Access and Benefit Sharing: Special Disclosure Requirements in Patent Applications - "Country of Origin/Source", "Prior Informed Consent"

Paris, 28 Jun 2005

Summary

Issue
Proposals have been advanced at the national level, and within intergovernmental forums, to mandate disclosure of "Country of Origin/Source" and/or proof of "Prior Informed Consent".

General positions of ICC

The following guide ICC's overall view of such proposals.

• ICC fully supports the aims of the CBD and its recognition of sovereign rights of states to control access to their own genetic resources pursuant to national policies; and supports in particular the objectives of the Convention calling for "sustainable use (of the components of biological diversity) and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources."

• ICC supports efficient and effective utilization of intellectual property protections as necessary and appropriate to stimulate innovation in use of genetic resources, to enhance the value of those resources, and to facilitate the equitable sharing of benefits from the use of those resources.

• ICC believes that there is no inherent conflict between the obligations in the CBD and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

ICC does not have consensus regarding any of the specific proposals for disclosure currently under consideration, but does have a general view that such disclosure will not significantly advance the aims of access and benefit sharing; and has consensus on a number of considerations relevant to the proposals.

Considerations related to special patent disclosure requirements

The Intergovernmental forums considering proposals for patent disclosure must take into account the broader context of access and benefit sharing and the specific implications of proposals for the patent system. To that end, the ICC offers the following.

• Consideration of proposals for special patent disclosure need to expressly recognize the differing implications for the three major sectors engaged in modern biotechnology research.

• Pharmaceutical sector;

• Industrial biotechnology sector; and

• Agricultural sector.

• Workable national frameworks are essential to any meaningful access and benefit sharing advances.

• National frameworks need to recognize the role of academic and other research institutions and other providers of ex-situ genetic resources as key participants in any overall scheme of access and benefit sharing and regulate them accordingly.

• Any scheme relating to access and benefit sharing, whether connected to patents or otherwise, poses different challenges with respect to new in-situ access versus resources already ex-situ, particularly resources removed from the country of origin.

• Implications of disclosure obligations associated with patent applications should be deliberated in the forum in which the countries invest their technical expertise in implementing the patent system, WIPO.
• Disclosure obligations beyond existing requirements, particularly as a new condition of patentability, risk deterring innovation.

• Disclosure of "Prior Informed Consent" is not appropriate.

• Any consideration of disclosure obligations needs to recognize the distinction between "Disclosure of Country of Origin" versus "Disclosure of Source":

• Any consideration of disclosure obligations needs to distinguish between human and other genetic resources.

• Any consideration of disclosure obligations needs to distinguish between biologic and genetic resources to be consistent with CBD.

• Any consideration of disclosure obligations needs to carefully examine both the potential for unintended consequences, and relationship between cause and effect.

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