Patentable Subject Matter, IP Waiver For Health Discussed At WTO

Patentable subject matter was discussed this week at the World Trade Organization with entrenched positions, according to sources, and the momentum started in October on ways to improve a public health exception within the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, appeared to have lost some steam.

The Council on TRIPS met for a brief session yesterday with two main discussion topics. The first one focussed on Article 27 of the agreement, in particular, Art. 27.3(b) on the exclusion from patentability of plants or animals other than non-biological and microbiological processes, and the compulsory protection of plant varieties.

The second one was about the so-called Paragraph 6 waiver, named in reference to the 2001 Doha Declaration on TRIPS and Public Health. It addressed concern that pharmaceutical exporter countries could face difficulties in making effective use of compulsory licensing under the TRIPS agreement to export to countries lacking sufficient manufacturing capacities. A temporary waiver to TRIPS was agreed in August 2003 allowing countries manufacturing under compulsory licences to export more generic medicines to countries with no manufacturing capacity. The same waiver was agreed as a permanent amendment to TRIPS in December 2005, but so far not enough countries have ratified it to bring it into effect.

Paragraph 8 of the August decision asks that the TRIPS Council annually review the functioning of the system to ensure its effective operation and should report to the General Council. In the October session of the Council, a day was set aside for the annual review (IPW, WTO, 29 October 2010).

According to sources, meeting Chair Martin Glass of Hong Kong had circulated questions compiled from the October review about country experiences with paragraph 6 to be presented at this week’s meeting.

In previous sessions, some delegations expressed concern that the system had only ever been used once since 2003 and it had taken about three years for the medicines to be effectively delivered to Rwanda by a Canadian generic manufacturer. Many developing countries called for a workshop including other stakeholders than member states in order to better understand why the system was not being used and how to improve it.

Some countries, such as the European Union, opposed this position in the past, arguing that the Paragraph 6 system was for member states to implement (IPW, WTO, 10 June 2010). This week several developed countries insisted that the experience of governments should be explored first in the TRIPS Council, not closing the door, afterward, to a broader discussion, according to a WTO official.

Non-Disclosure of Motivations Behind Blockage of CBD

A newcomer to the Council discussion about Article 27.3(b) was the recently adopted 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 [pdf] of the United Nations Convention on Biological Diversity (CBD). However, the review of the provisions of the article was a display of entrenched positions, according to some sources.

The Nagoya Protocol is an international instrument ensuring that access to genetic resources are matched with fair and equitable sharing of the benefits that might arise from the utilisation of those genetic resources.

No consensus was reached on whether the CBD body should brief the TRIPS Council about the Nagoya Protocol and the question of granting an observer status to the CBD at the Council was opposed in particular by the US, according to a source.

The issue of the disclosure of the source of genetic resources and traditional knowledge in patent applications was discussed, with some saying that the Nagoya Protocol did not make disclosure mandatory, and noting that some countries are not signatories to the CBD, such as the US.

According to a WTO official, some countries said the TRIPS agreement should not be used as a tool to enforce the Nagoya Protocol and favoured the fight against misappropriation of resources through other means such as databases and contracts. In particular, Australia and Canada oppose disclosure requirements.

The TRIPS agreement requires a review of Article 27.3(b) and paragraph 19 of the Doha Declaration has broadened the discussion and said that the TRIPS Council should also look at the relationship between TRIPS and the CBD, and the protection of traditional knowledge and folklore.

These issues are also discussed at the World Intellectual Property Organization, and this week is the focus of an experts working group meeting on the protection of genetic resources (IPW, WIPO, 28 February 2011).

Some developed countries that are large producers of pharmaceuticals drawn from developing country genetic resources have sought to pump up discussions in WIPO, which has no dispute settlement mechanism, while resisting the discussion in the WTO context where a dispute mechanism exists.

At the heart of the discussion is a possible amendment to Article 27.3(b).

Disclosure of origin as a TRIPS obligation has been supported by a number of developing countries represented by Brazil and India and including Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the African Group and some other developing countries, according to the WTO. Switzerland favours disclosure through WIPO’s Patent Cooperation Treaty.

In a statement yesterday, Brazil said it was in favour of amending the TRIPS agreement to include a mandatory requirement. It asked that patent applicants state whether they have complied with the applicable prior informed consent and access and benefit-sharing legislation, so that the TRIPS agreement supports compliance with the CBD and the Nagoya Protocol.

The Fight to Prevent Patents on Living Organisms

Bolivia submitted a document proposing an amendment of Article 27.3(b) of TRIPS to prohibit the patenting of life forms, saying that prior to the adoption of the article, life forms and components of life forms such as cells, genes, biochemical substances and proteins were not generally patentable but since the adoption of the article “triggered a process which led to the proliferation of policies and laws that permit life forms and parts thereof to be considered patentable subject matter.”

According to its submission, Bolivia said this “rush” toward patenting of life forms has led to “monopolistic control over some of the most important sectors, such as food, agriculture and health, a trend facilitated by the patent system.”

The sensitive subject of Article 27.3(b) is the object of informal consultations chaired by WTO Director General Pascal Lamy.

Glass handed the chairmanship of the Council to Federico González of Paraguay at the end of the meeting.

William New contributed to this story