Developing countries fear that a proposed treaty to harmonize patent laws globally could have a devastating impact on their access to essential medicines, diagnostics and vaccines. A passionate and fractious debate around the proposed treaty underscores the vital role of trade and intellectual property for public health.
Indian HIV/AIDS activists and an international lawyers' group lodged an objection in late March 2006 to a patent application for an AIDS drug filed by a multinational company in India, arguing the patent would restrict access to this medicine. The case illustrates the impact that global harmonization of patent law could have on public health in developing countries, as it could remove the legal basis for such objections in future.
Last year, India, an important global provider of cheap generic medicines to other developing nations, adopted a new law on patents to bring the country in line with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Under the new law, the Indian Government retained the right of its people or companies to oppose new applications for patents in India prior to approval by national patent offices. Now, groups fighting to improve access to medicines say proposals for global patent harmonization could strip national patent offices of this and other responsibilities.
The TRIPS Agreement established minimum standards for patents in WTO member states, but left room for each country to decide which patents to grant. In addition, TRIPS provided flexibilities, which were reinforced in the 2001 WTO Doha Ministerial Declaration, so that countries could escape some provisions in a public health emergency. Countries have barely used these flexibilities (see story on pp. 342-343) and now the work of another Geneva-based international body--the UN World Intellectual Property Organization (WIPO) threatens to eliminate them entirely.
Some TRIPS provisions were first proposed when WIPO started working on global patent harmonization in the 1980s. In 2000, some procedures for patent filing worldwide were streamlined under the WIPO Patent Law Treaty. Since then, the European Union, Japan and the United States have pushed for further harmonization by reviving WIPO's efforts to harmonize substantive aspects of patent processing, i.e. aspects that go beyond procedure. But most of WIPO's 183 members stand firmly opposed to this.
The primary vehicle for harmonization at WIPO is the proposed Substantive Patent Law Treaty (SPLT), which is being negotiated by the WIPO Standing Committee on the Law of Patents. But since it was first proposed in 2001, the SPLT has snagged year after year, partly because its chief promoters, the European Union, Japan and the United States--the "trilateral" countries-- cannot agree, but also because developing countries see little advantage in proceeding with it.
Developing countries fear that the proposed treaty would mean less autonomy in national decision-making with regard to patents, loss of TRIPS flexibilities, and higher prices for medicines.
"Quite clearly, it is not in the interests of developing countries to seek either a 'light' SPLT or a more comprehensive SPLT, since they have little to gain from a broader harmonization of substantive patent law," said Professor Carlos Correa, Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law at the University of Buenos Aires.
Correa and Sisule Musungu, Acting Coordinator of the Programme on Innovation, Access to Knowledge and Intellectual Property at the Geneva-based South Centre, argue that harmonization will lead to a situation where the United States' definition of patent law is imposed on all countries. They have called for an assessment--governmental or independent--of the impact patent harmonization would have on developing countries.
Trilateral industry groups, meanwhile, are stepping up the pressure on WIPO to make progress towards harmonization. …