Cross-Border Evidence Collection under the Hague Convention

Case Summary

In an era where global commerce and intellectual property disputes increasingly transcend national boundaries, the interplay between domestic laws and international judicial cooperation becomes a critical arena of legal exploration. The case of Pfizer Inc. & Ors. v. Softgel Healthcare Private Limited, adjudicated by the Madras High Court in 2025, stands as a compelling testament to this dynamic.

This legal battle, rooted in a patent infringement dispute originating in the United States, showcases the intricate mechanisms of the Hague Evidence Convention and the principles of international comity. At its core, the case examines whether an Indian court can compel a third party to produce evidence for a foreign litigation, balancing confidentiality, sovereignty, and the pursuit of justice across jurisdictions.

Detailed Factual Background

The dispute traces its origins to a patent litigation pending before the United States District Court for the District of Delaware, where Pfizer Inc., along with its affiliates FoldRx Pharmaceuticals, LLC, PF PRISM IMB B.V., and Wyeth LLC, alleged infringement of their “441 Patent.” This patent pertains to Tafamidis 61 mg capsules (VYNDAMAX), used for treating Transthyretin Amyloid Cardiomyopathy.

The petitioners claimed that Cipla and Zenara Pharma Pvt. Ltd. (now Hikma) submitted ANDAs to the U.S. FDA to market generic versions before the patent’s expiration. Specifically, Cipla’s ANDA No. 218409 and Zenara’s ANDA No. 218205 were cited as infringing.

Softgel Healthcare Private Limited, not a direct party to the U.S. case, was claimed to have crucial evidence. The petitioners sought this evidence through Letters Rogatory issued on May 13, 2024, under the Hague Evidence Convention.

Softgel argued that Pfizer’s application for VYNDAMAX was rejected in India under Section 3(d) of the Patents Act, 1970, undermining the legitimacy of evidence collection efforts in India.

Detailed Procedural Background

The petitioners filed O.P. (PT) Nos. 5 and 6 of 2024 before the Madras High Court under Order XXVI Rules 19-22 and Sections 78 and 151 of the CPC, seeking appointment of a Local Commissioner and establishment of a Confidentiality Club.

Zenara raised confidentiality concerns and requested protection of the Letters Rogatory content, leading to a redacted version being filed. Softgel challenged the maintainability and propriety of the petitions.

Issues Involved

• Jurisdiction and Maintainability: Could the Madras HC enforce Letters Rogatory against a non-party?
• Scope of the Hague Convention: Did it allow oral and documentary evidence from third parties?
• Conflict with Domestic Law: Did India’s patent rejection bar cooperation?
• Confidentiality: Could commercial secrets be protected?
• Specificity and Proportionality: Were the document requests valid or a “fishing expedition”?
• International Comity: How should it be balanced with sovereignty and commercial interests?

Submissions of the Parties

Petitioners

They argued the Letters Rogatory were compliant with the Hague Convention and supported by the CPC. They proposed protective measures such as a Confidentiality Club and in-camera proceedings.

Respondent (Softgel)

They argued they were not a party to the U.S. litigation and that disclosure conflicted with Articles 11 and 23 of the Hague Convention and Article 39 of TRIPS. They claimed the requests were vague and harmful to commercial interests.

Judgments Cited

• Aventis Pharmaceuticals v. Dr. Reddy’s – supported Letters Rogatory under Hague and CPC.
• Pfizer Inc. v. Unimark Remedies – affirmed non-party evidence collection.
• Wooster Products v. Magna Tek – emphasized judicial duty in cross-border cooperation.
• Norwich Pharmacal Co. v. Customs – established duty of third parties to assist in tort claims.
• Leighton International v. Gavin John Hodge – limited documentary evidence from third parties.
• Fenix Diamonds v. Carnegie – rejected non-party discovery requests.
• Societe Nationale v. US District Court – introduced comity factors used by both parties.

Judicial Reasoning and Analysis

The judge upheld jurisdiction under CPC and Hague Convention. He emphasized that both oral and documentary evidence are allowed. The Letters Rogatory were found to be specific, and objections could be raised before the Commissioner.

The rejection of the Indian patent was deemed irrelevant. Confidentiality was preserved via Confidentiality Club and in-camera hearings. The “fishing expedition” claim was rejected based on petitioner’s categorical statements.

The court aligned with Andhra Pradesh, Bombay, and Delhi High Courts in favor of evidence collection, emphasizing international cooperation without violating domestic law.

Final Decision

The Madras High Court allowed the petitions on January 28, 2025. Mr. Adarsh Ramanujam was appointed as Local Commissioner. Confidentiality Club was established, and proceedings were ordered in-camera. Costs were to be borne by the petitioners.

Law Settled in This Case

• Indian courts may assist in foreign litigation by compelling evidence from third parties under CPC and Hague Convention.
• Evidence includes both oral and documentary material.
• Specificity issues are delegated to Local Commissioners.
• Confidentiality may be protected through clubs and sealed proceedings.
• International comity must guide judicial cooperation, despite domestic patent decisions.

Case Details

Case Title: Pfizer Inc. & Ors. Vs. Softgel Healthcare Private Limited

Date of Order: January 28, 2025

Case No.: O.P. (PT) Nos. 5 and 6 of 2024

Court: High Court of Judicature at Madras

Judge: Justice Abdul Quddhose