For years, India did not offer any patent protection for chemical compounds, but was obliged to do this after joining the World Trade Organization. In 2005, the patent protection act therefore was amended to also include such compounds, but only if they proved significant clinical efficacy enhancements over already patented compounds, Section 3(d) of the Indian patent law.
The battle for the cancer medicine Glivec in India has been going on since 2006, when Novartis’s patent application for Glivec was rejected. The application then was rejected based on the law aimed at preventing companies from getting new patents by making only minor changes to existing drugs, a practice known as “evergreening”.
In 2009 Novartis filed a Special Leave Petition with the Indian Supreme Court, challenging the decision to reject a patent for Glivec and also challenging aspects of the Indian patent law, since Novartis considered the concept of innovation was too narrowly defined. Specifically at issue was Section 3(d), since Glivec is a salt formulation of the already known molecule Imatinib.
In the beginning of April 2013, the Supreme Court rejected the arguments from Novartis and came to the conclusion that Glivec is not novel, not inventive and does not satisfy Section 3(d). In this contect, it should be noted that Glivec has been patented in nearly 40 countries including US, Russia, China and Taiwan.
Ranjit Shahani, Vice Chairman and Managing director, Novartis India Limited, commented the outcome, saying “We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options”.
“The Supreme Court’s decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.” said Dr Unni Karunakara, MSF International President, one of many organisations celebrating the decision.
In view of the decision of the Supreme Court, viewed alongside other recent patent setbacks for Bayer (see previous blog) and Roche (see previous blog), Novartis, as well as other multinational drug companies, are concerned about the deteriorating innovation environment in India, and will probably carefully evaluate whether to launch new drugs in India in the future.
Jeanette Jakobsson, European Patent Attorney