India’s progressive patent laws have long enabled it to serve as the pharmacy of the developing world, supplying about 80 percent of the drugs used to treat AIDS in the Global South. These laws have also long been the target of pharmaceutical companies that would like to crowd out the relatively inexpensive Indian generics sold worldwide. A case currently before India’s Supreme Court may determine the future of the generic drug industry in India and, by extension, the ability of large segments of the world’s poor to access life-saving medicines.
The case, Novartis AG v. Union of India & others, is the most recent attempt by Swiss pharmaceutical giant Novartis International AG to gain a patent for its anti-leukemia drug, Glivec. India rejected the multinational’s patent application in 2006 because the drug was not found to show increased efficacy from earlier versions, a requirement under section 3(d) of India’s patent law.
Novartis has since taken two tracks to try to gain a patent: After losing a challenge to the constitutionality of section 3(d), the company appealed the original patent decision all the way to the Supreme Court, where it is contending that the interpretation of 3(d) is too strict. Hearings were set to begin September 6, but were postponed after a judge found to have attended conferences co-sponsored by Novartis recused himself from the case.
Why all the fuss over one clause? “Evergreening” – the process of patenting minor changes to existing drugs that is effectively prohibited by 3(d) – is one way that pharmaceutical companies retain patent monopolies, preserving higher drug prices. Generics of Glivec are currently available in India at less than one-tenth of the brand name cost. Although Novartis cites its research and development costs as a rationale for this higher price, the company was eligible for U.S. tax rebates equal to half the cost of its clinical trials.
Novartis’ legal challenge would not have been possible without a global patent régime that has compelled poor countries to adopt the same standards used by rich ones. From 1970 until 2005, Indian law prohibited patents on medicine entirely. This changed when, following the completion of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, India and other developing countries were required to amend their laws and grant patents that provided at least 20 years of exclusive rights to sell products.
One of the few countries to retain protections for public health in its new laws, India has since come under sustained pressure over its intellectual property laws. The country has appeared repeatedly on the Office of the U.S. Trade Representative’s “special priority watch list” of countries with inadequate intellectual property protection, and a 2008 cable from the U.S. embassy in New Delhi released by WikiLeaks reveals that the United States has lobbied Indian policymakers over 3(d).
But looser patent regulations in India have been key to expanding treatment across the developing world. When the Indian firm Cipla began to sell triple-combination therapy for AIDS in 2001, the annual cost of treating a patient fell from more than $10,000 to $1,200.Medical access campaigners believe that if Novartis waters down section 3(d) to gain its patent, prices on many types of medicine will once again soar.
Under public criticism for its case, Novartis has argued that its interest is in clarifying intellectual property rights in India, not driving out generic competitors. But Leena Menghaney of the humanitarian group, Médicins Sans Frontières, told In These Times that a win by Novartis would “disrupt supply in a big way” for MSF by creating confusion among generic producers about what they may legally manufacture and exposing them to costly lawsuits from multinationals.
While acknowledging that generics alone are not the solution, Menghaney, India representative of MSF’s Campaign for Access to Essential Medicines, insists that they are a crucial aspect of campaigns for universal healthcare in India and around the world. In order to pressure governments to assume the costs of treatment, “one of the things we need is the ability to show that the drugs that are available are affordable,” says Menghaney. “If we are to ensure universal access, and we are to move forward on that in the coming decade, we definitely need affordable drugs to be produced in this country.”