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India Revokes Roche Hepatitis Patent

An Indian panel Friday revoked a patent granted to Swiss giant Roche for a hepatitis C drug, marking the latest setback for global pharmaceutical firms in the country's $12 billion medicine market.

The Intellectual Property Appellate Board overturned the patent awarded by the Indian Patent Office to Hoffmann-La Roche's drug Pegasys, citing a lack of evidence that it was a "new class" of drug.

The ruling represents another blow to western drug firms in India that have been looking to the country of 1.2 billion people to boost sales but are worried about patent protection and fear competition from its generic knockoffs.

While Roche can still challenge the decision in India's courts, patients' advocacy groups called the ruling a significant victory.

"If we get the manufacture of lower-costing generic drugs, millions suffering from hepatitis C -- both in India and globally -- will benefit," said patients' rights lawyer Anand Grover.

"This is a big win for hepatitis C patients," Grover told Agence France Presse.

India is the world's leading exporter and manufacturer of cheap, non-branded medicines -- mainly to other poor, developing countries.

Earlier this year, the same board allowed a local firm to produce a vastly cheaper copy of Bayer's patented drug Nexavar for liver and kidney cancer, saying the $5,300 price charged by the German company was "exorbitant".

The decisions involve interpretation of new patent protection rules introduced by India in 2005 to comply with World Trade Organization regulations.

The patent appeal board said on Friday it had found no proof that Pegasys was a "new class" of drug. "In the end, the invention is held to be obvious," the board said, ordering the patent to be "set aside".

The ruling was in response to an appeal against the patent filed by a Mumbai non-profit group, The Sankal Rehabilitation Trust, which helps drug users who frequently contract hepatitis C through use of dirty needles.

Hepatitis C -- a viral disease transmitted largely through infected blood that can lead to liver cirrhosis and cancer -- represents a huge public health problem in India and globally.

Patients with chronic Hepatitis C had to purchase Pegasys at a market price of up to 436,000 rupees ($8,750) for a course of treatment, a price that is beyond the means of most poor patients, the Sankal trust said.

Some 10 million to 12 million Indians, including 50 percent of injecting drug users, are infected with the virus, but many receive no treatment because of the high cost, according to the trust.

"People are dying due to hepatitis C because they cannot afford to buy the medicine," said trust director Eldred Tellis.

There was no immediate reaction available from Roche, which was granted a patent to market Pegasys in 2006.

Source: Agence France Presse


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