The Hindu Business Line : Novartis' case may spark patent vs patient debate

THE death-knell may have been rung for Exclusive Marketing Rights (EMR) when the patent regime came into effect, in January 2005. But the ghosts of the past, it seems, can be exorcised only after the Patents (Amendment) Ordinance 2005 gets ratified in the coming Budget session of Parliament.

The first pharma company to get an EMR in India for its cancer drug, Novartis, has heard from the Indian Patent Office on the implementation of the Madras High Court order on giving the drug free to patients who cannot afford it.

Mr Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India, confirmed that he had received the letter from the Patent Controller. He told Business Line that the company had given the anti-cancer drug free to about 3,306 patients and only 45 were actually paying for the medicine. "On an average, about 30-odd patients enrol for the free cancer drug per week," he said.

The pharma industry itself sees the recent development as a prelude to the rough ride ahead for the Patent Ordinance in Parliament. The Government has asked Novartis for market-related data on the drug, the pricing and the number of patients who need it. This could be laying the ground for Government intervention if the price is found to be too high and if patients have been denied the drug, an industry representative said.

The Government can allow other local companies to produce the same cancer drug and hence bring down its price. The other option before the Centre is to fix the price on the drug through some sort of a price-control, said a patent attorney.

Either way, the Government would be able to support the Patent Ordinance in its present avatar and convince Parliament that safeguards are in place to protect the patient, he added.

Ever since the EMR was granted in November 2003, something or the other has been happening for the Indian subsidiary of the Swiss-drug major Novartis AG. Novartis had taken legal recourse to get Indian companies to stop marketing copies of the same drug. A year's course of the anti-cancer drug Glivec internationally costs about $27,000 (about Rs 11,61,000), while local copies from India sell at $2,700 (about Rs 1,16,100). Indian companies, on their part, too contested the EMR and the case is in the apex court.

Pharma industry representatives said that while the EMR is being contested, the Centre could still take up Novartis's patent application for the cancer drug. The two issues are separate, a Mumbai-based lawyer concurred.

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