April 1 could well be a landmark day for the Indian pharma industry and global pharma companies with interests in India. On that Monday, the Supreme Court is expected to announce
its much-awaited verdict in the patent case involving Glivec, the cancer drug of Basel-headquartered Novartis.
On March 27, Novartis, at a short notice, organised a media conference call to provide journalists with what it called "a background to the case and for a briefing regarding the ongoing patent dispute for Glivec in India". It was addressed by Paul Herrling, Chairman on the board of Novartis Institute for Tropical Diseases.
The call was aimed at reviewing "the facts of the case".
Novartis and many companies see the final decision on Glivec, whose generic
versions are currently sold in the Indian market, as a landmark judgment for it would bring clarity on the interpretation and implementation of the Indian Patents Act.
The judgment will be crucial for global and Indian pharma companies not just because it will give an indication on what is patentable, it will also clarify many definitions such as those relating to the efficacy of a drug. Most importantly, the judgement could be a signal to many other countries, especially emerging economies, on the provisions they can have in their own patent law.
Novartis, as many
Business Today readers would know, has sought a patent for Glivec (imatinib mesylate) in India since 1998. 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 authorisation of pharmaceutical compound patents.
The Indian Patent Office rejected the patent request in 2006, and the case was eventually transferred to the
Indian Patent Appellate Board (IPAB). In 2009, the IPAB refused to grant a patent for Glivec based on an additional requirement introduced in 2005 in the law.
Novartis appealed before the Supreme Court of India. In 2011, the Supreme Court agreed to hear the case, and the hearing began on September 11, 2012. The hearing ended on December 4, 2012, and the verdict is expected on April 1, 2013.
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