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Novartis says Indian Glivec verdict "discourages innovation"

Country's Supreme Court denies the cancer drug patent protection

Novartis has reacted angrily to its defeat in India's Supreme Court over patent protection for its cancer drug Glivec, saying the verdict "discourages future innovation in India".

The patent was denied yesterday "despite global recognition of Glivec as a life-saving, breakthrough drug", said the Swiss pharma company, which pointed out that Glivec has been awarded patents in a number of emerging markets, including China, Russia and Taiwan.

Novartis also claimed that Glivec (imatinib mesylate) is being provided free of charge to 95 per cent of Indian patients, with the remaining 5 per cent either reimbursed for treatment, insured or in a "very generous" co-pay programme.

Critics argue that Novartis is not factoring in patients in India already being treated with low-cost generics, which sell for less than $200 per month while Glivec costs around $2,600.

"This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," said Ranjit Shahani, managing director of Novartis India, which has been fighting to get a patent in India for seven years.

Novartis was trying to argue in the case that the crystalline structure of the mesylate salt of imatinib which is used in Glivec was a critical development for the product, improving its bioavailability and allowing it to be delivered effectively and safely in an oral dosage form. However, it was denied a patent in 2007 on the grounds that the salt was a new form of a known substance.

The latest lawsuit tried to overturn the element of Indian patent law - section 3(d) - that underpinned the 2007 patent verdict, arguing that it did not meet World Trade Organization (WTO) rules. 

"We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs," said Shahani.

One consequence of the results is likely that India will become even less of an investment region for big pharma, which in any event seem to be more interested in building capacity in China and other Asian countries of late given India's approach to intellectual property protection.

In the last six months or so there have been patent defeats for Roche with its Pegasys (peginterferon alfa-2a) hepatitis drug, Merck & Co's asthma treatment Singulair (montelukast), Gilead Sciences HIV drug Viread (tenofovir) and Pfizer's cancer drug Sutent (sunitinib) in India, as well as a compulsory license for Bayer's cancer drug Nexavar (sorafenib tosylate).

The Novartis verdict was hailed by medical charities and healthcare activist groups, with Médecins Sans Frontières (MSF) calling it a "major victory for patients' access to affordable medicines in developing countries".

“Instead of seeking to abuse the patent system by bending the rules and claiming ever longer patent protection on older medicines, the pharmaceutical industry should focus on real innovation,” commented MSF president Dr Unni Karunakara.

"Governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access," he added. "This is a dialogue that needs to happen."

2nd April 2013

From: Sales, Regulatory

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