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Washington, 11 Aug 2006

Introduction and Summary

The American BioIndustry Alliance (ABIA) welcomes the opportunity to comment on document WIPO/GRTK/IC/9/5 ("The Protection of Traditional Knowledge: Revised Objectives and Principles," January 9, 2006). ABIA members strongly support WIPO's work and believe that continued focused efforts in WIPO will bring greater clarity to the needs of biodiverse developing countries that seek both social and economic benefits from the sustainable use of genetic resources and associated traditional knowledge. Traditional Knowledge Digital Libraries (TKDL), databases, and registries are an area of particular promise where the work of WIPO has already been helpful. Much more, however, needs to be done. To that end, the ABIA urges WIPO to expand the work program on traditional knowledge (TK) of the Intergovernmental Committee on Intellectual Property and Genetic ߣߣÊÓƵ, Traditional Knowledge and Folklore (IGC) both to develop a universal system to harmonize existing TK databases and digital libraries and also to ensure that their benefits reach the smaller developing country members of WIPO. The ABIA was established in September 2005 as a non-profit, non-government organization to provide focused advocacy in support of the full patentability of biotechnology inventions and seeks enabling conditions for biotechnology in developed and developing countries through sustainable, mutually beneficial Access and Benefit Sharing policies. The ABIA believes that WIPO's program to protect traditional knowledge (TK) should support measures that simultaneously (i) help all stakeholders achieve their Access and Benefit Sharing (ABS) objectives and (ii) provide incentives for research in provider countries. Countries as varied as ߣߣÊÓƵ and Costa Rica have used this approach in developing measures that serve to leverage their rich biodiversity into a recognized capacity for innovation based on their GR and related TK assets ABS Enforcement and the Patent System The ABIA is of the view that enforcement of ABS should be se! parate f rom the administration of patent rights, which are critical to the generation of the potential benefits that all parties seek from any ABS scheme. The biotechnology industry is united in the view that strong patent rights remain essential for the successful commercialization of new biotechnology products.

Additional, mandatory patent disclosure would not provide any positive incentives for research by provider countries, or create benefits for developing countries. Instead, a patent-centric system for the enforcement of ABS would create uncertainty; discourage the very patent-related activity that developing countries seek to benefit from; and, in any event, would not effectively address the issue of access and benefit sharing.

Positive Alternatives for TK Protection ABS Agreements

Over the past year, the ABIA has engaged with other stakeholders in developing positive alternatives to the patent-centric enforcement of access and benefit sharing of GR inventions and related TK. Such alternatives would simultaneously protect TK and provide up-front benefits to provider countries.

Such solutions include a system of ABS agreements, made on mutually agreed terms, which provide front-loaded benefits to provider countries. Under this approach, provider countries can gain highly important non- monetary benefits that can have a positive impact on research budgets, staff training; empowerment of human resources; technology transfer/infrastructure support; and conservation efforts. In addition, they can gain legal certainty through protection of intellectual property, market- oriented policies and a commitment to science and research, all of which facilitate the transfer of technology from the North to the South. At the ABIA Side-Event held at the CBD Eighth Conference of the Parties (COP-8), representatives from ߣߣÊÓƵ and Costa Rica explained how, consistent with the sustainable use of their GR and protection of TK, they had used such ABS agreements to gain social and economic benefits from their biodiversity.1 [...]