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. 342343) 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. Phil Thorpe, Deputy Director of the United Kingdom Patent Office, warned that developing countries may lose influence in the debate if that debate moves outside WIPO, as some have suggested it should.
The trilateral proposal calls for discussions on four issues: the uses of a given innovation prior to patent application; possible patent protection when details about an invention have been disclosed before approval; how a product or an idea adds something new; and whether an innovation represents a step forward.
In addition, key developing countries have sought to include in these discussions talks on genetic resources, especially a requirement that the origin of the resources be disclosed in patent applications, and on protection of traditional knowledge (see story below).
The impact of the proposed treaty on patent harmonization will depend on how it defines what may or may not be patented, or patentability, according to Professor Brook K. Baker of the Northeastern University School of Law. Baker said that developed countries with strong innovative pharmaceutical industries have increased the scope of what can be patented, broadening the definition of, for example, what is new. This has led to a "growing insistence on patents for new uses, new formulations, new combinations, and for minor, therapeutically de minimus changes in chemical structures," he said, referring to minimal changes that some argue should not be covered by separate patents at all.
Baker said that new chemical entities represented the only area where harmonization of patentability could have a positive impact on access to medicines, but that the standards of patentability currently under discussion in treaty negotiations "would have a negative impact on public health, because they would expand the scope and extend the time period of patent protections on pharmaceutical products". He added: "The predictable consequence is that prices will be higher and access lessened."
The March 2006 objection to the Indian patent filing was that there was nothing new in GlaxoSmithKline's fixed-dose combination of two existing HIV/AIDS drugs, zidovudine/lamivudine or AZT/3TC (Combivir), for which it was seeking a patent. Their argument: that the combination of two existing drugs of which there are generic versions is not an invention.
Ellen 't Hoen, Director of Policy and Advocacy at Médecins Sans Frontières, drew a link between the Indian case and the proposed treaty, as it shows the diversity in what may or may not be patented today. "If WIPO gets its way with harmonization there will be no diversity, meaning that a mistake in one patent office will not be corrected in another."
She gave the example of the way strict patentability requirements in Indian law allowed the Indian Patent Office to reject a patent application from Novartis for the anti-cancer drug Gleevec earlier this year, even though that patent had been granted in other countries. Following, opposition to the patent from a cancer patient association and generic companies, the Indian Patent Office rejected the application on the grounds that a new form of a known substance is not an invention.
But Louise Dunn, a spokesperson at GlaxoSmithKline, argued that the situation in India is evidence that patents are not a root cause for the lack of access to medicines.
"The root cause of developing countries' inability to address their health-care problems does not lie with the patenting system but with a lack of funding, a lack of political will, and inadequate health-care infrastructure," Dunn said, citing a common industry argument for inadequate access to medicines in developing countries.
The proposed treaty and its potential impact on public health remain highly controversial. A WIPO open forum on the proposed treaty in March 2006 showed that differences go deep and passions run high. Industry assertions similar to Dunn's were vigorously opposed at the forum, a meeting intended to feed the WIPO negotiating process.
Eric Noehrenberg, Director of International Trade and Market Policy at the International Federation of Pharmaceutical Manufacturers & Associations, told the WIPO forum that research and development-based industry is developing the best treatments for neglected diseases, that patents are not blocking access to essential medicines in poor countries, that compulsory licences are harmful to countries, and that the debate over flexibilities in international agreements is an "industrial policy" debate not a health policy debate. He said industry had endeavoured to provide much-needed medicines to poor countries, but has been blocked by the governments of those countries.
William Haddad, US generics industry leader and Chief Executive Officer of Biogenerics, called Noehrenberg's remarks "false and misleading".
"These are real crises, not patent pricing arguments," Haddad, a former US congressional aide, said: "We need real arguments".
1 William New is Editor-in-Chief of Intellectual Property Watch, a Geneva-based newsletter.