As the press agency Reuters announced today, the Indian Patent Office yesterday effectively ended German drugmacker Bayer’s monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.


It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds.

„This could well be the first of many compulsory rulings here,“ said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers‘ Association. „Global pharmaceutical manufacturers are likely to be worried as a result … given that the wording in India’s Patent Act that had been amended from ‚reasonably priced‘ to ‚reasonably affordable priced‘ has come into play now.“

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

India has one of the world’s fastest-growing rates of HIV and heart disease is another big killer, but widespread poverty in Asia’s third-largest economy makes many non-generic drugs unaffordable for millions. Bayer’s Nexavar cancer drug costs around $5,500 a month in India, making it „not available to the public at a reasonably affordable price“, the patent office ruled.

Natco’s finance chief, Baskara Narayana, told Reuters that sales of the generic version of Nexavar, whose chemical name is sorafenib, were expected to be about 250 million to 300 million rupees ($5-6 million) a year once it is launched.

Bayer, which developed Nexavar with U.S. biotech firm Onyx Pharmaceuticals, said it was evaluating its options. „We are disappointed by the decision of the Patent Controller in India to grant a compulsory license for Nexavar,“ Bayer said in a statement. Tapan Ray, director general of the Organization of Pharmaceutical Producers of India, an industry group of multi-national drugmakers, said the Bayer ruling was disappointing. „The solution to helping patients with innovative medicines does not lie in breaking patents or denying patent rights to the innovators.“

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