Canada's Position on Intellectual Property issues at the WTO

TRIPS and Public Health

In the November 2001 Doha Ministerial Declaration, World Trade Organization (WTO) members recognized the gravity of the public health problems afflicting many least-developed and developing countries, especially those resulting from human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS), tuberculosis, malaria and other epidemics.

On August 30, 2003, the WTO General Council reached a decision to waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which could have prevented developing and least-developed WTO-member countries from importing less-expensive versions of patented pharmaceutical products produced under compulsory licence.

Canada was the first country to take concrete steps toward implementing this decision. Canada’s legislation implementing the August 30, 2003 decision entered into force on May 14, 2005 (see News Release - May 13, 2005). The implementation of the Decision in Canada required Amendments to both the Patent Act and the Food and Drugs Act, and to their corresponding regulations. The challenge was to establish an effective system that removes barriers to the delivery of affordable pharmaceutical products to countries in need while ensuring that the regime not be used for industrial or commercial objectives. It is also important to ensure that products manufactured under the regime are not diverted from their intended beneficiaries and that the regime as a whole respects the intellectual property rights that are so critical to the development of new and improved pharmaceutical products. Canada’s legislation is limited to the export of products manufactured under a compulsory licence, in conformity with the August 30, 2003 Decision and therefore has no application for the Canadian market.

The August 2003 WTO Decision will be in effect until there is a formal amendment to TRIPS incorporating its substance. Amendment negotiations first began in November 2003, and were scheduled to be completed by June 2004. However, disagreement amongst developing and developed members on the nature and scope of such an amendment led to the negotiations continuing until just prior to the December 2005 Hong Kong Ministerial.

On December 6, 2005, WTO members finally concluded its access to medicines negotiations  whenthe General Council adopted a Protocol Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641).  The Protocol is open for acceptance by Members until 31 December 2013 or such later date as may be decided by the Ministerial Conference

Canada strongly welcomed this agreement as positively demonstrating how WTO members can work together to respond to the needs of developing and least developed countries.

Geographical Indications

According to the TRIPS Agreement, a geographical indication (GI) identifies a good as originating in a particular territory where "a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin" (Article 22.1). The agreement contains obligations relating to all GIs, and it includes an enhanced protection for wines and spirits.

In addition, the TRIPS Agreement confirms that negotiations on establishing a multilateral system of notification and registration of GIs for wines and spirits shall be undertaken (Article 23.4). These negotiations are currently underway.
Countries belonging to the World Wine Trade Group (including Canada) and a number of other WTO Members are calling for a voluntary, facilitative, simple and low-cost registration system that will provide information on GIs that are notified by Members. Canada does not favour a system that includes obligations beyond those currently contained in the TRIPS Agreement, especially in light of the development focus of the Doha Round of WTO trade negotiations.

The European Union and its Member States, together with Switzerland are leading the call for extending the enhanced level of GI protection currently reserved for wine and spirit GIs to a broad range of agricultural products. Canada and other World Wine Trade Group countries (e.g. Australia, New Zealand, and the United States) are opposed. In our view, extending the level of GI protection to other products would be highly costly and burdensome: producers could be forced to stop using commercially significant terms, and to rename, re-label and find new ways of marketing products that use such terms, in both domestic and overseas markets.

To learn more, see Agri-Food Trade Policy on TRIPS.

Patentability of Higher Life Forms

Regarding the patenting of humans, animals and plants, Canada supports the continued flexibility in the TRIPS Agreement which allows WTO Members to decide whether or not to patent these life forms. Since 1999 the provision (Article 27) in question has been undergoing a mandatory review dealing with technical and scientific interpretation issues. In December 2002, the Supreme Court of Canada held that a genetically-modified mouse was not an invention under Canada’s current Patent Act, although the biochemical processes to create the genetically modified mouse may be. Following that decision, humans, plants, and animals remain un-patentable subject matter in Canada. It should be noted, however, that the May 2004 decision of the Supreme Court of Canada in Schmeiser v. Monsanto Inc. clarified that all molecular matter up to the level of a plant or an animal, be it genetically modified or not, is patentable subject matter in Canada.

On sui generis protection of plant varieties, Canada supports the flexibility allowing WTO Members to determine which type of regime meets the requirement of sui generisprotection, as long as the form of protection adopted meets certain objective criteria. Regimes other than those under International Convention for the Protection of New Varieties of Plants (UPOV) would need to be assessed on a case-by-case basis. It is important to note that nothing in the TRIPS Agreement would seem to limit a Member’s ability to implement a sui generis system that allowed farmers to save and sow seed.

TRIPS and the Convention on Biological Diversity

The Doha Declaration called for an examination of the relationship between the TRIPS Agreement and the 1992 United Nations Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments that Member governments raised in the review of the TRIPS Agreement. Canada supports genuine and continued discussion on the importance of preventing misappropriation and bio-piracy in the collection and/or use of genetic resources and traditional knowledge. Canada continues to consider that an effective means of finding agreement on this objective would be to continue to engage in more purposeful discussion on the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) as well as the protection of traditional knowledge and folklore.

In Canada’s view, such a work plan should not result in a duplication of Members’ resources. It is Canada’s understanding that many countries recognize and support continuing the useful and substantive work of the World Intellectual Property Organisation (WIPO)’s technical Committees, particularly the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) and the Standing Committee on the Law of Patents. This work should not be supplanted by any possible actions undertaken by TRIPS Council, but should continue to inform the discussion at the WTO.

On the subject of patent disclosure, Canada welcomes a more detailed, diagnostic discussion on these proposals that does not preclude or prejudge any options or outcomes, and could lead Countries towards envisaging a common approach on the issue of patent disclosure.

Non-violation and Situation Complaints

Article XXIII of the GATT 1994 allows WTO members to make complaints about measures taken by other Members that nullify or impair benefits granted under a WTO Agreement, even if such measures do not conflict with the provision of the agreement or as a result of “any other situation” (“non-violation and situation complaints” or “NVNI”). Article 64.2 of the TRIPS Agreement, however, provides that non-violation and situation complaints “shall not apply to the settlement of disputes under this Agreement for a period of five years from the date of entry into force of the WTO Agreement.”

With the period allowed for in Article 64.2 set to expire, the 1999 Seattle Ministerial Conference agreed to extend the period for examination and the 2001, 2004 and 2011 (Doha) Ministerial Conferences extended it again. The Cancun Ministerial text, had it been agreed, would have directed TRIPS Council to “continue its examination of the scope and modalities for [non-violation and situation] complaints (...) and make recommendations to the first Ministerial Conference to be held after 1 August 2004 (...)”There is now as much uncertainty about the process by which a permanent decision is to be made as there is about whether and how such complaints should apply in the context of the TRIPS Agreement.

Canada’s position is that NVNI complaints should not apply in the context of the TRIPS Agreement. Because NVNI has not so far applied in TRIPS, agreeing to apply it now would shift the balance WTO Members have maintained since the Uruguay Round. In Canada’s view, the onus is now on the few delegations who support the application of NVNI to explain why the Council should agree to change that status quo.

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