Delhi High Court Bans Zydus' Pertuzumab Biosimilar Sigrima in Patent Infringement Case
Key Insights
The Delhi High Court issued an interim injunction barring Zydus Lifesciences from selling its breast cancer (search) biosimilar Sigrima (search), a version of Roche's Perjeta (pertuzumab), following a patent infringement lawsuit.
Zydus received conditional approval for its pertuzumab biosimilar on April 4, 2024, and marketing permission on June 27, 2024, but failed to disclose these developments during ongoing court hearings.
The court criticized Zydus for launching the product strategically to establish market presence before potential judicial restrictions, calling it a violation of procedural fairness.
The Delhi High Court has issued a landmark interim injunction restraining Zydus Lifesciences from selling its breast cancer (search) biosimilar Sigrima (search), a version of Roche's Perjeta (pertuzumab), in a patent infringement case that has raised serious concerns about procedural fairness in pharmaceutical litigation.
Court Finds Strategic Launch Violated Legal Process
Justice Sanjeev Narula criticized Zydus for what he termed a strategic move to establish market presence before judicial restrictions could be imposed. The court found that Zydus launched Sigrima (search) on June 27, 2024, despite ongoing litigation, with Dr. Reddy's Laboratories launching their co-marketed version Womab (search) on June 28, 2024.
"The timing of the product's launch suggests a strategic move by the defendant to establish a market presence before any potential judicial restrictions could be imposed," Justice Narula stated in his Tuesday order.
Roche had sought injunctive relief against both Sigrima (search) and Womab (search), arguing they infringe patents numbered IN 268632 and IN 464646. Dr. Reddy's entered into a licensing agreement with Zydus in June to co-market the biosimilar under the brand name Womab.
Regulatory Approval Timeline Concealed from Court
The court took particular exception to Zydus' failure to disclose critical regulatory developments during hearings held on February 23, April 4, April 24, and May 13, 2024. Zydus received conditional approval from the Central Drug Standard Control Organisation (search) (CDSCO) on April 4, 2024, and marketing permission from the National Institute of Biologicals (search) on June 27, 2024.
During court proceedings, C.S. Vaidyanathan, Senior Counsel representing Zydus, had assured the court that regulatory authorities were expected to take at least three months before making a final decision. However, the court noted that despite specific inquiries in hearings conducted after the April 4 approval, Zydus chose not to disclose this significant development.
"It was reasonable to expect that Zydus would provide timely updates about significant developments," the court observed, emphasizing that such transparency is crucial in legal proceedings, particularly in cases of this significance where timely information could influence judicial decisions.
Market Protection Concerns Drive Injunction
The court expressed concern that allowing continued sale and distribution of the biosimilar could alter market conditions and significantly disadvantage Roche, especially if the product is later found to infringe patents.
"An injunction serves as a preventive measure to avoid the market from being flooded with the infringing product, thus protecting the plaintiffs' interests while the substantive issues are conclusively resolved," the order stated.
Clinical Significance of Pertuzumab
Pertuzumab represents a critical treatment for HER2 positive breast cancer (search) patients. Zydus Research Centre's team developed its biosimilar in-house, positioning it as a potentially more accessible alternative to Roche's original formulation.
The case highlights ongoing tensions in the biosimilar market, where companies seek to provide lower-cost alternatives to expensive biologics while navigating complex patent landscapes. Both Zydus and Dr. Reddy's spokespersons declined to comment, citing that the matter remains sub-judice.
The injunction remains in effect while the court considers the substantive patent infringement claims, with the outcome potentially setting important precedents for biosimilar launches during ongoing patent disputes.