.’ 37 C.F.R. §401.14(d). Second, the Federal
agency must make this request ‘within 60 days after learning of the failure of the [grant
recipient] to disclose [...].’ 37 C.F.R. §401.14(d)(1.)’223
That under section 202 title does not transfer automatically to the
Government results even clearer when its language is compared to the language of the
Federal Nonnuclear Energy Research and Development Act (FNERDA). “Unlike the
permissive and conditional language of the statute and regulation here [section 202 and
401.14], FNERDA clearly provides that ‘title to any invention made or conceived under a
FNERDA contract shall vest in the United States.”224
Disputes involving title to the invention between the Federal agency and
the funded inventor may not benefit third parties. The court said: “Simply put, I fail to see
how the allegations of improper delay, even if true, are at all material to this patent
infringement case. These allegations concern the Jewish Hospital-NIH funding contract
and its procurement. But whether Jewish Hospital mislead the NIH has no bearing on any
legitimate issues in IDEXX’s answer or counterclaims. IDEXX cannot benefit from
potential disputes between Jewish Hospital and the NIH arising under the contract and
procurement process.”225
Actually, if it is not possible to identify here a case of inequitable conduct,
because the funding contract is not material to the issue of patentability, the failure to
timely disclose the invention to the government and to society at large (through the notice
on the patent letter) may raise a question of unclean hands—which apparently the District
judge’s Order failed to address. The question is that the notice on the patent informs the
public that the government—and, consequently, tax payers—has interests in the patented
Jewish Hospital, supra note 153, at 4. The court noted: “Indeed, the very title of regulation 401.14(d) is
‘Conditions When the Government May Obtain Title.’ 37 C.F.R. §401.14(d).” Emphasis added by the
District Court.
224
Id. at 4, footnote 3. Citation omitted. Emphasis added by the District Court.
225
Id. at 4-5. These aspects of Chapter 18 represent a departure from pre-existing law. In a case involving
the alleged infringement of patented invention made under a 1974 grant from the Public Health Service
(invention which was communicated to the funding agency nearly eighteen years after the grant expired),
VDI Technologies, Inc. v. Price, Civil No. 90-341-M, Order of August 31, 1994 (D.C.N.H. 1994) (available
at www.nhd.uscourts.gov/oo/oo_index.asp (last visited on December 22, 2002), the District Court of New
Hampshire said that “While the regulations and reporting requirements did not automatically vest title to
grant-related inventions in the United States, they did automatically vest in the government the exclusive
right to determine who could obtain and exercise ownership rights and on what terms.” Id. at 8. “For
purposes of the present declaratory judgement action, Sudbury’s ownership of the ‘854’ patent is not
established, rendering the purported case and controversy between these parties unripe, at least as to the
patent related claims. [citation omitted].” Id. at 9. “Moreover, what Sudbury knew, or should have known,
of the reporting requirements would be critical to an assessment of whether Sudbury was guilty of
inequitable conduct before the Patent and Trademark Office (‘PTO’). If Sudbury did know of the
restrictions on patentability and deliberately withheld that information, then the ‘854’ patent would most
probably be unenforceable. [citation omitted.]” Id. at 10. “At this juncture, until the government exercises
its right to determine ownership of the invention, and, the scope of those ownership rights are determined if
they are awarded to Sudbury, the regulations operate to preclude its claim to record ownership of the patent
and preclude its current claim of infringement. [citation omitted].” Id. at 11.
223
58
invention, which may include the royalty-free use of the invention by the government
itself, or, if some circumstances of public interest arise, march-in rights claims. 35 U.S.C.
206. Even though it seems that the government, and the NIH in particular, will be very
parsimonious in resorting to the extreme solution of marching in private patent rights,226
the possibility exists nonetheless. Failure to communicate the USPTO that ownership of a
certain invention made under federal funding is limited by Federal statutes and
regulations may be seen a serious omission of facts relevant to public policy, and
therefore any attempt to enforce rights thus acquired might be deemed abusive.
On its face, the U.S. requirement is substantially distinct from the Requirement
because it does not establish a condition of patentability, in other words, neither will the
Patent Office reject a patent application because the applicant failed to inform about the
fact that the claimed invention was made under a Federal grant nor will a court invalidate
or refuse to enforce patent rights on that ground. However, that is not the point, because,
as seen above, the Requirement is not always imposed as a condition of patentability.
Furthermore, even when it is not a formal condition of patentability, the Requirement is
in violation of those WIPO treaties that deal with formal requirements (which are not
necessarily patentability conditions), such as the PCT and the PLT. Therefore, even not
being a formal condition of patentability, the U.S. requirement could be in violation of
United States international obligations under the PCT and the PLT. But it is not. The
government funding disclosure requirement helps the funding agency and tax payers to
assess matters of attribution of rights in the invention, i.e., ownership. Patent laws in
general designate inventors as the original owners of patented inventions. But ownership
may as well stem from contractual arrangements between inventors and their
employers227 or funding providers.
Worried that entities benefiting from federal grants were not reporting adequately
inventions made and in compliance with a statutory mandate,228 two federal agencies
have already inspected the levels of actual implementation of 35 U.S.C. 202. The first
report was elaborated by the Office of Inspector General of the Department of Health and
Human Services, in 1994. It specifically checked the reported disclosure of inventions
made under NIH grants at the Scripps Research Institute229 and concluded that they were
underreported. The Inspector General recommended a review of patents obtained by NIH
grantees (to the argument that such a review would cause too much work, the Inspector
226
See Determination In the Case of Petition of Cell Pro, National Institutes of Health, Office of the
Director, of August 1, 1997, available at www.nih.gov/news/pr/aug97/nihb_01.htm (last visited on
February 4, 2003). The Director said that in the NIH were “wary […] of forced attempts to influence the
marketplace for the benefit of a single company, particularly when such actions may have far-reaching
repercussions on many companies’ and investors’ future willingness to invest in federally funded medical
technologies. […] In exercising its authorities under the Bayh-Dole Act, NIH is mindful of the broader
public health implications of a march-in proceeding, including the potential loss of new health care
products yet to be developed from federally funded research.” Id. at 8.
227
See U.S. v. Dubilier Condenser Corp., 289 U.S. 178 (1933).
228
See 35 U.S.C. 202(b)(3).
229
See Underreporting Federal Involvement in New Technologies Developed at the Scripps Research
Institute, Office of Inspector General, Department of Health and Human Services, June 1994, available at
oig.hhs.gov/oas/reports/phs/c9300029.pdf (last visited on February 20, 2003).
59
suggested that the NIH took a “risk-based approach that would ensure that those grantees
most likely to have inventions and file for patents are reviewed.”).230
The second report was issued by the United States General Accounting Office
(GAO), in August 1999.231 This second Report also concluded that there was not enough
information on patent documents on government interests in inventions made under
federal grants. Based on that conclusion, the GAO recommended Congress to consider
amending the Bayh-Dole Act “to standardize, improve, and streamline the reporting
process for inventions subject to both the Act and Executive Order 12591.”232 In order to
achieve that, the GAO recommended:
“The Congress could consider (1) requiring the Secretary of Commerce to
develop standardized disclosure forms and utilization reports for federally funded
inventions, (2) making the patent the primary control mechanism for reporting
and documenting the government’s rights and the only written instrument for
confirming the government’s royalty-free license, and (3) requiring the Patent and
Trademark Office to provide information to the funding agencies to assist them in
monitoring compliance.”233
GAO’s argument was that the “patent database is a better source than the
Government Register for determining the government’s rights to federally sponsored
inventions. It is more accessible than the Government Register in that the official patent
records are available for inspection and a user can obtain from PTO’s Internet Web site
the full text of patents issued since 1976.”234 Among the measures aiming to streamline
the reporting process, the GAO had suggested to require that the notice on the patent
application include “the name of each specific agency that funded research, the contract
or grant number(s) under which the invention was created, and a provision stipulating
that the government has a nonexclusive, paid-up, royalty-free right to the use of the
invention.;”235 the GAO proposed also that the USPTO should keep the funding agency
informed of events that might affect the government’s rights during the application’s
prosecution (so that the funding agency could take preventive measures to protect its
interests in the invention) and that the Patent Gazette include a notice on the
government’s interest on patents issued.236 The GAO also proposed that the USPTO
could charge applicants a fee for applications that contain a government interest notice.237
230
Id. at 9-10.
Reporting Requirements for Federally Sponsored Inventions Need Revision, Report to the Chairman,
Committee
on
the
Judiciary,
U.S.
Senate,
August
1999,
available
at
ott.od.nih.gov/NewPages/RCED99242.pdf (last visited on February 20, 2003).
232
Id. at 19.
233
Id.
234
Id. at 14-15.
235
Id. at 32.
236
Id.
237
Id.
231
60
The USPTO agreed that the requirement, if adopted in GAO’s terms, would be in
compliance with the draft of the Patent Law Treaty that was then being negotiated. What
the USPTO did not agreed with was the increased burden on patent applicants.238
The GAO’s recommendations were not implemented and thus the USPTO has no
obligation to seek information on the nature or origin of the funds used by inventors for
making claimed inventions. Interestingly, many of the proposals made by the GAO could
have been subscribed by environment agencies of biodiversity-rich countries seeking
ways and means to monitor compliance with contracts on access to genetic resources
(likewise, the GAO was seeking a practical means to monitor, through patent documents,
compliance with contracts of access to government funds). To the allegation that using
the patent system to monitor the use of genetic resources is not efficient because it would
not cover inventions kept undisclosed, the GAO would answer that is not a problem
because section 202 actually requires a patent to be filed. Therefore, in principle, all
inventions made with government funding and that are patentable subject matter will find
their way to the USPTO. But that is not the issue, of course. The issue is that it would be
wrong (however not offensive to international legislation) to use patents to verify whether
contractors have complied with their contractual obligations. The idea that patents are not
certificates of good behavior does not apply to bioprospection only, it applies also to
government funding.
Anyway, the government funding disclosure requirement is consistent with the
obligations of the United States under the four international agreements mentioned above.
First, it is compatible with the TRIPS Agreement, and not only because it is not a
formal condition of patentability. Actually, if the US requirement were a (formal)
condition of patentability, it would be nonetheless compatible with Article 62 of the
TRIPS Agreement. And the reason was given above: it is reasonable indeed to impose
any conditions necessary to identify the right to ownership of the invention. In contrast
with the Requirement, as explained, under which suppliers of genetic resources or of
associated TK have not a claim of inventorship, the funding Federal agency may indeed
claim property rights in the invention, in the event that the contractor fails to do so within
the established period. Moreover, there are public interests involved in the notice
concerning public funding because, in view of the public nature of the funding, march-in
rights may be invoked by the government as per interested third parties’ request. The
notice on the patent, therefore, operates as a notice to society at large that the rights
deriving from that particular patent are subject to some considerations and actions that
may be dictated by public policy.239 In contrast, the Requirement has the single purpose
238
Id. at 20.
As the Office of Inspector General of the Department of Health and Human Services said: “When the
Government is not aware of a grantee’s invention, it is not able to exercise its rights and to protect the
taxpayers’ interest.” See Report supra note 229, at 7. The GAO also took note of the rationale set out by
Federal Regulations:
“It is important that the Government and the contractor know and exercise their rights in
inventions conceived or first actually reduced to practice in the course of or under Government
contracts in order to ensure their expeditions available to the public and to enable the Government,
239
61
of informing stakeholders of an eventual interest in the results of the research or of the
commercial exploitation of the claimed invention—results to which the patent does not
contribute. If the claimed invention consists of a cloned animal cell line, for example, the
original material of which was the product of bioprospection, the fact that the Patent
Office may be informed of the circumstances in which the raw material was obtained will
have no consequences at all if in the country in question cloning technology may not be
commercially exploited (in many countries it cannot be exploited either).
The UPOV Convention is not affected by the U.S. requirement, which applies to
patents only (including, eventually, plant patents). However, if the U.S. requirement were
applicable to plant variety protection, again, unlike the Requirement, it would be
UPOV(1991)-consistent. The reason is that Article 1 of UPOV 1991 defines “breeder” as
“- the person who bred, or discovered and developed, a variety,
“- the person who is the employer of the aforementioned person or who has
commissioned the latter’s work, where the laws of the relevant Contracting Party
so provide, or
“- the successor in title of the first or second aforementioned person, as the case
may be.”
As a supplier of financial resources to the breeder, the Federal agency would
acquire title, if the U.S. Plant Variety Act so established, and provided the breeder failed
to claim the right or disclose the origin of the funding, as a commissioner of the breeder’s
work. And since the basic obligation of the Contracting Parties to the UPOV Convention
is to “grant and protect breeders’ rights” (Article 2), it follows that Congress may impose
an obligation on the precise identification of the breeder (including its employers and
commissioners) within the application for a variety certificate.
The U.S. requirement not only is compatible with PCT provisions, but it is also
expressly permitted by the Treaty.240 Actually, among the formal requirements the PCT
the contractor, and the public to avoid unnecessary payment of royalties and to defend themselves
against claims and suits for patent infringement.”
48 C.F.R. 27.305-1(a). See Report supra note 231, at 4.
240
Actually, the United States government itself may have thought, at some point, that the U.S. requirement
could be in conflict with the PCT because it has proposed to add a new subparagraph to Rule 51bis.1 of the
PCT Regulations (on “Certain National Requirements Allowed”) as follows:
“where the invention was invented as part of the work performed under a contract with the
government of the designated State, any document containing a statement which indicates any
government license rights in the invention and identifies the government contract.”
See Proposed Amendments of the PCT Regulations and Modifications of the PCT Administrative
Instructions, Relating to the Draft Patent Law Treaty, document PCT/A/28/2, of January 28, 2000, Annex
I, at 12. Later the U.S. Delegation withdrew this proposal, “in light of having undertaken a review of the
controlling statutory provision. That review revealed that the controlling statutory provision only imposed
an obligation on a contractor-applicant to include in the application a statement as referred to in proposed
(vi); it did not provide any authority for the United States Patent and Trademark Office to require such
statement.” See Report, Twenty-Eighth (16th Extraordinary) Session of the PCT Assembly, document
62
refers to, there is a mention of the identification of “the name and other data concerning
the inventor where the national law of at least one of the designated States requires that
these indications be furnished at the time of filing a national application.” (Article 4, on
the Request). The U.S. requirement, which applies to United States patent applications
only (35 U.S.C. 202(6)), concerns the identification of the inventor—concept which
comprises the funding Federal agency which, under the circumstances established in
Chapter 18, acquires the rights which originally belong to the inventor, thus becoming
“the inventor” for all legal purposes.
Because the U.S. requirement has the purpose of clarifying issues of ownership,
and because ownership is crucial to the patent system, the U.S. requirement is consistent
with PLT provisions (which, as explained, incorporates the conditions of patentability
established by the PCT) and with the draft SPLT provisions (which permits Contracting
Parties to define the conditions under which third parties may succeed the inventor in
his/her rights in the invention (Article 4.2)).
In conclusion, the U.S. requirement not only makes good sense in view of the
public policy considerations that buttress it, but also is entirely consistent with U.S.
international obligations.
(ii)
Non-statutory standards and the duty of disclosure
In the absence of a statutory provision obliging patent applicants to inform the
USPTO of the use of TK either as a lead or as a component of the claimed invention,
U.S. courts may hesitate to recognize TK holders’ legal standing to claim compensation
from patent owners. Let us take the following hypothetical example: a bioprospector
obtains information from a shaman on the medicinal use of a given genetic resource; the
bioprospector may then buy some samples of that resource from the shaman or may
receive them as a gift, and, back in the United States, provides the information and the
collected samples to a pharmaceutical company. Guided by such information, the
company identifies a bioactive component in the resource, discovers its useful properties
and develops such information into a final product, several years later. Eventually, the
company obtains a patent on the isolated and purified bioactive component as well on its
use. The company also obtains marketing approval from the FDA and starts selling the
drug on the market.
PCT/A/28/5, of March 17, 2000, at paragraph 11. Actually, the U.S. delegation was correct in concluding
that there was no need for the proposed amendment, but the real reason, as explained above, is not that the
USPTO has no authority to verify compliance with the statutory requirement. Actually, the PCT is not
about the authority of patent offices to impose formal requirements: it is indeed about the possibility of
Contracting Parties to impose those requirements, either through statutes or patent offices’ administrative
practices. If the PTO argument prevailed, countries could establish the Requirement as a condition of
validity of patents, provided patent offices had not the task of verifying compliance (which would be left to
courts). To this extent, the U.S. requirement may indeed be scrutinized in the light of the PCT. But the
reason is different: actually, the PCT allows for the U.S. requirement because it relates to the identification
of third parties’ ownership interests in the claimed invention.
63
As discussed above, we have here two different situations: in one of the situations
(the patent on the isolated and purified component), the shaman has supplied information
and samples of the genetic resources, and in exchange he has received either a very small
amount of money or no payment whatsoever; in a second situation, the shaman is indeed
an inventor or co-inventor, because he (or one of his ascendants) was the person who
created the mental concept of the solution for the technical problem (the problem was a
certain illness and the solution was the use of the bioactive compound to combat the
illness or its symptoms). The second situation is already dealt with by patent law, and the
following discussion will not cover it. The difficulty lies in the first situation (in the
absence, of course, and as noted, of a special statute). As seen, 241 the shaman cannot be
deemed a co-inventor, regardless of the importance of the raw material to the final
inventive output. His contribution concerned raw material in which no inventive concept
was embodied—or, if it was (for example, the breeding work that made it possible for the
genetic material to acquire (or enhance) the properties in question), it did not have any
influence whatsoever on the inventive work of isolating and purifying the compound. The
shaman’s contribution to the invention, therefore, was not of an intellectual nature.
The problem is whether the shaman can allege that the bioprospector had failed to
disclose to him the potential or actual value of the genetic resource (and the associated
element of TK, which consists of discovering the bioactive properties of the resource),
otherwise he would have requested an increased payment (or, eventually, a share in the
commercial gains derived from the final output). Is the bioprospector, and the company
as his/her successor, liable of fraudulent concealment? Does the bioprospector (or the
company) have a duty to disclose information to the shaman on the effective or potential
value of his TK? Is the bioprospector, therefore, liable in the event he/she fails to do so?
If the answer is yes, TK holders may have standing for asking U.S. courts to make
biosquatters accountable for concealment.
The controlling case is Laidlaw v. Organ (1817),242 where the Supreme Court
held that the buyer did not have the duty of disclosing to the seller of tobacco the news
that a treaty of peace had been signed at Ghent between England and the United States,
which caused the value of tobacco to rise “from 30 to 50 percent.”243 Justice Marshall,
who delivered Court’s opinion, wrote:
“The question in this case is, whether the intelligence of extrinsic circumstances,
which might influence the price of the commodity, and which was exclusively
within the knowledge of the vendee, ought to have been communicated by him to
the vendor? The court is of opinion that he was not bound to communicate it. It
would be difficult to circumscribe the contrary doctrine within proper limits,
where the means of intelligence are equally accessible to both parties. But at the
241
See supra note 121 and accompanying text.
Laidlaw v. Organ, 15 U.S. 178 (1817).
243
Id. at 187.
242
64
same time, each party must take care not to say or do any thing tending to impose
upon the other.”244
If we extrapolate this holding to the contractual relationship between the
bioprospector and the shaman, we will notice that: 1) most probably the bioprospector is
not aware of the real value of the genetic resource; the information he/she controls is that
eventually the genetic resource shown to him/her by the shaman has potential
pharmacological value, but ultimately such value will be assessed several years later,
after much research and testing; anyway, that is already a piece of information that the
shaman did not know; therefore, that is not a situation “where the means of intelligence
are equally accessible to both parties,” in the words of Justice Marshall; 2) the increased
value of the genetic resource (as compared to the value the shaman thinks it has) is both
intrinsic and extrinsic to it—it is intrinsic to the extent that it is a medicinal bioactive
component of the resource that adds value to it; and it is extrinsic to the extent that the
firm’s activities of screening, researching, isolating, purifying and testing the
pharmaceutical product, not to mention the FDA’s administrative act of granting
marketing approval, are the factors that increase the resource’s commercial value; 3)
where the bioprospector does not disclose to the shaman what he already knows about the
resource’s potential value can be deemed a misrepresentation by silence245 and the failure
in informing the shaman of the increased value as a result of the downstream activities
carried out by the pharmaceutical firm could eventually be seen as continuing
misrepresentation.246
Keeton explains that the law after Laidlaw was expanded and that the buyer has
no duty to disclose to the vendor circumstances that make the property much more
valuable, “and this is true regardless of whether the fact concealed is extrinsic or
intrinsic.”247
One might argue that this is an unfair rule, to the extent that it preserves a
situation of unequal information and power between the contracting parties. But, as
Keeton suggests, “the law cannot hope to put all parties to every contract on an equality
as to knowledge, experience, skill and shrewdness; even if it could, would such be a just
and equitable law?.”248 The point is that there is no economic efficiency in promoting
negligence and laziness, and, on the contrary, there is economic efficiency in rewarding
those who diligently pursue information and knowledge. “It is pointed out”, Keeton said,
“that [the duty to disclose information to an indolent vendor] is neither just to the
individual nor is it a wise social policy to follow because it tends to discourage industry
and training.”249
244
Id. at 195.
See W. Page Keeton, Fraud—Concealment and Non-Disclosure, 15 TEXAS L. REV. 1 (1936).
246
Id. at 6.
247
Id. at 21 and 22. Keeton exemplifies with several cases holding that a purchaser of real estate who is
aware of the existence of valuable mineral ores underlying the property has not the duty to disclose such
information to the seller, even when he is aware that the seller is not in possession of such information.
248
Id. at 22-23.
249
Id. at 23.
245
65
Based on this argument, Kronman has crafted the theory that where the individual
obtains information as a result of deliberate efforts, such information should be
considered the subject matter of property rights.250 Therefore, and whereas “The only
feasible way of assigning property rights in short-lived market information is to permit
those with such information to contract freely without disclosing what they know.”, 251 the
bioprospector should be allowed to conceal the information about the intrinsic value of
the genetic resource and associated TK from the shaman. The reason for distinguishing
between knowledge that has been deliberately acquired by the bioprospector (or his/her
employer—the pharmaceutical company) and knowledge that has been acquired casually
is that denying protection to the latter “will have no significant effect on his future
behavior. Since one who casually acquires information makes no investment in its
acquisition, subjecting him to a duty to disclose is not likely to reduce the amount of
socially useful information which he actually generates.”252
Under Kronman’s approach, therefore, the duty to disclose information on the
value of the genetic resource would take place only where genetic resource collection is
random or ethnobotanical,253 and provided the bioprospector is actually in possession of
such information—most frequently he is not. In contrast, taxonomic collection would
never be subject to the duty of disclosure, because taxonomic collection is deliberated
and targeted, which leads to the presumption that knowledge about the value of the
collected genetic resources has been previously acquired.
Another commentator, with the same purpose of fostering acquisition of socially
useful information, stretched Kronman’s idea and proposed that doctors and
biotechnological firms should be allowed to lie to patients who contribute with materials
extracted from their own bodies.254 Accordingly, bioprospectors should not only be
allowed to conceal information for taxonomic collection of genetic resources: they should
also be allowed to lie, if asked by the shaman about their intentions as to the utilization of
the resources.
250
Anthony T. Kronman, Mistake, Disclosure, Information, and the Law of Contracts, 7 J.L. STUDIES 1, 14
(1978).
251
Id. at. 15.
252
Id. at 15-16.
253
See supra note 76 and accompanying text, for an explanation of the three types of collection: random,
ethnobotanical and taxonomic.
254
See Robert Heidt, Maintaining Incentives for Bioprospecting: The Occasional Need for a Right to Lie,
13 Berkeley Tech. L. J. 667 (1998). Bioprospecting, in Heidt’s comment, means “the search for valuable
cells.” Id. at 667. Heidt addresses a single situation: a doctor extracts some material from the body of one
of his patients, and he/she finds some interesting and potentially valuable properties in some cells. But
because the cells did not resist the tests and perished, the doctor needs to obtain additional material. Heidt
suggests that the doctor should not only be entitled to omit that information to the patient (which would
have Kronman’s assent) but also, if asked by the patient, he should also be allowed to lie about the real
value of the cells. For a general discussion about how patent law applies to collection of human genetic
material, see Cynthia M. Ho, Who Deserves the Patent Pot of Gold?: An Inquiry into the Proper
Inventorship of Patient-Based Discoveries, 2002 Hous. J. Health L. & Pol’y 107. See supra note … and
accompanying text for a discussion about why rarely shamans can be seen as co-inventors of the inventions
that derive from the genetic materials they supply.
66
Keeton, however, notes that courts tend to include non-economic factors in their
analysis of contractual relationships where differences in knowledge may lead to
misinformed consent, or mistakes:
“In the present stage of the law, the decisions show a drawing away from this idea
[that law is concerned with freedom of contract, not with morals], and there can
be seen an attempt by many courts to reach a just result in so far as possible, but
yet maintaining the degree of certainty which the law must have. The statement
must often be found that if either party to a contract of sale conceals or suppresses
a material fact which he is in good faith bound to disclose then his silence is
fraudulent. [citations omitted].
“[...] [I]t would seem that the object of the law in these cases should be to impose
on parties to the transaction a duty to speak whenever justice, equity, and fair
dealing demand it. This statement is made only with reference to instances where
the party to be charged is an actor in the transaction. This duty to speak does not
result from an implied representation by silence, but exists because a refusal to
speak constitutes unfair conduct.”255
Given that the issue has become a matter of fairness, and in the absence of a rule
of mathematical precision to dispose of all situations, Keeton lists a series of items to be
checked so as to assess whether there is or not a duty to disclose:
(1)
The difference in the degree of intelligence of the parties to the
transaction. This factor would speak mostly in favor of shamans, who are generally not
in a position to identify the value of the bioactive compounds of the genetic resources
they have bred and used for generations. Moreover, if they had, that might mean that they
were using systematic means of research (in laboratories, for example), which would
destroy the traditional nature of the knowledge. Bioprospection, in that sense, would
become a normal operation of technology and material transfer.
(2)
The relation that the parties bear to each other. This factor could have a
mixed impact on the bioprospector’s duty. If he/she were an anthropologist, fully aware
of the shaman’s cultural values, this second factor could speak in shaman’s favor. But
that would not apply to a tourist who casually subtracts a sample of a plant from a
shaman’s hut, as a holiday souvenir.
(3)
The manner in which the information is acquired. Keeton understands that
the duty is minimal, if not irrelevant, when the information has been acquired casually or
by chance. He thinks, however, that when the information was a result of the collector’s
“bringing to bear the skill and experience acquired by diligent effort, no one would
contend that a duty of disclosure should always exist.”256 Actually, Kronman, as shown
above, contends, on economic grounds, that the duty exists in those circumstances.
Keeton’s standing is one of fairness—which does not always find exact correspondence
255
256
Keeton, supra note 245, at 31.
Id, at 35.
67
in economic considerations. However, as shown above, mistrust by shamans and other
TK holders in general have led to situations of complete blockage of bioprospecting
activities in countries, situations in which all parties have to lose. The duty of disclosure,
if established in reasonable terms, however, may reduce transaction costs and therefore
have an economic justification of its own. Probably, if we narrow our discussion to
associated TK, the most economic way to address those problems of unequal knowledge
is to create formal property rights in the shaman’s knowledge—exactly the other way
around as compared to Kronman’s proposal. For the shaman to prove later that his
knowledge has been misappropriated it would be a simple matter of handing over the
formal title to his property—eventually a certificate of TK registration. There would still
be problems of information. Actually, a prospect licensee may approach a patent owner
and convince him/her of charging a low royalty rate (eventually, a small lump sum) as a
result of his concealing market information about the value of the patented product (or
process). The fact that the patent owner has property rights in the invention may not help
him/her very much in attempting to renegotiate the contract, absent fraudulent
concealment by the licensee. Anyway the existence of formal property rights in TK
would help the shaman negotiate a license, conditioning the future marketing of endproducts to future royalty payments. Therefore, the solution to differences of knowledge
would ultimately be given by the market.
(4)
The nature of the fact disclosed. This factor has to do with the intrinsic or
extrinsic nature of the valuable information. It also concerns whether the information is
qualitative or quantitative. As seen above, associated TK covers both aspects, so this
element, according to Keeton’s list, would operate in shaman’s favor.
(5)
The general class to which the person who is concealing the information
belongs. The bioprospector would have a lower level of duty because buyers are not
expected to inform vendors about the actual value of the good. The general view is that
vendors themselves should diligently obtain information about their own property.
(6)
The nature of the contract itself. This factor would have a mixed impact
on the duty to disclose. Keeton suggests that in contracts of insurance and other contracts
that “greatly affect the life and happiness of some particular individual, and the interest of
society in guaranteeing to each individual a moral and social existence outweighs the
interest of substance of some other person”,257 almost all matters must be disclosed.
Therefore, on the one hand, the bioprospector would not be required to inform the
shaman that eventually the genetic resource the latter is selling may have considerable
economic value, because the transaction in question is eventually a simple contract of
sale of seeds or other reproductive parts of a plant. But, on the other hand, the intangible
element of those seeds—i.e. the traditional knowledge of their practical use—is an
element of identification of the shaman’s culture, it is a part of his identity and soul. In
this sense, this is the sort of contract that society is interested in interfering with, as a
matter of protection of minorities.
257
Id. at 36.
68
(7)
The materiality of the fact not disclosed. Generally, this factor would help
the shaman to request full disclosure by the bioprospector and his/her successor, because
all new (or expanded) uses of genetic resources tend to have an enormous impact on the
their value, for those uses may expose them to a global market, in contrast to the
dimension of the traditional community to which the use has been confined. For example,
the knowledge that a genetic resource traditionally consumed as a food staple within a
single community may be added to the menu of a fast food restaurant chain is
undoubtedly a fact of material relevance.
(8)
The type of damage which the ignorant person will, or is likely to, suffer
from a non-disclosure. When the shaman is interested in simply exercising his right to
say “no” because the piece of information collected by a bioprospector and later put to
commercial use has a religious nature, that damage may be deemed relevant enough to
impact on the duty of disclosure. But if the damage is purely material—stemming from
unjust enrichment, that is, an imbalance in the gains that both parties extracted from the
contract—the link between the type of damage and the duty is not so clear.
(9)
Finally, the conduct of the person with knowledge of the fact non
disclosed. One cannot devise the situation in which a bioprospector takes measure to
prevent the shaman from acquiring by himself knowledge about the value of the genetic
resource in question. However, a bioprospector should know, or should have reasons to
know, that the shaman is not aware of the value of the genetic resources involved in their
transaction nor is he in a position to acquire or develop information in that sense.
Therefore, it is possible that governments may wish to correct a situation of inherent
imbalance as regards the level of information—actually, that is what the CBD provision
on benefit sharing under Article 8(j) is all about.
In conclusion, it is possible that a shaman may persuade a U.S. court to determine
a biosquatter and/or his successors to compensate him for the omission in informing him
of the real or potential value of a genetic resource and/or associated TK, so as to enable
the shaman to request a review of the amounts paid (and eventually, where it may make
economic sense, a rescission of the contract258). This has nothing to do, as a matter of
course, with patent law. What the shaman may complain about is the lack of transparency
or candor by the bioprospector. The fact that a patent application does not disclose any
element that may help the shaman assess the real value of the information he had
provided may simply constitute an additional element for persuading the judge that the
bioprospector has acted without good faith.
(v)
Revisiting a solution to the need for an additional disclosure requirement:
the unclean hands doctrine
258
Actually, some transfers of genetic material do require a continued supply. This is particularly true in
the cosmetics and perfume industry, where synthetic materials are never as efficient as the natural ones. But
in the pharmaceutical sector the same circumstances may also arise. For example, it has been reported that
efforts to successfully synthesize taxol are still undergoing. The use of that bark of the Pacific yew to
produce the anti-cancer drug has put serious strain in the tree’s population. See Pacifi Yew: The Taxol
Story, Canadian Forest Service, at www.pfc.forestry.ca/ecology/yew/taxol_e.html (last visited on January
30, 2003).
69
When TK is used, directly or indirectly, as a basis for creating inventive uses for
genetic resources to which they are associated, and where those inventions become the
subject matter of patents, society has two ways to deal with the need for ensuring the
sharing of eventual benefits arising from those inventions with TK holders: one is to
adopt the Requirement as a condition of patentability; the other is to adopt the unclean
hands doctrine.
The Requirement, as noted above, should not constitute a condition of
patentability. That would undermine the value of patents as effective means of securing
property rights in inventions. The possibility of attacking the validity of those rights
because of factors concerning conditions that are intrinsic to raw materials used, and
extrinsic to the invention itself or to inventorship, would create unpredictability. Patents
would lose much of their accuracy as reliable meters of the invention’s value, as their
validity could depend on elements that have nothing to do with the invention. As said
above, patents are certificates of inventive behavior, and that is in that capacity that they
perform their usefully social function. If transformed into certificates of good behavior,
patents cease being patents as such and become certificates of origin of genetic materials.
Incidentally, the validity of patents could also be scrutinized vis-à-vis acquisition of other
raw materials and research tools, and their purpose of securing intangible assets would
necessarily become meaningless. Moreover, the Requirement, where established as a
condition of patentability does not promote benefit sharing: it simply generates
information about the use of genetic resources and associated TK in the making of
claimed inventions. Most patents fail to generate any economic revenue, particularly in
the pharmaceutical industry, where patent applications are filed very early in the research
process, and patent applicants are far away from obtaining a positive outcome. Thus, as a
monitoring tool, the Requirement would give TK holders information about the existence
of a patented invention only. It would not inform them about the commercial exploitation
of that invention, let alone the financial gains of the patent owner.
I have proposed elsewhere that governments could resort to the unclean hands
doctrine as an alternative to adopting the Requirement as a condition of patentability.
“[…] courts should be able to sanction the lack of candor of patent applicants who
knowingly failed to disclose the source in a manner that would facilitate benefit
sharing, as established by article 15 of the CBD. Actually, the determination that
the concealment of information might lead to the implementation of public
policies concerning benefit sharing is fraudulent is a matter of law. Consequently,
any attempt to enforce patent rights thus obtained would be an abuse of rights. In
compliance with paragraph 2 of article 8 of the TRIPS Agreement and given that
infringement both direct and contributory is a tort, [citation omitted] it can be
imposed that one must have clean hands to obtain relief from an equity court.
[citation omitted] Only after a patentee abandons its unlawful practice and the
effects of the misuse are completely dissipated may it sue infringers. [citation
omitted] In the case of the Requirement, this implies that patent owners would
have to disclose the origin and obtain the appropriate authorizations from the
70
appropriate stakeholders (governments, local authorities, and traditional
knowledge holders) before the patent rights could be enforced against infringers.
“In sum, the national or regional laws of WTO members that restrict access to the
genetic resources found in their territory may require that patent applicants
indicate, if known, the source of genetic resources directly or indirectly used in
obtaining the invention. The lack of that indication by a patent applicant who
knew or had reason to know constitutes fraud. Therefore, the enforcement of the
resulting patent therefore, may be deemed an abuse of rights.
“In the same vein, if one obtains the genetic resource directly or indirectly used in
making a patented invention in a country that has adopted legislation requiring
prior informed consent, the failure to obtain that consent constitutes fraud and,
therefore, an attempt to enforce that patent may be deemed an abuse of rights. In
both cases the patentee’s cleaning his hands by providing the missing information
and/or obtaining the required prior consent, would purge the abuse of rights.
“Importantly, this proposal would not raise transaction costs to an unacceptable
level, making patents ineffective. The sort of care required from patent applicants
would be reasonable under the circumstances. They would be required to indicate
the origin of the resources that they knew or that they had a reason to know—this
is a reasonable care standard. In many cases, mere evidence of compliance with
the national laws of the countries providing the genetic resources would suffice,
without imposing on the patent applicants the burden of engaging in complicated
and costly investigative efforts. On the other hand, infringers would not be able to
get away with illegal practices because the burden of proving the failure by the
patent owner to meet the reasonable care standard would fall upon them. If they
provided no evidence, no defense would exist against the patent owner.
Nevertheless, as explained before, that standard would not be impossible to meet
particularly where the countries of origin had enacted laws on access to genetic
resources. In these cases, assessing whether the patent owner met the standard
would be almost a matter of objective fact finding.”259
The use of the unclean hands doctrine would have advantages over the
patentability condition approach:
Firstly, as a rule on enforcement, it would be compatible with the different
international treaties mentioned above (namely the TRIPS Agreement, the UPOV
Convention, the PCT and the PLT);
Secondly, it would not affect the patentability of an invention. Actually,
the idea proposed is not to use the inequitable conduct rule, because inequitable conduct
can be alleged when the patent applicant fails to disclose to the patent office some
material fact that may be (or probably is) material to the patentability; therefore,
inequitable conduct, like the Requirement, is linked to the conditions of patentability. The
259
See Carvalho, supra note 12, at 399-400.
71
inequitable conduct may also lead to the partial or total unenforceability of the patent but,
unlike the unclean hands doctrine, it cannot be purged.260 To this extent, the idea of
permitting the biosquatter to clean his/her hands is a mitigated inequitable conduct
approach.
It should be noted, however, that when the claims contain matter that is TK (such
as the turmeric patent261) the obligation to disclose it is already clearly established by
patent law. Likewise, when the origin of a genetic resource is relevant for enabling an
appropriate description of the invention, applicants are already under the obligation to
disclose it in the specifications.262 In those two circumstances, failure to inform the patent
examiner about those facts amounts to conceal elements of material importance for the
assessment of the patentability. Those would be grounds for a finding on irremediable
inequitable conduct.
And, thirdly, the unclean hands doctrine does indeed promote benefit
sharing because it surprises the patent owner at the moment he/she is using the court
authority to collect revenue from an infringer (in the form of damages) and/or to impose
its exclusive rights (and maintain its position of exclusive user of the invention in the
market by means of an injunction). Because the court will refuse to do so until the patent
owner cleans his/her hands, the patent owner has no solution other than seeking a
settlement with both the supplier of the genetic resources and the licensor of the
associated TK.
One commentator has already discussed this point in relation to the collection of
human material from patients. Commenting Judge Mosk’s dissent in Moore,263 she wrote:
“[...] [I]n the case of failing to disclose patient contributions, unless the law
changes with respect to whether patients can jointly conceive of an invention,
failure to disclose the identity of patients, or even their contributions, would not
rise to the level of material information for patentability purposes. Although
patients believe that but for their actions, no patentable invention would have
been conceived in the first instance, this information is not material to whether the
ultimate invention is patentable. In addition, allowing information that is not
material to the patentability analysis to be the basis for inequitable conduct runs
counter to the traditional basis for such unenforceability. [...]
260
An overview of recent cases on the inequitable conduct doctrine can be found in Lisa A. Dolak, The
Inequitable Conduct Doctrine: Lessons from recent Cases, 84 J.P.T.O.Soc’y 719 (2002).
261
See supra note 72 and accompanying text.
262
Several countries, in their responses to the WIPO questionnaire on the Requirement, have noted that
aspect. See Initial Report, supra note 11, in particular paragraphs 57 et seq. The countries that noted that
applicants are already under the obligation to identify the origin of genetic resources in the specifications
when it constitutes an important element for enabling the understanding and the reproduction of the
claimed invention are: Germany, Switzerland, the United States, Vietnam, France and the European
Community.
263
Moore v. The Regents of the University of California, 51 Cal. 3d 120 (Sup. Court of Cal., 1990), cert.
denied, 499 U.S. 936 (1991). See supra note 136 and accompanying text.
72
“In addition, even if the patent laws were amended to make patents unenforceable
if patient contributions were not properly disclosed to the patent office, it is
unclear whether this would be an optimal approach. In particular, for patients who
want to share of patent profits, creating a new rule for unenforceability would
negate any such hope of profits. Nonetheless, if patients cannot be considered
joint inventors, an unenforceability rule might provide a helpful bargaining
platform for some patients. Accordingly, perhaps patients should advocate a new
patent rule requiring all patent applicants to disclose the extent of patient
contributions to the invention, as well as what compensation, if any, has been
provided for such contributions.”264
I do agree. The inequitable conduct, like the Requirement (as a condition of
patentability), destroys the economic incentive for the inventor and seriously reduce the
possibility of the TK holder to share benefits. Of course, it is not because the patent will
become unenforceable that the inventor will cease completely to obtain gains from its
exploitation. A patent is not a sine qua non guarantee of commercial success. Nor once it
is lost or expired, ceases the inventor from commercially exploiting it. We can think of a
very long list of inventions that continued being profitably exploited by their inventors
after the expiry of the respective patents. Nonetheless, the expiry of the patent (or the
lapse of the rights to enforce it) reduces the patentee’s capacity of reaping the fruit of a
commercially successful invention because nothing will prevent others from doing the
same.
The unclean hands doctrine approach has the advantage that it does not affect the
enforceability of the patent—it just suspends it until the patent owner cleans his/her
hands.265
IV.
THE POSITIVE PROTECTION OF TK
“He who seeks to build a better mousetrap today has a long path to tread before
reaching the Patent Office.”, Justice Clark wrote.266 Justice Clark, of course, was not
referring to shamans who would wish to walk to the Patent Office in search of legal
protection for their knowledge. Justice Clark was referring to the widening of the prior art
in many technical fields, of which the patent applicant must be aware because of their
impact on the appropriate tests of patentability. But Justice Clark’s sentence applies in the
264
Id. at 154. The commentator describes a situation that is almost exclusive to U.S. law. In most countries
patents cannot be granted on cells, cell lines, genes or gene sequences, if of human origin. See Review of
the Provisions of Article 27.3(b)—Illustrative List of Questions, WTO document IP/C/W/273/Rev.1, of
February 18, 2003.
265
See Manuel Ruiz, The International Debate on Traditional Knowledge as Prior Art in The Patent
System:
Issues
and
Options
for
Developing
Countries,
available
at
www.southcentre.org/publications/occasional/paper09/toc.html (last visited on November 26, 2002), and
Commission on Intellectual Property Rights (CIPR), INTEGRATING INTELLECTUAL PROPERTY RIGHTS AND
DEVELOPMENT POLICY (London, September 2002), at 86-87, available at www.iprcommission.org (last
visited on November 13, 2002).
266
Graham v. John Deere Co., 383 U.S. 1 (1965).
73
context of the article as well: indeed shamans who have invented a better plant or animal
genetic resource and/or a practical application thereof have a long path to tread before
reaching the Patent Office. But differently than patent applicants, the long path that lies
ahead for shamans is more of a legal nature. Before having to worry with the niceties of
formalities and procurement procedures in the patent office, shamans have the urgent
need for a legal system that treads that path.
TK holders may pursue two different avenues: in some countries, they may resort
to traditional mechanisms, such as copyright, patents and trademarks, to protect those
elements of their knowledge that meet the specific legal conditions; in other countries, sui
generis regimes are already available that purportedly are better adapted to the special
characteristics of TK, in particular their holistic nature. Let us have a brief overview of
how WIPO Members have used the two solutions, as communicated by their delegations
to the WIPO Committee.267
(a)
Traditional IP systems as tools for protecting TK
A number of Committee Members, such as Sweden and Switzerland, have
indicated that IP mechanisms are, in general, available for the protection of TK, provided
the conditions imposed by law are met. But other Committee Members have informed
about experiences concerning the actual use of traditional IP mechanisms. For example:
Indonesia, New Zealand, Qatar, Samoa, Uruguay and the European
Community said that copyright and related rights law could eventually protect some
traditional creations. Australia mentioned a few court opinions that relied on copyright to
protect Aboriginal creations.268 Canada noted that the Copyright Act was used by
Aboriginal artists, composers and writers to protect their creation (some examples
included wood carvings, silver jewelry, songs and sound recordings, and sculptures).269
Costa Rica, Hungary, Japan, the Republic of Korea, the Republic of
Moldova, New Zealand, and Romania said that patent law was generally available for
protecting traditional inventions, provided the conditions of patentability were met.
Kazakhstan gave several concrete examples of patents covering TK-based inventions
such as “method of producing kumis (mare’s milk)” (Patent of the RK No. 33), a “method
of producing shubat (female camel’s milk)” (Patent of the RK No. 6237), and “method
Kushkon of manufacturing relief picture of leather” (Patent of the RK No. 4619). The
267
The following information was extracted from documents WIPO/GRTKF/IC/3/7,
WIPO/GRTKF/IC/4/7, and WIPO/GRTKF/IC/5/7, supra note 13. This information concerns basically TK
stricto sensu, as defined above. Factual information on national experiences in the use of intellectual
property law for protecting expressions of TK can be found in Final Report on National Experiences with
the Legal Protection of Expressions of Folklore, document WIPO/GRTKF/IC/3/10, of March 25, 2002.
268
The delegation of Australia has informed the Committee that further information can be located at
www.austlii.edu.au.
269
A study produced for the Canadian government in 1999 provides an overview of areas of Canadian
intellectual property law of most relevance to Aboriginal people. It sets out brief examples of Aboriginal
peoples’ use of, and their perspectives on, copyright, industrial design, trade-marks, patent and trade
secrecy protection. This paper is available at www.ainc-inac.gc.ca/pr/ra/intpro/intpro_e.html.
74
Russian Federation also has granted several patents for TK-based inventions, namely
several medicines based on medicinal plants. Vietnam informed about Patent No.
VN1017, for a “Traditional preparation of medicinal plants used for assistance in
stopping drug-addition.”
New Zealand and Turkey noted that plant variety protection (plant
breeders’ rights) was also available for tradition-based creations, including arts and
crafts.
Hungary, Indonesia, the Republic of Moldova, Uruguay and the European
Community informed the Committee that TK-based products could be identified and
distinguished under trademarks. Australia said that trademark law, and in particular
certification marks, could be used for helping protect the interests of Indigenous peoples
through identifying or authenticating TK-based goods, as a mechanism to promote the
arts and crafts of indigenous people. Canada noted that trademarks, including
certification marks, are often used by Aboriginal people to identify a wide range of
traditional goods and services, such as traditional art and artwork, food products,
clothing, tourist services and enterprises run by First Nations. Many Aboriginal
businesses and organizations have registered trademarks relating to traditional symbols
and names, but the number of unregistered trademarks used by Aboriginal businesses and
organizations is considerably greater than those that are registered. In Costa Rica,
Indigenous peoples have marked cattle with distinctive signs. France mentioned, as an
example of a collective mark, “Laguiole Origine Garantie” for designating cutlery articles
made in Laguiole, a commune in the Aveyron department. Mexico informed about the
experience obtained from the registration of “Arte Seri,” a trademark that identifies
handicrafts made by the Seri People. The delegation of Mexico elaborated on several
problems arising from that registration, namely the financial and administrative burdens
(given the different nature of the handicrafts, several registrations had to be filed,
according to specific nature of the crafts produced) as well as the legal problem of the
absence of a clear identification of the community as a legal entity. In view of that
problem the Seri people had to constitute a cooperative—a legal concept that does not
correspond to Indigenous customs and traditions. Besides, as a cooperative, the trademark
collective owner may exclude Seri individuals from the use of the trademark, which
would run against the collective nature of their knowledge. The government of New
Zealand informed that it had funded the development of a “Maori Made Mark.” The
Maori Made Mark is a mark of authenticity and quality, which indicates to consumers
that the creator of works is of Maori descent and produces work of a particular quality.
The delegation of Portugal gave several examples of collective trademarks (such as
“Arraiolos” for carpets, “North Alentejo” for handicraft). Vietnam mentioned trademark
registration No. 30848 (Truong Son Balsam), which designates traditional balm of
medicinal plants.
-
Some IP mechanisms are more adequate than others for protecting TK,
because of the special nature of their respective subject matters. Geographical indications
seem to be one of those mechanisms that have been developed having in view the
75
protection of TK. The WIPO Secretariat acknowledge that in a document prepared for the
third session of the Committee:
“For example, it was noted above that some Committee Members seem to
understand that a few intellectual property mechanisms are more suitable for the
protection of traditional knowledge than others. Geographical indications seem to
be one of those mechanisms. Venezuela and Vietnam have provided concrete
examples of the use of geographical indications with that purpose. Geographical
indications, as defined by Article 22.1 of the TRIPS Agreement, and appellations
of origin, as defined by Article 2 of the Lisbon Agreement for the Protection of
Appellations of Origin and their International Registration, of October 31, 1958,
rely not only on their geographical connotation but also, essentially, on human
and/or natural factors (which may have generated a given quality, reputation or
other characteristic of the good). In practice, human and/or natural factors are the
result of traditional, standard techniques which local communities have developed
and incorporated into production. Goods designated and differentiated by
geographical indications, be they wines, spirits, cheese, handicrafts, watches,
silverware, and others, are as much expressions of local cultural and community
identification as other elements of traditional knowledge can be. Additionally, the
geographical reference of a geographical indication or appellation of origin is an
indirect means of appropriation of traditional techniques that otherwise might be
in the public domain. This second element is clearly predominant in certifications
marks, under which, unlike geographical indications, the technical content of the
knowledge is the most visible part of the equation, irrespectively of any
geographical link”270
At the third session of the Committee, several Members expressed their discomfort
with the prominence accorded by the Secretariat to geographical indications,271 because
of their concerns with the ongoing discussions on Articles 23.4 and 24.2 (part of the
TRIPS Agreement built-in agenda) in the TRIPS Council. For that reason, the special
reference to geographical indications was deleted from the subsequent edition of that
document—but the propriety of the Secretariat’s note remains intact. In its responses to
the first WIPO questionnaire on national experiences with the use of traditional
mechanisms, Mexico informed about two geographical indications (Olinalá and Tequila)
and said that, because geographical indications, under Mexican law, belong to the
government, the risk of certain Indigenous individuals being excluded from its utilization
was avoided. For this reason, geographical indications were seen as more appropriate
than collective marks. France, Italy, the Republic of Moldova, Portugal, the Russian
Federation, Tonga, Turkey, Venezuela and Vietnam also provided information and
concrete examples of geographical indications designating Indigenous handicrafts or
agricultural products.
270
Document WIPO/GRTKF/IC/3/7, supra note 13, at paragraph 40.
See Report of the third session, supra note 13, statements by the Delegations of Venezuela (at paragraph
176), Argentina (at paragraph 177), Brazil (at paragraph 178) and Guatemala (at paragraph 186).
271
76
- Australia, Costa Rica, New Zealand and Toga stated that industrial designs were
appropriate for the protection of TK. In Kazakhstan the external appearance of traditional
clothing, head dresses (saykele), head dresses (saykele), carpets (tuskiiz), decorations of
saddles, national dwellings (yurta) and their structural elements are registered as
industrial designs. And so are women’s accessories such as bracelets (blezik), national
children’s cots-crib-cradles and table wares (piala, torcyk). In the Russian Federation,
among several examples, the famous matrioshka dolls, in different configurations
(including an assembling doll), are also the subjet of industrial design registrations.
- Canada, Hungary, Indonesia and the United States of America added that trade
secret protection was particularly fit for protecting undisclosed TK. In Australia a court
has already used the common law doctrine of confidential information to prevent the
publication of a book containing culturally sensitive information (Foster v Mountford
(1976) 29 FLR 233).
(b)
Sui generis systems for the protection of TK
(i)
The idea of a sui generis system for the protection of the contents of TK
databases
Is a sui generis system really necessary for protecting TK? The United States has
insisted in the Committee that before embarking on such an exercise, it would be more
convenient to explore first the experiences developed at the national level. In fact, “given
that it was possible to protect TK now, using a contractual regime for access to genetic
resources, TK and benefit-sharing, [the Delegation of the United States] questioned
whether it was necessary to develop an international sui generis system of protection of
TK. […] It concluded by stating that, whilst it did not wish to discourage other countries
from developing their own sui generis systems at a national level (so long as they
complied with existing international obligations272), so far as it was concerned, the case
for an international sui generis had not yet been made, and further study was needed.
Only once it was clear that there was a compelling international problem that could be
addressed by IP systems, and that national sui generis regimes alone could not solve this
problem, should the Committee consider possible international solutions. The
international level should not be a first recourse, but rather the last.”273
But the need for a sui generis regime does not necessarily stem from the
insatisfactory experience of the use of traditional IP regimes at the national level. In some
cases, actually, when there is a clear incompatibility between those regimes and the
characteristics of the subject matter, there is no need for obtaining some frustrating
experiences beforme moving towards the adoption of a sui generis regime. The treatment
272
The United States delegation was probably referring to the disclosure requirement. As far as national
treatment and most-favored-nation treatment obligations, because TK (while protected by a sui generis
regime) is not either the subject matter of the Paris Convention or of the TRIPS Agreement, they do not
apply. The reciprocity clauses of Panama’s Law No. 20 (see infra Section IV(b)(ii)(2)) and of the Thai Act
(see infra Section IV(b)(ii)(5)), for example, do not infringe any of those two countries’ obligations under
both the Paris Convention and the TRIPS Agreement.
273
See Report of the fourth session, supra note 24, at paragraph 136.
77
given by the United States to layout-designs of integrated circuits, for example, could
serve as a useful guideline: after enacting legislation to protect layout-designs under a sui
generis regime at the national level, the United States negotiated with its trading partners
the extension (under a reciprocity regime) of that protection to their territories and moved
to multilateral negotiations on the IPIC.274 Because those negotiations failed (on
differences of view concerning compulsory licenses) and the IPIC Treaty has never
entered into force, the sui generis regime was later incorporated (with modifications) into
the TRIPS Agreement.275 276
Likewise, moving to international negotiations on the protection of TK under a
sui generis regime would not be necessarily irresponsible, provided it became clear that
traditional regimes are not entirely adequate to fit the special characteristics of TK. The
questions, therefore, are: does TK have special characteristics that make it unfit for
existing IP regimes? If yes, what characteristics are those?
A short fable may help illustrate the nature of TK and its peculiar
characteristics.277 Let us imagine that a member of an Amazon tribe does not feel well
and requests the pajé’s medical services (pajé is the tupi-guarani word for shaman). The
shaman, after examining the patient, will go to his garden (many shamans in the Amazon
rain forest are plant breeders indeed278) and collect some leaves, seeds and fruits from
different plants. Mixing those materials according to a method only he knows, he
prepares a potion according to a recipe of which he is the sole holder. While preparing
the potion and, afterwards, while administering it to the patient (according to a dosage he
will likewise prescribe), the pajé prays to the gods of the forest and performs a religious
dance. He may also inhale the smoke of the leaves of a magical plant (the “vine of the
soul”279). The potion will be served and saved in a vase with symbolic designs and the
pajé will wear his ceremonial garments for the healing. In certain cultures, the pajé is not
seen as the healer, but as the instrument that conveys the healing from the gods to the
patient.
The TK of the Amazon shaman is a combination of all those elements. If taken
separately, existing IP mechanisms could protect most of, if not all, those elements. For
example: the different plants from which the shaman has made the potion may be
protected under a plant variety protection system, provide the plants are new, stable,
274
Treaty on Intellectual Property in Respect of Integrated Circuits (1989), adopted at Washington on May
26, 1989.
275
TRIPS Agreement, Part II, Section 6.
276
An overview of the enactment of layout-design protection in the United States can be found in Charles
R. McManis, International Protection for Semiconductor Chip Designs and the Standard of Judicial
Review for Presidential Proclamations Issued Pursuant to the Semiconductor Chip Protection Act of 1984,
22 GEORGE WASHINGTON J. INT’L L. & ECON. 331 (1989).
277
The shaman’s fable and the discussion that follows were originally addressed in the article cited supra
note 1, at 10-11, and was borrowed by documents WIPO/GRTKF/IC/3/8 and 4/8, supra note 19, at
paragraphs 22 et seq. and 38 et seq. respectively.
278
See Plotkin’s description of how the rainforest shamans collect materials for their potions, supra note
61, at 200 et seq.
279
See Richard Evans Schultes and Robert F. Raffaut, Vine of the Soul—Medicine Men, Their Plants and
Rituals in the Colombian Amazonia, ed. Synergetic Press and Conservation Int’l, 1992.
78
distinct and uniform; the potion (or the formula thereof) can be the subject matter of a
patent, provided it is new, inventive and susceptible of industrial application; if not yet
disclosed and the shaman has taken measures to prevent others from learning it, the
potion can be protected as undisclosed information; the use and the dosage of the potion
can also be protected by a patent, under the laws of a few countries which make patents
available for new uses of substances as well as for new and inventive therapeutic
methods; the prayer, once fixed, could enjoy copyright protection, and under many
countries’ laws may also enjoy copyright protection in the absence of fixation; the
performance, once fixed, can be protected by copyright-related rights, and the shaman—
as performer—can be accorded the right to authorise the fixation of the performance; the
vase containing the potion can be patented or protected under a utility model certificate if
it has new and inventive functional features; if not, it can be protected under an industrial
design system; the designs on the vase and on the garments can be protected either by the
copyright or by the industrial design systems.
However, the possibility of protecting separately the elements of TK does not
necessarily cover the need for protection of TK. Traditional knowledge is not the mere
sum of its separated components: it is the consistent and coherent combination of those
elements into an indivisible piece of knowledge and culture. For the pajé, needless to say,
the merit of the healing resides in the combination of the extract with the religious rituals,
and not on the potion individually. The features of the several IP mechanisms mentioned
above do not accept such a combination of elements of knowledge as a subject matter. It
may be necessary, therefore, to design a system that responds to the holistic nature of TK
and takes a comprehensive approach to it. Patents, trademarks, designs, etc, may be very
effective in providing protection for the individual elements of TK; but they do not attend
to its holistic nature.
Traditional knowledge, in that holistic concept, has four unique characteristics:
the spiritual and practical elements of TK are intertwined and thus are inseparable (it is in
this sense that every element of TK serves as an inherent factor of cultural identification
of its holders); since traditional communities generate knowledge as a response to a
changing environment, TK is in constant evolution and incrementally improving; TK
covers different fields, in areas of cultural expressions and in technical domains; finally,
because its creation is not undertaken through a formal, expressly systematic procedure,
TK cannot be described with the same technical detail as required for patent
specifications—shaman may be indeed very knowledgeable about uses and properties of
a given genetic resource, but they do not necessarily know its chemical or biological
composition.
With those four characteristics in view, the only way adequate for documenting
and formalizing the protection of TK is through collections, or inventories, or databases
of TK.280 Through such a mechanism, a shaman could go to the patent office and file a
280
This idea was first spelled in 1999 (see Carvalho, supra note 1, at 10 et seq.). Since then, it has gained
support from several delegations:
Brazil: “The forms of protection of traditional knowledge is another issue that calls for
clarification. One possibility to ensure such protection could be the establishment of databases at
79
general written description of his knowledge about the uses and properties of, say, the
plants he employs in his daily activities in the tribe. Along with the description of the
uses and properties, the shaman eventually would need to include recordings of the songs
and the dances, and drawings of the symbols and the garments. Only an inventory of TK
would permit such a collection of indissociable data without obliging the shaman to
dismember his knowledge into separate elements.
As a matter of course, when referring to TK databases, there is no necessary
mention to electronic databases: TK databases mean just collections of elements of TK in
an organized manner and/or in accordance with certain selection criteria. To that extent,
existing ethonobotanical or anthropological books describing medicinal plants and the
the national or international levels, and the enforceability of rights in the data against their use by
unauthorized parties.” Statement of the Delegation of Brazil at the WIPO Meeting on Intellectual
Property and Genetic Resources, Geneva, April 17 and 18, 2000 (on file with the WIPO
Secretariat). At the third session of the Committee, the delegation of Brazil clarified this statement
by saying that “Databases could be potentially useful for preventing unauthorized use, provided
that the burden of proof was not on the holders of TK and that the registry in such databases was
not a requisite for the protection of TK.” See Report of the third session, supra note 13, at
paragraph 219.
Group of Countries of Latin America and the Caribbean: “System of sui generis databases:
among the positions taken by legal writers, [citation omitted] there are some that tend to claim that
the best way of protecting traditional knowledge, given its characteristics, variety and sheer scale,
would be through the introduction of sui generis databases. Apart from the standard rights in
databases that are original in terms of the selection or arrangement of their contents, these would
be characterized by the following additional features: Protection of undisclosed information:
protection of the arrangement of the information within the database would not be sufficient;
there would have to be rights in the knowledge actually recorded. Without protection of the
subject matter, there would be no incentive to pass it on in the case of innovations, or to organize
it and refine it in the case of traditional knowledge. Right of exclusion applicable not only to
reproduction of the information, but also to the use of registered information. No need for prior
fixing of the information as a condition of the grant of protection.” Traditional Knowledge and the
Need to Give It Adequate Intellectual Property Protection — WIPO Committee on the
Relationship Between Intellectual Property, Genetic Resources and Traditional Knowledge —
Documents submitted by the Group of Countries of Latin America and the Caribbean (GRULAC),
document WIPO/GRTKF/1/5, of March 16, 2001, Annex I, at 9.
Venezuela: “The Delegation concluded that the only manner to adequately address the concerns of
traditional knowledge holders would be to develop a positive protection system by means of a sui
generis system for the intellectual property protection of the contents of indigenous knowledge
databases.” Statement of the Delegation of Venezuela, speaking on behalf of Cuba, Ecuador and
Venezuela at the third session of the Committee, Report, supra note 13, at paragraph 122.
Asian Group and China: “Member States may document their traditional knowledge to avoid its
loss with the passing away of the older generations. When documenting the traditional knowledge,
governments may take into account existing intellectual property standards and distinguish
between traditional knowledge which is in the public domain and traditional knowledge which is
not in the public domain. Based on this distinction, Member States may: […] establish registers of
traditional knowledge elements which are not in the public domain and keep the contents of the
registers undisclosed, pending the possible establishment of new protection standards for the
traditional knowledge elements contained in the registers.” Position Paper of the Asian Group and
China, document WIPO/GRTKF/IC/2/10, of December 3, 2001, at 3.
France: “[…] [P]rotection of traditional knowledge requires a sui generis system which will need
the establishment of inventories in which they will be compiled.”
To this, we may add the recently enacted statutes of Peru and Portugal, which have adopted a sui
generis system of registration and protection of TK inventories (see Section IV(b)(ii)(3) and (4)).
80
uses certain communities give them are TK databases. Moreover, there is no need for
maintaining a single sort of database as an instrument of rights acknowledgement. A
certain Indigenous community may wish to describe their medicinal, agricultural and
other technical knowledge in separate inventories. Another community may prefer to
describe the whole of its knowledge in a single document. A country may also decide to
make a single, national TK database—such as Biozulua.281
TK rights must cover the contents of such databases. Those contents are indeed
the products of creative work, and in that sense they are original, because their origin can
be attributed—frequently, the attribution falls upon a community, but in some cases it
may designate an individual within a certain community.
Because TK lato sensu comprises ideas and expressions, the rights conferred
should be those of excluding others from using the ideas, and/or of excluding others from
reproducing the expressions (and/or fixing the performances). This is the second element
of the sui generis regime: a regime that combines features of industrial property law with
those of copyright and related rights. This distinction needs not to be made at the
registration phase. Once vested in the title, the shaman is able to go to a court and
demand protection against a third party who uses his potion’s formula to develop a
product. In this event, the judge may not only order the payment of compensation but
also issue an injunction prohibiting the infringer to continue using the shaman’s
proprietary formula. But where a third party reproduces one of the shaman’s songs or
uses it as a basis for a new song, the judge may issue an injunction against the
reproduction of that song.
The protection being formalized through a description of the different elements of
the shaman’s TK, it will be possible for him to come back to the patent office to expand
the database with new elements or with modified elements. A database—unlike patent
specifications—is flexible enough to accept such improvements without the need for an
entirely new registration procedure. Protection should be granted for every new element
added to the original database. If the law establishes terms of protection from the date of
the registration, then a new term would be applied to each new element added. This idea
has to do with the fact that TK is not necessarily old, that is, it continues evolving.282
Therefore, TK creators should be given the possibility of reflecting the evolution of their
knowledge in the documents that formalize their rights.
Finally, no one should expect that a shaman would be able to identify the
chemical compositions of his potions or the scientific principles of their uses. A
description would be necessary only for a third person to understand (and, eventually, to
reproduce) the use given by the shaman to a determined genetic resource.283 Such a
simple (but minimally enabling) description would be, nonetheless, necessary for
substantiating a claim of property rights. That is, by the way, the whole idea of TK
databases as tools of positive protection. Property rights, as said above, are essentially the
281
Supra note 114 and accompanying text.
See supra Section II(a).
283
See Portugal’s Decree-Law No. 118/2002, Article 3.2(b).
282
81
right to prohibit others to trespass. But for the prohibition to be enforceable, it is of the
essence that the limits of the land be publicly announced so that others can be informed
of those boundaries. The same concept applies in IP. Patented inventions must be
disclosed so that others can be informed about their rights and obligations concerning the
claimed and patented invention: if they cross the boundaries identified in the claims and
can allege no exception to the patent rights confereed, they will be found in infringement.
A shaman may not allege biosquatting (or, once his rights are clearly identified,
infringement) and request a court to rule accordingly if third parties have no way to
clearly identify where the boundaries of TK rights are. TK databases, as simple as they
can be, constitute the ultimate piece of evidence of the shaman’s property rights.
Should patent offices examine claimed TK? Panama and Peru have answered yes.
In Panama, there will be a technical exam concerning the regulation of use adopted by the
community. The patent office of Panama will also look at whether the description of the
techniques, materials and uses of the claimed piece of TK (the style of handicrafts, as
discussed infra284) correspond to the regulation supplied by the community. Moreover,
third parties’ eventual oppositions will be decided. In Peru, the patent office will have to
examine claimed TK as to its novelty: disclosed TK will integrate a public inventory;
undisclosed TK will be kept in a secret inventory.285 In Portugal TK will not be
administratively examined286: it follows that the conditions of registration (and
consequently its validity) will be assessed by a court if challenged by a third party.
The idea of a sui generis regime of protection of original contents of TK
databases is not incompatible, as explained above, with measures enforcing rights in
specific elements of TK. If a third party uses the formulation of the potion invented by
the shaman, enforcement measures should be available to address such an act of
infringement regardless of the lack of the reproduction of the prayer or the performance
by the infringer. This “minimalist” approach has an example in patent law: an infringer
does not need to “trespass” on all the claims of a patent to be liable as such. Infringement
of one claim may be enough, as a matter of law. Similarly, it is possible to infringe
copyright in a musical work by different acts (reproduction, broadcasting, making
available to the public, etc.) without necessarily carrying out them all. The “holistic”
notion of TK calls for a simple mechanism for its recording and registering, but should
not stand in the way of the enforcement of rights in each of its individual elements.
Protection of original contents of databases is not an entirely new idea. It can be
found actually in two international agreements. One is the TRIPS Agreement and its
provision on protection of test data (Article 39.3). The other is the United Nations
Convention to Combat Desertification (UNCCD) and its provisions on the elaboration of
inventories of TK and protection of their contents (Article 18.2(a) and (b)).
284
See infra Section IV(b)(ii)(iv).
See infra Section iv(b)(ii)(3).
286
See infra Section IV(b)(ii)4).
285
82
In the light of Article 39.3 of the TRIPS Agreement,287 the protection of test data
against disclosure is an obligation that merely adds to the primary obligation of
protection data against unfair commercial use and which is thrust upon environmental
and sanitary governmental agencies. The primary obligation of those agencies is to
refrain from facilitating the registration of competing products based on simple
bioequivalence tests when the marketing approval of the first product was based on
original and undisclosed data. Article 39.3, however, says that test data may be disclosed,
where necessary to protect the public, or unless steps are taken to ensure that the data are
protected against unfair commercial use. This means that governments can eventually
disclose test data, provided they will not destroy the commercial value of those data
(disclosure is, in fact, out of question, because competitors could benefit from it so as to
obtain marketing approval in other countries). It should be stressed however that Article
39.3 provides exclusive protection to test data which can eventually be enforced even if
the data were disclosed by the government. We are not looking here at trade secret
protection, but to exclusive protection of data contained in a collection or compilation of
data aimed at providing evidence on the safety and efficacy of pharmaceutical and
agricultural chemical products. So, Article 39.3 actually provides for the exclusive
protection of the contents of databases submitted by pharmaceutical and agricultural
chemical companies as a condition for obtaining marketing approval. Article 39.3 is
indeed about a sui generis system of protection of a certain sort of pharmaceutical and
agricultural chemical databases.288
(ii)
An overview of the statutes of Brazil, Panama, Peru, Portugal and
Thailand
(1)
Brazilian sui generis law
287
Article 39.3 reads:
“3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new chemical entities, the submission of undisclosed
test or other data, the origination of which involves a considerable effort, shall protect such data
against unfair commercial use. In addition, Members shall protect such data against disclosure,
except where necessary to protect the public, or unless steps are taken to ensure that the data are
protected against unfair commercial use.”
For a detailed explanation of Article 39.3 of the TRIPS Agreement, see Carvalho, supra note 81, at 267 et
seq..
288
In this sense, see Elements of a Sui Generis Regime, supra note 19, at paragraph 50. See also document
WIPO/GRTKF/IC/4/8, id., at paragraph 70. At the fourth session of the Committee, the delegations of Peru,
Panama and Argentina asked the WIPO Secretariat to delete that reference to Article 39.3 of the TRIPS
Agreement because WIPO has no mandate to interpret provisions of the TRIPS Agreement. See Report of
the fourth session, supra note 24, at paragraphs 141, 157 and 158. Of course, that was not the problem,
because those two same documents refer to other provisions of the TRIPS Agreement, and yet they invited
no similar requests from delegations. The real problem was one of disagreement among WTO Members
over compliance with Article 39.3 in particular, of which the disputes between the United States and
Argentina are one example (see WTO documents WT/DS171/1, of May 10, 1999, WT/DS171/3, of June
20, 2002, WT/DS/196/1, of June 6, 2000 and WT/DS/196/4, of June 20, 2002). The many references to
lack of adequate protection for test data by U.S. WTO trading partners in the 2002 Special 301 Report
show that is really a matter of major concern. The Report is available at www.ustr.gov.
83
The Brazilian sui generis regime was established by Provisional Measure No.
2186-16, of August 23, 2001, which regulates the protection of TK as a component of
access to genetic resources and associated traditional knowledge. The stated objectives of
the statute are to legislate on access to the genetic heritage in the national territory, the
continental platform and the exclusive economic area for the purposes of scientific
research, technological development or bioprospection; access to traditional knowledge
relating to the genetic heritage, relevant to the preservation of biological diversity, the
integrity of the country’s genetic heritage and the use of its components; the fair and
equitable sharing of the benefits derived from the exploration of the genetic heritage and
related traditional knowledge; access to technology and the transfer of technology for the
preservation and use of biological diversity (Article 1). Human genetic material is
excluded from the scope of the law (Article 3).
Brazil’s statute does not provide for a system of documentation and registration of
TK. Articles 8(II) and 10(II)(d) mention the eventual organization of a database
containing biodiversity-associated TK, but its purpose is for the sake of documenting
only, and not as a requirement of protection. According to Article 8, biodiversityassociated TK is protected “against illegal use and exploitation and other actions that are
harmful or have not been authorized by the Management Council referred to in Article 10
or by an accredited institution.”289 However, TK holders are not entitled to a simple right
to remuneration: they are indeed allowed to say “no” against the use of their TK. In other
words, the Management Council can only authorize the use of TK if an authorization has
been previously granted by TK holders. This stems from Articles 8(I) (which recognizes
the right of communities to decide on the use of their TK) and 10(IV)(b), which says that
the Council can deliberate on “authorization of access to associated traditional
knowledge, subject to the prior consent of the owner.” There is, nonetheless, some
limitation to Indigenous communities’ rights in their knowledge because they will need
an approval by the Council to confirm their authorization. Perhaps this is due to the fact
that the Brazilian Provisional Measure does not contemplate the possibility of contracts
of TK transfer without the transfer of genetic materials. Actually, Article 29 provides that
any contract on access that does not obtain the approval from the Management Council
shall be null and void.
TK holders are granted the rights “to have the origin of the access to traditional
knowledge mentioned in all publications, uses, exploitation and disclosures” (Article
9(I)) and “to prevent unauthorized third parties from “(a) using or carrying out tests,
research or investigations relating to associated traditional knowledge; (b) disclosing,
broadcasting or re-broadcasting data or information that incorporate or constitute
associated traditional knowledge.” (Article 9(II)). The Provisional Measure adds that TK
holders are also entitled to “obtain profits from the economic exploitation by third parties
of associated traditional knowledge the rights in which are owned by the community as
provided in [the] Provisional Measure.” (Article 9(III)). In other words, TK holders are
allowed to license or assign their rights in TK.
289
The Genetic Heritage Management Council (Conselho de Gestão do Patrimônio Genético) was
established by Decree No. 3,945, of September 28, 2001. Laws, regulations and documents concerning
access to genetic resources are available at the Council’s website, at www.mma.gov.br.
84
Under Article 4, protection of TK does not apply to exchange of genetic resources
and associated knowledge “within indigenous and local communities for their own
benefit and based on customary usage.”
Article 25 lists (not exhaustively) some of the benefits that must be shared with
TK holders, such as division of profits, payment of royalties, technology access and
transfer, unrestricted licensing of products or services, and training of human resources.
Obviously, only the first two modalities may be of interest to TK holders. The others are
interesting only to research and government institutions involved in collecting and
transferring samples of biological material.
Violation of the provisions of the Provisional Measure shall entail civil measures
(payment of damages not inferior to “twenty per cent of the gross invoiced amount
obtained through the marketing of the product or of royalties obtained from third parties
by the guilty party as a result of the licensing of the product or process or the use of the
technology, whether or not protected by intellectual property.” (Article 26). Additionally,
administrative sanctions may apply, including the payment of fines (Article 30).
The protection of TK, as accorded by the Provisional Measure, “shall not affect,
prejudice or limit rights pertaining to intellectual property.” (Article 8(IV)).
As mentioned above, TK may be owned collectively “even if only one single
member of the community holds that knowledge.” (Article 9, sole paragraph). This
provision is not entirely clear, but, in view of its specific language used, it seems to
indicate that individuals may also own and exercise rights in TK. If TK ownership were
necessarily collective, the provision would not use the word “may” but “shall.”
As it has already been noted, the Brazilian Provisional Measure contains an element
of defensive protection of TK, insofar as Article 31 makes the grant (and, consequently,
the validity) of industrial property rights in products or processes derived from TK
dependent on the obligation of specifying “the origin of the genetic material and the
associated traditional knowledge, as the case may be.”290
(2)
Panama’s sui generis regime
In 2000 Panama adopted Law No. 20 of June 26, 2000, regulated by Executive
Decree No. 12 of March 20, 2001, entitled “Special Intellectual Property Regime
Governing the Collective Rights of Indigenous Peoples, for the Protection and Defense of
their Cultural Identity and their Traditional Knowledge, and Other Provisions.” The
objectives of Law No. 20 are the protection and defense of the collective intellectual
property rights and the traditional knowledge of indigenous peoples in relation to their
creations, such as inventions, models, drawings and designs, innovations contained in
images, figures, symbols, graphics, petroglyphs and other material. Additionally,
protection is accorded to the cultural elements of their history, music, art and traditional
290
See supra Section III(b)(i).
85
artistic expressions that are suitable for commercial use, by means of a special system of
registration, promotion and commercialization of their rights, with a view to enhancing
the socio-cultural values of indigenous culture and doing social justice to those peoples.
The cultural heritage of indigenous peoples may not be the subject of any form of
exclusive rights in favor of third parties not authorized under the intellectual property
system, such as copyright, industrial design and trademark rights, and the rights in
geographical indications and other subject matter, except where the application is made
by the indigenous peoples themselves.
Law No. 20 defines collective indigenous rights as indigenous cultural and
intellectual property rights that relate to art, music, literature, biological, medical and
ecological knowledge and other subject matter and manifestations that have no known
author or owner or date of origin, being the heritage of an entire indigenous people.291
The rights granted are of an exclusive nature but they may be recognized to the benefit of
third parties provided the request is filed by the indigenous peoples themselves.
Protection is granted upon registration. The administrative procedures are
payment-free and do not require the representation of a lawyer. The Traditional
Indigenous Congress(es) or Authority (Authorities) of the indigenous peoples are
entrusted with representing them and complying with the requirements laid down in the
Regulations under the Law. The intellectual property agency of Panama (DIGERPI) will
create a position of examiner on indigenous collective rights, for the protection of the
intellectual property and other traditional rights of the indigenous communities. This
public officer will have the power to examine all the applications that are filed before
DIGERPI related with the collective rights of the indigenous communities, so the
registration will not be granted against this law. The Regulations provide that there can
be traditional knowledge of indigenous peoples in the form of creations shared between
members of two or more communities, in which case the benefits accrue to both or all of
them collectively, according to customary law.
Law No. 20 provides for two prior user exceptions to rights conferred. Under
Article 23, “The small non-indigenous artisans that dedicates to the manufacture,
productions and sale of the reproduction of crafts belonging to indigenous Ngobes and
Buglés that reside in the districts of Tolé, Remedios, San Félix and San Lorenzo of the
Province of Chiriqui are exempt of this law. These small non-indigenous artisans will be
able to manufacture and to market these reproductions, but they will not be able to claim
the collective rights recognized by this Law to the indigenous group.” A similar
exception is granted by Article 24 to non-indigenous artisans who are registered as such
in the General Office of National Craftsmanship. Indigenous traditional authorities must
nonetheless be informed.
291
The delegation of Panama noted that work is currently undergoing on a draft law for the protection of
the collective rights of local communities, which broadens the definition as follows: they are the
intellectual property rights of indigenous peoples and local communities the subject matter of which is art,
music, literature, biological, medical and ecological knowledge, rituals, games, cultural expressions,
traditional science and technology, gastronomy, cultural traditions, beliefs and other aspects of the cultural
heritage that are not dissociable from the cultural identity of a whole community.
86
Law No. 20 provides for administrative, civil and criminal sanctions against
infringement of TK. Custom and industrial property laws are the primary sources of
enforcement measures. In cases not provided for in either custom legislation or industrial
property legislation, violations of Law No. 20 are punished with fines ranging from 1,000
to 5,000 U.S. dollars, depending on their seriousness. In the event of a repeat offense, the
amount of the fine is doubled. The sanctions provided for in the Law are applied in
addition to the seizure and destruction of the materials used to commit the infringement.
Under the Law and its Regulations, TK holders may license the use of registered
collective rights. There is no provision for the grant of compulsory licenses.
Some aspects of industrial property are complementary to TK protection. Law
No. 20 establishes that the provisions on collective and certification marks contained in
Law No. 35 of 1996 shall be applicable in so far as they do not conflict with the rights
provided for in Law No. 20 itself. The application for registration should (1) include
rules of use, which, in addition to the identifying particulars of the applicant authorities,
should specify the grounds on which use of the collective rights may be denied to a
member of the indigenous people, and (2) include a favorable report by the competent
administrative body on the Regulations of use.292
Under Article 25 of Law No. 20, protection accorded to citizens of Panama may
be extended to citizens of other nationalities in accordance with reciprocity agreements
with those other countries.
(3)
Peru’s sui generis regime
The sui generis regime of Peru was established by Law No. 27,811 of 2002,
whose objectives are the following: (a) to promote respect for and the protection,
preservation, wider application and development of the collective knowledge of
indigenous peoples; (b) to promote the fair and equitable distribution of the benefits
derived from the use of that collective knowledge; (c) to promote the use of the
knowledge for the benefit of the indigenous peoples and mankind in general; (d) to
ensure that the use of the knowledge takes place with the prior informed consent of the
indigenous peoples; (e) to promote the strengthening and development of the potential of
the indigenous peoples and of the machinery traditionally used by them to share and
distribute collectively generated benefits under the terms of this regime; and (f) to avoid
situations where patents are granted for inventions made or developed on the basis of
292
The delegation of Panama has informally communicated to the WIPO secretariat that the first act of
registration of handicrafts (the molas of the Kunas) is near completion, upon approval of its Regulation of
Use. The regime for the protection of handicrafts, as devised by Decree No. 12 of 2001 (which sets the
regulations of Law No. 20), deals with the registration of the “style” of handicrafts, in the sense that the
registration will not be granted to individual crafts, but rather to the style that informs a given line of
products. In describing the handicrafts, Indigenous communities will need to describe the materials and
techniques used, colors, patterns, etc. The registration is, then, granted to the whole concept. To some
extent, the “style” of handicrafts corresponds to the notion of “trade dress”, and comprises those elements
that are uniform and peculiar to a line of products. Based on the general registration, Panamanian
Indigenous peoples may then seek to register individual derivatives, for enhanced protection.
87
collective knowledge of the indigenous peoples of Peru without any account being taken
of that knowledge as prior art in the examination of the novelty and inventiveness of the
said inventions.293
Protection is afforded to collective knowledge of Indigenous peoples associated to
biological resources, as defined in Article 2 of the Law.294 Under Article 10, TK may not
be individually owned. Indigenous peoples will exercise and enforce their rights through
their representative organizations.
Law No. 27,811 grants Indigenous peoples the right to accord consent to the use
of their TK (provided it precedes the use and is informed). In the event of access for the
purposes of commercial or industrial application, a license agreement shall be signed so
as to ensure due reward for the said access and guarantee the equitable distribution of the
benefits deriving therefrom. Contracts must be written and they shall be registered with
the intellectual property agency (INDECOPI). The Law establishes two minimum royalty
rates (which seem to be cumulative): a percentage which shall not be less than ten per
cent of the value, before tax, of the gross sales resulting from the marketing of goods
developed on the basis of collective knowledge shall be set aside for the Fund of the
Development of Indigenous Peoples provided for in Articles 37 et seq.. The parties may
agree on a greater percentage according to the degree of direct use or incorporation of the
said knowledge in the resulting end product and the degree to which the said knowledge
contributed to the reduction of the cost of research and development work on derived
products, among other things. (Article 8). Additionally, the licensing agreement shall
provide for the compensation of indigenous peoples for the use of their collective
knowledge; such compensation shall include an initial monetary or other equivalent
payment for its sustainable development, and a percentage of not less than five per cent
of the value, before tax, of the gross sales resulting from the marketing of the goods
developed directly and indirectly on the basis of the said collective knowledge, as the
case may be. (Article 27(c)). 295
Law No. 27,811 distinguishes three categories of TK according to its level of
novelty. Under Article 13, collective knowledge that has been made accessible to persons
293
The protection of TK in Peru has, therefore, two distinct but correlated objectives: to positively and
defensively protect TK.
294
The term “Indigenous peoples” means aboriginal peoples holding rights that existed prior to the
formation of the Peruvian State, maintaining a culture of their own, occupying a specific territorial area and
recognizing themselves as such. These include peoples in voluntary isolation or with which contact has not
been made, and also rural and native communities. “Collective knowledge” means the accumulated,
transgenerational knowledge evolved by indigenous peoples and communities concerning the properties,
uses and characteristics of biological diversity. And the term “Biological resources” means genetic
resources, organisms or parts thereof, populations or any other kinds of biotic component of ecosystems
that are of real or potential value or use to mankind.
295
In a nutshell, contracts involving the licensing of TK shall generate a remuneration of not less than 15%
of the value, before tax, of the gross sales of products resulting directly or indirectly from the use of the
licenses TK. Except for the pharmaceutical sector, there are not many fields in which royalty rates reach
such a high percentage. The figures adopted by Law No. 27,811 seem a little farfetched and unrealistic,
particularly having in view the proportion of the participation of TK in the work of researching and
developing derived products and processes.
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other than the indigenous peoples by mass communication media such as publication or,
when the properties, uses or characteristics of a biological resource are concerned, where
it has become extensively known outside the Indigenous peoples and communities, is
deemed in public domain. However, in the event the collective knowledge has passed
into the public domain within the previous 20 years, a percentage of the value, before tax,
of the gross sales resulting from the marketing of the goods developed on the basis of that
knowledge shall be set aside for the Fund for the Development of Indigenous Peoples
provided for in Articles 37 et seq.. In other words, TK that has been disclosed within the
previous twenty years is subject to a sort of paid public domain regime. TK holders will
have not the right to oppose to its use by third parties—they are entitled to a mere right of
remuneration. Both categories of TK in the public domain will be contained in the Public
Register of Collective Knowledge of Indigenous Peoples. The third category is TK which
has not been publicly disclosed and therefore has not fallen into the public domain.
Undisclosed TK will be registered in the Confidential National Register of Collective
Knowledge of Indigenous Peoples as per Indigenous peoples’ request. Both Registries
will be administered and maintained by INDECOPI.
The rights conferred are those of registering (Article 20)296 and licensing (Article
27) TK. Moreover, Indigenous peoples possessing collective knowledge shall be
protected against the disclosure, acquisition or use of that collective knowledge without
their consent and in an improper manner provided that the collective knowledge is not in
the public domain. Registered TK shall likewise be protected against unauthorized
disclosure where a third party has legitimately had access to collective knowledge
covered by a safeguard clause. (Article 42). Indigenous peoples possessing collective
knowledge may bring to the Office of Inventions and New Technology, of INDECOPI,
infringement actions against persons who violate their rights in TK. An infringement
action shall also be permissible where there is an immediate danger of such violation.
Infringement actions may be brought ex officio by order of INDECOPI. (Article 43).
Where infringement of the rights of an indigenous people possessing specific collective
knowledge is alleged, the burden of proof shall be on the defendant. (Article 44). 297 TK
holders may bring the actions claiming ownership and compensation that are available to
them under the laws in force against a third party who, in a manner contrary to the
provisions of this regime, has directly or indirectly made use of the said collective
knowledge. (Article 45). Provisional measures are available.
Registration can be cancelled at any time by INDECOPI, either ex officio or at the
request of a third party, after the parties concerned have been heard, where: (a) the
registration or license has been granted in violation of any of the statutory provisions; or
(b) it is shown that the essential data contained in the application are false or inaccurate
(Article 34).
296
However, registration of TK is declaratory, and not constitutive of rights. This means that rights precede
or are independent of registration. The importance of registration is in the establishment of elements of
evidence of the rights’ existence.
297
Because TK holders may enforce rights in non-registered TK, the reversal of the burden of proof should
be limited to allegations of infringement of registered TK. In this event, there is already a presumption of
ownership. But where registration is absent, there is nothing else than the word of the TK holder—word
which should not be more valuable than that of the defendant, under a principle of fairness and equity.
89
As noted above, protection of TK in Peru has both a positive and a defensive
purpose. On the defensive side, the Law establishes that, with a view to opposing pending
patent applications, challenging granted patents or otherwise intervening in the grant of
patents for goods or processes produced or developed on the basis of collective
knowledge, INDECOPI shall send the information entered in the Public National Register
to the main patent offices of the world in order that it may be treated as prior art in the
examination of the novelty and inventiveness of patent applications (Article 23).298
Furthermore, the second complementary provision says that “Where a patent is applied
for in respect of goods or processes produced or developed on the basis of collective
knowledge, the applicant shall be obliged to submit a copy of the license contract as a
prior requirement for the grant of the rights concerned, except where the collective
knowledge concerned is in the public domain. Failure to comply with this obligation shall
be a cause of refusal or invalidation, as the case may be, of the patent concerned.”
(4)
Portugal’s sui generis law
The object of the Portugal’s Decree-Law No. 118, of April 20, 2002 is to establish
“the legal regime of registration, conservation, legal custody and transfer of plant
endogenous material with an actual or potential value for agriculture, agro-forestry and
landscape-related activities, including local varieties and spontaneous material as defined
in Article 2,299 as well as knowledge associated thereto […].” (Article 1). In Article 3
traditional knowledge is defined as “all the intangible elements associated to the
commercial or industrial use of local varieties300 and other endogenous material
developed by local communities, collectively or individually, in a non-systematic manner
and that are inserted in the cultural and spiritual traditions of those communities,
including, but not limited to, knowledge relating to methods, processes, products and
denominations that are applicable in agriculture, food and industrial activities in general,
including handicrafts, trade and services, informally associated to the use and
preservation of local varieties and other endogenous and spontaneous material that is
covered by the present law.”
Protection is provided against the “commercial or industrial reproduction and/or
use” of traditional knowledge, “provided the following conditions of protection are met:
a) traditional knowledge shall be identified, described and registered in the Registry of
Plant Genetic Resources (RPGR); b) the description referred to in the previous
subparagraph shall be made in a manner that allows for other persons to reproduce or use
298
It is hard to envisage the practical dimension of this provision. INDECOPI will not only need to
translate TK inventories into the languages used by “the main patent offices of the world” (eventually,
English, Japanese, German and Chinese), but it will also need to make information available in a manner
that makes it easily retrievable by patent examiners. INDECOPI, therefore, will need to provide for the
information under some sort of patent classification.
299
Article 2.1 identifies the varieties covered by the Decree-Law and excludes those “that are protected by
intellectual property rights or relating to which there is an ongoing process aiming at providing for such
protection”. The purpose of this provision is, obviously, to avoid overlapping with UPOV as well as the
patent system.
300
The term “local varieties” means landraces. The Portuguese Decree-Law is indeed the first law ever that
establishes a system for the protection of landraces.
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the traditional knowledge and obtain results that are identical to those obtained by the
knowledge holder.” (Article 3.2). Article 3.3 provides that “traditional knowledge holders
may opt for keeping it in confidentiality, in which event the regulation will set forth the
modality of its publication in the gazette of registration […], which shall be limited to
give notice of the existence of the knowledge and to identify the varieties to which they
are associated, the protection conferred by the certificate being limited to the event they
have been acquired by third parties in an unfair manner.”
The Portuguese Decree-Law identifies two additional (and alternative) conditions
for protection: traditional knowledge must not have become publicly known beyond the
local community in which it has been developed; but, if it has, it may nonetheless be
protected, provided it has not been industrially (or commercially) utilized. (Article 4).
Knowledge that meets those conditions shall confer “the right: i) To prevent unauthorized
third parties from reproducing, imitating and or using, directly or indirectly, for
commercial purposes; ii) To assign, transfer or license the rights in traditional knowledge,
including transfer by succession; iii) Traditional knowledge that is the subject matter of
specific industrial property registrations is excluded from protection.”301
Protection is conferred upon registration (Article 3.5) by local communities.302
The registration of traditional knowledge shall provide effects for a period of 50 years
from the date of the application, renewable for an identical period. (Article 3.6). Civil,
criminal and administrative remedies are available.
(5)
The Thai law on protection and promotion of traditional medicine
Thailand has enacted a statute that protects traditional medicine-related
knowledge through a sui generis mechanism largely inspired in patent law. The Thai
statute (officially designated as “Act on Protection and Promotion of Traditional Thai
Medicinal Knowledge, B.E. 2542”303) provides for three types of registries (managed by
the Institute for Traditional Thai Medicine) of medicinal formulations: “national
formulae,” “general formulae” and “personal formulae.” “National formulae” are those
traditional formulae of special medical or public health value. They are considered to be
in the public domain. Third parties can obtain a paid license for using those formulae for
research and development of new drugs. “General formulae” are those traditional Thai
formulae of common knowledge and use by the population or those the intellectual
property protection of which has expired. Like the “traditional formulae,” “general
formulae” are the subject of paid public domain (Section 33). “Personal formulae” are
those attributable to Thai nationals (as well as to foreigners, subject to reciprocity
(Section 43))—the inventor, the improver or the inheritor of a new formula (Section 21).
301
The sui generis system established by Decree-Law 118, therefore, does not overlap either with UPOV or
the patent system. However, being an industrial property system, it has the advantage of taking registered
landraces and the associated traditional knowledge out from the FAO multilateral system, under the FAO
International Treaty on Plant Genetic Resources for Food and Agriculture.
302
Article 9 sets forth a system of acknowledgement of local communities by the municipal authorities.
The notion of local communities is linked to the geographical boundaries of the zones in which the local
varieties exist or the endogenous spontaneous material presents “the highest genetic variability”.
303
A non-official English version of the Thai Act is on file with the WIPO Secretariat.
91
“Personal formulations,” when registered, are the subject of exclusive intellectual
property rights.
Only formulae that consist of the transformation of extracts from natural
substances (animals, plants or microorganisms) can be registered as “personal formulae”
(Section 22). This condition, as well as other requirements that will be established in the
regulations, shall be the subject of substantive examination (Section 23). Registration
procurement, visibly inspired in patent law, provides for interference procedures (where
more than one individual apply for the same formula)—the conflict will be solved
through the application of the first-to-file principle (Section 26). But if the applications
were filed on the same date, then the applicants will be invited to settle the dispute,
otherwise the applications will be rejected. Procurement procedures also include appeals
and oppositions (Sections 28 in conjunction with Sections 66 et seq., and Section 29).
Evidence of title will be provided by a registration certificate, which will be issued if the
formal and substantive conditions are met, and the due fees are timely paid (Section 31).
The term of protection of registered “personal formulae” is the life time of the
owner plus 50 years after his/her death.
Registration certificates generate private property rights of excluding others from
making the drug, distributing or improving it. (Section 34). The right does not apply to
experimental use and the preparation of drugs (where the prescription was issued by the
certificate’s holder). An additional exception to rights benefits the government: the
making and use of registered traditional drugs by state agencies and state hospitals is
exempt from liability. (Section 34). Rights can be licensed (Section 36 in conjunction
with Section 34) but they cannot be assigned unless transfer occurs by succession
(Section 35).
Registration can be revoked if the substantive conditions of registrability were not
met (Section 38) or ex officio in the event of rights misuse (Section 37). Right misuse can
also be grounds for the Registrar to cancel licensing agreements (Section 41). Revoked
registrations can be renewed one year after the revocation (Section 40).
As noted above, national treatment can be applied to nationals of other countries
that extend protection of local traditional medicine to Thai citizens (reciprocity approach)
(Section 43).
(6)
A comparative evaluation of the five sui generis regimes
A definitive evaluation of the five legal regimes briefly described above would
require an assessment of their practical implementation. But, in the absence of empirical
data, and because it is still early for those statutes to have already had a significant
impact, one can only issue a view based on a conceptual approach.
The five statutes range from a very imprecise, informal and open-ended regime of
intellectual property protection, such as the Brazilian system, to a very detailed system,
92
based on patent law, like the Thai regime. On its face, it seems that a simple and flexible,
and yet reasonably formal regime, like the Portuguese and Peruvian systems, would
better fit the characteristics and needs of TK. They both have, in different degrees, the
advantage of simplicity and effectiveness and seem to ensure predictability.
Of the two regimes, the Portuguese system seems to be more consistent with
traditional features of intellectual property. It admits both individual and collective TK—
which is important in a European country where much of the knowledge developed in
connection with plant genetic resources has originated from individual farmers. TK
registries or databases are to be disclosed—another crucial element (which is not
available in Peru’s regime) so as to project erga omnes private property rights and yet
ensure dissemination of useful knowledge that may be the seed for improvements and
developments by third parties, such as research institutions. But where TK holders wish
to keep their knowledge (or elements of it) secret, that wish is respected by the
Portuguese statute, with the caveat that in such an event only the diminished and relative
protection of unfair competition law will apply.
Because the Portuguese system has adopted a concept of commercial novelty, it is
useful that predefined terms of protection have been adopted. Of course, the fact that the
laws of Panama and Peru do not establish terms of protection does not mean that
protection is perpetual. Protection may be indefinite, but it is not perpetual. The reason is
that duration of protection corresponds to the life of right owners. Because what
characterizes TK is its cultural identification function, where the culture disappears and
nothing is left for identifying, TK (and the rights in it) disappears automatically. But the
Portuguese approach, which ensures a long period in which TK holders will enjoy of
exclusive commercial rights, enhances transparency and clarity.
A great advantage that the Portuguese regime has over the Peruvian system is that
TK creators are the ultimate owners and managers of their rights. The government of
Portugal will interfere in granting accession to genetic resources. But registered TK is the
exclusive property of its (collective or individual) creators and the government cannot
interfere with their private rights. To this extent, the Portuguese law, more than the laws
of Brazil, Peru and Thailand, are about the empowerment of people, not of their
government.
Another important aspect of the Portuguese system is that it provides for the
conditions of registrability, but, for the sake of administrative simplicity, there is no
substantive examination. Failure to comply with those conditions will be a matter for
courts to scrutinize in the event of a challenge or of an infringement case (where
invalidity may be raised as a defense). It is foreseeable that some aspects concerning
procurement of rights will be detailed in future regulations, but Portuguese authorities
wish to keep administrative procedures as simple as possible.
The shortcoming of the Portuguese statute is its relatively narrow scope, as
compared to the statutes of Brazil and Peru, which cover TK associated with all
biological resources (therefore comprising animals and microorganisms in addition to
93
plants). At the same time, as sui generis mechanisms are breaking new ground, it may
make sense to start with a narrow field of application and expand legislative protection
further as long as practical experience is acquired.
V.
FROM THE SHAMAN’S HUT TO FOREIGN PATENT
EXPANDING TK PROTECTION BEYOND NATIONAL BORDERS
(a)
Current multilateral provisions on the protection of TK
(i)
The Convention on Biological Diversity (CBD)
OFFICES:
The Convention on Biological Diversity (CBD) was agreed to with three
objectives: the conservation of biological diversity; the sustainable use of biological
diversity’s components; and the fair and equitable sharing of benefits arising out of the
utilization of genetic resources (Article 1).
It stems from the CBD’s stated objectives that protection of TK is not a separated
value or objective per se. Protection of TK is, therefore, ancillary to access to genetic
resources. It is exactly because of that perspective, that Article 8(j) refers to protection of
TK in non-mandatory terms. Article 8 is about in situ conservation of genetic resources—
it is not about protection of TK. Protection of TK is the subject of a mere
recommendation to Contracting Parties and as far as it is relevant for the conservation
and sustainable use of biological diversity. TK (designated as “knowledge, innovations
and practices of indigenous and local communities embodying traditional lifestyles”) that
is associated to biodiversity but is not relevant for those two purposes is not within the
scope of the CBD.
Actually, the CBD does not use the word “protection.” Article 8(j) refers to
“respect”, “preservation” and “maintenance.” None of these words imply a legal
mechanism that permits the assertion of proprietary rights. Article 8(j) says also that
measures should be taken to “encourage the equitable sharing of benefits arising from the
utilization of [TK].” Sharing of benefits can be encouraged through bilateral agreements.
If a legal regime is envisaged, a simple right to remuneration would suffice, without the
need for a system of proprietary rights.
In Article 10(c), the CBD uses the term “protection” in association with TK: it
says that Contracting Parties should “[p]rotect and encourage customary use of biological
resources in accordance with traditional cultural practices that are compatible with
conservation or sustainable use requirements.” However, like Article 8(j), Article 10(c)
also contains a simple recommendation (measures shall be taken “as far as possible and
as appropriate”). Besides, and more importantly, although Article 10(c) recommends the
protection of the “customary use of biological resources”—term that describes almost all
biodiversity-related technical TK—, it does not give any hint or lead on how such
protection should be accorded. Customary uses could be protected, for example, if in
local projects of sustainable development, beneficiaries of government subsidies and
funding were obliged to incorporate suitable and tested TK. Therefore, an IP system can
94
be enacted to protect knowledge concerning “customary uses of biological resources,”
but that is not strictly necessary.
Paragraph 2 of Article 17 (on “Exchange of Information”) provides that exchange
of information relevant to the conservation and sustainable use of biodiversity shall
include “specialized knowledge, indigenous and traditional knowledge as such as in
combination with” biotechnology. There is nothing in this provision that refers to or even
implies intellectual property protection of TK. “Exchange of knowledge” does not mean
technology transfer. The provision of the CBD that deals with technology transfer is
Article 16 (on “Access and Transfer of technology”).
Finally, Article 18.4 provides that “Contracting Parties shall, in accordance with
national legislation and policies, encourage and develop methods of cooperation for the
development and use of technologies, including indigenous and traditional technologies
[…].” Article 18.4 does not imply IP protection of TK either. It deals with cooperation
between Contracting Parties for the development and use of TK. Of course, one may
conclude that, given that IP protection has a dynamic function of promoting the creation
of technology, it might as well promote the development of TK. We have seen, however,
that, as far as TK is concerned, the dynamic impact of IP protection is not
considerable.304
The conclusion is that the CBD does not contain any language providing for the
proprietary protection of TK. Of course, it can be said that CBD provisions on genetic
resources comprise those which have been modified by human creation, regardless of
their level of domestication. The CBD, therefore, might imply some mechanism of
protection of the intangible creations embodied in genetic resources. But it does not: the
CBD is about access to tangible resources and about their preservation. It is indeed one of
the major current misunderstandings in the debate on protection of TK (whether
embodied in biological resources or not) to rely on the CBD as a conceptual framework
for an IP mechanism. And it is no surprise that, more than ten years after its adoption in
Rio de Janeiro, no substantive outcome or breakthrough has arisen from discussions in
the CBD that could serve as a guidance for countries wishing to enact IP protection.
(ii)
The International Treaty on Plant Genetic Resources for Food and
Agriculture
The FAO International Treaty on Plant Genetic Resources for Food and
Agriculture was adopted by the FAO Conference on November 3, 2001, after several
years of difficult negotiations, and replaced the International Undertaking on Plant
Genetic Resources for Food and Agriculture, of 1983.305 Although overlapping as far as
plant genetic resources that have an application in food and agriculture are concerned, the
FAO Treaty and the CBD have different purposes: for the CBD, preservation of
biodiversity is an end; for the FAO Treaty, agricultural diversity is a means to achieve
304
See supra Section II(b).
Information about the International Undertaking and the negotiations for its review can be found on the
FAO website, at www.fao.org/ag/cgrfa.
305
95
food security. Article 9 of the FAO Treaty, which deals with “Farmers’ Rights”,
provides:
“9.1. The Contracting Parties recognize the enormous contribution that the local
and indigenous communities and farmers of all regions of the world, particularly
those in the centers of origin and crop diversity, have made and will continue to
make for the conservation and development of plant genetic resources which
constitute the basis of food and agriculture production throughout the world.
“9.2 The Contracting Parties agree that the responsibility for realizing Farmers'
Rights, as they relate to plant genetic resources for food and agriculture, rests with
national governments. In accordance with their needs and priorities, each
Contracting Party should, as appropriate, and subject to its national legislation,
take measures to protect and promote Farmers' Rights, including:
“(a) protection of traditional knowledge relevant to plant genetic resources for
food and agriculture;
“(b) the right to equitably participate in sharing benefits arising from the
utilization of plant genetic resources for food and agriculture; and
“(c) the right to participate in making decisions, at the national level, on matters
related to the conservation and sustainable use of plant genetic resources for food
and agriculture.
“9.3 Nothing in this Article shall be interpreted to limit any rights that farmers
have to save, use, exchange and sell farm-saved seed/propagating material,
subject to national law and as appropriate”
The first paragraph recognizes the contributions of farmers. The second
paragraph, the language of which is inspired in Article 8(j) of the CBD, calls upon
national governments to protect and promote farmers’ rights. And the third paragraph
establishes a kind of farmers’ exemption that is different from any existing exception to
intellectual property rights conferred, given that the existing exceptions (including those
under UPOV 1978) do not permit third parties to engage in commercial activities (such as
selling farm-saved seed/propagating material).
Part IV of the FAO Treaty establishes a multilateral system of access to plant
genetic resources as well as of benefit sharing. On access, intellectual property is called
into question in two subparagraphs of Article 12.3, which establishes the conditions of
access to plant genetic resources:
“[…]
“(d) Recipients shall not claim any intellectual property right or other rights that
limit the facilitated access to the plant genetic resources for food and agriculture,
96
or their genetic parts or components, in the form received from the Multilateral
System;
“[…]
“(f) Access to plant genetic resources for food and agriculture protected by
intellectual and other property rights shall be consistent with relevant international
agreements, and with relevant national laws; […].”
Nothing prevents recipients (other than, eventually, contract clauses) from
claiming intellectual property rights in modifications and improvements introduced in the
resources they received. Patent protection must be available for inventions made by the
recipients upon the genetic materials they have received under the access mechanism.
Subparagraph (f) states that genetic resources covered by intellectual property rights
(namely patents and plant breeders’ rights) may not be extracted from the rights holder’s
control. The last word on releasing control over intellectual property rights, as well as the
conditions for such control to be released, always belongs to the patent or plant breeders’
rights owner.
The FAO Treaty creates a Multilateral System (the “MS”), which covers the plant
genetic resources for food and agriculture listed in Annex I to the Treaty (a long—and
expandable—list of crops, legume forages, grass forages and other forages). Access to
those genetic resources is to be ruled by the conditions set forth by the Treaty (Article
12). Recipients who commercialize products that are plant genetic resources for food and
agriculture and that incorporate material obtained from the Multilateral System (including
thus all materials derived, directly or indirectly, from accessed plant genetic resources
covered by the MS), shall pay to a trust account (Article 19.3(f)) “an equitable share of
the benefits arising from the commercialization” of those products.
In practice, this means that traditional farmers do not have the right to oppose the
inclusion of their wild varieties and landraces in the MS whenever they fall under the
Annex I to the Treaty. Secondly, the benefits arising from the commercialization of
products derived from wild varieties and landraces do not go to the farmers who have
preserved and, eventually, improved them by natural breeding: they go to a trust account.
In sum, the FAO Treaty is not about intellectual property rights: farmers do not have the
right to say “no” to the unauthorized use by third parties; nor are they entitled to sell their
traditional varieties for a price. Once included in the MS, the wild varieties and landraces
of traditional farmers become subject to a sort of paid public domain.
This is not, of course, intellectual property, as the FAO representative stated at the
second session of the WIPO Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore.306 On the contrary, once the
landraces are integrated into MS, it will be impossible for traditional farmers to assert any
rights in their traditional creations. The need for the creation of a new intellectual
property regime that covers landraces (probably within the framework of a new, sui
306
See Report of the second session, supra note 100, at paragraph 15.
97
generis system of intellectual property rights in traditional knowledge) becomes then
more relevant and urgent, both at the national and international levels. The legal
protection of landraces as intellectual creations in their own right will trigger the
application of Article 12.3(f) of the FAO Treaty, thus avoiding the preemption of
farmers’ rights in technical creations by the Multilateral System.
(iii)
The United Nations Convention to Combat Desertification (UNCCD)
Unlike the CBD and the FAO Treaty, the UNCCD has several provisions that do
call for an IP protection of TK, albeit in the very narrow context of TK relevant to
combat desertification and mitigate the effects of drought. It is also noteworthy that the
UNCCD has some language that suggests that the best manner to accomplish such
protection is through (proprietary) protection of original contents of TK databases.
Those provisions can be found in three Articles of the UNCCD. Firstly, Article 16
(on “Scientific and technical cooperation”) provides:
“The Parties agree […] to integrate and coordinate the collection, analysis and
exchange of […] data and information to ensure systematic observation and land
degradation in affected areas to understand better and assess the processes and
effects of drought and desertification. […] To this end, they shall, as appropriate:
“[…]
“(g) subject to their respective national legislation and/or policies, exchange
information on local and traditional knowledge, ensuring adequate protection for
it and providing appropriate return from the benefits derived from it, on an
equitable basis and on mutually agreed terms, to the local populations concerned.”
Article 16(g) recommends307 two sorts of measures: on the one hand, Parties shall
ensure “adequate protection for TK;” on the other, Parties shall provide “appropriate
return for it.” That language seems to indicate that appropriate return (which theoretically
could be obtained through a simple right to remuneration308) shall be ensured in addition
(and not alternatively) to protection. Although one can devise other possible meanings for
“protection” in Article 16(g), it makes sense to understand the word as comprising
measures that may lead to appropriation of TK. But the UNCCD contains language that is
even clearer.
The right to remuneration is also mentioned in Article 17(c), which provides for
support of that research activities that “protect, integrate, enhance and validate traditional
and local knowledge, know-how and practices, ensuring […] that the owners of that
307
The UNCCD, like the CBD and the FAO Treaty, contains mere recommendations, because any
measures are to be taken in accordance with national law and/or policy, and only “as appropriate.” The
reason for the CBD to ensure that national law shall prevail over its provisions was the wish of several
negotiating Parties, in Rio de Janeiro, to preserve treaties negotiated with local tribes and subsequently
enacted national legislation. See Glowka, supra note 190, at 48.
308
And not necessarily through an exclusive proprietary right.
98
knowledge will directly benefit on an equitable basis and on mutually agreed terms from
any commercial utilization of it or from any technological development from that
knowledge.”
Article 17(c), very importantly, says that the financial benefits (which, as in the
CBD, may result both from commercial exploitation and from other types of exploitation,
such as scientific research (leading to “any technological development”) shall be
attributed to the owners of TK. This language, therefore, clearly implies that TK holders
are vested in ownership. Recognition of ownership goes beyond ensuring a right to
remuneration, because, as owners, TK creators have the right to say ‘no’ against the
unauthorized use. Governments, therefore, must not only ensure that TK holders will
benefit from the use of their knowledge: they must also seek their authorization for
integrating TK into research and development initiatives. As owners, TK holders are
entitled to manage their intangible assets—the UNCCD, therefore, shows a way that is
entirely apart from the thrust of both the CBD and the FAO Treaty.
Article 18, which contains measures on the transfer, acquisition, adaptation and
development of “environmentally sound, economically viable and socially acceptable
technologies relevant to combat desertification and/or mitigation of the effects of
drought” (paragraph 1), calls for the protection of the original contents of TK databases
in the following terms:
“2. The parties shall, according to their respective capabilities, and subject to their
respective national legislation and/or policies, protect, promote and use in
particular relevant traditional and local technology, knowledge, know-how and
practices and, to that end, they undertake to:
“(a) make inventories of such knowledge, know-how and practices and their
potential uses with the participation of local populations, and disseminate such
information, where appropriate, in cooperation with relevant intergovernmental
and non-governmental organizations;
“(b) ensure that such technology, knowledge, know-how and practices are
adequately protected and that local populations benefit directly, on an equitable
basis and as mutually agreed, from any commercial utilization of them or from
any technological development derived therefrom;
“(c) encourage and actively support the improvement and dissemination of such
technology, knowledge, know-how and practices or of the development of new
technology based on them; and
“(d) facilitate, as appropriate, the adaptation of such technology, knowledge,
know-how and practices to wide use and integrate them with modern technology,
as appropriate.” (emphasis added).
The main points of paragraph 2 of Article 18 are the following:
TK (relevant for understanding the causes of and combating
desertification and the effects of draught) should be collected into inventories (or
databases);
99
TK contained in those databases are the subject of ownership (Article
17(c)) and should be protected—in other words, the UNCCD calls upon the
establishment of a legal regime that recognizes and protects ownership in (original)
contents of TK databases;
protection of TK is recommended by the UNCCD not simply with a static
purpose of preserving it, but also with the dynamic objective of promoting the creation of
new TK and its dissemination; the idea that UNCCD takes the dynamic dimension of IP
protection into account stems from the differences in language between subparagraphs (c)
and (d): subparagraph (d) purports the creation of “modern technology”, i.e., nontraditional technology, on the basis of TK; subparagraph (c), in contrast, purports the
creation of new technology based on TK; subparagraphs (c) and (d) may not refer to the
same knowledge to be developed on the basis of TK, otherwise they would be redundant;
it follows, then, that in contrast with the “modern technology” of subparagraph (d),
subparagraph (c) does indeed say that the improvement of TK is (or should be) one of the
purposes of its legal protection.
In view of the above, we could say that, to some extent, the UNCCD contains
already the seed for a future harmonized sui generis regime of protection of TK. But its
provisions are not sufficient for that purpose because they are not only very limited in
their scope, but also because they provide for no clues on national treatment.
(b)
Some ideas for an international treaty on the protection of TK
Intellectual property has the propensity for being guided by international and
harmonized rules. Because it has intangible assets as subject matter, these will flow from
one country to another without physical constraints. If harmonized protection is not
adopted in different territories, the flow of technology and ideas probably will be
generated by unauthorized third parties only, for IP owners will be reluctant to invest in
the commercialization of their assets in territories where, given the absence of IP
protection, they will be the victims of free riding and other parasitic behavior. The same
goes with TK. The many denounced cases of biosquatting, even if most are not based on
reality, reveal that there is a general perception that harmonized protection must be
adopted in different territories.
It is nonetheless too early to envisage the possibility of having all 178 WIPO
Member States gathered at a diplomatic conference to approve uniform sui generis
standards of protection.309 There is a general conviction that TK is important and that it is
309
As far as expressions of TK (or expressions of folklore) are concerned, work is progressing towards an
international treaty in the United Nations Educational, Scientific and Cultural organization (UNESCO),
which, at its 31st session of its General Conference, held in Paris, on October 15 to November 3, 2001,
approved the preparation of “a report calling for standard-setting [regulating the protection of traditional
culture and folklore] and on the possible scope of such standard-setting, together with a preliminary draft
international convention.” That report (and the draft convention) will be discussed at the 32 nd session of
UNESCO’s General Conference. Resolution 30 of the 31 st session, available on UNESCO’s website, at
www.unesco.org. If UNESCO is successful in developing international standards, WIPO
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also important to entertain discussions on what sort of features a sui generis regime for its
protection should adopt. But there are different views on how to achieve that at the
national level, let alone at the international level. Therefore, it is probable that the
discussions in the WIPO Committee will evolve into the preparation of recommendations
or other modalities of soft law (such as Model provisions or Guidelines), following the
example, e.g., of the recommendation on the protection of well-known trademarks,
discussed in the WIPO Standing Committee on the Law of Trademarks, Industrial
Designs and Geographical Indications and adopted by the Assembly of the Paris Union
and the general Assembly of WIPO, in 2000.310 Joint Recommendations or Model
Provisions are not binding but they have the advantage of being attractive to those WIPO
Members that are still reluctant to embark on a norm setting exercise. Besides, a Joint
Recommendation can be formulated (like the mentioned Recommendation on wellknown trademarks) in a manner that is very similar to an international treaty, that is, as a
legal framework aiming at being implemented at the nationally level. WIPO Members
States could then negotiate bilaterally or regionally the adoption of such
recommendation.311
One main point of concern is the fact that several developed countries have
developed, or are in the process of developing, their own national legislation dealing with
relations with native tribes and Indigenous peoples. Some of those relations have been
established along centuries, and naturally those countries are worried that binding rules
might interfere with and jeopardize those relations. However, the idea of an international
treaty on the protection of TK would not be completely absurd if two preliminary points
were made. First, the treaty should adopt a Paris Convention-sort of national treatment, as
opposed to the TRIPS Agreement type of national treatment. The difference is that
Article 2 of the Paris Convention establishes that
“Nationals of any country of the Union shall, as regards the protection of
industrial property, enjoy in all the other countries of the Union the advantages
that their respective laws now grant, or may hereafter grant, to nationals; all
without prejudice to the rights specially provided for by this Convention.
Consequently, they shall have the same protection as the latter, and the same legal
remedy against any infringement of their rights […].” (emphasis added)
In other words, the “same treatment” approach of the Paris Convention only
requires that the rights of citizens of other Members be protected when the country in
Intergovernmental Committee Members at some point must evaluate whether it is worth to continue
discussions on expressions of TK, in order to avoid duplication of work (or, worse, the adoption of
conflicting standards).
310
See Joint Recommendation Concerning Provisions on the Protection of Well-Known Trademarks,
WIPO, 2000, Publication No. 833(E).
311
For instance, Article 4 of the Agreement between the United States of America and the Hashemite
Kingdom of Jordan on the Establishment of a Free Trade Area establishes that each Party shall give effect
to Articles 1 through 6 of the Joint Recommendation on the protection of well-known trademarks. This
Agreement can be found on the website of the United States Trade Representative, at www.ustr.gov.
101
question protects the rights of its own citizens. If such protection is not accorded to
nationals, the country in question does not have to grant it to foreigners.312
In contrast, Article 3.1 of the TRIPS Agreement provides that
“Each member shall accord to the nationals of other Members treatment no less
favourable than that it accords to its own nationals […].” (emphasis added).
In the light of Article 3.1 of the TRIPS Agreement, WTO Members must accord
nationals of other WTO Members the minimum levels of protection established in the
Agreement even if they do not accord such a protection to their own citizens.313
A Paris Convention-like approach would give Members with different views on
the urgency and criteria for protecting TK at the national level the possibility of coming
together and be joined under the same treaty. But, in order to avoid that the treaty
becomes an empty and irrelevant instrument, or that only a few countries accept to adhere
to it, its scope—like the Paris Convention’s—should be sufficiently broad so as to attract
countries with different interests as regards TK protection. The idea, then, could be to
include not only positive standards of protection but also defensive ones, as described
below. Therefore, countries which so far have shown an exclusively defensive concern
with sui generis protection of TK, such as the United States, could take their time and
continue testing the applicability of traditional IP mechanisms—which, anyway, are
available to foreign TK holders under the national treatment principles of the Paris
Convention, the Berne Convention and the TRIPS Agreement.
Given the particular nature of TK, the principle of independence of rights would
not apply. In fact, TK being a means of cultural identification, it may never be completely
dissociated from its originators. Therefore, events that may affect the rights in TK at the
national level, should also affect it in other jurisdictions.314
As to the principle of priority, its relevance depends on whether protection of TK
is formal or informal. For those countries that are adopting a system of registration of
inventories (a sui generis protection of original contents of databases) on a criterion of
novelty, such as Peru and Portugal, priority may be important. But not for others. So, the
principle of priority could be adopted on the understanding that it would apply only to
those Contracting Parties that had adopted a system of national registration (either as a
source of origin of a registration or as a recipient of a foreign request).
312
For an explanation of Article 2 of the Paris Convention, see Bodenhausen, supra note 168, at 27 et seq..
For an explanation of the differences between the national treatment principle under the Paris Convention
and the TRIPS Agreement, see Carvalho, supra note 81, at 75 et seq.
313
The words “nationals” and “citizens” are not used here in their correct sense. The correct concept of
“nationals” is provided for by Articles 2 and 3 of the Paris Convention and footnote 1 of the TRIPS
Agreement.
314
A parallel can be drawn with geographical indications, the IP mechanism that is almost exclusively
dedicated to protecting TK (see supra Section IV(a)). Under Article 24.9 of the TRIPS Agreement, WTO
Members have no obligation “to protect geographical indications which are not or cease to be protected in
their country of origin, or which have fallen into disuse in that country.”
102
Under the flexible notion of a Paris-like national treatment, a first treaty on sui
generis protection of TK would contain minimum, mandatory standards315 on: a)
acquisition of rights; and b) enforcement; and it would leave countries free to define, at
the national level, a) the scope of protection and b) the identification of the owners
(attribution of rights).
On acquisition of rights, one single mandatory provision would refer to
recognition and protection of rights in TK, that is, ideas and expressions thereof
developed by traditional communities and Indigenous peoples, in a traditional and
informal way, as a response to the needs imposed by their physical and cultural
environments and that serve as means of cultural identification.316 The treaty could than
identify a preferred manner of documenting and registering TK stricto sensu (that is, the
ideas, as opposed to the expressions), through the submission of inventories of TK to the
national competent authorities.317 The conditions of protection (such as novelty and
identification of TK holders) would be left for national law. The importance of setting
some rules on registration and documentation is that Contracting Parties may make it
mandatory as a condition of enforceability.
On the other hand, countries could be left free to decide on establishing exclusive
rights as opposed to a right to remuneration (this solution was adopted by Peru for TK
that was disclosed in the last twenty-years318). They should also decide on the rights to
license and assign TK. Technical ideas, in principle, might be licensed and even assigned
without harming the cultural identity of the community and the holistic integrity of the
TK. But expressions and handicrafts should not be the subject matter of licenses or
assignment contracts because of their closer link to the cultural identity. Once a
handicraft is regularly made by a person who does not belong to a traditional community,
it loses its cultural link, the thread of Ariadne that maintains TK connected to the
community as an element of its identification and ceases ipso facto to be an element of
TK.
The second mandatory provision should contain some rules on civil measures of
enforcement, clarifying at least that compensation for damages and injunctions (including
provisional measures) must be made available by Contracting Parties to protect separate
elements of the registered databases. Where countries do accord informal protection (i.e.,
with no need for registration), it makes sense to require registration for the purposes of
substantiating the filing of a law suit: TK, given its cultural background, is fluid and
315
As under the Paris Convention, standards would be mandatory only to those countries that adopt
protection at the national level. Under the Paris Convention, the provisions on compulsory licensing of
patents (Article 5(A)) are mandatory only for those countries that have patent protection at the national
level.
316
See supra in section I(a) an explanation of this definition.
317
The Portuguese Decree-Law provides that the description of registered TK “shall be made in a manner
that allows for other persons to reproduce or use the traditional knowledge and obtain results that are
identical to those obtained by the knowledge holder.” (Article 3.2(b)). In other words, within some natural
limitations, the description of registered TK must also be enabling.
318
See supra Section III(b)(ii)(3).
103
frequently difficult to identify; a registered inventory makes easier for a judge or a jury to
understand the real nature of the subject matter of the rights infringed. Whether criminal
measures should also be included would be a matter for discussions: on the one hand, it
might not be convenient , because of the natural difficulties in assessing criminal intent in
TK infringement, particularly when in so many cases the infringing product will be
separated from the original TK by ten, fifteen years of research, development and
marketing efforts; on the other hand, delegates may wish to pay special attention to the
nature of TK infringement, which generally implies a sort of cultural offense or human
rights violation. For the same reason, border measures could be recommended, but not
established as mandatory.
Contracting Parties would be free to define the scope of protection (countries may
prefer to narrow TK protection to biodiversity-associated knowledge; others may even
narrow it further to TK associated with plant genetic resources; other countries may wish
to use the system to protect expressions of TK or handicrafts). The importance of such a
flexible provision would be not only to permit the articulation at the international level of
different national approaches, but also to make it clear that TK is holistic and that in the
end there is no incompatibility between ideas and expressions—the enforcement
measures will necessarily vary according to the specific element of TK infringed, but
they are all elements of the same, holistic TK.
The treaty should also leave Contracting Parties free to determine the exceptions
to rights conferred, including compulsory licenses. As said above, because some elements
of TK should not be licensed, otherwise they would lose their identification characteristic
and purpose, those elements cannot be the subject of compulsory licenses of exceptions
to rights granted. But others can be: if a shaman has the knowledge of how to cure AIDS
and refuses to transfer it, societal interests recommend that a compulsory license should
be granted. On the other hand, the CBD seems to suggest that all benefits arising from
any utilization given to the genetic resource should generate the right to share.319
Therefore, it seems that there should be no exceptions to rights conferred for the private
or non-commercial or the scientific use of genetic resources. Universities, botanical
gardens and other research institutions should be obliged to pay in the event they extract
any benefit from their research (benefits which can take either a commercial form, if they
transfer those results to a commercial firm, or other forms, such as grants, awards).
Customary uses of TK320 as well as prior use by small firms and artisans321 have been
exempted from liability as exceptions to TK rights conferred.
Contracting parties should also be free to attribute rights in registered TK to the
communities or to individuals. The ultimate decision, as the laws of Panama, Portugal
319
CBD, Article 15.7:
“[…] with the aim of sharing in a fair and equitable way the results of research and development
and the benefits arising from the commercial and other utilization of genetic resources […].”
(emphasis added).
320
Brazil’s provisional Measure No. 2,186-16, Article 8(III). Peru’s Law No. 27,811, Article 4.
321
Panama’s Law No. 20, Article 23.
104
and Costa Rica322 make it clear, should stem from customary law (which could be the
subject of a description in the inventory, so as to create certainty for third parties).
A provision could be added in order to clarify the relationship between sui generis
protection and other IP mechanisms. Sui generis protection should co-exist with other
forms of protection, not only as regards the databases per se (the selection and
arrangement of whose contents are to be protected under copyright law, when original, to
the benefit of the database makers) but also as regards their contents. TK holders would
be capable of, when the necessary conditions are met, to seek protection under patent,
trademark and industrial design laws, if they wished so. Such protection should add to the
sui generis regime. The shortcoming is that, once a patent expired, its subject matter
would fall into public domain, and it would not be possible to recapture and reintegrate it
to the database.
On defensive measures, a treaty on sui generis protection of TK could include two
mandatory rules, one concerning distinctive signs, the other concerning patents.
On distinctive signs, the treaty could include a provision establishing a system of
notification of Indigenous peoples and traditional communities insignia and other
spiritual symbols, so as to avoid their registration and use as distinctive signs in trade (in
the form of trademarks or trade names). Those notifications, which should be made by
governments (which would imply some sort of prior examination of the basis of the
allegation made by the community as to the relevance of the insignia), would be
registered by WIPO, which could draw inspiration from its database on official insignia
and emblems, under Article 6ter of the Paris Convention—and which serves exactly the
same purpose. Contracting Parties could also be encouraged to adopt provisions, at the
national level, permitting the invalidation of trademarks registered in bad faith, prior to
the treaty’s entry into force.
On patents, a provision would instruct patent applicants to identify the person or
persons who have provided information about an element of TK from which the
invention was derived, as well as a description of that element of TK, and how it was
instrumental to the making of the claimed invention.323 Where an applicant, who
possessed or had reasons to be in possession of that information, failed to provide it in the
patent specifications, he/she would not be entitled to enforce his/her patent rights against
third parties until he/she obtained the required authorization from the TK324 holder. In
other words, third parties would be able to raise the unclean hands argument as a
personal defense.
Costa Rica’s Law No. 7,788, Article 85; Panama’s Law No. 20, Article 15.
This aspect may be important for assessing the standing of the shaman: as a supplier of knowledge and
materials, which were used just as leads for further research and development; or as an actual co-inventor.
324
Such TK should be registered or not, depending on whether the country in question would wish to make
the registration of TK a constitutive or declaratory formality.
322
323
105
The treaty, finally, could include provisions on arbitration and mediation between
Contracting Parties and between citizens of Contracting Parties.325
VI.
CONCLUSION
The article took stock of the last developments in the international discussions on
the protection of TK, with a particular emphasis on a sui generis regime. The road is
definitely under construction so that the shaman can walk from his hut and knock on the
patent office’s door seeking for formal recognition and title to his knowledge. The
construction is far completion, but it seems that the works are advancing well. However,
this Article has emphasized that the construction works should address two major
concerns: one is the market response to the economic value of TK; the other is the need
for legal security. Both concerns have an economic dimension, but experience shows that
where the realities of market have been disregarded, legal measures tend to vanish in
oblivion and discredit. Because the market has yet to express its appreciation for TK, any
legal measures should be simple enough so as not to create costly barriers and
encumbrances to the effective transfer of TK into marketable goods and services; those
measures should also be flexible, so as to permit their adaptation and enhancement,
according to the actual response from the market. On the other hand, the interests of TK
holders are to be carefully assessed along with those of the industry. Both stakeholders
must be aware of their rights and obligations. Therefore, a system for the protection of
TK must be set in the form of clear and straightforward rules, preferably based on
existing and tested legal principles and practices. There is no need to develop a sui
generis regime from scratch, because, as shown in this Article, the basic concepts—
including those of a sui generis regime of protection of original contents of databases—
have already been expressed in national and international law.
Finally, when we discuss about a regime for the protection of TK, it is assumed
that it must be adequate and effective. But the word “effective” has two possible
meanings: it means that something is “adequate to accomplish a purpose; producing the
intended or expected result;” and it also means “in operation or in force; functioning;
operative.”326 In other words, if TK holders—who are or will be the users of any regime
developed to protect their knowledge—are not involved in the discussions leading to the
preparation of legislation with that purpose, they may not feel compelled to use the
mechanism because of failure to see the advantages or benefits they can extract from it.
325
If drafted in clear and realistic terms, such a treaty could then be the subject of multilateral negotiations
aiming at incorporating it into the framework of paragraph 19 of the Doha Ministerial Declaration (see
supra Section II(b)(ii)(vi)). However, because paragraph 19 is part of a work programme, which does not
necessarily entail negotiations, biodiversity-rich WTO Members may have to wait until a next multilateral
round of negotiations is launched, for moving towards the adoption of trade-related rules on TK protection.
Under a WTO rationale, such an adoption will require bargaining, which eventually will comprise the
reduction of the exceptions to patentability under Article 27.3(b) of the TRIPS Agreement—which,
actually, would suit well the interests of biodiversity-rich countries and TK holders, because a large
proportion of TK-related and derived inventions concern animals and plants. Expanding patentability to
plants and animals helps ensure that benefits will be made and consequently shared.
326
Webster’s College Dictionary (Random House, 1991)
106
Therefore, in order to make whatever regime effective, it is of the essence to promote the
participation of TK holders in national and/or international discussions.
107