The patent controller issued India’s first compulsory licence for the cancer treatment in March 2012.
Generic manufacturer Natco applied for the licence under section 84 of the Patents Act, arguing that: (a) the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in India.
The patent controller sided with Natco on all three grounds, granting the licence with a royalty rate of 6% of net sales.
The Intellectual Property Appellate Board upheld the licence in March, setting up the appeal to the Bombay High Court. Speaking to Managing IP a few days after the decision, then IPAB chairperson Prabha Sridevan argued that compulsory licences are not an attack on IP rights.
“IP laws say, ‘these are the owner’s rights, and of course this means ownership and control’,” she stated. However, Sridevan pointed out that all rights are limited by law, and compulsory licenses are simply a part of that law.
The Nexavar decision has raised concerns among international drug companies that it would be the first of many compulsory licences, a fear that has been partially realised. In January, the Department of Pharmaceuticals started the process to procure compulsory licences for three more cancer drugs under section 92 of the Patents Act, which allows the government to request a compulsory licence during national emergencies. However, the Department of Industrial Policy and Promotion has denied the compulsory licence application for Roche’s Trastuzumab. Meanwhile, the decisions concerning Bristol Myers-Squibb‘s Ixabepilone and Dasatinib are still pending.
