[Ip-health] Novartis' case may spark patent vs patient debate

[Ram]

> From The Hindu Business Line

Novartis' case may spark patent vs patient debate

P. T. Jyothi Datta

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.