VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
Conference on Biodiversity, Biotechnology and
the Protection of Traditional Knowledge
Washington University School of Law
Saint Louis
April 4-6, 2003
Holder and User Perspectives in the Traditional Knowledge Debate
Prof. dr. Geertrui Van Overwalle
Center for Intellectual Property Rights (CIR)
Faculty of Law
Catholic University Leuven
Belgium
Final draft, January 19 2004
1
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
2
Content
I. INTRODUCTION ............................................................................................................................................. 3
II. TRADITIONAL KNOWLEDGE ................................................................................................................... 3
A. CONCEPT ........................................................................................................................................................ 3
1. Traditional knowledge sensu lato and sensu stricto .................................................................................. 3
2. Holders and Users ..................................................................................................................................... 4
B. CLASSIFICATION ............................................................................................................................................. 4
III. HOLDER PERPECTIVES ............................................................................................................................ 5
A. POSITIVE PROTECTION ROUTE......................................................................................................................... 5
1. Overview .................................................................................................................................................... 5
a. Traditional Medicinal Knowledge .......................................................................................................................... 5
b. Traditional Agricultural Knowledge ....................................................................................................................... 7
2. Patents ....................................................................................................................................................... 7
a. Intrinsic thresholds.................................................................................................................................................. 7
b. Practical impediments ............................................................................................................................................ 9
3. Contracts ................................................................................................................................................... 9
a. Monetary and non-monetary benefits ..................................................................................................................... 9
b. Prior informed consent and disclosure procedures ............................................................................................... 10
c. Bilateral or multilateral scope ............................................................................................................................... 11
B. DEFENSIVE PROTECTION SYSTEMS ................................................................................................................ 11
III. USER PERSPECTIVES .............................................................................................................................. 12
A. PATENT LAW ................................................................................................................................................ 12
1. Pre-grant options..................................................................................................................................... 12
a. Disclosure of origin requirement .......................................................................................................................... 12
b. Prior informed consent requirement ..................................................................................................................... 14
2. Post grant options.................................................................................................................................... 15
Humanitarian use resctriction ................................................................................................................................... 15
B. ALTERNATIVE MEASURES ............................................................................................................................. 15
1. Self standing regulations ......................................................................................................................... 15
2. ‘Doctrine of unclean hands’ .................................................................................................................... 15
IV. CONCLUSIONS ........................................................................................................................................... 16
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
3
I. INTRODUCTION
The present contribution offers an overview of conceptual issues and intellectual property
problems in the traditional (medicinal) knowledge debate, reviewing and commenting on the
papers which have been submitted for the Saturday afternoon session ‘Traditional knowledge:
What is it and how (if at all) is it to be protected?’ and referring to various related papers in
other sessions as well.
II. TRADITIONAL KNOWLEDGE
A. Concept
1. Traditional knowledge sensu lato and sensu stricto
The scope of the term ‘traditional knowledge’ has been the subject of many debates.
According to ANDRIANTSIFERANA traditional knowledge concerns “all aspects of life (food,
health, housing, communications) and the environment (relations between biodiversity and
ecological factors, identification criteria of biodiversity elements)” 1. In his view, traditional
knowledge is characterized by a holistic approach relating to every component of the
environment and giving an equal importance to rational thinking and to spiritual beliefs and
social considerations. BALICK argues that traditional knowledge is to be considered as “a
body of information and set of skills developed by a group of people over time” 2. By way of
example he refers to canoe making, use of fish poisons, use of sea plants and planting taro.
BRUSH for his part takes the view that traditional knowledge is associated with “folk
nomenclatures, taxonomies of plants, the environment, practical domains such as disease
etiology and agricultural practices” 3. He argues that a number of criteria can be used to
differentiate traditional knowledge: localness, oral transmission, origin in practical
experience, emphasis on the empirical rather than the theoretical, repetitiveness,
changeability, being widely shared, fragmentary distribution, orientation to practical
performance, and holism. LEWIS and RAMANI describe traditional knowledge as “a body of
knowledge built by a group of people living in close contact with nature, which includes a
system of classification, a set of empirical observations and a system of self-management that
governs resource use” 4. DE CARVALHO from his side argues that, given the vast scope and
vague boundaries of traditional knowledge, it is not very meaningful to look for a final and
complete definition 5. He prefers to adopt a practical approach of finding statutory
characteristics that traditional knowledge must present in order to be eligible for legal
protection.
For now, one interpretation seems to be commonly accepted. The term traditional knowledge
is understood to comprise both aesthetic and useful elements, as well as literary, artistic or
1
2
3
4
5
See the contribution of Rabodo ANDRIANTSIFERANA entitled ‘Traditional Knowledge Protection in the
African Region’ in the current proceedings.
See the contribution of Michael BALICK entitled ‘Traditional Knowledge: Lessons from the Past, Lessons
for the Future’ in the current proceedings.
See the contribution of Stephen B. BRUSH entitled ‘The Demise of ‘Common Heritage’ and Protection for
Traditional Agricultural Knowledge’ in the current proceedings.
See the contribution of Walter H. LEWIS and Veena RAMANI, ‘Ethics and Practice in Ethnobiology:
Analysis of the International Cooperative Biodiversity Project in Peru’, in the current proceedings, with
reference to JOHNSON, p. 1.
See the contribution of Nuno Pires DE CARVALHO entitled ‘From the Shaman's Hut to the Patent Office: In
Search of Effective Protection for Traditional Knowledge’ in the current proceedings, p. 5.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
4
scientific creations. Consequently, categories of traditional knowledge include, amongst
other things, expressions of folklore in the form of music, dance, song, handicrafts, designs,
stories and artwork; elements of language; agricultural knowledge; medicinal knowledge 6.
DE CARVALHO introduces an interesting disctinction in this regard: ‘traditional knowledge
stricto sensu’, encompassing the knowledge itself and ‘traditional knowledge lato sensu’,
encompassing the former plus expressions of traditional knowledge 7.
2. Holders and Users
The scope of the term ‘traditional knowledge holder’ and ‘user’ has also been widely
discussed. According to the World Property Organisation (WIPO), traditional knowledge
holders are "all persons who create, originate, develop and practice traditional knowledge in a
traditional setting and context. Indigenous communities, peoples and nations are traditional
knowledge holders, but not all traditional knowledge holders are indigenous" 8.
According to TOBIN and BARBER “users of genetic resources” are defined as those individuals
or entities that actually import and utilize genetic resources, whether for commercial or purely
scientific purposes. Examples include: botanic gardens that collect, display, and conduct
research on plant species from other countries; pharmaceutical and biotechnology firms
engaged in drug discovery and product development based on genetic resources accessed
from another country; and cosmetic and nutritional companies that import, process and sell a
wide variety of consumer goods that are based on natural products 9. By analogy “users of
traditional knowledge” might be defined as individuals or institutions making use of
traditional knowledge for commercial or scientific purposes.
Many countries are both "holders" or "providers" and "users" of genetic resources and
traditional knowledge. However, there has been a tendency in the international debate to
view developing countries as primarily providers, while more industrialized developed
countries have been portrayed as users. TOBIN and BARBER correctly underline the
inaccuracy of such generalizations and argue that in many cases industrialized countries, such
as Australia or Brasil, are also important providers, while some developing countries, such as
Brasil, have highly developed biotechnology and agro-industrial capacities 10.
B. Classification
Efforts have also been made to classify the various types of traditional kowledge. In
international discourse it is agreed that the term ‘traditional knowledge’ refers to tangible as
well as to non-tangible components 11.
The tangible component of traditional knowledge mainly refers to genetic resources. BRUSH
correctly underlines that genetic resources encompass pharmaceutical as well as natural
product resources and crop genetic resources 12.
The intangible component of traditional knowledge has been subdivided in three classes:
traditional medicinal knowledge (TMK), traditional agricultural knowledge (TAK) and
6
7
8
9
10
11
12
Cf. WIPO, Intellectual Property Needs and Expectations of Traditional Knowledge Holders (WIPO Report
on Fact-finding Missions on Intellectual Property and Traditional Knowledge – 1998-1999), Geneva, 2001,
26 (abbr. WIPO, 2001).
See the contribution of DE CARVALHO, p. 6.
The term ‘knowledge holder’ is used in WIPO, 2001, 26.
See the contribution of Brendan TOBIN and BARBER, 'Options for Developing Measures in User Countries
to Implement the Access and Benefit-Sharing Provisions of the Convention on Biological Diversity' in the
current proceedings (Draft for Comment, March 15 2003), p.12.
See the contribution of TOBIN and BARBER, p. 10.
Cf. WIPO, 2001, 25.
See the contribution of BRUSH, p. 9, 18, 29.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
5
traditional ecological knowledge (TEK) 13. According to ANDRIANTSIFERANA the class of
traditional medicinal knowledge can be subdivided in three categories: category 1 deals with
medicine(s) prepared by a traditional health practitioner for a patient, category 2 encompasses
medicine(s) originating from the community but having commercial applications and category
3 relates to products originating from research and academic institutions 14. BRUSH rightly
says that the class of traditional agricultural knowledge relates to knowledge leading to crop
improvement 15. BALICK adds another class to the trinomial classification, i.e. more specific
traditional cultural knowledge (TCK): in his view the extinction of language is an excellent
example of devolution, for related to cultural knowledge 16.
The present survey mainly focuses on traditional medicinal knowledge.
III. HOLDER PERPECTIVES
There is a growing consensus that indigenous communities which are involved in the
identification of therapeutic properties of native plants should be compensated for the
exploitation of their traditional medicinal knowledge. However, there seems to be a lot of
obscurity and uncertainty as to the appropriate legal instruments that should be used to give
shape to the right to compensation. Overlooking past and presents efforts to establish an
appropriate model that fits the contribution of indigenous communities, we can observe two
approaches 17.
A. Positive protection route
A first approach, the so-called “positive protection” route, is based on the assumption that
protection of indigenous knowledge is important to safeguard the rights of knowledge
holders in view of commercial exploitation and benefit.
1. Overview
a. Traditional Medicinal Knowledge
Various existing IP systems have been suggested as a protection system for traditional
medicinal knowledge: patent law, copyright protection, database protection, utility models
(Petty patents, Gebrauchsmuster) and geographical indications 18. ANDRIANTSIFERANA,
OTTEN and JONES focus on pre- and post grant problems when applying for patents 19.
BALICK stresses the importance of copyright protection: one-way of strengthening the position
of traditional healers is to consider these people as colleagues and teachers, rather than as
informants. By including traditional healers who have provided information for research as
13
14
15
16
17
18
19
Cf. WIPO, 2001.
See the contribution of ANDRIANTSIFERANA, p. 5.
See the contribution of BRUSH, p. 19.
See the contribution of BALICK, p. 5.
Cf. WENDLAND, W., ‘Intellectual Property and the Protection of Cultural Expressions: the Work of the
World Intellectual Property Organisation’, Articles on Cultural Expressions and Indigenous Knowledge,
GROSHEIDE, W. & BRINKHOF, J. (eds.), in Intellectual Property Law - Molengrafica Series, Intersentia,
Antwerp-Oxford-NewYork, 2002, 101-138; WENDLAND, W. B, ‘Intellectual Property, Traditional
Knowledge and Folklore: WIPO’s Exploratory Program’, 33 International Review of Industrial Property and
Copyright Law, 2002, 485-504 and 606-621.
See VAN OVERWALLE, G., ‘Protection of Traditional Knowledge: a Critical Synthesis’, in Articles on
Cultural Expressions and Indigenous Knowledge, GROSHEIDE, W. & BRINKHOF, J. (eds.), in Intellectual
Property Law - Molengrafica Series, Intersentia, Antwerp-Oxford-NewYork, 2002, 251-268 and the
references cited there.
See the following section.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
6
co-authors or providing acknowledgement using their names, all parties benefit 20. Both
ANDRIANTSIFERANA and BALICK underline the need for database protection: workers in the
ethno-sciences are collecting data and are using modern technology to catalog and study this
information. Although data gathering may not be as useful with regard to long-term
preservation of the actual knowledge, IP protection of the data collections might still be
worthwhile 21. Various types of database management can be established: free access, access
associated with a material transfer agreement, access subject to scientific evaluation, etc. 22.
On top of existing IP systems, a new IP tool has been suggested to fit the needs of indigenous
peoples: the adjudication to knowledge holder countries of a special form of IP protection for
traditional medicinal knowledge, a so-called sui generis solution 23. Such an approach could
find a legal basis in article 27 (3) (b) of the TRIPs Agreement 24 which provides for an
effective sui generis system for plant variety protection and which would offer an opportunity
to introduce an alternative protection system modeled along the needs of indigenous
peoples 25. OTTEN and DE CARVALHO both critically explore this route 26.
Another route to provide protection for traditional knowledge is the establishment of
appropriate, national access and benefit sharing (ABS) measures. As LEWIS rightly points
out, such measures place the burden upon the government and can only be successful in
practice if the national government involved is willing to espouse the interest of the
indigenous peoples involved and protect such rights for them 27.
Still another attempt to give shape to the expectations and needs of indigenous peoples is the
voluntary concluding of contractual arrangements between a variety of institutions from
provider and user countries. ANDRIANTSIFERANA, BALICK, BENBROOK, GÁMEZ, MILLER and
OTTEN all extensively examine this option 28. Last but not least, ANDRIANTSIFERANA
suggests the establishment of ‘Community Intellectual Rights’ 29.
20
21
22
23
24
25
26
27
28
29
See the contribution of BALICK, p. 13.
See the contribution of BALICK, p. 3, 20, and 22.
See the contribution of ANDRIANTSIFERANA, p. 8.
There is a vast literature on this subject. A selection: BLAKENEY, M., 'Bioprospecting and the Protection of
Traditional Medical Knowledge of Indigenous Peoples: An Australian Perspective', EIPR, 1997, (298), 298;
DA COSTA E SILVA, E., 'The Protection of Intellectual Property for Local and Indigenous Communities',
EIPR, 1995, (546), 549; POSEY, D.A., Traditional Resource Rights. International Instruments for Protection
and Compensation for Indigenous Peoples and Local Communities, Gland (Switzerland), IUCN (The World
Conservation Union), 1996, 13-22; POSEY and DUTFIELD, ‘Plants, Patents and Traditional Knowledge:
Ethical Concerns of Indigenous and Traditional Peoples’, Patent Law, Ethics and Biotechnology, VAN
OVERWALLE, G. (ed.), Brussel, Bruylant, 1998, (112), 126; WALDEN, 'Intellectual Property Rights and
Biodiversity', International Law and the Conservation of Biological Diversity, BOWMAN M. & REDGWELL,
C. (eds.), in International Environmental Law and Policy Series, London - the Hague - Boston, Kluwer Law
International, 1996, (171), 182-189.
Agreement on Trade-Related Aspects of Intellectual Property Rights (Annex 1C of the Marrakech
Agreement Establishing the World Trade Organization, signed in Marrakech, Morocco on 15 April 1994),
see http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm. For a critical review of article 27 TRIPs, see
CORREA C.M. & YUSUF, A. A., Intellectual Property and International Trade: the TRIPs Agreement, The
Hague, Kluwer Law International, 1998. Also see par. 19 of the Doha Declaration.
The relationship between TRIPs and the CBD is the subject of an intense discussion. See, Study on the
Relationship between the Agreement on TRIPs and Biodiversity Related Issues, Final Report for DG I
European Commission, 2000, see http://europa.eu.int/comm/trade/miti/intell/ceas.htm.
See their respective contributions in the current proceedings, DE CARVALHO, p. 77 ff.
See the contribution of LEWIS and RAMANI.
See the following sections.
See the contribution of ANDRIANTSIFERANA, p. 5.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
7
b. Traditional Agricultural Knowledge
There is a well-established IP tool, which offers adequate legal protection for traditional
agricultural knowledge: the plant breeder’s rights system. This system will not be further
discussed here 30. HAMILTON has addressed some of the recent developments 31.
2. Patents
The suggestion has been made that indigenous communities which are involved in the
identification of the therapeutic properties of native plants, should be compensated for the
exploitation of their medicinal knowledge by way of patents. The premises, concepts,
interpretation and requirements of patent laws, however, have largely been dictated by the
industrial and technological circumstances in Western economies 32. In this context it is
questionable whether the contribution of traditional knowledge from which a pharmaceutical
product has been developed, can be the sort of contribution that will meet patentability
standards 33.
a. Intrinsic thresholds
A first problem in analyzing traditional knowledge in conventional patent terms is the
observation that indigenous peoples do not view their heritage in terms of property at all, but
in terms of community and individual responsibility. Possessing medicinal knowledge carries
with it certain responsibilities such as to show respect and maintain a reciprocal relationship
with the human beings, animals, plants and places with which the medicine is connected 34.
There are two catches in this observation, however. First, there is most probably not one,
monolithic indigenous view on property, but a diversity of views on how to regulate property
internally. Second, not much is know about internal protocols 35.
A second problem relates to the final goal of patent law. The principal rationale of patent law
is to provide an incentive for inventiveness and creativity, commercialization and distribution,
by offering the patent holder a period of time during which his rights are immunized from
competition. Indigenous peoples have been reported to be not primarily concerned with the
commercial exploitation of their knowledge and market economic values. As BALICK points
out, knowledge may have its greatest value to indigenous peoples because of its ties with
cultural identity or its sacred significance 36. This observation should probably be put in
perspective because such a point of view would imply a monolithic indigenous view and
30
31
32
33
34
35
36
An impressive quantity of literature exists on plant breeders’ rights. See VAN OVERWALLE, G., ‘Patent
Protection for Plants: a Comparison of American and European Approaches’, 39 IDEA-Journal of Law and
Technology (USA), 1999, 143-194 and the references cited there.
See the contribution of Neil D. HAMILTON, ‘Forced Feeding: Inventorying New Legal Issues in the
Biotechnology Policy Debate’ in the current proceedings, more in particular the section on ‘Intellectual
Property Rights and Agriculturally Important Genetic Material’.
BLAKENEY, o.c., 1997, (298), 298; MOUFANG, R., ‘The Concept of ‘Ordre Public’ and Morality in Patent
Law, Patent Law, Ethics and Biotechnology, VAN OVERWALLE, G. (ed.), Brussel, Bruylant, 1998, (65),
77 referring to BEIER, ‘Patent und Ethik im Spiegel der technischen Evolution’, GRUR, 1994, 541 ff. und
BEIER, ‘Gewerblicher Rechtsschutz, Soziale Marktwirschaft und Europäischer Binnenmarkt’, GRUR, 1992,
228 ff.
POSEY and DUTFIELD, o.c., 1998, (112), 112.
DAES, E.I., Discrimination Against Indigenous Peoples: Study on the Protection of the Cultural and
Intellectual Property of Indigenous Peoples, 1993, paragraph 26 quoted in PURI, ‘Cultural Ownership and
Intellectual Property Rights Post-Mabo: Putting Ideas into Action’, Intellectual Property Journal, 1995, (293),
308. Cf. WELLS, A.J., 'Patenting New Life Forms: An Ecological Perspective', EIPR, 1995, 111-118.
Similarly, WIPO, 2001, 220.
See the contribution of BALICK. Cf. BLAKENEY, o.c., 1997, (298), 300; POSEY and DUTFIELD, o.c.,
1998, (112), 115.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
8
because there might well be diverging views on the value of knowledge in indigenous
communities.
A third impediment is the novelty requirement. Two difficulties can be observed in this
regard. First en foremost it is often said, cf. LEWIS, that indigenous knowledge is
transgenerational, communally shared and considered to be in the public domain and,
therefore, unprotectable 37. Recent investigations, however, have shown that not all
indigenous knowledge is communally shared, and not all of it is considered to be in the public
domain 38. Various healing methods have been reported to have been held under a secrecy
regime. Second, it is often argued that a problem with the patent claims of indigenous
peoples in relation to traditional medicinal knowledge is that ethnobotanists and
ethnopharmacologists often publish accounts of the uses of plants by indigenous peoples 39.
This may have the effect of destroying the novelty of therapeutic claims, especially in a
European patent setting. The US, however, handles prior art and publication from foreign
locations differently than Europeans do. Moreover, the patents applied for often do not
concern the precise use undertaken by the indigenous community. The rosy periwinkle
case 40 might serve as a good example of this issue. The indigenous knowledge provided the
lead and it is unacceptable that this was not recognized, but the patent was not on the
particular use revealed by the indigenous community.
A fourth obstacle is the notion in contemporary patent law of the inventor as an individual,
solitary and original creator, or a group of individuals (so-called joined inventorship), not
collective entities 41. It is often claimed that for indigenous peoples knowledge and
determination of the use of resources are collective. As LEWIS correctly observes, custodians
of traditional medicinal knowledge and indigenous peoples in general, do not fit the
individuality model and might therefore be denied patent protection 42. Once again, this
observation should be put in perspective, since knowledge and determination of use are not
necessarily collective. Diverging views exist within indigenous communities on this issue 43.
The concept of joint inventorship is only helpful at times, because it requires that each of the
joint inventors must have contributed to the inventive conception, working on the same
subject matter and making the same contribution to the inventive thought and to the final
result 44. One does not become a joint inventor by being the first to observe a useful property
or effect of an invention. In order to claim joint inventorship, some demonstrable role in the
final conception needs to be established. As DE CARVALHO points out, in case of
collaboration with indigenous peoples or shamans, the problem is that their cooperation with
ethnopharmacologists may be considered to be too indirect to the process of joint invention 45.
However, both LEWIS and ROSENTHAL have observed some successful events in this context,
37
38
39
40
41
42
43
44
45
See the contribution of LEWIS and RAMANI. Cf. POSEY and DUTFIELD, o.c., 1998, (112), 115.
See WIPO, 2001, 57-65.
BLAKENEY, o.c., 1997, (298), 299; HUFT, ‘Indigenous Peoples and Drug Discovery Research: A Question
of Intellectual Property Rights’, Nw. U.L.R., (1678), 1718.
Cf. KADIDAL, S., 'Plants, Poverty and Pharmaceutical Patents', The Yale Law Journal, 1993, 223-258.
Cf. BLAKENEY, o.c., 1997, (298), 299; POSEY and DUTFIELD, o.c., 1998, (112), 115.
See the contribution of LEWIS and RAMANI. Cf. BLAKENEY, o.c., 1997, (298), 299; POSEY and
DUTFIELD, o.c., 1998, (112), 115; WELLS, o.c., 1995.
Similarly, WIPO, 2001, 219.
JANSSENS, M.C., Uitvindingen in dienstverband met bijzondere aandacht voor uitvindingen aan
universiteiten – Employee and University Inventions (Summary), Brussel, Bruylant, 1996, 24-26; SINGER,
R. and SINGER, M., Europaïsches Patentübereinkommen: Kommentar, Carl Heymanns Verlag, Köln, 1989,
174.
See the contribution of DE CARVALHO, p. 34.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
9
more in particular in the Peruvian ICBG project 46. In case of collaboration with scientific
institutions joint inventorship might be exacted, as GÁMEZ experience with regard to INBio
clearly shows 47.
b. Practical impediments
A first practical problem, mentioned by LEWIS and others, is that patents are expensive: next
to the cost of patenting, which is high, the costs of opposition proceedings and infringement
actions should be added, which can also be very high 48. Acquiring and defending patent
protection requires substantial financial resources. These actions tend to be complex and
time-consuming and well beyond the means of indigenous peoples. The securing and
enforcement of patents will therefore often be prohibitively expensive for indigenous peoples.
However, costs associated with the use of the patent system have been argued not to make the
system inherently unjust, particularly if ways can be found to lower costs or to assist indigent
persons and communities to use the system 49.
A second practical impediment relates to the lack of intellectual property expertise of
traditional knowledge holders. GOLLIN takes the view that fairness dictates that when poor
and excluded people are confronted with the very complicated issues involving intellectual
property, they should have access to expert advice and representation. In order to provide
such advice, he took the laudable initiative to establish an independent international service
and referral organization, the Public Interest Intellectual Property Advisors (PIIPA) 50.
3. Contracts
Another attempt to give shape to the rights of knowledge holders is the voluntary concluding
of contracts between a variety of communities and institutions from provider and from user
countries.
a. Monetary and non-monetary benefits
Experience shows that contractual arrangements first and foremost deal with tangible
aspects, monetary benefits. They focus on what – quite significantly - has been termed by
BALICK ‘the gold standard’ 51 and has been experienced in an ICBG-setting by LEWIS 52: the
user countries agree to pay a lump sum for the right to analyze indigenous material from
plant and animal origin, complemented by a royalty for the benefits derived from this
material. BALICK and GÁMEZ testify that in various cases substantial research budgets have
been acquired on top of that 53.
However, it has been repeatedly argued that contracts and partnerships can only be successful
on the long term if both monetary and non-monetary benefits are shared. Various innovative
strategies have been developed that go beyond the gold standard and include both tangible
and non-tangible elements. GÁMEZ correctly says that scientific and technological capacity
46
47
48
49
50
51
52
53
See the contribution of LEWIS and RAMANI. See the conbribution of Joshua ROSENTHAL, ‘Politics,
culture and governance in the development of prior informed consent and negotiated agreements with
indigenous communities’, in the current proceedings.
See the contribution of Rodrigo GÁMEZ entitled ‘The Link Between Biodivesity an Sustainable
Developmemnt: Lessons from INBio’s Bioprospecting Program in Costa Rica’ in the current proceedings, p.
11/15.
See the contribution of LEWIS and RAMANI. Cf. BLAKENEY, o.c., 1997, (298), 300; POSEY and
DUTFIELD, o.c., 1998, (112), 115-116.
WIPO, 2001, 222.
See the contribution of Michael A. GOLLIN, ‘Answering the Call: Public Interest Intellectual Property
Advisors’, in the current proceedings.
See the contribution of BALICK, p.5.
See the contribution of LEWIS and RAMANI, p. 9 ff.
See the contribution of BALICK, p.5 and the contribution of GÁMEZ, p. 10-11.
VAN OVERWALLE, Geertrui
Holder and User Perspectives in the TK Debate
January 19, 2004
10
building is a very important non-tangible asset that can contribute directly and significantly to
the formulation of proper national policy and legislation regulating the access to, and benefit
sharing derived from biodiversity resources 54. Similarly, BENBROOK states that leveraging
local knowledge is of major importance 55. MILLER equally underlines that activities that
improve research capacity through institutional support, training, and technology transfer, can
have significant impact in developing countries 56. BALICK in turn argues that the concept of
cultural support is a very important aspect of non-monetary benefit sharing. This support is
not limited by the financial resources of the investigator, but only by their level of cultural
sensitivity, understanding and desire to make a difference 57.
b. Informed consent and disclosure procedures
In general, agreements should be based, as ANDRIANTSIFERANA rightly brings into mind, on
the principles of equality, mutual respect, partnership, mutually beneficial relations and the
sharing of results 58. The concluding of contracts might require intense ‘grass root efforts’,
speaking in BALICK’S language 59.
More in particular, contracts should pay special attention to prior informed consent
procedures. Prior informed consent in the context of genetic resources is defined by the
International Union for Conservation of Nature and Natural Resources’ (IUCN) guide to the
Convention on Biodiversity (CBD) as “consent of the contracting party which is the genetic
resource provider, based on full and complete information provided by the potential genetic
resource user prior to consent for access being granted…” 60. MILLER argues that informed
consent has to be obtained from the party providing access to genetic resources. However
difficult and expensive obtaining informed consent may very well be, it has led to a very
positive re-examination of collaborative research, which has fostered short-term benefits that
have greatly supported the development of biological research capacity in source countries 61.
As LEWIS and RAMANI rightly point out, informed consent should also be obtained of the
concerned local community for the use of traditional knowledge 62. In this context,
ROSENTHAL offers a very interesting analysis of two landmark projects and draws some
lessons about the role of culture, politics and local governance as they influenced the differing
outcomes. In particular, he points to the role of preexisting and broadly representative
indigenous governance as a key factor in determining the feasibility and integrity of prior
informed consent for the use of traditional knowledge 63. In the same vein, LEWIS & RAMANI
and MC MANIS focus extensively on one of those cases, the successful Peruvian ICBG
project 64.
54
55
56
57
58
59
60
61
62
63
64
See the contribution of GÁMEZ, p. 10.
See the contribution of Charles BENBROOK, entitled ‘Principles Governing the Long-Run Risks, Benefits,
and Costs of Agricultural Biotechnology’ in the current proceedings.
See the contribution of James MILLER, ‘Impact of the Convention on Biological Diversity: The Lessons of
Ten Years of Experience with Models for Equitable Sharing of Benefits, in the current proceedings, p. 4 and
Table 1.
See the contribution of BALICK, p. 24.
See the contribution of ANDRIANTSIFERANA, p. 5.
See the contribution of BALICK, p. 27.
GLOWKA, L.F., BURHENNE-GUILMIN, et al., A guide to the Convention on Biological Diversity, Gland,
Switzerland, 1994, IUCN.
See the contribution of James MILLER, p. 13.
See the contribution of LEWIS and RAMANI, p. 6 and 9.
See the contribution of ROSENTHAL.
See the contribution of LEWIS and RAMANI. Also see Mc MANIS, C., Intellectual Property, Genetic
Resources and Traditional Knowledge Protection: Thinking Globally, Acting Locally’.
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According to OTTEN, it is questionable whether contracts should also deal with the disclosure
requirement 65.
c. Bilateral or multilateral scope
Another aspect to be considered is the scope of the agreements: do bilateral agreements
suffice or should multilateral contracts be negotiated? According to VOGEL, the greatest threat
to sustainability is no longer biopiracy per se but something far more insidious: the biofraud
inherent to all bilateral contracts between a corporation and only one supplier. These
contracts fuel a price war denying everyone the possibility of garnering an economic rent 66.
VOGEL proposes a cartel as a solution. In such a cartel, the price of access is fixed and the
benefits are distributed among all who could have supplied the same resource or
knowledge 67.
Negotiating multilateral contracts between knowledge holders and
bioentrepreneurs on an international level is definitely a step in the good direction.
As a closing remark, one can point to LEWIS and RAMANI, who offer an overview of the
various CBD and WIPO reports which contain model clauses that the parties to a contractual
agreement could use taking into account both the concerns of knowledge holders and users 68.
B. Defensive protection systems
A second approach, the so-called “defensive approach” route, aims at the protection of
indigenous knowledge, mainly in an effort to protect these assets against acquisition and
exploitation by third parties.
The major route to protect indigenous knowledge against the unauthorized use and
unauthorized acquisition of patents over traditional knowledge by third parties, is the
documenting of traditional knowledge 69. In this context, DE CARVALHO points to two
possible alternatives 70. First, knowledge holders may apply for patent rights with the single
purpose of avoiding that others acquire rights in their knowledge. Second, traditional
knowledge holders may publish the information and as a result of publication, the knowledge
becomes part of the state of the art and is novelty destroying for future patent applications
based on or related to this knowledge.
Another – informal - effective way of protecting knowledge against unauthorized use is
secrecy. A secrecy regime is usually maintained with regard to a formula for a chemical
compound, a process of manufacturing, a pattern for a machine or other device, but it could
also be applied to the field of traditional medicine, e.g. with regard to healing methods or
techniques for using certain ingredients of particular plants in well balanced amounts. Some
traditional knowledge holders have pointed out that it is sometimes difficult to maintain
secrecy within small communities, where close-range interaction and collaboration constrains
the innovator’s ability to conceal his innovation. Innovators often rely on modifications of
traditional techniques, which have been passed on in the community from one generation to
another. Therefore, minimal observation might suffice for would-be infringers to imitate the
innovation 71.
65
66
67
68
69
70
71
See the contribution of Adrian OTTEN.
VOGEL, J.H. (ed.), The Biodiversity Cartel. Transforming Traditional Knowledge into Trade Secrets,
CARE, Proyecto SUBIR, 2000.
See the contribution of Joseph Henry VOGEL, ‘From the “Tragedy of the Commons” to the “Tragedy of the
Commonplace”: Analysis and Synthesis through the lens of Economic Theory’, in the current proceedings.
See the contribution of LEWIS and RAMANI.
Cf. WIPO, 2001, 6, 217.
See the contribution of N.P. DE CARVALHO, p. 21 ff..
See WIPO, 2001, 61.
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It has been reported that yet another – informal – way of protecting knowledge, is the use of
ritual or magical components that form part of traditional medicine. Those rituals often allow
traditional healers to control the use of their innovations in spite of full disclosure of their
techniques and methods within the local community 72. Some people have pointed out that
rituals operate as a barrier against reverse engineering; in other words, rituals function as a
mechanism that prevents the use and development of technologies based on imitation.
Apparently, ritual regimes can create exclusive rights similar in strength to patents, at least in
the local context and within supportive cultural frameworks 73.
III. USER PERSPECTIVES
Since the entry into force of the CBD, attention on regulation of access and benefit sharing
has tended to focus on measures taken by provider countries to implement adequate measures.
Recently, however, greater attention has been given to the promotion of a range of measures
countries, particularly developed countries, could take in their role as users of genetic
resources and traditional knowledge accessed from provider countries.
A. Patent law
Various attempts are being made to modify patent law in developed countries in order to meet
various objections and public concerns relating to the patenting of traditional knowledge by
user countries and to adapt the patent system in a way that the expectations and needs of
source countries and indigenous peoples can better be accommodated.
This can be achieved in a number of ways. Firstly, one can think of a few options which are
available for user countries in the pre-grant phase: the reassessment of the current novelty
regime and the introduction of additional requirements for the grant of a patent, in particular
the incorporation of a disclosure of origin and a prior informed consent requirement.
Secondly, some routes are also available in the post-grant phase, notably with regard to
tempering the effects of granted patent, through the introduction of responsible governance of
patent rights.
1. Pre-grant options
a. Disclosure of origin requirement
The introduction of a disclosure of origin requirement in patent law is a possibility for
production of evidence in respect of access and benefit sharing rules.
In Europe, the origin requirement was implemented in the European Union Biotechnology
Directive of 6 July 1998 74, in particular in recital 27 75. Recital 27 requires that “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
72
73
74
75
Cf. WIPO, 2001, 62.
Cf. GOLVAN, C., ‘Aboriginal Art and the Protection of Indigenous Cultural Rights’, 7, EIPR, 1992, 227232; WIPO, 2001, 62.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of
Biotechnological Invention, 213 Official Journal EC- L, July 30 1998, 13.
For more information on the history of the development of recital 27, see BLAKENEY, M., 'Biotechnology,
TRIPs and the Convention on Biological Diversity', Bio-Science Law Review, 1998-1999, (144), 148;
STRAUS, J., 'Biodiversity and Intellectual Property', AIPPI Yearbook 1998/IX, (99), 99: “Genetic resources
have become an issue of high priority to scientists, industry, politicians and even the public at large. ... they
form a warehouse of enormous use potentials for plant – and animal breeding, food, chemical and
environmental industries, pharmaceuticals and medicine”.
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processing of patent applications or the validity of rights arising from granted patents”.
Although recital 27 contains a praiseworthy principle, the wording of recital 27 is so
noncommittal, that one can wonder if the recital will have any effect at all.
So far, Belgium and Denmark are the two only member states which to have taken recital 27
seriously: Denmark recently implemented the origin requirement in its patent act and Belgium
intends to do so in the near future. The current Danish Patent Act stipulates that where an
invention involves or uses a biological material of vegetable or animal origin, the patent
application shall contain information about the geographical origin of the material, if the
applicant for the patent has knowledge about this. If the applicant for the patent has no
knowledge about the geographical origin of the material, this shall be indicated in the
application. A lack of information about the geographical origin of the material or the
applicant's lack of knowledge about this does not affect the manner in which the patent
application is treated or the validity of the rights that follow from the patent issued 76.
In the initial Belgian proposal, non-compliance with the disclosure requirement was severely
sanctioned 77. The proposal stipulated that the exploitation of an invention is contrary to
'ordre public' and morality, when the invention is developed on the basis of biological
material that was collected or exported in breach of articles 3, 8 j), 15 and 16 CBD.
Consequently, an invention using plant or animal material imported in violation of the law of
the country of origin, would run counter to Belgian public order and morality and the relating
patent could be nullified 78. A lot of protest was raised against this severe approach. The
current Belgian proposal softens the origin requirement to a great extent: the origin should be
mentioned if known and if the origin is not communicated, no sanction is provided 79.
OTTEN and DE CARVALHO are critical with regard to systems equivalent to the Belgian
proposal, aiming at including the origin requirement as a substantial rather than just a formal
requirement 80. They argue that the obligation to disclose the origin of genetic resources
and/or traditional knowledge as a substantial requirement for granting a patent could infringe
article 27 of the TRIPs Agreement. This obligation might be taken up as a procedural
requirement, within the meaning of "reasonable procedures" of article 62 TRIPs. TOBIN and
BARBER share this concern, with regard to article 27 TRIPs but take the view that if the
implementation of benefit sharing under the CBD framework is a matter of vital importance
to countries both from an economic and a technological perspective, an origin requirement in
patent law might not be contrary to TRIPs 81.
On 12 September 2002 the European Commission announced that it welcomes disclosure of
origin requirement, production of evidence in respect of access and benefit sharing rules as
long as this requirement does not constitute an additional formal or substantial patentability
criterion and as long as it has no bearing on the patentability of the invention or the validity of
76
77
78
79
80
81
Order n° 1086 of 11 December 2000, entering into force 20 December 2000, amending Order n° 374 of 19
June 1998 on patents and supplementary protection certificates.
For more information on the initial Belgian proposal, see VAN OVERWALLE, G., ‘Belgium Goes Its Own
Way on Biodiversity and Patents’, EIPR, 2002, 233-236; VAN OVERWALLE, G., ‘Traditional Medicinal
Knowledge, Patents and the Convention on Biological Diversity’; Revue de droit intellectuel - l'Ingénieur
Conseil, 2001, 161-182.
Article 49 §1 (1) 1984 BPA stipulates that a patent may be revoked by court if the subject matter of the
patent falls within articles 3 or 4, or does not meet the requirements of articles 2, 5, 6 and 7. Cf.
article 138 (1) (a) EPC that stipulates that a European patent may be revoked if the subject matter of the
European patent is not patentable within the terms of articles 52 to 57.
Belgian Parliament (Belgische Kamer Van Volksvertegenwoordigers), 2001-2002, DOC 50 1886/001.
See the contribution of DE CARVALHO, p. 30. Also see DE CARVALHO, N.P., ‘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’, Washington University Journal of Law and Policy, 2000,
(317), 379-380.
See the contribution of Brendan TOBIN and BARBER, p. 5.
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the patent 82. It is clear that the Belgian legislator, in his latest proposals, has aligned himself
with the Danish approach and the European Commission’s declaration.
b. Informed consent requirement
Next to the addition of an origin requirement in patent law, the suggestion has been made to
introduce an informed consent principle in patent law as well. This principle, laid down in
article 15.5 CBD, would imply that every patent applicant has to show evidence that he
received consent was obtained from the government or local communities where the material
originates from. ANDRIANSIFERANA repeats in this respect that prior informed consent should
not only be obtained in case of access to biological resources, knowledge or technologies, but
also in case of application for any form of intellectual property protection 83. HUNTER and
JONES underline that inserting the prior informed consent in patent law is a way of integrating
human rights in IPR law 84.
Initially the European Commission did not make any reference to the prior informed consent
requirement for the use of biological material: the EU Biotechnology Directive of 1998 does
not mention informed consent for the use of biological material. An informed consent
requirement has been taken up in the Danish patent act, but has not been foreseen in the
Belgian proposal. The Danish patent act stipulates that where an invention involves or uses a
biological material of human origin, the patent application shall indicate whether the person
from whom the biological material originates has given consent for the application to be
submitted. The information concerning consent does not affect the manner in which the
patent application is treated or the validity of the rights that follow from the patent issued 85.
Meanwhile the European Union has underlined its desire to take into account the principles
embedded in CBD. The European Commission recently stated that it welcomes the Bonn
Guidelines on Access to Genetic Resources and Benefit-sharing, agreed by the Conference of
the Parties (COP) in the Hague on April 19 2002 86 which sets out practical ways and means
of implementing the principles of prior informed consent and of mutually agreed terms
enshrined in article 15 of the CBD at national level 87.
82
83
84
85
86
87
Communication by the European Communities and their Member States to the TRIPs Council on the Review
of Article 27.3(b) of the TRIPs Agreement, and the Relationship between the TRIPs Agreement and the
Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge and Folklore – A
Concept Paper, Brussels, European Commission - Directorate General for Trade (12 September 2002). Also
see: Submission by the European Community and its Member States on Traditional and Intellectual Property
Rights – 3rd Session of the WIPO Intergovernmental Committee on IP and Genetic Resources, Traditional
Knowledge and Folkore (13-21 June 2002) Also see: Review of Article 27.3(B) of the TRIPs Agreement and
the relationship between the TRIPs Agreement and the Convention on Biological Diversity and the
Protection of Traditional Knowledge and Folklore – A Concept Paper, submitted by the European
Communities under Paragraph 32 (ii) to the WTO (14 February 2003).
See the contribution of ANDRIANTSIFERANA, p. 6.
See the contribution of John HUNTER and Chris JONES entitled ‘Bioprospecting and Indigenous
Knowledge in Australia: Valuing Indigenous Spiritual Knowledge and its Implications for Integrated Legal
Regimes’ in the current proceedings, p. 25.
Order n° 1086 of 11 December 2000, entering into force 20 December 2000, amending Order n° 374 of 19
June 1998 on patents and supplementary protection certificates.
COP 6 Decision VI/24, see http://www.biodiv.org/decisions/default.asp?lg=0&dec=VI/24.
Communication by the European Communities, Brussels, 12 September 2002 (see previous footnote). Also
see the Submission by the European Community and its Member States on Traditional and Intellectual
Property Rights, Brussels, 14 June 2002. Also see the references in footnote 81.
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2. Post grant options
Humanitarian use resctriction
Regulation of some post-grant issues might contribute to achieve a better balance between the
rights of inventors/investors and traditional knowledge holders. In this respect KHUSH
advocates the implementation of humanitarian use restrictions in licenses 88. Humanitarian
use has been defined as use in developing countries (according to FAO definition) by resource
poor farmers who make less than US$10,000 per year, leaving the company free to explore
commercial prospects for the technology 89. To date licenses have been given to five major
rice-growing countries namely the Philippines, India, China, Vietnam and Indonesia.
B. Alternative measures
1. Self standing regulations
Ethical concerns regarding the patenting of inventions based on biological material of plant
origin and local traditional knowledge can be taken care of within patent law, but can also be
cured in other laws by introducing a supplementary provision, prescribing that the origin of
the plant material must have been disclosed and that the knowledge holder must have had an
opportunity of expressing prior, free and informed consent to access, use and patenting. Such
a provision can be issued by a government and carries an obligation to comply. This
approach has been advocated by DE CARVALHO 90 and has also been suggested by the
European Commission 91. However, it remains to be seen what type of information will be
requested and what the legal consequence will be of failure to disclose. To have any effect,
non-compliance, in casu the non-existence of a disclosure of origin and informed consent,
should probably result in a regulatory penalty.
2. ‘Doctrine of unclean hands’
As should be clear from the above, there are differing opinions with regard to the question
whether requiring disclosure of origin and legal provenance of genetic resources and
traditional knowledge is in fact in conformity with TRIPs. TOBIN & BARBER and DE
CARVALHO, however, point to an area of the debate about which there appears to be more
widespread agreement. This relates to the principle that the holder of a patent, which has
been obtained following an illegal act, should not be entitled to benefit from his illegal act,
through exercise of the rights obtained in the grant of the IPR. This is generally referred to as
the application of the “doctrine of unclean hands”. On the basis of article 8.2 of TRIPS,
which authorizes WTO members to adopt appropriate measures to prevent the abuse of IPRs,
TOBIN and BARBER argue that if genetic resources are directly or indirectly used in making a
patented invention and have been obtained in a country that has adopted legislation requiring
prior informed consent, then failure to obtain that consent would amount to fraud 92.
88
89
90
91
92
See the contribution of Gurder S. KHUSH, entitled ‘Biotechnology: Public-Private Partnership and IPR in
the Context of Developing Countries’, in the current proceedings, p. 12/20.
POTRYKUS, I. 2001, ‘Golden Rice and Beyond’, 125 Plant Physiology, 2001, 1157-1161.
See the contribution of DE CARVALHO.
Communication by the EU to the TRIPs Council, 12 September 2002. Also see the references in footnote 81.
See the contribution of TOBIN and BARBER, p. 28. See the contribution of DE CARVALHO. Also see DE
CARVALHO, l.c., 2000, 389-401 (footnote 79).
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IV. CONCLUSIONS
The legal protection of traditional knowledge and the equitable sharing of its benefits have
gained wide concern in civil society and have triggered stakeholders, government officials,
politicians and scholars to develop new lines of thought.
For traditional knowledge providers protection within existing IPR systems remains
problematic, but various alternative initiatives have been established or are under way which
take into account their expectations and needs. For user countries in the Western world,
establishing sharing mechanisms offers a unique chance to rebalance North-South relations
in a spirit of corporate social responsibility. However difficult as it may seem from a TRIPs
point of view, the disclosure of origin and prior informed consent requirements need to be
implemented as substantial patentability requirements, or at least as self standing regulations
with substantial regulatory penalties. Doing so will reduce the public reserve with regard to
the current use of patents by the bioindustry and restore trust in bioentrepreneurship and in
the patent system. Also in contracts, efforts should be made to establish monetary standards
and non-monetary requirements on a multilateral or international level, avoiding time
consuming recurrent discussions in bilateral negotiations.