MUMBAI, India — India’s government on Monday authorized a drug manufacturer to make and sell a generic copy of a patented Bayer cancer drug, saying that Bayer charged a price that was unaffordable to most of the nation.
The decision by the controller general of patents, designs and trademarks was the first time a so-called compulsory license of a patented drug had been granted in India.
Legal specialists and patient advocates said it could open the door to a flood of other compulsory licenses in India and possibly in other developing countries, creating a new supply of cheap generic drugs.
According to the decision, Bayer must license the drug Nexavar, or sorafenib, to Natco Pharma, an Indian company. In exchange, Natco must pay Bayer a 6 percent royalty on its net sales and must sell the drug for 8,800 rupees ($176) a month, about 3 percent of the 280,000 rupees ($5,600) that Bayer charges for it in India. Natco’s drug will be for use only in India, the decision said.
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