WORLD TRADE
ORGANIZATIONIP/C/W/356
24 June 2002
(02-3480)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE
CONVENTION ON BIOLOGICAL DIVERSITY AND THE
PROTECTION OF TRADITIONAL KNOWLEDGE
By means of a communication dated 21 June 2002, the following text has been received from
the Permanent Mission of Brazil on behalf of the delegations of Brazil, China, Cuba, DominicanRepublic, Ecuador, India, Pakistan, Thailand, Venezu ela, Zambia and Zimbabwe with the request that
it be circulated to TRIPS Council Members.
_______________
Summary
- We believe that the TRIPS Agreement and the Convention on Biological Diversity should
be mutually supportive and promote the sustainable use of resources.  Modifications in
the TRIPS Agreement are necessary to ensure that it will not run counter to the objectivesof the CBD.
- While the CBD recognizes Members’ sovereign rights over their biological resources, the
TRIPS Agreement allows Members to provide patents over biological resources (plants,
animals and micro-organisms).  Currently, the TRIPS Agreement contains no provisions
preventing biopiracy acts, in which a person may claim patent rights in one country over
genetic resources that are under the sovereignty of another country.
- In particular, the TRIPS Agreement contains no provisions ensuring the prior informed
consent of the owners of the biological resources used in the invention.  The Agreement
also contains no provisions allowing a Member’s claims to enforce its national regimes
for fair and equitable sharing of benefits from the patenting of its own genetic resourcesin another country.
- In this connection, the TRIPS Agreement should be amended in order to provide that
Members shall require that an applicant for a patent relating to biological materials or to
traditional knowledge shall provide, as a condition to acquiring patent rights:
(i) disclosure of the source and country of origin of the biological resource and of the
traditional knowledge used in the invention;
(ii) evidence of prior informed consent through approval of authorities under the relevant
national regimes; and
(iii) evidence of fair and equitable benefit sharing under the national regime of the country
of origin.
- Failure to provide a solution to ensure a mu tually supportive relationship between TRIPs
and the CBD may turn out to be detrimental to the objectives of both instruments.  With a
view to avoiding conflicts in the implementation of TRIPS, an amendment of theIP/C/W/356
Page 2
Agreement to accommodate some essential elements of the CBD will be a necessary
outcome of the single undertaking of negotiations under the outstanding implementation
issues, as part of the multilateral round of trade negotiations under the Doha Development
Agenda.IP/C/W/356
Page 3
THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND
THE CONVENTION ON BIOLOGICAL DIVERSITY AND
THE PROTECTION OF TRADITIONAL KNOWLEDGE
A. INTRODUCTION
1. The Doha Ministerial Declaration has taken a significant decision to examine the relationship
between the Convention on Biological Diversity (C BD) and the Agreement on Trade Related Aspects
of Intellectual Property Rights (TRIPS).  The Decl aration provides, in paragraphs 12 and 19, mandate
for Members to introduce proposals for negotiations in the context of outstanding implementation
issues, which “ shall be an integral part of the Work Programme ” (paragraph 12) established by the
Ministerial Conference. In light of Paragraph 47 of the Doha Ministerial Declaration, “ the conduct,
conclusion and entry into force of the negotiations shall be treated as part of a single undertaking ” of
the multilateral round of trade negotiations under the Doha Development Agenda.
2. It should be recalled that, in the context of the review of Article 27.3(b) of the TRIPS
Agreement, a number of Members, in particular developing countries, have presented their views onthe relationship between the Agreement and the Convention on Biological Diversity, which include a
number of proposals to ensure compatibility between the TRIPS Agreement and the CBD
1.
Furthermore, in the Seminar on the Protection and Commercialization of Traditional Knowledge
(New Delhi, 3-5 April, 2002)2, several developing countries have expressed support for the need to
develop an internationally agreed instrument that recognizes protection of traditional knowledge at thenational level, as it would not only prevent misappropriation but also ensure that national level benefit
sharing mechanisms and laws are respected worldwide.
3. Based on Paragraphs 12 and 19 of the Doha Ministerial Declaration, this submission
addresses “the relationship between the TRIPS Agreement and the CBD and protection of Traditional
Knowledge”.  The elements addressed in this documen t in no way exhaust the issues to be raised in
the context of the relationship between the TRIPs Agreement and the CBD in light of paragraphs 12
and 19. The co-sponsors of this proposal may bring further clarifications and complements to the
issues contained in this document.  This submission is without prejudice to positions that its co-
sponsors might take subsequently.
B. RELEVANT PROVISIONS IN THE CONVENTION ON BIOLOGICAL DIVERSITY
4. The TRIPS Agreement and the Convention on Biological Diversity contain important
elements in common.  Among other relevant provisions in the CBD, its objectives, as stated in
Article  1 , are the conservation of biological diversity, the sustainable use of its components and the
fair and equitable sharing of the benefits arising out of the utilisation of the genetic resources.
Article 3  of the Convention recognizes the principle of sovereign right of its Contracting Parties to
                                                     
1 See, for instance, documents WT/GC/W/282 of 6 July 1999 by Venezuela; WT/GC/W/25 of  13 July
1999 by the Least Developed Countries; WT/GC/W/362 12 October 1999 by Bolivia, Colombia, Ecuador,
Nicaragua, and Peru; IP/C/W/166 of 5 November 1999 by Cuba, the Dominican Republic, Honduras andNicaragua; IP/C/W/195 of 12 July 2000 by India; IP/C/W/206 of 20 September 2000 by the African Group; andIP/C/W/228 of  24 November 2000 by Brazil.
2 The International Seminar was convened by the Government of India and UNCTAD, with the
participation of representatives from Brazil, Cambodia, Chile, China, Colombia, Cuba, Egypt, Kenya, Peru,
Philippines, Sri Lanka, Thailand, Venezuela and India.IP/C/W/356
Page 4
exploit such resources.  Article 15  specifically obliges the Parties to take necessary measures to share
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 Party providing such resources, on
mutually agreed terms.  Article 15 unambiguously states that the authority to determine access to
genetic resources rests with national governments and is subject to national legislation and that access,where granted, shall be on mutually agreed terms and shall be subject to the prior informed consent of
the Contracting Party providing such resources.  Article 16(5)  of the CBD further states that
Contracting Parties, recognizing that patents and other intellectual property rights may have an
influence on the implementation of this Convention, sh all 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.  Finally, Article 8(j)  of the CBD enjoins Contracting Parties to respect,
preserve and maintain knowledge, innovations and practices of indigenous and local communities andencourages the equitable sharing of benefits arising from their utilization.
5. Moreover, the VI Conference of the Parties of the CBD recently adopted (in the Hague,
Netherlands, 7 - 19 April 2002) under Decision VI/24 (“Access and benefit-sharing as related to
genetic resources”) the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable
Sharing of the Benefits Arising out of their Utilization , which serves as inputs when developing
and drafting legislative, administrative or policy measures on access and benefit-sharing with
particular reference to provisions under Articles 8(j), 10 (c), 15, 16 and 19; and contracts and other
arrangements under mutually agreed terms for access and benefit-sharing.  Among other important
provisions, the Bonn Guidelines define, under the Chapter “Roles and Responsibilities in Access and
Benefit-Sharing Pursuant to Article 15 of the Convention on Biological Diversity”, that “ContractingParties with users of genetic resources under their jurisdiction should take appropriate legal,
administrative, or policy measures, as appropriate, to support compliance with prior informed consent
of the Contracting Party providing such resources and mutually agreed terms on which access was
granted.  These countries could consider, inter alia , the following measures:  (…) (ii) Measures to
encourage the disclosure of the country of origin of the genetic resources and of the origin oftraditional knowledge, innovations and practices of indigenous and local communities in applications
for intellectual property rights; (iii) Measures aimed at preventing the use of genetic resources
obtained without the prior informed consent of th e Contracting Party providing such resources."
Under the provisions on “National monitoring a nd reporting”, the Bonn Guidelines further defines
that “depending on the terms of access and benefit-sharing, national monitoring may include (…) (c)
applications for intellectual property rights relating to the material supplied”.
6. Regarding the “Role of Intellectual Property Rights in the Implementation of Access and
Benefit-Sharing Arrangements” under the Bonn Guidelines, the Conference of the Parties to the CBD
“invites Parties and Governments to encourage the disclosure of the country of origin of genetic
resources in applications for intellectual property rights, where the subject matter of the application
concerns or makes use of genetic resources in its development, as a possible contribution to tracking
compliance with prior informed consent and the mutually agreed terms on which access to those
resources was granted".  The COP “also invites Parties and Governments to encourage the disclosure
of the origin of relevant traditional knowledge, innovations and practices of indigenous and local
communities relevant for the conservation and sustainable use of biological diversity in applications
for intellectual”.
C. THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION
ON BIOLOGICAL DIVERSITY
7. We believe that the TRIPS Agreement and the CBD should be mutually supportive and
promote the sustainable use of resources.  At the implementation level, conflicts between the twoIP/C/W/356
Page 5
Agreements could arise, for instance, in the case of patents claimed over genetic resources (sometimes
even in naturally occurring genetic resources), which are protected by the CBD.  Some examples are
already well known to the general public.  In its paper on " Protection of Biodiversity and Traditional
Knowledge " (IP/C/W/198),  for instance, India reports its experience with cases of patents claimed
over turmeric, karela, basmati and the neem tree; another example is the case of the ayahuasca vine (anative plant of the Amazonian rainforest used by thousands of indigenous peoples of the Amazon for
sacred religious and healing ceremonies).
8. Unauthorized patents on a Member’s genetic resources, granted outside its territory raises the
issue of potential conflicts with the principle of the sovereignty of the Contracting Parties of the CBD
over their genetic resources. Currently, the TRIPS Agreement allows Members to provide for patents
– which are private rights – over genetic resour ces (plants, animals and micro-organisms).  The
Agreement, however, contains no provisions preventing a person to claim patent rights in one countryover genetic resources that are under the sovereignty of another country. In particular, TRIPS contains
no provisions allowing a Member’s claims to enforce fair and equitable sharing of benefits from the
patenting of its own genetic resources abroad. In th e absence of clear provisions in TRIPS providing
for a mutually supportive relationship of that Agreement with Members’ obligations under the CBD,
implementation of the TRIPS Agreement may allow for acts of biopiracy and thus result in systemic
conflicts with the Convention.  With a view to avoiding conflicts in the implementation of TRIPS, an
amendment of the Agreement to accommodate some essential elements of the CBD will be a
necessary outcome of negotiations related to the mandate in Paragraphs 12 and 19 of the Doha
Ministerial Declaration.  Failure to provide a solution to this relationship may turn out to be
detrimental to the objectives of both instruments.
9. In order to provide a mutually supportive relationship between the TRIPS Agreement and the
Convention on Biological Diversity, one important  step would be to ensure that patenting of
biological resources – plants, animals or micro-orga nisms – shall not run counter to the provisions of
the CBD, in particular those provisions recognizing the sovereignty of the Contracting Parties of the
CBD over their genetic resources; the objectives of benefit sharing and of prior informed consent; andthe protection of traditional knowledge.
D. PROPOSAL
10. In this connection, it is proposed that the TRIPS Council recommends to the Trade
Negotiations Committee that it takes a decision to the effect that the TRIPS Agreement should be
amended in order to provide that Members shall require that an applicant for a patent relating to
biological materials or to traditional knowledge shall provide, as a condition to acquiring patentrights:
(i) disclosure of the source and country of origin of the biological resource and of the
traditional knowledge used in the invention;
(ii) evidence of prior informed consent through approval of authorities under the relevant
national regimes;
(iii) evidence of fair and equitable benefit sharing under the relevant national regimes.
11. Such measures are fully in line with the prov isions of the Convention on Biological Diversity
and the recommendations of the Bonn Guidelines on Access to Genetic Resources and Fair and
Equitable Sharing of the Benefits Arising out of their Utilisation.  An amendment of the TRIPSIP/C/W/356
Page 6
Agreement to include such provisions would prevent systemic conflicts with the CBD arising from
the implementation of TRIPS.
12. From a practical standpoint, it would be more cost-effective to establish an internationally
accepted solution as suggested above to prevent biopiracy than to divert national resources to
expensive judicial processes for the revocation of patents that include illegal genetic resources (asexperienced, for instance, by the Government of India and Amazonian countries in challenging
patents abroad over its genetic resources).  Developing countries, in particular, do not have the
resources to follow each and every patent issued outside their territories on the use of their resources.
13. Besides addressing a crucial problem of coherence between two binding international
agreements, fulfilling such requirements would not  be any more burdensome than any other regular
requirement in the already existing patent application procedures.  Certainly, law-compliant, bona fide
companies and individuals would not have difficulties in fulfilling the requirements mentioned inparagraph 14 above – and many of which already engage in bilateral contracts that include the
elements of such requirements.  Consequently, th e proposed amendment would have the clear benefit
of providing a predictable environment for Gove rnments, investors, traditional communities and
researchers.  Research and development in biotechnology in developing countries would thus be
encouraged, which would be in line with the objectives of the TRIPS Agreement to promotetechnological innovation and the transfer and dissemination of technology.
14. In line with Article 16 of the CBD, several countries
3 today are putting in place legislation to
regulate access to genetic resources, many of which contain intellectual property-related provisions.
In many cases, such countries include requirements to disclose the origin of the source of the genetic
material used in biotechnological inventions and the related traditional knowledge used in theinvention, as well as requirements of evidence of benefit sharing and prior informed consent from the
relevant national authorities.
15. The proposed requirements in paragraph 14 would also represent an important step towards
ensuring, although only to a limited extent, protection of traditional knowledge from unauthorised
patenting by third persons without the prior informed  consent of the traditional communities that hold
the involved knowledge.  Traditional communities have faced threat of misappropriation of their
knowledge arising from increasing evidence of biopiracy and the grant of bad patents.  One of the
major concerns in the global community today refers to the patenting of new biotechnological
inventions based on the biological resources and a ssociated traditional knowledge, without any share
of the benefits arising out of commercial use to the communities who conserved and developed such
resources and knowledge.
16. The incorporation of the proposed requirements in the TRIPS Agreement, however, would
only provide defensive protection for traditional communities from misappropriation of their
knowledge – associated or not to genetic resources – through unauthorized patenting.  Consequently,it might be necessary for the TRIPS Council to give further consideration to proposals regarding an
international framework to provide positive pr otection of traditional knowledge, which would
recognize protection of traditional knowledge at the national and regional levels.  As reflected in the
Communiqué issued by the Seminar on the Protection and Commercialization of Traditional
Knowledge (New Delhi, 3-5 April, 2002) regarding the process of identifying essential components of
a framework for international recognition of various sui generis systems, customary law and others
for protection of TK, “some of the possible components identified include:  (i) local protection to the
rights of TK holders through national level sui generis  regimes including customary laws as well as
others and its effective enforcement inter alia through systems such as positive comity of protection
systems for TK (ii) protection of traditional knowledge through registers of TK databases in order to
                                                     
3 The Andean Community, Brazil, Costa Rica, India, the Philippines, Sweden, among others.IP/C/W/356
Page 7
avoid misappropriation (iii) a procedure whereby the use of TK from one country is allowed,
particularly for seeking IPR protection or commercialization, only after the competent national
authority of the country of origin gives a certificate that source of origin is disclosed and prior
informed consent, including acceptance of benefit shar ing conditions, obtained (iv) an internationally
agreed instrument that recognizes such national level protection.  This would not only preventmisappropriation but also ensure that national level benefit sharing mechanisms and laws are
respected worldwide.”
17. In light of the above, Members reserve the right to bring further proposals in the context of
negotiations under paragraphs 12 and 19 of the Doha Ministerial Declaration regarding other issues
regarding the relationship between the TRIPs Agreement and the Convention on Biological Diversity,
such as the development of an international framework for positive protection of traditional
knowledge.
__________