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United States Of America vs Softgel Healthcare Private Limited
2025 Latest Caselaw 2117 Mad

Citation : 2025 Latest Caselaw 2117 Mad
Judgement Date : 28 January, 2025

Madras High Court

United States Of America vs Softgel Healthcare Private Limited on 28 January, 2025

Author: Abdul Quddhose
Bench: Abdul Quddhose
    2025:MHC:241


                                                                       O.P. (PT) Nos.5 and 6 of 2024

                              IN THE HIGH COURT OF JUDICATURE AT MADRAS

                                            Reserved on : 20.01.2025

                                           Pronounced on : 28.01.2025

                                                    CORAM:

                                  THE HON'BLE MR. JUSTICE ABDUL QUDDHOSE

                                          O.P. (PT) Nos.5 and 6 of 2024

                     1. Pfizer Inc.
                     235 East 42nd Street,
                     New York, NY 10017,
                     United States of America,
                     Represented by its Constituted Attorney,
                     Mr.Pankaj Pahuja

                     2. FoldRx Pharmaceuticals, LLC,
                     Corporation Trust Center,
                     1209 Orange St.,
                     Wilmington, DE 19801,
                     United States of America,
                     Represented by its Constituted Attorney,
                     Mr.Pankaj Pahuja

                     3. PF PRISM IMB B.V.,
                     Rivium Westlaan 142, 2909 LD,
                     Capelle aan den IJssel,
                     The Netherlands,
                     Represented by its Constituted Attorney,
                     Mr.Pankaj Pahuja

                     4. Wyeth LLC,
                     Corporation Trust Center,
                     1209 Orange St.,
                     Wilmington, DE 19801,

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                                                                             O.P. (PT) Nos.5 and 6 of 2024

                     United States of America,
                     Represented by its Constituted Attorney,
                     Mr.Pankaj Pahuja                                       .. Petitioners
                                                                            In both O.Ps.

                                                             vs.

                     Softgel Healthcare Private Limited                     .. Respondent
                                                                            In both O.Ps.

                     COMMON PRAYER: Common Joint petition filed under Order XXVI
                     Rule 19 to 22 and Sections 78 and 151 of C.P.C., 1908 for the following
                     reliefs:
                                  i) An order appointing a Local Commissioner, preferably a senior
                     person having good knowledge in the field of Chemistry such as a retired
                     Professor or a District Judge for collection of evidence, documents (as
                     mentioned in Clause 11 and Schedule A to the Letters Rogatory) as well
                     as for obtaining and recording the testimony (as mentioned in Clause 10
                     and Schedule B to the Letters Rogatory) from the Respondent and its
                     authorized representatives whose details are given in Clause 9 of the
                     Letters Rogatory; and


                                  ii) An order conferring 'Special Powers' on the aforesaid
                     Commissioner including the power to summon the person or persons
                     including corporations and/or their authorized representatives to produce
                     documents and things; the power to accept copies of the said documents
                     and things; the power to summon person or persons including
                     corporations and/or their authorized representatives, to administer oath to
                     them and to record their evidence; the power to allow the Petitioners' and

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                                                                               O.P. (PT) Nos.5 and 6 of 2024

                     the Respondent's respective Indian counsel the opportunity to examine or
                     cross-examine the aforesaid witnesses; the power to permit the
                     Petitioners' and the Respondent's respective foreign representatives to
                     attend and observe the examination of said person or persons including
                     corporations and/or their authorized representative; the power to record
                     the testimony of the said person or persons including corporations and/or
                     their authorized representative; the power to have the said recording
                     transcribed verbatim; and the power to provide, both the documents and
                     recording and the transcript to the Petitioners' and the Respondent's
                     respective representatives, their respective Indian Counsel, and


                                  iii) An order setting up a Confidentiality Club consisting of the
                     persons stated in paragraph 12 and on the lines stated as stated in
                     paragraph 13 of the instant petitions; and


                                  iv) An order to conduct the further proceedings before this Court
                     as well as before the Local Commissioner in camera with only the
                     members of the 'Confidentiality Club' being present; and


                                  v) An order directing the officials of the Registry of this Court as
                     well as the Commissioner to keep all the documents and records
                     pertaining to these petitions or the matters arising therefrom including
                     the evidence collected by the Commissioner in a sealed cover and allow
                     access to the said documents only to the members of the aforesaid
                     Confidentiality Club; and


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                                                                               O.P. (PT) Nos.5 and 6 of 2024

                                  vi) An order directing the said Commissioner to send the
                     evidence/documents collected and the testimony recorded to the United
                     States District Court for the District of Delaware in a sealed cover.

                                  For Petitioners
                                  In both O.Ps.            :     Mr.Sathish Parasaran
                                                                 Senior Counsel
                                                                 for Mr.Pravin Anand

                                  For Respondent
                                  In both O.Ps.            :     Mr.V. Raghavachari
                                                                 Senior Counsel
                                                                 for Dr.Mohan Devan

                                                     COMMON ORDER

These petitions have been filed before the Intellectual Property

Division (IPD) of this Court under Order XXVI Rules 19 - 22 read with

Sections 78 and 151 of C.P.C., seeking to execute the Letters Rogatory

dated 13.05.2024 issued by the United States District Court under the

Hague Convention, 1870, seeking judicial assistance from this Court

against the respondent. Letters Rogatory are formal requests from one

Court to another to obtain judicial assistance.

2. The petitioners in O.P. (PT) No.5 of 2024 claim that in the case

pending before the United States District Court at Delaware, they had

alleged, among other things, that the submission of Abbreviated New

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O.P. (PT) Nos.5 and 6 of 2024

Drug Application (ANDA) No.218409 by CIPLA, which seeks approval

from the FDA to market a generic version of VYNDAMAX® ("CIPLA's

ANDA Product") before the expiration of the petitioners' "441 Patent",

constitutes an act of infringement with respect to the "441 Patent".

3. The petitioners in O.P. (PT) No.6 of 2024 claim that in the case

pending before the United States District Court at Delaware, they had

alleged, among other things, that the submission of Abbreviated New

Drug Application (ANDA) No.218205 by Zenara (now Hikma), which

seeks approval from the FDA to market a generic version of

VYNDAMAX® ("Zenara's ANDA Product") before the expiration of the

petitioners' "441 Patent", constitutes an act of infringement with respect

to the "441 Patent".

4. Since the directions sought for in both the petitions are similar

in nature, they are disposed of by a Common Order.

5. A patent dispute is pending adjudication before the United

States District Court between the petitioners and Zenara Pharma Pvt.

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O.P. (PT) Nos.5 and 6 of 2024

Ltd. (hereinafter referred to as 'Zenara'), CIPLA and other Indian

pharmaceutical Companies viz., Aurobindo Pharma Limited and Dexcel

Pharma Technologies and Limited.

6. The present petitions pertain to Zenara's ANDA Product, which

according to the petitioners, infringes their "441 Patent" issued by the

U.S. Patent Office for their TAFAMIDIS 61 mg capsules sold under the

brand name VYNDAMAX®, which are used for treatment of

TRANSTHYRETIN AMYLOID CARDIOMYOPATHY. According to

the petitioners, they believe that the respondent and its employees who

are associated with Zenara possesses information and documents relating

to Zenara ANDA product that are relevant for proving infringement of

441 Patent belonging to the petitioners.

7. In the Civil proceedings, pending before the United States

District Court at Delaware between the petitioners and Zenara, CIPLA

and other Indian pharmaceutical companies, the petitioners filed a

request for international judicial assistance (Letters Rogatory) as per

Hague Convention of 18.03.1970 for taking evidence abroad in Civil or

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O.P. (PT) Nos.5 and 6 of 2024

Commercial matters to which both India and the Unites States are

signatories and to obtain evidence for the purpose of being used in the

Civil proceedings before the United States District Court for the District

of Delaware.

8. The United States District Court for the District of Delaware has

issued Letters Rogatory dated 13.05.2024 requesting this Court for

obtaining the deposition of documents from the respondent herein.

Subsequent to the issuance of Letters Rogatory, Zenara, one of the

defendants in the U.S. proceedings, raised confidentiality concerns

regarding certain portions of the Letters Rogatory and requested the

petitioners' counsel not to divulge the Letters Rogatory unless a

confidential club is formed.

9. According to the petitioners, to maintain the confidentiality,

they have filed a redacted version of the Letters Rogatory dated

13.05.2024 and the petitioners have requested this Court to grant leave

for them to place on record the full un-redacted version of the said

Letters Rogatory once this Court directs the formation of a

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O.P. (PT) Nos.5 and 6 of 2024

confidentiality club as prayed for in these petitions. However, as seen

from the pleadings of the respondent filed before this Court, they have

raised the following defences to these petitions:

a) The respondent is a third party and in the absence of any

infringement claim made by the petitioner against the respondent, these

petitions are not maintainable;

b) The respondent being a non-party to the original litigation

pending before the United States District Court at Delaware, they cannot

be compelled to provide evidence beyond the boundaries as per the

Hague Convention;

c) The respondent is entitled to invoke article 11 (1) of the Hague

Convention to refuse participation, if the request conflicts with domestic

laws or sovereignty;

d) Article 39 of the Hague Convention explicitly safeguards

confidential data, which is the core of the respondent's pharmaceutical

research and development;

e) Compelling disclosure by the respondent under the current

circumstances would be contrary to India's obligation under the TRIPS

agreement:

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O.P. (PT) Nos.5 and 6 of 2024

f) The Indian Patent Office has refused the petitioners' patent

application for the drug VYNDAMAX under Section 3 (d) of the Patents

Act, 1970, rejecting the application on the ground that it constitutes a

new form of a known substance. This decision negates the petitioners'

ability to enforce the patent rights within the territory of India;

g) The International Convention, such as Hague Evidence

Convention, cannot be invoked to override the domestic laws of India,

particularly when the petitioner is not asserting valid patent rights in

India. The Indian Patents Act, 1970 governs the enforceability of patent

rights within India and the Indian Patent Office's administration to reject

the petitioners' application renders any claim for this right is invalid;

h) The petitioners cannot make a fishing expedition in the guise of

evidence collection. The petitioners' requests are vague and violate the

principles of specificity and proportionality required under Article 23 of

the Hague Convention;

i) The respondent has legitimate source about the misuse of

sensitive information which unfairly benefit the petitioners in

circumventing the refusal of their patent application in India;

j) Forcing the respondent, a non-party to the U.S. litigation, to

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O.P. (PT) Nos.5 and 6 of 2024

disclose sensitive research and development data, would cause

disproportionate hardship to its commercial interest and those of its

equitable collaborators;

k) The respondent states that any information, the petitioner is

seeking regarding Zenara and CIPLA, ought to have been first addressed

before the United States District Court at Delaware.

10. Heard Mr. Sathish Parasaran, learned senior counsel and

assisted by Mr.Pravin Anand, learned counsel for the petitioners and

Mr.V. Raghavachari, learned senior counsel appearing for Dr.Mohan

Devan, learned counsel for the respondent.

11. Both the learned senior counsels reiterated the respective

contentions of the respective parties as seen from their pleadings filed

before this Court. Both of them have referred to the relevant documents

and relevant clauses in the Hague Convention as well as the Letters

Rogatory issued by the United States District Court at Delaware in

support of their respective contentions.

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O.P. (PT) Nos.5 and 6 of 2024

12. The learned senior counsel appearing for the petitioners in

support of the petitioners' contentions drew the attention of this Court to

the following authorities and submitted that in identical matters, the

Andhra Pradesh High Court, Bombay High Court and Delhi High Court

allowed similar reliefs for enforcement of Letters Rogatory issued by a

foreign Court:

a) Aventis Pharmaceuticals Inc. Vs. Dr. Reddy's Laboratories Inc.

reported in MANU/AP/0650/2008;

b) Pfizen Inc Vs. Unimark Remedies Limited reported in 2016

SCC Online Bom 8599;

c) Wooster products Inc., Vs. Magna Tek Inc. and Others reported

in MANU/DEL/0102/1988;

13. The learned senior counsel for the petitioners also drew the

attention of this Court to the House of Lords decision rendered in

Norwich Pharmacal Co. and Others Vs. Customs and Excise

Commissioners reported in Roskill LJ A.C. 133 and would submit that

where a person, albeit innocently and without incurring any personal

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O.P. (PT) Nos.5 and 6 of 2024

liability, became involved in the tortious acts of others, he came under a

duty to assist the one injured by those acts by giving him full information

by way of discovery and disclosing the identity of the wrongdoers.

14. Learned senior counsel appearing for the petitioners also

submitted that only in cases where

a) The execution of the Letters Rogatory does not fall within the

powers of the Indian Courts; and

b) The Letters Rogatory issued will affect the sovereignty or

security of India,

the question of refusing to execute the Letters Rogatory issued by the

foreign Court will arise.

15. According to him, in the present case, there is no prohibition

for this Court to enforce the Letters Rogatory issued by the United States

District Court, Delaware against the respondent since there are no legal

restrictions. According to him, the Letters Rogatory issued by the United

States District Court is in complete compliance with the Hague

Convention 18.03.1970 to which both India and United States are

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O.P. (PT) Nos.5 and 6 of 2024

signatories and India has also ratified it.

16. The learned senior counsel appearing for the petitioners also

submitted that the respondent's allegation in its counter statement that the

documents, that are sought for from it, are already in the possession of

CIPLA, is wrong. He also drew the attention of this Court to the

respondent's counter statement and would submit that the respondent has

admitted to the fact that it is also in possession of the documents

pertaining to CIPLA's ANDA product. According to him, there became a

necessity for the petitioners to seek for Letters Rogatory from the United

States District Court, Delaware since CIPLA, one of the defendants in

the said litigation, did not furnish all the necessary documents and they

had suggested that they would obtain the same from the respondent.

Since CIPLA did not produce the documents, Letters Rogatory was

issued by the United States District Court.

17. On the other hand, learned senior counsel appearing for the

respondent in support of the respondent's objections, relied upon the

following authorities:

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O.P. (PT) Nos.5 and 6 of 2024

a) A judgment of the Gujarat High Court in the case of Leighton

International Limited and Others Vs. Gavin John Hodge and Others

reported in 2014 SCC Online Guj 15738;

b) A decision of the Gujarat High Court in the case of Fenix

Diamonds LLC Vs. Carneige Institute of Washington reported in 2020

SCC Online Guj 1628.

18. Relying upon the aforesaid decisions, the learned senior

counsel appearing for the respondent would submit that this Court cannot

compel the respondent to produce the documents as it would amount to

causing serious prejudice to them as it will strip-off their protection,

privilege and confidentiality. He would also submit that the aforesaid

decisions have also made it clear that the production of documents

pursuant to the issuance of Letters Rogatory is limited to the parties to

the proceedings and a fishing expedition in the guise of evidence

collection cannot be permitted through the assistance of Indian Courts.

19. The learned senior counsel for the respondent reiterated the

contentions of the respondent as pleaded by them before this Court and

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O.P. (PT) Nos.5 and 6 of 2024

would submit as follows:

a) Since the respondent is not a party before the United States

District Court, the present petitions are not maintainable;

b) The Hague Convention does not enable this Court to grant the

relief as sought for in these petitions against a third party;

c) The Hague Convention cannot be invoked to override the

domestic laws of India. Since the patent application filed by the

petitioners pertaining to a similar invention as claimed before the United

States District Court has been refused to be granted by the Indian patent

office, no relief can be granted by this Court as sought for by the

petitioners in these petitions.

20. According to the learned senior counsel for the respondent, if

these petitions are allowed, it would amount to overriding the Indian

domestic laws, governing the issuance of patent. The petitioners ought to

have exhausted all remedies before the United States District Court

before seeking international judicial assistance. Having not done so, they

cannot file these petitions before this Court and therefore, they are not

maintainable.

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21. Learned senior counsel for the respondent further contended

that the petitioners cannot make a fishing expedition in the guise of

evidence collection. The respondent has legitimate source about the

misuse of sensitive information, which could unfairly benefit the

petitioners in circumventing the rejection of the patent application of the

petitioners by the Indian Patent Office. By forcing the respondent, a non-

party to the US litigation, to disclose sensitive Research and

Development data would cause disproportionate harm to its commercial

interests and those of its global collaborators.

Discussion:

22. To pursue discovery from foreign entities, litigants often

request Letters Rogatory (or Letters of request for Judicial assistance)

from a foreign Court. In the instant case, the petitioners had sought

assistance for the issuance of Letters Rogatory against the respondent

from the United States District Court, Delaware and the same was also

granted. The petitioners claim that the documents sought for from the

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O.P. (PT) Nos.5 and 6 of 2024

respondent before this Court are relevant for the purpose of proving the

petitioners' patent infringement claim before the United States District

Court in respect of Zenara ANDA product and CIPLA ANDA product

which according to the petitioners has violated the petitioner's "441

Patent".

23. The petitioners have also categorically confirmed through their

pleadings that they do not have any claim against the respondent and that

they have filed these petitions only for the purpose of assisting them in

proving their patent claim against Zenara and CIPLA, which are pending

adjudication before the United States District Court, Delaware. Letters

Rogatory dates back to early American Law, when courts of one state

would formally request the taking of evidence from any other state but

now Letters Rogatory are used to request judicial assistance in taking

evidence abroad. According to the petitioners, in respect of the

pharmaceutical drug, which is the subject matter of the patent litigation

before the United States District Court at Delaware, the respondent is

having information of the same, which will aid in proving the petitioners'

patent claim against Zenara ANDA product and CIPLA ANDA product

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before the United States District Court at Delaware.

24. It is not in dispute that in so far as India is concerned, the

respondent is having contractual relationship with Zenara and CIPLA,

pertaining to manufacture and sale of the special drug manufactured and

sold by Zenara and CIPLA. Zenara and CIPLA are the defendants in the

suit filed by the petitioners before the United States District Court at

Delaware.

25. The Hague Evidence Convention relied upon by the

petitioners, to which India is a signatory, facilitates access to evidence in

foreign jurisdiction, if certain jurisdiction based conditions are met.

Letters Rogatory is often the first step in the discovery of documents

from foreign jurisdiction.

26. Chapter I of the Hague Evidence Convention, 1970 deals with

Letter of Request. Article 3 states that a Letter of Request shall specify

the evidence sought for. Clause (d) of Article 3 states that Letter of

Request shall specify the evidence to be obtained or other judicial Act to

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O.P. (PT) Nos.5 and 6 of 2024

be performed. Clause (g) of Article 3 states that a Letter of Request,

where appropriate, shall specify the documents or other property, real or

personal to be inspected.

27. Article 9 of the Hague Evidence Convention permits a judicial

authority that executes a Letter of Request to apply its own municipal

laws. In India the enabling power to execute the Letter of Request issued

by a foreign Court is under Order XXVI Rule 19 - 22 read with Section

78 of the C.P.C., 1908.

28. Order XXVI Rule 19 - 22 of C.P.C. as well as Section 78 of

the C.P.C. are extracted hereunder:

"19. Cases in which High Court may issue commission to examine witness.—(1) If a High Court is satisfied.—

(a) that a foreign court situated in a foreign country wishes to obtain the evidence of a witness in any proceeding before it,

(b) that the proceeding is of a civil nature, and

(c) that the witness is residing within the limits of the High Court’s appellate jurisdiction, it may, subject to the provisions of rule 20, issue a

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commission for the examination of such witness. (2) Evidence may be given of the matters specified in clause (a), (b) and (c) of sub-rule (1)—

(a) by a certificate signed by the consular officer of the foreign country of the highest rank in India and transmitted to the High Court through the Central Government, or

(b) by a letter of request issued by the foreign Court and transmitted to the High Court through the Central Government, or

(c) by a letter of request issued by the foreign court and produced before the High Court by a party to the proceeding.

20. Application for issue of commission.—The High Court may issue a commission under rule 19—

(a) upon application by a party to the proceeding before the foreign court, or

(b) upon an application by a law officer of the State Government acting under instructions from the State Government.

21. To whom commission may be issued.—A commission under rule 19 may be issued to any Court within the local limits of whose jurisdiction the witness resides, or the witness resides within the

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O.P. (PT) Nos.5 and 6 of 2024

local limits of [the ordinary original civil jurisdiction of the High Court], to any person whom the Court thinks fit to execute the commission.

22. Issue, execution and return of commissions, land transmission of evidence to foreign Court.— The provisions of rules 6, 15, [sub-rule (1) of rule 16A, 17, 18 and 18B] of this Order in so far as they are applicable shall apply to the issue, execution and return of such commissions, and when any such commission has, been duly executed it shall be returned, together with the evidence taken under it, to the High Court, which shall forward it to the Government General in Council along with the letter of request for transmission to the foreign court.] "

"78. Commissions issued by foreign Courts.— Subject to such conditions and limitations as may be prescribed the provisions as to the execution and return of commissions for the examination of witnesses shall apply to commissions issued by or at the instance of—

(a) Courts situate in any part of India to which the provisions of this Code do not extend; or

(b) Courts established or continued by the authority

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of the Central Government outside India; or

(c) Courts of any State or country outside India."

29. Article 23 provides that a contracting State may at the time of

signature, ratification or accession, declare that it will not execute a

Letter of Request issued for the purpose of obtaining pre-trial discovery

of documents as known in Common Law Countries. India in its

declaration has stated that "The Republic of India will not execute Letter

of Request issued in pursuance of Article 23 of the Convention for the

purpose of obtaining pre-trial discovery of documents, which requires a

person to produce any documents other than particular documents

specified in the Letter of Request, which are likely to be in his

possession, custody or power".

30. When evidence of a witness residing in India has to be taken in

a civil proceeding pending before a foreign court, a commission is issued

by the High Court to obtain evidence of a witness under Order XXVI

Rule 19 read with Section 78 of the Code of civil procedure, 1908. If the

ingredients of the said Rule 19 are fulfilled, the High Court will issue a

commission for the purpose of obtaining evidence/testimony of

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O.P. (PT) Nos.5 and 6 of 2024

witnesses in accordance with the Letter of Request issued by the Foreign

Court.

31. The High Court will issue a commission under Order XXVI

Rule 19 of C.P.C. upon an application preferred by a party to the

proceedings before the Foreign Court. Under Rule 19, if the High Court

on perusal of the application finds that a foreign Court situated in a

foreign country wishes to obtain the evidence of a witness in any

proceeding before it, that the proceeding is of civil nature and the

witness is residing within the High Court's local jurisdiction, it must

issue a commission in furtherance of and to execute the Letter of

Request. The High Court will not go into the proprietary of the Letter of

Request or the questions of relevance or admissibility of evidence, which

is an exclusive prerogative of the Foreign Court which has issued the

Letter of Request.

32. After considering the relevant provisions of Code of Civil

Procedure, 1908 and the definition of 'Evidence' in the Indian Evidence

Act, 1872, it can be construed that the commission appointed by a High

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Court on request of a Foreign Court on the basis of a Letter of Request

issued by a Foreign Court under the Convention under Order XXVI Rule

19 read with Section 78 of the Code of Civil Procedure, 1908 would be

for obtaining both oral as well as documentary evidence.

33. The word evidence cannot be narrowly construed in isolation,

ignoring the meaning and definition of the term 'evidence' under the

Indian Evidence Act. Any other Interpretation that limits the evidence to

be obtained under Order XXVI Rule 19 is arbitrary and contrary to Order

XXVI Rule 19 of the Code of Civil Procedure, 1908. Such a narrow

construction of the term 'evidence' used in order XXVI Rule 19 of the

Code of Civil Procedure, 1908 defeats the very purpose of obtaining

evidence if the same cannot be backed by documentary evidence. There

is no provision in the Code of Civil Procedure, 1908 that would limit or

not permit documentary evidence to be obtained at the behest and request

of a Foreign Court under Order XXVI Rule 19 read with Section 78 of

the Code of Civil Procedure, 1908.

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34. There is an inherent contradiction within Order XXVI Rule 19

of the Code of Civil Procedure, 1908, which widens the scope of

evidence that can be obtained under the above-mentioned Rule. Rule 19

uses the phrase 'High Court may issue to examine witnesses' and 'wishes

to obtain evidence of a witness...'. When two interpretations are possible,

the more liberal interpretation which is in consonance with the Hague

Evidence Convention needs to be followed. Therefore, Rule 19, has to be

liberally construed and a High Court may issue a commission to obtain

both oral as well as documentary evidence.

35. The Andhra Pradesh High Court, the Bombay High Court and

the Delhi High Court have rightly allowed similar reliefs for enforcement

of Letters Rogatory issued by a foreign Court. However, with due respect

to the Gujarat High Court, this Court is of the considered view that the

view taken by the Gujarat High Court in the case of Leighton

International Limited and Others Vs. Gavin John Hodge and Others

reported in 2014 SCC Online Guj 15738 and in the case of Fenix

Diamonds LLC Vs. Carneige Institute of Washington reported in 2020

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O.P. (PT) Nos.5 and 6 of 2024

SCC Online Guj 1628 that only oral evidence is permissible, is not a

correct view. Both oral and documentary evidence can be procured from

the Indian party, provided the evidence sought for is not in violation of

the Hague Evidence Convention. The only objection raised by India as a

signatory to the Hague Evidence Convention under Article 23 of the said

convention is that they will not execute Letter of Request issued in

pursuance of Article 23 of the Convention for the purpose of obtaining

pre-trial discovery of documents, only in cases where the documents are

not specified. In the case on hand, documents have been specified in the

Letters Rogatory issued by the United States District Court at Delaware,

though the respondent may contend that they are vague. Whether the

documents disclosed are specific and procurable or not, can be

ascertained only after a Commissioner is appointed by this Court who is

empowered to seek for clarification from both the parties if the need

arises for the purpose of ascertaining the specificity of the documents.

Such an objection with regard to vagueness cannot be raised by the

respondent at this premature stage that too when documents have been

disclosed in these petitions, which were also considered by the United

States District Court at Delaware before granting Letters Rogatory as per

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the Hague Evidence Convention as requested by the petitioners.

36. The U.S. Supreme Court in its decision rendered in

Aerospatiale case (Societe Nationale Industrielle Aerospatiale Vs.

United States District Court for the Southern District of Lowa reported in

482 U.S. 522 (1987), also relied upon by the learned senior counsel for

the respondent has made it clear that the foreign Courts should scrutinize

request for issuance of Letters Rogatory on a case to case basis to

determine whether they satisfy international comity (i.e., there is no

violation of courtesy to the foreign valuation).

37. As seen from the Hague Evidence Convention, good cause for

denying the request of the Courts in the Country where the main

litigation is being pursued may exist where the disruption to international

comity outweighs the value of the requested information in furthering

justice. But, it has been made clear in the aforesaid decision of the US

Supreme Court which has followed Hague Evidence Convention that

where requests for international discovery properly balances

consideration of comity, Letters Rogatory is a valuable tool for seeking

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O.P. (PT) Nos.5 and 6 of 2024

collection of evidence.

38. Analysing international comity requires Courts to weigh the

relevant Costs and benefits that pursuing discovery will bestow on each

party.

39. The U.S. Supreme Court in Aerospatiale case referred to supra,

presented five factors that Courts can consider to weigh the international

comity considerations:

a) The importance to the litigation of the documents or other

information requested;

b) The degree of specificity of the request;

c) Whether the information originated in the United States;

d) The availability of alternative means of securing the

information; and

e) The extent to which non-compliance with the request would

undermine important interests of the United States, or compliance with

the request would undermine important interests of the State where the

information is located.

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O.P. (PT) Nos.5 and 6 of 2024

40. In the case on hand, a categorical plea has been taken by the

petitioners that the respondent is having all the information pertaining to

the documents sought for through the Letters Rogatory issued by the

United States District Court at Delaware. Admittedly, Zenara and

CIPLA, the defendants in the patent litigation pending before the United

States District Court at Delaware are Indian entities. A categorical

assertion has also been made by the petitioners that the documents

disclosed in the Letters Rogatory issued by the United States District

Court at Delaware are available only with the respondent. The learned

senior counsel for the respondent during the course of the submissions

made a submission that the documents listed out in the Letters Rogatory

are vague and unless there is specificity, the question of allowing these

petitions does not arise. On the other hand, the learned senior counsel for

the petitioners would submit that there is no vagueness in the listed

documents and if at all a clarification is required, once a Court

Commissioner is appointed by this Court, he can seek for clarification.

Therefore, at this stage, the objections raised by the respondent in respect

of their claim, that there is no specificity in the documents disclosed in

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O.P. (PT) Nos.5 and 6 of 2024

the Letters Rogatory is not maintainable. The petitioners have also taken

a categorical plea that the only source for them to inspect the documents

disclosed in the Letters Rogatory is only through the respondent. The

said statement has also not been disproved by the respondent through any

documentary evidence to prove their contention that there are other

sources available to the petitioner through whom the documents listed

out in the Letters Rogatory can be accessed.

41. No iota of evidence has also been placed by the respondent to

prove that the petitioners can source the documents in the United States

itself and that there is no necessity to seek for production of documents

by the respondent which is an Indian entity with the assistance of Indian

Courts.

42. The petitioners have also categorically pleaded that the Indian

National Security interest will not be undermined if the prayer sought for

in these petitions are granted. The respondent has also not submitted any

iota of evidence that the production of documents by the respondent will

be detrimental to the national security interest of India.

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O.P. (PT) Nos.5 and 6 of 2024

43. The petitioners have also categorically pleaded that they do not

have any claim against the respondent and the only limited relief they are

seeking before this Court is to seek for the evidence sought for in these

petitions, which according to the petitioners, are available only with the

respondent.

44. Article 12 of the Hague Convention, which has been relied

upon by both the senior counsels provides for limited grounds when

execution of Letters Rogatory issued by a foreign Court can be refused

by the state of execution and the state of execution in the present case is

India and they are

a) In the state of execution, the execution of the Letter of request

does not fall within the functions of the judiciary or;

b) The state addressed considers that its sovereignty or security

would be prejudiced thereby.

45. The request of the petitioners does not fall under any of the

above mentioned categories stipulated under Article 12 of the Hague

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O.P. (PT) Nos.5 and 6 of 2024

Evidence Convention. Hence, there is no prohibition for this Court to

allow these petitions filed under Order XXVI Rule 16 to 22 read with

Sections 75 to 78 and 151 of C.P.C.. The Letters Rogatory issued by the

United States District Court at Delaware in favour of the petitioners are

also in complete compliance with the Hague Convention dated

18.03.1970, to which both India and United States are signatories and

India has also ratified it in the year 2007 itself.

46. The petitioners' patent litigation before the United States

District Court at Delaware involves entities in India with whom the

respondent is having a contractual relationship. The petitioners

categorically claim that they have been unable to access the sought for

documents in United States of America and only due to the same, they

are constrained to seek for international judicial assistance through the

issuance of Letters Rogatory by the United States District Court at

Delaware. The aid rendered by one nation to judicial or quasi-judicial

proceeding in another Country's Tribunal / Courts is called international

judicial assistance.

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O.P. (PT) Nos.5 and 6 of 2024

47. The issuance of Letters Rogatory are designed to remedy the

problems faced to procure testimony from an absent or a non-resident

witness and the said testimony is essential for proving the case of the

party seeking for issuance of Letters Rogatory. The Letters Rogatory are

the medium in effect, whereby one Country can through it's own Courts

and the methods of Court proceedings peculiar thereto and entirely

within the latter's control to assist the administration of justice in the

former Country: such request being made and usually granted by reasons

of comity existing between nations in ordinary peaceful time. India and

United States of America, being signatories to the Hague Convention,

1970, which provides for international judicial assistance and there being

no prohibition as per the said convention for this Court to accede to the

Letters Rogatory issued by the United States District Court at Delaware

in favour of the petitioners, necessarily this Court will have to allow

these petitions as prayed for by the petitioners.

48. The International Comity of Courts, which has strengthened

through the Hague Convention, 1970, mandates this Court to allow these

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O.P. (PT) Nos.5 and 6 of 2024

petitions as prayed for by the petitioners.

49. The petitioners have been unable to procure the evidence as

sought for in these petitions from the defendants in the litigation pending

before the United States District Court at Delaware. A categorical

assertion has also been made to that effect in the pleadings of the

petitioners. No contra evidence has also been produced by the

respondent to prove that the petitioners can source the evidence in

United States of America itself. Admittedly, the respondent is also

having a contractual relationship in India with Zenara in respect of

Zenara's ANDA Product. Therefore, issuance of Letters Rogatory is

virtually the only effective procedure available to the petitioners for

procuring the evidence as sought for in these petitions.

50. The petitioners have satisfied, through its pleadings and

supporting documents, the following:

a) The importance of the documents / evidence sought for from the

respondent to the litigation pending before the United States District

Court at Delaware;

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O.P. (PT) Nos.5 and 6 of 2024

b) The details of the documents which have been sought for by the

petitioners are disclosed, though the respondent claims that they are

vague. However, this Court is of the considered view that specificity can

be ascertained only when a Commissioner is appointed by this Court and

if the need arises, he / she seeks for a clarification with regard to the

specificity;

c) Both India and Unites States of America are signatories to the

Hague Convention, 1970 and they are bound by the said convention.

Unless and until the request does not fall within the powers of this Court

or the Indian state considers that its sovereignty or security would be

prejudiced if the Letters Rogatory issued by the United States District

Court at Delaware is acceded to, the question of not granting the reliefs

prayed for in these petitions does not arise. Admittedly, the request of the

petitioners does not fall under any of the aforementioned prohibitions;

d) Admittedly, as seen from the pleadings and the evidence placed

on record, it is also confirmed from the Letters Rogatory issued by the

United States District Court at Delaware that there is no availability of

alternative means of securing the information as sought for in these

petitions by the petitioners except to approach this Court.

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O.P. (PT) Nos.5 and 6 of 2024

51. Eventhough the respondent alleges that the documents sought

for by the petitioners are already in possession of CIPLA, the said

statement is not supported by any evidence. In paragraph No.8 of the

counter statement filed by the respondent before this Court, they have

stated that they are in possession of the documents pertaining to CIPLA

ANDA product, which is the subject matter of patent litigation before the

United States District Court at Delaware. The fact that no evidence has

been placed on record to prove that the documents sought for by the

petitioners are already in possession of CIPLA and the fact that in

paragraph No.8 of the counter statement filed by the respondent before

this Court, the respondent has stated that they are in possession of the

documents pertaining to CIPLA ANDA product, which is the subject

matter of patent litigation before the United States District Court at

Delaware makes this Court to infer that the documents sought for by the

petitioners through the Letters Rogatory issued by the United States

District Court at Delaware are only in the possession of the respondent,

which is an Indian entity.

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O.P. (PT) Nos.5 and 6 of 2024

52. The confidentiality of the information sought for by the

petitioners from the respondent is fully protected since the United States

District Court, Delaware, in the Letters Rogatory order dated 13.05.2024

has made it clear that each party is bound by the terms of the stipulated

protective order. The protective order has categorically stated that any

confidential information produced by the respondent will be used for the

purpose of the U.S. litigation only and will not be publicly disclosed. To

ensure confidentiality of documents / testimonies, the petitioners in their

petitions have themselves sought for the formation of a confidentiality

club. Therefore, once the confidentiality club is formed, all the members

of the said club will be required to sign an undertaking, which forms part

of the protective order passed by the United States District Court,

Delaware along with the Letters Rogatory order dated 13.05.2024.

53. Article 39 of the TRIPS agreement does not prohibit disclosure

of confidential information, if it is sought for by a Court of law. The

Courts in India would not go behind the letter of request upon an

enquiry, as the jurisdiction for the issuance of letter of request has to be

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O.P. (PT) Nos.5 and 6 of 2024

accepted and executed owing to reciprocity between two sovereign

countries.

54. The International Comity of Courts is a principle that requires

Courts to consider the interest of other jurisdictions when making legal

decisions. It involves balancing the competing interest of the public and

private and take into account any conflicts between the public policies of

the domestic and foreign countries. Since the Letters Rogatory issued by

the United States District Court, Delaware is not in conflict with the

municipal law of India and the implementation of the Letters Rogatory

aids in adherence to international treaties, which in the instant case is the

Hague Evidence Convention to which India is a signatory, necessarily

the relief sought for in these petitions has to be granted by this Court in

the interest of International Comity of Courts. Though the respondent

may contend that the petitions lack specificity with regard to the

particulars of the documents, the question of raising such an objection at

this stage is too premature and if at all such an objection can be raised, it

can be raised only after a Court commissioner is appointed as sought for

by the petitioners in these petitions. The Court commissioner on his/her

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O.P. (PT) Nos.5 and 6 of 2024

appointment can seek for clarification from the petitioners or through

any other source with regard to the specificity of the documents in case

there is no clarity and the respondent can also assist the Court

commissioner to decide as to whether the particulars of the documents

sought for by the petitioners are procurable or not.

55. In the decisions of the Gujarat High Court, relied upon by the

learned senior counsel for the respondent, referred to supra, they were

decisions when the Court Commissioners were already appointed by the

Gujarat High Court pursuant to a Letters Rogatory issued by a foreign

Court. In the case on hand, the Court Commissioner is yet to be

appointed and in these petitions, the petitioners seek for appointment of a

Court Commissioner to execute the Letters Rogatory issued by the

United States District Court, Delaware. Therefore, the Gujarat High

Court's decision has no bearing to the facts of the instant case.

56. The decisions of the Delhi High Court, Andhra Pradesh High

Court and Bombay High Court relied upon by the learned senior counsel

for the petitioners have elaborately discussed the powers of an Indian

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O.P. (PT) Nos.5 and 6 of 2024

Court with regard to the execution of Letters Rogatory issued by a

foreign Court and they have consistently held that unless the Letters

Rogatory violates the Indian domestic law, the question of refusing to

grant an order for execution of the Letters Rogatory by the Indian Courts

does not arise. In the case on hand, as observed earlier, there is no

violation of the Indian Laws if these petitions are allowed as prayed for.

57. The confidentiality of the documents to be produced by the

respondent is also fully protected by the formation of a confidentiality

club as agreed to by the petitioners before the United States District

Court, Delaware, which has also been incorporated in the Letters

Rogatory order dated 13.05.2024.

58. These petitions have been filed only for the limited extent of

executing the Letters Rogatory issued by the United States District Court

at Delaware. The rejection of patent applications of the petitioners by the

Indian Patent Office has no relevance for adjudicating these petitions.

These petitions are not in contravention to Indian Laws and they are

being entertained by this Court only in accordance with the Hague

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O.P. (PT) Nos.5 and 6 of 2024

Evidence Convention and by adhering to the International Comity of

Courts.

59. For the foregoing reasons, it is just and necessary for this

Court to issue the following directions:

a) A 'confidentiality club' as prayed for in these petitions will have

to be set up by this Court on the following lines:

(i) An agreement signed between the parties to the proceedings as

well as the party from whom evidence and testimony is sought to be

collected to the effect that the (a) pleadings, (b) the Letters Rogatory

along with all annexures and (c) the information, documents, evidence,

samples, etc. that may be collected pursuant to executing the Letters

Rogatory be only seen by a limited number of people on each side. All of

these people are bound by confidentiality undertakings in relation to the

information/documents stipulated hereinabove.

(ii) The hearings in the instant matter before this Hon'ble Court as

well as before the Local Commissioner who may be appointed are

conducted in camera only with the members of the Confidentiality Club

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O.P. (PT) Nos.5 and 6 of 2024

being present.

(iii) Directing the Learned Registrar General of this Court as well

as the Local Commissioner to keep the original Letters Rogatory, all

other documents, transcripts of deposition etc. pertaining to the instant

case in sealed covers and allow access to the confidential documents

only to the members of the Confidentiality Club identified above.

(iv) That the Registrar General of this Court as well as the Local

Commissioner be empowered to de-seal the documents for inspection by

members of the Confidentiality Club in his presence, on a formal request

being made by either party to the Registrar General or Local

Commissioner with simultaneous intimation to the other members of the

Confidentiality Club who have the option to remain present for such

inspection. The documents shall be resealed thereafter by the Registrar

General or the Local Commissioner as the case may be."

60. The learned counsel for the Petitioners on instructions

suggested the following names to be part of the Confidentiality Club:

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O.P. (PT) Nos.5 and 6 of 2024

A. Petitioners' representatives:

1. Michele Winneker

2. Jeffrey Rennecker

B. Petitioners' foreign counsels:

1. Thomas H.L. Selby

2. Stanley E. Fisher

3. Seth R. Bowers

4. Andrew L. Hoffman

5. Rhochelle Krawetz

6. Max C. Accardi

7. Megan E. Dellinger

8. Ayelet Evrony

C. Petitioners' foreign experts:

1. Adam Matzger

2. Shellie Rigby-Singleton

3. Martyn Davies

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O.P. (PT) Nos.5 and 6 of 2024

D. Petitioners' local counsels:

1. Mr. Pravin Anand

2. Ms. Tusha Malhotra

3. Mr. K. Prem Chandar

4. Mr. N.C. Vishal

5. Ms. Tanvi Bhatnagar

E. Respondent's foreign counsels:

1. Neal C. Belgam

2. Daniel A. Taylor

3. Louis H. Weinstein

4. Frank Rodriguez

5. Amlan Ray

6. Joshua I. Miller

F. Respondent's local counsels: Names to be provided by the

respondent to the local Commissioner appointed by this Court and on

furnishing the names, the local Commissioner appointed by this Court

shall include them also as members of the Confidentiality Club.

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If the parties wish to nominate more members to the confidentiality club,

the same may either be done by mutual consent or by way of an

application to either this Court or the appointed Local Commissioner.

61. Once the confidentiality club is in place, the Petitioners can

place the original in a sealed cover before this Court and also share a

copy of the complete version of the Letters Rogatory dated May 13, 2024

with all the members of the Confidentiality Club.

62. The Petitioners made the following prayers in paragraph 24 of

the respective petitions:

(i) an order appointing a Local Commissioner, preferably a senior

person having good knowledge in the field of Chemistry such as a retired

Professor or a District Judge for collection of evidence, documents (as

mentioned in Clause 11 and Schedule A to the Letters Rogatory) as well

as for obtaining and recording the testimony (as mentioned in Clause 10

and Schedule B to the Letters Rogatory) from the Respondent and its

authorized representatives whose details are given in Clause 9 of the

Letters Rogatory; and

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O.P. (PT) Nos.5 and 6 of 2024

(ii) an order conferring 'Special Powers' on the aforesaid

Commissioner including the power to summon the person or persons

including corporations and/or their authorized representatives to produce

documents and things; the power to accept copies of the said documents

and things; the power to summon person or persons including

corporations and/or their authorized representatives, to administer oath to

them and to record their evidence; the power to allow the Petitioners' and

the Respondent's respective Indian counsel the opportunity to examine or

cross-examine the aforesaid witnesses; the power to permit the

Petitioners' and the Respondent's respective foreign representatives to

attend and observe the examination of said person or persons including

corporations and/or their authorized representative; the power to record

the testimony of the said person or persons including corporations and/or

their authorized representative; the power to have the said recording

transcribed verbatim; and the power to provide, both the documents and

recording and the transcript to the Petitioners' and the Respondent's

respective representatives, their respective Indian Counsel, and

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(iii) an order setting up a Confidentiality Club on the lines stated

in paragraph 13 of the petitions; and

(iv) an order to conduct the further proceedings before this Court

as well as before the Local Commissioner "in camera" with only the

members of the 'Confidentiality Club' being present; and

(v) an order directing the officials of the Registry of this Court as

well as the Commissioner to keep all the documents and records

pertaining to this petition or the matters arising therefrom including the

evidence collected by the Commissioner in a sealed cover and allow

access to the said documents only to the members of the aforesaid

Confidentiality Club; and

(vi) an order directing the said Commissioner to send the

evidence/documents collected and the testimony recorded to the United

States District Court for the District of Delaware in a sealed cover; and

(vii) such further Order(s) as this Court deems fit and proper in the

circumstances of the case may also be passed."

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63. As the present matter may require a certain level of technical

expertise in the Commissioner himself, the Petitioners have sought for

appointment of a person well versed in the field to be appointed as the

local commissioner.

64. For the foregoing reasons, these petitions are allowed and the

following directions are issued by this Court:

a) Within a period of 2 weeks from the date of receipt of a copy of

this order, the Respondent is directed to designate the person(s) who

shall depose and give testimony regarding the subjects identified in

Schedule B to the Request for International Judicial Assistance (Letters

Rogatory) dated May 13, 2024;

b) Ms.Vindhya S.Mani, having wide experience in the subject

matter, and having office at No.6, 5th floor, M/s.Lakshmi Kumaran and

Sridharan Attorneys, Chennai House, Esplanade Road, Chennai - 108,

Mobile No.83769 51693 is appointed as a local Commissioner for

collecting evidence, including documentary evidence as mentioned in

Schedule A to the Letters Rogatory, and also for obtaining and recording

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O.P. (PT) Nos.5 and 6 of 2024

the testimony and depositions from the person(s) designated by the

Respondent as mentioned in Schedule B to the Letters Rogatory.

Ms.Vindhya S.Mani is required to adhere to the terms of the protective

order dated December 15, 2023;

c) Ms.Vindhya S.Mani, the appointed Commissioner is conferred

with "Special Powers' including the power to -

i. Summon a person to produce documents and things as per

Schedule A to the Letters Rogatory, which shall be done as per the

schedule set by the appointed Commissioner and should be at least three

weeks prior to the commencement of the testimony;

ii. Accept copies of the said documents and things, and provide the

same to the members of the confidentiality club from the Petitioner's

side;

iii. Set the schedule for the collection of the testimony of the

Respondent's witness on a day-to-day basis;

iv. Decide to collect evidence based on the digitized files of the

court record and as collected from the Court;

v. Summon a person, to administer oath to her/him and to record

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O.P. (PT) Nos.5 and 6 of 2024

his/her evidence.

vi. Allow the Petitioners' and Respondent's respective Indian

counsel the opportunity to examine or cross-examine the aforesaid

person;

vii. To record the objections, if any, of the parties and conclude,

without delay, the testimony of the witness nominated by the

Respondent. To not stall the testimony of the witness, once started, for

technical grounds and reasons. It is clarified, that the questions, as asked

should be recorded along with the answers given;

viii. Permit the Petitioners' and Respondent's respective foreign

representatives to attend and observe the examination of the said person;

ix. Video record the testimony of the said person;

x. Have the said recording transcribed verbatim;

xi. Provide both the documents and recording and the transcript to

the Petitioners and Respondents respective representatives and their

Indian Counsels;

d) A 'Confidentiality Club' is set-up by this Court consisting of the

persons stated in Paragraph 60 above and on the terms set out in

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O.P. (PT) Nos.5 and 6 of 2024

paragraph 13 of the petition; and

e) All proceedings before Ms.Vindhya S.Mani will be in camera

with only the members of the 'Confidentiality Club' being present; and

f) The Registrar (Original Side), Madras High Court, is directed to

keep all documents and records pertaining to these petitions or the

matters arising therefrom, including the evidence collected by

Ms.Vindhya S.Mani under seal. They shall allow access to those

documents only to the members of the Confidentiality Club.

g) The venue of collecting evidence and recording testimony of the

respondent shall be at the Arbitration Centre, Madras High Court and the

Cost of Arbitration Centre as well as the secretarial expenses shall be

borne by the petitioners;

h) Ms.Vindhya S.Mani, to conduct proceedings as per the above

terms and send the evidence/ documents collected and the testimony

recorded to the Registrar General of this Court who would then forward

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O.P. (PT) Nos.5 and 6 of 2024

it to the United States District Court for the District of Delaware in a

sealed cover.

i) Ms.Vindhya S.Mani shall be paid an initial remuneration of

Rs.2,00,000/- and the same shall be paid by the petitioners within a

period of one week from the date of receipt of a copy of this order. The

Commissioner is also permitted to seek additional remuneration once the

work is completed.

28.01.2025 Index: Yes/ No Speaking order / Non speaking order Neutral citation : Yes ab

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O.P. (PT) Nos.5 and 6 of 2024

ABDUL QUDDHOSE, J.

After pronouncement of the order at 10.30 a.m., a mention was

made by the learned counsel for the respondent at 12.30 p.m. informing

this Court that the local commissioner appointed by this Court has

appeared for one of the parties in a connected matter and therefore, the

name of the local commissioner will have to be changed. This Court

suggested the name of Mr.Adarsh Ramanujam as local commissioner in

the place of Ms.Vindhya S.Mani, which was agreeable to both the

counsels. Accordingly, Mr.Adarsh Ramanujam, having office at No.6,

Ground Floor, Ram's Flat, 2nd Main Road, Gandhi Nagar, Adyar,

Chennai - 600 020, Mobile No.99999 84703, is appointed as local

Commissioner. The replaced commissioner shall adhere to the same

directions given by this Court in the preceding paragraphs.

28.01.2025 ab Note: Office is directed to issue order copy by today itself.

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O.P. (PT) Nos.5 and 6 of 2024

ABDUL QUDDHOSE, J.

ab

pre-delivery order in O.P. (PT) Nos.5 and 6 of 2024

28.01.2025

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