Similar Isn’t Identical? How the Roche v. Zydus Judgment Interprets Section 104A – SpicyIP

The Delhi High Court, in its recent Pertuzumab patent dispute decision, interpreted the application of Section 104A in biologics patent disputes. Breaking down the decision, Subhalaxmi Mukherjee writes on what the provision seeks to prevent and how the Court clarified its scope to curb fishing expeditions in pharma patent disputes. Subhalaxmi is a third-year B.Sc LL.B. (Hons.) student at the West Bengal National University of Juridical Sciences (WBNUJS), Kolkata. She is interested in a wide range of public and commercial law subjects, including intellectual property, gender rights, and international arbitration.

Similar Isn’t Identical? How the Roche v. Zydus Judgment Interprets Section 104A

By subhalaxmi mukherjee

A single-judge bench of the Delhi High Court, while passing a judgment in F. Hoffman-La Roche AG and Anr v. Zydus Lifesciences Limited on July 23, 2025, had an opportunity to deliberate upon the applicability of Section 104A of the Patents Act, 1970 (“the Act”) in biologics patent disputes. For context, Section 104A provides that in process patent infringement cases, the burden shifts to the defendant to prove they used a different process, but only after the patentee first establishes that the defendant’s product is identical to that of the patentee’s product obtained through the patented process. The judgment was passed in the ongoing Pertuzumab patent dispute (previously discussed here and here). Pertuzumab is a life-saving biologic drug used in the treatment of HER2-positive metastatic breast cancer. Crucially, the Court in this case made it clear that Section 104A doesn’t draw a line between biologics and non-biologics, applying to both equally. Even though biologics, by their very nature, resist exact replication, the Court brushed aside this argument by Roche and held them to a stringent standard, i.e. to satisfy the prerequisite that Zydus’ product is identical to Roche’s product, for the Court to direct disclosure of Zydus’ manufacturing process.

This post unpacks the Court’s reasoning to see how the burden shifts between the parties and understand why that actually makes sense.

What Triggered the Patent Battle in Roche v. Zydus?

Roche filed a suit seeking a permanent injunction against Zydus for allegedly infringing two of their Indian patents, i.e. IN 268632 and IN 464646 (“the suit patents”). The suit patents comprised a product patent and a process patent, both involving the drug Pertuzumab, or as marketed by Roche, Eternity. Anticipating that Zydus intended to launch a biosimilar version of the drug, Roche had initiated a because it is afraid action (previously discussed here, here and here), which triggered a lengthy litigation that continues to unfold.

On February 23, 2024, the Court, acknowledging the technical complexity of the dispute, directed Roche to undertake a ‘claim mapping’ exercise, comparing the claims of the product patent with Zydus’s patent application to assess potential infringement. To facilitate this, Zydus was ordered to submit its manufacturing process in a sealed envelope. The Court had noted that, if necessary, it would establish a ‘confidentiality club’ to regulate access to this sensitive information. Now, Roche has filed the present application seeking a direction to Zydus to disclose the manufacturing process of Sigrima (the alleged biosimilar whose launch Roche had anticipated) to the members of the confidentiality club.

What did the Parties Argue?

To shift the burden of proof under Section 104A, Roche advanced three primary arguments. Firstlyit challenged the applicability of Section 104A at the stage of confidentiality club formation, stating that this question must arise at a later stage in the trial. Secondlywhile countering the allegation that it had failed to meet the threshold of ‘absolute replication’ required to invoke Section 104A, Roche argued that such a threshold holds no weight for biologics like Eternity and that the correct standard should be a ‘high degree of similarity’ as established by the Guidelines on Similar Biologics, 2016 (“the Guidelines”), which it claimed to have met. Finally, it invoked Order XI of the Civil Procedure Code, 1908which talks about discovery and inspection in civil suits, arguing that under the general discovery provisions, there is no requirement to establish a First facie case.

Zydus opened its submissions by arguing that there is no valid basis for seeking disclosure, as Roche has failed to establish a First facie case of infringement. To bolster its argument, Zydus contends that both Pertuzumab and its manufacturing process have been public law; i.e. a part of the public domain, since as early as 1986. Hence, the entire foundation of Roche’s claim is rendered dubious, as how does one claim exclusivity over a well-established public knowledge? It also pointed to inconsistencies in Roche’s submissions, noting that while Roche earlier claimed to meet the prerequisites of Section 104A in their interim applications, it now argues the provision does not apply at this stage at all. Zydus stated that disclosure to the confidentiality club cannot be sought without first invoking Section 104A. It further maintained that while its product was a biosimilar of Pertuzumab, it was not identical. FinallyZydus dismissed Roche’s reliance on the general discovery provisions, reiterating that special laws like the Act prevail over general ones.

Strict Standards Apply: How the Court Interpreted Section 104A and the Threshold of Identity

The Court began by deconstructing Section 104A, identifying it as a departure from the general rule that the burden of proof lies on the party asserting a fact. The Court acknowledged that the provision is specifically designed for process patent infringement cases, where the plaintiff faces clear informational asymmetry due to the defendant’s undisclosed manufacturing process. However, it also underscored the narrow scope of the provision’s application, noting that its invocation requires strict compliance with the legislative prerequisites embedded within it. This narrow application is owed to the sensitive nature of the commercial information involved, and since the provision attempts to protect companies from being compelled to disclose such information without a sufficient basis, the standard applies at all stages, from interim to final.

Turning to the interpretation of ‘identical’, the Court referred to precedents such as Natural Remedies Pvt. Ltd. v. Indian Herbs Research and Supply Co. Ltd. (Karnataka High Court, 2011) and Bristol-Myers Squibb Holdings Ireland v. Mylan Laboratories Limited (Telangana High Court, 2014) and clarified that ‘identical’ means ‘exactly alike’ and is materially distinct from ‘similar’, the former being a much higher threshold. In the present case, the Court observed that Roche had not submitted any document or evidence establishing that Zydus’ product was identical to theirs. The Court, while noting this shortcoming, refused to water down the strict standard of proof needed to shift the burden onto the defendant, regardless of whether the product is biological or not.

Due to Roche’s failure to establish sufficiently convincing evidence of similarity between its product and Zydus’ allegedly infringing formulation, it did not meet the conditions required to invoke Section 104A and, as a result, had no legitimate basis to seek any disclosure from Zydus. Consequently, the Court dismissed the present application and stated that proof of absolute identity between the two products in question is a sine qua non for the applicability of this provision.

Conclusion

This judgment addresses a textbook example of a fishing expedition and solidly shuts down such backdoor attempts to gain illegitimate access to a competitor’s commercial secrets. The term describes an overly inquisitive plaintiff using disclosure provisions to their advantage, on flimsy or unproven grounds. Roche’s demand for disclosure of Zydus’s process patent, without meeting the prerequisites of Section 104A and relying on technicalities to sidestep a key safeguard, illustrates this perfectly. Section 104A is indeed a powerful tool for plaintiffs seeking to overcome the significant informational gap in process patent cases. However, the Act also recognises the serious burden placed on an alleged infringer when they are compelled to disclose highly valuable commercial data. That’s precisely why the law embeds strict mandatory conditions for its invocation. The Court’s decision to hold the line and insist on compliance with these safeguards is therefore a welcome move; it prevents misuse of the provision to fish for information or punish a party without the establishment of a First facie legal injury. That said, Roche’s argument, that a different standard of proof should apply to pharmaceutical drugs due to their unique scientific nature, is worth noting. Whether this reflects a genuine scientific limitation or simply a clever attempt to dodge legal obligations, however, remains an open question.