Hoffman La Roche wins patent war against Cipla in Delhi High Court

Cipla suffered a setback in the Delhi High Court yesterday when a Division Bench of Justices Pradeep Nandrajog & Mukta Gupta held that the pharmaceutical giant had infringed upon Hoffman La Roche’s patent in manufacturing lung cancer drug ‘Erlotinib hydrochloride’ which is also sold under the name of Tarceva..In the 106-page judgment, the Bench has said that while Cipla’s lung cancer medicine, Erlocip, was one polymorphic form of the Erlotinib Hydrochloride compound, the said compound could exist ‘in several forms’ and that Roche’s patent claim was not limited to any one version.Setting aside the Single Bench order of 2012 which had said that Cipla was not infringing Roche’s patent and refused to grant any injunction against the Indian company, the Bench also 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.”Besides the verdict going against it, Cipla was also ordered to pay costs to the tune of Rs 5, 00, 000/- . However, the Bench declined to grant an injunction in favor of Roche as the patent held by the company was expiring in March 2016.“…affirming the impugned judgment and decree dated September 07, 2012 passed by the learned Single Judge in so far counter claim filed by Cipla seeking revocation of IN ‗577 in favour of Roche has been dismissed, we set aside the impugned decision dismissing suit for injunction filed by Roche……but keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla (because as noted above there was no interim injunction in favour of Roche and due to said reason Cipla continued to manufacture and sell Erlocip).”The verdict came in the background of an appeal filed by both companies following the 2012 order of Justice Manmohan Singh who had held that Cipla had succeeded in proving that its generic version of Tarceva was a polymorph B variant of Roche’s patented drug.However the Bench had not invalidated Roche’s patent over the product either; thereby leading to the dismissal of the suit by Roche and the counter-claim by Cipla.