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PatentAllowed May 6, 2019

Eisai Co. Ltd. & Anr. v. Satish Reddy & Anr.

2019:DHC:2476

Court
Delhi High Court
Bench
J.R. Midha, J.
Outcome
Allowed
Date of judgment
5/6/2019

Statutory provisions

Section 3(d), Patents Act 1970 — Exclusions from patentability for new forms or derivatives of known substances without enhanced efficacySection 48, Patents Act 1970 — Exclusive rights conferred on a patenteeSection 64, Patents Act 1970 — Grounds for revocation of patentsSection 83, Patents Act 1970 — General principles governing the working of patented inventionsSection 84, Patents Act 1970 — Compulsory licensing remedies for non-working of patentsSection 165, Indian Evidence Act 1872 — Power of a judge to put questions or order production

Key issue

Whether the patentee of an anti-obesity compound is entitled to an interim injunction restraining generic competitors from marketing a specific salt form where the patent had not yet been commercially launched in India and the competitors failed to clear the path before obtaining regulatory approval.

Summary

The plaintiffs instituted an infringement suit seeking an interim injunction against the defendants to prevent them from launching an anti-obesity drug covering the patented molecule Lorcaserin and its salts. In response, the defendants argued that their salt form was excluded from the suit patent, asserted that the patent was invalid, and highlighted that the plaintiffs had not worked the invention in India. The court rejected these defenses at the interlocutory stage, finding that the broad genus patent covered the contested salt form and that non-working should be addressed via compulsory licensing rather than unauthorized manufacture. Additionally, the court underscored that the defendants failed to seek revocation or clear the way before securing commercial permissions despite acknowledging the plaintiffs' patent. Consequently, the court granted an interim injunction restraining the defendants from manufacturing or distributing the infringing pharmaceutical product pending final disposal of the suit. Result: Plaintiffs' application for interim injunction allowed; defendants restrained from manufacturing, marketing, or offering for sale the patented drug pending trial.

Tags

#pharmaceutical patent#interim injunction#genus patent#clearing the way#non-working of patent#Lorcaserin#Section 3(d)#Section 48
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