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Bayer's Nexevar hit by landmark Indian patent ruling

Natco’s generic version of the pharma company's cancer drug is made available in first case of compulsory licensin

A generic version of Bayer's cancer drug Nexevar (sorefinib) has been licensed in India under a new ruling that effectively overturns the drug's patent.

In the first case of 'compulsory licensing' for a pharmaceutical product in the country, India's patent office has allowed Natco Pharma to sell its version of the drug after ruling that Bayer had not made Nexevar available to the public at a "reasonable affordable price".

The patent office describes a compulsory licence as an "involuntary contract between a willing buyer and an unwilling seller imposed and enforced by the State".

Bayer's drug, which is used in the treatment of both liver and kidney cancer, costs about 280,428 Indian rupees ($5,600) a month per patient in India.

Natco Pharma has proposed to sell its version at a fraction of the cost – about 8,800 Indian rupees ($176) per patient per month and under the terms of the licence Bayer will be entitled to 6 per cent of Natco's net sales.

Hyderabad-based Natco will also have to supply the drug free of cost to 600 "needy and deserving patients" per year.

A Bayer spokesman told PMLiVE: "We are disappointed by the decision of the Patent Controller in India to grant a compulsory license for Nexavar. We will evaluate our options to further defend our intellectual property rights in India."

The news will also be of concern for other pharma companies operating in the region, including Novartis, which has an ongoing case in the Indian Supreme Court to obtain a patent for its cancer treatment Glivec.

However, Médecins Sans Frontières (MSF), the charity that aims to provide medical aid in developing countries, praised the 'game-changing' decision.

"This news is significant because of the precedent it sets," MSF said. "It means that new medicines in India that are now under patent - including some of the newest HIV medicines - could potentially have generic versions produced for a fraction of the cost, making them more affordable, and widening access to those who need it most."

Natco also welcomed the decision, stating it “opens up a new avenue of availability of life savings drugs at an affordable price to the suffering masses in India”.

Further information about India's complex patent system can be found in PMGroup's Country Report: India.

13th March 2012

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