India’s first compulsory license granted to Natco for Nexavar

India’s first compulsory license has been granted to Natco for Bayer’s drug Nexavar. Nexavar, Sorafenib Tosylate, was launched in 2005 for the treatment of Kidney Cancer which, later, in 2007, also received approval for the treatment of Liver cancer. Nexavar, although is not a life saving drug, has shown to extend life of a patient for around 4-5 years in kidney cancer and around 6-8 months in liver cancer.

Natco’s compulsory license is with respect to Bayer’s patent on Sorafenib Tosylate, IN 215758, which was granted in 2008. Bayer had received the approval for importing and marketing the drug in India in 2008. Bayer has always been marketing the drug in India by importing the drug. Natco received DCGI license to market the drug in India, in April 2011. Subsequent to Natco receiving DCGI license, Natco had approached Bayer to seek a voluntary license for manufacturing and marketing the drug in India. Natco’s request for voluntary license never materialized, following which Natco filed for a compulsory license in July 2011.

The compulsory license was granted by the patent office upon being convinced that the reasonable requirement of public was not met, the drug was not available to public at reasonably affordable prices, and that the patentee failed to work the invention within the territory of India.

Natco’s compulsory license would make the drug available to public at a much reduced price. The drug which costs patients around Rs. 2.8 Lakhs/ month, through Bayer, would now be available to public at just around Rs. 8800/month.

Source: Spice IP Blog