Disclosure of Origin – towards equity or another exercise in futility? Brendan Tobin UNU-IAS COP 8 Side event Disclosure Requirements in Patent Applications ICTSAD, UNU-IAS, IDDRI, CPDR, Chatham House.
Outline Arguments for disclosure Form of disclosure requirements Are disclosure requirements compatible with international law Resistance to Disclosure Potential Role of Certificates Devil in the detail
Arguments for Disclosure Policing use of genetic resources and TK is beyond the capacity of developing countries and communities Need for incentives to promote compliance with ABS laws and rights over TK Disclosure supports transparency Disclosure would shift the burden of proof regarding rights to use genetic resources and TK from the provider to the user Use a market tool to control market use
Disclosure and International law Disclosure is at the heart of IP law Requirement of disclosure of use of genetic resources or TK in patent applications is ok. Obligation to include evidence of a legal right to use resources in patent application may be ok.
Disclosure Requirements: –Declaration regarding use of genetic resources and/or TK –If yes - provide evidence of PIC Potential checkpoints –Patents –Product approvals –Publications
Resistance to disclosure Disincentive to invest in R & D Majority of patents don’t involve use of genetic resources Difficult to identify the origin of resources Patent offices don’t have capacity to identify whether national ABS laws have been complied with. Determining equity of benefit sharing is beyond the remit of patent offices.
Defining a way out of disclosure Direct use Immediate use Access to genetic material Exclude all indirect use? e.g for identification of valuable proteins Excludes all uses in the future - technologies allow for storage for 50 + years Excludes use of derivatives - bioinformatics
Some ideas on disclosure Origin/ source/ source legal provenance Prior informed consent – may be evidenced by compliance with ABS law Fair and equitable benefit sharing –is evidence of MAT enough? If not will this requirement undermine legal certainty and serve as a disincentive to use?
Role of Certificates of origin Need for simplified mechanism to demonstrate the origin of resources Means for tracing genetic resource flows. Act as evidence of prior informed consent. Proposals now exist for alternatives such as certificates of source and legal provenance.
Certificate schemes Origin Legal provenance Source provided by country of origin – evidence PIC Provided by resource collection or other intermediary with legal title to resources Evidence of provider but does not evidence a legal right for commercial use.
Trade offs What will countries be required to give up to get disclosure requirements If WTO is not likely to adopt adequate DR - bring the issue back to CBD. Decision 6/24C Danger of a disclosure system which would establish limits on what can be done, Better no agreement than a weak one. May require revision of advanced legislation such as Decision 486 of the Andean Community