F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd.

Relevant Acts and provisions

Patents Act, 1970

Section 2(1)(j)Section 3(d)Section 48Section 64

Provisions considered: Sections 2(1)(j), 3(d), 48 and 64 of the Patents Act, 1970, on validity and infringement.

Brief facts

Roche held an Indian patent for Erlotinib Hydrochloride, an anti-cancer drug marketed as Tarceva, and sued Cipla for infringement when Cipla launched a generic version called Erlocip. The Single Judge dismissed Roche's application for an interim injunction and, after trial, dismissed the suit, holding that Roche had not proved infringement and that Cipla's challenge to validity had substance. Both parties filed cross-appeals before the Division Bench, Roche seeking a finding of infringement and Cipla seeking revocation of the patent.

Issues before the Court

1. Was the patent for Erlotinib Hydrochloride valid, or liable to be revoked as obvious or barred by Section 3(d)?
2. Was the patent confined to a specific polymorphic form, and did Cipla's product infringe Claim 1?
3. If infringement was established, what relief should follow given the imminent expiry of the patent?

Court's findings

The Court held that Roche's patent for Erlotinib Hydrochloride was valid and not liable to be revoked, rejecting Cipla's contentions on obviousness and rejecting the argument that the invention was barred as a mere derivative of a known substance without enhanced efficacy under Section 3(d). The Court held that Claim 1 was not confined to any particular polymorphic form, disagreeing with the Single Judge's finding that the patent covered only a specific polymorph.

The Court observed that Cipla's product contained Erlotinib Hydrochloride falling within the scope of Claim 1, and accordingly held that Cipla had infringed the patent, reversing the Single Judge on this point.

The Court noted that since the patent was due to expire shortly, an injunction restraining further sales would serve little purpose, and considering the public interest in continued availability of the drug, declined to injunct Cipla but remanded the question of accounting of profits to the Single Judge.

Decision

Roche's patent held valid and infringed; no injunction granted given imminent expiry; costs imposed and the matter remanded for determination of damages or accounts of profits.

Cases cited

• Novartis AG v. Union of India, (2013) 6 SCC 1

Authorities referred to in the decision. Please verify each citation in the judgment itself.

Keywords

Claim Construction Patent Infringement Pharmaceutical Patent Polymorph Section 3(d)