Ruling intended to prevent patenting of inventions known earlier.

GlivecIn yet another setback to Swiss drug multinational Novartis AG, the Indian patent office has rejected its application to secure a patent for an alfa crystal form of its blockbuster cancer medicine, Glivec.

The patent office had earlier refused patent protection to the beta crystal form of the same medicine, a decision that has been challenged by Novartis in the Madras High Court.

Glivec is a key blockbuster medicine and a global money spinner for Novartis. However, the company says 99 per cent patients on Glivec in India get it for free and the others who pay for the drug are reimbursed.

The ruling of the patent office, which came on March 30, was based on the pre-grant oppositions filed by Indian drug firms Sun Pharma, Okasa and Time Cap Pharma Labs Pvt Ltd against the five-year-old application of Novartis.

“Novartis is disappointed that the patent for the alpha crystalline form of imatinib mesylate (chemical name of Glivec) has been rejected, even though the impact of the decision is low. We have 90 days to review the merits of the decision and to evaluate and decide our options,” said Ranjit Shahani, vice-chairman and managing director, Novartis India.

The patent office decision comes when the apex complaint redressal forum, the Intellectual Property Appellate Board (IPAB), is about to give its verdict on Novartis’s appeal against the rejection of a patent to the beta crystal form of Glivec. The patent rejection for Glivec was one of the first instances of India using the special clause (3-d) in the patent law to prevent patenting of inventions that were known earlier.

According to Shahani, under the Glivec International Patient Assistance Program (GIPAP), Novartis has provided Glivec (beta form of imatinib mesylate) completely free of charge to more than 35,000 patients in 80 countries. “In India, around 11,000 patients currently receive Glivec absolutely free of charge through GIPAP. Since inception of GIPAP in India in late 2002, Novartis has distributed Glivec valued at more than Rs 2,900 crore free of charge to patients in need,” he said.

The rejection of patent to alpha and beta forms was on similar grounds. “If granted, it would have been a clear case of frivolous patenting. The different form of Glivec is in no way superior to the other form for which patent was not granted,” said an attorney involved in the pre-grant opposition.

It is known that the low-cost version of the alpha crystal form of Glivec is being sold by domestic companies in India.

Novartis’ fight for protection to Glivec has been the most high-profile of patent battles in the Indian pharmaceutical space after the changes in domestic patent laws. India’s shift from a process patenting system to the product patent regime as part of its commitments to the World Trade Organisation has turned it into an attractive market for global drug giants.

Novartis AG has recently announced plans to increase its stake in its Indian subsidiary to make full use of its domestic presence. Its public offer to acquire up to 90 per cent shares of its Indian subsidiary is expected to open next month.