Glivec patent ruling a welcome turn for Novartis

The rejection of Novartis’ patent application for the beta crystalline version of cancer drug Glivec (imatinib mesylate) by the Intellectual Property Appellate Board (IPAB) on the ground that it is priced beyond the reach of the common man may have given the company new ground to challenge Indian patent rules.

The Swiss drug major is now reported to be preparing for a protracted legal battle by taking the litigation to the next level based on some loose ends in the IPAB order.

“We are reviewing the decision and will look at the various options available to us,” a company spokesperson had said without specifying the options after the verdict came in. Legal experts say Novartis could take the case to a higher court in India and also appeal to international fora.

IPAB ruled that Novartis’ patent application covering Glivec is not patentable as it fails to satisfy the requirements under Section 3(d) of the Indian Patents Act, which requires that in order to be patentable, a pharmaceutical product must demonstrate significantly enhanced “efficacy” over and above the prior known molecule.

Curiously, however, IPAB chose to base its rejection on Section 3 (b) of the Act, too, saying the drug cost Rs 120,000, a price that was way beyond the reach of the common man. Section 3 (b) holds that patents cannot be granted to an invention, the primary or intended use or commercial exploitation of which could be contrary to public order, or morality, or which causes serious prejudices to human, animal or plant life or health or to the environment. Pricing of the drug is taken as a part of this.

The IPAB ruled that any patent granted to support such a high monopoly price would be against ‘public order’. This may be the first time any country has denied a patent to a product on the ground that it is excessively priced.

Predictably, the IPAB ruling has left intellectual property (IP) experts aghast. Anuradha Salhotra, partner at New Delhi based IP firm Lall, Lahiri & Salhotra, said, “Denying patent using section 3 (d) of the Indian Patent Act is understandable. But the IPAB has also used section 3 (b), which is preposterous.” She said patentablity can be decided only on basis of whether the product is an invention or not. “IPAB cannot rule on basis of pricing. That’s for the pricing authorities to decide.”

Shamnad Basheer, professor at the National University of Judicial Sciences in Kolkata, said the use of pricing as a criterion for denying patent would be against the wordings of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, which India is party to. “There is no support for such a ludicrous legal proposition from either Indian or international patent law,” he said.

“Pricing is never an issue while deciding on patent. But the strongest point of rejection was that Glivec lacked innovation,” said Feroz Ali, a Chennai-based lawyer who has closely followed the Glivec case. He said while the pricing reference in the ruling might get Novartis mileage, it may not be enough to get a reversal on the decision, as the ruling said Glivec lacked enhanced efficacy.

Meanwhile, Natco, one of the Indian firms opposing the grant of patent to Novartis, is also preparing for the next round of legal battle. “It’s a 192-page order from the IPAB. We are going through that. But we don’t think the order itself will rest the case. There will be more to it, maybe yet another legal battle at a higher level this time,” M Adi Narayana, the legal affairs executive of Natco, said.