Novartis to challenge Glivec patent rejection
Novartis AG, the Swiss pharmaceuticals major, is thinking of challenging an Indian tribunal’s decision to deny its blood cancer drug Glivec patent protection in the country, the company said in a statement on Saturday.
The drugmaker may approach the World Trade Organization’s Trade Related Intellectual Property Rights forum and also a high court in the matter, media reports speculated.
In a June 26 ruling, the Intellectual Property Appellate Board (IPAB) rejected Novartis’ patent plea on the grounds that Glivec’s efficacy wasn’t significantly higher than other similar molecules. It said the drug, a beta crystalline form of Novartis’ drug imatinib mesylate, didn’t meet the requirements of Section 3 (d) of the Indian Patent Act.
Besides, the panel pointed out, at Rs 1.2 lakh for a monthly course, it was too costly for the common man and couldn’t be given monopoly in the market. “Any patent granted to support such a high monopoly price would be against public order,” the IPAB said in its ruling. The generic versions of the drug are available for a much lesser Rs 10,000.
While expressing satisfaction with the fact that the IPAB accepted that the company’s “patent application fulfils all international patentability criteria”, Novartis said the ruling would hamper research in the pharmaceutical industry. “Unfortunately, IPAB upheld the objections under Section 3(d), a legal provision unique to Indian patent laws, which constitutes a hurdle to innovation in the pharmaceutical field,” it said.
The drugmaker added that it was exploring ‘options’ for its next step. “We are concerned about the patent systems in India. We are currently reviewing the decision and will look at the various options available to us,” it said.
The ruling follows a four-year battle between the Swiss pharma giant and the government of India. Besides the government, certain Indian pharma firms and patients rights groups have also opposed patent protection for Glivec. Known the world over for its low-cost generics, India is facing pressure from western nations, especially Europe, to tighten patent laws, which in turn could harm both the Indian industry and poor patients.
Novartis has also been involved in a bitter mudslinging match with patients group Cancer Patients Aid Association over the drug. The group’s executive director Shubha Maudgal called the IPAB’s decision a landmark one.
The group has slammed Novartis for trying to push the drug out of the reach of the common man but the drugmaker maintains it helps cancer victims through its Glivec International Patient Assistance Program. “In India, more than 11,000 patients currently receive their medicine through the program.
Since its inception in India in 2002, Novartis has distributed Glivec valued at close to Rs 3,000 crore to patients enrolled under the program absolutely free of any charge,” the company said.
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