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Delhi's ruling over Nexavar drug both hailed and hated

Health activists applaud Indian government's decision to allow drug company to make and sell cheap version of patented cancer medicine, but ruling will not be welcome by global drug makers.

NEW DELHI // Health activists have welcomed the Indian government's decision to allow a generic drug company to make and sell a cheap version of a patented cancer medicine, saying it could open the door for poor patients to access a wide range of life-saving drugs.

India's patent office this week ruled that Nexavar, a drug for advanced kidney and liver cancers owned by German's Bayer, was not affordable to Indian patients.

It granted its first-ever compulsory licence, allowing local generic drugmaker Natco Pharma to produce it.

Under the order, Natco must sell the drug, 30 tablets, for US$176 (Dh646) a month - 30 times cheaper than the price charged by Bayer.

India is only the second country to grant a compulsory licence. Thailand issued four such licences between 2006 and 2008, also on grounds of affordability.

"This is a very positive development," said Leena Menghaney, a Delhi-based access coordinator for Medecins Sans Frontieres (Doctors Without Borders).

"Western companies have argued in the past that patents should only be broken for epidemics like HIV or in emergencies. We expect to see more and more licences for cancer and chronic problems like diabetes."

The ruling will not be welcome by global drug makers. With many of their most lucrative 20-year patents in western countries due to run out soon, they have been eyeing India and other developing countries as fresh sources of revenue.

Pfizer, the world's largest research-based pharmaceutical company, has questioned the issue of affordability, saying many Indians are well off and can afford the medicines.

"There is huge wealth in India," Pfizer CEO Ian Read told Reuters. "There are 100 million people in India who have wealth equivalent to or greater than the average European or American, who don't pay for innovation."

That still leaves 1.1 billion Indians, the majority of whom live on less than US$2 (Dh7.35) per day.

The ruling will be a particular worry for the Swiss firm Novartis, which is preparing for a landmark case in India's supreme court on March 28.

Novartis hopes to gain exclusive rights in India on its drug medicine Glivec and aims to weaken a clause in India's patent laws that prevents monopolies on all but the most recent and innovative new drugs.

India's patent laws allow generic drug companies to apply for the right to make cheap copies of patented medicines on the grounds of high pricing, rather than wait for the government to take action.

Generic companies can challenge on grounds of high pricing after 3 years of the patent being granted.

Under the compulsory licence, Natco Pharma must pay a 6 per cent royalty to Bayer on its net sales. A royalty system is seen as a possible compromise in the battle between intellectual property rights and providing access to the world's poor.


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