Preservation and Use of Genetic Resource Assets and the International Patent System

In 1992 the Convention on Biological Diversity (CBD) was adopted at the Rio Conference. In 1994 the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in Marrakech. From the outset, questions were raised as to whether there are conflicts or potential conflicts between the objectives and rules of these two international undertakings. These questions have been on the agenda of the WTO TRIPS Council and the Committee on Trade and Environment, they have been raised in the context of work programs and negotiations at the World Intellectual Property Organization (WIPO), they have been considered by the Conference of the Parties of the CBD, and they are the subject of numerous studies and reports by governments, intergovernmental and non-governmental organizations. This study attempts to clarify the issues at stake in analysis of the relationship between the TRIPS Agreement, related international patent system rules and the CBD. It examines the conflicts or potential conflicts between the objectives and rules of these international undertakings, and it makes certain recommendations regarding the promotion of complementarity among these systems. In terms of subject matter, this study considers only genetic resources and does not address "traditional knowledge". This study first identifies the objectives of the international patent system as it is embodied in the TRIPS Agreement and WIPO Conventions, and how these objectives are implemented. Second, it identifies the objectives of the CBD and its method of implementation. Third, it identifies conflicts or potential conflicts between the objectives and methods of implementation of the two rule systems. Fourth, it examines proposals that have so far been made to ameliorate or resolve conflicts. Fifth, it suggests means for promoting complementarity between the two systems, including rule changes where necessary or appropriate.The study concludes that promotion of the objectives of the CBD would be furthered by multilateral adoption of a mandatory requirement for the disclosure of the source and origin of genetic resources in patent applications. Such a requirement is appropriate to protect the interests of developing and developed countries which house genetic resource stocks. This requirement would be consistent with existing rules of the TRIPS Agreement. However, to give it effect it should be adopted as a new TRIPS Agreement rule. While national action to give effect to such a requirement is permitted under existing WIPO administrative treaties, establishing a mandatory multilateral standard under such treaties would also require amendment. The strength of any set of legal rules is dependent upon its enforceability. Therefore, it is important that states be obligated to provide for the effective enforcement of a mandatory disclosure requirement.Existing patent law standards among advanced legal systems impose upon patent applicants affirmative duties with respect to the disclosure of information and establish penalties which include determinations of invalidity or provision for revocation of patents. Because the failure to disclose information regarding the source and origin of genetic resources may be relevant to the issue of patentability, including inventorship, it is appropriate that existing equitable doctrines that protect the integrity of the international patent system be extended to this area. It should not be an objective of prospective remedial measures to introduce insecurity into the international patent system, recognizing that patents are inherently insecure. Rather, the objective of prospective remedial measures should be to effectively encourage compliance with agreed upon rules, in this case designed to promote the objectives of the CBD.