SC refuses stay on Zydus cancer drug launch, tells BMS to seek relief in HC

Apex court declines to halt Zydus' biosimilar nivolumab launch, asks Bristol Myers Squibb to seek interim relief before Delhi High Court

The Supreme Court on Wednesday refused to stop Zydus Lifesciences from proceeding with the manufacture and sale of its biosimilar version of the cancer drug nivolumab, sold globally by US-based Bristol Myers Squibb (BMS) under the brand Opdivo.

 

At the same time, the Court asked BMS to undertake a detailed mapping of Zydus’ product concerning its patent claims and seek appropriate interim relief before the Delhi High Court, depending on the outcome of that exercise.

 

BMS had moved the apex court after the Delhi High Court, in an order dated January 12, permitted the Ahmedabad-headquartered drugmaker (Zydus) to commercialise its version of nivolumab. The multinational pharma company has alleged that Zydus’ product infringes its patent rights.

 

 

Zydus, however, maintained that its biosimilar would reduce treatment costs by nearly 70 per cent compared with the innovator product, and argued that its formulation does not violate BMS’ patent. It also pointed out that the patent itself is under challenge, with a post-grant opposition pending through a group entity.

 

The Delhi High Court, while refusing to restrain Zydus, underscored the public interest dimension of the dispute.

 

Observing that the drug in question is life-saving, the High Court had noted that where issues are complex and require a full trial, courts must weigh the consequences of restricting access to essential therapies. It cautioned that withholding such treatment from patients could result in serious and irreversible harm.

 

The Supreme Court also took into account the limited remaining term of BMS’ patent, which is set to expire on May 2. With only a few months left before expiry, the bench indicated that the arrangement struck by the High Court would balance competing interests while ensuring that patients in need are not denied access to the medicine during the intervening period.

 

BMS had argued that Zydus was conducting clinical trials and preparing for launch during the subsistence of the patent. Zydus rejected these claims, reiterating that its product does not infringe and that the patent’s validity is itself contestable.