Madras High Court Quashes Order Allowing Pfizer To Seek Documents From Indian Drug Manufacturer For US Suit

The Madras High Court has overturned a Single Judge's order that had permitted pharmaceutical giant Pfizer to enforce Letters Rogatory issued by a United States court to obtain documents and testimony from Chennai-based Softgel Healthcare Pvt. Ltd. Letters Rogatory are formal requests sent by a court in one country to a court in another country seeking assistance in gathering evidence for a legal proceeding

A division bench of Justice G Jayachandran and Justice Mummineni Sudheer Kumar ruled on November 25 that the U.S. court's request amounted to pre-trial discovery, which is barred in India because the country has invoked its right under the Hague Convention to reject such requests.

“It is undoubtedly an attempt to collect pre-trial documents. When the Government of India has declared that it will not execute Letters of Request in respect of pre-trial document, the Learned Single Judge, has allowed the petitions without consideration the rights exercised by the Republic of India. Thus, the order allowing the application goes contrary to law,” the Court said.

The court also said that “the Letters Rogatory is vague, without any specificity as required under Article 3 of the Hague Convention.”

Pfizer owns a U.S. patent for crystalline forms of Tafamidis, the drug sold as Vyndamax. The company has sued Cipla and Zenara (now Hikma) in the District Court of Delaware for alleged infringement. During those proceedings, Pfizer claimed that Softgel was manufacturing the drug for the defendants and sought documents relating to testing, development and manufacturing processes through Letters Rogatory addressed to Indian authorities.

Pfizer and its associated companies asked the Madras High Court to appoint a commissioner with powers to collect documents, record testimony and create a confidentiality club. Softgel objected. The company told the Court it was not a party to the U S litigation and argued that the disclosure sought would damage its confidential manufacturing data and business interests. Softgel also noted that Pfizer's corresponding Indian patent application had already been rejected by the Indian Patent Office and that an appeal is still pending.

The Single Judge had accepted Pfizer's arguments and allowed the petitions. The Division Bench disagreed. It found that the evidence sought lacked the clear, specific description required under Article 3 of the Hague Convention and that the documents listed were in the nature of procuring pre-trial documents. The Bench added that India has formally invoked Article 23 of the Convention, which allows a country to refuse execution of Letters Rogatory aimed at pre-trial discovery.

The Court also held that Softgel, as a non-party to the U.S. case, could not be compelled to share information that might prejudice its rights, particularly when the related Indian patent application stands rejected. The bench said the request was nothing more than an attempt to secure pre-trial material that India has expressly refused to assist with under the Hague Convention. It noted that the Single Judge overlooked India's declared position, leading to an order that goes 'contrary to law.'

The High Court allowed Softgel's appeals, set aside the Single Judge's order and dismissed Pfizer's applications seeking enforcement of the Letters Rogatory.

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