Introduction

On July 9, 2024, in F-Hoffmann-La Roche Ag & Anr v. Zydus Lifesciences Limited [1], the Delhi High Court issued a temporary injunction preventing Zydus Lifesciences from selling its breast cancer drug, Sigrima. This biosimilar of Roche’s Pertuzumab (marketed as Perjeta®) became the center of a patent infringement lawsuit initiated by Roche against Zydus and Dr. Reddy’s Laboratories.

Facts

F-Hoffmann-La Roche AG (the Plaintiff) sought interim relief against the sale and distribution of “Sigrima,” claiming it infringed upon their patents IN 268632 and IN 464646. Zydus Lifesciences (the Defendant) had entered a commercial licensing agreement with Dr. Reddy’s Laboratories to co-market “Sigrima” in India. Despite ongoing legal proceedings, Zydus launched Sigrima after obtaining regulatory approval without informing the Court in a timely manner.

Court Proceedings and Issues

The Court had specifically inquired about the status of Zydus’ regulatory approval during multiple hearings. On February 23, 2024, Zydus’ counsel indicated that approval was pending and could take up to three months. However, Zydus received conditional approval from the Central Drug Standard Control Organization (CDSCO) on April 4, 2024, and full approval to market the drug on June 27, 2024. Despite this, Zydus did not disclose these developments to the Court in subsequent hearings on April 24, 2024, and May 13, 2024. This lack of transparency was seen as overreaching the court process.

Court’s Rationale

The Court emphasized that Zydus’ failure to communicate significant regulatory developments during the legal proceedings compromised the principles of fairness and equity. The Defendant’s non-disclosure deprived both the Plaintiff and the Court of critical information that could have influenced the timing and content of judicial orders. Had complete and accurate timelines been disclosed to the Court, it would have allowed the Court to schedule the hearings more effectively, and issue timely and appropriate orders. The delay in informing the Court of these developments raised questions about procedural fairness and the Defendant’s adherence to transparency norms. The Court found this lack of transparency particularly troubling, as it allowed Zydus to potentially gain an undue advantage by launching their product before a legal resolution was reached.

Balance of Convenience and Injunction

The timing of Sigrima’s market launch suggested a strategic move by Zydus to establish a presence before any judicial restrictions. The Court recognized that allowing Zydus to continue selling Sigrima could unfairly disadvantage Roche if the product was later found to infringe on Roche’s patents. Therefore, the Court issued an injunction, preventing Zydus from marketing or selling Sigrima until the next hearing, thereby protecting Roche’s interests while the substantive issues are resolved.

Our Analysis and Conclusion

The injunction against Zydus Lifesciences, preventing the sale of Sigrima highlights the complexities of biosimilar launches and patent protection in India. It serves as a preventive measure to ensure that market is not affected by a product whose legal status is still in dispute. Additionally, maintaining transparency in disclosing any developments during the legal proceedings related to the biosimilar launch is essential to ensure procedural fairness and equity. By restraining Zydus from marketing or selling their product, the Court prevented irreversible harm to Roche’s market position and patent rights. Fairness, equity, and the balance of convenience favoured Roche as any harm or market advantage gained by Zydus during the interim period could be prejudicial to Roche.

The granted injunction remains in effect until the next hearing date. However, the Court’s reasoning could set a precedent, potentially leading courts to grant quia timet injunctions that impose a significant burden on defendants to be fully informed about all aspects of allegedly infringing products. Though the decision will be given after next hearings scheduled in this matter, the outcome of this case may set important precedents for future disputes concerning biosimilars and patent rights in India.