The existing norms on compulsory licensing for pharmaceutical companies are comprehensive and no further guidelines are required, the Department of Industrial Policy and Promotion said on Monday.
DIPP said it would take a decision on such applications on a case-to-case basis under the Indian Patents Act.
Compulsory licensing (CL) is a system provided in the TRIPS agreement of the WTO under which any Government can allow third parties (other than patent holder) to produce and market patented product without the consent of patent owner.
DIPP, the nodal Government department which oversees the patent office in India, in August 2010, prepared a discussion paper examining the option of introducing compulsory licensing under the Indian Patents Act in the pharmaceutical sector.
Most developed countries globally have a provision for invoking compulsory licensing. But in India, no CLs have been issued under the amended Patents Act.
“The framework of the Indian Patents Act and Rules fully meets all these obligations and provides adequate guidance for the issue of compulsory licences. Government has decided that there is no need to issue additional guidelines for the issue of compulsory licences. The circumstances of application of each of the relevant sections will depend upon the facts of each case,” DIPP said.
The department received 38 responses. Ten of these responses were received from stakeholders based in countries outside India including Thailand, South Africa, the US, the UK and Japan.
DIPP also said that the Controller General has been advised to ensure prompt and effective compliance with all the reporting requirements of patentees stipulated in the Patents Act.
The Controller General has also been requested to specifically review the data received from patentees under Section 146 of the Patents Act, it added.