In a landmark judgment, the Intellectual Property Appellate Board (IPAB), the apex body on patent and trademark disputes in the country, has ruled that Novartis's controversial cancer drug, Glivec, lacks innovation and cannot be granted patent in the country.
In its decision, IPAB 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.
IPAB panel said that the high price tag of Rs 1,20,000 per month per patient would be too high for the common man in the country. Any patent granted to support such a high monopoly price would be against public order, the panel said.
The IPAB ruling brings curtains down on a high profile three-year legal battle over patent rights between the Swiss multinational drug major and the Indian government.
Meanwhile, in a press release Novartis said, "We are pleased that the IPAB acknowledged that our patent application fulfils all international patentability criteria. Unfortunately, the 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."
"We are currently reviewing the decision and will look at the various options available to us," Novartis spokesperson Svetlana Pinto said in the release.