‘Erlocip’ cancer treating drug manufactured by Cipla, found infringing patent of Swiss pharmaceutical company

Delhi High Court: While addressing to the issue of patent violation, the Court concluded that Cipla (Defendant) was infringing on Swiss pharmaceutical company Hoffman-La Roche’s (Plaintiff) patent in lung cancer drug erlotinib hydrochloride, sold under the name of Tarceva. Cipla’s drug named Erlocip, used for treatment of non-small cell lung cancer, violated the patent rights of Hoffman la Roche, which had patented the basic medicinal compound. The division bench comprising of Pradeep Nandrajog and Mukta Gupta JJ., ruled in favour of Roche after noting that Cipla’s lung cancer medicine, Erlocip, was one polymorphic form of the erlotinib hydrochloride compound, which may exist in several forms, and Roche’s patent claim was not limited to any one such version.

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.”

The bench held that the Cipla drug violated the Roche patent, but has at the same time refused to issue any injunction against Cipla restraining it from manufacturing the medicine, after observing that the life of the patent granted to Roche was ending in March 2016. The Court held“…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),”. It has also imposed case costs of Rs 5 lakh on Cipla to be given to Roche. [Hoffman la Roche Ltd. v. Cipla Ltd., 2015 SCC OnLine Del 13619, decided on 27-11-2015]

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