“Identity Before Disclosure” – Delhi High Court Clarifies Section 104A Prerequisites and Supremacy of the Patents Act over Commercial Courts Act in Process-Patent Suits

Introduction

In F-Hoffmann-La Roche AG & Anr. v. Zydus Lifesciences Ltd. (2025 DHC 5927) the Delhi High Court was asked to set up a confidentiality club and compel the defendant (Zydus) to disclose, under seal, the manufacturing process of its newly launched biosimilar “Sigrima” (pertuzumab). The plaintiffs (Roche/Genentech) hold two patents:

IN 268632 – product/formulation patent for an aqueous pertuzumab formulation (expires Oct 2025).
IN 464646 – process patent covering a method of preparing pertuzumab with defined variants (expires Apr 2034).

Roche feared infringement and sought quia-timet injunctions, plant-wide disclosure under a confidentiality club, and interim relief. Those injunctions were either vacated or withdrawn. The sole live issue became disclosure of Zydus’ process. Justice Amit Bansal’s judgment comprehensively analyses the interplay of:

Section 104A of the Patents Act 1970 (burden of proof in process-patent suits);
Order XI discovery provisions of the Commercial Courts Act 2015;
Biosimilar regulatory guidelines; and
The requirement of “identical” products as a jurisdictional fact for shifting the burden.

Summary of the Judgment

The Court dismissed Roche’s application (I.A. 5827/2024) for constitution of a confidentiality club and access to Zydus’ sealed process documents. Key holdings:

Section 104A applies at the interlocutory stage; plaintiffs must first prove that the defendant’s product is identical to the product directly obtained by the patented process.
“Similar” biosimilarity under CDSCO guidelines is not equivalent to “identical” under Section 104A; mere regulatory reference to the originator biologic does not establish identity of either product or process.
The Patents Act is a special statute; its Section 104A overrides the broader discovery tools in Order XI CPC as amended by the Commercial Courts Act.
Because Roche failed to demonstrate identity (its process yields pertuzumab + variants, while Zydus’ filings refer only to pertuzumab), the statutory pre-conditions for shifting the burden and compelling disclosure were not met.
The Court therefore refused disclosure and dissolved the confidentiality-club request, leaving merits to trial.

In-Depth Analysis

Precedents Cited and Their Influence

Natural Remedies Pvt. Ltd. v. Indian Herbs Research (Karnataka HC, 2011): First Indian exposition of Section 104A; emphasised “identical, not similar” products as sine qua non. Justice Bansal cites and follows this ratio.
Bristol-Myers Squibb v. Mylan (A.P. HC, 2014): Reiterated identicality requirement; adopted in present case to show Section 104A activates only after identity proved.
Centrient Pharma v. Dalas Biotech (Del HC, 2021): Warned against “fishing and roving” discovery in process-patent suits. Used to deny Roche’s interrogatory-styled request.
Telefonaktiebolaget LM Ericsson v. CCI (Del HC, 2023, DB) & Ericsson v. Lava (Del HC, 2024): Affirmed primacy of specialised patent statute over general statutes; relied on to prefer Patents Act over Commercial Courts discovery regime.
Pfizer Ireland v. Samsung Bioepis (Fed. Court of Australia, 2017): Not Indian precedent but persuasive; held biosimilarity alone does not imply identical manufacture.

Legal Reasoning

Statutory Construction of Section 104A
• Section 104A(1) conditions: (a) new product; or (b) substantial likelihood; and plaintiff must first prove the defendant’s product is “identical”.
• Section 104A(2) protects defendant’s trade secrets; therefore disclosure orders must be judicious and only after conditions met.
Temporal Applicability
The Court rejects Roche’s plea that Section 104A is “only for final trial” reasoning: the statute does not postpone its application; earlier Karnataka/A.P. authorities have applied it pre-trial.
Hierarchy of Laws
Employing the doctrine generalia specialibus non derogant, the specialised Patents Act overrides Order XI CPC discovery provisions where the two conflict.
Identity vs. Similarity in Biosimilars
Regulatory definitions (CDSCO/DBT 2016 Guidelines) focus on safety & efficacy, not molecular/process identity. Thus a biosimilar being “similar” or using originator as “reference product” does not satisfy Section 104A’s statutory “identical” threshold.
Factual Application
• Roche’s own pleadings show IN 646 yields “pertuzumab + variants”.
• Zydus’ CDSCO filings cite only “pertuzumab” as reference drug.
• No analytical data or reverse-engineering provided by Roche to prove Zydus’ launched product is identical to “pertuzumab + variants”.
Consequently, burden cannot shift; disclosure refused.

Impact and Implications

Discovery Strategy in Process-Patent Litigation – Plaintiffs must now anticipate a higher evidentiary burden pre-discovery. Reverse-engineering or detailed analytical testing will be crucial before approaching court.
Biosimilar Industry – Innovators cannot assume that biosimilarity filings equate to patent infringement; they must separately establish identity as defined by patent claims.
Procedural Precedent – Reinforces that Section 104A is available at interlocutory stages and that confidentiality-club orders cannot circumvent statutory prerequisites.
Interplay of Special and General Statutes – Confirms a line of case-law favouring the Patents Act over later commercial-procedure legislation where conflict exists (an aspect likely to influence future commercial suits outside IP domain as well).

Complex Concepts Simplified

Biosimilar (Similar Biologic): A “follow-on” biologic that is highly similar to an approved originator biologic in terms of safety, efficacy, and quality. Due to cellular production, it can never be a molecular replica (unlike small-molecule generics).
Section 104A (Burden of Proof): A special rule in Indian patent law for process patents. Ordinarily the plaintiff must prove infringement, but if (and only if) the plaintiff shows the defendant’s product is identical to the patented product, the court may compel the defendant to prove it uses a different process.
Confidentiality Club: A procedural mechanism permitting limited, secure access to sensitive documents to a small set of lawyers/experts bound by confidentiality undertakings.
Generalia Specialibus Non Derogant: Legal maxim meaning a special statute overrides a general one when both deal with the same subject matter.

Conclusion

Justice Amit Bansal’s decision re-anchors Indian process-patent jurisprudence to the statutory language of Section 104A. The judgment unequivocally states that:

“Identity precedes disclosure.”

Until a patentee proves that the impugned product is the same as the patented output, courts will not compel a defendant to open its laboratory doors—even under the cloak of a confidentiality club. For biologics, this means innovators must perform rigorous analytical and comparative studies rather than rely on regulatory filings. For litigants generally, the ruling underscores the Patents Act’s primacy over broader commercial-procedure reforms. The case thus sets a significant procedural precedent that will shape discovery tactics, biosimilar litigation, and the delicate balance between patent enforcement and protection of trade secrets in India.