* Case study – Ist compulsory license issued by India
* Terms under which Compulsory License is Issued
Compulsory licensing is when a government allows someone else to produce the patented product without the consent of the patent owner. The patent owner still enjoys the rights over patent .He is paid by the Licensee some amount as a royalty for his patent. The TRIPS Agreement list a number of conditions for issuing compulsory licenses. 1. Normally the person or company applying for a license has to have tried to negotiate a voluntary license with the patent holder on reasonable commercial terms. If that fails compulsory license can be issued. 2. When a compulsory license has been issued, the patent owner has to receive payment.
At nearly Rs 3 lakh for a month's treatment, Bayer is pricing out almost everybody in a country like India. Patents represent the rights and efforts of the patent holder in innovating new products. But, it also states that the innovative product should be available to larger number of people at reasonable and affordable rates. Thus comes the concept of Compulsory license. It regulates balance and breaks the monopoly of patent holder where the access is denied to large number of needy population.
First Compulsory Licence issued in India – 9th March 2010
Indian Patent Office issued compulsory licence to Natco for Bayer's anti-cancer drug Sorafenib This simply means, Bayer’s pharma manufacture the Drug Sorafenib tosylate under the name Nexavar, costing Rs.2.8 lakh, will now be available at Rs 8,800 per month. The 97% reduction in cost of drug is due to issue of Compulsory Licence to Natco Pharma.
Drug Sorefenib is carboxy substituted Diphenyl Ureas.This drug is used in advanced stages of liver and kidney cancer. The patentee Bayer developed the drug and named it as Nexavar for...