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Roche files patent suit against Cipla over Tarceva

Opposes launch of generic version of the lung cancer drug


Cause for difference

Roche patent gives it a 20-year sales monopoly on the drug.

Generic version costs Rs 1,600/tablet against Roche’s Rs 4,800.


P.T. Jyothi Datta

Mumbai, Jan. 18 After Novartis’ cancer drug Glivec, it is Roche’s lung cancer drug Tarceva that has run into litigation, with Roche filing a patent infringement suit against Cipla in the Delhi High Court.

Roche’s patent infringement suit comes after Cipla launched its generic version of Tarceva in the Indian market. The case came up for its first hearing on Friday. Roche India’s Managing Director, Dr Girish Telang, confirmed the development, but did not want to comment on the case.

Cipla’s Chief Executive Officer, Mr Amar Lulla, told Business Line that the generic version of Tarceva had been launched in the domestic market at Rs 1,600. Roche reportedly sells Tarceva at Rs 4,800 per tablet, amounting to over Rs 1 lakh per month, as the medicine is taken once a day.

Erlotinib is the generic version of Tarceva and is being viewed by patient groups and patent experts as the next Glivec.

Roche has been granted a patent on Tarceva, which means the company should have a 20-year sales monopoly on the drug. But with Cipla going ahead and launching the drug, the development is being viewed by Roche as a patent infringement.

Cipla, however, believes that it has a strong case to oppose the Tarceva patent, even after it has been granted in India. In fact, another Indian drug-maker, Natco had opposed Roche’s patent application, before the patent was granted by the Patent Controller’s office.

At present, though, Natco is seeking a compulsory licence on Tarceva to export the drug to Nepal. Natco is believed to have offered a royalty payment to Roche and the issue would now have to be sorted out by the patent office in Delhi.

Patent lawyers point out that the developments around Tarceva are assuming similar contours as Novartis’ Glivec case. With the price difference being steep between Glivec and its generic versions made by local drug companies, Novartis’ patent application on the drug drew attention from local and international patient groups, besides a slew of litigation.

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