On January 28, the Madras High Court passed an order related to an ongoing patent dispute in the United States. The dispute concerned Cipla’s and Zenara (Hikma)’s ANDA applications seeking approval to market their generic versions of Vyndamax (tafamidis), a drug used to treat transthyretin amyloid cardiomyopathy (ATTR-CM), in the US. Pfizer, the petitioner, argued before the US District Court, Delaware that the ANDA applications infringed its US patent. To further prove its allegation Pfizer requested the Court to issue a Letter Rogatory to the Madras High Court for its assistance in obtaining certain documents that can then be used in the proceedings. These documents were allegedly in possession of Softgel Healthcare Private Limited, a business partner of both Cipla and Zenara, which was not a party to the suit. In this post, we’ll look at how the Madras High Court upheld the principle of judicial assistance but in doing so failed to check the information being sought.
Before that, let’s understand what a Letter Rogatory is. Based on the principle of comity, a Letter Rogatory is a request from the court of one country to the court of another seeking judicial assistance for collecting evidence. Seeking such cross-border assistance from Courts is permitted in civil and commercial cases under the Hague Convention, 1970. In India specifically, it is allowed under Order XXVI Rule 19 – 22 read with Section 78 of the C.P.C. 1908 whereby an Indian Court can direct the execution of a commission requested by a foreign court through an appointed commissioner.
It Happens (hopefully not only) in India
Taking the Letter of Rogatory from the Delaware Court, Pfizer approached the Madras High Court (under Order XXVI Rule 19 2(c) CPC r/w S. 78) seeking the appointment of a commissioner who could execute a collection of the information sought by the Delaware Court and also establish a confidentiality club. The request for a confidentiality club was to address Zenara’s concern expressed before the Delaware Court, wherein it asked not to divulge the contents of the letter unless a confidentiality club was formed.
This resulted in a Catch-22 situation where a redacted version of the letter was taken on the record by the Court and Pfizer assured that an unredacted version would be filed once the club was formed. However, for the club to be formed, shouldn’t the Court know whether it is allowed to share the information with the foreign court? It is important to note that Article 12 of the Hague Convention states that a State may refuse to share the information if the execution of the letter doesn’t fall within the function of the judiciary or if sharing the information sought will prejudice India’s sovereignty or security. Without knowing the exact nature of the information sought, can it be said that the same will not fall under Article 12? Instead of asking Pfizer to overcome this problem, the Court shifted the onus on Softgel to furnish the evidence that the information sought would fall under Article 12, without taking into account that Softgel had been arguing that the scope of the information sought is vague for it to understand!
Softgel also opposed the disclosure of information because they were not a party to the US suit, that Pfizer’s patent was rejected in India, and that TRIPS mandates protection of its confidential information. However, the Court dismissed these arguments. It held that it was not necessary for Softgel to be a party in the US suit to share the mandated information. The Court clarified that its role was somewhat of a facilitator to execute the collection of the necessary documents. This is contrary to the US approach (discussed below) where the US courts, inter alia, will assess the relevance of the document. It further raises the question of whether a court can direct the collection of evidence from a person without making them a party to the dispute. The Court also held that Pfizer’s patent rejection is not relevant to the present case and that Article 39 of the TRIPS agreement does not prohibit disclosure of confidential information if sought by a Court.
The Court dismissed Softgel’s argument on the vagueness of the information sought, by finding that it was a premature stage to determine whether the information sought was vague or not. Instead, it directed the appointed commissioner to determine it and seek clarity from the parties if required.
Thus, to sum it up, the Court accepted the Letter Rogatory from the Delaware Court without really taking into account the nature of the information sought from it. A more convenient solution would have been to ask Pfizer to furnish the unredacted letter in seal covers, as previously done by the Bombay High Court in matters concerning confidential information, and then determine whether it can direct Softgel to share the information sought or not.
US’ Approach Towards Discovery of Documents for Foreign Courts
It also makes me wonder if the US could ever accept such a cryptic, redacted version of a Letter Rogatory from India. It seems highly unlikely because (as explained here at page 784), the US has an additional set of qualifiers, which also considers specificity, alongside the Hague Convention to determine whether it can share the sough information with a court or not. The qualifiers were enumerated in the Aerospatiale case (which was also cited by the Madras High Court in the present case) where the US Supreme Court listed the following factors to determine whether a request for the discovery of a document is reasonable or not:-
(1) the importance of the documents,
(2) the specificity of the request,
(3) whether the information originated in the United States,
(4) the availability of alternate means of discovery, and
(5) whether compliance with the request undermines or enhances the interests of the United States and the host nation, respectively so
The above factors clearly state that it is the Court’s job to check that the information sought is specific or not before granting the request for the discovery. However, in the present case, the Court left it to the local commissioner to make such a determination later and prioritized upholding the comity with the US court.
The order can play a major role in the outcome of the dispute and if Pfizer can eventually secure a favorable order from the Delaware Court then the litigation is going to impact access to these drugs in the States which are currently available for around $23,324 for a supply of 30 capsules.