Compulsory licences are granted according to the provisions of the Patents Act, 1970 and the term ‘Mandatory Licence’ is not used under the Act. Till date, one Compulsory Licence has been granted by the Controller of Patents under Section 84 of the Patents Act 1970 to M/s. NATCO Pharma, Hyderabad on 9-3-2012 for Indian Patent No. 215758 (Carboxyaryl substituted diphenyl ureas) which was granted to M/s. Bayer Corporation on 03-03-2008.

The drug covered under this patent is “Sorafenibtosylate” and sold under the brand name “NEXAVAR”, isused for the treatment of kidney and liver cancer.

Compulsory Licences are issued as per the provisions in the Patents Act, 1970. There is no specific proposal pending at present before the Government for the grant of a compulsory licence.

This information was given by the Minister of State of Commerce and Industry, C. R. Chaudhary, in a written reply in the Lok Sabha today.

Compulsory licence under patent law can be granted for patented medicines, with one licence previously issued. Compulsory licences are regulated by the Patents Act, 1970 and the term 'Mandatory Licence' is not used. One compulsory licence was granted by the Controller of Patents to M/s. NATCO Pharma in respect of a pharmaceutical originator's patent for a cancer treatment drug, and compulsory licences are issued only in accordance with the Act's provisions; no specific proposal for a further compulsory licence was pending at the time of the official statement.