An Indian appellate ruling has upended how pharmaceutical patent evidence gets collected across borders. If your cases touch India’s generic drug supply chain, the old playbook no longer works.
Most e-discovery professionals I talk to have a working understanding of cross-border data transfer issues: GDPR, blocking statutes, the usual suspects. Far fewer have India on their radar. That’s about to change.
On November 25, 2025, the Madras High Court’s Division Bench handed down a ruling in Softgel Healthcare Private Limited v. Pfizer Inc. that refused to execute Letters Rogatory issued out of a U.S. federal court in Delaware. Pfizer had been trying to collect manufacturing records (batch data, X-ray diffraction results, stability protocols) from an Indian company that supplied the active pharmaceutical ingredient (API) at the center of a Hatch-Waxman patent litigation. The Indian court said no. And not on narrow procedural grounds. The bench went article by article through the Hague Evidence Convention and found independent reasons to refuse under four separate provisions.
That alone would be worth paying attention to. But what happened next raised the stakes further: India’s Supreme Court took up the appeal, directed the Union of India to join as a party, and signaled it intends to “settle the law” on how Indian courts handle foreign discovery requests. This is no longer a one-off decision. It’s a case that could reshape the entire framework.
A Quick Primer for the Non-Pharma Crowd
For those who don’t live in pharmaceutical patent litigation, here’s the short version. Under the Hatch-Waxman Act, when a generic drug company files an Abbreviated New Drug Application (ANDA) with the FDA, the patent holder can sue for infringement in U.S. federal court. These cases are big, document-intensive, and, more and more often, international.
In the Pfizer matter, the underlying litigation sits in the District of Delaware (Pfizer Inc. v. Dexcel Pharma Technologies). Pfizer holds U.S. patents on tafamidis, the active ingredient in its cardiac drugs Vyndaqel and Vyndamax. Cipla and Zenara Pharma filed ANDAs to market generic versions. Pfizer’s theory was that these companies sourced their API from two Indian manufacturers: Softgel Healthcare in Chennai and Teena Biolabs in Hyderabad. Neither Indian company was named in the Delaware suit. So, Pfizer went through the Hague Convention’s Letters Rogatory process, which, in plain terms, is a formal request from the Delaware court asking Indian courts to help collect evidence.
Same Request, Opposite Results
Here’s where it gets interesting. Pfizer filed parallel Letters Rogatory in two different Indian courts and got completely different results.
The Telangana High Court handled the Teena Biolabs request the way most practitioners would have expected. It appointed a chemist as Local Commissioner, established a Confidentiality Club, ordered in-camera proceedings, and let the process move forward. This was the template that had worked in Indian courts for years, in Bombay, Delhi, and Telangana, going back at least a decade.
The Madras High Court took a different view entirely. A single judge had initially followed the Telangana approach and appointed a Local Commissioner. On appeal, the Division Bench reversed. The bench didn’t just find a procedural defect. It conducted what I can only describe as a systematic teardown of Pfizer’s request across multiple provisions of the Hague Convention.
Four Grounds, Four Different Problems
Under Article 3 of the Hague Convention, the court found Pfizer’s document requests too broad. Phrases like “all documents and electronically stored information” relating to manufacturing and testing didn’t meet the Convention’s specificity requirements. Anyone who has drafted a Rule 34 request in U.S. litigation will recognize that language and will now need to understand that it simply does not translate to the Hague framework as interpreted by this court.
Under Article 11, the bench recognized Softgel’s right as a non-party to decline production. Softgel was a witness, not a litigant, and Indian law gives non-party witnesses protections that the bench was not willing to override.
Article 12(b) is where it gets really consequential. The court noted that Pfizer’s Indian patent application for the same drug had been refused by the Indian Patent Office. The bench reasoned from that refusal: why should an Indian court compel an Indian company to hand over proprietary manufacturing data to enforce a patent that India itself declined to grant? The court held that doing so would prejudice India’s sovereignty. This is, as far as I’m aware, without direct precedent. The status of a domestic patent application being treated as a dispositive factor in whether a foreign discovery request gets executed is a new development, and one that changes the calculus for any innovator whose Indian patent portfolio is less than airtight.
Under Article 23, the bench held that Pfizer’s requests amounted to prohibited pre-trial discovery under India’s qualified declaration. India filed this declaration when it ratified the Hague Convention in 2007, but no Indian appellate court had previously applied it with this force in a pharmaceutical case. That changed here.
What’s Happening at the Supreme Court
Pfizer appealed. On January 29, 2026, a bench led by Chief Justice Surya Kant heard the matter. The court issued notice to Softgel but pointedly said this was “not because we are convinced” by Pfizer’s arguments. Rather, the court wanted to settle the legal position on Letters Rogatory once and for all.
Two things stood out from the hearing. First, the court directed the Union of India to be made a party. That’s unusual. It signals the court views this as a matter of national policy, not just a dispute between a U.S. pharmaceutical company and an Indian manufacturer. Second, the bench raised the question of reciprocity head-on: would American courts show the same cooperative spirit if an Indian company needed evidence from the United States?
No stay was granted. No interim relief. Pfizer pointed to its April 27, 2026, trial date in Delaware, but the court didn’t appear moved by the urgency. As of late February, no further hearing date has been reported.
Why E-Discovery Professionals Should Care
India is the world’s largest exporter of generic pharmaceuticals. The manufacturing ecosystem there is enormous: over 1,500 API plants, 75-plus FDA-approved facilities, and contract testing labs spread across Hyderabad, Chennai, Ahmedabad, and Pune. All of that is deeply woven into global drug supply chains. In any Hatch-Waxman case where the generic product originates in India, the critical electronically stored information (ESI) probably sits there too. Batch records, bioequivalence studies, analytical testing data, stability protocols. Much of it held by entities that are not parties to the U.S. litigation.
If the Supreme Court upholds or even just narrows the Madras ruling without overturning its core reasoning, the standard Hague Convention route for collecting that evidence becomes much harder to rely on. India is not alone in restricting discovery under the Convention, either. Twenty-eight countries maintain blanket reservations against pre-trial discovery. The UK requires a direct link to specific proceedings. Germany excludes non-party document requests. France layers its Hague restrictions on top of a criminal blocking statute. What sets the Softgel ruling apart is the Article 12(b) sovereignty analysis tied to local patent validity. That particular move, connecting the fate of a domestic patent application to whether a foreign court’s discovery request gets executed, breaks new ground.
Some Practical Notes
A few things worth thinking through if your work touches this space.
Exhaust U.S.-based discovery first. If the ANDA filer has a U.S. subsidiary, start with Rule 34. If parent and subsidiary companies share quality management systems, databases, or reporting lines, U.S. courts are generally willing to compel production from the domestic entity regardless of what’s happening in Indian courts. Don’t treat this as a fallback. Treat it as the primary route.
If you do pursue Letters Rogatory, get specific. Broad requests are dead on arrival after Softgel. You need named custodians, identified document categories tied to particular manufacturing sites, and specific test protocols. Pulling that together requires on-the-ground intelligence about India’s pharmaceutical supply chain: who actually conducted the bioequivalence studies, which facility holds the batch records, what the contractual chain looks like between the ANDA filer and its Indian contract manufacturers.
Think about voluntary collection. Where evidence sits with an independent third party, say a contract research organization or a stability testing lab, it may be possible to negotiate a consensual, supervised collection using a neutral forensic intermediary. This takes the Indian courts out of the equation entirely, though it depends on the third party’s willingness to cooperate.
And don’t overlook § 1782. Under 28 U.S.C. § 1782, if an Indian entity has a U.S. affiliate, a U.S.-based agent, or filed a Drug Master File through a U.S. representative, that touchpoint may support an application for judicially compelled discovery on American soil.
Looking Ahead
Several things are coming to a head in the next few months. The Delaware trial is set for late April. The USTR’s 2026 Special 301 Report, which reviews IP enforcement globally, is expected around the same time. That report will be the first opportunity for groups like PhRMA and the U.S. Chamber’s Global Innovation Policy Center to formally flag the Softgel ruling with the U.S. government. India has sat on the USTR Priority Watch List for years over patent enforcement issues, and a judicial barrier to evidence collection could sharpen that scrutiny.
The real event to watch, though, is the Supreme Court. If it formalizes restrictive guidelines for executing Letters Rogatory, particularly if it mandates reciprocity requirements or cements the link between Indian patent status and discovery cooperation, the effects will reach well beyond pharmaceutical cases. Any cross-border matter involving Indian entities and ESI held in India could feel the impact.
One last thing. I’ve been struck by how little Western commentary this ruling has generated. No major U.S. or international IP firm has published on it. Nothing has appeared on SSRN. The analysis has come almost entirely from Indian legal blogs and law firms. That gap between the ruling’s importance and its visibility in U.S. legal circles is itself telling. Whether it reflects a lag in awareness or a wait-and-see posture pending the Supreme Court’s final word, practitioners in this space would do well not to wait along with them.
