So far, one Compulsory License has been granted by the Controller General of Patents, Designs and Trade Marks for the anti-cancer drug containing the compound ‘Sorafenib Tosylate’ which is used for treatment of kidney and liver cancer to a drug manufacturing company, namely M/s Natco Pharma Ltd. The grant is under section 84 of the Patent Act, 1970 (as amended). The patent was originally granted to M/s Bayer Corporation, USA by the Indian Patent Office.

Compulsory license provisions are enshrined in the Patents Act and these provisions will be implemented in a situation befitting the issue.

In January, 2013, Ministry of Health & Family Welfare forwarded to this Department, minutes of the meeting of the Committee set up under that Ministry for invoking provisions of Compulsory Licensing of Drugs in India in which it was recommended to put three drugs namely Herceptin, Dasatinib and Lxabepilone under Compulsory Licensing as per the provisions of Section 92 of the Patents Act, 1970. The said recommendations were examined in detail in this Department and the Ministry of Health and Family Welfare was requested to furnish the relevant information. Subsequently patent on Herceptin was not renewed by the patentee and lxabepilone was considered unsafe by the Ministry of Health and Family Welfare. Ministry of Health and Family Welfare was requested to furnish further information on Dasatinib.

This information was given by the Minister of State (Independent Charge) in the Ministry of Commerce & Industry Smt. Nirmala Sitharaman in a written reply in Lok Sabha today.

Compulsory licensing of drugs enables domestic manufacture of patented oncology medicines to address access and supply concerns. A compulsory licence was granted for an anti cancer drug containing Sorafenib Tosylate, permitting domestic manufacture despite a patent held by the original patentee under statutory compulsory licence provisions. Subsequent ministerial recommendations to consider compulsory licences for three other oncology drugs prompted inter ministerial scrutiny: one patent lapsed, one drug was found unsafe by health authorities, and further information was requested for the remaining candidate before any compulsory licensing action.