Novartis's famed cancer drug, Glivec, will not get patent protection in India. The apex body on patent and trademark disputes, the Intellectual Property Appellate Board (IPAB), has ruled that the drug "lacks innovation" and the high price tag of Rs 120,000 per month per patient would be too high for the common man.
"Any patent granted to support such a high monopoly price would be against 'public order'," the ruling said.
This brings the curtains down on a high profile three-year legal battle over patent rights between the Swiss multinational drug major and the Indian government.
The IPAB panel, comprising Chairman ZS Negi and Technical Member PC Chakraborti, ruled that the beta crystalline version of the drug was not patentable under section 3(d) of the Indian Patent Act and lacked "significant enhanced efficacy" over and above the prior known molecule. The panel, in its decision on June 26, also ruled that the patents granted for the drug in about 40 countries may not be applicable to India.
In an e-mail response, Novartis said, "We are pleased that IPAB acknowledged that our patent application fulfils all international patentability criteria. Unfortunately, IPAB upheld the objections under Section 3(d), a legal provision unique to Indian patent law, which constitutes a hurdle to innovation in the pharmaceutical field."
Novartis said it was concerned about the patent system in India and was looking to have a system that supported innovation in the pharmaceutical field. "We are currently reviewing the decision and will look at the various options available to us," Novartis said.
Shubha Mudgal, executive director of Cancer Patient Aid Association, which opposed the patent application in 2006, was predictably happy and said the "landmark judgement is a victory for patients as it will set a precedent in India to offer critical drugs at affordable prices."
Patent expert Shamnad Basheer said in his blog spicyip that Section 3(d) details that patents cannot be granted to an invention for commercial exploitation which could be contrary to public order or cause morality or harm the health of humans, animals and the environment.
