The end of Indian generics?
On its face, the Indian Supreme Court hearing regarding Novartis’ failed patent application for one of its drugs, Gleevec, would seem to only excite interest among the truly hardcore, pedantic patent law observers. Previously, the Madras High Court and Indian patent Appellate Board upheld an earlier ruling by India’s Patent Office that held that under Section 3(d) of the Indian Patent Act, the beta-crystalline formulation of Gleevec, allowing for greater absorption within the body, was not novel enough to be patented. What makes this case different from your common patent validity case is that it has the possibility to upend India as the global provider of cheap, life saving generic drugs. Many see the hearing as a high-stakes showdown between defenders of intellectual property rights, who say the generic knockoffs stifle innovation by drug makers, and Indian drug companies and international aid groups, who warn that a ruling in favor of Novartis could dry up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases.
The drug in question, Gleevec (generically as imantib mesylate) was designed to treat chronic myeloid leukemia and other forms of cancer, such as gastrointestinal cancer. A patent for the drug was denied to Novartis in 2006 under Section 3(d). Section 3(d) is set in place to specifically prohibit the practice of “evergreening.” Evergreening is the act of securing patent protection on minor variations of previously patented matter. Novartis contends this is not a case of evergreening because the initial compound was never marketed or intended for market. According to Novartis, when a drug company discovers a compound that fits some specifications in a test tube or animal study, they patent it to protect themselves from imitators. However, that initial compound is often not suitable for use as a drug. Therefore, modifications are made until a suitable form is found, which is then patented.
Unfortunately for Novartis and other major drug companies, India’s government had stopped granting drug patents since 1970 and only recently began to do so as part of World Trade Organization agreement on patents in 2005. Medicines created before 1995, however, do not qualify. India has developed quite a lucrative generic drug market, exporting $10 billion worth of medicines every year. As such, the generic firms are a powerful lobby in the country and a leading industry which politicians want to nurture. Further, non-profits, such as Medecins Sans Frontieres, believe poorer countries rely on India’s generic firms to produce low-cost medicines, and without them, the health of millions could suffer. Their sentiment is understandable, considering the price of Gleevec (in the US) can cost $70,000 a year, while Indian generic versions cost about $2,500. It’s important to note that a victory for Novartis would not shut off the production of any existing generics, but it could impede the ability of Indian manufacturers to develop generic versions of future drugs. Furthermore, Novartis contends that there are other legal ways for generic and subsidized brand-name drugs to reach the poor.
In addition to settling the patent validity dispute, the decision will also hopefully bring clarity to the true scope of Section 3(d), which could have major implications beyond the biopharma world. India’s patent law does not define “efficacy” or say how it should be measured. If the decision goes in Novartis’ favor, the term would encompass modifications that might make a drug safer and easier to use, not just more effective in treating a disease. Such clarity would provide pharmaceutical companies, which spend many years and capital in producing a drug, a better idea on how to pursue patents in the future.