India Pharma Outlook Team | Saturday, 26 July 2025
The Delhi High Court has declined to issue directions to Zydus Lifesciences to disclose the manufacturing process of its breast cancer drug Sigrima, following a plea by Swiss multinational F. Hoffmann-La Roche. The Court held that Roche failed to meet the mandatory prerequisites under Section 104A of the Patents Act, 1970.
The dispute arose from Roche’s allegation that Zydus' Sigrima infringes its patent rights over monoclonal antibody biologic Pertuzumab, marketed as Perjeta. Roche sought to invoke Section 104A, which shifts the burden of proof in process patent infringement cases to the defendant. However, the Court ruled that this provision is only applicable when the plaintiff first proves that the defendant’s product is identical to the one obtained by the patented process and that it is likely made using the same method.
Zydus had submitted its manufacturing details in a sealed cover in March 2024. The Court observed that mere similarity between end products does not establish that the same process was used. It also rejected Roche’s argument that Zydus’ reference to Pertuzumab in its application to the Central Drugs Standard Control Organisation (CDSCO) amounted to an admission of process similarity.
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Justice Amit Bansal, in the July 22 order, said Roche’s shifting stance regarding Section 104A’s applicability at the confidentiality club stage was contrary to the statute. He also noted that Roche had not undertaken any analytical characterization or reverse engineering of Zydus’ product to substantiate its claims.
The Court clarified that its observations are limited to the current application and will not affect the outcome of the ongoing suit.
