The Department of Industrial Policy and Promotion (DIPP) has recently asked the Health Ministry to be cautious in regard to the grant of compulsory licences (CL) and to make sure that compulsory licensing should be invoked only in cases where such licensing would clear all kinds of judicial scrutiny.
DIPP is treading cautiously on CLs as it does not want to lose ground in a law suit later. Moreover the move is a likely result of the US criticism over India’s grant of CL to a generic drug company Natco. This came as a reaction when the Health Ministry requested DIPP to issue a compulsory license for Dasatinib, the chronic myeloid leukaemia drug.
This action by DIPP is likely to affect the Ministry’s plan to grant licences to generic companies that wish to manufacture Dasatinib. Further, DIPP has also demanded justifications from the Health Ministry as to how Dasatinib is aright candidate for issuance of CLs to generic companies under government initiative.
The Ministry wishes to pursue the “government route” for the grant of CL as provided under Section 92 of the Patents Act. Apart from the “government route”, a CL can be issued under Section 84 of the Patents Act by pursuing the “private commercial use” route. However, generic drug companies avoid this route as it involves high risk of litigation and rather opt for the “government route” prescribed under Section 92.
Under Section 92, which talks of the government route for CL, the controller can grant any licence based on a central government notification citing circumstances of national emergency or circumstances of extreme urgency or in case of public non-commercial use. It is the route that the DIPP is cautious to take now. Before any such grant, DIPP wishes to ensure that all aspects and material facts are carefully looked into even if it leads to a delay in issuing the CL notification.
The DIPP has sought a clarification from the Health Ministry as to which route between Section 92 and Section 84 is a suitable choice for the generic drug companies to opt for the grant of CL.
In 2012, a CL was granted to Hyderabad-based Natco Pharma, to manufacture a generic version of kidney and liver cancer drug sorafenib (Nexavar) patented by German major Bayer under Section 84. This is the only incident where a CL has been granted to a generic drug maker company in India.