WTO DISCLOSURE TALKS TRY TO CLARIFY CBD-TRIPS RELATIONSHIP

At the meeting of the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) on 14-15 March, WTO Members continued to struggle with their differences on the need to clarify the relationship between the Convention on Biological Diversity (CBD) and the TRIPS Agreement. In a new submission, the US reiterated its opposition to the proposed multilateral requirement for the disclosure of the source of biological materials and related traditional knowledge in patent applications -- together with evidence of prior informed consent and equitable benefit sharing -- and highlighted alternative means to address the issuance of 'bad patents'. In their submission, proponents of this requirement -- the so-called "Disclosure Group" -- provided definitions of the technical elements that they feel are necessary to fulfil the Doha Declaration paragraph 19 mandate to examine the CBD-TRIPS relationship. In the afternoon of 15 March, in separate informal consultations mandated by paragraph 12 of the Doha Declaration on implementation issues, Members examined a list of eleven questions offered by the Chair to overcome political divergences on the TRIPS-CBD relationship.

While Members for the most part reiterated previously-stated positions, examination of technical issues -- such as how disclosure provisions could prevent biopiracy, how they could be implemented in practice and why the proponents feel that the US contract-based approach is insufficient -- facilitated the elimination of some misconceptions on the connection between access and benefit-sharing (ABS) and disclosure as well as convergence on what, realistically, disclosure requirements could be expected to accomplish. While the paragraph 19-mandated TRIPS Council session looked at the TRIPS-CBD relationship overall and related technical issues, the informal paragraph 12-mandated negotiations were more political in nature, focusing on the different arguments for and against disclosure requirements.

US questions purpose of disclosure

The US submission (IP/C/W/469) built on its two previous submissions and responded to papers presented by Bolivia, Brazil, Colombia, Cuba, India and Pakistan (IP/C/W/459) and Peru (IP/C/W/441), which were themselves issued in reaction to US papers. In the document, the US continued to argue that national ABS laws outside the patent system that directly and effectively regulate conduct of businesses were critical. In response to claims that disclosure requirements would help prevent the issuance of "bad patents", i.e. where the invention does not fulfil basic patent requirements, the US argued that disclosure of source would not accomplish this, as it would not provide details on prior art -- that is, the existence of public information that demonstrates that the invention is not new or the result of a step beyond the existing state of the art -- beyond what is already required by most patent laws.

The US also noted that national regimes outside the patent system could better guarantee prior informed consent and equitable benefit sharing for all commercially traded genetic resources, whether patented or not. The problem of mistakenly issued patents, they argued, could be dealt with through searchable, organised databases, normal national requirements to disclose information directly relevant for patentability, and the use of post-grant opposition and/or re-examination procedures. While welcoming concrete cases, such as the tumeric example or Peru's camu illustration, the US contended that these did not prove the need for a disclosure requirement, and instead called for the TRIPS Council to engage in a fact-based discussion on national experiences to elucidate the connection between genetic resources, national ABS regimes and related gaps.

Members of the 'Disclosure Group' -- which includes India, Brazil, Peru, Ecuador, Colombia, Sri Lanka, Cuba and Thailand, frequently along with Kenya and Zimbabwe -- reacted by acknowledging that disclosure requirements in themselves were unlikely to stop biopiracy. Instead, they pointed out that there were two problems at hand: firstly, the quality of patents and the problem of the issuance of bad patents for which prior art already exists; and secondly, the lack of knowledge in diversity-rich countries regarding patent applications involving their genetic resources that have been submitted in other countries. They argued that the US had only looked at the first problem, while it was the second that disclosure requirements could address. According to these WTO Members, since 1992 they have been obliged under the CBD to protect their genetic resources and ensure that any access to these resources is subject to the Convention's rules on access and benefit sharing. They argued that lack of transparency in foreign patent application and granting procedures had caused source countries to lose control over their resources, thereby compromising their ability to enforce the Convention within their sovereignty. A disclosure requirement, they argued, would make it easier for them to monitor which components of their genetic resources were being claimed in different countries, thereby enabling them to identify where they need to ensure that transfer of resources has been conducted legally and in compliance with ABS requirements.

A second paper submitted by Cuba, Ecuador, India, Sri Lanka and Thailand sought to respond to questions from Switzerland regarding technical definitions of biopiracy and misappropriation, biological and genetic resources, country of origin and source of biological/genetic resources. In addition, the countries attempted to elaborate what evidence of prior informed consent and benefit-sharing could look like, thereby trying to sooth fears from some countries that requirements could be burdensome or provide disincentives to bioprospecting.

Implementation: questions used to focus talks

In the second track of talks on the relationship between the CBD and TRIPS rules, mandated by paragraph 12 of the Doha Declaration on implementation issues, WTO Deputy Director General Rufus Yerxa held an informal consultation on the afternoon of 15 March that was framed by a document outlining eleven questions related to disclosure that delegates felt would be able to focus the debate.

The document posed the questions whether the patent system, as presently constituted and applied, provides effective safeguards against the grant and maintenance of erroneous patents; if disclosure requirements of the sort proposed necessary or helpful for reducing the existence of erroneous patents; whether the effective functioning and the enforcement of national access and benefit-sharing regimes can be secured on the basis of national legislation, including contracts, without a disclosure requirements in the patent system; and how the national-based approach and the various disclosure proposals would contribute towards achieving these aims.

In taking up these questions, the Disclosure Group reiterated its call for a specific mandate for text-based negotiations on a multilateral disclosure requirement (see Bridges Trade BioRes, 28 October 2005), and used the questions along with a number of examples to try to dispel misunderstandings and demonstrate that disclosure requirements would not be burdensome. The US reiterated its support for national ABS schemes and a contract-based approach. Japan noted that it did not support disclosure requirements. Canada, Australia and New Zealand suggested they were undecided and asked for more information. Argentina, on the other hand, noted that it had never been part of the Disclosure Group and took a stand against a multilateral disclosure requirement. Norway said that while they did not believe that there was per se a contradiction between the CBD and the TRIPS Agreement, they were in support of amending the TRIPS Agreement to include an international mandatory disclosure requirement in patent applications. The EU continued to support disclosure, though not a binding requirement, while Switzerland persisted in trying to move discussions to the World Intellectual Property Organization (WIPO).

WTO Members suggested that the structure of the informal consultations led to "very positive" discussions that will continue on 23 March. However, it was clear that the differing levels of political ambition have yet to be resolved, with one official saying that "some of us want to play soccer while others want to play rugby".

ICTSD Reporting; "WTO Discussions On Biodiversity Intensify As Differences Remain," IP WATCH, 15 March 2006; "New Submissions Feed CBD Debate At TRIPS Council Meeting," IP WATCH, 14 March 2006.