Roche Slammed for Seeking Zydus' Confidential Process for Cancer Drug Sigrima Without Meeting Patent Threshold
Delhi High Court
New Delhi: In a major relief to Zydus Lifesciences, the Delhi High Court dismissed F. Hoffmann-La Roche's plea seeking disclosure of Zydus' manufacturing process for its biosimilar of Pertuzumab, branded as Sigrima. The Court held that the threshold conditions under Section 104A of the Patents Act, 1970 had not been met, and hence Roche was not entitled to disclosure at this stage.
Roche filed a suit seeking permanent injunction against Zydus for allegedly infringing two Indian patents relating to its breast cancer biologic Pertuzumab, sold under the brand Perjeta. The two patents in question were: IN 268632 – a formulation patent covering pharmaceutical composition comprising Pertuzumab; and IN 464646 – a process patent for manufacturing Pertuzumab and its variants.
Zydus had procured Perjeta vials in 2023 and used the reference drug to seek regulatory approvals. Based on Zydus' application to the CDSCO and clinical trial registry referencing Perjeta, Roche alleged imminent launch and infringement, filing the suit as a quia timet action to prevent a potential future infringement.
Senior counsels for Roche argued that since Zydus used Perjeta as the reference product for its biosimilar Sigrima, there was a “reasonable apprehension” that Zydus was using the same process protected under IN’646.
Roche submitted in court filings: “The defendant’s process of manufacturing the similar biologic... is within the special knowledge of the defendant only… it is imperative that the defendant discloses its process to the members of the confidentiality club…”
They relied on Order XI Rules 1(7), 1(12), and 5 of the CPC (as amended by the Commercial Courts Act, 2015), arguing that discovery of the defendant’s process was essential for infringement mapping and that no prima facie case was required for such discovery.
Zydus, represented by senior advocates Dushyant Dave and Rajshekhar Rao, opposed the plea and stated: “The plaintiffs have failed to establish a prima facie case of infringement of patent against the defendant… The attempt is a backhanded effort to access proprietary information under the garb of confidentiality club formation.”
They further argued that Section 104A of the Patents Act sets a high bar before requiring a defendant to disclose its manufacturing process, and that Roche failed to show the “identicality” of products — a statutory prerequisite.
Zydus emphasized that the plaintiffs' own biosimilar guidelines (from CDSCO/DBT) clearly state that biosimilars are only “similar” and not identical, which defeats the core requirement under Section 104A.
Although Roche had asserted in its interlocutory application that the conditions for invoking Section 104A of the Patents Act were met, it later changed its position during oral arguments. It contended that Section 104A is not applicable at the stage of setting up a confidentiality club and becomes relevant only during the final adjudication. The Court rejected this shift in stance, holding it to be inconsistent with the statutory framework.
The Court also noted that Roche’s claim mapping does not establish that the composition disclosed in its product patent is identical to the one described in Zydus’ patent application for Sigrima.
Justice Amit Bansal agreed with Zydus, holding that Section 104A does apply at the interlocutory stage when disclosure is sought:
"From a plain reading of Section 104A of the Act, there is nothing to suggest that Section 104A cannot be invoked at an earlier stage, particularly when the plaintiffs are seeking disclosure of the defendant’s process by way of an interlocutory application.”
Citing precedent, the Court said:
“The products of the plaintiff and the defendant being identical is a sine qua non for the applicability of Section 104A of the Act. Mere similarity between the two products would not suffice.”
On Roche’s contention that biosimilar cases warrant a relaxed interpretation, the Court said:
“The statutory use of the term ‘identical’ reflects the legislature’s conscious choice, and to read the same in a lower threshold would amount to judicial dilution of the requirement.”
The Court also refused to bypass Section 104A by invoking general discovery provisions under CPC, stating:
"The Patents Act is a specialized legislation dealing with cases relating to patents including patent infringement cases, whereas the Commercial Courts Act, 2015 is a general legislation dealing with all commercial disputes. It is a settled position of law that provisions of a special statute would always prevail over the provisions of general law. Therefore, Section 104A of the Act would prevail over the discovery provisions under the CPC as amended by the Commercial Courts Act, 2015."
Subsequently, the Delhi High Court dismissed Roche’s application (I.A. 5827/2024), noting:
"Based on the aforesaid discussion, in my considered view, 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 further clarified that the observations made in the judgment are limited to the present application and will not affect the final adjudication of the suit.
To view the original judgement, click on the link below:
