India Allows Compulsory Licensing Of Bayer's Anti-Cancer Drug Sorafenib To NATCO Pharma

India Allows Compulsory Licensing Of Bayer’s Anti-Cancer Drug Sorafenib To NATCO Pharma

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Recently, expert opinion of Advocate Rahul Dev, Bioscience Business Lawyer & Patent Attorney, was published in cover story of BioSpectrum India.

The globally watched case related to an Indian pharma company’s request to the country’s patent office for a compulsory license to make a generic version of Bayer’s patented drug to treat liver and kidney cancer has been settled on March 13, 2012. In a first-of-its-kind ruling in one of the world’s fastest growing pharma makets, the Indian Patent Office has granted permission to pharma company NATCO to make anti-cancer drug sorafenib for the India market.

The Indian Patent Office’s ruling is subject to certain conditions, such as maintaining account of sales, and payment of royalty at six percent of the net sales on a quarterly basis to Bayer. The order also makes it obligatory for NATCO to supply the drug free-of-cost to at least 600 needy and deserving patients per year. Immediate beneficiaries will be the 29,000 patients suffering from liver and kidney cancer who could not afford treatment with Nexavar, which was patented by Bayer in India in 2008. Bayer sold the drug for approximately $5,714 for a month’s dosage of 120 tablets. The average annual income of an Indian is approximately $6,000. Under the compulsory license, NATCO will make a generic version of the drug in India and has been directed to sell it at $180 for a month’s dosage, a cost which is 32 times less than that of the original drug. Hailing this order, NATCO opined that this opens up a new avenue of availability of life-saving drugs at an affordable price to the suffering masses in India.

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Send Advocate Rahul Dev an email at rahul [dot] d [at] techcorplegal [dot] com.

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