Thursday, August 09, 2007

What do we need to know about the Novartis case decided by the Madras High Court?

The media has reported just a few days back about the Madras High Court striking down a case filed by the pharma major Novartis about India’s patent regime not being compliant with TRIPS regime of the WTO. Novartis being a Swiss pharma major and that too when a Swiss dignitary was visiting India, there was all round expectation that the Swiss authorities would pressure the Indian government on behalf of Novartis. But no such thing happened and the very next day the Union Minister of Commerce and Trade Mr. Kamal Nath was clarifying that no other country has a grouse against India’s Intellectual Property Regime. The visiting Swiss federal councilor Doris Leuthard was also quoted as saying “We have to accept the settlement and the Swiss government never engages itself or questions any judicial announcements.”

What exactly was at stake in the case?

Novartis manufactures a drug called Glivec, which is used for treatment of cancer. It was granted patent for this by India in 1998. At that time India did not have product patent regime. It was having only a process patent regime. The product patent regime came as a result of our acceding to the IPR of the WTO. At present also India’s patent laws do not prohibit a company from getting patents for incremental innovations, if the drugs enhance efficacy. The patent granted to Novartis in 1998 will be valid till 2018 i.e., for a good 20 years. If it keeps making enhancements to the drug decade after decade, there is a possibility that its patent can keep on getting extended – a process derisively called ‘evergreening.’

The government of India is trying to publish clear guidelines as to what constitutes ‘enhanced efficacy’ of drugs. This is expected to help the patent examiners distinguish between what constitutes genuine incremental innovation and ‘evergreening.’

By going to court what Novartis was trying to do was force the making of laws by India which would recognize incremental innovations per se. The Madras High Court has rightly ruled that a court is not the forum to decide such issues and that the company has to approach the appellate tribunal for patents and plead its case.

UPDATE: As this is an important issue from every point of view, you should also be looking at experts' opinion. Take a look at it here. This debate is about granting patents for incremental innovation.