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Delhi High Court refuses to direct Zydus to disclose manufacturing process of Sigrima
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Gireesh Babu, New Delhi
July 26 , 2025
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The Delhi High Court has said that it cannot issue direction to Zydus Lifesciences to disclose its manufacturing process of its breast cancer drug Sigrima, as petitioner Swiss multinational firm F. Hoffmann-La Roche failed to fulfil the mandatory requirements to invoke the relevant provisions under the Patents Act, 1970, for the same.
The latest order is in connection with a dispute raised by Roche against Zydus, alleging that the latter's drug Sigrima infringes its patent rights for monoclonal antibody (MAb) biologic drug Pertuzumab, branded as Perjeta.
The Court has been considering enabling confidentiality club and permitting its members to access the process used by Zydus Lifesciences for manufacturing its product Sigrima, invoking the Section 104A of the Patent Act. Zydus had earlier submitted the details of the manufacturing process as sealed, with the Court in March, 2024.
Section 104A shifts the onus of proof from the petitioner to the defendant, in cases involving infringement of process patents. This is based on the premises that the process adopted by a defendant in manufacturing its product would only be known to the defendant and would be difficult for the plaintiff to determine.
The Court observed that the Section applies only when the petitioner proves that the defendant's product is identical to the product directly obtained by the patented process, and there is a substantial likelihood that the identical product is made by the same process.
Merely because the end products are similar, it does not lead to the conclusion that both were derived from the same process.
Considering the argument of Roche that Zydus has referred to Pertuzumab in its product application with the Central Drugs Standard Control Organisation (CDSCO) for the product, the Court said 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.
While Roche, in its interlocutory application has asserted that the grounds for invoking Section 104A of the Act are satisfied, during the oral arguments, it altered the stance, arguing that the Section is not attracted at the stage of constitution of the confidentiality club and is only relevant at the final adjudication stage. The Court observed this as contrary to the statute and dismissed the argument.
It added that the claim mapping filed by Roche also does not help to conclude that the composition described in Roche's product patent and Zydus' patent application for Sigrima are identical.
"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," said the order issued by Justice Amit Bansal on July 22, dismissing the application.
The Court added that any observations made in the judgement are only for the purposes of deciding the present application and would have no bearing on the final adjudication of the suit.
Zydus launched the product in market in June, 2024, but 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, which is a statutory requirement under Section 104A of the Act, observed the Court.
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