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India Grants Compulsory Pharma License

Issued: March 01 2012

Innovator pharmaceutical corporations have recently faced a tough time enforcing their patent rights in India. The past couple of years have seen the power of low pricing by generics manufacturers as a major threat to the pharma patents monopoly system, reports Rahul Chaudhry, a partner at Lall Lahiri & Salhotra in Gurgaon. To add to their fears, the recent first-ever grant of a compulsory license in India has shaken the pharma industry.

“Remarkably, there is no precedent to guide the tribunal, and the order is first ever of its kind in India,” Chaudhry says.

Natco filed an application seeking a compulsory license under Section 84 of the Indian Patents Act, from Bayer for the drug Sorafenib tosylate, which is useful in advanced stages of liver and kidney cancer. Section 84 states that at any time after the expiration of three years from the date of the grant of a patent, any person may make an application to the Controller for grant of compulsory license on the grounds that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or that the patented invention is not available to the public at a reasonably affordable price, or that the patented invention is not worked in India.

It is worth noting that Sorafenib is not a life-saving drug but a life-extending drug. Prior to filing the compulsory license application, the Applicant had already made effort to obtain from Bayer a license for making and selling the drug, which was refused by Bayer as Applicant did not propose any terms and conditions in their request.


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