F. Hoffmann-La Roche Ltd and OSI Pharmaceuticals Inc. v. Cipla Ltd

This dispute concerns a patent infringement and revocation suit over the cancer drug Erlotinib Hydrochloride, sold by the plaintiffs as 'Tarceva'. The plaintiffs, F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc., alleged that Cipla Ltd. was infringing their patent (IN'774) by manufacturing a generic version. Cipla counter-claimed, seeking revocation of the patent on grounds of obviousness, lack of inventive step, violation of Section 3(d) of the Patents Act, and non-disclosure under Section 8. The court found that Cipla failed to prove obviousness or violation of Section 3(d) for the main patent but succeeded in showing non-disclosure under Section 8. However, the court declined to revoke the patent based on its discretion. Crucially, the court found that the plaintiffs failed to prove infringement because their product, Tarceva, was a Polymorph B version of Erlotinib Hydrochloride, which was not intended to be covered by the original patent IN'774, and was instead the subject of a separate patent application (IN'507) that had been rejected in India. Result: Plaintiffs' suit for patent infringement and Cipla's counter-claim for patent revocation were both dismissed.