Newspaper article International Herald Tribune

India Issues License for Locally Made Generic Copy of Bayer Cancer Drug

Newspaper article International Herald Tribune

India Issues License for Locally Made Generic Copy of Bayer Cancer Drug

Article excerpt

The government authorized an Indian drug manufacturer to make and sell a generic copy of Nexavar, a patented cancer drug, saying that Bayer charged too much.

The Indian government authorized a drug manufacturer Monday to make and sell a generic copy of a patented Bayer cancer drug, saying that Bayer charged a price that was unaffordable to most Indians.

The decision, by the controller general of patents, designs and trademarks, granted the first compulsory license of a patented drug in India. Legal experts and patient advocates said it could open the door to a flood of other such licenses in India and possibly in other developing countries, ushering in a new supply of low-cost generic pharmaceuticals.

Under 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 a monthly price of 8,800 rupees, or $176, about 3 percent of the 280,000 rupees that Bayer charges in India. Natco's drug is for use only in India, the decision said.

Nexavar, a tablet, is used to treat advanced kidney cancer and liver cancer and has been shown to extend lives by a median of about three months. It was used to treat fewer than 200 Indians in 2011, or about 2 percent of the people afflicted with the kind of cancers that it is meant to treat.

Oliver Renner, a spokesman for Bayer at its headquarters in Germany, said it was disappointed and was evaluating its options under the law "to continue to defend our intellectual property."

Advocates for cheaper generic medicines cheered the decision, which they said could provide a model in developing countries, where most people cannot afford retail prices for many important medicines and do not have access to insurance plans that would pay for them.

"I think it's the way forward," said Shamnad Basheer, a professor at the West Bengal National University of Juridical Sciences who has written extensively about the case. …

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