Zydus Lifesciences Limited v. E.R. Squibb and Sons, LLC & Ors.

Brief facts

By a judgment dated 18 July 2025 in CS(COMM) 376/2024, a Single Judge of the Delhi High Court restrained Zydus from manufacturing or releasing its product ZRC 3276, an anti-cancer biologic, at the instance of the patentees. Zydus appealed to the Division Bench. The suit patent was due to expire on 2 May 2026.

Issues before the Court

1. Whether the interim injunction restraining launch of ZRC 3276 should be sustained.
2. What weight public interest carries in an interlocutory patent injunction where the product is a life-saving drug.

Court's findings

The Division Bench held that, besides the classical tests of prima facie case, balance of convenience and irreparable loss, public interest is a pre-eminent consideration when deciding whether to grant an interlocutory injunction.

Where the issue is triable or involves complicated technical questions and the product is a life-saving drug, the Court must err in favour of public interest and secure the plaintiff's interest by alternative means, short of keeping the drug off the market while the suit is pending. An injunction should issue only where there is irrefutable material that a patented product is being released without the patentee's permission in breach of Section 48 (para 26.5.8).

On the facts, the issues that led the Single Judge to grant the injunction were extremely technical, would require expert evidence, and did not make out a clear prima facie case (para 26.5.9). The approaching expiry of the patent on 2 May 2026 reinforced this view (para 26.5.10). On other issues the Bench declined to substitute its own view for the Single Judge's, applying the Wander principle.

Decision

Appeal allowed in part. The injunction was vacated and Zydus was directed to file, with the Registry and an advance copy to the respondents, audited accounts of amounts earned from sales of the allegedly infringing product until the suit patent expired. No costs. This is an interim decision; it does not decide infringement or validity.

Important paragraph references

Para 26.5.8: public interest and life-saving drugs; para 26.5.9: no clear prima facie case on highly technical issues; para 26.5.10: imminent expiry of the patent; paras 27-29: operative directions.
Related: this judgment modifies E.R. Squibb and Sons, LLC v. Zydus Lifesciences Limited (Delhi High Court, 18 July 2025), also on IP Lex.

Important: This case note is a research summary only. It must be verified against the full judgment by a qualified lawyer, advocate or patent/trade mark attorney before any reliance. Do not rely on it as legal advice; Ragulika IP accepts no responsibility for its accuracy or for any action taken on it.