Professor Kamal Puri
Director, WIPO-QUT Master of Intellectual Property Law Program
QUT, Brisbane, Australia
Many patent applications cover inventions that consist directly of
existing TK, or are obvious adaptations or applications of it. By
strict interpretation of the patent law, such applications should be
rejected outright because they do not meet the novelty and nonobviousness requirements.
Clearly, the patent applicant has not derived the right to apply from
the true inventor. Further, the TK pertaining to the alleged
invention constitutes as relevant prior art under the patent
law. However, because TK is often orally transmitted, evidentiary
and other issues including the date of the disclosure and whether
the disclosure was sufficient to enable the recipient to put the new
technology into effect, crop up.
From the Patent Office’s perspective, the practical issue is: what
should constitute the relevant prior art? Is it possible to halt or
minimise the cultural and financial harm to indigenous owners by
commercialization of TK through the vehicle of patent protection?
Before attempting to change the patent law and practice, it is
important to become aware of the serious harm that the
unrestrained usurpation of TK is causing to the indigenous
communities who are collectively holding vast TK through a form
of custodianship with responsibilities for maintaining and passing
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 Exclusive rights for 20 years for new, non-obvious and industrially
applicable ideas.
 “Actual inventor” to be stated – the person who made the
discovery, i.e., the idea for it originated in his or her mind.
 Person entitled to apply: inventor, person entitled to have the
patent assigned upon grant, assignee or legal representative.
 Actual inventor to be identified in the Notice of entitlement identification of the inventor is fundamental as the patent right is
derived, directly or indirectly, from the act of invention.
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 How is novelty assessed against the prior art base?
 Has the applicant declared all relevant known prior art?
 Does TK constitute prior art?
 Do patent search authorities take account of TK in the course of
assessing the validity of patent applications?
 Is TK-related prior art accessible to patent authorities?
 Is TRIPS compatible with TK?
 Should TRIPS require mandatory disclosure of origin by patent
applicants for avoiding the patenting of inventions that are based
on TK or derived from or guided or made use of TK?
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Tradition-based know-how and information on the
management of natural resources, traditional medicine,
crafts and artistic designs.
 Originates in a wide range of social, cultural, environmental and
technological contexts.
 Dynamic, not static or antique.
 Often not recorded in writing - orally transmitted knowledge.
 Passed down from generation to generation.
 Collectively held by communities.
 Use and dissemination often governed by long-standing
customary law and practice.
 Innovative and has scientific or technological components
 Often associated with genetic resources.
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 Article 27(1) obliges governments to make inventions eligible for
patenting that are new, involve an inventive step (or be nonobvious) and capable of industrial application (or be useful).
 TK will normally not be eligible for patentability because of lack of
novelty.
 Further, TK usually created by a community and not on an
individual basis will not fall within the definition of patentability.
 Lack of protection of TK under TRIPS has raised an assumption
that TK is freely accessible.
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 Came into effect on 1 January 1995.
 To date, the most comprehensive multilateral agreement on IP.
 Triggered globalisation of IP by providing for global minimum
standards concerning the availability, scope and use of IPRs.
 Overall objectives: advancement of global free trade; reduction of
distortions and impediments to international trade and
development of trade-friendly measures and procedures to enforce
IPRs .
 Governments allowed to reduce any short term costs through
various exceptions, e.g., to tackle public health problems.
 Trade disputes over IPRs to be resolved under the WTO’s dispute
settlement system.
 WTO chosen as a forum for TRIPS because it has greater
enforcement power through international trade mechanisms than
WIPO.
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 Report by WTO’s DG, Pascal Lamy (21 April 2011).
 Purpose: to reduce the risk of patents being incorrectly granted
over genetic resources and associated TK.
 Options: disclosure requirement, database system, nationalbased approaches to enforcing PIC and equitable benefit sharing,
or the use of contracts.
 Queries: Whether a mandatory disclosure requirement would
• really bolster the capacity of patent law to reward innovation;
• be unreasonably burdensome for patent applicants and/or IP offices;
• result in uncertainty and deter investment in innovation, thus
undermining the role of the patent system; and
• be workable without more precise definitions for "genetic resources"
and "traditional knowledge“.
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Disclosure as a TRIPS obligation: Brazil, India Bolivia, Colombia,
Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the
African group and some other developing countries: amend TRIPS so that
patent applicants required to disclose the country of origin of genetic
resources and TK used in the inventions, evidence that they received PIC
and evidence of “fair and equitable” benefit sharing.
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Disclosure through WIPO: Switzerland: amend the regulations of
WIPO’s PCT (and, by reference, WIPO’s Patent Law Treaty) so that
domestic laws may ask inventors to disclose the source of genetic
resources and TK when they apply for patents. Failure to meet the
requirement could hold up a patent being granted or, when done with
fraudulent intent, could entail a granted patent being invalidated.
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Disclosure, but outside patent law: EU’s position includes a proposal
to examine a requirement that all patent applicants disclose the source or
origin of genetic material, with legal consequences of not meeting this
requirement lying outside the scope of patent law.
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Use of national legislation, including contracts rather than a
disclosure obligation: US - CBD’s objectives could be best achieved
through national legislation and contractual arrangements based on the
legislation, which could include commitments on disclosing of any
commercial application of genetic resources or TK.
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Despite agreeing on the general usefulness for patent examination of TK and
genetic resources databases, members doubted whether:
 databases could serve as the primary way to prevent erroneous
patents;
 fully exhaustive databases of TK were feasible, given the oral
character of much TK;
 recording TK in a database could itself lead to its
misappropriation;
 fully mapping out all the genetic resources potentially available
in a mega-diverse country was possible;
 a mandatory disclosure requirement would really bolster the
capacity of patent law to reward innovation;
 the requirement would help direct patent examiners towards
the relevant databases; and
 the additional costs and burden of incorporating the mandatory
disclosure requirement as compared to existing obligations
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29.1 of the TRIPS Agreement would be justified.
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 Unlike other areas of technology, prior art involving TK-related
patents rarely found in patent literature and often absent from the
general scientific literature routinely searched by patent
authorities.
 Orally disclosed information can be treated as prior art, but lack of
documentation raises evidentiary and other issues including the
date of the public disclosure and whether the disclosure was
sufficient to enable the recipients to put the new technology into
effect.
 TK must be part of the inventive process – a mere lead or a hint is
not enough.
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 Published information or public oral disclosures and actions
anywhere in the world.
 Universal novelty required for an invention to qualify for a patent.
 Prior art includes:
• Information published in written form locally or in foreign
countries.
• Information orally disclosed locally or in foreign countries.
 Oral disclosure - “doing an act”
 Disclosure must be public – disclosure to one other person enough
if without an obligation of confidentiality.
 Public working of an invention forms part of the prior art base.
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 No examination guidelines specific to TK or genetic resources.
 No judicial decisions relating to the relevance of TK or genetic
resources as prior art.
 No specific rules regarding the assessment of the person skilled in
the art for the determination of inventive step when an element of
TK is involved.
 The only common general knowledge that can be used in
objections of lack of inventive step is the common general
knowledge in Australia.
 If the knowledge is confidential to the community then it does not
form part of the common general knowledge and so is not
available to be used in any assessment of inventiveness.
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 Two Patent Office decisions.
 Vincent Joseph Collins and Maryann Collins v William Robert
McGilvray [2002] APO 23 - a method for producing a blue colored
oil from a mixture of the bark and wood from the Australian native
Northern Cypress Pine.
 Frank D’Amelio v Australian All Natural Pty Ltd [2003] APO 25 - a
composition comprising an aqueous alcoholic extract from a plant
commonly known as old man weed (Centipeda cunninghamii).
 TK was clearly important background prior art.
 However, both decisions relied on conventionally published
documents for the purposes of novelty and inventive step.
 In both, applications were found to be novel and inventive in light
of the prior art provided at the hearing.
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 TK that helped an Aboriginal elder to get rid of severe pain by
rubbing the bark of a tree to the top of his finger that had been
bitten by a crocodile.
 Collaboration with Prof Ron Quinn which has led to a patent by GU
and the Jarlmadangah Burru Aboriginal Community.
 Commercialisation licence granted to Avexis Pty Ltd, a Gold Coast
biotech company.
 The Aboriginal community has established its own company, JJ Lab
Pty Ltd to supply the raw materials required for development and
production of a product that could be sold over the counter.
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TK and biodiversity were specifically mentioned in the Doha Ministerial
Declaration (2001): “We instruct the Council for TRIPS, in pursuing its
work programme including under the review of Article 27.3(b) … to
examine, inter alia, the relationship between the TRIPS Agreement and
the Convention on Biological Diversity, the protection of traditional
knowledge and folklore. . . .”
Proposed by 77 developing countries in the Doha Round at the WTO to
amend the TRIPS to require patent applicants to disclose the origin of
biological resources and of TK used in inventions as well as evidence of
prior informed consent and of fair and equitable benefit-sharing.
Rationale: a mandatory requirement would establish a safeguard
mechanism against the misappropriation of TK.
Swiss proposal regarding the mandatory declaration of the source of
origin.
Swiss law now requires applicants to declare the source of genetic
resources and TK in patent applications.
Fines of up to 100,000 Swiss Francs and the possibility for judges to make
their rulings public.
Examples of countries such requirements have been introduced into their
law are India, Andean Communities (Bolivia, Colombia, Ecuador and Peru)
and Costa Rica (see also Recital 27 of European Directive 98/44, though
voluntary).
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 Establishment of a TK digital library in India with 150,000
medicinal categories of knowledge which it shares with the patent
examiners on access basis.
 Flip side – if included in a database, then the community from
which it came no longer would be able to apply for patent on its
own TK.
 Broadening of the “minimum documentation” under the PCT to
cover a wide array of TK-related publications, e.g., Journal of
Chinese Medicine; Indian Journal of Traditional Knowledge,
Medicinal and Aromatic Plants Abstracts.
 Development of a new main group for the International Patent
Classification, with approximately 200 subgroups, in the field of
medicinal preparations containing plants to assist the patent
examiners to locate already published TK.
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 The essence of the patent system is transparency and disclosure.
 Goal: To minimise the grant of patents that wrongly claim
inventions that are based on, derived from, guided by or make use
of TK.
 Applicants for patents which consist of, or are developed from, TK
or genetic resources should identify the source and provide proof
that they were acquired with the prior informed consent of the
country from which they were taken.
 Digital Registers and Databases to assist patent examiners.
 Experiences at the national level are mostly inconclusive.
 Reopening the TRIPS Agreement is unlikely to be successful given
that TRIPS is a compromise.
 Collective/certification marks as well as geographical indications
may be used.
 Training of Patent office examiners on the context of TK and
sensitivities about its use and handling.
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