Natco has now won appeals at all three stages, from the the Intellectual Property Appellate Board (IPAB), High Court and now, the SC
The Supreme Court of India (SC) has dismissed Bayer’s Special Leave Petition (SLP) against India’s first Compulsory License (CL), which was awarded to Hyderabad-based Natco Pharma for Bayer’s Sorafenib Tosylate (brand Nexavar), a drug used to treat liver and kidney cancer. In its two line order dated December 12, the SC says, ‘In the facts of the present case, we are not inclined to interfere. The Special Leave Petition is dismissed, keeping all questions of law open.’ The order was passed by Justices Ranjan Gogoi and Rohinton Fali Nariman.
Reacting to the SC dismissal, Adheesh Nargolkar, IP Partner, Khaitan & Co commented that the decision would prompt innovator companies to price their drugs appropriately in order to maintain viability, and at the same time, deal with the objective of avoiding a CL. He also cautioned that patent holders would now need to take appropriate precautions while negotiating voluntary licenses with counterparties so as to avoid a scenario where this forms the pedestal for a CL application.
The decision has been hailed by medical aid agency MSF Access Campaign as a ‘major win for public health’. Reacting to the decision, Leena Menghaney, Regional Head – South Asia, MSF Access Campaign said that the SC decision demonstrates the independence of the Indian judiciary in upholding India’s right to legislate with public health interests in mind. “MSF is encouraged by this particularly strategic win for public health and access to medicines, whereby the SC has worked to ensure continued patient access to affordable versions of this lifesaving cancer drug, in spite of a multi-year campaign by Bayer to reverse the decision,” she said.
Natco has now won appeals at all three stages, from the the Intellectual Property Appellate Board (IPAB), High Court and now, the SC. The company was awarded the CL in March 2012, under the provisions of Section 84 of the Indian Patents Act, 1970 for Sorafenib Tosylate (brand Nexavar) owned by German drug major Bayer.
Bayer had petitioned for a stay on the order but this was rejected by the IPAB in September 2012. The MNC then challenged the IPAB order in the Bombay HC which was dismissed on July 15 this year, following which Bayer filed the SLP against the Union of India, Natco and others.
Bayer was represented by senior advocate Sudhir Chandra, and advocates Sanjay Kumar, Arpita Sawhney, Bhagabati Prasad Padhy, Arun Kuamr Jana.
The respondents, Union of India and others, were represented by senior advocates Anand Grover, Gagan Gupta, and advocates Rajeshwari Hariharan, Rameshwari Rao, Viveka Truman, and Geetanjali Sharma.
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