The Delhi High Court permitted a plaintiff to inspect confidential regulatory submissions in a biosimilar dispute, a move with significant implications for patent litigation and data exclusivity norms.
DHC Allows Limited Access to Confidential Regulatory Submissions
In a significant pre-trial discovery ruling, the Delhi High Court has permitted Hetero Labs to examine regulatory dossiers submitted by Cadila Healthcare to the Central Drugs Standards Control Organisation (CDSCO), despite claims of confidentiality. The order, issued in the ongoing patent dispute over an oncology biosimilar, allows Hetero’s expert to review the data in a sealed cover under strict confidentiality protocols.
Judge Pratibha Rani held that the principle of 'efficiency of justice' outweighs commercial confidentiality when the inspection is strictly limited to technical verification and governed by an undertakings regime. The court emphasized that the right to protect trade secrets under TRIPS Article 39.2 must be balanced against procedural fairness under Section 30 of the Specific Relief Act and judicial authority under Order XVI Rule 12 of the CPC.
The court observed that 'where the efficacy and novelty of a biological product are contested, access to regulatory data may be indispensable to test the veracity of claims.'This development precedes the Supreme Court’s hearing of Special Leave Petitions filed by both parties on November 3, 2026, on interim relief and procedural conduct.
For IP practitioners, this signals a shift toward active case management in complex, science-intensive litigation. Courts may increasingly allow limited disclosure of protected data where justified by necessity, potentially affecting strategy in biosimilar, agrochemical, and pharmaceutical disputes. Parties must now anticipate heightened discovery demands and prepare robust confidentiality frameworks.
Citations
- Order in CS(COMM) 123/2025, Cadila Healthcare Ltd v Hetero Labs Ltd (DHC, 2026)
