Question : Patented Medicines

(a) the names of patented medicines for which mandatory licence has been issued by the Government in the country so far;

(b) whether the Government proposes to issue mandatory licence to certain other patented medicines also and if so, the details thereof;

(c) whether the Government has received any proposals in this regard; and

(d) if so, the details thereof and the action taken/proposed to be taken by the Government in this regard?

Answer given by the minister

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THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE & INDUSTRY
(SHRI C.R. CHAUDHARY)

(a): While the term ‘Mandatory Licence’ is not used under the Patents Act, 1970, compulsory licences are granted as per the provisions of the Act. To 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 the said patent is “Sorafenib tosylate” and sold under the brand name “NEXAVAR”, which is used for the treatment of kidney and liver cancer.

(b) to (d): 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.
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