U.S. trade office reviewing India's Supreme Court drug ruling

WASHINGTON Tue Apr 2, 2013 3:52pm EDT

A Novartis logo is pictured on its headquarters building in Mumbai April 1, 2013. REUTERS/Vivek Prakash

A Novartis logo is pictured on its headquarters building in Mumbai April 1, 2013.

Credit: Reuters/Vivek Prakash

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WASHINGTON (Reuters) - The United States said on Tuesday it was considering its response to an Indian Supreme Court ruling that U.S. drug manufacturers warn is the latest sign of a "deteriorating" environment for intellectual property rights in the country.

"We are ... reviewing the Court's order. We look forward to continued engagement and successful collaboration with India on these issues," said Andrea Mead, a spokeswoman for the U.S. Trade Representative's office.

India's top court on Monday dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec in a victory for Indian manufacturers of cheap generics.

The U.S.-India Business Council on Tuesday joined other U.S. business groups in criticizing the ruling, which bodes badly for other drug companies including Pfizer and Roche Holding AG, which have ongoing disputes in India.

"Over 40 countries including China, Russia and Taiwan have already granted a patent for Novartis' Glivec and India now stands out as unique for not granting a patent to this incremental innovation," the council said in a statement.

"The denial of the Glivec patent may now exclude from patentability many other significant inventions in the pharmaceuticals area," the council said in a statement.

Pharmaceutical Research and Manufacturers of America (PhRMA) said on Monday it was "very disappointed" with the ruling that Glivec was not different enough from previous versions of the drug to warrant patent protection.

"This decision marks yet another example of the deteriorating innovation environment in India," said PhRMA President John Castellani.

Pfizer's chief intellectual property counsel, Roy Waldron, in March told a U.S. congressional hearing India had created a "protectionist regime that harms U.S. job creators" in favor of the country's generic drug manufacturers.

India last year revoked Pfizer's patent for Sutent, a cancer medicine, and is currently considering allowing generic production of additional patented drugs.

"If left alone, this trend will destroy the market for innovative pharmaceuticals in India," Waldron said at the March congressional hearing.

He urged U.S. government officials to pursue both direct talks with India and to "review all available policy tools," including possible action at the World Trade Organization, to defend U.S. intellectual property rights.

The U.S. Trade Representative's office has a chance to further comment on the Indian Supreme Court ruling at the end of this month, when it releases its annual report on intellectual property rights protection around the world.

India is already on that's report "priority watch list" for countries with weak property rights protections.

(Reporting by Doug Palmer; Editing by Todd Eastham)

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