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Policy

Roche Is Denied Injunction In Indian Patent Case

Cipla can sell generic version of Tarceva pending final decision

by Jean-François Tremblay
March 26, 2008

The High Court of Delhi has denied Roche an injunction seeking to stop the Indian generic pharmaceutical producer Cipla from selling its version of Roche's lung cancer drug Tarceva. The case marks the first time that an Indian generics company has attempted to market a drug protected under the patent regime that India introduced in 2005.

Without denying that Roche's patent is valid, Justice S. Ravindra Bhat found some merit in Cipla's claim that Tarceva could have been invented, on the basis of publicly available literature, by "a normal but unimaginative person skilled in the art" of formulating pharmaceuticals.

Pending a final decision on the validity of Roche's patent, the judge found that denying lung cancer patients in India the benefits of a cheaper version of a life-saving drug would have been too drastic a step to take. Still, Bhat ordered Cipla to maintain sales records for its drug in the event that the firm must later compensate Roche for patent infringement.

Cipla Chairman Yusuf K. Hamied tells C&EN that a final court decision on the validity of Roche's patent will likely come within a month. "I hope we can set some sort of precedent," he says.

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