- Количество слайдов: 11
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 • Exclude all indirect use? e. g for identification of valuable proteins • Immediate use • Excludes all uses in the future - technologies allow for storage for 50 + years • Access to genetic material • Excludes use of derivatives bioinformatics
Some ideas on disclosure • Origin/ 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 • provided by country of origin – evidence PIC • Legal provenance • Provided by resource collection or other intermediary with legal title to resources • Source • 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 6/24 C • 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