The Delhi High Court has delivered a significant ruling in favor of Zydus Lifesciences, declining to order the disclosure of manufacturing details for its breast cancer drug Sigrima following a patent infringement challenge by Swiss pharmaceutical giant F. Hoffmann-La Roche. Justice Amit Bansal ruled on July 22 that Roche failed to meet the mandatory prerequisites under Section 104A of the Patents Act, 1970.
Patent Dispute Over Monoclonal Antibody Drug
The legal dispute centers on Roche's allegation that Zydus' Sigrima infringes its patent rights over the monoclonal antibody biologic Pertuzumab, which Roche markets as Perjeta. Roche sought to invoke Section 104A of the Patents Act, a provision that shifts the burden of proof in process patent infringement cases from the plaintiff to the defendant.
However, the court determined that this section only applies when the plaintiff first proves that the defendant's product is identical to the one obtained by the patented process and demonstrates a substantial likelihood that the identical product is made using the same method.
Court's Analysis of Manufacturing Process Claims
Zydus had submitted its manufacturing details in a sealed cover to the court in March 2024. The court observed that "merely because the end products are similar, it does not lead to the conclusion that both were derived from the same process."
The ruling also addressed Roche's argument that Zydus' reference to Pertuzumab in its application to the Central Drugs Standard Control Organisation (CDSCO) constituted an admission of process similarity. The court rejected this interpretation, stating that "it cannot be said that the reference made by the Zydus in its application is to the product obtained from the patented process IN'646 of Roche."
Roche's Shifting Legal Strategy
Justice Bansal noted inconsistencies in Roche's legal approach, observing that the company's "shifting stance regarding Section 104A's applicability at the confidentiality club stage was contrary to the statute." Initially, Roche asserted in its interlocutory application that grounds for invoking Section 104A were satisfied, but during oral arguments, it altered its position, arguing that the section was not relevant at the confidentiality club stage.
Lack of Product Analysis
A critical factor in the court's decision was Roche's failure to conduct proper product analysis. The court noted that "Roche had not undertaken any analytical characterization or reverse engineering of Zydus' product to substantiate its claims." This analytical work represents a statutory requirement under Section 104A of the Patents Act.
The court emphasized that Zydus launched Sigrima in the market in June 2024, yet "Roche have not conducted any analytical characterisation or a reverse engineering of the defendant's product to show that the defendant's product is identical, or even similar, to the plaintiffs' product manufactured using the process patent."
Legal Implications and Future Proceedings
Justice Bansal concluded that "the plaintiffs have failed to fulfil the mandatory requirements of Section 104A of the Act. Therefore, no direction can be issued to the defendant to disclose its manufacturing process filed in a sealed cover."
The court clarified that its observations were made solely for deciding the present application and would have no bearing on the final adjudication of the suit. The ruling also noted that the claim mapping filed by Roche did not help conclude that the composition described in Roche's product patent and Zydus' patent application for Sigrima are identical.
This decision represents a significant legal victory for Zydus Lifesciences, protecting its proprietary manufacturing information while the broader patent infringement case continues through the judicial system.
