Despite growing support for requiring patent applicants to disclose the biological resources or traditional knowledge involved in their inventions, WTO Members remain divided on the issue.
Nearly all developing country WTO Members – or 80 out of the organisations’s total membership of 151 countries – now support the inclusion of a disclosure requirement in the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) in order to prevent misappropriation of genetic resources and associated traditional knowledge (TK).
They have proposed an amendment that would require patent applicants not only to disclose where (or from whom) they obtained the genetic resources and any associated TK, but also oblige them to provide evidence of compliance with prior informed consent from the source/ country of origin, as well proof that benefits arising from the commercial use of the resources and/or knowledge will be shared in a fair and equitable manner. The amendment proponents argue that only a threat of patent revocation if disclosure requirements are not adequately met will prevent biopiracy.
Only a handful of developed countries spoke at the short March meeting of the TRIPS Council, and their interventions largely reiterated long-standing positions.
Australia, Canada, Japan, Korea, New Zealand and the US stated again that they did not believe there was a conflict between the TRIPS Agreement and the Convention on Biological Diversity, and thus saw no need for amending WTO patent rules. They argued for considering alternative methods for preventing the misappropriation of traditional knowledge and genetic material, such as the database system proposed by Japan (IP/C/W/504 and IP/C/W/ 472). More facts-based discussions on concrete cases of misappropriation were needed, they said.
The US has previously argued that the proposed origin disclosure requirement would be ineffective in achieving the proponent’s primary objective of preventing mistakenly granted patents. Information indicating country of origin, ex situ collection sites, etc., the US argued, would do little to ascertain “appropriate inventorship, novelty or inventive step, because such information does not generally address the considerations underlying these requirements, such as acts of invention or the state of the relevant art” (IP/C/W/434).
The EU reiterated that it was prepared to negotiate a disclosure of origin obligation, but that it would not support requirements for either prior informed consent or proof of equitable benefit-sharing. It also argued that in order to preserve the viability of the patent system, a failure to provide accurate information on the origin of genetic resources or traditional knowledge used in an invention should not result in patent revocation. Sanctions, it claimed, should be sought outside patent law. It also said that the World Intellectual Property Organisation, rather than the WTO, was the appropriate forum for discussions on disclosure (see page 10).
Nevertheless, the TRIPS Agreement itself provides for a review of Article 27.3(b), which deals with the patentability of plants and ‘essentially biological’ processes for producing them. The Doha mandate asked WTO Members to broaden this review to look at the relationship between the TRIPS Agreement, the Convention on Biological Diversity, and the protection of traditional knowledge and folklore.
Members Look to Doha Round to Press Claims
Despite the lack of substantive debate at the March meeting, the amendment proponents are determined to obtain a confirmation that the disclosure requirement proposal will be addressed in the Doha Round negotiations once a preliminary deal has been struck in agriculture and industrial market access. Another group of countries spearheaded by the EU is seeking similar assurances regarding geographical indications for food names.