Recently, Madras High Court pronounced an order relating to an ongoing patent dispute in the United States. Pfizer, a pharmaceutical giant has patented “VYNDAMAX” aka “TAFAMIDIS”, a drug used to treat a heart condition called “Transthyretin Amyloid Cardiomyopathy (ATTR-CM)” in the United States. This case centres around Cipla and Zenara (Hikma) filing ANDAs with the United States Food & Drug Administration (FDA) for the approval to sell generic versions of the drug Vyndamax. Later on, Pfizer filed a suit in the US District Court at Delaware claiming that the generic versions of the drug infringe upon its U.S. patent rights.
Why Is India Involved?
According to Pfizer, Softgel Healthcare Private Limited, an Indian company and apparently a business partner of Cipla and Zenara possesses certain set of documents that can help Pfizer to prove their case in the US Delaware Court. Further to prove its allegations, Pfizer requested the US District Court to issue a Letter Rogatory to the Madras High Court for its assistance in obtaining the documents that can be helpful in the proceedings. However, Softgel is not a direct party to this dispute and opposed sharing of confidential information.
The Comity Blunder
Pfizer asked the Madras High Court to appoint a commissioner and set up a confidentiality club to collect the required information from Softgel. The request for setting up a confidentiality club was raised to address Zenara’s concern regarding the confidentiality of the documents. Zenara asserted that the contents of the documents should not be disclosed unless a confidentiality club was set up.
Therefore, on January 28, 2025, the Madras High Court passed on order to facilitate judicial assistance. It accepted a redacted version of the letter rogatory from Pfizer on an assurance of filing an unredacted version once the confidentiality club was formed. Seeking such cross-border assistance is permitted in the Hague Convention, 1970 and in the Indian legislations under Order XXVI Rules 19 to 22 read with Section 78 of Civil Procedure Code, 1908. But this order sparked controversy regarding the Principle of Comity- A legal doctrine whereby the executive, judicial and legislative actions of the countries are mutually recognized.
However, Article 12 of Hague Convention states that a state may refuse to share information with another country if it feels that the execution of such a Letter Rogatory doesn’t coincide with the judicial laws or if sharing such information shall compromise with the countries’ sovereignty or security. But the Madras High Court did not look into this aspect and instead of asking Pfizer to come up with a solution to this problem, the court shifted the onus on Softgel, asking them to prove whether sharing of such information would fall under Article 12 or not.
On the contrary, Softgel had been constantly opposing such sharing of information, upholding the following arguments:
1. They were not a party to the U.S. suit.
2. The Pfizer’s patent was rejected in India.
3. The TRIPS agreement mandates protection of a country’s confidential information.
4. The information sought by Pfizer was too vague for them to understand.
The Madras high court dismissed the oppositions by stating that for sharing information, being a party to the US suit is not necessary. The court also held that Pfizer’s patent rejection in India is irrelevant to the case and that TRIPS agreement does not prohibit a country from sharing confidential information if it is sought by a court. The court further appointed a commissioner to determine the vagueness of the information sought. It is argued that while the court upheld judicial co-operation, it failed to thoroughly scrutinize the scope and relevance of the information sought and whether such sharing aligns with the interests of the country, potentially leading to broader issues on international collaborations. A more effective solution here would have been to ask Pfizer to submit official unredacted version of the letter and then decide whether the information sought can be shared or not.
Analysing US’s Approach To Judicial Assistance
If we compare present situation to the U.S., things would’ve turned out differently. Unlike India, US courts would not have accepted such a vague, redacted version of Letter Rogatory from India. The U.S. courts carefully examine such requests before acting & has established a certain set of qualifiers to consider the laws and accordingly determine whether it is feasible to share the confidential information or not. These qualifiers were laid down in the “Aerospatiale Case” (also cited by the Madras High Court in the present case) where it lists the following factors to determine whether a request for sharing a confidential document is valid or not:
1. The importance of documents,
2. Whether the request is specific or not,
3. Whether the sought information originated in the United States or not,
4. Are alternate means of obtaining information available?
5. Whether such a request for information contributed to the interests of the country and the host nation.
The above factors clearly uphold that it is the court’s job to determine whether the information sought is specific and in the interest of the country or not. However, in the current situation, the court did not undertake the scrutiny and merely prioritized comity with the US court.
Conclusion
This order plays a major in the outcome of the dispute. If Pfizer manages to secure a decision in their favour, it will have a huge impact on the availability of these drugs in the United States. Pfizer may block Cipla and Zenara’s generic versions keeping Vyndamax expensive while limiting access to cheaper alternatives. Ultimately, this dispute underscores the complexities inherent in international patent disputes especially when it involves multiple jurisdictions and third-party entities. It highlights a fine line of balance to be maintained by the courts between providing judicial assistance and safeguarding third party rights and interests.
Authors: Seema Meena, Manasvi Shah & Devanshi Gotecha