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Novartis Gears Up For Legal Fight On Glivec

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Novartis is gearing up for the final round of legal battle to get patent protection for its cancer drug Glivec in India.

The Supreme Court will start a two-month long hearing on the case from September 11. The Basel, Switzerland based multinational drug major is challenging a few crucial provisions in the Indian Patent Law on patentability criteria. The ongoing legal battle for the last seven years had attracted international attention.

Those who campaign against Novartis say the case is an attempt to threaten the availability of affordable medicines for the world’s poorest patients. Novartis says its attempts are to protect the rights related to innovation made by spending massive money on research and development.

Following the rejection of its patent application for Glivec, Novartis had filed a case in May 2006 challenging the patent office’s decision at the Madras High Court. After an year, the court directed the case to be heard by the Indian Patent Appellate Board (IPAB). In July 2009, the IPAB turned down Novartis' patent claim and ratified the decision of the patent office.

IPAB observed that  the drug cannot be granted patent under Section 3(d) of the Indian Patent Law,  since the drug is not a new invention and is only a minor tweak of an older compound that already has a
patent, and is therefore only an incremental innovation (‘ever greening’ of patents) without significantly enhancing therapeutic efficacy.  Patent experts say Novartis’s arguments to win the case in the apex court are likely to revolve around the interpretation on ‘enhancing therapeutic efficacy’, rather than trying to shot down Section 3 (d) clause of the Indian patent law.

Novartis says Glivec, whose chemical name is imatinib mesylate, is not an ‘evergreen’ drug and had got patent in 40 countries, including China, Russia, Taiwan and all major developed countries.

“We developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine. This process, which took years, was more than just an incremental improvement – it was a breakthrough -- and certainly cannot be interpreted as "evergreening”, says a fact-file on Glivec published by Novartis.

Novartis’ decision to continue the legal battle in Supreme Court is despite a global campaign to drop the case. In February, an international non-governmental organisation coalition, which included Oxfam, Act Up and Health Gap, had urged Novartis to drop the Glivec patent case in India.

“What is at stake goes far beyond the only granting of a patent for this anti-cancer drug. This legal challenge aims in fact at weakening a legitimate and invaluable public health clause of the Indian law, section 3(d), which intends to limit the multiplication of patents on trivial changes to existing medicines, a common practice by multinational pharmaceutical companies”, says Patrick Durisch, health programme coordinator of the ‘Berne Declaration’, which asked Novartis to drop the case.

“With net sales of $4.7 billion in 2011, Novartis can easily survive without a patent for Glivec in India, whilst its designated successor, Tasigna (Nilotinib-a blood cancer drug), was already granted one in India”, he says.

Whether Novartis wins the case in Supreme Court or not, the battle for Glivec patent will remain as one of the longest and most controversial intellectual property debates on medicines in India.