Novartis’ Special Leave Petition is scheduled for pronouncement of judgment by the Supreme Court of India on April 1.
The MNC has doggedly pursued the litigation with a view to ‘seek clarity on the unique aspects of India’s patent law and to foster an innovative environment to the benefit of patients’, as per a statement on its website.
The case dates back to 1998 when Novartis sought a patent for Glivec (imatinib mesylate) in India. India granted marketing approval for Glivec in 2001, but it was not until 2005 that the country established the Indian Patents Amendment Act and provided for the authorisation of pharmaceutical compound patents.
After the Indian Patent Office rejected the patent request in 2006, the case was eventually transferred to the Indian Patent Appellate Board (IPAB). In 2009, the IPAB acknowledged that international patentability standards were met, but refused to grant a patent for Glivec based on an additional requirement introduced in 2005 in the national Indian law.
Novartis appealed to have the case heard before the Supreme Court of India. In 2011, the Supreme Court agreed to hear the case, and after many delays, the hearing began on September 11, 2012. The hearing ended on December 4 and the verdict of the court is expected on April 1.
EP News Bureau – Mumbai