SC rejects Bayer's appeal against compulsory licence for Nexavar

Indian pharma company, NATCO, can continue manufacturing generic version of liver and kidney cancer drug

By Jyotsna Singh
Published: Monday 15 December 2014

imageThe Supreme Court on Friday rejected Bayer Corporations' special leave petition against the compulsory licence granted for producing the generic version of its anti-cancer drug Nexavar. This allows NATCO Pharma Ltd of Hyderabad to continue with the manufacture and sale of sorafenib, generic name of the drug for treating liver and kidney cancers. Bayer had filed the appeal against Bombay High Court's decision, upholding NATCO’s compulsory licence to produce cheaper version of drug Nexavar.

The SC order was being watched in the pharmaceutical industry as it would have implications for many other patented drugs. Patented drugs are sold at high prices, which the poor can little afford. Some of them include drugs for various cancers and communicable diseases like hepatitis C. 

The apex court order means that NATCO can continue to produce sorafenib, even though Bayer holds its patent. NATCO will have to pay a royalty on the net sales every quarter to Bayer. Compulsory license is a provision in Trade Related Intellectual Property Rights agreement under which government can allow a company to produce drugs used by wider public which are patented by some other company. The innovator company gets royalty from the other company as decided by the government. 

Responding to an email query, Bayer's spokesperson, Eva Bretschneider, said: “We are disappointed with the decision of the Supreme Court. We are analysing the order and will determine any future course of action afterwards.”

NATCO was the first company to have received compulsory licence for the anticancer drug in 2012. Before approaching the Bombay High Court, Bayer went to the Intellectual Property Appellate Board in 2012, which rejected its appeal. 


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