Draft Text On Protection Of Genetic Resources On Its Way To WIPO Assembly

At the end of a weeklong drafting exercise, World Intellectual Property Organization delegates have produced a text on the protection of genetic resources that appears to be headed to the organisation’s annual General Assembly next September. And some members hope that a high-level meeting will be convened in the course of 2014 to agree on an international instrument or instruments protecting genetic resources against misappropriation.

The Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) took place from 4-8 February.

IGC Chair Wayne McCook from Jamaica was lauded by participants as the draft decisions [pdf] were swiftly adopted this afternoon without modifications.

“I applaud delegations that exercise flexibility when flexibility is warranted but also are clear about their limitations when they have no flexibility because it is a fool’s errand when somebody promises something here in Geneva that their capital cannot deliver, encouraging delegates to consult,” he said.

Reflecting on the progress accomplished during the week, McCook said, “We are at a point of shared discomfort, which is an important point in the negotiation, where everybody feels they do not have what exactly what they wanted and everybody also has concerns that they are not holding on to what they originally had in the same way, but a negotiation is about give and take, and that means what it says.”

The consolidated document relating to intellectual property and genetic resources – Rev 2 [pdf] will be transmitted to the WIPO General Assembly in September 2013 in accordance with the committee’s mandate (IPW, WIPO, 8 February 2013), after it has been amended by the facilitators to take into account any errors and omissions, according to WIPO. All other interventions made on the text by member states will be recorded in the report of the session.

The text, bearing a large number of brackets, shows that divergences still need to be bridged. The IGC meeting scheduled for July has three extra days planned for the end to discuss the three legs of the IGC: genetic resources, traditional knowledge and traditional cultural expressions. But this genetic resources text is not expected to be reopened then.

Joint Recommendations, Proposals

Some developed countries submitted two joint recommendations, and a proposal.

One joint recommendation was resubmitted after it was decided to postpone the discussion when it was first submitted at the 20th session of the IGC.

Canada, Japan, Norway, South Korea and the United States, resubmitted their joint recommendation on genetic resources and associated traditional knowledge, for a non-binding instrument without a disclosure requirement. This was presented to the plenary on 7 February.

On 1 February, Canada, Japan, South Korea, and the US also submitted a proposal for the terms of reference for the study by the WIPO secretariat on measures related to the avoidance of the erroneous grant of patents and compliance with existing access and benefit-sharing systems, also presented to the plenary on 7 February. At the same time, the group further presented another joint recommendation on the use of databases for the defensive protection of genetic resources and traditional knowledge associated with genetic resources, submitted on 5 February.

The US, presenting the joint recommendation on genetic resources and associated traditional knowledge, said the joint recommendation captures key objectives and facilitates the establishment of effective mechanisms for the protection of genetic resources and associated traditional knowledge.

“As one of the top 20 mega-diverse countries, the US recognises the value that biodiversity contributes towards society,” the delegate said. The joint recommendation means to facilitate clear procedures for obtaining authorised access to genetic resources in exchange of equitable monetary or non monetary benefits, but such access and benefit-sharing procedures should be entirely independent of the filing of patent applications, he said and the enforcement of prior informed consent and mutually agreed terms through the IP system is unnecessary, he added.

The three documents raised a variety of reactions and concerns from developing countries. In particular, they underlined that the mandate given to the IGC by the October 2012 General Assembly was to work on the consolidated document. The fact that the three documents do not include any mention of mandatory disclosure requirement was pointed out by developing countries as not representing consensus.

On the establishment of databases, some developing countries said they could achieve the opposite effect than to help protect genetic resources and actually facilitate misappropriation. Indigenous peoples representatives underlined the fact that some of their traditional knowledge could be included in those databases without their consent, on the assumption that it is in the public domain. Bolivia shared the same concern, as well as about the cost of the establishment of such databases.

India, which is a precursor with its Traditional Knowledge Digital Library, agreed that databases are useful as one of the tools to prevent the granting of erroneous patents, but the subject was already part of the discussion and therefore did not separate discussion.

Defensive measures, such as databases, should be complementary to a legally binding instrument, said Brazil. A number of other developing countries remarked that defensive measures were already included in the consolidated document (in Article 3). They did not wish to have parallel discussions on the same subject, which would duplicate discussions already being carried out on those matters within the expert group.

The US said the Russia might join the co-sponsors of the draft terms of reference on the study, which would be carried out by the WIPO secretariat without prejudice to the work of the IGC. Russia, although interested in the study, has put a number of questions to US before making its decision, it said.

Japan, one of the co-sponsors, said evidence was needed to support new norms and no such evidence support the mandatory disclosure mechanism. The study would analyse the impact of mandatory disclosure and its effect on innovation. According to developed country sources, mandatory disclosure of genetic resources in patent applications would have a chilling effect on biotech innovations because it would create legal uncertainty and increase the risk of litigation.

Switzerland in Favour of Mandatory Disclosure

In the IGC, Switzerland has an uncommon position in the group of developed countries. The country tabled a proposal in 2003 about a disclosure of the source requirement of genetic resources and traditional knowledge in patent applications, Martin Girsberger, head of Sustainable Development and International Cooperation at the Swiss Federal Institute of Intellectual Property told Intellectual Property Watch.

The country has had such a mandatory disclosure of source requirement in its legislation since July 2008, he said.

The consolidated document includes important elements of this proposal, for example parts dealing with the concept of source, the concept that inventions need to be directly based on genetic resources and traditional knowledge, pre-grant and post-grant sanctions, the international gateway and the notification procedure.

On the joint recommendation on databases, Girsberger said, “It is always helpful to have more information at hands for patent examiners.” The proposal to have databases can go in parallel with the mandatory disclosure. They can be mutually supportive approaches to resolve the issues at hand.

One of the objectives of the disclosure requirement is to facilitate the job of patent examiners. The fact that they know genetic resources come from a certain country will not be enough by itself, but it can help the patent examiners when searching for more specific information to resort to a database or some other tools, he said.

“One key issue with databases is to determine who has access and how to regulate that access. There needs to be a system to limit and secure access,” he added in response to concerns of some developing country that databases could actually make misappropriation easier.

On the necessity of the study requested by Canada, Japan, South Korea and the US, Girsberger said, “Any study would be helpful but enough information is available to negotiate, and negotiations should go along.”

“Based on our experience up to now, we are not aware of any discouragement from the biotech industry because of mandatory disclosure of source requirement,” he added.

Countries also have divergent views on the relationship with other international agreements. The US for example is not party to the UN Convention on Biological Diversity (CBD) and said the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity was not implemented yet. Developing countries are in favour of a consistency between the future instrument(s) and the other international agreements dealing with access and benefit sharing.

The relationship with existing international agreements was also addressed in the Swiss proposal, he said.

“It is quite obvious that what we do here in WIPO should take into account the relevant instruments on access and benefit-sharing, such as the CBD, the Nagoya Protocol, and the International Treat on Plant Genetic Resources for Food and Agriculture.” The list of terms should refer to the same definitions as these other instruments in order to achieve a mutually supportive solution.