The Delhi High Court has declined to direct Zydus Lifesciences to disclose the manufacturing process of its breast cancer drug Sigrima, stating that F. Hoffmann-La Roche failed to meet the mandatory requirements under Section 104A of the Patents Act, 1970.

The ruling stems from Roche’s patent infringement suit against Zydus, alleging that Sigrima violates its patent on Pertuzumab, a monoclonal antibody (MAb) biologic marketed as Perjeta. Roche argued that Zydus' product is derived from the same patented process and sought access to Zydus’ manufacturing method through a confidentiality club, a mechanism that allows sensitive information to be shared securely during litigation.

However, Justice Amit Bansal, in an order dated July 22, noted that Section 104A can only be invoked if the plaintiff first establishes that the defendant’s product is identical to the one directly obtained through the patented process and that there's a substantial likelihood it was made using the same process. The Court held that Roche had not provided sufficient evidence to meet this threshold.

The Court also dismissed Roche’s reliance on Zydus’ product application to the Central Drugs Standard Control Organisation (CDSCO), which referenced Pertuzumab. It ruled that this reference does not prove that Zydus used the same patented process (IN’646) as Roche.

Moreover, Roche’s shift in legal stance—arguing during oral submissions that Section 104A need not be satisfied at this stage—was found to be inconsistent with the law. The Court also noted that Roche had not conducted reverse engineering or analytical characterization of Zydus’ product, which is essential to support claims of similarity under Section 104A.

Zydus had submitted its manufacturing process in a sealed cover in March 2024, but the Court emphasized that no disclosure can be ordered without meeting the legal prerequisites.

“This Court is of the view that the plaintiffs have failed to fulfill the mandatory requirements of Section 104A. Hence, no direction can be issued to the defendant to disclose its manufacturing process,” stated the order. It clarified that the observations were limited to the current application and would not affect the final outcome of the case.

Zydus launched Sigrima in the Indian market in June 2024. The legal dispute remains ongoing, with final adjudication still pending.