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The Division Bench of the Delhi High Court (HC), on October 16, 2024, reinstated the injunction preventing Zydus from manufacturing, selling, or marketing its breast cancer drug Sigrima, a biosimilar of Roche's pertuzumab (Perjeta). The decision, made in response to Roche's appeal on October 16, 2024, reversed an earlier order from October 9, 2024.
Recently, the single bench of the Delhi HC had vacated the injunction restraining Zydus from selling or marketing its product ‘Sigrima’ vide its order dated October 9, 2024. However, the court had extended the injunction for an additional two weeks, until October 23, 2024, to allow Roche to file an appeal. Zydus subsequently challenged this extension of injunction before the Division Bench of the Delhi HC, which, after hearing the matter, accepted Zydus’s plea and permitted the sale and marketing of “Sigrima” as on October 15, 2024.
In an official statement following the ruling, Roche stated, "On October 16, 2024, the Division Bench of the Delhi HC, upon hearing the appeal of Roche, has reinstated the injunction in favour of Roche. This injunction once again restrains Zydus from manufacturing, selling, or marketing Sigrima.”
This now reinstates the legal position previously pronounced by the Delhi HC in its order dated July 9, 2024 where it had originally barred Zydus from launching Sigrima due to ongoing patent infringement litigation initiated by Roche. Zydus had controversially introduced the product to the market on June 27, 2024, after receiving "conditional" regulatory approval from the National Institute of Biologicals (NIB) in April, while the legal dispute was still underway.
Roche had sought injunctive reliefs against the sale and distribution of Sigrima, which purportedly infringes on Roche’s patents numbered IN 268632 and IN 464646. Roche had on July 9, 2024, received a temporary injunction order against Zydus from a previous bench of the High Court, restraining Zydus from marketing, selling their product Sigrima.
The court had taken objection to Zydus launching the drug even as the litigation pertaining to the case was underway and Zydus not providing timely updates about significant regulatory developments.
“The timing of the product’s launch suggests a strategic move by the defendant (Zydus) to establish a market presence before the potential judicial restrictions could be imposed,” Justice Sanjeev Narula had said in his July 9 order.
Zydus' legal and regulatory challenges are exacerbated by ongoing scrutiny of the clinical trials for Sigrima. In April 2024, Roche requested the Drugs Controller General of India (DCGI) to investigate potential lapses in Zydus’ trial process, including allegations of unauthorized sourcing of the reference drug. Roche has maintained that the safety of patients should remain the top priority, urging regulators to ensure that any biosimilar approved for sale adheres to rigorous standards.
Patient safety has been a key issue in the Roche-Zydus dispute, with Roche raising concerns about the quality, efficacy, and regulatory compliance of Zydus' biosimilar. Roche has in the past argued that biosimilars have an important role to play in the sustainability of healthcare systems. At the same time, any biosimilar introduced in the market should meet the highest standards of safety, efficacy and quality in the interest of patients and enable healthcare professionals to make informed decisions.
Recent FDA observations concerning manufacturing practices at Zydus have also raised concerns about manufacturing practices and product quality, highlighting the need for rigorous compliance. Maintaining stringent manufacturing practices is essential to protecting India’s reputation as a trusted player in the global pharmaceutical landscape.
The court’s decision underscores the importance of patient safety and sends a clear message that deviations from protocols will not be tolerated.
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