F. Hoffmann-La Roche v. Cipla Ltd.

Facts

• Roche held Indian patent for erlotinib (Tarceva), a lung cancer drug priced at approximately Rs.4,800 per tablet
• Cipla launched generic erlotinib (Erlocip) at approximately Rs.1,600 per tablet
• Roche sought interim injunction to restrain Cipla pending trial on merits
• Cipla defended on grounds of patent invalidity and public interest

Issue

1. Whether interim injunction should be granted against a generic manufacturer of a life-saving cancer drug when prima facie infringement is established.

Held

• Interim injunction refused (initial 2008 order; sustained through appeals). The Court balanced: (1) prima facie case of infringement existed; (2) balance of convenience: public interest in affordable cancer treatment outweighed Roche's exclusivity interest; (3) irreparable harm: damages could adequately compensate Roche if infringement is later established; denial of medicine causes irreversible harm to patients. On merits (2015), infringement was established but structured relief balanced access concerns.

Ratio Decidendi

In pharmaceutical patent cases involving life-saving drugs, the court must consider public interest as a factor in granting injunctive relief. Where the patented drug is for a serious/life-threatening condition and the generic alternative significantly improves access, the balance of convenience may favour refusing interim injunction. Monetary damages (accounts of profits/royalty) can adequately compensate the patentee. Denial of access to a life-saving drug constitutes irreparable harm to patients that outweighs the patentee's pecuniary interest.