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Patent case crucial for pharma industry

New Delhi, Aug 20 () : Coming Wednesday the Supreme Court hearing which has a far-reaching impact on the generic drug makers will start on the Swiss drug maker Novartis AG vs India’s patent office.

Patent office refused to grant a patent on the Novartis cancer drug Glivec since it is not a new medicine but an amended version of a known compound.

Since 2006, to get a patent on an amended form of Glivec, Novartis has been fighting, which oncologists view as a major advance in treating chronic myeloid leukaemia and some gastrointestinal cancers.

Patent office rejected Novartis claim because an older version of Glivec was granted a patent in 1993 in some markets, though not in India since drug patents were not applicable at the time.

The case matters to Swiss company Novartis because India is an important emerging market. The Swiss company says it needs certainty if it is to invest in the country in the long-term and wanting very clear legal clarity about what kind of innovation is patentable.

India’s patent law does not give patents on a newer form of a known drug unless it offers a significant development in efficacy. The aim is to prevent adding new patents by just tweaking a product to extend exclusivity. Novartis argues this initial patent was for a version of the drug that needed a major re-design to make it effective and so does not apply to Glivec.

Emerging countries like Brazil and China which are competition to India as supplier of cheap drugs to developing countries will be watching closely. “ The judgment will have a far-reaching impact,” said Deepak Malik, analyst at brokerage Emkay.

Western drugmakers, who are targeting their expanding middle classes of emerging market economies are increasingly wary about ceding too much market power at a time when U.S. and European sales are flagging. China changed its patent laws, although the measure has not yet been used to enable companies to produce generic versions of patented drugs in certain circumstances.

If patents are easily available in India, there will be less reason to produce different varieties of generics. India would like to see a more qualitative system that only awards patents for truly new inventions but Novartis wants patent quantity.