Fate of Generic Drugs in India Awaits High Court Ruling

According to a recent Washington Times article, the fate of India’s $26 billion generic drug industry is awaiting a ruling by India’s Supreme Court early this year. India, which produces much of the world’s generic cancer, malaria, tuberculosis and AIDS drugs that are provided to poor countries, has been accused of ignoring intellectual property and causing Western drug companies to reconsider investing money in drug development.

The pending Supreme Court opinion centers around the Novartis drug Glivec, a cancer fighting drug. Novartis attempted to patent a new form of the drug, giving it another 20 years of patent protection. Patient advocacy groups argue that the drug has not been substantially altered and that Novartis is “evergreening” in order to block generic access to the drug. Novartis has released the following statement about the pending decision:

The Glivec case is about gaining clarity on the application of patent law in India, which is important to the economic future of the country. Novartis challenged the decision not to grant a patent to our life-saving medicine Glivec because we strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients. We also believe that working through the judicial system is a legitimate approach to gaining clarity on the unique aspects of India’s patent law. Novartis actively supports innovative approaches to increase access to medicines, such as public-private partnerships, tiered pricing arrangements and shared contribution models in addition to donation programs. More than 95% of all Glivec patients in India receive their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP).

Doctors Without Borders, a secular humanitarian aid organization issued an open letter to Novartis and its CEO regarding the litigation, which states, in part:

India’s patent law has prevented market monopolies of Novartis’s cancer drug Gleevec and many other essential drugs, including those used to treat HIV. This has allowed generic competition to drive prices down and increase access to those that cannot afford the prices of patented medicines. In India, Gleevec costs over CHF 2,100 a month [about $2,180]; the generic costs CHF 170 [about $176]….. If you are successful, you will set a legal precedent and weaken the Indian patent law of much of its meaning. Because your actions will affect the supply of medicines—both in India and beyond, as Indian generics supply 80 percent of the HIV/AIDS medicines used in the developing world, to take just one example—we urge you to reconsider.

The implications of the court’s ruling have global implications on world health and drug development.  Stay tuned for further news as it develops.