The Delhi High Court allowed a rival expert access to confidential regulatory data in a sealed cover in the ongoing Cadila-Hetero biosimilar dispute ahead of the Supreme Court hearing. The order raises critical questions about the scope of discovery and confidentiality in IP litigation.
Delhi HC Permits Rival Expert Access to Confidential Regulatory Submissions
In a significant pre-trial discovery ruling on 3 November 2026, the Delhi High Court directed that a court-appointed expert may examine confidential regulatory data submitted by a pharmaceutical company to drug authorities, despite objections over commercial sensitivity. The order came in the context of the long-running patent dispute between Cadila Healthcare and Hetero Labs over a biosimilar cancer drug, ahead of the Supreme Court’s scheduled hearing on the same day.
The court held that the public interest in ensuring accurate patent enforcement outweighed the plaintiff’s claim to confidentiality, particularly where questions of data integrity and regulatory compliance were central to the case. The data was ordered to be handed over in a sealed cover to the expert, under strict confidentiality undertakings.
"Confidentiality cannot be a shield against legitimate scrutiny where public health and market competition are at stake,"observed the bench.
The decision underscores the judiciary’s increasing willingness to allow forensic examination of regulatory filings in complex IP disputes, especially in the life sciences sector. Practitioners must now anticipate that regulatory submissions, even those designated as confidential, may be subject to limited disclosure under court supervision. This trend may influence settlement strategies and pre-litigation risk assessments in biosimilar and patent linkage cases.
