F. Hoffmann-La Roche AG & Anr. versus Zydus Lifesciences Limited
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.
Factual Background
The plaintiffs, F. Hoffmann-La Roche AG and its affiliate, hold two Indian patents relevant to this dispute:
- Indian Patent No. IN 268632: “Pharmaceutical Formulation Comprising HER2 Antibody” – a product patent covering an aqueous pharmaceutical formulation of Pertuzumab with specific excipients.
- Indian Patent No. IN 464646: “Pertuzumab Variants and Evaluation Thereof” – a process patent detailing a method for producing Pertuzumab and its variants.
The defendant, Zydus Lifesciences Limited, sought regulatory approval to manufacture and sell a similar biologic, ZRC-3277, referencing Perjeta in its clinical trial application. The plaintiffs filed a quia timet suit alleging potential infringement.
Procedural Background
The suit, CS(COMM) 159/2024, included applications for:
- Interim injunctions (I.A. 4196/2024 and I.A. 33509/2024)
- Confidentiality club constitution (I.A. 5827/2024)
Summons were issued on February 23, 2024. The plaintiffs were directed to conduct claim mapping. The defendant filed its manufacturing process under sealed cover on March 22, 2024. After a series of legal developments and appeals, the plaintiffs chose to focus solely on I.A. 5827/2024.
Core Dispute
The central issue: Were the plaintiffs entitled to access the defendant’s manufacturing process through a confidentiality club to verify infringement of their process patent (IN 646)?
The plaintiffs invoked Section 104A of the Patents Act and discovery provisions under the Commercial Courts Act. The defendant argued that prerequisites for applying Section 104A were unmet, and that their product and process differed materially.
Discussion on Judgments
Plaintiffs relied on:
- F. Hoffmann-La Roche v. Drugs Controller General of India (2025 SCC OnLine Del 934) – argued for discovery under Commercial Courts Act.
- Roche Products v. DCGI (2016 SCC OnLine Del 2358) – biologics cannot be identical, Section 104A impractical for biologics.
Court’s response: Distinguished the above, affirming IN 646’s validity and requiring strict compliance with Section 104A.
Defendant relied on:
- Natural Remedies Pvt. Ltd. v. Indian Herbs Research (Karnataka HC, 2011) – identicality must be proven before disclosure.
- Bristol-Myers – supports Section 104A at interlocutory stages.
- Ericsson v. CCI – Patents Act prevails over Commercial Courts Act.
- Pfizer v. Samsung Bioepis (Australia, 2017) – similarity ≠ process infringement.
Reasoning and Analysis
The court focused on Section 104A’s scope, clarifying that it permits burden-shifting only when:
- The plaintiff proves that the defendant’s product is identical to the patented product.
- The patented process is novel or substantially likely used.
The court held that Section 104A applies even at interlocutory stages. The plaintiffs’ discovery request under the Commercial Courts Act was dismissed due to the special nature of the Patents Act. The court emphasized that “identical product” is a legislative threshold that cannot be diluted for biologics.
Claim mapping showed formulation differences (arginine citrate vs. histidine acetate). The defendant’s use of Perjeta as a reference did not imply process infringement. Thus, the plaintiffs failed to meet Section 104A conditions.
Final Decision
The court dismissed I.A. 5827/2024, denying constitution of a confidentiality club. It clarified that the ruling was limited to the application and would not affect the suit’s final outcome.
Law Settled in This Case
- Section 104A governs disclosure in process patent cases and applies at all stages.
- Plaintiffs must prove product identity before invoking Section 104A.
- The Patents Act prevails over general laws like the Commercial Courts Act.
- “Similar biologic” is not equivalent to “identical product.”
- Reference to a branded biologic in regulatory filings does not imply process infringement.
Case Information
- 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
- Judge: Honourable Mr. Justice Amit Bansal
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor – Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539
