Courts must consider public interest before granting injunction against life-saving drugs: Delhi High Court

The Delhi High Court recently held that public interest is an important consideration while deciding whether to grant an injunction denying market access to life-saving drugs [Zydus Life Sciences v. ER Squibb].

A Bench of Justices Hari Shankar and Om Prakash Shukla observed that injunctions on such drugs should not be imposed without a clear product-to-claim comparison.

"Courts have to be acutely conscious of their duties in such matters. The tightrope is shaky, and walking it is not always an enviable enterprise. Our oath of office, however, obligates us to do so and, while doing so, we have to bear in mind our duty to the teeming citizenry of this country who may be in dire need of the therapy, the release of which a plaintiff seeks to injunct."

At the same time, calling for a balanced consideration between patent rights and public interest, the Court said that the "mere fact that the injuncted product is a life saving drug is no absolute armour against injunction".

The Court modified an interim injunction that had restrained Zydus Lifesciences Limited from manufacturing or launching its anti-cancer drug.

The respondents, ER Squibb and Sons and its affiliates, hold a patent relating to monoclonal antibodies targeting Programmed Death-1 (PD-1) for cancer treatment. The patented antibody is internationally known as Nivolumab and is marketed by the respondents as Opdivo outside India and Opdyta in India.

Zydus developed ZRC 3276, describing it as a biosimilar intended for cancer therapy. It asserted that treatment using its product would be significantly cheaper.

Anticipating the commercial launch of ZRC 3276, the respondents filed a patent infringement suit before the Delhi High Court, contending that infringement was imminent. A single-judge restrained Zydus from manufacturing or releasing the product, proceeding on the footing that since the drug had not yet been launched, direct comparison between the product and the patent claims was not possible.

The legal battle centered on whether Zydus’s product infringed upon a patent held by a global pharmaceutical firm. Zydus argued that its drug would be significantly more affordable for patients. While the Court acknowledged the importance of affordable medicine, it maintained that legal protections for inventors must remain intact. The Bench noted:

"Products which infringe patents of others cannot be permitted to circulate in the market. Intellectual property rights are entitled to protection."

A central issue in the appeal was the lack of "product-to-claim mapping," which is a standard requirement for proving patent infringement. As the drug was not yet commercially available, the initial injunction had been granted without a technical comparison between the Zydus product and the patented formula. The Court found this problematic, stating:

"There is admittedly no mapping of the appellant's product...onto the claims in the respondent's suit patent at any stage."

The Court took into account that the patent in question is set to expire in early May 2026. Given the short timeframe remaining, the Bench determined that a total ban on the drug's release was no longer a proportionate response. The judges observed that as only a few months remain,

"This arrangement would...ensure that the availability of the appellant's product to the public, who may be in need of it, is not restrained any further."

Rather than maintaining a total block on the drug, the Court substituted the injunction with a financial reporting requirement. This allows the product to be sold while ensuring the patent holder can seek damages if infringement is later proven. The Court concluded:

"In these circumstances, we are of the opinion that the interests of justice would be adequately subserved if the impugned judgment is modified by vacating the injunction...and requiring the appellant, instead, to file...audited accounts of the amounts earned by the appellant by sale of the allegedly infringing product, till the expiry of the suit patent."

Zydus Lifesciences Limited was represented by Senior Advocates Abhishek Manu Singhvi and Dayan Krishnan with Advocates Adarsh Ramanujan, Bitika Sharma, Vrinda Pathak, PS Manjunathan, Rajnish Kumar, Aakashi Lodha, Shreedhar Kale, Parth Singh, Chanan Parwani and Rishi Agrawala.

ER Squibb was represented by Senior Advocate Sandeep Sethi with Advocates Pravin Anand, Archana Shanker, Prachi Agarwal, Devinder Singh Rawat, Elisha Sinha, Manan Mondal, Krisna Gambhir and Shreya Sethi from Anand & Anand.

[Read Judgment]