Introduction
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. This case study delves into the factual and procedural intricacies, the contentious issues, the arguments of the parties, the judicial precedents invoked, and the reasoning that shaped the final decision, offering a comprehensive analysis of a landmark ruling.
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 (collectively, the petitioners), alleged infringement of their "441 Patent." This patent pertains to Tafamidis 61 mg capsules, marketed under the brand name VYNDAMAX, a drug used to treat Transthyretin Amyloid Cardiomyopathy. The petitioners claimed that two Indian pharmaceutical companies, Cipla and Zenara Pharma Pvt. Ltd. (now Hikma), infringed this patent by submitting Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA) to market generic versions of VYNDAMAX before the patent’s expiration. Specifically, Cipla’s ANDA No. 218409 and Zenara’s ANDA No. 218205 were cited as acts of infringement.
Softgel Healthcare Private Limited, the respondent, emerged as a pivotal entity in this saga despite not being a direct party to the U.S. litigation. The petitioners asserted that Softgel, an Indian company with contractual ties to Cipla and Zenara, possessed critical documents and information related to the ANDA products. These materials were deemed essential to proving the infringement claims in the Delaware court. The petitioners had unsuccessfully sought these documents from Cipla and Zenara in the U.S. proceedings, prompting them to request international judicial assistance via Letters Rogatory issued by the Delaware court on May 13, 2024, under the Hague Evidence Convention of 1970, to which both India and the United States are signatories.
The factual complexity deepened with the respondent’s assertion that the petitioners’ patent application for VYNDAMAX had been rejected by the Indian Patent Office under Section 3(d) of the Patents Act, 1970, as a new form of a known substance. This rejection fueled Softgel’s contention that the petitioners lacked enforceable patent rights in India, raising questions about the legitimacy of their evidence-seeking expedition in Indian jurisdiction.
Detailed Procedural Background
The procedural journey began in the U.S., where the petitioners, unable to secure the necessary evidence from Cipla and Zenara, sought and obtained Letters Rogatory from the Delaware court. These letters formally requested the Madras High Court to assist in obtaining documents and testimony from Softgel, as outlined in Schedules A and B of the request. The petitioners then filed two original petitions, O.P. (PT) Nos. 5 and 6 of 2024, before the Intellectual Property Division of the Madras High Court under Order XXVI Rules 19-22 and Sections 78 and 151 of the Code of Civil Procedure (CPC), 1908. These petitions sought the appointment of a Local Commissioner to collect evidence, the establishment of a Confidentiality Club to protect sensitive information, and the execution of the Letters Rogatory in a manner compliant with Indian law and international obligations.
The petitions were reserved for judgment on January 20, 2025, and pronounced on January 28, 2025, by Justice Abdul Quddhose. During the proceedings, confidentiality concerns arose, with Zenara requesting that the Letters Rogatory not be disclosed publicly unless safeguarded by a Confidentiality Club. Consequently, the petitioners filed a redacted version of the Letters Rogatory, seeking permission to submit the unredacted version once protective measures were in place. The respondent, Softgel, mounted a robust defense, challenging the maintainability of the petitions and the propriety of compelling a third party to disclose sensitive commercial data.
Issues Involved in the Case
The case presented a constellation of legal and procedural issues, each layered with international and domestic implications:
Jurisdiction and Maintainability: Could the Madras High Court entertain petitions to execute Letters Rogatory against a third party not involved in the U.S. litigation?
Scope of the Hague Convention: Did the Hague Evidence Convention permit the collection of both oral and documentary evidence from a non-party, and were the petitioners’ requests compliant with its provisions, particularly Articles 3, 9, 12, 23, and 39?
Conflict with Domestic Law: Did the rejection of the petitioners’ patent application in India under the Patents Act, 1970, preclude the court from assisting in evidence collection for a foreign patent dispute?
Confidentiality and Commercial Interests: Could the court balance the petitioners’ need for evidence with the respondent’s right to protect confidential research and development data?
Specificity and Proportionality: Were the documents sought in the Letters Rogatory sufficiently specific, or did they constitute an impermissible “fishing expedition” under Article 23 of the Hague Convention?
International Comity: How should the court weigh the principles of international judicial cooperation against India’s sovereignty and the respondent’s commercial interests?
Detailed Submission of Parties
The petitioners, represented by Senior Counsel Mr. Sathish Parasaran and Mr. Pravin Anand, argued that the Letters Rogatory were a legitimate tool under the Hague Convention to secure evidence critical to their U.S. litigation. They emphasized that Softgel, despite being a third party, held documents vital to proving infringement by Cipla and Zenara, as confirmed by Cipla’s suggestion in the U.S. proceedings that such materials could be obtained from Softgel. They contended that Order XXVI Rules 19-22 and Section 78 of the CPC empowered the court to issue a commission for evidence collection, and that the Hague Convention supported both oral and documentary evidence procurement. To address confidentiality concerns, they proposed a Confidentiality Club and in-camera proceedings, aligning with the protective order issued by the Delaware court. They further argued that the Indian Patent Office’s rejection was irrelevant, as their claim was limited to evidence collection, not enforcement of patent rights in India.
The respondent, represented by Senior Counsel Mr. V. Raghavachari and Dr. Mohan Devan, countered with a multi-pronged defense. They asserted that as a non-party to the U.S. litigation, Softgel could not be compelled to produce evidence, especially given the absence of an infringement claim against it. They invoked Article 11(1) of the Hague Convention, arguing that participation could be refused if it conflicted with domestic laws or sovereignty, and Article 39 of the TRIPS Agreement to protect confidential data integral to their pharmaceutical research. They highlighted the Indian Patent Office’s rejection of the petitioners’ application, contending that it negated their right to seek evidence in India for a patent unenforceable domestically. They labeled the petitioners’ requests as vague and disproportionate, constituting a “fishing expedition” barred by Article 23, and warned that disclosure would disproportionately harm their commercial interests and those of their collaborators.
Detailed Discussion on Judgments Cited by Parties and Their Context
Both parties relied on a rich tapestry of judicial precedents to bolster their arguments, each cited with specific relevance to the case’s issues:
Aventis Pharmaceuticals Inc. v. Dr. Reddy’s Laboratories Inc., MANU/AP/0650/2008 (Andhra Pradesh High Court): Cited by the petitioners, this case upheld the enforcement of Letters Rogatory to collect evidence from an Indian entity for a foreign patent dispute. The court ruled that Indian courts could assist under the CPC and the Hague Convention, provided no violation of domestic law occurred. The petitioners used this to argue that precedent favored their request.
Pfizer Inc. v. Unimark Remedies Limited, 2016 SCC Online Bom 8599 (Bombay High Court): Another petitioner-cited case, it affirmed the execution of Letters Rogatory for evidence collection in a patent matter, emphasizing the Hague Convention’s role in facilitating international cooperation. The court allowed evidence from a third party, supporting the petitioners’ stance that Softgel’s status as a non-party was immaterial.
Wooster Products Inc. v. Magna Tek Inc. and Others, MANU/DEL/0102/1988 (Delhi High Court): The petitioners referenced this ruling, where the court permitted evidence collection via Letters Rogatory, reinforcing that Indian courts have a duty to assist foreign proceedings absent legal prohibitions. It underscored the liberal interpretation of CPC provisions.
Norwich Pharmacal Co. v. Customs and Excise Commissioners, Roskill LJ A.C. 133 (House of Lords): The petitioners invoked this English precedent, which established that a third party innocently involved in a tortious act must assist the injured party by disclosing information. They argued that Softgel, linked contractually to Cipla and Zenara, had a similar duty.
Leighton International Limited v. Gavin John Hodge and Others, 2014 SCC Online Guj 15738 (Gujarat High Court): Cited by the respondent, this decision limited evidence collection to oral testimony, rejecting broad documentary requests as prejudicial to third parties. Softgel used this to argue against compelled disclosure of sensitive data.
Fenix Diamonds LLC v. Carnegie Institute of Washington, 2020 SCC Online Guj 1628 (Gujarat High Court): The respondent relied on this case, where the court restricted Letters Rogatory execution to parties in the foreign litigation, refusing broad discovery from non-parties. It supported their claim that the petitions were maintainable only against Cipla and Zenara.
Societe Nationale Industrielle Aerospatiale v. United States District Court for the Southern District of Iowa, 482 U.S. 522 (1987) (U.S. Supreme Court): Both parties cited this landmark ruling, which outlined five factors for assessing international comity in discovery requests: importance of the evidence, specificity, origin, alternative means, and impact on national interests. The petitioners argued these factors favored their request, while the respondent contended they highlighted the lack of specificity and harm to Indian interests.
Detailed Reasoning and Analysis of Judge
Justice Abdul Quddhose’s reasoning was a meticulous blend of statutory interpretation, international law, and judicial precedent, culminating in a decision that prioritized international cooperation while safeguarding confidentiality. He began by affirming the court’s jurisdiction under Order XXVI Rules 19-22 and Section 78 of the CPC, which empower High Courts to issue commissions for evidence collection at the behest of foreign courts in civil proceedings. He interpreted “evidence” broadly, encompassing both oral and documentary forms, rejecting the Gujarat High Court’s narrower view in Leighton and Fenix Diamonds as inconsistent with the CPC and the Hague Convention’s intent.
The judge analyzed the Hague Convention’s provisions, noting that Article 3 required specificity in evidence requests, which the Letters Rogatory satisfied by listing documents in Schedules A and B. He dismissed the respondent’s vagueness objection as premature, delegating specificity disputes to the Local Commissioner. Article 12’s grounds for refusal—lack of judicial function or prejudice to sovereignty—were deemed inapplicable, as the request fell within the court’s powers and no national security threat was evidenced. Article 23’s limitation on pre-trial discovery was inapplicable, as the documents were specified, aligning with India’s declaration.
Addressing the respondent’s domestic law argument, Justice Quddhose held that the Indian Patent Office’s rejection was irrelevant, as the petitions sought evidence, not patent enforcement in India. He distinguished the Gujarat precedents, noting their post-commissioner contexts, and aligned with the Andhra Pradesh, Bombay, and Delhi rulings, which supported evidence collection absent legal violations. The Aerospatiale factors were applied: the documents’ importance to the U.S. litigation was clear, their specificity was ascertainable by the Commissioner, they originated in India, no alternative sources were proven, and no significant Indian interest was undermined.
Confidentiality concerns were meticulously addressed through the establishment of a Confidentiality Club, in-camera proceedings, and sealed records, ensuring compliance with the Delaware court’s protective order and Article 39 of the TRIPS Agreement. The judge rejected the “fishing expedition” claim, emphasizing the petitioners’ categorical assertion—unrebutted by evidence—that Softgel uniquely possessed the documents. International comity, reinforced by the Hague Convention, compelled the court to assist, balancing the petitioners’ justice-seeking needs with Softgel’s commercial interests through protective measures.
Final Decision
The Madras High Court allowed both petitions on January 28, 2025, issuing comprehensive directions. It appointed Mr. Adarsh Ramanujam as Local Commissioner (replacing Ms. Vindhya S.Mani due to a conflict) to collect evidence and testimony as per the Letters Rogatory, conferring special powers to summon, record, and transcribe. A Confidentiality Club was established with named members from both sides, proceedings were ordered in-camera, and documents were to be sealed, accessible only to club members. The evidence was to be forwarded to the Delaware court in a sealed cover, with the petitioners bearing costs and the Commissioner’s remuneration set at Rs. 2,00,000 initially.
Law Settled in This Case
This ruling clarified several legal principles: Indian courts can compel third parties to produce evidence for foreign litigation under the CPC and Hague Convention, provided no domestic law is violated; “evidence” includes both oral and documentary forms; specificity objections are resolved post-commissioner appointment; and confidentiality can be safeguarded through structured mechanisms like a Confidentiality Club. It reinforced the primacy of international comity in judicial assistance, subordinating domestic patent rejections to the limited scope of evidence collection.
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
Neutral Citation: Yes
Name of Court: High Court of Judicature at Madras
Name of Judge: Justice Abdul Quddhose
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
