Case Title: Pfizer Inc. v. Softgel Healthcare Private Limited
Date of Order: 28 January 2025
Case No.: O.P. (PT) Nos. 5 and 6 of 2024
Neutral Citation: 2025:MHC:241
Court: High Court of Judicature at Madras
Judge: Justice Abdul Quddhose
Facts:
Pfizer Inc. and its affiliated companies, involved in the manufacturing of VYNDAMAX®, a drug for treating transthyretin amyloid cardiomyopathy, sought judicial assistance from the Madras High Court in enforcing Letters Rogatory issued by the United States District Court for the District of Delaware. The case in the U.S. involved allegations that CIPLA and Zenara (now Hikma) had submitted Abbreviated New Drug Applications (ANDAs) seeking approval for generic versions of VYNDAMAX® before the expiration of Pfizer's "441 Patent," constituting patent infringement.
Pfizer sought to obtain evidence from Softgel Healthcare, an Indian entity with alleged connections to Zenara, to prove infringement in the U.S. litigation. The Letters Rogatory requested the appointment of a local commissioner to collect documents and testimony from Softgel Healthcare under the Hague Evidence Convention. Softgel Healthcare opposed the petitions, arguing that it was not a party to the U.S. litigation and that compliance would violate Indian domestic laws and trade secrecy protections.
Issues:
Whether the Madras High Court should enforce the Letters Rogatory issued by the United States District Court and compel Softgel Healthcare, a non-party to the U.S. litigation, to provide evidence.
Reasoning and Analysis of the Judgment:
The Court examined the applicability of the Hague Evidence Convention, the Code of Civil Procedure, 1908, and international judicial assistance principles. It held that Letters Rogatory are a well-established mechanism for obtaining evidence across jurisdictions and that India's ratification of the Hague Convention obligated Indian courts to facilitate evidence collection unless it conflicted with domestic laws, national security, or sovereignty.
The Court rejected Softgel Healthcare’s argument that compliance would violate Indian patent law, noting that India’s refusal of Pfizer’s patent application did not negate its obligation under international treaties. It also dismissed the claim that Softgel Healthcare, as a third party, could not be compelled to provide evidence, citing precedents where Indian courts had enforced similar Letters Rogatory.
The Court emphasized that the confidentiality of Softgel Healthcare’s documents would be safeguarded by forming a "Confidentiality Club" and conducting proceedings in-camera. It further held that the request for documents was sufficiently specific and that objections regarding the scope of discovery could be addressed by the appointed local commissioner.
Decision:
The High Court allowed Pfizer’s petitions, appointed a local commissioner to oversee evidence collection, and directed Softgel Healthcare to comply with the Letters Rogatory. The commissioner was granted special powers to summon witnesses, administer oaths, and ensure confidentiality. The collected evidence was to be transmitted to the U.S. court in a sealed cover.
