Section 104A of Patent Act 1970 and Disclosure Challenges in Biologic Patent Litigation
Introduction: The case of F. Hoffmann-La Roche AG & Anr. versus Zydus Lifesciences Limited represents a significant patent infringement dispute in the realm of biological drugs, specifically concerning the monoclonal antibody Pertuzumab, used in treating breast cancer.
This case, adjudicated by the High Court of Delhi, centers on the plaintiffs’ attempt to protect two Indian patents related to Pertuzumab’s formulation and manufacturing process against alleged infringement by the defendant’s similar biologic product. The core issue revolves around the plaintiffs’ application for the constitution of a confidentiality club to access the defendant’s manufacturing process, invoking provisions of the Patents Act, 1970, and the Commercial Courts Act, 2015.
Factual Background: The plaintiffs, F. Hoffmann-La Roche AG and its affiliate, hold two Indian patents relevant to this dispute. The first, Indian Patent No. IN 268632, titled “Pharmaceutical Formulation Comprising HER2 Antibody,” is a product patent covering an aqueous pharmaceutical formulation of Pertuzumab with specific excipients, including sucrose and a histidine acetate buffer, maintaining a pH between 5.5 and 6.5. The second, Indian Patent No. IN 464646, titled “Pertuzumab Variants and Evaluation Thereof,” is a process patent detailing a method for producing a composition comprising Pertuzumab and its variants, such as unpaired cysteine variants and low- or high-molecular-weight species. These patents underpin the plaintiffs’ commercial product, Perjeta, a prescription medicine approved in the United States in 2012 and India in 2014 for treating early-stage and metastatic breast cancer by inhibiting HER2 receptor dimerization.
The defendant, Zydus Lifesciences Limited, an Indian pharmaceutical company, sought regulatory approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell a similar biologic, ZRC-3277, using the plaintiffs’ Perjeta as the reference biologic in its clinical trial application filed on September 9, 2021.
The plaintiffs, upon discovering this through CDSCO’s Subject Expert Committee recommendations in January 2024 and a Clinical Trial Registry of India document, filed a quia timet suit, apprehending that the defendant’s product would infringe their patents. The defendant countered that Pertuzumab itself is not patented, as it was disclosed in prior art (WO/2001/00245) and that their product, using an arginine citrate buffer, differs from the plaintiffs’ formulation and process.
Procedural Background: The suit, filed as CS(COMM) 159/2024, was accompanied by multiple interlocutory applications, including I.A. 4196/2024 and I.A. 33509/2024 for interim injunctions, and I.A. 5827/2024, the focus of this case study, seeking the constitution of a confidentiality club to access the defendant’s manufacturing process. Summons and notice were issued on February 23, 2024, when the court directed the plaintiffs to conduct claim mapping for the product patent (IN 632) against the defendant’s patent application.
The defendant filed its manufacturing process under a sealed cover on March 22, 2024. The plaintiffs’ application for interim injunction (I.A. 33509/2024) was dismissed on October 9, 2024, but this was overturned by a division bench on October 16, 2024, remanding the matter back to the single judge. The defendant challenged this via a Special Leave Petition before the Supreme Court, leading to the lapse of an ad interim injunction on November 21, 2024. The plaintiffs subsequently chose not to press the interim injunction applications, focusing instead on I.A. 5827/2024.
Core Dispute:The central issue in this case was whether the plaintiffs were entitled to access the defendant’s manufacturing process for their similar biologic, ZRC-3277, through a confidentiality club to determine if it infringed the plaintiffs’ process patent (IN 646)? The plaintiffs argued that the defendant’s designation of Perjeta as the reference biologic in its CDSCO application implied that their product and process were substantially similar, necessitating disclosure to map the claims of IN 646. They contended that Section 104A of the Patents Act, which shifts the burden of proof in process patent infringement cases, was inapplicable at this stage and that discovery provisions under the Commercial Courts Act, 2015, should govern.
The defendant countered that Section 104A’s prerequisites—proving that the products are identical and that the patented process likely produces the defendant’s product—must be met before disclosure could be ordered. They argued that their product, a similar biologic, was not identical to the plaintiffs’ product (Pertuzumab plus variants) and that their process, using a different buffer, did not infringe IN 646. The dispute thus hinged on the interpretation of Section 104A, the nature of biologics, and the balance between discovery rights and proprietary protections.
Discussion on Judgments: Several judgments were cited by the parties to support their positions, each contextualized within the arguments over disclosure and Section 104A’s applicability.
The plaintiffs relied on F. Hoffmann-La Roche v. Drugs Controller General of India (2025 SCC OnLine Del 934), where a coordinate bench allowed discovery under the Commercial Courts Act, 2015, noting that Section 104A was irrelevant because the patents in that case had expired. The court in the present case distinguished this, emphasizing that IN 646 was valid, making Section 104A applicable. The plaintiffs also referenced Roche Products v. Drugs Controller General of India (2016 SCC OnLine Del 2358), which clarified that biologics cannot be identical due to their synthesis by living organisms, arguing that Section 104A’s “identical product” requirement was impractical for biologics. The court rejected this, noting that the 2016 case did not address Section 104A directly.
The defendant cited Natural Remedies Pvt. Ltd. v. Indian Herbs Research and Supply Co. Ltd. (O.S. No. 1 of 2004, Karnataka High Court, dated December 9, 2011), where the court held that Section 104A requires proof of identical products before compelling disclosure, and disclosure is not warranted at the pleading or evidence stage unless the patent’s validity and product identity are established. The court in the present case endorsed this, applying it to deny premature disclosure. The defendant also relied on Bristol-Myers (unspecified citation, referenced in the context of an interim injunction appeal), which supported the application of Section 104A at interlocutory stages, reinforcing the need for plaintiffs to meet statutory thresholds. Additionally, the defendant cited Telefoniaktiebolaget LM Ericsson (PUBL) v. Competition Commission of India , which established that the Patents Act, as a special statute, prevails over general laws like the Commercial Courts Act, supporting the primacy of Section 104A. Finally, the defendant referenced Pfizer Ireland Pharmaceuticals v. Samsung Bioepis (MANU/AUF/0847/2017, Federal Court of Australia), which held that similarity in biologics does not imply identical processes, bolstering their argument that their similar biologic did not necessarily infringe IN 646.
Reasoning and Analysis of the Judge : Court focused on the applicability and scope of Section 104A of the Patents Act, which allows courts to shift the burden of proof to the defendant in process patent infringement suits if the plaintiff proves that the defendant’s product is identical to the product of the patented process and that the process is either novel or substantially likely to have been used. The court emphasized that Section 104A is a statutory exception to the general evidentiary principle that the plaintiff bears the burden of proof, but it is not automatic and requires fulfilling specific conditions.
The court rejected the plaintiffs’ argument that Section 104A applies only at the final adjudication stage, citing Natural Remedies and Bristol-Myers to affirm its relevance at interlocutory stages. The court further held that disclosure of the defendant’s process is integral to Section 104A, as sub-section (2) explicitly protects against unreasonable disclosure of trade secrets, indicating that disclosure requests fall within its ambit.
The plaintiffs’ reliance on the Commercial Courts Act’s discovery provisions (Order XI Rules 1(7), 1(12), and 5) was dismissed, as the court, citing Ericsson, ruled that the Patents Act, as a special statute, prevails over general laws. Regarding biologics, the court acknowledged the plaintiffs’ argument, supported by Roche Products, that biologics cannot be identical due to their complex synthesis, but held that Section 104A’s “identical product” requirement is a deliberate legislative choice that cannot be diluted. The court analyzed the Guidelines on Similar Biologics, 2016, noting that a similar biologic requires only comparable safety, efficacy, and quality, not identical processes, and cited Pfizer to reinforce that similarity does not imply process infringement.
The court found that the plaintiffs failed to prove that the defendant’s product, ZRC-3277, was identical to the product of IN 646 (Pertuzumab plus variants), as the defendant’s CDSCO application referenced Perjeta, which the plaintiffs admitted was prior art, not the patented composition. The plaintiffs’ claim mapping for IN 632 showed differences (arginine citrate vs. histidine acetate buffer), further undermining their case. Thus, the court concluded that the plaintiffs did not meet Section 104A’s prerequisites, precluding disclosure.
Final Decision: The court dismissed the plaintiffs’ application (I.A. 5827/2024) for the constitution of a confidentiality club and disclosure of the defendant’s manufacturing process, finding no merit in the request. The court clarified that its observations were limited to the application and would not affect the suit’s final adjudication.
Law Settled in This Case:This case clarifies several aspects of patent law in India, particularly for process patents involving biologics. It establishes that Section 104A of the Patents Act governs disclosure requests in process patent infringement suits, requiring plaintiffs to prove that the defendant’s product is identical to the product of the patented process before compelling disclosure. The court affirmed that this requirement applies at both interlocutory and final stages, rejecting arguments that it is limited to final adjudication. The decision underscores that the Patents Act, as a special statute, prevails over general discovery provisions under the Commercial Courts Act, 2015. For biologics, the court held that the statutory threshold of “identical product” under Section 104A cannot be relaxed to “similar” despite the scientific variability of biologics, preserving the legislature’s intent. The case also highlights that regulatory filings citing a reference biologic do not automatically indicate process infringement, as similar biologics may employ different manufacturing processes.
Case Title: F. Hoffmann-La Roche AG & Anr. versus Zydus Lifesciences Limited
Date of Order: July 23, 2025
Case Number: CS(COMM) 159/2024
Neutral Citation: 2025:DHC:5927:
Name of Court: High Court of Delhi at New Delhi
Name of Judge: Honourable Mr. Justice Amit Bansal
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
