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US ‘no’ to IPR standards use for PIC and benefit sharing

by Chakravarthi Raghavan

Geneva, 7 May 2001 - - The World Intellectual Property Organization is to do further work on development of guidelines and model intellectual property clauses for contractual agreements on access to genetic resources and benefit sharing, but has been blocked, at least for now on model guidelines for national patent laws and international standards for ensuring IPRs support Prior Informed Consent (PIC) for access to genetic resources and benefit sharing.

The mandates for work on Intellectual Property (IP) and Genetic Resources (GR), Traditional Knowledge (TK) and Folklore was given by an Intergovernmental Committee of the WIPO which held its first session last week. The IGC will meet again in December.

Though there was majority support for the idea of new patent standards (and model national laws and measures) to support the PIC for access to genetic resources, the opposition to such work was led by the United States and Japan.  Though seemingly not opposed, the EU and several other industrialized countries gave it a much lower priority, and thus not an urgent task for the WIPO bureau and the IGC.

At issue here has been the way pharmaceutical corporations, and northern academics, researchers and others have gone on exploratory work to identify bio-diversity, and get information from local communities, often indigenous groups, and either have committed bio-piracy’ by illegally taking away samples and genetic resources, developed abroad products, claiming them to be ‘inventions’, or entered into some socalled contractual benefit-sharing arrangements where the traditional communities have given away their rights for a pittance.

In some cases, these contracts have been like the way Europeans went on exploration all over the world (the Americas, Asia, Australia and New Zealand and Africa) and got rights, including sovereign rights, over territories from native tribes in exchange for beads and pieces of glassware.

The general discussion in the IGC, and the views of key delegations on priorities for further work, bring out clearly that as far the United States is concerned, a “one-size-fit-all” approach is legitimate and justified in the WTO trading system and its rules, including those for global corporate monopoly rights in TRIPS. However, in the US view development of a new intellectual property-type regime to protect TK “did not appear to be the best fit” for holders of such knowledge. Also, there were so many different expectations, goals and native systems for approaching ownership and transgression of ownership, that a “useful, enforceable global system” would be virtually impossible to create.

“Indeed,” said the US delegate at the IGC, “a ‘one size fits all’ approach could be interpreted as demonstrating a lack of respect for local customs and traditions..”

WIPO officials said that though the IGC had listed the subjects involved separately as genetic resources, traditional knowledge and folklore, genetic resources and their use often involved traditional knowledge and the two could not really be separated.

Within the WTO, and its TRIPs Council, there have been proposals that countries granting patents on processes and products derived from genetic resources, should require those filing for such patents to indicate the source or origin of the genetic resource and how this was collected or acquired - so that the rights of the local communities could be protected, and ensure that national laws relating to these are observed, and there is no piracy or theft. There have also been calls that the United States which has one of the loosest definitions and administration of patent laws in respect of the normal requirement of ‘novelty’ and ‘inventiveness’. Also, while it accepts ‘oral traditions’ inside the United States as prior publication and thus not ‘inventive’, it does not so recognise oral traditions abroad.

This has enabled the corporations to use genetic resources pirated from abroad, and based on the knowledge of their use prevalent abroad in oral traditions, and claim them to ‘novel’ intentions for patenting in the USA.

A WIPO official side-stepped this issue in relation to the discussions on genetic resources and patenting and benefit sharing, by suggesting that the different criteria and standards adopted by countries in judging ‘novelty’ or ‘inventiveness’ was a matter to be dealt with through patent harmonization treaty.

In the WIPO document for the IGC, in relation to genetic resources and benefit sharing, a number of elements had been identified for further work.

Possible Task A.1 that received the green signal calls for the development of a ‘guide contractual practices’ or guidelines, and model intellectual property clauses for contractual agreements on access to genetic resources and benefit sharing, taking into account the specific nature and needs of different stakeholders within different sectors of genetic resource policy.

The UN Convention on Biodiversity has provisions relating to access to genetic resources and benefit sharing and the rights of countries with biodiversity to make access conditional on benefits and technology transfer. But besides laws of contract (relating to access and benefit sharing), the WIPO document has pointed out that IP issues on genetic resources are rapidly arising as sovereign States exercise their authority to determine access to their genetic resources by developing legal and policy frameworks to regulate such access, which may interface in multiple ways with national IP legislation, in particular patent laws.

The UNCBD had convened a panel of experts on access and benefit sharing and they identified two primary issues, the WIPO document notes: (i) intellectual property rights as a possible “international measure to support prior informed consent” and (ii) the recording of interests in inventions that arise from access to or use of genetic resources. The panel had suggested that CBD Parties should investigate IPRs as “incentive-based measures to support, in user countries, prior informed consent requirements in provider countries:”

As for the second issue of ownership interests, the WIPO document points out, it has been proposed to establish as a requirement that patent documents shall disclose the origin of genetic resources used in the development of inventions and/or provide evidence that the resource was acquired legally.”

The WIPO document had outlined several issues that need to be looked at, and had suggested as ‘Task A2’ (various tasks in genetic resources and benefit sharing) further work: development of appropriate provisions or guidelines for national patent laws which facilitate consistency with measures of States concerning access to genetic resources and which are consistent with existing international intellectual property standards.

The report of the IGC shows that the US “opposed”” this task as it was “inconceivable” for the US, that “access issues would have any nexus to appropriate provisions or guidelines for national patent laws. To the extent there is any overlap, the issue is already being addressed in the context of applicable and appropriate requirement of enabling disclosure of a claimed invention.”

Japan also made clear that it “could not support new patent standards” (to support prior informed consent, as called for by the panel of experts of the CBD).

The tasks three and four, suggested for further work by the WIPO bureau, related to multilateral systems for facilitated access to genetic resources and benefit-sharing and protection of biotechnological inventions including certain related administrative and procedural issues.

In summing up the discursions, the chairman of the IGC that Task 1 had been supported by almost all speakers, and that while 2 and 4 had received majority support, some delegations had opposed certain of these tasks or suggested their postponement. The third task (for multilateral systems to facilitate access) had been generally agreed, but taking account of developments elsewhere including FAO.

The debates also showed that several of the developing countries were less inclined to the individual contractual arrangements (between local communities and foreign corporations or researches) on access to genetic resources and benefit sharing, but wanted national laws, and international measures to support these.

Brazil pointed out that the exercise of IPRs should not run counter to the objectives of sustainable exploitation of genetic resources. One concern ought to be that private rights inherent in IPRs might put i question sovereign rights of States over their genetic resources. Brazil did not share the view that patents are in inherent conflict with sustainable exploitation of genetic resources. On the contrary patents might serve as a useful tool to promote benefit sharing.

However in Brazil’s view “contracts are limited tools to promote benefit-sharing, as contracts are bilateral and include parties with differing negotiating strengths.” It was hence important to include prior informed consent in contractual arrangements and mechanisms should be established to provide legal assistance to traditional communities when entering into contractual arrangements.

But contracts were also not easily enforceable. Hence, said Brazil, “the Committee should give more emphasis to task related to legislative,  administrative and policy measures, as well as multilateral systems. Loose or unclear standards for patentability also undermined the patent system as a whole, and the Committee should consider that naturally occurring organises are not inventions. And while Brazil supported bio-technology, “it opposed biopiracy”. –SUNS4990

The above article first appeared in the South-North Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief Editor.

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