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Madras High Court Rejects U.S. Request for Evidence in Patent Dispute

11/29/2025, 7:47:22 AM

Overview of the Case

The Madras High Court has dismissed a Letters Rogatory issued by the district court of Delaware, USA, seeking oral and documentary evidence from Softgel Healthcare Private Limited, a pharmaceutical company based in Chengalpattu, India. This request was part of a patent dispute involving Pfizer and Indian pharmaceutical companies Cipla and Zenara regarding the drug Vyndamax, which is used to treat transthyretin amyloid cardiomyopathy.

Legal Framework and Court Ruling

The Division Bench, comprising Justices G. Jayachandran and Mummineni Sudheer Kumar, ruled that the request could not be honored under Article 23 of the Hague Convention, which allows signatory countries to refuse requests related to pre-trial discovery of evidence. The judges noted that Pfizer had initiated a civil suit against Cipla and Zenara in Delaware for alleged patent infringement, and had sought the Letters Rogatory to collect evidence from Softgel, which was contracted to manufacture the drug.

The court highlighted that a prior ruling by a single judge had permitted Pfizer's request, appointing a Legal Commissioner to oversee the evidence collection. However, Softgel appealed this decision, arguing that complying would jeopardize its confidential information and that Pfizer was attempting a broad inquiry under the guise of the Letters Rogatory.

Implications of the Ruling

The Division Bench emphasized that Softgel, not being a party to the U.S. litigation, should not be compelled to disclose documents that could threaten its registered patent in India. The judges criticized the Letters Rogatory for being vague and lacking the specificity required by Article 3 of the Hague Convention, which both India and the United States have ratified. They concluded that Softgel was entitled to refuse to provide evidence based on Article 11 of the Convention and the Indian government's notification regarding the execution of such requests.

Criticism & Opposition

The ruling has drawn attention to the complexities of international legal cooperation in patent disputes. Critics may argue that such decisions could hinder the ability of companies to protect their intellectual property rights across borders, potentially allowing for patent infringement without adequate recourse.

Verbatim Quotes

“In such circumstances, this appellant (Softgel), who is neither a party before the United States district court nor connected with any trade of respondents (Pfizer), cannot be forced to part away with documents when there is a potential threat to the appellant’s registered Indian patent,” — Justice G. Jayachandran

“The privilege to refuse also arises from Article 23 read with the notification of the Government of India which excludes execution of a Letters Rogatory in respect of pre-trial discovery of documents,” — Justice Mummineni Sudheer Kumar

Conclusion

The Madras High Court's decision underscores the limitations of international judicial assistance in patent disputes, particularly regarding pre-trial evidence collection. This ruling may have significant implications for how pharmaceutical companies navigate patent litigation across jurisdictions.