Mumbai: Swiss drug maker Novartis AG may challenge the Indian patent tribunal’s verdict that its blood cancer drug Glivec cannot be granted patent protection in the country.
Novartis may challenge the ruling at the Trade Related Intellectual Property Rights (TRIPS) forum of the World Trade Organization (WTO) and also in one of the high courts of India, escalating the dispute.
A Novartis spokesperson on Saturday said the company is exploring all the options available before it.
The Swiss drug maker lost its four-year-long legal fight to patent Glivec in India when the country’s Intellectual Property Appellate Board (Ipab) ruled last week that the drug cannot be granted a patent, citing its non-compatibility with the country’s patent law and unaffordable pricing.
Drawn out battles: Chronology of events in Novartis’ five year-long battle to patent glivec in India. Ahmed Raza Khan / Mint
Ipab cited a provision under which a patent is granted only if a product is more efficacious than existing drug molecules.
Shamnad Basheer, an expert in international patent law and professor at the National University of Juridical Sciences at Kolkata, said the ruling could be challenged in international forums for its interpretation of the terminology “enhanced efficacy” mentioned in Indian patent law.
And the other reason cited by the tribunal, that the decision was based on the “excessive pricing” of the drug, may not be compatible with provisions required to decide on patent issues, Basheer said. It is the first time that the tribunal used the price of a drug as a reason to reject a patent appeal.
Ipab noted that Glivec costs Rs1.2 lakh for a month’s treatment per patient, saying it was far too high a price for ordinary people and, therefore, any patent granted to support such a high monopoly price would be against public order.
A corporate lawyer, who didn’t want to be identified because he is advising an Indian firm in the Glivec case, said Novartis would most likely move an Indian court against the Ipab ruling.
Section 3(d) of India’s patent law doesn’t permit any modified form of an invention that was known prior to 1995 seeking a patent right in the country unless the claimed modification results in increased efficacy.
Glivec is a beta crystalline form of a known blood cancer drug, imatinib mesylate, owned by Novartis, which sells this drug in about 40 countries under patent protection.
In a 198-page ruling that was released on Friday, the Ipab panel consisting of chairman Z. S. Negi and technical member P.C. Chakraborti stated that while the drug had novelty as well as inventiveness, it failed to demonstrate “significantly enhanced efficacy”.
The Ipab ruling was first reported by Spicy IP, a blog on intellectual property rights maintained by Basheer, in a Saturday posting.
“We are concerned about the patent systems in India and are looking to have systems that support innovation in the pharmaceutical field. We are currently reviewing the decision and will look at the various options available to us,” Novartis said in a statement on Saturday.
The company added that it was pleased that Ipab acknowledged that its patent application fulfilled all international patentability criteria. It was unfortunate that the tribunal upheld objections under section 3(d), which is unique to Indian patent law, the company said.
Novartis had in 2006 challenged a decision by the Chennai patent office to reject its application for Glivec.
The company questioned the decision of the patent office that heard at least six pre-grant oppositions filed by patient groups and local drug makers, on the grounds that the drug had been granted patents in several countries accepting its inventiveness.
Shubha Maudgal, executive director of the Cancer Patients Aid Association, which opposed the Novartis patent application, said Ipab had delivered a landmark decision. Cancer patients in India can’t afford such costly drugs under a patent monopoly, Mudgal said.
Novartis’ patent application was also opposed by companies such as Natco Pharma Ltd, Ranbaxy Laboratories Ltd and Cipla Ltd, among others.
Natco’s legal affairs executive, Adi Narayana, said the Ipab decision was very important for Indian healthcare as it was a battle fought for affordable treatment of Indian cancer patients.
On pricing of Glivec, Novartis said the company had been assisting patients who cannot afford critical medicines.
“Since the Glivec International Patient Assistance programme’s inception in 2002, Novartis has provided Glivec at no cost to more than 37,000 patients in 80 countries. In India, more than 11,000 patients currently receive their medicine through this programme,” it said.