Third parties can be compelled to provide evidence if it aids justice.
Introduction: This case concerns an international patent dispute between Pfizer Inc. and Softgel Healthcare Pvt. Ltd., arising from litigation pending before the United States District Court, Delaware. The petitioners sought to execute Letters Rogatory under the Hague Evidence Convention, 1970, requesting judicial assistance from the Madras High Court for collecting evidence and recording testimony related to alleged patent infringement concerning the pharmaceutical drug VYNDAMAX® (Tafamidis 61 mg capsules), used in the treatment of Transthyretin Amyloid Cardiomyopathy.The main issue before the Madras High Court was whether it could execute the Letters Rogatory and direct the appointment of a Local Commissioner to collect evidence from Softgel Healthcare, an entity based in India but not a party to the U.S. litigation.
Petitioner's submission: Petitioner alleged that Indian pharmaceutical companies, including CIPLA and Zenara (now Hikma), had filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of VYNDAMAX® before the expiry of Pfizer’s U.S. Patent No. 441.
Respondents Submission: Respondent Claimed to be an independent entity not involved in the U.S. litigation.Allegedly possessed documents and information related to Zenara and CIPLA’s ANDA products, which Pfizer sought for use in the U.S. litigation.
Proceedings in the U.S.:Pfizer filed lawsuits against Zenara, CIPLA, Aurobindo Pharma Ltd., and Dexcel Pharma Technologies Ltd. in the U.S. District Court, Delaware.The U.S. Court issued Letters Rogatory on May 13, 2024, requesting the Madras High Court’s assistance in collecting testimonies and documentary evidence from Softgel Healthcare. Reliefs Sought by Pfizer in India:Appointment of a Local Commissioner to collect evidence/documents.Formation of a Confidentiality Club to safeguard sensitive information.Conducting in-camera proceedings to protect confidential data.Forwarding the collected evidence to the U.S. Court in a sealed cover.
Petitioners (Pfizer Inc. and Others): The Hague Evidence Convention, 1970, allows international judicial assistance in civil and commercial matters.Softgel Healthcare possessed relevant documents and information concerning Zenara and CIPLA’s generic versions of VYNDAMAX®.The Madras High Court had jurisdiction under Order XXVI Rules 19-22 of CPC and Sections 75-78 CPC to execute the Letters Rogatory.There was no violation of India’s sovereignty or security, as required under Article 12 of the Hague Convention for denying a request.The petition did not violate Indian patent laws, as the evidence was sought only for U.S. litigation and not for enforcing Pfizer’s patent in India.Past precedents support executing Letters Rogatory, including: Aventis Pharmaceuticals Inc. vs. Dr. Reddy’s Laboratories Inc. (AP High Court),Pfizer Inc. vs. Unimark Remedies Ltd. (Bombay High Court),Wooster Products Inc. vs. Magna Tek Inc. (Delhi High Court)
Respondent (Softgel Healthcare Pvt. Ltd.):Softgel was not a party to the U.S. litigation, making the request unjustified. Confidentiality concerns: Disclosing sensitive pharmaceutical R&D data could harm commercial interests. Article 39 of the TRIPS Agreement protects confidential business data. Pfizer’s Indian patent application for VYNDAMAX® was rejected under Section 3(d) of the Patents Act, 1970 (for being a modification of a known substance).The Hague Convention cannot override Indian laws if disclosure violates domestic regulations.The request amounted to a fishing expedition, violating Article 23 of the Hague Convention.Gujarat High Court precedents (Leighton International Ltd. and Fenix Diamonds LLC) held that Indian courts are not bound to execute Letters Rogatory against third parties.
Key Legal Precedents Considered:Societe Nationale Industrielle Aerospatiale vs. U.S. District Court, 482 U.S. 522 (1987) (U.S. Supreme Court)Clarified that international judicial assistance should be granted unless it disrupts national interests.Norwich Pharmacal Co. vs. Customs and Excise Commissioners (House of Lords) Held that third parties can be compelled to provide evidence if it aids justice. Aventis Pharmaceuticals Inc. vs. Dr. Reddy’s Laboratories Inc. (AP High Court)Allowed execution of Letters Rogatory in a similar pharmaceutical patent case. Pfizer Inc. vs. Unimark Remedies Ltd. (Bombay High Court)Ruled that both oral and documentary evidence can be obtained under Order XXVI Rule 19 CPC. Leighton International Ltd. vs. Gavin John Hodge (Gujarat High Court, 2014)Held that Indian courts cannot compel non-parties to foreign litigation. Fenix Diamonds LLC vs. Carnegie Institute of Washington (Gujarat High Court, 2020)Denied execution of Letters Rogatory, citing confidentiality concerns.
Reasoning of the Court:Jurisdiction & Applicability of Hague Convention:Since India is a signatory to the Hague Evidence Convention, the Madras High Court had the authority to execute Letters Rogatory. Balancing Confidentiality & Evidence Collection: A Confidentiality Club was ordered to protect sensitive data. Only specific persons could access confidential documents. Non-Party Argument Rejected: The Norwich Pharmacal doctrine allows non-parties to be compelled if they possess crucial evidence. Softgel’s involvement with Zenara and CIPLA made it relevant to the U.S. case. Article 23 of the Hague Convention Not Violated:India’s reservation under Article 23 applies to pre-trial discovery. Here, specific documents were sought, not general discovery.
Decision of the Court: Petitions Allowed: The Madras High Court permitted execution of the Letters Rogatory. Local Commissioner Appointed: Mr. Adarsh Ramanujam was appointed to collect evidence. Confidentiality Club Established: Only designated members could access the evidence. In-Camera Proceedings Ordered: Hearings would be conducted privately. Evidence to be Sent to the U.S. Court in a Sealed Cover.
Concluding Note:This ruling reinforces India’s commitment to international judicial cooperation under the Hague Evidence Convention. The judgment carefully balanced intellectual property rights, confidentiality, and legal obligations, setting a precedent for handling cross-border patent disputes in India.
Case Title: Pfizer Inc. vs. Softgel Healthcare Pvt. Ltd.
Date of Order: January 28, 2025
Case No.: O.P. (PT) Nos. 5 & 6 of 2024
Neutral Citation: 2025:MHC:241
Court: Madras High Court
Judge: Hon’ble Mr. Justice Abdul Quddhose
Advocate Ajay Amitabh Suman
[Patent and Trademark Attorney]
High Court of Delhi
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