The Delhi High Court permitted a rival company's expert to examine confidential regulatory approvals in a sealed cover, rejecting claims of confidentiality. This pre-Supreme Court discovery order raises significant IP and regulatory data protection questions.
DHC Allows Limited Access to Regulator’s Approvals in Biosimilar Litigation
In a significant development ahead of the Supreme Court hearing in the Cadila-Hetero biosimilar dispute, the Delhi High Court on 3 November 2026 ruled that confidential regulatory data submitted to drug regulators could be accessed by the plaintiff’s expert under strict confidentiality. The order allows discovery of data related to drug approvals, traditionally considered privileged, in a sealed cover format to balance commercial sensitivity and fair litigation.
The case concerns a biosimilar cancer drug, where the plaintiff, Cadila Healthcare, alleged patent infringement by Hetero Biopharma. Central to the dispute is whether data generated for regulatory approvals—typically protected under Section 22 of the Drugs and Cosmetics Act, 1940 and data exclusivity norms—can be disclosed during inter partes litigation. The DHC held that
"the right to confidentiality cannot be absolute when weighed against the administration of justice and the need for informed judicial determination", setting a precedent for future pharma litigation.
Implications for IP and Regulatory Practice
Practitioners must now anticipate greater judicial scrutiny of regulatory dossiers in IP disputes. The order signals a shift toward transparency in data usage, potentially affecting how companies structure regulatory submissions and defend patent claims. With the Supreme Court set to hear the Special Leave Petition, this discovery ruling may influence broader questions on data exclusivity and patent linkage in India’s evolving biopharma regime.
Citations
- Drugs and Cosmetics Act, 1940, Section 22
