Pfizer Inc., holder of US Patent No. 9,777,441 for crystalline forms of Tafamidis sold as VyndaMax, filed infringement suits in the US District Court, Delaware against Cipla and Hikma upon their ANDA submissions; to gather evidence from Indian third-party manufacturer Softgel Healthcare allegedly supplying the API, the US court issued letters rogatory under the Hague Convention; the Madras High Court single judge allowed execution by appointing a commissioner in O.P.(PT) Nos.5 & 6 of 2024 on 28.01.2025; Softgel appealed contending the request contravenes India's Patents Act 1970 and India's reservation against pre-trial discovery; the division bench, finding the request aimed at pre-trial documents which India excludes under Article 23 of the Hague Convention, lacking specificity under Article 3, and prejudicial to sovereignty under Article 11 given Softgel's pending Indian patent application, allowed the appeals on 25.11.2025 setting aside the single judge order and dismissing the applications for commission.
- India has declared under Article 23 of the Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters, 1970 that it will not execute letters of request issued for pre-trial discovery of documents (Para 33).
- Letters rogatory from a foreign court must contain the specificity required under Article 3 of the Hague Convention; vague or non-specific requests are not enforceable in India (Para 34).
- Under Article 11 of the Hague Convention, a person may refuse to give evidence if it would prejudice the sovereignty or security of the requested state, particularly when the evidence relates to a pending patent application in India (Para 34).
- Execution of letters rogatory in India under Order XXVI Rules 19-22 read with Section 78 CPC is subject to compliance with the Hague Convention and India's reservations thereunder; requests for pre-trial discovery in patent matters pending in India may be refused (Para 32).
Case Title: Softgel Healthcare Pvt. Ltd. Vs Pfizer Inc. & Ors.
Order Date: 25 November 2025
Case Number: L.P.A. Nos.17 & 18 of 2025
Neutral Citation: Not yet assigned
Court: High Court of Judicature at Madras
Judge: Hon’ble Dr. Justice G. Jayachandran & Hon’ble Mr. Justice Mummineni Sudheer Kumar
[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]
[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]
