In an ongoing suit filed for infringement of patent numbers IN 268632 and IN 464646 by F. Hoffman La Roche AG against Zydus Lifesciences Limited, the Delhi High Court heard an urgent application by Roche pressing for urgent interim relied against Zydus. It was brought to the attention of the Court that while the issue of interim injunction was still being heard by the Court, Zydus had launched their infringing product Sigrima^®, a biosimilar of Roche’s anti-tumor monoclonal antibody pertuzumab (Perjeta^®) covered by IN 268632 and IN 464646.

In its decision dated July 9, 2024, (F. Hoffmann La Roche AG & Anr. vs Zydus Lifescience Limited [CS (COMM) 159/2024]) in relation to Roche’s urgent application, the Delhi High Court restrained Zydus from marketing Sigrima^® until the next date of hearing.

The infringement suit had been initiated by Roche as a quia timet action to prevent the anticipated release of a similar biologic by Zydus. Amidst the ongoing deliberations on the grant of an interim injunction, Zydus launched their product Sigrima^® and entered into a commercial licensing arrangement with a third party for co-marketing their launched product. This prompted Roche to seek injunctive relief against the sale and distribution of Sigrima^® through an urgent application

Notably, during the arguments on the interlocutory application for interim injunction, while Zydus’s biosimilar was awaiting regulatory approval, they did not adequately disclose information regarding the status of their application for regulatory approvals and their biologic manufacturing processes. This lack of transparency led Roche to request the Court to direct Zydus against launching Sigrima^® into the market. In response, the Court specifically enquired about the status of Zydus’s drug approval application, to which Zydus assured the Court that the regulatory authority was expected to take three months’ time and there was no pressing urgency to restrain them from launching their product. Consequently, the Court did not issue any directive restraining Zydus from proceeding with the launch during the arguments in relation to the interim injunction application.

Despite specific enquiries in subsequent hearings, Zydus did not inform the Court that regulatory approval was imminent. Additionally, there was no disclosure regarding the receipt of approval from the Central Drug Standard Control Organisation and subsequent launch either.

The Court noted Zydus’s failure to provide timely updates on significant developments, particularly when specifically asked during hearings about the timeline for regulatory approvals. Emphasizing the importance of transparency in legal proceedings, especially in a quia timet case of this significance, the Court highlighted that timely and accurate information could have influenced its decisions and the Plaintiffs’ responses, directly impacting the equitable treatment of all parties involved.

The Court stressed that the principle of fairness in procedural conduct, especially in commercial disputes, is essential. The Defendant’s actions raised significant concerns regarding fairness. The Court further underscored that principle of equity requires that no party should gain an undue advantage by withholding information or acting in a manner contrary to the spirit of fair legal proceedings. Zydus’s conduct, according to the Court, demonstrated a potential to undermine the equitable handling of the case. 

Considering these circumstances and the principles of fairness, equity, and the balance of convenience, the Court granted an interim injunction restraining Zydus from marketing Sigrima^® until the next date of hearing of the application. The Court remarked that such an injunction would prevent the market from being flooded with the infringing product, as strategically planned by the Defendant, thereby protecting the Plaintiffs’ interest.

This decision by the Delhi High Court underscores the importance of transparency and fairness in commercial litigation, setting a precedent for equitable resolution.