Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 1 of 25 PageID #: 11
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`In re Ex Parte Application of
`
`REGENERON PHARMACEUTICALS, INC.
`
`Applicant,
`
`for an Order Pursuant to 28 U.S.C. § 1782 to Take
`Discovery for Use in Foreign Proceedings
`
`Civil Action No. _______________
`
`MEMORANDUM OF LAW IN SUPPORT OF REGENERON’S EX PARTE
`APPLICATION FOR AN ORDER PURSUANT TO 28 U.S.C. § 1782 TO TAKE
`DISCOVERY FOR USE IN FOREIGN PROCEEDINGS
`
`

`

`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 2 of 25 PageID #: 12
`
`TABLE OF CONTENTS
`
`INTRODUCTION .................................................................................................................. 1
`I.
`II. FACTUAL BACKGROUND ................................................................................................. 2
`III. LEGAL STANDARD ............................................................................................................. 8
`IV. ARGUMENT ........................................................................................................................ 10
`A.
`Regeneron’s Application Meets the Section 1782 Statutory Requirements ................. 10
`B.
`The Discretionary Intel Factors Weigh in Favor of Granting Regeneron’s
`Application .................................................................................................................... 13
`1. Amgen US Is Not a Party to the Contemplated Actions Before the General Division of
`the High Court of Singapore ......................................................................................... 13
`The High Court of Singapore Is Receptive to U.S. Judicial Assistance ....................... 14
`2.
`3. No Foreign Discovery Restrictions Bar Regeneron’s Requested Discovery ................ 15
`4. Regeneron’s Discovery Is Narrowly Tailored and Not Unduly Intrusive or
`Burdensome .................................................................................................................. 16
`V. CONCLUSION ..................................................................................................................... 20
`
`i
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 3 of 25 PageID #: 13
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Cryolife, Inc. v. Tenaxis Med., Inc.,
`No. C08-05124 HRL, 2009 WL 88348 (N.D. Cal. Jan. 13, 2009) ........................................... 18
`
`Fed. Republic of Ger. in Matter of Smith,
`154 F.R.D. 196 (N.D. Ill. 1994) ................................................................................................ 19
`
`Fed. Republic of Nigeria v. VR Advisory Servs., Ltd.,
`27 F.4th 136 (2d Cir. 2022) ...................................................................................................... 15
`
`In re Aflibercept Patent Litigation,
`Case No. 1:24-md-03103 (N.D.W. Va.) ..................................................................................... 4
`
`In re Alghanim,
`No. 17-mc-00406, 2018 WL 2356660 (S.D.N.Y. May 9, 2018) .............................................. 12
`
`In re Application of AIS GmbH Aachen Innovative Sols. & Abiomed Eur. GmbH,
`No. 5:16-MC-80094-EJD, 2017 WL 3115228 (N.D. Cal. July 21, 2017)................................ 18
`
`In re Application of Gilead Pharmasset LLC,
`No. 14-mc-00243, 2015 WL 1903957 (D. Del. Apr. 14, 2015) ......................................... 12, 15
`
`In re Batbold,
`No. 21-mc-00218, 2021 WL 4596536 (S.D.N.Y. Oct. 6, 2021)......................................... 11, 15
`
`In re Bayer AG,
`146 F.3d 188 (3d Cir. 1998)) ...................................................................................................... 9
`
`In re Biomet Orthopaedics Switzerland GmBh,
`742 F. App’x 690 (3d Cir. 2018) .............................................................................................. 14
`
`In re Chevron Corp.,
`633 F.3d 153 (3d Cir. 2011)...................................................................................................... 13
`
`In re EWE Gasspeicher GmbH,
`612 F. Supp. 3d 402 (D. Del. 2020) ............................................................................................ 9
`
`In re Ex Parte Global Energy Horizons Corp.,
`647 F. App’x 83 (3d Cir. 2016) .......................................................................................... 16, 17
`
`In re Fetzima,
`No. 2:17-CV-10230-ES-SCM, 2019 WL 2385699 (D.N.J. June 6, 2019) ............................... 19
`
`In re FourWorld,
`No. 23-cv-01460, 2024 WL 1637400 (D. Del. Apr. 16, 2024) ......................................... passim
`
`ii
`
`

`

`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 4 of 25 PageID #: 14
`
`In re Iraq Telecom,
`No. 19-mc-00175, 2023 WL 2402873 (E.D. Pa. Mar. 8, 2023) ............................................... 12
`
`In re Matter of Wei,
`No. 18-mc-00117, 2018 WL 5268125 (D. Del. Oct. 23, 2018) ................................................ 11
`
`In re Mota,
`No. 19-cv-00369, 2020 WL 95493 (D. Del. Jan. 8, 2020) ....................................................... 10
`
`In re Mother’s Milk, Inc.,
`No. 5:20-MC-00004-M, 2020 WL 2514315 (E.D.N.C. May 15, 2020) ................................... 19
`
`In re O’Keeffe,
`646 F. App’x 263 (3d Cir. 2016) .............................................................................. 9, 13, 14, 16
`
`In re O’Keeffe,
`No. 14-cv-05835, 2015 WL 540238 (D.N.J. Feb. 10, 2015) .................................................... 10
`
`In re Request for Int'l Jud. Assistance from the Norrkoping Dist. Ct., Sweden,
`219 F. Supp. 3d 1061 (D. Colo. 2015) ...................................................................................... 19
`
`In re Request from Vienna,
`No. 23-mc-00258, 2023 WL 6278815 (D. Del. Sept. 26, 2023) .............................................. 10
`
`In re RH2 Participaes Societrias LTDA,
`No. 23-cv-04025, 2024 WL 3598379 (D.N.J. July 31, 2024) .................................................. 15
`
`In re Selman,
`No. 23-cv-00895, 2024 WL 1092025 (D. Del. Mar. 13, 2024) .......................................... 16, 17
`
`In re Third Eye Capital Corp.,
`No. 22-cv-00963, 2022 WL 714758 (D.N.J. Mar. 10, 2022) ............................................. 11, 15
`
`In re Top Matrix Holdings Ltd.,
`No. 18 MISC. 465 (ER), 2020 WL 248716 (S.D.N.Y. Jan. 16, 2020) ..................................... 12
`
`Intel Corp. v. Advanced Micro Devices, Inc,
`542 U.S. 241 (2004) ........................................................................................................... passim
`
`John Deere v. Sperry Corp.,
`754 F.2d 132 (3d Cir. 1985)...................................................................................................... 10
`
`Lundbeck v. Lupin Ltd.,
`No. CV 18-88-LPS, 2021 WL 4944963 (D. Del. Sept. 30, 2021) ............................................ 19
`
`Mees v. Butler,
`793 F.3d 291(2d Cir. 2015)....................................................................................................... 12
`
`iii
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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 5 of 25 PageID #: 15
`
`Otsuka Pharm. Co. v. Mylan Inc.,
`No. CV 14-4508 (JBS-KMW), 2017 WL 5162807 (D.N.J. Nov. 7, 2017) .............................. 19
`
`Regeneron Pharm., Inc. v. Mylan Pharm. Inc. et al.,
`No. 2024-2351 (Fed. Cir. Sept.) ................................................................................................. 5
`
`Regeneron Pharmaceuticals, Inc. v. Amgen, Inc.,
`Case No. 1:24-cv-00039 (N.D.W. Va.) ...................................................................................... 4
`
`SPS Corp I v. General Motors Corp.,
`110 F.4th 586 (3d Cir. 2024) ..................................................................................................... 11
`
`Via Vadis Controlling GmbH v. Skype, Inc.,
`No. 12-mc-00193, 2013 WL 646236 (D. Del. Feb. 21, 2013) .................................................. 14
`
`ZF Auto. US, Inc. v. Luxshare, Ltd.,
`596 U.S. 619 (2022) .................................................................................................................. 10
`
`Statutes
`
`28 U.S.C. § 1782 .................................................................................................................... passim
`
`Regulations
`
`21 CFR § 601.2 ......................................................................................................................... 7, 18
`
`iv
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 6 of 25 PageID #: 16
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`Applicant Regeneron Pharmaceuticals, Inc. (“Regeneron”) respectfully applies to this
`
`Court ex parte for an order pursuant to 28 U.S.C. § 1782 (“Section 1782”) granting Regeneron
`
`leave to obtain targeted discovery from Amgen Inc. (“Amgen US”) for use in foreign
`
`proceedings involving Amgen US’s Singaporean subsidiary, Amgen Singapore Manufacturing
`
`Pte. Ltd. (“Amgen Singapore”). This application is supported by the memorandum of points and
`
`authorities provided below and the declarations of Shohta Ueno (“Ueno Decl.,” attached as
`
`Exhibit C) and Daryl Ong Hock Chye (“Ong Decl.,” attached as Exhibit D) filed concurrently
`
`herewith. A Proposed Order and Rule 45 subpoenas (Exhibits A-B) to be ordered and authorized
`
`to serve on Amgen US accompany this application.
`
`I.
`
`INTRODUCTION
`
`Regeneron seeks limited and targeted discovery highly relevant to and for use in
`
`forthcoming patent infringement litigation in Singapore against Amgen Singapore. The litigation
`
`will relate to Amgen Singapore’s manufacture of aflibercept, the active ingredient in Amgen
`
`US’s biosimilar version of Regeneron’s prescription eye medication EYLEA® (aflibercept),
`
`which has been approved by the U.S. FDA and is called PAVBLUTM (aflibercept-ayyh).
`
`Regeneron intends to file an action for patent infringement and a request for injunctive relief in
`
`Singapore, seeking to stop Amgen Singapore’s infringing manufacture of aflibercept. Regeneron
`
`seeks discovery in this district pursuant to 28 U.S.C. § 1782(a), which allows “[t]he district court
`
`of the district in which a person resides or is found” to order that person “to produce a document
`
`or other thing for use in a proceeding in a foreign or international tribunal….” Discovery from
`
`Amgen US is directly relevant to Regeneron’s forthcoming legal proceedings in Singapore and
`
`cannot be obtained in the ordinary course at any stage from Amgen US through Singaporean
`
`discovery mechanisms, as Amgen US is not an anticipated party to the contemplated
`
`Singaporean actions.
`
`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 7 of 25 PageID #: 17
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`As explained in detail below, Regeneron’s application satisfies Section 1782’s three
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`statutory requirements for this Court to order production of this discovery from Amgen US.
`
`First, discovery is sought from an entity that “resides” in this District, as Amgen US is
`
`incorporated in Delaware. Second, Regeneron seeks discovery “for use” before a “foreign
`
`tribunal,” specifically the General Division of the High Court of Singapore. Third, Regeneron
`
`qualifies as an “interested person” in the foreign proceedings as a prospective claimant asserting
`
`its patent rights against Amgen Singapore.
`
`The U.S. Supreme Court’s discretionary Intel factors also weigh in favor of granting
`
`Regeneron’s request. First, Amgen US is not an anticipated party to the contemplated actions in
`
`Singapore, putting it outside of the foreign tribunal’s jurisdictional reach and rendering the
`
`discovery Regeneron seeks unobtainable without the aid of Section 1782. Second, the
`
`Singaporean courts are receptive to the type of discovery sought by Regeneron, and the request is
`
`not made to circumvent any discovery rules imposed by those tribunals. Finally, Regeneron’s
`
`request is narrowly tailored, not unduly intrusive or burdensome, and is intended for use in
`
`support of Regeneron’s claims in the contemplated Singaporean proceedings. Accordingly,
`
`Regeneron respectfully requests that the Court enter the proposed order accompanying this
`
`application, allowing Regeneron to serve the subpoenas attached as Exhibit A-B.
`
`II.
`
`FACTUAL BACKGROUND
`
`Regeneron is a leading biotechnology company that invented, manufactures, and markets
`
`EYLEA® (containing the recombinant fusion protein aflibercept). EYLEA® has been used to
`
`treat millions of patients globally suffering from diseases that can cause vision loss or even
`
`blindness, including macular degeneration, macular edema, diabetic retinopathy, retinopathy of
`
`prematurity, and macular edema following retinal vein occlusion. Ueno Decl. at ¶ 2. EYLEA®
`
`is marketed around the world, including in Singapore. In Singapore, Regeneron’s partner Bayer
`
`2
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 8 of 25 PageID #: 18
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`(South East Asia) Pte. Ltd. (“Bayer”) is the market authorization holder for EYLEA®, which was
`
`approved in Singapore on April 29, 2013. Ueno Decl., Ex. 1 (Singapore Health Sciences
`
`Authority EYLEA® listing). Regeneron holds numerous patents worldwide related to
`
`aflibercept, the active ingredient in EYLEA®. Among those patents, at least the following
`
`Singaporean patents are relevant to the forthcoming proceedings in Singapore:
`
` Manufacturing patents that provide a method for preparing aflibercept for commercial
`
`use, and which expire on August 18, 2040:
`
` SG11202110964Q (the “’964 Patent,” or “Tustian 1”)
`
` SG11202110955V (the “’955 Patent,” or “Tustian 2”)
`
` SG11202110968V (the “’968 Patent,” or “Tustian 3”)
`
` SG11202110953U (the “’953 Patent,” or “Matthew”)
`
` SG11202110972U (the “’972 Patent,” or “Wang”)
`
` SG11202110958Q (the “’958 Patent,” or “Lawrence”)
`
` Production cells patent that relates to the cells which produce aflibercept, and which
`
`expires on October 21, 2035:
`
` SG11201703149R (the “’149 Patent,” or “Shen”)
`
`Ueno Decl. at ¶ 3. These patents relate to manufacturing methods and processes for aflibercept,
`
`and its formulation contained in EYLEA®. These patents were issued between March 25, 2020
`
`and August 21, 2024. Id. at ¶ 3. Claim 1 of the ’964 Patent is illustrative:
`
`1. A method of producing aflibercept, comprising:
`
`(a) producing a clarified harvest of cells cultured in a chemically defined medium
`(CDM);
`
`(b) binding aflibercept from said clarified harvest to a Protein A resin, wherein
`said aflibercept includes variants that have at least one oxidized amino acid
`
`3
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 9 of 25 PageID #: 19
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`residue selected from the group consisting of methionine, tryptophan, histidine,
`phenylalanine, tyrosine and a combination thereof;
`
`(c) eluting said aflibercept of step (b) forming an affinity eluate, wherein said
`eluate has a first color;
`
`(d) subjecting said eluate comprising aflibercept to anion exchange
`chromatography (AEX) column; and
`
`(e) collecting a flowthrough fraction, wherein said flowthrough fraction has a
`second color, and wherein said first color of said affinity eluate is a more intense
`yellow brown color than said second color of said flowthrough fraction when said
`affinity eluate and flowthrough fraction protein concentrations are normalized.
`
`Ueno Decl., Ex. 2 (’964 Patent) at 210. Amgen US is a corporation organized under the laws of
`
`the State of Delaware that is engaged in the development of biosimilar dugs, including an
`
`approved biosimilar version of Regeneron’s EYLEA® called PAVBLUTM (aflibercept-ayyh).
`
`Amgen US filed an abbreviated Biologics Drug Application 761298 (“BLA 761298”) in the
`
`United States on August 23, 2023 for PAVBLUTM (aflibercept-ayyh), and that BLA 761298 was
`
`approved by the Food and Drug Administration on August 23, 2024. Ueno Decl., Ex. 3
`
`(PAVBLUTM Approval Letter).
`
`Regeneron has ongoing patent infringement litigation against Amgen US in the United
`
`States related to Amgen US’s launch of PAVBLUTM (aflibercept-ayyh). See Regeneron
`
`Pharmaceuticals, Inc. v. Amgen, Inc., Case No. 1:24-cv-00039 (N.D.W. Va.), consolidated into
`
`In re Aflibercept Patent Litigation, Case No. 1:24-md-03103 (N.D.W. Va.). Regeneron moved
`
`for a preliminary injunction seeking to stop Amgen US’s launch in the United States based on a
`
`claim of infringement of U.S. Patent No. 11,084,865 (the “’865 Patent”). Unlike the
`
`Singaporean patents referenced above, the ’865 Patent does not claim methods of manufacturing
`
`the drug substance used in EYLEA®; the ’865 Patent’s claims refer to “an ophthalmic
`
`formulation suitable for intravitreal administration that comprises,” among other things, “a
`
`vascular endothelial growth factor (VEGF) antagonist” such as aflibercept. The district court
`
`4
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`

`

`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 10 of 25 PageID #: 20
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`denied Regeneron’s motion for a preliminary injunction, which is currently on appeal before the
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`United States Court of Appeals for the Federal Circuit. Regeneron Pharm., Inc. v. Mylan Pharm.
`
`Inc. et al., No. 2024-2351 (Fed. Cir.) (oral argument scheduled January 14, 2025).
`
`Amgen US announced the launch of PAVBLUTM (aflibercept-ayyh) in the United States
`
`on October 31, 2024. Ueno Decl., Ex. 4. Amgen Singapore is a key element of Amgen US’s
`
`product launch strategy in the United States and worldwide. Upon information and belief,
`
`Amgen Singapore is a wholly owned subsidiary of Amgen US, located in and organized under
`
`the laws of Singapore. Amgen US is licensed in the United States to manufacture the drug
`
`substance for PAVBLUTM (aflibercept-ayyh) only at Amgen Singapore’s facilities. Ueno Decl.,
`
`Ex. 3 (PAVBLUTM Approval Letter) at 2 (“Under this license, you are approved to manufacture
`
`PAVBLUTM (aflibercept-ayyh) drug substance at Amgen Singapore Manufacturing Pte. Ltd., in
`
`Singapore 637026, Singapore”). The drug substance is then shipped for the vial PAVBLUTM
`
`(aflibercept-ayyh) product to Amgen US’s facilities in Thousand Oaks, CA for manufacturing
`
`and filling. Id.
`
`Regeneron is preparing to file an infringement action against Amgen Singapore seeking
`
`both damages and injunctive relief to stop Amgen Singapore’s infringing manufacture of
`
`aflibercept. Ueno Decl. at ¶ 6. Production of documents in Singaporean litigation is more
`
`limited than in an action in the United States. In a Singaporean action, the parties are required to
`
`produce and exchange documents in their possession or control which (i) they will be relying on;
`
`and (ii) are, or ought to be reasonably known to be, adverse to its case. Ong Decl. at ¶ 5. While
`
`the Singaporean court may order a broader scope of production, there are certain classes of
`
`documents that parties are not required to produce, including (i) documents that merely lead a
`
`party on a train of inquiry to other documents (except in a special case); (ii) documents which are
`
`5
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 11 of 25 PageID #: 21
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`a party’s private or internal correspondence unless such correspondence are known adverse
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`documents (or unless demonstrated to be in a special case); and/or (iii) subject to any written
`
`law, documents subject to any privilege or where production would be contrary to the public
`
`interest. Id. Additionally, when a court in Singapore orders a broader scope of production, the
`
`requesting party must identify the documents and, among other requirements, show that the
`
`requested documents are “material” to the issues in the case, meaning that there must be a
`
`demonstrable nexus between the requested documents and at least one of the issues, and the
`
`requested documents must have a significant bearing on an issue in a case, such that it could
`
`potentially affect the court’s ultimate decision. Id. at ¶ 6 (explaining that this threshold has
`
`become higher and stricter over time).
`
`Amgen US is a United States entity that is unlikely to be a party to the patent
`
`infringement action against Amgen Singapore, meaning it would not be subject to the production
`
`obligations of the Singaporean courts. Id. at ¶ 7. Absent due and proper service of an
`
`originating claim or originating process issued by the Singaporean court on Amgen US, or
`
`Amgen US’s voluntary submission to the jurisdiction of the Singaporean court, the Singaporean
`
`court would not have civil jurisdiction over Amgen US, including for the purposes of requiring
`
`the production of documents from Amgen US. Id.
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`Singaporean civil procedure also allows for a party to file an application for pre-action
`
`discovery to seek documents from a potential defendant for use in a potential patent infringement
`
`action. Id. at ¶ 8. In such a proceeding, a Singaporean court may order the production of
`
`documents and information before the commencement of proceedings or against a non‑party to
`
`identify possible parties to any proceedings, to enable a party to trace the party’s property, or for
`
`6
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 12 of 25 PageID #: 22
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`any other lawful purpose in the interests of justice. Id. Again, the scope of discovery in such a
`
`proceeding must satisfy the test of “materiality” described above. Id.
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`Regeneron believes that information relating to the manufacture of the drug substance for
`
`PAVBLUTM (aflibercept-ayyh) will be highly relevant to its forthcoming infringement suit
`
`against Amgen Singapore. Regeneron intends to assert that the manufacture of Amgen US’s
`
`approved biosimilar in Singapore infringes one or more claims of Regeneron’s Singaporean
`
`patents. Ueno Decl. at ¶ 6. Amgen US possesses key evidence that Regeneron will use to
`
`further assess and support these allegations; Amgen US is the holder of BLA 761298 for
`
`PAVBLUTM (aflibercept-ayyh) in the United States and manufactures and fills vials of the final
`
`drug product in the United States. Id. at ¶ 6; Ex. 3 (PAVBLUTM Approval Letter) at 2. Upon
`
`information and belief, Amgen Singapore is also a wholly owned subsidiary of Amgen US.
`
`Amgen US therefore has access to documents that relate to the manufacture of Amgen US’s
`
`approved biosimilar. See 21 CFR § 601.2. Additionally, Amgen US is in possession, custody, or
`
`control of the drug substance manufactured at Amgen Singapore’s facilities, both through receipt
`
`of that substance from Amgen Singapore and through its relationship, upon information and
`
`belief, as corporate parent of and whole owner of Amgen Singapore. Likewise, Amgen US has
`
`control, either in the form of access to or the ability to obtain samples related to the manufacture
`
`of the drug substance, which are relevant to Regeneron’s claims of infringement in Singapore.
`
`Ueno Decl., Ex. 3 (PAVBLUTM Approval Letter) at 2.
`
`Further, Regeneron cannot obtain the requested discovery from Amgen US in the foreign
`
`proceedings, as Amgen US is anticipated to be a non-party. Ong Decl. at ¶ 7. Without this
`
`Court’s assistance, Regeneron will be unable to obtain this discovery for use in Singapore in any
`
`meaningful way.
`
`7
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 13 of 25 PageID #: 23
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`Accordingly, Regeneron seeks limited document, sample, and deposition discovery from
`
`Amgen US pertaining to a narrow set of topics: (1) the process by which Amgen Singapore
`
`manufactures aflibercept, including information about the formulation of the approved
`
`biosimilar; (2) samples of the drug substance manufactured by Amgen Singapore, including
`
`samples from a limited number of specific intermediate steps in the manufacturing process; (3)
`
`manufacturing records of the drug substance manufactured by Amgen Singapore, including
`
`master batch records, individual batch records for particular commercial batches, lists of batches
`
`produced by Amgen Singapore, documents relating to the shipping of that drug substance from
`
`Amgen Singapore to the United States, and documents related to the quantities of drug substance
`
`being stored and/or stockpiled; and (4) Amgen US and Amgen Singapore’s plans to bring their
`
`biosimilar to market globally. Regeneron also seeks to depose at least one representative of
`
`Amgen US knowledgeable about the subject matter of these requests. Full copies of
`
`Regeneron’s approved subpoenas are attached hereto as Exhibits A-B.
`
`III.
`
`LEGAL STANDARD
`
`“Section 1782 is the product of congressional efforts, over the span of nearly 150 years,
`
`to provide federal-court assistance in gathering evidence for use in foreign tribunals.” Intel
`
`Corp. v. Advanced Micro Devices, Inc, 542 U.S. 241, 247 (2004). Section 1782 provides, in
`
`pertinent part:
`
`The district court of the district in which a person resides or is found may order
`him to give his testimony or statement or to produce a document or other thing for
`use in a proceeding in a foreign or international tribunal . . . . The order may be
`made . . . upon the application of any interested person and may direct that the
`testimony or statement be given, or the document or other thing be produced,
`before a person appointed by the court.
`
`28 U.S.C. § 1782(a). In deciding whether to grant a Section 1782 application, the Court “must
`
`first determine whether certain statutory requirements are met, and if those requirements are
`
`8
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`

`

`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 14 of 25 PageID #: 24
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`satisfied, the Court may then consider other factors to determine whether to exercise its
`
`discretion to grant the application.” In re O’Keeffe, 646 F. App’x 263, 265-66 (3d Cir. 2016);
`
`see also Intel, 542 U.S. at 264. Section 1782 sets forth three threshold statutory requirements:
`
`“(1) the person from whom discovery is sought resides or is found within the district; (2) the
`
`discovery is for use in a proceeding in a foreign or international tribunal; and (3) the application
`
`is made by an interested person.” In re EWE Gasspeicher GmbH, 612 F. Supp. 3d 402, 404 (D.
`
`Del. 2020) (citing 28 U.S.C. § 1782(a); In re Bayer AG, 146 F.3d 188, 193 (3d Cir. 1998)).
`
`Once the statutory requirements are met, a district court is to consider several
`
`discretionary factors set forth by the Supreme Court in Intel to determine whether to grant
`
`discovery. These factors include: (1) whether “the person from whom discovery is sought is a
`
`participant in the foreign proceeding,” because “the need for § 1782(a) aid generally is not as
`
`apparent as it ordinarily is when evidence is sought from a nonparticipant”; (2) “the nature of the
`
`foreign tribunal, the character of the proceedings underway abroad, and the receptivity of the
`
`foreign government or the court or agency abroad to U.S. federal-court judicial assistance”; (3)
`
`“whether the § 1782(a) request conceals an attempt to circumvent foreign proof-gathering
`
`restrictions or other policies of a foreign country or the United States”; and (4) whether the
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`request is otherwise “unduly intrusive or burdensome.” Intel, 542 U.S. at 264-65. In exercising
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`its discretion under the Intel factors, “the district court must remain mindful of the twin aims of
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`Section 1782: (1) providing efficient assistance to participants in international litigation, and (2)
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`encouraging foreign countries—by example—to provide similar assistance to our courts.” In re
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`FourWorld, No. 23-cv-01460, 2024 WL 1637400 at *3 (D. Del. Apr. 16, 2024); see also Intel,
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`542 U.S. at 252. “When assessing whether the material is being sought ‘for use’ in a foreign
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`proceeding, courts should not consider whether the Section 1782 application seeks information
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`9
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`

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`Case 1:25-cv-00017-UNA Document 3 Filed 01/06/25 Page 15 of 25 PageID #: 25
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`that would be discoverable or admissible in the foreign forum.” In re O’Keeffe, No. 14-cv-
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`05835, 2015 WL 540238 at *3 (D.N.J. Feb. 10, 2015) (citing Intel, 542 U.S. at 259-64; John
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`Deere v. Sperry Corp., 754 F.2d 132, 138 (3d Cir. 1985) (“a district court is not to predict the
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`admissibility of discovered evidence in foreign tribunals”)).
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`An ex parte application is an acceptable method for seeking Section 1782 discovery. See
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`In re Mota, No. 19-cv-00369, 2020 WL 95493 at *1 (D. Del. Jan. 8, 2020) (noting that
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`“[d]iscovery applications under § 1782 are often granted ex parte”).
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`IV.
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`ARGUMENT
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`A.
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`Regeneron’s Application Meets the Section 1782 Statutory Requirements
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`Regeneron’s application meets all three statutory Section 1782 requirements.
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`First, Amgen US is incorporated in Delaware, and thus “resides” in this District for
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`purposes of Section 1782. See In re Request from Vienna, No. 23-mc-00258, 2023 WL 6278815
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`at *2 (D. Del. Sept. 26, 2023) (“it is undisputed that Sandoz Inc. is a Delaware corporation and
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`that it therefore resides within this district for § 1782 purposes”).
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`Second, the discovery is sought for use in anticipated “proceeding[s] in a foreign or
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`international tribunal.” 28 U.S.C. § 1782(a). Specifically, Regeneron seeks the information for
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`use in its anticipated action against Amgen Singapore in the General Division of the High Court
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`of Singapore seeking damages and injunctive relief related to Amgen Singapore’s infringement
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`of Regeneron’s patents. The Supreme Court has interpreted the phrase “foreign or international
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`tribunal” to mean “an adjudicative body that exercises governmental authority” belonging to
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`another nation or country. ZF Auto. US, Inc. v. Luxshare, Ltd., 596 U.S. 619, 628-89 (2022).
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`The General Division of the High Court of Singapore is a division of the Supreme Court of
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`Singapore, which is an adjudicative body in Singapore as part of the Government of Singapore
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`that exercises both original and certain appellate jurisdiction in civil and criminal matters as
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`prescribed under the Supreme Court of Judicature Act 1969. Ong Decl. at ¶ 4. As such, it
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`qualifies as a “foreign or international tribunal” under the statute. Indeed, District Courts have
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`previously held that courts in Singapore qualify as “tribunals” for the purposes of Section 1782.
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`See, e.g., In re Third Eye Capital Corp., No. 22-cv-00963, 2022 WL 714758 at *4 (D.N.J. Mar.
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`10, 2022) (granting Section 1782 application to obtain discovery for use in action in the General
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`Division of the High Court of the Republic of Singapore); In re Batbold, No. 21-mc-00218, 2021
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`WL 4596536 (S.D.N.Y. Oct. 6, 2021) (granting application and finding that Singapore is
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`receptive to Section 1782 discovery).
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`Additionally, the Supreme Court has made clear that “Section 1782(a) does not limit the
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`provision of judicial assistance to ‘pending’ adjudicative proceedings.” Intel, 542 U.S. at 258.
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`Instead, Section 1782(a) requires only that the underlying action “be within reasonable
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`contemplation.” Id. at 259. “It is not necessary for the proceeding to be pending at the time the
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`evidence is sought, but only that the evidence is eventually to be used in such a proceeding.”
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`SPS Corp I v. General Motors Corp., 110 F.4th 586, 591 (3d Cir. 2024) (citing Intel, 542 U.S. at
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`259) (cleaned up); see also In re Request from Vienna, 2023 WL 6278815 at *4 (granting
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`Section 1782 application seeking discovery for use in contemplated patent infringement actions
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`in Europe). To show that a foreign proceeding is within reasonable contemplation, “an applicant
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`must provide ‘reliable indications of the likelihood that proceedings will be instituted within a
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`reasonable time’ for a proceeding to be within ‘reasonable contemplation.’” In re Matter of Wei,
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`No. 18-mc-00117, 2018 WL 5268125 at *2 (D. Del. Oct. 23, 2018). “In determining whether a
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`contemplated proceeding is within reasonable contemplation, courts have considered whether a
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`theory of litigation has been articulated, whether foreign counsel has been retained, and whether
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`applicants have represented their intent to initiate further litigation upon obtaining additional
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`11
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`information, among other factors.” In re Iraq Telecom, No. 19-mc-00175, 2023 WL 2402873 at
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`*5 (E.D. Pa. Mar. 8, 2023). “When an applicant has not yet initiated a foreign proceeding,
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`discovery is available if the materials may help the applicant either to plead or to prove an
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`anticipated claim.” In re Alghanim, No. 17-mc-00406, 2018 WL 2