Supreme Court allows patent mapping in cancer drug dispute between Squibb and Zydus

The Supreme Court on February 11 permitted ER Squibb and Sons LLC and its affiliates to undertake a “product-to-claim mapping” exercise against Zydus Lifesciences Limited’s cancer drug [ER Squibb Vs Zydus].

To facilitate this exercise, a Bench comprising Chief Justice of India (CJI) Surya Kant and Justice Joymalya Bagchi directed that a sample of the product be supplied by Zydus to Squibb within 24 hours.

Product-to-claim mapping is the technical exercise of comparing each feature of an allegedly infringing product with the specific elements of a patent’s claims to determine whether the product falls within the scope of the patented invention.

The Court was hearing an appeal arising out of a January 12 judgment of the Delhi High Court.

Noting that Zydus’ product is already available in the market, the Court granted liberty to ER Squibb to carry out direct mapping of the product with the patented claims.

The Bench further clarified that subject to the outcome of the mapping exercise, the petitioners (ER Squibb) may approach the Division Bench of the Delhi High Court for appropriate interim directions. The appeal was accordingly disposed of.

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

A single-judge of the Delhi High Court had initially restrained Zydus from launching its product on the ground that, since it had not yet been commercialised, direct product-to-claim comparison was not possible.

On appeal, a Division Bench of Justices C Hari Shankar and Om Prakash Shukla of High Court on January 12 found this approach problematic on the ground that there was admittedly no mapping of the Zydus’ product onto the claims in the suit patent at any stage.

The Division Bench held that courts must weigh public interest before granting injunctions that block access to life-saving drugs.

Thus, the Division Bench modified the interim injunction which had restrained Zydus from manufacturing or launching its anti-cancer drug ZRC 3276, a biosimilar intended for cancer therapy.

The Bench underscored the need for balance, noting that courts must remain conscious of their duty to patients who may be in dire need of therapy whose release is sought to be injuncted.

Given that Squibb's patent is set to expire in early May 2026 and only a few months remain, the High Court vacated the blanket injunction and instead required Zydus to file audited accounts of the revenue earned from the allegedly infringing product until expiry of the patent.

This led to the appeal before the apex court.

The Supreme Court has now allowed the product-to-claim mapping and the High Court will then take a call based on the outcome of that exercise.

ER Squibb and Sons LLC and its affiliates were represented by Senior Advocates Mukul Rohatgi and Shyam Divan along with a team from Anand & Anand and Karanjawala & Co comprising advocates Pravin Anand, Ruby Singh Ahuja, Archana Shanker, Prachi Agarwal, Kritika Sachdeva, Megha Dugar, Elisha Sinha, Manan Mondal, Tribhuvan Narain Singh, Keshav Sehgal and Yashvardhan Singh.

Zydus Lifesciences Limited was represented by Senior Advocates AM Singhvi and Neeraj Kishan Kaul along with advocates Mahesh Agarwal, Rishi Agrawala, Chanan Parwani, Abhinabh Garg, Bitika Sharma and L Nidhi Ram.

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