India’s patent appeals office has rejected Bayer AG’s plea to stop the production of a cheaper generic version of a patented cancer drug in a ruling that health groups say is an important precedent for getting inexpensive lifesaving medicines to the poor.
Last year, India’s patent office allowed local drug manufacturer Natco Pharma Ltd to produce a generic version of Bayer’s kidney and liver cancer drug Nexavar on the grounds it would make the drug available to the public at a reasonably affordable price. It was the first use of compulsory licensing under Indian patent laws passed in 2005.
The Intellectual Property Appellate Board rejected the German drug maker’s appeal of last year’s ruling on Monday.
Bayer sells a one-month supply of the drug for about US$5,600. Natco’s version would cost Indian patients US$175 a month, less than one-thirtieth as much.
The patent appeals office also ruled that under the license, Natco must pay 7 percent in royalties on net sales to Bayer.
There was no immediate reaction to the decision from Bayer.
Western pharmaceutical companies have been pushing for stronger patent protections in India to regulate the country’s US$26 billion generics industry they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.
Health groups welcomed the decision, saying it would check the abuse of patents and open up access to affordable versions of patented medicines.
“The decision means that the way has been paved for compulsory licenses to be issued on other drugs, now patented in India and priced out of affordable reach, to be produced by generic companies and sold at a fraction of the price,” said Leena Menghaney of medical humanitarian aid organization Medecins Sans Frontieres.
Under WTO rules, governments have the right to issue compulsory licenses to overcome barriers to access to cheaper versions of a patented drug without the consent of the company that invented the drug. Several Western pharmaceutical giants say India’s 2005 Patent Act fails to guarantee the rights of investors who finance drug research and development.
Swiss drug maker Novartis AG is awaiting a decision by India’s Supreme Court on the rejection of patents for its cancer drug Gleevec. That case revolves around a different legal provision allowing India to block “evergreening” — extensions of patents based on minor changes to existing treatments. The Supreme Court’s ruling on the case is expected soon.