1. FEASIBILITY OF NATIONAL DISCLOSURE OF ORIGIN REQUIREMENTS 21 April 2005 WTO Symposium, Geneva Disclosure Requirements: Incorporating the CBD Principles in the TRIPS Agreement on the Road to Hong Kong Michael A. Gollin Venable LLP 575 7 th St., NW Washington, D.C. 20004 magollin@venable.com © Michael A. Gollin 2005, for limited distribution

2. Issue: Are national disclosure of origin (DOO) requirements feasible? Laws would require patent applicants to (1) disclose the source of genetic resources used in an invention (2) disclose the source of traditional knowledge used in the invention, and/or (3) provide evidence that the provider gave prior informed consent and received a share of benefits

3. Options DOO requirements could be (a) direct (mandatory and enforceable through loss of patent rights) (b) indirect (mandatory but enforceable only through means other than the patent system) (c) voluntary/permissive.

4. The swift and obvious answer: It depends! The devil is in the details

5. How to evaluate feasibility compatibility with existing international treaties compatibility with national legislation political viability –domestically – internationally consistency with rules and customs of patent practice Consistency with other laws ease of implementation.

6. Summary Direct DOO requirements for genetic resources and TK and requiring evidence of ABS are more problematic than indirect approaches. Indirect compulsory approaches are more problematic than voluntary approaches. All approaches impose implementation costs and concerns.

7. How to implement Pass national legislation amending patent laws Promulgate regulations for the national patent office to follow. Avoid multilateral or bilateral treaties that preclude DOO requirements. Satisfy principles of jurisprudence –laws need to be clear, comprehensible, and fair Specify details –circumstances triggering DOO requirement –Timing –Content –Format –Level of detail required from the applicant –Consequences of a failure to disclose

8. Example – Strict, direct DOO Requirement For every patent application based on genetic resources or traditional knowledge obtained anywhere in the world, the applicant must identify –where the material was obtained –the person or organization providing it –any traditional or indigenous knowledge that was employed The applicant must –have entered into an ABS agreement with the appropriate rights- holder –provide a copy of the agreement. Failure to satisfy any of these requirements would result in rejection of a patent application, or invalidity of a patent that was erroneously allowed to issue.

9. Examples: Less strict (a)permitting retroactive cure for any provision that was not satisfied initially (b)accepting the applicant's certification that all applicable ABS requirements were satisfied (instead of requiring copies of ABS agreements (c)requiring disclosure only for genetic resources and traditional knowledge obtained from within the country that has a DOO law. (d)regional framework such as the Andean Pact could provide that an applicant seeking a patent from any country in the Pact would need to provide disclosure regarding resources or knowledge obtained from any of them.

10. Arguments against DOO (1)inconsistency with international treaties as a matter of law --most forms of DOO requirements would be consistent with international treaties[1] --need to apply to applicants from all countries --can not preclude the filing of national phase PCT applications. (2)inconsistency with domestic laws --Depends on specifics (3)opposition by particular countries (4)impracticality (5)other negative domestic public policy consequences. [1] Joshua D. Sarnoff, Consistency with Patent Law Treaties of Application Disclosure Requirements Regarding Origins of Genetic Resources and Traditional Knowledge, Discussion draft of June 23, 2004 available at http://www.piipa.org/DOO_Memo.doc. [1] http://www.piipa.org/DOO_Memo.doc

11. Problems impracticality Negative domestic consequences Many countries lack a practical ABS regime, so a strict DOO requirement might be impossible to satisfy, precluding genetic resources patents.[1[1 National patent office capacity –Under-funded – already required to examine extremely complex technical and bibliographic information – may lack capacity to handle additional DOO requirements. burden patent applicants in the life sciences over applicants in other technologies. other measures outside patent law, like civil or criminal sanctions, might be a better use of resources to improve compliance with ABS regimes.

12. Moving Forward international consideration of DOO requirements –CBD –WIPO –WTO Commission intellectual property professionals to draft model legislation Cover a range of specific DOO requirements Specifics of draft model legislation beneficial: –test consistency with international treaties –Test consistency with domestic laws –build consensus on the policy merits of particular options. Focus attention on the key issue --

13. The ultimate goal? Promote conservation of biological resources Maintain cultural diversity Enhance sustainable innovation –By providers –By recipients –Encourage technology transfer

14. Issue Restated Are DOO requirements an effective way to promote conservation of biological and cultural diversity, in balance with innovation and technology transfer?

15. Intellectual property’s role Innovation and technology adoption can have positive or negative effects on environment Promote environmental technology innovation Promote adoption via technology diffusion (development and commercialization) Bias toward environmental (beneficial) technology is desirable but difficult Supports and amplifies market forces for innovation Rely on other legal structures to restrict damaging technology and activities