The Delhi High Court’s recent decision in Zydus Lifesciences Ltd. v. E.R. Squibb & Sons, LLC [2026:DHC:178-DB, dated 12 January 2026] marks an important precedent in the handling of biosimilars and injunctions.
The Dispute
At the heart of the case was Zydus’s proposed launch of ZRC 3276, a biosimilar to the monoclonal antibody Nivolumab, marketed internationally as Opdivo® and in India as Opdyta®. The Indian patent for Nivolumab (IN 340060) is held by E.R. Squibb & Sons, LLC, a subsidiary of Bristol Myers Squibb. In July 2025, a single judge granted an interim injunction restraining Zydus from marketing its biosimilar on grounds of patent infringement.
The Appeal
On appeal, the Division Bench (Justices C. Hari Shankar and Om Prakash Shukla) overturned the interim injunction and permitted Zydus to market ZRC 3276 until the patent’s expiry in May 2026. To safeguard the patentee’s interests, the Court directed Zydus to maintain detailed accounts of sales and submit them to the Court, ensuring compensation could be awarded later if infringement was ultimately proven.
Ratio Decidendi
In arriving at its decision, the Division Bench emphasized that the injunction had been granted without proper ‘product-to-claim’ mapping, as required under the Delhi High Court Rules Governing Patent Suits, 2022. It rejected the single judge’s reliance on ‘product-to-product’ comparison and assumptions about biosimilars having identical amino acid sequences, reasoning that the appellate court found flawed. The Court also noted the significant price differential, with Zydus’s drug being 70% cheaper, along with the imminence of patent expiry. These factors weighed heavily in balancing intellectual property rights against public interest.
Critical Contradiction
An additional factor that weakened Squibb’s case was a contradiction in its own arguments. During pre-grant patent prosecution, Squibb had defined “specifically binds to PD-1” as requiring no statistically significant cross-binding to other CD28 proteins. Yet in litigation against Zydus, it argued the opposite, claiming that some cross-binding was acceptable. The Division Bench highlighted this inconsistency, noting that both Zydus’s biosimilar and Squibb’s own product showed significant cross-binding, meaning neither met Squibb’s original definition. This contradiction eroded Squibb’s infringement claim and further tipped the balance against granting an interim injunction.
Obiter Dicta
In a striking observation, the Court remarked, “Courts owe a debt to society,” underscoring the imperative to balance intellectual property rights with the broader public interest, particularly in cases involving life-saving medicines.
Broader Implications
This case underscores India’s pro-public interest stance in pharmaceutical patent disputes. It highlights the judiciary’s role in balancing innovation incentives with patient welfare, especially in the context of life-saving drugs. By allowing access while preserving the patentee’s financial rights, the Court struck a pragmatic balance that resonates not only in India but also in global debates on access to medicines.
