1 Apr 2013

India rules against Novartis in cancer drug case

In a victory for health campaigners against big pharmaceuticals, India’s supreme court rules that pharmaceutical giant Novartis cannot patent an updated version of a cancer drug.

India dismissed the Swiss drugmaker’s attempt to win patent protection for the drug Glivec, in a blow to Western firms targeting India to drive sales.

Novartis called it a “setback for patients”, announcing that it would no longer invest in further drug research in India.

Yet it is a victory for local makers of generic drugs – copies of drugs whose patents have expired – who argue that poor people will still be able to gain access to cheaper, generic forms of lifesaving treatments.

The move sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of the 1.2 bn population.

Headache ahead

Analysts say it does not bode well for foreign firms embroiled in ongoing disputes in India, including Pfizer Inc and Roche Holding.

“The multinational companies will have to find new ways of doing business in India,” said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs such as Glivec.

Ranjit Shahani, managing director of Novartis India Ltd, the firm’s locally listed unit, said it will be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products.

It will continue to refrain from research and development activities there.

“The intellectual property ecosystem in India is not very encouraging,” Mr Shahani told reporters in Mumbai after the ruling.

Medicine market

However it cements the role of local companies as big suppliers of inexpensive generics to India’s rapidly growing drugs market, worth £8.5 bn a year, and also across the developing world.

Healthcare activists have called on the government to make medicines cheaper in a country where many patented drugs are too costly for most people, 40 percent of whom earn less than 85p a day, and where patented drugs account for under 10 percent of total drug sales.

“This appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines,” said Leena Menghaney, Medecins Sans Frontieres’ Access Campaign manager for India.

Over 16,000 patients in India use Glivec and the vast majority of those get it free of charge, Novartis says. By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports.

The Supreme Court’s decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006.