Limits on Executing Foreign Letters Rogatory in India: Article 23 of the Hague Evidence Convention and Non‑Party Rights in Softgel Healthcare v. Pfizer

I. Introduction

The decision of the Madras High Court in Softgel Healthcare Private Limited v. Pfizer Inc. & Ors. (L.P.A. Nos. 17 & 18 of 2025, judgment dated 25 November 2025) is a significant pronouncement on:

• the execution of foreign Letters Rogatory in India under Order XXVI Rules 19–22 CPC read with Section 78 CPC;
• the effect of India’s declaration under Article 23 of the Hague Evidence Convention (Convention of 18 March 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters); and
• the rights of non‑party Indian entities (particularly pharmaceutical manufacturers) when their confidential technical and commercial documentation is sought in aid of foreign patent litigation.

The Division Bench (Dr. Justice G. Jayachandran and Justice Mummineni Sudheer Kumar) overturned a Single Judge’s order which had allowed execution of Letters Rogatory issued by the United States District Court for the District of Delaware in US patent infringement proceedings concerning Pfizer’s Patent No. 9,770,441 (crystalline forms of Tafamidis, marketed as “Vyndamax”).

At the core of the ruling lies a new, clearly articulated principle: Indian courts cannot execute foreign Letters Rogatory that, in substance, seek pre‑trial discovery of documents, are vague or omnibus in nature, and fail to comply with the specificity and sovereignty safeguards built into the Hague Evidence Convention and India’s own declaration under Article 23. This is particularly true where the request is directed against a non‑party witness and relates to a field (such as patents) in which domestic proceedings and policy interests are directly implicated.

II. Factual and Procedural Background

A. The Underlying US Patent Litigation

Pfizer Inc., a New York‑incorporated company, holds US Patent No. 9,770,441 (“the 441 patent”) for crystalline forms of Tafamidis 61 mg, marketed as Vyndamax in the United States. When:

• Cipla (ANDA No. 218409), and
• Zenara (now Hikma; ANDA No. 21805)

filed Abbreviated New Drug Applications (ANDAs) in the US, Pfizer initiated Civil Action No. 23‑879 (GBW) (CJB) before the District Court for the District of Delaware alleging patent infringement on the ground that the ANDA filings were made prior to expiry of the 441 patent.

In those US proceedings, Pfizer sought discovery from the defendants, and Cipla and Zenara disclosed that certain manufacturing and development activities for the ANDA products were being undertaken in India by Softgel Healthcare Private Limited, an Indian contract manufacturer.

B. Letters Rogatory from the US District Court

Relying on the Hague Evidence Convention, the US District Court in Delaware issued Letters Rogatory (Letters of Request) dated 13.05.2024 to the “appropriate authorities” in India, seeking:

• production of specified categories of technical and manufacturing documents; and
• deposition (oral evidence) of representatives of Softgel Healthcare,

in relation to the Tafamidis API and finished product supplied to Cipla and Zenara.

C. Original Petitions Before the Madras High Court

On the strength of these Letters Rogatory, Pfizer Inc. and its related entities (FoldRx Pharmaceuticals LLC, PF Prism IMB B.V., and Wyeth LLC) filed O.P.(PT) Nos. 5 & 6 of 2024 before the Madras High Court, invoking:

• Order XXVI Rules 19–22 read with Section 78 of the Code of Civil Procedure, 1908 (CPC), which enable Indian courts to act upon requests from foreign courts; and
• the Hague Evidence Convention’s framework for mutual legal assistance in taking evidence abroad.

They sought, inter alia:

• appointment of a Local Commissioner (preferably a person with chemistry expertise) to collect documents and record testimony in terms of the Letters Rogatory;
• “special powers” for the Commissioner to summon persons and documents, administer oaths, record evidence, and transmit material to the US Court;
• constitution of a Confidentiality Club and conduct of proceedings in camera to protect sensitive information; and
• directions to the Registry and Commissioner to maintain all materials under sealed cover.

D. Softgel’s Objections Before the Single Judge

Softgel Healthcare, though not a party to the US litigation, was arrayed as respondent in the Madras proceedings and objected on several grounds:

• It was a non‑party to the US suit and could not be subject to a “fishing expedition” under the cover of Letters Rogatory.
• The Letters Rogatory were vague, omnibus and unspecific, seeking broad, category‑based discovery rather than particular documents and named witnesses.
• The information demanded was highly confidential and related to proprietary manufacturing processes and know‑how, protected under domestic law and international frameworks like TRIPS.
• Pfizer’s patent application for Tafamidis/Vyndamax had been refused by the Indian Patent Office (Application No. 20171005783). Allowing Pfizer to gather extensive technical data in India would, in substance, undermine the Indian patent regime and domestic determinations.
• Under Article 23 of the Hague Evidence Convention, and pursuant to a notification by the Government of India, India had declared that it would not execute Letters of Request for pre‑trial discovery of documents “as known in common law countries”.

E. The Single Judge’s Order

The learned Single Judge held that:

• Softgel was not a stranger to the underlying controversy, since it had contractual links with Cipla and Zenara for manufacturing the very drug products at issue in the US litigation;
• Order XXVI Rules 19–22 read with Section 78 CPC empowered the High Court to execute Letters Rogatory, including issuing commissions to obtain both oral and documentary evidence;
• Rule 19 should be liberally construed in the interests of international judicial cooperation;
• safeguards such as a Confidentiality Club and a technically qualified Commissioner could sufficiently protect Softgel’s concerns.

Accordingly, the Single Judge allowed Pfizer’s petitions and issued directions for execution of the Letters Rogatory.

F. Letters Patent Appeals

Softgel challenged that order by filing L.P.A. Nos. 17 & 18 of 2025 under Clause 15 of the Letters Patent, leading to the present Division Bench decision.

III. Issues Before the Division Bench

The Division Bench distilled the controversy into a central question:

“Whether the order passed by the Learned Single Judge is contrary to the Domestic law in India and the provisions of the Hague Convention?”

Embedded within this were several sub‑issues:

• Does India’s declaration under Article 23 of the Hague Evidence Convention bar execution of Letters Rogatory that seek pre‑trial discovery of documents?
• Is the Letters Rogatory in question compliant with Article 3 (specificity as to persons, questions, and documents)?
• What is the scope of Order XXVI Rule 19 CPC in light of such international obligations and declarations?
• Can a non‑party Indian entity like Softgel be compelled to divulge extensive confidential information where:
• • similar subject‑matter patent proceedings are pending or have been decided under Indian law, and
  • there is a risk of prejudice to domestic sovereignty and policy?
• Do confidentiality mechanisms (like a Confidentiality Club) cure the fundamental legal defects in the request?

IV. Summary of the Judgment

The Division Bench allowed the appeals, set aside the Single Judge’s orders in O.P.(PT) Nos. 5 & 6 of 2024, and dismissed Pfizer’s applications seeking execution of the Letters Rogatory.

Key holdings include:

• India’s declaration under Article 23 of the Hague Evidence Convention—refusing to execute Letters of Request for pre‑trial discovery of documents—must be given full effect by Indian courts.
• Letters Rogatory must comply with Article 3 by specifying:
  • the persons to be examined,
  • the subject‑matter of examination, and
  • the particular documents or property to be inspected.
  The Letters Rogatory in this case were held to be vague and omnibus.
• Under Article 11, a person may refuse to give evidence where there is a privilege or duty under either:
  • the law of the State of execution (India), or
  • the law of the State of origin.
  Softgel, as a non‑party, was entitled to invoke such privilege.
• The Court emphasised that while domestic law (CPC) enables execution of Letters Rogatory, such cooperation is conditional and cannot override:
  • India’s treaty‑based declaration under Article 23, and
  • concerns of sovereignty and security (Article 12(b)).
• The requested evidence was found to be in the nature of pre‑trial discovery in foreign litigation between Pfizer and other parties, not Softgel; India had declined to execute such requests.
• Given that Pfizer’s corresponding Indian patent application had been refused and an appeal was pending, compelling Softgel to surrender extensive technical documentation risked undermining India’s own patent system and thereby its sovereignty.
• The Single Judge’s order, rendered without adequately considering India’s Article 23 declaration and the scope of Articles 3, 11 and 12, required interference.

V. Detailed Analysis

A. Statutory and Treaty Framework

1. Code of Civil Procedure, 1908 (CPC)

Order XXVI governs commissions, including those issued at the request of foreign courts.

• Rule 19 permits the High Court to issue a commission for examination of a witness on receipt of a letter of request from a foreign court in connection with a civil proceeding, where the witness resides within the High Court’s jurisdiction.
• Rules 19–22 and Section 78 together form the domestic statutory basis for executing Letters Rogatory.

Earlier case law had often been read to mean that the Indian court’s role is largely mechanical once the three basic conditions of Rule 19 are met:

1. There is a civil proceeding in a foreign court;
2. The foreign court has requested assistance;
3. The witness resides within the Indian court’s jurisdiction.

The Division Bench, however, makes it clear that these conditions are necessary but not sufficient where the request comes under a treaty framework (such as the Hague Evidence Convention) and where the Government of India has exercised specific reservations or declarations.

2. Hague Evidence Convention – Key Provisions

The Court closely examined four provisions:

(a) Article 3 – Content and Conditions of Letters of Request

Article 3 requires that a Letter of Request set out:

• the authorities involved (requesting and requested);
• names and addresses of parties and their representatives;
• the nature of the proceedings and the judicial act to be performed; and
• where appropriate:
  • names and addresses of persons to be examined,
  • questions to be put or subject‑matter of examination,
  • the documents or other property to be inspected,
  • any special procedures or oath requirements.

Specificity is central. A request that merely outlines broad categories or open‑ended classes of documents, without clear delimitation, fails this standard.

(b) Article 11 – Privilege and Duty to Refuse Evidence

Article 11 allows the person concerned to refuse to give evidence:

• where he or she has a privilege or duty to refuse under the law of the State of execution (India); or
• under the law of the State of origin, where such privilege or duty is specified in the Letter or otherwise confirmed.

This article embeds witness protections and privileges into the execution of Letters Rogatory, underscoring that cooperation is not absolute.

(c) Article 12 – Grounds of Refusal

Article 12 permits refusal “only to the extent that”:

• execution does not fall within the functions of the judiciary in the State of execution; or
• the State addressed considers that its sovereignty or security would be prejudiced thereby.

The Division Bench explicitly links this to the need for a sovereignty‑based filter before executing foreign requests.

(d) Article 23 – Pre‑Trial Discovery of Documents

Article 23 provides:

“A Contracting State may at the time of signature, ratification or accession, declare that it will not execute Letters of Request issued for the purpose of obtaining pre‑trial discovery of documents as known in Common Law countries.”

The Court records that the Republic of India has exercised this right, issuing a declaration that it will not execute Letters of Request for such pre‑trial discovery, particularly where:

• the request seeks unspecified or broad categories of documents rather than specific, identified documents likely to be in the witness’s possession, custody or power.

This declaration is the cornerstone of the Division Bench’s reasoning.

B. Parties’ Arguments and the Court’s Evaluation

1. Softgel’s Contentions

Softgel’s submissions, accepted in substance by the Division Bench, included:

• Non‑party status: Softgel was not a defendant in the US patent suit; it was a third‑party contract manufacturer and should not be subjected to invasive foreign discovery via Indian courts.
• Pre‑trial discovery in disguise: The Letters Rogatory sought wide‑ranging technical information and internal correspondence, amounting to pre‑trial discovery of documents, which India had expressly reserved against under Article 23.
• Vagueness and overbreadth: The requests were omnibus and unspecific, with a sweeping final category – “any further document deemed necessary” after review of produced documents – a classic “fishing expedition”.
• Indian patent refusal and domestic proceedings:
  • Pfizer’s Indian patent application for “Vyndamax”/Tafamidis had been refused by the Indian Patent Office.
  • Allowing Pfizer to gather highly specific and confidential manufacturing data in India in aid of enforcing its US patent would undermine the domestic decision and ongoing appellate processes.
• TRIPS and confidentiality: The information constituted trade secrets and confidential business information, meriting protection.
• Abuse of process / lack of necessity: Pfizer should first exhaust discovery mechanisms within the US against the defendants Cipla and Zenara. A direct approach to Softgel via Letters Rogatory, without exhausting those remedies, was characterised as abusive.

2. Pfizer’s Contentions

Pfizer, through its senior counsel, argued:

• Domestic statutory authority: Order XXVI Rule 19 CPC empowers Indian courts to act upon Letters Rogatory; this power is well recognised and has been routinely exercised.
• Letters Rogatory enforceable against non‑parties: Prior Indian case law (including a recent Telangana High Court decision in a similar Pfizer matter) authorises the enforcement of Letters Rogatory even against non‑party witnesses.
• Specificity of documents: The categories in Appendix‑I (testing and development records, polymorphism data, spectral analysis records, etc.) were sufficiently described and not “vague”.
• Confidentiality safeguards: The Single Judge’s order creating a Confidentiality Club and sealed‑cover regime adequately protected Softgel’s confidential information; Roeing enquiry was thus constrained.
• Secrecy not a defence in patent litigation: In patent disputes, especially concerning polymorphic forms and manufacturing processes, secrecy cannot be used as a shield against legitimate evidentiary needs.
• International comity: Refusing to execute the Letters Rogatory would undercut judicial comity and reciprocity between the US and India.

3. The Court’s Evaluation

The Division Bench balanced these positions through the lenses of:

• India’s Article 23 declaration (pre‑trial discovery),
• Article 3 specificity requirements,
• Articles 11 and 12 (privilege and sovereignty), and
• the domestic framework of Order XXVI Rule 19 CPC.

Critically, the Court concluded:

• The Letters Rogatory were indeed seeking pre‑trial discovery of documents in a pending US civil action.
• The requests lacked the level of particularisation demanded by Article 3 and India’s own understanding of permissible assistance (they were more akin to “category discovery”).
• Softgel, as a non‑party whose domestic legal interests (including a “potential threat to [its] registered Indian patent”) could be prejudiced, had a meaningful privilege and duty to refuse under Article 11 and Indian law.
• Executing such Letters Rogatory, when India has expressly declined pre‑trial document discovery, would prejudice India’s sovereignty (Article 12(b)) and contravene the notification issued by the Government of India.

C. Precedents Cited and Their Treatment

1. M/s Wooster Products Inc. v. M/s Magna Tek Inc. & Ors. (Delhi High Court)

The Delhi High Court’s judgment in Wooster Products is a foundational authority on Letters Rogatory in India. It held, inter alia, that:

• The relevance and admissibility of evidence sought are to be decided primarily by the foreign court issuing the Letter of Request, not by the executing Indian court.
• Indian courts should not sit in appeal over the foreign court’s assessment of relevancy; the issuance of the request itself implies a determination of necessity and relevance.
• Third parties (interveners) generally cannot resist production on grounds of privilege, except to the extent permitted as witnesses.

The Division Bench in Softgel noted that Wooster is “oft‑quoted,” but highlighted an important nuance:

• Wooster concerned a context in which India’s Article 23 declaration was not in issue or addressed.
• While Wooster supports execution of Letters Rogatory based on comity and CPC, it also recognises that witnesses themselves may claim privilege (a point the Madras High Court emphasises in favour of Softgel).

Thus, Softgel does not displace Wooster but situates it within the more constrained regime created by Article 23 and India’s declaration.

2. Upaid Systems Limited v. Satyam Computer Services Ltd. & Another (2009 SCC OnLine Del 2006)

In Upaid, the Delhi High Court:

• considered the power under Order XXVI Rule 19 CPC to execute Letters Rogatory;
• emphasised that so long as there is an enabling provision in Indian law, the mere reference to an international convention (even where India is a limited signatory) does not prevent the court from acting; and
• treated the three conditions of Rule 19 (existence of foreign civil proceedings, request from foreign court, witness within jurisdiction) as the primary threshold.

The Division Bench in Softgel respectfully diverges from the Upaid reading to this extent:

• It stresses that execution of a Letter of Request must additionally ensure that:
  • India’s sovereignty is not prejudiced (Article 12(b)); and
  • India’s own treaty declarations (Article 23) are given full effect.
• It characterises a purely textual reading of Order XXVI Rule 19 as incomplete, insisting that international obligations and reservations form part of the legal context.

In a notable passage, the Division Bench states that in “the spirit of preserving comity among nations,” sovereignty cannot be “put on the back burner”. Thus, Softgel recalibrates the balance between comity and sovereignty.

3. Telangana High Court Decision in a Similar Pfizer Matter

Pfizer relied on a judgment of the Telangana High Court in a similar scenario, where a third‑party Indian entity (non‑party to foreign patent proceedings) was directed to cooperate with Letters Rogatory in Pfizer’s favour.

The Madras High Court acknowledges this authority but observes that, in many earlier decisions (including this Telangana case), courts did not have occasion to consider India’s Article 23 declaration and its implications for pre‑trial discovery. To that extent, Softgel can be seen as:

• filling a doctrinal gap; and
• establishing a more restrictive, treaty‑compliant standard for future cases.

D. The Court’s Legal Reasoning

1. Characterising the Request as Pre‑Trial Discovery

A pivotal finding is the Court’s conclusion that the Letters Rogatory are squarely in the nature of pre‑trial discovery of documents.

The Appendix‑I to the redacted US application sought, from Softgel:

• “All documents and electronically stored information” related to testing and development of the Tafamidis API or Cipla’s ANDA product.
• “All documents” about intermediates, polymorphism, X‑ray powder diffraction peaks, solid‑state NMR shifts, Raman spectroscopy peaks, and polymorphic conversion into or out of the patented Form I.
• “All communications” between Softgel and Cipla relating to polymorphic forms or testing.
• “All documents” relating to the 441 patent.
• A sweeping catch‑all: “Any further document deemed necessary upon receipt and perusal of the documents discovered through the present proceedings.”

The Court viewed this as:

• not merely seeking specific, identified documents, but
• an open‑ended, category‑based discovery exercise typical of common law pre‑trial discovery (precisely what Article 23 allows States like India to reject).

2. Non‑Compliance with Article 3 (Specificity)

The Court held that the Letters Rogatory were “vague” and “without any specificity” required under Article 3:

• While some technical descriptors were present, the operative language was “all documents… that refer or relate to…” across multiple broad themes.
• The final residual category (any further document deemed necessary) was particularly problematic, creating an open‑ended mandate.

Thus, the Court concluded that the Letters Rogatory failed to meet the precision and limitation requirements under Article 3 and India’s approach to permissible evidence‑gathering.

3. Witness Privilege and Non‑Party Rights under Article 11

The Division Bench underscores that:

• Softgel, as a non‑party Indian entity, is essentially in the position of a witness vis‑à‑vis the foreign proceedings.
• Under Article 11, such a person may refuse to give evidence where a privilege or duty arises under Indian law.
• Softgel’s confidentiality interests, trade secrets, and potential patent rights in India create a legitimate basis for claiming such privilege.

It is not merely a matter of convenience or business preference; rather, the Court recognises a legal privilege to refuse disclosure where compliance would prejudice domestic legal rights and broader sovereign interests.

4. Sovereignty and the Indian Patent Regime

The Court attaches particular weight to the status of Pfizer’s Indian patent application for the same or similar subject‑matter:

• Pfizer’s application for the Tafamidis formulation (Vyndamax) was rejected by the Indian Patent Office.
• An appeal against that rejection was pending in India.
• At the same time, Pfizer was seeking extensive technical and manufacturing information from Softgel to support enforcement of its US patent against Cipla and Zenara.

The Court reasons that:

• forcing Softgel to disclose detailed manufacturing and polymorphism data could have the effect of prejudicing Softgel’s standing and rights in domestic litigation (including, possibly, its own patents);
• such compelled disclosure, in aid of enforcing a foreign patent that has no Indian counterpart (and whose Indian variant has been refused), would risk undermining India’s policy choices and its patent system;
• this implicates India’s sovereignty within the meaning of Article 12(b).

5. Comity vs. Sovereignty: Re‑balancing the Equation

While acknowledging the importance of international judicial assistance and comity, the Division Bench explicitly states that:

“In the spirit of preserving comity among nations, sovereignty of the Country cannot be put to back burners.”

This sentence encapsulates the shift from a largely comity‑driven approach to a sovereignty‑conscious, treaty‑compliant standard. Execution of Letters Rogatory in India is:

• permitted, but not automatic;
• subject to treaty‑based reservations (Article 23); and
• subject to scrutiny to ensure no prejudice to sovereignty or security (Article 12).

6. Inadequacy of Confidentiality Club as a Cure

Pfizer placed heavy reliance on the Confidentiality Club and sealed‑cover procedures ordered by the Single Judge. The Division Bench, however, treats these mechanisms as procedural safeguards that cannot:

• override a substantive bar stated in Article 23 and the Government’s declaration; or
• cure fundamental jurisdictional and treaty‑compliance defects in the Letters Rogatory.

In other words, the presence of a Confidentiality Club cannot turn an otherwise impermissible pre‑trial discovery request into a lawful one.

E. Impact and Significance

1. For Cross‑Border Patent and Pharmaceutical Litigation

This judgment will have particular resonance in the pharmaceutical sector, where:

• global innovators often litigate patents in the US and Europe while related or parallel issues arise in India; and
• Indian companies act as contract manufacturers or API suppliers for products targeted in foreign litigation.

Key implications:

• Foreign patentees (like Pfizer) will face a higher hurdle in using Letters Rogatory to compel third‑party Indian manufacturers to disgorge large tranches of technical data for use in foreign patent litigation.
• Where the same or similar patent claims have been refused in India (or are subject to domestic disputes), Indian courts are likely to be more reluctant to assist with broad evidence‑gathering for foreign enforcement.
• Foreign litigants will need to:
  • craft highly specific Letters Rogatory;
  • avoid omnibus discovery language; and
  • demonstrate that the request is not, in substance, pre‑trial discovery of documents as understood by Article 23.

2. For Execution of Foreign Letters Rogatory Generally

More broadly, Softgel establishes that:

• Indian courts must actively scrutinise Letters Rogatory for:
  • conformity with Article 3 (specificity),
  • compliance with Article 23 (no pre‑trial discovery), and
  • non‑prejudice to sovereignty and security (Article 12).
• The earlier, more mechanical application of Order XXVI Rule 19 (once its three conditions are met) is no longer tenable in cases governed by the Hague Evidence Convention.
• Non‑party witnesses have substantial rights under Article 11 and domestic law to refuse cooperation where legitimate privilege/confidentiality interests exist.

3. For Third‑Party Confidentiality and Trade Secrets

The judgment strengthens the position of Indian companies whose trade secrets and proprietary data are sought incidentally in foreign disputes:

• They are not mere passive repositories of evidence; they have rights and privileges recognised by treaty and domestic law.
• Even sophisticated mechanisms like Confidentiality Clubs do not negate the right to refuse where a treaty‑based bar or sovereignty concern is present.

4. For the Relationship Between Domestic Law and Treaties

Finally, the decision highlights a nuanced approach to treaties:

• Domestic enabling provisions (like Order XXVI Rule 19 CPC) are to be read in harmony with India’s treaty commitments and declarations.
• Courts cannot apply the CPC in isolation when the very request is framed under a treaty regime (Hague Evidence Convention).

In that sense, Softgel offers a more integrated, treaty‑aware interpretation of Indian procedural law.

VI. Complex Concepts Simplified

1. Letters Rogatory (Letters of Request)

A Letter Rogatory is a formal request from a court in one country to the courts of another country, asking for assistance in obtaining evidence (documents, testimony, inspections) for use in ongoing proceedings.

• The requesting court cannot directly compel persons abroad to produce evidence.
• Instead, it asks the foreign court to use its own procedures and powers to obtain that evidence.

2. Hague Evidence Convention

The Hague Evidence Convention is an international treaty that:

• standardises the process by which courts in one contracting State may request evidence from another;
• lays down minimum content requirements for Letters of Request (Article 3);
• provides protections for witnesses (Article 11) and States (Article 12); and
• allows States to opt out of executing requests for pre‑trial discovery of documents (Article 23).

3. Article 23 and “Pre‑Trial Discovery of Documents”

In common law jurisdictions (like the US), pre‑trial discovery of documents often involves:

• wide‑ranging requests for categories of documents (“all documents relating to X”);
• requests designed to allow a party to search for helpful evidence among an opponent’s records (sometimes called “fishing expeditions”).

Article 23 allows contracting States to declare that they will not execute such requests via their own courts. The Madras High Court proceeds on the basis that India has made such a declaration, restricting execution of Letters Rogatory that seek:

• broad classes of documents,
• without naming specific documents, and
• primarily for pre‑trial preparation.

4. Confidentiality Club

A Confidentiality Club is a procedural mechanism used in complex IP and commercial litigation, whereby:

• only a limited set of individuals (e.g., specific lawyers, experts, and sometimes designated company representatives) are allowed access to sensitive documents;
• such individuals undertake obligations not to disclose or misuse the information.

It is a way to permit discovery while reducing the risk of trade secret leakage. However, as Softgel makes clear, such clubs do not override substantive legal bars (such as Article 23 declarations).

5. ANDA (Abbreviated New Drug Application)

In the US, an ANDA is a regulatory filing by a generic drug manufacturer seeking approval to market a generic version of a branded drug:

• It demonstrates bioequivalence to the already approved drug, without repeating extensive clinical trials.
• Filing an ANDA with a “Paragraph IV certification” (asserting that a patent is invalid or not infringed) is treated as an artificial act of infringement under US law, allowing the patent holder to sue.

Pfizer’s US suit against Cipla and Zenara revolves around such ANDA filings for Tafamidis.

6. Letters Patent Appeal (LPA)

An LPA is an intra‑court appeal provided for in the Letters Patent constituting certain High Courts (like the Madras High Court):

• It is an appeal from the judgment of a Single Judge to a Division Bench of the same High Court, in certain categories of cases.
• Here, Softgel used the LPA route to challenge the Single Judge’s order executing the Letters Rogatory.

VII. Conclusion

The Madras High Court’s decision in Softgel Healthcare Private Limited v. Pfizer Inc. & Ors. marks an important doctrinal development in the law governing international judicial assistance in India.

The key takeaways are:

• Execution of foreign Letters Rogatory under Order XXVI CPC is subject not only to the three classic conditions (foreign civil proceeding, request from foreign court, witness within jurisdiction) but also to:
  • specificity requirements under Article 3 of the Hague Evidence Convention,
  • witness privileges under Article 11,
  • sovereignty protections under Article 12(b), and
  • India’s Article 23 declaration against pre‑trial discovery of documents.
• Requests that are vague, omnibus, or category‑based—designed to allow broad pre‑trial fishing—are likely to be rejected.
• Non‑party Indian entities like Softgel enjoy meaningful protections and may refuse to cooperate where compliance would compromise trade secrets, domestic patent positions, or broader sovereign interests.
• Domestic policy choices in areas like patent regulation cannot be indirectly undermined through foreign evidence‑gathering mechanisms.
• While international comity remains important, it does not trump India’s sovereign right to structure and protect its legal system and economic interests.

In sum, Softgel recalibrates the interaction between Indian procedure and international judicial assistance, setting out a treaty‑conscious, sovereignty‑protective framework that will guide future cases involving foreign Letters Rogatory, especially in high‑stakes fields such as pharmaceutical patents.