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‘India-made’ offer for patent

New Delhi, Sept. 13: Swiss pharma company Novartis today held out the hope of producing its anti-leukaemia medicine Glivec in India, an arrangement that will have the potential to bring down prices, if it were granted a patent on the drug.

Novartis lead counsel Gopal Subramanium told the Supreme Court that grant of patents allowed “free flow” of medicines into a country, and cited the checks in place in India’s patent laws to allay fears of adverse consequences.

Glivec is now priced in India at Rs 1.2 lakh for a month’s treatment. Subramanium said that since the drug was produced in Europe, where ingredients and labour are costlier, it was priced higher.

“If a patent is allowed, a manufacturing unit may even be set up in India,” he said. It would be perfectly all right for Indian authorities to impose the condition of manufacturing in India, he added.

Subramanium said that before India had signed multilateral treaties such as the Trade-related Intellectual Property Rights (Trips), similar drugs would come to India 20 years after their launch. “Trips enables free flow of supply of such drugs,” he said.

When the bench observed that the free flow came at a “price” — a reference to Glivec’s price — Subramanium said the price was an investment a country made in long-term medicine supplies.

He insisted that grant of patent would not hurt public health in India as the authorities were free under the law to direct the company to compulsorily part with licences relating to the drug anytime three years after the grant of patent.

A reasonable royalty that the patent holder gets in such a case too is fixed by the authorities, he pointed out.

Subramanium cited how Bayer was forced to grant Indian company Natco Pharma a licence for generic manufacture of the German firm’s kidney cancer drug in the public interest. The Bayer product cost Rs 2.8 lakh a month in India while Natco promised to sell its generic version for Rs 8,800 a month. The royalty for Bayer was fixed at 6 per cent of the selling price.

Even otherwise, Subramanium argued, if a patent was granted on Glivec, it would expire at the end of 2017 (because the patent application was made 20 years earlier). After that, the drug would be available at much cheaper prices in India, he said.

The company has been denied a patent by India’s Intellectual Property Appellate Board, whose order has been upheld by a high court. The pharma major has now moved the top court challenging the applicability of Section 3(d) of the Indian Patents Act, 1970, to its case.

Section 3(d) bars companies from making cosmetic changes to patented drugs and holding on to the successive patents for ever, a concept dubbed “evergreening” in pharma parlance.

Novartis is striving to prove Glivec is covered under Section 2(j), which allows patenting of inventive steps, and does not have to meet the rigours of Section 3(d), intended to prevent evergreening.

However, the bench has so far refused to buy this argument. “You will still have to satisfy Section 3(d),” Justice Aftab Alam, sitting alongside Justice Ranjana Desai, observed today. Arguments will continue next Tuesday.