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Indian Government allow legal generic cancer drug under TRIPS

India’s government for the first time will allow a generic-drug maker to produce and sell cheaper copies of a patented cancer medicine, a decision that pressures brand-name manufacturers to lower prices.Sorafenib - nexavar

Natco Pharma Ltd. (NTCPH) received a so-called compulsory license to make Bayer AG (BAYN)’s Nexavar, which goes by the generic name sorafenib, and will have to sell it at a 97 percent discount to Bayer’s existing product, India’s Controller General of Patents Designs and Trademarks said yesterday in a statement on its website.

Sorefenib (Nexavar)The ruling marks the first time India, the world’s second- most populous nation, has permitted a generic-drug maker to manufacture copies of a medicine that is protected by patents in the country. More patients could potentially gain access to cheaper versions of other patented treatments, such as new HIV drugs, in India, international aid organization Medecins Sans Frontieres said in a statement.

Under a World Trade Organization agreement known as Trade- related aspects of intellectual property rights or TRIPS, member countries can use these compulsory licenses to ensure access to affordable medicines, MSF said. Governments can grant compulsory licenses to allow a company to make a patented product or use a patented process without the consent of the patent owner.

Bayer (BAYRY) is “disappointed” with India’s decision to issue a compulsory license, the company said in an e-mailed statement. “We will evaluate our options to further defend our international property rights in India.

The drug is used for the treatment of advanced stage kidney and liver cancer. Nexavar, which sells for more than 280,000 rupees ($5,605) a month in India, can extend the life of a kidney cancer patient by four to five years, the patent office said.

Under the terms of the license, Natco can charge a maximum of 8,800 rupees for a monthly dose of 120 tablets. The company would have to pay 6 percent of its sales revenue to Bayer as royalty and supply the drug at no cost to at least 600 needy patients each year, the patent office said.

Cipla Ltd. (CIPLA), India’s third-biggest drugmaker, also sells a generic version of the treatment for 28,000 rupees a month and had sales of about 90 million rupees last year, Hitesh Mahida, a Mumbai-based analyst at Fortune Equity Brokers, said in an interview. The drugmaker, which began selling the drug in 2010, is locked in a patent dispute with Bayer in the Delhi High Court.

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Category: CANCER

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