Also unchanged were members’ positions on non-violation complaints. The TRIPS Council has to make a recommendation on the present moratorium at the next Ministerial Conference in Geneva 15–17 December 2011.
 

Some details

The ‘triplets’
Article 27.3(b), biodiversity and traditional knowledge

Essentially, old positions remained largely unchanged but in a new context —the Nagoya Protocol adopted by the Conference of the Parties (COP) to the UN Convention on Biological Diversity (CBD) at its 10th meeting on 29 October 2010 in Nagoya, presented to the TRIPS Council by Japan as the conference’s host country.

Consultations: Some delegations welcomed the recently resumed consultations on this subject, chaired by Director-General Pascal Lamy.

These consultations are separate from the TRIPS Council and were mandated by WTO ministers meeting in Hong Kong in 2005 to pursue an issue identified in the 2001 Doha Declaration — the relationship between the CBD and TRIPS. Some countries want to reinforce this relationship by amending the TRIPS Agreement to require patent applicants to disclose at least the source or origin of genetic resources used in inventions.

A number of members now want the “disclosure” proposal linked to two topics on geographical indications. Other members oppose the link or the “disclosure” proposal or both, even though members widely support the CBD’s general objectives including equitable sharing of the benefits of inventions.
  

Nagoya/CBD: There was no consensus on whether the CBD Secretariat should be invited to brief the TRIPS Council on the Nagoya Protocol. Japan, as host country, made a brief presentation on the protocol. Several members repeated their call for a future briefing by the CBD but again there was no consensus, as was also the case on whether the CBD should be an observer in the council.

The countries supporting “disclosure” said an amendment is still needed because the Nagoya Protocol and the CBD do not make disclosure mandatory and not all WTO members have signed the CBD

Others continue to oppose this saying Nagoya was recently agreed and should not be renegotiated immediately, and that the WTO’s TRIPS Agreement should not be used as a tool to enforce it. They continued to argue that misappropriation of resources and bad patenting (“biopiracy”) are best tackled through databases, contracts and other means.

The Nagoya Protocol — 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” — deals with “access and benefit sharing” with countries or local communities when inventors use genetic materials and any associated traditional knowledge. It builds on the long-established principles of the CBD itself.

Some countries arguing for a TRIPS Agreement amendment say patent applicants should disclose the source or origin of genetic resources and traditional knowledge that they use. Others want information on “prior informed consent” and benefit sharing to be disclosed as well.

Some countries already have “disclosure” in their patent laws.  

Bolivia presented a more detailed paper on its proposal to amend the TRIPS Agreement so that patenting of all life forms is banned.

It argued that patenting life forms is immoral, violates the beliefs and values that indigenous people hold sacred, overturns farmers’ traditional rights to seeds, extends capitalism and concentrates the domination of a handful of rich-country multinational corporations, stifles research and development, jeopardizes food security and undermines humankind’s ability to respond to climate change.

On delegation agreed. Some called for further study without endorsing the idea. Some simply said they would study the proposal.

Several countries argued that TRIPS Art.27.3(b) is already flexible enough for countries to decide for themselves how to handle policies related to biotechnology patenting. Some said patent protection is a necessary, time-limited incentive for innovation in biotechnology that can bring benefits to human health and wellbeing, and that existing life forms cannot be patented because they are not new inventions.

Article 27.3(b) deals with patentability or non-patentability of plant and animal inventions, and the protection of plant varieties. Broadly speaking, it allows governments to exclude some kinds of inventions from patenting, i.e. plants, animals and “essentially” biological processes (but micro-organisms, and non-biological and microbiological processes have to be eligible for patents). However, plant varieties have to be eligible for protection either through patent protection or a system created specifically for the purpose (“sui generis”), or a combination of the two.

In other words, Art.27.3(b) offers countries the choice of whether to protect or not in some circumstances, and requires them to provide protection of some kind in others. Bolivia’s proposed ban, first presented in March 2010, would turn that around.
  

TRIPS and public health:
the Par.6 system and follow up to the annual review

The discussion on the TRIPS and public health “Par.6 system” was a follow up to the annual review in the last meeting. The system is designed to remove an intellectual property obstacle preventing countries from using compulsory licences to manufacture generic medicines exclusively for export to countries unable to make them themselves.

A number of questions were asked in the October 2010 review (see documents IP/C/57 and IP/C/57/Corr.1) and they were compiled into a list for this meeting.

Some developed countries replied to questions they had been asked on how their laws or regulations deal with their use of the system as potential exporters, for example on technology transfer or ensuring the generic medicines supplied are safe and effective. Also replying to questions, the World Health Organization and World Intellectual Property Organization described the technical assistance they give to developing countries on public health and intellectual property issues.

Some developing countries repeated their view that the system is not working because it has only been used once. Several developed countries said they were disappointed that potential importing countries did not reply to questions about their experience in using or trying to use the system and any obstacles they faced.

Some developing countries repeated their call for a workshop involving pharmaceutical companies, non-governmental organizations, health practitioners and others, which they said is necessary to answer the questions. Some developed countries repeated their view that the Par.6 system is for governments to implement and therefore the experience of governments should be explored first in the TRIPS Council, leaving open the question there should be a broader workshop afterwards.

Background: The 2003 “waiver” (and the 2005 pending TRIPS amendment) removes a requirement that generics produced under compulsory licence should be mainly for the domestic market, which would hinder their export to countries that cannot make the medicines. It is sometimes called the “Paragraph 6” system after the provision in the 2001 Doha Declaration on TRIPS and Public Health that led to its creation.

The TRIPS Council reviews how well the system is working every year, a requirement for any waiver under Art.IX.4 (9.4) of the WTO Agreement. This usually takes place in October, but until recently with little depth or detail. Members sought a more detailed review for 2010 and therefore the whole day of 27 October was allocated for this agenda item.

For the first time, the discussion was also organized into topics to give it more focus. These covered actual experiences, various legal aspects such as any domestic legislation needed and the international treaty process of accepting the TRIPS Agreement amendment, capacity building, alternative ways of achieving access to medicines, and what to do next.
  

Chairperson: Mr Martin Glass of Hong Kong, China, handing over to Ambassador Federico A González of Paraguay at the end of the meeting

Next meetings

TRIPS COUNCIL (REGULAR) MEETING (could change):

• Tuesday-Wednesday 7–8 June 2011
• Tuesday-Wednesday 25–26 October 2011

TRIPS NEGOTIATIONS (FORMAL SPECIAL SESSION):

• Thursday 3 March 2011