Swiss pharmaceutical company Novartis heads to the Indian Supreme Court today in New Delhi, in a final bid to undermine a key public health safeguard in Indian patent law specifically designed to prevent drug companies from abusive patenting practices which keep medicine prices high. If successful, the move would have a devastating impact on access to essential medicines across the developing world, according to international humanitarian medical organisation Médecins Sans Frontières (MSF), which relies on affordable generic drugs produced in India to carry out its work in 68 countries.
“For six years, Novartis has been trying to browbeat India into changing a part of its patent law that protects people’s access to affordable medicines, not corporate profits,” said Leena Menghaney, manager of MSF’s Access Campaign in India. “The current system in India was designed to prevent drug companies from extending patent monopolies with additional patents on the same medicine.”
Novartis has been engaged in a legal battle over a part of India’s patent law (known as Section 3d) which says that a new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy over existing compounds; this is a provision to stop the common industry practice of extending, or ‘evergreening,’ their patent monopolies for routine modifications of known compounds.
Section 3d, which is in line with international trade rules, formed the basis for Novartis not being granted a patent for its cancer drug imatinib mesylate (marketed as Gleevec) in 2006. Novartis’ patent application was on a new form of the imatinib molecule already described several years previously in patents in the US and other developed countries.
“We’ve already seen the benefits of public health safeguards in India’s patent law in practice,” said Menghaney. “Thanks to India’s strict law, patent applications on paediatric versions and fixed-dose combinations of drugs used to treat HIV have been rejected. These are the very medicines that need generic competition to be affordable.”
The ramifications of a Novartis win would be global, with India in the future being forced to grant far more patents than it currently does. This in turn would greatly restrict the kind of generic competition that has, for example, been instrumental in bringing the price of HIV medicines down by 99 per cent since 2000, and made the scale-up of HIV treatment to eight million people in developing countries possible.
“Because India is the developing world’s pharmacy, the consequences of this case stretch far beyond the country’s borders,” said Dr Manica Balasegaram, Executive Director of MSF’s Access Campaign. “Novartis’s legal actions are a direct threat to the lifeline for millions of people in developing countries.”
In 2006, Novartis challenged Section 3d in India’s High Court as unconstitutional, which prompted MSF to launch the Novartis Drop the Case campaign in a bid to get them to drop their case. Nearly half a million people signed a petition, which was presented to the company. Novartis didn’t drop the case, but lost in a court ruling in 2007. The company is now seeking to challenge the interpretation of Section 3d, or attempting to weaken the law of any substance, in the Indian Supreme Court.