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Cipla infringing Roche’s patent in lung cancer drug: High Court

New Delhi: In a setback to Cipla, the Delhi High Court on Friday held that the Indian drug major was infringing Swiss pharmaceutical company Hoffman-La Roche’s patent in lung cancer drug erlotinib hydrochloride, sold under the name of Tarceva.

A division bench of Justice Pradeep Nandrajog and Justice Mukta Gupta held that Cipla’s lung cancer medicine, Erlocip, was one polymorphic form of the compound, which may exist in several forms.

“This (the patent) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself. This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent.

“Therefore as Cipla’s Erlocip is admittedly one particular polymorphic form of the erlotinib hydrochloride compound (polymorph B), it will clearly infringe the IN 774 patent (of Roche),” said the court.

It added: “We thus conclude this issue by noting that the single judge’s finding that ‘Tarceva’ and ‘Erlocip’ were based on the polymorph B version of erlotinib hydrochloride, though correct factually, is irrelevant to the subject matter of the present patent as Cipla has clearly infringed Claim 1 of Roche’s IN 774 patent in arriving at the said polymorph.”

The court’s order came on the pleas of Cipla and Roche, both of which had challenged the September 7, 2012 order of a single judge, who had held that Cipla was not infringing Roche’s patent and refused to grant any injunction against the Indian company.


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