Delhi High Court Denies Relief To Roche In Patent Case Against Zydus, Emphasizing Need For 'Claim Mapping'

Delhi High Court Denies Relief To Roche In Patent Case Against Zydus, Emphasizing Need For 'Claim Mapping'

In a significant ruling, the Delhi High Court has denied an application for an ad interim injunction filed by F. Hoffmann-La Roche AG and Genentech Inc. against Zydus Lifesciences Limited regarding the marketing of the biosimilar product “Sigrima.” The Court emphasized that such relief cannot be granted without thorough claim mapping to establish patent infringement.

Justice Saurabh Banerjee observed that merely holding a registered patent is insufficient for an injunction. He stated, “Without any ‘claim mapping,’ there is no basis for this Court to render any finding against the defendant.”

The plaintiff, Roche and Genentech, is an established pharmaceutical entity with a rich history in healthcare innovation. It holds Indian Patent Nos. IN 464646 and IN 2686323 for its drug Pertuzumab, which is critical for treating HER2-positive breast cancer. The plaintiff alleged that Zydus’s Sigrima product infringed upon these patents and sought a permanent injunction to prevent its marketing, demanding the recall of existing stocks.

Initially, the High Court had issued an injunction on July 9, 2024, but this decision was revisited as new evidence emerged during hearings.

The plaintiff contended that its patents were being infringed, seeking an immediate injunction based on the similarities between Sigrima and Pertuzumab. It sought to restrain Zydus and its affiliates from selling or distributing Sigrima.

Conversely, Zydus argued that the plaintiff had failed to present a prima facie case of infringement. It pointed out the lack of claim mapping in the plaintiff's submissions and asserted that restricting access to Sigrima would negatively impact public health by limiting affordable treatment options.

Justice Banerjee elaborated on the importance of claim mapping in patent law, asserting, “Granting an injunction merely on the basis of a registered patent cannot be the intention of the legislature.” He remarked that without adequate evidence of claim mapping, the Court could not conclude that Zydus was infringing the plaintiff's patents simply because Sigrima is a biosimilar of Pertuzumab. “The same shall render the purpose of the existence of the provisions of the Patent Act, 1970 otiose,” he stated, stressing the need for a meticulous examination of patent claims.

In its ruling, the Court acknowledged the broader implications of its decision, particularly concerning public access to affordable healthcare, reiterating that the absence of claim mapping undermined the plaintiff's position. Justice Banerjee highlighted that the relief sought was discretionary and dependent on the plaintiff demonstrating a prima facie case, balance of convenience, and likelihood of suffering irreparable harm. The plaintiff failed to establish these criteria, prompting the Court to reflect on the potential impact of its decision on public health. The plaintiff had not only failed to substantiate their claims adequately but also did not address the implications of claim mapping in their submissions.

The court concluded, “Without referring to or arguing anything regarding ‘claim mapping,’ the plaintiff has not made out any case in their favor against the defendant.” Ultimately, the Delhi High Court dismissed the application for an ad interim injunction, ruling that the plaintiff had not met the necessary criteria to warrant such relief.