Geneva, 04 Jun 2003
Document prepared by the Secretariat
I. OVERVIEW
1. This document concerns a draft technical study on requirements in patent law systems to disclose information about genetic resources and traditional knowledge (TK) relevant to patented inventions. Such requirements have been proposed in a number of international forums in particular as a possible means of strengthening the relationship between the patent system and arrangements for access and benefit-sharing relating to biological resources and associated TK. Existing patent laws contain a range of general disclosure mechanisms, which in some cases have had the effect of disclosing relevant genetic resources and TK. There are a number of proposals and several national laws which establish disclosure obligations specific to genetic resources or TK, or both, with varying legal effect.
2. A study of this issue was requested by the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore ("the Committee") at its third session, building on earlier work within WIPO and responding also to an invitation made by the Conference of Parties (COP) of the Convention on Biological Diversity (CBD). The draft study, which is annexed to this document, is based on an initial report (document WIPO/GRTKF/IC/4/12) that was considered by the Committee at its fourth session.
3. The draft study reviews salient aspects of the patent system and of legal mechanisms concerning access to genetic resources and associated TK, and surveys the responses to a questionnaire circulated to WIPO Member States on patent disclosure requirements. It discusses the range of relevant disclosure mechanisms, noting that these may differ according to the required linkage between genetic resources or TK and the invention, and according to the legal basis for the disclosure mechanism. The study also reviews relevant provisions of WIPO treaties that may be relevant to disclosure requirements. It concludes with a discussion of disclosure methods consistent with general patent principles and WIPO treaties in particular. These are provided as the basis of further policy discussion in this area rather than as a definitive view on treaty compliance.
II. INTRODUCTION
4. The background to this study is discussed in detail in document WIPO/GRTKF/IC/4/11 ("Initial Report on Technical Study on Disclosure Requirements Related to Genetic Resources and Traditional Knowledge"), which was considered by the Committee at its fourth session.1
Among the tasks proposed for the Committee at its inception was consideration of intellectual property (IP) questions related to genetic resources, including:
- Contractual agreements for access to genetic resources and benefit-sharing;
- Legislative, administrative and policy measures to regulate access to genetic resources and benefit-sharing;
- Protection of biotechnological inventions, including certain related administrative and procedural issues; and
- Multilateral systems for facilitated access to genetic resources and benefit-sharing.2
5. The Committee's work on IP issues concerning genetic resources has focussed on IP-related provisions in licensing and contractual agreements concerning access to genetic resources and benefit-sharing. The Committee has also received reports on related developments and policy discussions in other fora, such as the adoption of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) under the auspices of the Food and Agricultural Organization (FAO)3 and certain decisions of the COP of the CBD, which include the adoption of the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization ("the Bonn Guidelines").4
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