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P. T. Jyothi Datta

Mumbai, July 4 The Intellectual Property Appellate Board (IPAB) has said that Novartis’ cancer drug Glivec (Imatinib Mesylate) is not patentable in the beta crystalline form.

But two process patent claims, 13 and 17, have been sent back to the Patent Controller’s Office for reassessment, a lawyer familiar with the development told Business Line.

“We are currently reviewing the decision and will look at the various options available to us,” a Novartis spokesperson said, without indicating if the company would appeal the judgment.

Swiss drug-maker Novartis’ product patent on Glivec (the beta crystalline version of Imatinib Mesylate) had been rejected by the Patent Controller’s office in January 2006, a decision that the multinational company contested in the courts.

In its recent ruling, the IPAB denied Glivec’s patentability by upholding objections under Section 3(d) of the amended Patent Law — under which a patent is granted only if a product proves to be more efficacious than the existing drug molecules.

On novelty and innovation, though, the judgment seems to make a favourable mention of Novartis’ Glivec, observed another lawyer.

Details of the judgment are still being digested by different parties to the case. On the face of it, domestic drug companies will be able to continue to sell their versions of Imatinib Mesylate, though they will not be able to use the two processes that have been sent for reassessment, said company representatives.

Domestic drug-makers including Natco, Cipla, Hetero and Ranbaxy, are party to the case, besides the Cancer Patients Aid Association.

The legal wrangle over Glivec has attracted international attention because it is the first test on the ground of India’s amended Patent Law. The product patent regime became effective in the country in 2005.

At the heart of the patent debate also appears to be the emotive price issue, with Novartis’ Glivec costing over Rs 1 lakh a month to a patient, while local drug companies make similar versions of the drug available at Rs 10,000 a month.

Novartis, however, has maintained that it has, as part of its GIPAP (Glivec International Patient Assistance Programme), given patients the medicine at no cost. “In India, more than 11,000 patients currently receive their medicine through GIPAP. Since the inception of the programme in India in late 2002, Novartis has distributed Glivec valued at close to Rs 3,000 crore to patients enrolled under GIPAP absolutely free of any charge,” Novartis said.

Further, it added that more than 99 per cent of patients on Glivec in India receive it free of charge under GIPAP, while less than one per cent of patients pay for it, and these are patients who are reimbursed.

The Glivec case is a benchmark, as the cancer drug was the first pharmaceutical product in the country to be given an Exclusive Marketing Right in 2003, in a run-up to the introduction of the product patent regime in January 2005. It has since got into litigation, when Novartis tried to prevent local companies from making similar versions.

Subsequently, after the Patent Office rejected Novartis’ patent application on Glivec in 2006, Novartis filed multiple writs in the Madras High Court contesting the rejection of its patent application and certain constitutional parameters that contributed to the rejection, including Section 3(d).

While this section was later upheld by courts, the Glivec case landed at the IPAB. There, too, there were issues — as the technical member on the IPAB had been head of the Patent Controller’s Office when Novartis’ Glivec patent was rejected in the first place. That got sorted after the IPAB appointed a new Technical Member last year. Arguments of all involved were taken on board and the judgment delivered late last month.

On the next step, lawyers observe that the judgment could be appealed at a High Court.

More Stories on : Pharmaceuticals | Courts/Legal Issues | IPR

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