US AND INDIA CLASH ON DISCLOSURE AT TRIPS MEETING

At the WTO Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) on 25-26 and 28 October, discussions on disclosure of the source of biological materials and related traditional knowledge in patent applications once again saw countries clash on whether such a patent-based system was indeed necessary to ensure the equitable sharing of benefits from genetic resources. In the morning of 26 October, in discussions on examining the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) mandated by paragraph 19 of the Doha Declaration, India introduced a paper which responds to the most recent US paper that advocated a contract-based approach to disclosure. In the afternoon in separate informal consultations mandated by paragraph 12 of the Doha Declaration on implementation issues relating to the TRIPS-CBD relationship, India put forward draft text for the Hong Kong Ministerial Declaration calling for negotiations specifically on disclosure requirements under the Doha Round's "single undertaking".

Under paragraph 12, Members are mandated to negotiate on resolving outstanding implementation issues, including an amendment of Article 27.3(b) -- dealing with the patentability of life forms -- to take into account the CBD (under the Compilation of Outstanding Implementation Issues Raised by Members, JOB(01)/152/Rev.1, 27 October 2001). These negotiations are held as a second track, parallel to those held in the regular session of the TRIPS Council under the paragraph 19 mandate. Developing countries have been pursuing discussions in both fora -- along with talks in the World Intellectual Property Orgainzation (WIPO; see BRIDGES Trade BioRes, 14 October 2005) and the CBD (see BRIDGES Trade BioRes, 4 March 2005) in the hopes of making progress in one of them.

Indian insists disclosure requirements are necessary

The Indian submission (IP/C/W/459) argues that under the current intellectual property regime, genetic resources and associated traditional knowledge are often erroneously dealt with as if they formed part of the public domain, open to appropriation by anybody without any obligation to ask for permission and pay back the provider. It responds to several statements made by the US in its June submission (IP/C/W/449; see BRIDGES Trade BioRes, 24 June 2005), including by noting that the TRIPS Agreement is in conflict with the CBD because it contains no effective provisions to protect genetic resources and associated knowledge from misappropriation and theft. While acknowledging the efforts taken domestically by the US to prevent such biopiracy, the paper says that the contract-based approach -- which simply encourages national authorities to enact legislation telling companies to set up private contracts with the holders of genetic resources -- would not prevent international misappropriation as it is difficult to enforce a foreign obligation for an act that is not prohibited in the country in which it is to be enforced. As most genetic resources are used and patented by multinational companies in foreign countries, India argued, a multilateral approach was necessary.

India also notes that three types of disclosure requirements have been suggested, namely (1) disclosure of source and country of origin of the genetic materials and associated traditional knowledge used in developing the invention claimed in the patent application; (2) disclosure of the evidence of prior informed consent and (3) disclosure of the evidence of benefit sharing agreement. In particular, such a system would prevent the issuing of bad patents rather than forcing the burden of revoking bad patents on aggrieved third parties after they have been issued. The submission also attempts to refute US allegations that disclosure requirements would increase uncertainty and lead to additional burdens and obligations on patent applicants and offices. The Indian paper, as the second paper in response to as many US papers, was submitted as part of a technical process launched in March 2004 that aimed to clarify disclosure-related issues. In its intervention during the meeting, India presented the paper and suggested that the discussion in the TRIPS Council has reached a level of maturity which calls for graduating the issue into a negotiating area.

The proposal was supported by Brazil, Peru, Ecuador, Pakistan, Sri Lanka, China, Cuba, Bolivia, Colombia, Thailand, Turkey and Indonesia. Although developed countries said that they have completed the checklist of questions that have driven the technical process since 2004, the US continued to resist discussions on a disclosure requirement and expressed similar reservations as Japan and Korea, arguing that a disclosure requirement would not solve the problems of ensuring benefit sharing and avoiding erroneous patenting.

Australia, the EC, Canada and New Zealand said that although they did not support India's paper as it was, they agreed with the need for further discussions on the implications of disclosure requirements. In particular, they said that talks on how disclosure could help prevent biopiracy were necessary. The EC, while generally supportive of a disclosure requirement, expressed some reservations about the prior informed consent and benefit sharing components of the disclosure approach supported by the developing countries.

Second-track talks continue on implementation

In the afternoon discussions on disclosure continued in an informal consultation session on outstanding implementation issues co-ordinated by Deputy Director General Rufus Yerxa. During the consultations, Indian Ambassador Ujal Singh Bhatia, supported by several developing countries, circulated a draft paragraph for the Hong Kong Ministerial Declaration. The text proposes an amendment to Article 27 of the TRIPS Agreement (on 'patentable subject matter'), arguing that paragraph 12 mandated negotiations on the CBD-TRIPS relationship. These negotiations should cover the details of the mandatory requirements on patent applications to disclose, as a requirement, the source and country of origin of the biological material and traditional knowledge used by the applicant; the prior informed consent obtained; the benefit-sharing agreement; and the details of the evidence to be submitted by the patent application, of adhering to the requirements. The proposal was well received by most developing countries, but the US, Canada and Australia said that the talks were not at a level of maturity to launch such disclosure-specific negotiations at this point.

Peru points to Camu Camu

In response to requests from developed countries for examples of specific cases of biopiracy, Peru presented a short paper documenting the story of Camu Camu (Myrciaria dubia), a Peruvian fruit which has been patented in Japan. The document, which is similar to a paper presented by them in June (IP/C/W/447), pointed out that national rules were unhelpful if the company that used the genetic resources made a patent application in another country. If such an application failed to disclose the origin of the genetic resource, mention the fact that the resource had already been in use in another part of the world, or provide evidence of an access and benefit-sharing agreement with the community of origin of the resource, then a bad patent could be issued.

No progress on public health amendment

The issue made relatively greater progress than the discussions on health and intellectual property rights, which focused primarily on process-related issues (see Bridges Weekly, 26 October 2005). Members have been working on how to convert the temporary "30 August 2003 Decision", which provided a system to enable countries to export generic drugs covered by patents to countries with a grave public health need. The discussions at the meeting attempted to craft a permanent amendment to the TRIPS Agreement in time for Hong Kong. Chair Ambassador Choi Hyuck of Korea said he will continue to hold informal consultations between the EU, US and African Group to try and reach a deal.

ICTSD Reporting.