Wednesday, September 5, 2012

Indian Supreme Court: Glivec® Patent Case

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

A landmark case will soon be decided in the Indian Supreme Court between the Swiss drugmaker Novartis and the Indian patent office. The case is set to begin on September 11, 2012 regarding whether Novartis should be awarded a patent for the cancer drug Glivec®. Glivec® is prescribed to treat chronic myeloid leukemia and many gastrointestinal cancers. The case rests on whether or not Glivec® should be considered an innovative therapy worthy of patent protection.

The case spans from 2006 when Novartis attempted to gain patent protection for Glivec® but was denied by the Indian courts due to Novartis’ receipt of a patent in 1993, for an earlier Glivec® formulation, that has since expired. Novartis claims that the new Glivec® is innovative and deserves patent protection for that reason. However, section 3(d) of the Indian Patent law has restrictions on approving multiple patents for a single drug. The Indian government does not consider the new formulation of Glivec® to be innovative. The Indian government includes this clause in the patent law to prevent companies from “evergreening” a therapy. This would allow companies to continuously patent formulations, claiming innovative modifications, essentially preserving patent protection.

The outcomes of this case will determine whether the Indian government puts patient health before profits. With the increase in healthcare costs rising globally, the need for more affordable therapies is an issue for governments around the world. This is especially true in emerging markets such as India and China where much is being done to increase the overall health and wellbeing of the general population. The outcome of this case will influence the level at which the Indian government can and will provide healthcare for its citizens.

How do you think the Indian Supreme Court should rule on this issue? Do you think Novartis should gain FDA approval for Glivec® based on its innovative new formulation for Glivec®?

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