INTRODUCTION: SETTING THE SCENE

On 23 July 2025, the Delhi High Court, under Justice Amit Bansal, issued a significant judgment in a patent dispute between F. Hoffmann-La Roche (a global pharmaceutical company) and Zydus Lifesciences (an Indian pharmaceutical manufacturer). This decision is particularly significant for companies involved in biopharmaceutical patent disputes, especially those related to process patents which protect the method or process used to make a product (not the product itself). In this case, Roche tried to use a legal provision Section 104A of the Indian Patents Act, 1970 to force Zydus to disclose the details of its manufacturing process for a biosimilar drug (Sigrima), which is similar to Roche’s patented biologic drug (Perjeta). Section 104A allows courts, under certain conditions, to shift the burden of proof in process patent cases. This judgment is especially significant for companies engaged in biopharmaceutical innovation and competition in India, as it clarifies the judicial approach to enforcing process patents and balancing proprietary rights with the interest of generic and biosimilar manufacturers. The court’s ruling will likely influence future litigation and the development of biosimilar markets in India and beyond.

UNDERSTANDING SECTION 104A OF THE PATENTS ACT, 1970 (INDIA)

Section 104A of the Patents Act, 1970 deals with the burden of proof in process patent infringement cases. In general, the law requires the plaintiff (the person who files the case) to prove that the defendant has infringed the patent. However, in cases involving process patents which protect the method of making a product it is often difficult for the plaintiff to know exactly what process the defendant used, since the method is not publicly visible. To address this challenge, Section 104A allows the burden of proof to shift from the plaintiff to the defendant, but only when two specific conditions are met. 

• First, the plaintiff must show that the defendant’s product is identical to the product obtained by the patented process. 

• Second, the plaintiff must prove that either the process leads to a new product or that it is highly likely the same process was used, and that the plaintiff has made reasonable efforts but could not find out the exact process used by the defendant.

If both these conditions are satisfied, then the burden shifts to the defendant, who must then prove that their process is different from the patented one. This provision helps ensure that patent holders can enforce their rights effectively, especially when direct evidence of the infringing process is not accessible.

INSIDE THE COURT’S REASONING

The Court’s judgment in F- Hoffmann -La Roche Ag & Anr vs Zydus Lifesciences Limited provided crucial legal clarifications, particularly regarding the interpretation and application of Section 104A of the Patents Act. A key issue addressed was the distinction between “identical” and “similar.” The Court emphasized that these terms are not synonymous, citing precedents such as Natural Remedies v. Indian Herbs and Bristol Myers Squibb v. Mylan. It held that “identity” requires exact sameness and cannot be equated with mere “similarity.” This distinction is especially significant in the context of biosimilars like Sigrima, where regulatory frameworks including the Central Drugs Standard Control Organization (CDSCO) Biosimilar Guidelines permit products that are similar, but not identical, to the reference biologic. However, under Indian patent law, particularly Section 104A, the Court reaffirmed that the legal standard demands identity, not similarity.

Roche contended that the burden of proof under Section 104A should apply only at the final adjudication stage, and not during interlocutory or interim proceedings, such as the establishment of a confidentiality club. The Court rejected this argument, clarifying that Section 104A is applicable at all stages of litigation, including interim ones. This interpretation broadens the scope of Section 104A’s application earlier in the dispute resolution process than Roche had advocated.

Furthermore, the Court examined the relationship between general procedural law and specialized statutory provisions. Roche sought to invoke discovery rules under the Civil Procedure Code (CPC), as amended by the Commercial Courts Act, 2015. The Court, however, underscored that Section 104A, as a special provision within patent law, supersedes the general discovery mechanisms of the CPC, thereby reinforcing the precedence of sector-specific legislation over general procedural rules in cases of conflict.

Ultimately, Roche’s application was dismissed. The Court observed that Roche failed to establish the requisite identity between its patented product and Zydus’ biosimilar. While Roche’s patent covered Pertuzumab and its variants, Zydus’ regulatory filings referred only to Pertuzumab itself. More critically, Roche did not conduct any analytical testing or reverse engineering of Sigrima to prove identity with the patented product. The absence of such concrete technical evidence significantly undermined Roche’s case, resulting in the rejection of its application.

WHY THIS JUDGMENT MATTERS

The judgment significantly impacts patent litigation involving biosimilars. It strengthens confidentiality protections by ruling that innovators must first prove the defendant’s product is identical before seeking access to confidential manufacturing details. It also raises the bar for plaintiffs, requiring strong analytical or reverse-engineering evidence in process-patent cases before discovery is granted. The Court clarified that regulatory similarity does not satisfy the legal requirement of identity under patent law. Importantly, the ruling affirms that the Patents Act overrides general civil procedure in case of conflict, reinforcing the authority of specialized patent legislation in such disputes.

CONCLUSION

The Delhi High Court’s judgment in the F- Hoffmann -La Roche Ag & Anr vs Zydus Lifesciences Limited case marks a pivotal moment in the landscape of biopharmaceutical patent litigation in India. By interpreting Section 104A of the Patents Act with greater clarity, the Court has set a precedent that strengthens the protection of process patents while simultaneously safeguarding the confidentiality of manufacturing information. The ruling underscores the necessity for patent holders to establish exact product identity through robust technical evidence before compelling disclosure of proprietary processes, thereby preventing undue advantage based on mere regulatory similarity. Furthermore, the judgment reinforces the supremacy of specialized patent law provisions over general procedural rules, ensuring that the unique complexities of biopharmaceutical innovations are appropriately addressed within the legal framework. For innovators and biosimilar manufacturers alike, this decision brings greater legal certainty and balance, fostering a fairer environment for competition and innovation in the Indian pharmaceutical industry. In essence, the F- Hoffmann -La Roche Ag & Anr vs Zydus Lifesciences Limited ruling not only delineates the boundaries of burden of proof in process patent disputes but also highlights the evolving interplay between patent rights and regulatory approvals in the age of biosimilars.