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Delhi HC bans Zydus' biosimilar Sigrima in a landmark injunction order

Shardul Nautiyal, Mumbai
Wednesday, July 10, 2024, 20:45 Hrs  [IST]

In a landmark injunction order, the Delhi High Court has banned Zydus' biosimilar Sigrima. As per the Delhi HC order, Zydus and Dr Reddy's launched 'Sigrima/Womab,' a biosimilar of Roche's 'Perjeta' (pertuzumab), in a clear contempt of court.

Roche had sought injunctive reliefs against the sale and distribution of Sigrima and Womab, which purportedly infringes Roche's patents numbered IN 268632 and IN 464646. During the court hearings (23rd February, 4th April, 24th April, 13th May, 2024), the biosimilar in question was still pending regulatory approval, and there was a lack of transparency about the processes employed by Zydus in manufacturing their biologic, as well as the status of their application for regulatory approvals.

Given these uncertainties, Roche’s senior counsel had explicitly requested the Court to direct Zydus not to launch their product in the market. Roche counsel argued that Defendant should have kept the Court informed of the expected timelines for obtaining regulatory approvals. Their failure to do so and the subsequent launch of the product amount to overreaching the court process.

During the hearings, in response to Roche Counsel's apprehensions, the Court had specifically inquired from C S Vaidyanathan, Senior Counsel representing the Defendant, about the status of their application for drug approvals. At that time, Vaidyanathan assured the Court that the regulatory authority was expected to take at least three months before making a final decision. Contrarily, today, Vaidyanathan has presented a different stance, stating that the Defendant never specified a timeframe.

Despite specific inquiries in subsequent hearings, the Court was not informed that regulatory approval was imminent. It has now come to light, through this application, that Zydus received approval from the Central Drug Standard Control Organisation (CDSCO) on April 4, 2024. Pertinently, in the hearings conducted after this approval - on April 24, 2024 and May 13, 2024- the defendant chose not to disclose this significant development to the Court.

It was reasonable to expect that Zydus would provide timely updates about significant developments. Specifically, when the Court explicitly inquired about the timeframe for regulatory approvals during the hearings, Zydus had a duty to disclose any pertinent information regarding the launch of the impugned product. Such transparency is crucial in legal proceedings, particularly in a quia timet case of this significance, where timely and accurate information could potentially influence the Court's decisions and the Plaintiff's responses.

The principle of fairness in procedural conduct, especially in commercial disputes is crucial. In this case, failure of Zydus to transparently communicate significant regulatory developments during the Court's deliberations raises serious concerns about fairness. This lack of disclosure directly impacts the equitable treatment of the parties involved, as it deprived Roche and the Court of critical information that could influence the Court's directions.

Zydus's recent undisclosed approval and subsequent commercial launch, bolstered by their business venture with Dr. Reddy's Laboratories, of their biosimilars Sigrima and Womab on 27th and 28th June, 2024 exemplifies a potential to undermine the equitable handling of the case. 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.

In light of these considerations - fairness, equity, and the balance of convenience - the Court finds compelling reasons to issue an injunction. The court takes strong objection to the violations. Zydus and Dr. Reddy's are restrained from marketing/selling their product "Sigrima", which is a biological similar of Plaintiffs" "Perjeta Â"/"Pertuzumab."


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