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India’s Nexavar patent ruling disturbs pharma

Published on 12/03/12 at 12:00am

India is to allow Bayer’s cancer treatment Nexavar to be subject to a compulsory licence, allowing a generic firm to copy the drug even though it is still patent-protected.

The ruling by the Indian Patent Office is the first ever, and has been greeted with horror by the pharma industry.

Compulsory licensing is designed to allow poorer countries to break patents on drugs when they face a public health emergency.

Natco says the Indian Patents Act allows a compulsory licence after three years of the grant of patent on drugs that are not available at affordable prices.

 Medecins Sans Frontieres (MSF) campaigns for access to drugs in poor countries, and welcomed the move, which it said would bring the price of the drug in India down from over $5,500 a month to close to $175.

"This decision serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence," said Michelle Childs, director of policy at the Geneva-based charity.

MSF believes the move means that new medicines in India that are still under patent, including some of the latest treatments for HIV/AIDS, could potentially have generic versions produced for a fraction of the cost.

The ruling will undermine pharma’s confidence in the Indian market. As one of the world’s biggest emerging markets for pharmaceuticals, India represents the future growth of the industry, but such decisions could undermine growth prospects.

Natco is now permitted to make and sell a low-cost version of Nexavar in India at a price fixed by the Controller General of Patents, Designs and Trademarks.  The generics company will also pay Bayer a small royalty on its sales.

Bayer said in a statement it was evaluating its legal options.

Natco's finance chief Baskara Narayana told Reuters that sales of the generic version of Nexavar, whose generic name is sorafenib, were expected to be about 250 million to 300 million rupees every year once it is launched.

Cipla is already defying the Indian patent system, having launched its own version of Nexavar in May 2010.

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