The Relationship between TRIPS and the Convention on Biological Diversity (CBD) - State of play in the TRIPS Council - WTO Symposium on Trade and Sustainable Development – Geneva, 11 October 2005 Wolf MEIER-EWERT Legal Affairs Officer Intellectual Property Division World Trade Organization

Doha Work Programme Doha Ministerial Declaration: WT/MIN(01)/DEC/1 Para. 19: “We instruct the TRIPS Council, in pursuing its work programme including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore... ” Para. 12: Outstanding implementation issues

The Relationship between TRIPS and the CBD (1) Main issues under discussion Compatibility between TRIPS & CBD How to implement TRIPS and CBD in a mutually supportive way so as to achieve shared objectives on access and benefit- sharing The Secretariat’s summary note IP/C/W/368 (being revised)

Convention on Biological Diversity Article 1. Objectives “The objectives of this Convention … are the conservation of biological diversity, the sustainable use …and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account …” Article 3. Principle “States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources …

The Relationship between TRIPS and the CBD (2) Compatibility between TRIPS & CBD: Inherent conflict TRIPS needs to be amended to remove such conflict. No conflict The two agreements can be implemented in a mutually supportive way through national measures. No inherent conflict, but case for international action Both can and should be implemented in a mutually supportive way but action required at the international level: three distinct proposals for a disclosure requirement

The Relationship between TRIPS and the CBD (3) National solutions, including legislation on access and benefit-sharing, and contracts Claimed advantages of a contract-based system Ensuring the achievement of prior informed consent and benefit sharing Providing flexibility in determining terms, including monetary and non-monetary benefit sharing Effective enforcement of the contract through criminal provisions and/or civil liability, choice of law and jurisdiction Examples of national practice given US National Cancer Institute’s Departmental Therapeutics Programme US National Park Services

The Relationship between TRIPS and the CBD (4) Three distinct proposals for a disclosure requirement Brazil, India and others TRIPS should be amended so that Members shall require patent applicants to disclose: the source and country of origin of any biological resources or traditional knowledge used in inventions Evidence of prior informed consent from the competent authority in the country of origin Evidence of fair and equitable appropriate benefit-sharing arrangements or have followed national law. Switzerland the Patent Cooperation Treaty of WIPO (PCT) should be amended so as to allow countries the option of asking patent applications to disclose the source of genetic resources or traditional knowledge used in inventions. EC Having a mandatory disclosure requirement on national, regional and international patent applicants to disclose information on the country of origin or source of genetic resources or traditional knowledge used in the invention.

The Relationship between TRIPS and the CBD (5) Brazil, IndiaSwitzerlandEC Proposalsto amend the TRIPS to require disclosure (Article 27.3.(b) or Article 29 or new article) to amend the Patent Co-operation Treaty (PCT) of WIPO to permit disclosure Elements of disclosure the source and country of origin of GR & related TK; evidence of prior informed consent; evidence of fair & equitable benefit sharing source of GR and associated TK country of origin, but if unknown, source of GR/TK associated with GR Optional vs. mandatory International vs. national mandatory both at the international and national level optional at the international level but can be mandatory at national level mandatory at international, regional and national level

The Relationship between TRIPS and the CBD (6) Brazil, IndiaSwitzerlandEC The trigger for the disclosure Any use, including incidental use GR: immediate use + physical access TK: direct basis for invention GR: direct basis Source: physical access + awareness TK: direct basis & awareness Nature of requirement SubstantiveFormal Legal effects of non-compliance Delay in processing of application; revocation of the patent; criminal/ administrative sanctions; full or partial transfer of the rights Delay in processing application; any legal effects of wrongful or non disclosure allowed for under the PCT & PLT, including invalidation of granted patents if the wrongful or non disclosure due to fraudulent intention Legal effects should be outside the ambit of patent law, (civil and/or administrative law) Burden of proofPatent applicantsAlleging party

The Relationship between TRIPS and the CBD (7) Continuing Discussion in the TRIPS Council Merits of “contractual approach” vs. “disclosure approach” Recent submissions Amendments to Articles 27.3 and 29 of TRIPS proposed (Peru IP/C/W/447) Questions regarding the legal and technical implications of the different proposals (Switzerland IP/C/W/446) Further discussion of the national approach (United States IP/C/W/449) Next TRIPS Council meeting on October 2005 Consultations on the matter as an outstanding implementation issue

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