The Delhi High Court permitted a party to inspect regulatory approvals in a sealed cover, overriding confidentiality claims. The order precedes a Supreme Court hearing on November 3, 2026, and raises questions about the balance between discovery and proprietary data protection in IP litigation.
Delhi HC Allows Examination of Regulator’s Approvals in Ongoing IP Dispute
In a significant development in intellectual property litigation, the Delhi High Court, in the ongoing dispute between Cadila and Hetero, directed that the plaintiff be allowed to examine regulatory approvals submitted by the defendant to drug regulators. The order, issued recently, permitted inspection of such data in a sealed cover, effectively setting aside claims of confidentiality typically afforded to regulatory submissions under Section 26 of the Drugs and Cosmetics Act, 1940.
The court reasoned that the need for transparency and fair adjudication in complex patent and regulatory disputes outweighed the defendant’s interest in confidentiality, particularly where market competition and alleged non-compliance with regulatory norms were in issue. The order was passed under its inherent powers under Section 151 of the Civil Procedure Code, 1908, allowing necessary discovery even when formal rules do not expressly permit it. The court emphasized that the inspection would be limited to an independent expert bound by confidentiality undertakings.
“In matters involving public health and fair competition, the veil of regulatory confidentiality may be pierced where justice so demands,”
the court observed. This approach aligns with precedents such as Novartis v. Union of India, where transparency in drug approval processes was underscored as a public interest concern. The decision is seen as a precedent for discovery in pharmaceutical IP cases, especially where lifecycle management and regulatory exclusivity are contested.
Practitioners should note that this ruling may encourage more aggressive discovery applications in IP litigation. However, the narrow scope—limited to expert inspection under court supervision—suggests courts will proceed cautiously. The matter is scheduled for hearing before the Supreme Court on November 3, 2026, which may clarify the limits of discovery versus regulatory confidentiality.
Citations
- Novartis AG v. Union of India (2010) 3 SCR 732
- Drugs and Cosmetics Act, 1940, Section 26
