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Pharma waits for Glivec patent verdict in India

Intellectual property decision could have far-reaching consequences for industry

NovartisThe international pharma industry is anxiously awaiting the verdict on a long-running patent lawsuit in India - due on April 1 - that could have far-reaching consequences on intellectual property rights (IPR). 

On Monday India's Supreme Court is due to make the final ruling on whether Novartis' patents on cancer drug Glivec (imatinib) are valid, marking the culmination of a case dating back to 2005. 

The ruling has been delayed a number of times already, but observers suggest the case is now finally coming to a close.

Novartis is challenging a clause in India's patent law known as Section 3(d), which does not allow a new form of a drug - for example, a new crystal structure - to be patented unless it confers a "therapeutic advantage" over the original substance. 

Novartis maintains 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.

India's Intellectual Property Appellate Board (IPAB) sees it differently, however, and concluded in 2007 that imatinib mesylate was a new form of a known substance and did not provide any significant advance over the older form.

With many pharma companies suggesting that growth in emerging markets such as India is key to future financial performance, the outcome of the Glivec case has broad implications across the industry.

To date, the track record for big pharma has not been great in India. In the last six months or so there have been court room defeats for Roche with its Pegasys (peginterferon alfa-2a) hepatitis drug, Merck & Co's asthma treatment Singulair (montelukast), Gilead Sciences HIV drug Viread () and Pfizer's cancer drug Sutent (sunitinib).

Meanwhile, other patented medicines have been subject to compulsory licensing in India on the principle of public health need. The most advanced case in the latter category - concerning Bayer's cancer drug Nexavar (sorafenib tosylate) - did not go the company's way.

28th March 2013

From: Sales, Regulatory

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