Delhi High Court ordered Cadila to allow Hetero’s expert access to sealed regulatory submissions in a biosimilar dispute. The unprecedented discovery ruling may set precedent for IP litigation involving complex technical data.
DHC Allows Discovery of Regulatory Data in Biosimilars Case
In a significant pre-trial order on November 3, 2026, the Delhi High Court permitted Hetero’s court-appointed expert to inspect Cadila Healthcare’s confidential regulatory submissions—sealed and filed with the regulator—as part of a discovery process in an ongoing biosimilar patent dispute. The court held that public interest in access to affordable biologics outweighs commercial confidentiality, especially where equivalence claims are contested.
The ruling arose during interlocutory applications in a suit involving a monoclonal antibody biosimilar. The plaintiff argued that comparative clinical data in regulatory dossiers was essential to challenge the defendant’s equivalence assertions. The court, applying Order XI Rule 1 CPC (now 170 BNSS), directed disclosure under strict confidentiality protocols, including non-disclosure agreements and limited use for expert opinion only.
This decision marks a shift in Indian IP litigation, where access to regulator-held data has traditionally been restricted. For practitioners, it signals greater judicial willingness to order discovery in complex pharmaceutical cases, particularly involving public health. The outcome may influence how courts balance Section 22(3) of the Biological Diversity Act, RTI claims, and common law rights to inspect during litigation. The matter is scheduled for Supreme Court review.
Citations
- Order XI Rule 1 CPC
- Section 22(3) Biological Diversity Act, 2002
