Brief Introductory Head Note Summary of Case
This case involves a dispute between an Indian pharmaceutical manufacturer, Softgel Healthcare Private Limited, and the US-based company Pfizer Inc., along with its affiliates. It centers on whether Indian courts should help enforce a request from a US court for evidence in a patent infringement lawsuit. Pfizer holds a US patent for a drug called Tafamidis, sold as Vyndamax, and sued Indian companies Cipla and Hikma (formerly Zenara) in the US for trying to sell generic versions before the patent expires. To gather proof, the US court issued "Letters Rogatory," asking Indian courts to collect documents and statements from Softgel, which makes the drug for Cipla and Hikma. Softgel challenged this, arguing it violates Indian laws and international agreements. The Madras High Court initially allowed the request but was appealed. The appeal court overturned it, protecting Softgel's confidentiality and India's sovereignty in patent matters.
Factual Background
Pfizer Inc., a large pharmaceutical company based in New York, USA, owns a patent (number 9,770,441, often called the '441 patent) for the crystalline form of a drug called Tafamidis meglumine, which is 61 mg and sold under the brand name Vyndamax in the US. This drug treats a rare heart condition. In the US, companies must get approval from the Food and Drug Administration (FDA) to sell generic versions of patented drugs. Cipla Limited, an Indian company, and Hikma (which bought Zenara Pharma Private Limited, another Indian firm), filed applications called Abbreviated New Drug Applications (ANDAs) to sell generic versions of Vyndamax. Pfizer claimed these applications were filed before their patent expired, which under US law counts as infringement.
Pfizer sued Cipla and Hikma in the US District Court for the District of Delaware. During the lawsuit, Pfizer asked Cipla and Hikma for documents about how the generic drug was made. Cipla and Hikma said they didn't have all the details because Softgel Healthcare Private Limited, an Indian company based in Tamil Nadu, was the actual manufacturer under contract. Softgel produces the drug at its facility in Pudupakkam Village, Chengalpattu District.
To get information from Softgel, who isn't part of the US lawsuit, the US court issued Letters Rogatory on May 13, 2024. These are formal requests from one country's court to another's for help in gathering evidence, based on an international agreement called the Hague Convention of 1970. The request asked for documents and witness statements from Softgel about the drug's manufacturing process, testing, and polymorphic forms (different crystal structures of the drug).
Pfizer then filed petitions in the Madras High Court (O.P.(PT).Nos.5 and 6 of 2024) to execute this request. They wanted a commissioner appointed to collect the evidence, with safeguards like a confidentiality club to protect sensitive information. Softgel opposed this, saying they weren't involved in the US case, the request was too broad, and it violated Indian patent laws since Pfizer's similar patent application in India (number 20171005783) had been rejected by the Indian Patent Office. Softgel argued this was like fishing for information and could harm their business secrets.
Procedural Detail
The process started in the US when Pfizer filed infringement suits against Cipla (Civil Action No.23-879) and others. After Cipla and Hikma disclosed Softgel as their manufacturer, the US District Court issued Letters Rogatory under the Hague Convention.
In India, Pfizer filed two petitions in the Madras High Court in 2024 to enforce these letters. A single judge heard the case and, on January 28, 2025, allowed the petitions. The judge appointed a commissioner, set up a confidentiality club with representatives from both sides and experts, and ordered the process to happen in private to protect secrets. The judge relied on Indian civil procedure rules (Order XXVI, Rules 19-22, and Section 78 of the Code of Civil Procedure, 1908) that allow courts to help foreign courts.
Softgel appealed this decision to a division bench (two judges) of the Madras High Court in Letters Patent Appeals (LPA Nos.17 and 18 of 2025). The appeals were reserved for judgment on November 11, 2025, and decided on November 25, 2025. Senior lawyers argued for both sides: Mr. V. Raghavachari for Softgel, emphasizing violations of confidentiality and Indian laws, and Mr. P.S. Raman for Pfizer, arguing that such requests are standard and protected by safeguards.
Core Dispute
The main issue was whether the Madras High Court should enforce the US court's Letters Rogatory against Softgel, a third party not involved in the US lawsuit. Softgel argued the request was vague, sought pre-trial discovery (which India has opted out of under the Hague Convention), violated their confidentiality rights, and undermined Indian patent laws since Pfizer's patent was rejected in India. They said it was like a broad search for evidence without specifics, harming their business.
Pfizer countered that the documents were specific and needed for their US case, Indian laws allow such cooperation, and safeguards like the confidentiality club would prevent misuse. They said Softgel wasn't a stranger since it manufactures for the sued companies, and international judicial help is recognized in India.
The court had to balance international cooperation with protecting national sovereignty, privacy, and domestic patent rules.
Detailed Reasoning and Discussion by Court Including on Judgement with Complete Citation Referred and Discussed for Reasoning
The division bench, consisting of Dr. Justice G. Jayachandran and Justice Mummineni Sudheer Kumar, carefully examined the arguments. They started by noting the point for consideration: whether the single judge's order violated Indian laws and the Hague Convention.
The court explained that India is a signatory to the Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters, 1970, but with reservations. Under Article 3, Letters Rogatory must specify details like parties, nature of proceedings, witnesses, questions, and documents. Article 11 allows a person to refuse evidence if it violates privileges under the law of the executing country (India) or the requesting country (US). Article 12 lets refusal if it doesn't fall under judicial functions or prejudices sovereignty. Crucially, Article 23 allows countries to refuse pre-trial discovery requests, and India has declared it won't execute such letters for broad document hunts not specifying exact items.
The bench found the US request vague and omnibus, listing broad categories like "all documents relating to testing and development" without naming specific witnesses or exact documents. They extracted the list from Appendix-I of the US application, noting it included "any further document deemed necessary," which seemed like fishing for evidence.
Discussing Indian law, the court referred to Order XXVI, Rule 19 of the Code of Civil Procedure, 1908, which allows issuing commissions for foreign court requests, but must be liberally construed while protecting sovereignty. They emphasized that domestic laws prevail, and no international convention overrides them.
The judges discussed several cited cases. First, Wooster Products Inc. v. Magna Tek Inc. (1983 SCC OnLine Del 29), where the Delhi High Court said Indian courts shouldn't question the foreign court's relevance but witnesses can claim privilege. The bench agreed but noted it supports refusal by witnesses like Softgel.
They distinguished Upaid Systems Limited v. Satyam Computer Services (2009 SCC OnLine Del 2006), where the Delhi High Court enforced a request, saying it didn't fully consider India's Article 23 reservation. In Upaid, the court held that as long as Order XXVI, Rule 19 conditions are met (civil proceeding, witness in jurisdiction), enforcement is possible, but the Madras bench disagreed, stressing sovereignty under Articles 11, 12, and 23.
The court also noted a Telangana High Court judgment (not named but similar to this case) where enforcement against a third party was upheld, but rejected it because it ignored India's opt-out from pre-trial discovery.
Reasoning further, the bench said Pfizer's Indian patent rejection means they can't enforce US rights in India indirectly. The litigation links (US suit and Indian appeal) make this pre-trial evidence collection, banned under India's Hague declaration. Softgel, not a US party, has rights under Article 11 to refuse if it prejudices sovereignty or confidentiality, protected under TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights).
Pfizer offered undertakings for safeguards, but the court said confidentiality clubs aren't enough against broad requests. They held the single judge erred by not scrutinizing the Hague limits and India's notification, making the order routine without protecting national interests.
Decision
The appeals were allowed. The single judge's order dated January 28, 2025, in O.P.(PT).Nos.5 and 6 of 2024 was set aside. The petitions to execute the Letters Rogatory were dismissed, with no costs. This means Softgel doesn't have to provide documents or testimony, protecting their confidentiality and India's patent sovereignty.
Concluding Note
This judgment highlights the careful balance courts must strike between helping international justice and safeguarding national laws and business secrets. It reinforces that India won't assist in broad pre-trial evidence hunts from foreign courts, especially in patent disputes where local patents differ. For companies like Softgel, it offers protection against foreign overreach, while reminding multinationals like Pfizer to respect territorial limits. This case could guide future cross-border evidence requests, emphasizing specificity and sovereignty.
Case Title: Softgel Healthcare Private Limited Vs Pfizer Inc. and Others Order Date: 25.11.2025 Case Number: L.P.A.Nos.17 & 18 of 2025 and C.M.P.Nos.11011 of 2025 & 11017 of 2025 Neutral Citation: 2025:MHC:1471 Name of Court: High Court of Judicature at Madras Name of Hon'ble Judge: Dr. Justice G. Jayachandran and Justice Mummineni Sudheer Kumar
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation. Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Suggested Titles for the Legal Analytical Article:
- Balancing International Judicial Cooperation and National Sovereignty: Lessons from the Softgel v. Pfizer Letters Rogatory Dispute
- Refusal of Pre-Trial Discovery in Cross-Border Patent Litigation: Analyzing the Madras High Court's Stance on Hague Convention Article 23
- Protecting Confidentiality in Pharmaceutical Patents: The Impact of India's Hague Reservation on Foreign Evidence Requests
- Letters Rogatory and Third-Party Rights: A Critical Examination of Enforcement Limits under Indian Law
- Sovereignty Over Secrets: How the Madras High Court Shielded an Indian Manufacturer from US Patent Infringement Probes
Madras High Court Overturns Order to Enforce US Letters Rogatory in Pfizer Patent Dispute
In a significant ruling on cross-border patent enforcement, the High Court of Judicature at Madras, in the case titled Softgel Healthcare Private Limited v. Pfizer Inc. and Others (L.P.A. Nos. 17 & 18 of 2025 and C.M.P. Nos. 11011 & 11017 of 2025), delivered on November 25, 2025, by the bench comprising Hon'ble Dr. Justice G. Jayachandran and Hon'ble Mr. Justice Mummineni Sudheer Kumar, set aside a single judge's decision to assist a US court in gathering evidence from an Indian manufacturer.
The case stemmed from a US patent infringement lawsuit filed by Pfizer Inc., holder of US Patent No. 9,770,441 for the drug Tafamidis (branded as Vyndamax), against Indian firms Cipla and Hikma (formerly Zenara) for submitting abbreviated new drug applications before the patent's expiry. The US District Court for Delaware issued Letters Rogatory under the 1970 Hague Convention, seeking documents and testimony from Softgel Healthcare Private Limited, a Tamil Nadu-based contract manufacturer for Cipla and Hikma.
Pfizer petitioned the Madras High Court to execute the request by appointing a commissioner and forming a confidentiality club. A single judge allowed this on January 28, 2025, citing provisions under Order XXVI of the Code of Civil Procedure, 1908. However, Softgel appealed, arguing the request was vague, violated confidentiality, and amounted to pre-trial discovery, which India has reserved against under Article 23 of the Hague Convention. They also noted Pfizer's similar patent application was rejected in India, undermining any enforcement here.
The division bench agreed, holding that the Letters Rogatory lacked specificity as required by Article 3 of the Hague Convention and prejudiced India's sovereignty under Articles 11 and 12. Emphasizing India's declaration against pre-trial document discovery, the court ruled that such requests cannot override domestic patent laws. The appeals were allowed, dismissing Pfizer's petitions without costs and protecting Softgel's business interests.
This decision underscores the limits of international judicial cooperation in patent matters, particularly when local laws diverge from foreign claims.
Disclaimer: This is for general information only and should not be construed as legal advice as it may contain human errors in perception and presentation: Advocate Ajay Amitabh Suman, IP Adjutor (Patent & Trademark Attorney), High Court of Delhi
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