Erlotinib Judgement Cipla Vs Roche
A division bench (judgement dated 27th Nov 2015) of the Delhi High Court sided with Roche against Indian firm Cipla, upholding the Swiss drug maker’s patent claims on key lung cancer drug erlotinib hydrochloride, branded Tarceva. Cipla’s Erlocip was launched in 2008 it cost around Rs 1,600 per tablet, as compared to Roche’s Tarceva which cost around Rs 4,800 per tablet.
The bench said “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)…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”
However, the bench did not grant any injunction in favour of Roche by restraining Cipla, saying the patent in favour of the Swiss company would expire in March 2016 and no such order had been passed by the single judge and the Indian company had continued to manufacture and sell Erlocip. “We decree that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip, for which purpose suit filed by Roche against Cipla is restored with direction that it be listed before the joint registrar who would record evidence pertaining to the profits made by Cipla concerning the offending product. Thereafter the report of the joint registrar shall be placed before the single judge as per roster for appropriate orders,” the bench said.
Also the bench in its judgement imposed a cost of Rs 5 lakhs on Generic company Cipla.
Read Full judgement: Cipla Vs Roche_Erlotinib
Source: Delhi High Court
