Letters Rogatory: a valuable tool for the collection of evidence across borders

The case involves a patent dispute between Pfizer Inc. and its subsidiaries (FoldRx Pharmaceuticals, LLC, PF PRISM IMB B.V., and Wyeth LLC) (Petitioners) against Softgel Healthcare Private Limited (Respondent), an Indian company.

The dispute centers around the alleged infringement of Pfizer’s “441 Patent” related to TAFAMIDIS 61mg capsules, sold under the brand name VYNDAMAX®, which are used for treating Transthyretin Amyloid Cardiomyopathy.

The Petitioners claim that the submission of Abbreviated New Drug Applications (ANDAs) under No.218409 by CIPLA and Zenara (now Hikma) for approval from the FDA to market generic versions of VYNDAMAX® before the expiration of the “441 Patent” constitutes an act of infringement.

The Petitioners sought judicial assistance from the Madras High Court to execute Letters Rogatory issued by the United States District Court at Delaware relying upon Order XXVI Rules 19 to 22 of the Code of Civil Procedure, 1908 (CPC). The CPC provisions provide the legal framework for Indian courts to issue commissions for the examination of witnesses in response to requests from foreign courts. These rules are particularly relevant when a foreign court seeks judicial assistance from an Indian court to obtain evidence for a civil proceeding.

The Letters Rogatory requested the collection of evidence and testimony from the Respondent, Softgel Healthcare Private Limited, and its authorized representatives. The Petitioners also requested the formation of a Confidentiality Club to protect sensitive information during the proceedings. The court’s assistance was sought due to the contractual relationships between the Indian entities (Zenara and CIPLA) and the Respondent, Softgel Healthcare Private Limited.

The specific documents requested by the Petitioners include:

• Documents related to the development, testing, and manufacturing of Zenara’s ANDA Product and CIPLA’s ANDA Product
• Communications between the Respondent and Zenara or CIPLA regarding the ANDA Products
• Any agreements or contracts between the Respondent and Zenara or CIPLA related to the ANDA Products
• Documents related to the marketing and sales of Zenara’s ANDA Product and CIPLA’s ANDA Product.

Respondent raised several objections:

1. The Respondent argued that they are a third party and not a party to the original litigation in the US, making the Petitions not maintainable.
2. They contended that the Petitioners’ requests were vague and violated the principles of specificity and proportionality required under Article 23 of the Hague Convention.
3. The Respondent claimed that compelling disclosure under the current circumstances would be contrary to India’s obligations under the TRIPS agreement.
4. They raised concerns about the misuse of sensitive information, which could unfairly benefit the Petitioners in circumventing the refusal of their patent application in India.
5. The Respondent also argued that forcing them to disclose sensitive research and development data would cause disproportionate hardship to their commercial interests and those of their equitable collaborators.
6. They stated that any information the Petitioner is seeking regarding Zenara and CIPLA ought to have been first addressed before the United States District Court in Delaware.

The court allowed the Petitioner’s request based on several key points:

• Compliance with Hague Convention: The court noted that the Letters Rogatory issued by the United States District Court at Delaware was in complete compliance with the Hague Convention, to which both India and the US are signatories.
• No violation of Indian laws: The court found that there was no violation of Indian domestic laws in executing the Letters Rogatory. The court emphasized that the execution of the Letters Rogatory did not fall within the prohibitions outlined in Article 12 of the Hague Convention. The court also noted that the Indian Patent Office’s rejection of the Petitioner’s patent application had no relevance to the current petition.
• International judicial assistance: The court highlighted the importance of international judicial assistance and comity between nations. It stated that the issuance of Letters Rogatory is a valuable tool for seeking the collection of evidence and that the request did not conflict with the municipal law of India.
• Confidentiality protections: The court addressed the Respondent’s concerns about confidentiality by setting up a Confidentiality Club. This club would ensure that any confidential information produced by the Respondent would be used solely for the purpose of the US litigation and would not be publicly disclosed.
• Necessity of evidence: The court acknowledged that the Petitioners had been unable to procure the necessary evidence from the defendants in the US litigation and that the Respondent was the only source for the required documents.
• Specificity of documents: The court dismissed the Respondent’s argument about the vagueness of the documents listed in the Letters Rogatory. It stated that any issues regarding specificity could be addressed by the appointed Court Commissioner.
• No prejudice to national security: The court found that the production of documents by the Respondent would not be detrimental to India’s national security interests.

Author’s comment

The case highlights the importance of international judicial cooperation and the role of Letters Rogatory in obtaining evidence across borders and how the Hague Convention facilitates access to evidence in foreign jurisdictions, ensuring that litigants can gather necessary information for their cases even when it is located in another country.

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