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Novartis Loses Historic India Patent Case On Cancer Drug Glivec: Asian Scientist | 5 April 2013

After a seven year protracted battle, the Supreme Court of India has rejected a patent application by Swiss pharma giant Novartis for an updated version of its blockbuster drug.

AsianScientist (Apr. 5, 2013) – After a seven year protracted battle in various courts, the Supreme Court of India finally rejected a patent application by Swiss pharma giant Novartis earlier this week (April 1) for an updated version of the anti cancer drug Glivec (imatinib mesylate).

This case is seen as one of the highest profile cases in India – keenly watched by the international pharmaceutical industry and health activists alike – with wide ranging implications for not only India but also other developing countries. Glivec is used for treating chronic myeloid leukemia (CML) and some other forms of cancers.

The Indian Supreme Court held that the new version of the drug differed slightly from the older known version but not substantially enough to categorize it as a novel product, and hence denied a patent to Novartis. The controversy revolves around the interpretation of a provision of the Indian Patents Act called Section 3(d), which disallows patenting of new forms of already known molecules. This provision prevents the ‘evergreening’ of patents by interested entities who slightly tweak patented molecules and seek a fresh patent beyond the normal duration of 20 years, thus posing a long-term challenge to the availability of affordable and cheap medicines to patients, especially in developing countries.

Pharma multinationals have been accused by non-profit health groups of earning large profits through patented medicines. While Novartis sells Glivec at Rs.120,000 (US$2,400) per monthly dose, its Indian generic equivalents cost only Rs. 8,000-12,000 (US$160-$240) for a monthly dose.

In 1998, Novartis had applied for a product patent on the beta crystalline form of imatinib mesylate, the original molecule having been discovered in early 1990s and patented by Novartis in the United States and other developed countries in 1993.

In 2006, the Chennai Patent Office rejected Novartis’ new application on grounds of lack of novelty and increased efficacy over the already known substance. Novartis filed an appeal against the rejection of its patent application and also challenged the constitutional validity of Section 3(d) in the Chennai High Court. In 2009, the Intellectual Property Appelate Board rejected Novartis’ appeal against Section 3(d) and Novartis approached the Supreme Court in 2009 which rejected its plea this week.

The Supreme Court judgment is widely seen as a setback for the multinational pharmaceutical lobby which may have been looking forward to protecting its turf by the ‘evergreening’ of existing patents. Quite clearly, its reverberations will be felt in various other cases – many already in various stages of litigation in Indian courts – involving Indian generic manufacturers and competing multinational companies.

On the heels of the Novartis judgment, Merck, Sharp & Dohme (MSD) has taken Mumbai based Glenmark Pharmaceuticals to the Delhi High Court alleging infringement of its patent for its anti diabetes blockbuster drugs, Januvia and Janumet. Glenmark is marketing its Zita and Zita-Met drugs as branded generics which are priced 30 percent cheaper than Merck’s products.