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Cancer drug patent battle

New Delhi, Sept. 10: Swiss pharma giant Novartis’s attempt today to convince the Supreme Court to change Indian patent laws, which allow local companies to produce cheap generic versions of its leukaemia drug Glivec, ran into trouble when the court asked the company to instead slash prices to drive out competition.

“Why don’t you sell it at five rupees?” said Justice Aftab Alam, who along with Justice Ranjana Desai is hearing the company’s appeal against denial of the patent.

To add to its discomfiture, Justice Alam described the existing prices of Rs 1,20,000 a month as “shocking”.

“Medicine prices are already too high in India. Sell it at Rs 5. You can slash prices and drive out all the competitors,” Justice Alam said.

His observations threw the Novartis legal team into a tizzy. Lead arguing counsel Gopal Subramanium insisted the company did not want to “profiteer without a conscience”.

Subramanium said the challenge to the existing patent regime was a battle for “vindication of honour”.

Novartis was denied a patent under Sections 3(b) and 3(d) of the Indian Patents Act, 1970. Section 3(d) says that a new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy. This is intended to prevent companies from extending their patent monopolies by making routine modifications.

Novartis, which claims Glivec is a path-breaking drug, challenged the denial in Madras High Court and lost. The company, which says it has patents for the drug in over 35 countries, approached the top court saying the country’s patent laws needed a change.

“All pharma companies would like to have patents,” Novartis argued. “All pharma companies would want to know about the patent protection regime in this country.”

In other countries, the company claimed, trials were fast-tracked because of the ground-breaking nature of the drug.

Justice Alam said: “This is a difficult country.”

Public health companies, the Cancer Association of India and other pharma companies such as Cipla, which produce the cheaper generic versions, are contesting the appeal filed by Novartis.

They claim a favourable verdict in the company’s favour would jeopardise attempts to supply cheap drugs to the needy. The cheap generic drugs produced in India through a process of reverse engineering are used in over 68 countries by humanitarian groups such as Medicine Sans Frontier, a press release from the organisation said.