“No Blanket Bans on Cancer Drugs”: Delhi High Court Reworks Patent Injunction Test

“No Blanket Bans on Cancer Drugs”: Delhi High Court Reworks Patent Injunction Test

Introduction

The Delhi High Court has underscored that courts must consciously weigh public interest before granting injunctions that deny market access to life-saving medicines. While affirming the sanctity of patent rights, the Court cautioned against mechanically restraining affordable therapies without adequate technical scrutiny, particularly where patients’ access to critical treatment is at stake.

Factual Background

The dispute arose between Zydus Lifesciences Limited and ER Squibb and Sons along with its affiliates. ER Squibb holds a patent covering monoclonal antibodies targeting Programmed Death-1 (PD-1), used in cancer treatment. The patented molecule, internationally known as Nivolumab, is marketed as Opdivo globally and Opdyta in India. Zydus developed ZRC 3276, a biosimilar intended for cancer therapy, asserting that it would be significantly more affordable and thus widen patient access.

Procedural Background

Anticipating the commercial launch of ZRC 3276, ER Squibb instituted a patent infringement suit before the Delhi High Court. A Single Judge granted an interim injunction restraining Zydus from manufacturing or launching the drug, reasoning that since the product had not yet been launched, a direct comparison with the patent claims was not feasible.

Zydus challenged this order before a Division Bench comprising Justices C. Hari Shankar and Om Prakash Shukla.

Issues

1. Whether an injunction restraining a life-saving drug can be sustained without a clear product-to-claim comparison.

2. How courts should balance patent rights with public interest in access to essential medicines.

3. Whether the interim injunction was proportionate, given the impending expiry of the patent.

Contentions of the Parties

Zydus argued that the injunction effectively blocked access to a more affordable cancer therapy and was granted without any technical mapping of its product to the patent claims. It emphasised the public interest in access to life-saving medicines.

ER Squibb contended that patent rights must be robustly protected and that infringing products cannot be allowed to enter the market merely because they relate to life-saving drugs.

Reasoning and Analysis

The Court acknowledged the delicate balance required in such cases, observing that courts “have to be acutely conscious of their duties” when dealing with injunctions affecting access to critical therapies. It stressed that judges must keep in mind their responsibility to the “teeming citizenry” that may be in urgent need of such drugs.

At the same time, the Bench clarified that the life-saving nature of a drug does not provide absolute immunity from injunctions, reiterating that “products which infringe patents of others cannot be permitted to circulate in the market.”

A decisive factor for the Court was the absence of product-to-claim mapping, a foundational requirement for establishing patent infringement. The Bench noted that there was admittedly no technical comparison of Zydus’s product with the claims of the suit patent at any stage, rendering the basis of the original injunction unsatisfactory.

The Court also took into account that the patent was due to expire in early May 2026. Given the limited remaining term, the Bench held that a complete restraint on the drug’s launch was no longer a proportionate response. It reasoned that continued restraint would unnecessarily delay access to treatment for patients who may urgently require it.

Decision

The Delhi High Court modified the interim injunction. Instead of continuing the total restraint on Zydus, the Court vacated the injunction and directed Zydus to maintain and file audited accounts of all revenues earned from the sale of the allegedly infringing product until the patent’s expiry. This arrangement, the Court held, adequately balanced patent enforcement with public interest by preserving the patent holder’s right to claim damages while ensuring that patient access to potentially life-saving therapy was not further curtailed.

In this case the appellant was represented by Dr. Abhishek Manu Singhvi and Mr. Dayan Krishnan, Sr Advs. with Mr. Adarsh Ramanujan, Ms. Bitika Sharma, Ms Vrinda Pathak, Mr. P.S. Manjunathan, Mr Rajnish Kumar, Ms. Aakashi Lodha, Mr. Shreedhar Kale, Mr. Parth Singh, Mr. Chanan Parwani and Mr. Rishi Agrawala, Advocates.

Meanwhile the respondent was represented by Mr. Sandeep Sethi, Sr. Adv., Mr. Pravin Anand, Ms. Archana Shanker, Ms. Prachi Agarwal, Mr. Devinder Singh Rawat, Ms. Elisha Sinha, Mr. Manan Mondal, Mr. Krisna Gambhir and Ms. Shreya Sethi, Advocates.