Delhi High Court Lifts Injunction, Allows Zydus To Manufacture And Market Lifesaving Cancer Drug

The Delhi High Court on Monday cleared Zydus Lifesciences Limited to manufacture and market its cancer drug ZRC 3276. The court set aside an injunction that had barred the drug's launch over alleged patent infringement of a medicine owned by US-based pharmaceutical major E.R. Squibb.

A Division Bench of Justice C Hari Shankar and Justice Om Prakash Shukla modified an earlier order passed by a single judge.

The Bench held that Zydus could not be restrained from launching a life-saving anti-cancer drug in the absence of clear product-to-claim mapping showing patent infringement, especially in light of paramount public interest.

The court observed, “Given the nature of the product, and applying the principle of balance of convenience, too, the interests of justice would require the appellant to be bound down to maintain accounts of the realizations from the sale of its product till the expiry of the suit patent, rather than depriving the ailing public of access to the product.”

The dispute concerns an Indian patent titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for Use in Treating Cancer”, held by E.R. Squibb, which covers the monoclonal antibody Nivolumab. The drug is marketed globally as Opdivo and in India as Opdyta, and is widely used in cancer treatment. Zydus Lifesciences developed ZRC 3276, a biosimilar version of Nivolumab, claiming that its introduction could make cancer treatment nearly 70% more affordable.

A Single Judge of the Delhi High Court had restrained Zydus from manufacturing or launching the drug, holding that it prima facie infringed E.R. Squibb's patent. Zydus challenged this order before the Division Bench, contending that the injunction was granted without undertaking a proper comparison between its product and the specific claims of the patent.

Accepting Zydus's submission, the Division Bench held that patent infringement must be determined through a product-to-claim mapping, and not by comparing one product with another. The Court noted that at no stage had E.R. Squibb mapped Zydus's product against the claims of its patent, which was essential to establish infringement.

The Bench disapproved the approach adopted by the Single Judge, the Court held that merely characterising a drug as a biosimilar does not give rise to a presumption of patent infringement. The judges also observed that the issue raised complex questions of patent law:

“The issue of whether a biosimilar product can, on that basis alone, be said to be infringing of the reference biologic, appears to us to be extremely thorny. If the impugned judgment is accepted, every biosimilar product would, on that basis alone, infringe the patent claimed by the reference biologic.”

Emphasising public interest, the Court noted that Zydus's product is a life-saving cancer therapy, and restraining its availability without clear proof of infringement would cause serious prejudice to patients. The Bench also took into account that the patent is set to expire on 2 May 2026, leaving only a limited period of exclusivity.

The Court further observed:

“Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives, and it is, therefore, only where the Court is in possession of irrefutable material to indicate that a patented product is being released in the market without permission of the patentee, in breach of Section 48, that an injunction can issue.”

Holding that no prima facie case warranting an injunction against Zydus was made out, and balancing the competing interests, the Court permitted Zydus to proceed with the sale of its drug. However, to safeguard E.R. Squibb's interests, Zydus was directed to maintain detailed accounts of sales and place them on record, should the patentee ultimately succeed in the suit.

Accordingly, the Delhi High Court modified the injunction order and allowed Zydus to market its anti-cancer drug.