WTO Ministerial Section • Volume 5 • Number 22 • 9th December 2005

Intellectual Property Rights @ Hong Kong

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See also

Calls to start negotiations on requirements to disclose the origin of genetic resources in patent applications have figured high in intellectual property-related negotiations in the lead-up to the Hong Kong Ministerial Conference. In addition to discussions in the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS), the need to introduce such requirements to prevent the misappropriation of biological material and associated traditional knowledge (TK) was emphasised in a paper entitled "Reclaiming Development in the WTO Doha Development Round", submitted by several developing countries to the Committee on Trade and Development on 28 November. Despite the fact that EU Trade Commissioner Peter Mandelson said on 30 November that the EU is open to this proposal, the reluctance of the US, Japan and Korea on the matter — along with slow movement on agriculture, non-agricultural market access and services — may make it unlikely that disclosure requirements will be taken up in Hong Kong. Nonetheless, two paragraphs in the draft Ministerial Declaration make reference to the ongoing negotiations on the relationship between the Convention on Biological Diversity (CBD) and the TRIPS Agreement and urge Members to continue discussions.

The relationship between the WTO’s TRIPS Agreement and the CBD — in the context of which the proposal on disclosure requirements has been made — has been the subject of two separate tracks of talks at the WTO, each of which has inserted a reference to the relationship in the draft Hong Kong Ministerial Declaration. Under negotiations mandated by paragraph 12 of the Doha Declaration, Members have been examining the relationship through attempts to better implement Article 27.3(b) of the TRIPS Agreement which deals with the biological matter that Members may exclude from patentability, while obliging them to protect microorganisms and certain biotechnological processes. The TRIPS-CBD relationship has also been subject to attention under the mandate of paragraph 19 of the Declaration, where Members have been focusing on the review of Article 27.3(b) and a particular mandate to examine the relationship between the TRIPS Agreement and the CBD, the protection of traditional knowledge and folklore.

The proponents of negotiations on the TRIPS-CBD relationship are countries that hold many of the genetic resources and associated TK which have raised concerns over the misappropriation of genetic resources and knowledge, commonly referred to as ‘biopiracy’, for use in patented inventions. These countries — which are also known as ‘provider’ countries and are led by India, Peru and Brazil and are overwhelmingly developing country WTO Members — point to high-profile cases such as the neem tree, basmati rice and maca as evidence that there needs to be an internationally binding, enforceable disclosure requirement that would oblige patent applicants to disclose the source and/or country of origin of the genetic materials and associated TK used in the invention claimed; evidence of prior informed consent with the original holders of the resource or knowledge; and evidence of a benefit sharing agreement with the original holders. On the other hand, the major users of genetic resources in patent inventions — which are overwhelmingly developed countries with significant research and development interests — have argued that a disclosure requirement could place unnecessary burdens on industry that could harm business.

Struggle for text for Hong Kong

Under the "implementation" track of talks on the TRIPS-CBD relationship in the WTO mandated by paragraph 12, India presented a proposal to include text on disclosure to be included in the draft Hong Kong Ministerial Declaration at an informal consultation held by WTO Deputy Director General Rufus Yerxa on 21 November. The proposal called for the Ministerial Conference to launch negotiations that would craft an amendment to the TRIPS Agreement to make disclosure requirements mandatory for patent applicants (see Bridges Trade BioRes, 28 October 2005).

Although the proposal had the support of many developing countries, the US, Japan and Korea said they were unable to support it. The US suggested that they did not believe that negotiations on disclosure were necessary, nor that there was a conflict between the CBD and the TRIPS Agreement that needed to be resolved. The US restated their earlier support for a "contract-based" approach that would recommend that WTO Members adopt laws that encourage private entities to sign contracts with the holders of genetic resources before applying for patents. As a result of the diverging opinions, the first draft of the Hong Kong Ministerial Declaration simply takes note of the work under the implementation track on the relationship between the TRIPS Agreement and the CBD, and instructs the group to continue talks under the auspices of the WTO Director-General.

While expressing disappointment with the failure to include a reference to disclosure or the need for new rules, developing countries felt that even the reference to the TRIPS-CBD relationship, and the positioning of the issue directly under the responsibility of the Director General, marked advances on the issue. The momentum built from the consultations, along with the clear reference to the issue as part of the "development" package by key actors, could lead to a political decision being taken in Hong Kong to move the issue forward and begin negotiations specifically on disclosure. Sources suggested that this outcome is not expected, but could take place if significant movement on the key issues in Hong Kong, namely agriculture, non-agricultural market access and services, could be achieved (see related story, this issue).

Meanwhile, in a 28 November meeting of the TRIPS Council, Members agreed to include a text that authorises continued negotiations on the CBD-TRIPS relationship mandated by paragraph 19 of the Doha Declaration. The reference keeps the mandate on CBD-TRIPS talks from the Doha Declaration in the TRIPS Council in the eye of negotiators. Discussions on the CBD-TRIPS relations in the Council have recently completed a technical process launched in March 2004 that aimed to clarify disclosure-related issues, but Members remain uncertain of how to move forward as the rifts between positions have remained largely the same.

Deal struck on TRIPS and public health

WTO Members agreed on 6 December 2005 to amend the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) to allow countries with insufficient pharmaceutical manufacturing capacity to import generic versions of drugs still under patent (see Bridges Weekly, 7 December 2005). However, NGOs from all over the world have criticised the agreement as being too burdensome and the international humanitarian aid group Médecins Sans Frontières (MSF) has warned that the amendment is "based on a mechanism that has failed to prove it can increase access to medicines." In addition, the 28 November TRIPS Council meeting agreed to grant least-developed countries (LDCs) an extension until July 2013 to apply rules protecting patents, copyrights, and other intellectual property under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) (see Bridges Weekly, 30 November 2005).

Disclosure obligations not included in US-Peru FTA

In related news, a draft free trade agreement (FTA) text was agreed to by the US and Peru on 7 December as part of wider negotiations between the US and Andean countries. Although the Andean negotiators had earlier proposed a provision that acknowledges the role of indigenous cultures in the preservation of plant life in exchange for their acceptance of test data protection for pharmaceuticals (5 years) and agrochemicals (10 years), the final agreement does not include IP related provisions on genetic resources and traditional knowledge. The Andean countries had been pressing, through the "role of indigenous cultures" clause and other measures, to include text in the agreement that would require prior informed consent from indigenous communities by researchers seeking to patent genetic processes. Despite the lack of biodiversity-related references in the final intellectual property chapter, a side letter signed by the parties to the agreement highlights the importance of ‘biodiversity and associated traditional knowledge’ but does not make any reference to IP.

The 1 December version of the draft Hong Kong Ministerial Declaration is available at http://www.ictsd.org/ministerial/hongkong/docs/05-12-01_draft_ministerial_text_revised.pdf

ICTSD Reporting; "LDCs Agree To Shorter Extension For TRIPS Implementation," IP WATCH, 29 November 2005; "TRIPS Council To Resume Talks On 29 November," IP WATCH, 25 November 2005. "US, Andean Nations Narrow Differences On IP In Trade Talks," IP WATCH, 2 December 2005; "US, Peru reach free trade agreement," ASSOCIATED PRESS, 7 December 2005.