`REGENERON PHARMACEUTICALS, INC.,
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`CELLTRION, INC.,
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`REGENERON PHARMACEUTICALS, INC.,
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`SAMSUNG BIOEPIS CO., LTD.,
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`REGENERON PHARMACEUTICALS, INC.,
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`FORMYCON AG,
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`Plaintiff,
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`v.
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`Defendant.
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`Plaintiff,
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`v.
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`Defendant.
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`Plaintiff,
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`v.
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`Defendant.
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`Case No. 1:23-cv-00089-TSK
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`JURY TRIAL DEMANDED
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`Case No. 1:23-cv-00094-TSK
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`JURY TRIAL DEMANDED
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`Case No. 1:23-cv-00097-TSK
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`JURY TRIAL DEMANDED
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 1 of 23 PageID #: 3688
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`PLAINTIFF’S MEMORANDUM IN SUPPORT OF ITS
`MOTION FOR ALTERNATIVE SERVICE
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 2 of 23 PageID #: 3689
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`
`TABLE OF CONTENTS
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`Page(s)
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`TABLE OF AUTHORITIES .......................................................................................................... ii
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`NATURE AND STATE OF PROCEEDINGS ................................................................................1
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`SUMMARY OF ARGUMENT .......................................................................................................4
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`STATEMENT OF FACTS ..............................................................................................................4
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`ARGUMENT .................................................................................................................................10
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`I.
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`II.
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`Legal Standard ...................................................................................................................10
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`Regeneron Should Be Permitted to Serve Defendants by Email to their U.S. Counsel ....11
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`A.
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`B.
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`C.
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`Service on U.S. Counsel Is Reasonably Calculated to Apprise Each
`Defendant of This Action and Satisfies Due Process ............................................11
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`Service by Email Is Not Prohibited by International Law .....................................12
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`Requiring Service Only Via Hague Convention Procedures May Delay
`This Litigation, Prejudicing Regeneron .................................................................13
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`CONCLUSION ..............................................................................................................................15
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`
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`i
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 3 of 23 PageID #: 3690
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`
`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
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`Acorda Therapeutics, Inc. v. Mylan Pharms., Inc.,
`817 F.3d 755 (Fed. Cir. 2016)................................................................................................... 1
`
`Affinity Labs of Tex., LLC v. Nissan N. Am. Inc.,
`2014 WL 11342502 (W.D. Tex. July 2, 2014) ....................................................................... 13
`
`Affinity Tool Works, LLC v. Hangzhou Great Star Indus. Co.,
`603 F. Supp. 3d 274 (W.D.N.C. 2022) ................................................................................... 12
`
`Amgen Inc. v. Apotex Inc.,
`827 F.3d 1052 (Fed. Cir. 2016)............................................................................................... 15
`
`Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc.,
`340 F.3d 1298 (Fed. Cir. 2003)............................................................................................... 10
`
`Celgard, LLC. v. Shenzen Senior Tech. Material Co.,
`2020 WL 2575561 (W.D.N.C. May 21, 2020) ................................................................. 11, 12
`
`Divx, LLC v. LG Elecs. Inc.,
`2021 WL 411708 (D. Del. Feb. 5, 2021) ................................................................................ 12
`
`Enovative Techs., LLC v. Leor,
`622 F. App’x 212 (4th Cir. 2015) ........................................................................................... 10
`
`Exch. Comm’n v. Richman,
`2021 WL 9816612 (N.D. Cal. July 19, 2021) ......................................................................... 13
`
`Facebook, Inc. v. Banana Ads, LLC,
`2012 WL 1038752 (N.D. Cal. Mar. 27, 2012) ........................................................................ 13
`
`Hanna v. Plumer,
`380 U.S. 460 (1965) ................................................................................................................ 11
`
`In GLG Life Tech Corp. Sec. Litig.,
`287 F.R.D. 262 (S.D.N.Y. 2012) ............................................................................................ 14
`
`In re One Apus Container Ship Incident on Nov. 30,
`2022, 2022 WL 17370122 (S.D.N.Y. Dec. 2, 2022) .............................................................. 13
`
`In re OnePlus Tech. (Shenzhen) Co., Ltd.,
`2021 WL 4130643 (Fed. Cir. Sept. 10, 2021) ........................................................................ 10
`
`ii
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`
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 4 of 23 PageID #: 3691
`
`
`In Re TFT-LCD (Flat Panel) Antitrust Litig.,
`2010 WL 1337743 (N.D. Cal. Apr. 2, 2010) .......................................................................... 12
`
`In re TK Holdings, Inc.,
`2021 WL 954827 (Bankr. D. Del. Mar. 8, 2021) .................................................................... 12
`
`Kaneka Corp. v. SKC Kolon PI, Inc.,
`2013 WL 11237203 (C.D. Cal. May 6, 2013) ........................................................................ 14
`
`Knit With v. Knitting Fever, Inc.,
`2010 WL 4977944 (E.D. Pa. Dec. 7, 2010) ............................................................................ 14
`
`Lexmark Int’l, Inc. v. Ink Techs. Printer Supplies, LLC,
`295 F.R.D. 259 (S.D. Ohio 2013) ..................................................................................... 13, 14
`
`Moore v. K-Mart Corp.,
`1994 WL 824518, at n.2 (W.D. Va. Dec. 15, 1994) ............................................................... 11
`
`Nexon Korea Corp. v. Ironmace Co.,
`2023 WL 3599548 (W.D. Wash. May 23, 2023).................................................................... 13
`
`Rio Properties, Inc. v. Rio International Interlink,
`284 F.3d 1007 (9th Cir. 2002) .......................................................................................... 10, 11
`
`Vanderhoef v. China Auto Logistics Inc.,
`2019 WL 6337908 (D.N.J. Nov. 26, 2019) ............................................................................ 13
`
`Williams v. Advert. Sex LLC,
`231 F.R.D. 483 (N.D.W. Va. 2005) ........................................................................................ 10
`
`Xilinx, Inc. v. Godo Kaisha IP Bridge 1,
`246 F. Supp. 3d 1260 (N.D. Cal. 2017) .................................................................................. 10
`
`STATUTES
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`35 U.S.C. § 271(e) .................................................................................................................. 5, 6, 7
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`42 U.S.C. § 262(k)-(l) ..................................................................................................................... 1
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`42 U.S.C. § 262(l) ........................................................................................................................... 5
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`42 U.S.C. § 262(l)(8)(C) ................................................................................................................. 1
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`RULES
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`Fed. R. Civ. P. 4 ............................................................................................................................ 11
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`Fed. R. Civ. P. 4(d) ....................................................................................................................... 11
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`iii
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 5 of 23 PageID #: 3692
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`Fed. R. Civ. P. 4(d)(1)................................................................................................................... 11
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`Fed. R. Civ. P. 4(e) ....................................................................................................................... 11
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`Fed. R. Civ. P. 4(f) .................................................................................................................. 10, 12
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`Fed. R. Civ. P. 4(f)(2) ..................................................................................................................... 9
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`Fed. R. Civ. P. 4(f)(3) ............................................................................................. 3, 10, 12, 13, 15
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`Fed. R. Civ. P. 4(h)(1)..................................................................................................................... 9
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`Fed. R. Civ. P. 4(h)(2)......................................................................................................... 3, 10, 15
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`Fed. R. Civ. P. 4(k) ....................................................................................................................... 11
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`
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`iv
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 6 of 23 PageID #: 3693
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`
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`NATURE AND STATE OF PROCEEDINGS
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`On November 8, 2023 Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an
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`action against Celltrion, Inc. (“Celltrion”), a Korean company, under the Biologics Price
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`Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262(k)-(l). Regeneron then filed suit
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`against Samsung Bioepis, Co., Ltd. (“Bioepis”), a Korean company, on November 21, and
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`against Formycon AG (“Formycon”), a German company, on November 29, also under the
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`BPCIA. Regeneron filed its suit against Celltrion in response to its provision of a notice of
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`commercial marketing by and through its counsel, pursuant to the BPCIA, notifying Regeneron
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`that it may commercialize its proposed biosimilar product in no less than 180 days. The statute
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`envisages that such notice may—as here—trigger a lawsuit and an ensuing motion for
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`preliminary injunction to prevent commercialization of the biosimilar product, for which the
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`parties must “reasonably cooperate” and conduct “expedite[d] . . . discovery.” 42 U.S.C. §
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`262(l)(8)(C).
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`Celltrion, Bioepis, and Formycon (collectively “Defendants”) had other plans. Rather
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`than permit this Court to adjudicate the patent infringement on the merits, Defendants are
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`erecting a series of wasteful and baseless procedural roadblocks in an effort to consume the
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`limited 180-day time period that the statute allocates to preliminary injunction proceedings.
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`Each of the Defendants has submitted a U.S. Food & Drug Administration (“FDA”) application
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`seeking approval to market its biosimilar product nationwide—the very act that, the Federal
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`Circuit has confirmed, confers personal jurisdiction in all fifty states. See Acorda Therapeutics,
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`Inc. v. Mylan Pharms., Inc., 817 F.3d 755 (Fed. Cir. 2016). Nevertheless, in a desperate effort to
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`avoid this Court—in particular its knowledge of the asserted patents obtained during the course
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`of Regeneron’s co-pending litigation against Mylan and Biocon—Defendants’ counsel indicated
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`their intent to contest personal jurisdiction. But the procedural gambits have not stopped there.
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`1
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 7 of 23 PageID #: 3694
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`After the filing of each complaint, Regeneron promptly provided via email a copy of the
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`complaint to each Defendant’s U.S. counsel—Gemini Law LLP (“Gemini”) for Celltrion,1 Quinn
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`Emanuel Urquhart & Sullivan, LLP (“Quinn Emanuel”) for Bioepis, and Jenner & Block LLP
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`(“Jenner & Block”) for Formycon. Regeneron asked each counsel to accept service of its
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`complaint on behalf of their client. Defendants’ counsel were not strangers to these cases; each
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`had repeatedly (and recently) conferred with Regeneron’s counsel and served papers frequently
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`on their respective Defendant’s behalf.
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`Remarkably, each U.S. counsel has declined to accept service, often after weeks of
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`silence. Bioepis’s counsel Quinn Emanuel, for example, failed to respond to the simple request
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`to accept service by email for more than two weeks before declining. Quinn Emanuel’s stated
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`basis for forgoing this formality—and it is just that, a formality, given that Bioepis and its
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`counsel long had notice of the dispute—was that accepting service may waive Bioepis’s ability
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`to challenge personal jurisdiction. But Bioepis knows that position is baseless, because it
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`previously agreed to a stipulation accepting service while preserving its defenses as to
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`jurisdiction and venue in a prior BPCIA case. See Genentech, Inc. v. Samsung Bioepis Co. Ltd.,
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`Case 1:20-cv-00859-CFC-JLH, Dkt. 5 (D. Del. July 6, 2020).
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`Nevertheless, in an attempt to avoid this motion, Regeneron agreed to meet and confer
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`with Bioepis on December 13, 2023. But Bioepis’s counsel remained unwilling to accept
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`service. On December 15, Regeneron provided caselaw to confirm that Bioepis’s concerns were
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`unwarranted and proposed a stipulation nearly identical to the one Bioepis previously accepted in
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`the Genentech matter.
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`1 Celltrion is also represented by Wilkie Farr & Gallagher LLP, but Gemini has been responsible for all
`relevant communication with Regeneron.
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`2
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 8 of 23 PageID #: 3695
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`
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`Celltrion’s U.S. counsel, Gemini, proceeded in even more egregious fashion. After
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`negotiating for weeks on a proposed preliminary injunction schedule and agreeing to accept
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`service if Regeneron would extend the date for Celltrion to respond to the complaint (which
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`Regeneron offered to do), see Ex. A (Nov. 13, 2023 Email from A. Zalcenstein to P. Patel),
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`Celltrion stopped engaging in those discussions. When Celltrion’s counsel finally responded to
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`Regeneron’s latest draft of the proposed schedule—weeks later—it became clear that Gemini
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`had determined it would stand shoulder to shoulder with the other Defendants in refusing to
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`accept service, thereby obstructing this litigation. Celltrion ultimately reneged on its month-old
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`commitment to accept service in a December 21 email in which it permitted Formycon’s counsel
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`to speak on its behalf.
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`Formycon’s U.S. counsel, Jenner & Block, ignored Regeneron’s request to accept service
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`for weeks. After finally stating that they were “working through [the service] issue with our
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`client,” Ex. B (Dec. 12, 2023 Email from S. Van Horn to A. Trask), Formycon continued to
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`negotiate a potential preliminary injunction schedule, making no further mention of concerns
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`about service. Indeed, during a meet and confer between Regeneron and all Defendants on
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`December 19, Formycon’s counsel suggested it was still awaiting approval from its client on
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`whether to accept service. Two days later, Formycon’s counsel, writing on behalf of all the
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`Defendants, also refused.
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`Defendants’ deliberate, and now coordinated, delay tactics have already hindered
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`progress in these litigations. Given the urgency of the 180-day time period set by statute to
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`adjudicate the preliminary injunction, Regeneron thus moves for entry of an order authorizing
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`alternative service on each of the Defendants. See Fed. R. Civ. P. 4(h)(2), 4(f)(3).
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`3
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 9 of 23 PageID #: 3696
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`
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`SUMMARY OF ARGUMENT
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`Alternative service on Defendants via email to their U.S. counsel is proper, because such
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`service is reasonably calculated to apprise Defendants of the actions, is not barred by
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`international agreement, and is necessary to ensure timely progression of this matter to litigation
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`on the merits. Defendants are already aware of this litigation, and have each been
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`communicating with their counsel and with Regeneron for months about the underlying subject
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`matter of this litigation—Defendants’ EYLEA® biosimilar products and Regeneron’s
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`infringement allegations. The Hague Convention does not address or prohibit service by email.
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`Finally, the circumstances of these cases, in particular the congressionally acknowledged need
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`for expedited discovery and a timely adjudication of Regeneron’s forthcoming motion for
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`preliminary injunction, especially in light of the impending potential FDA approval and launch
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`of Defendants’ biosimilar products, necessitate expeditious service. Numerous courts have
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`authorized service on foreign defendants via email to U.S. counsel in analogous situations.
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`STATEMENT OF FACTS
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`Regeneron invented, developed, and sells EYLEA®, the market-leading treatment for
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`several serious eye diseases. See Celltrion Compl. ¶ 2. Defendants are each in the process of
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`seeking approval to commercialize a biosimilar of EYLEA® in the United States. A brief
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`recitation of Regeneron’s interactions with each, conducted entirely with or through Defendants’
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`U.S. counsel, follows.
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`Celltrion
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`On June 30, 2023, Celltrion—a company organized under the laws of the Republic of
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`Korea—publicly announced that it had applied for approval from the FDA to commercialize
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`“CT-P42,” a biosimilar of EYLEA®. See id. ¶ 3. In September 2023, Celltrion provided
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`Regeneron with a copy of its abbreviated Biologics License Application or “aBLA” for CT-P42
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`4
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 10 of 23 PageID #: 3697
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`
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`and later provided its notice of commercial marketing, indicating its intent to begin marketing
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`and selling the biosimilar immediately upon receiving approval from the FDA. See id. ¶¶ 23, 25.
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`Because Celltrion’s submission of its aBLA constitutes an act of patent infringement under 35
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`U.S.C. § 271(e), Regeneron filed the above-captioned action for patent infringement to obtain
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`relief before Celltrion launches CT-P42 in the United States.
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`Regeneron has been in communication with Celltrion’s U.S. counsel since September
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`2023 as the parties followed the “patent dance” 2 procedures of the BPCIA and prepared for this
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`litigation. See Celltrion Compl. ¶ 2. All of Regeneron’s contact with Celltrion about its aBLA
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`has occurred through its U.S. counsel, Gemini. In early November, prior to the filing of the
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`complaint, counsel for Regeneron reached out to Celltrion’s U.S. counsel to discuss a proposed
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`preliminary injunction schedule and confidentiality agreement to govern this infringement
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`litigation. Counsel for Celltrion responded and acknowledged they were aware Regeneron
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`planned to file an action. Shortly thereafter, on November 8, 2023, Regeneron filed its
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`complaint, and the same day Regeneron’s counsel emailed Gemini a copy of the complaint and
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`requested that they confirm whether they would accept service of process on behalf of Celltrion.
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`When Celltrion’s counsel failed to respond, Regeneron followed up two days later, and on
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`November 13, Gemini “agree[d] to accept service of the complaint on behalf of Celltrion”
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`provided Regeneron agreed to an extension of Celltrion’s time to respond. Ex. A (Nov. 13, 2023
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`Email from A. Zalcenstein to P. Patel).
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`In the weeks that followed, Celltrion’s U.S. counsel continued to discuss the preliminary
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`injunction schedule with Regeneron, and the parties traded drafts of a proposed stipulated
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`2 The term “patent dance” refers to a set of pre-litigation steps outlined by the BPCIA, whereby the parties
`exchange infringement and validity contentions. See 42 U.S.C. § 262(l).
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`5
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 11 of 23 PageID #: 3698
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`
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`preliminary injunction schedule. In every iteration of the draft stipulation, counsel for Celltrion
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`agreed to accept service of process.
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`With the parties close to a final stipulation as to service and schedule, counsel for
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`Regeneron requested a December 1 meet and confer. Celltrion’s counsel asserted they were
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`unavailable, so Regeneron shared another set of proposed revisions via email and followed up on
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`the meet-and-confer request. Counsel for Celltrion did not respond. A week later, counsel for
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`Regeneron again requested a call to discuss the schedule and service issues, but counsel for
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`Celltrion was again unavailable. Regeneron would not hear from Celltrion again until its
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`December 19, 2023 meet and confer with all Defendants, during which Celltrion would no
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`longer commit to accepting service. Prior to that meeting, Celltrion gave no indication that it
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`might refuse service. Two days later, in a December 21 email from all Defendants (sent by
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`Formycon’s counsel), Celltrion finally and conclusively retracted its earlier commitment and
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`refused to accept service.
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`Samsung Bioepis
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`Bioepis—a company organized under the laws of the Republic of Korea—applied for
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`approval from FDA to commercialize “SB15,” a biosimilar of EYLEA®. Regeneron filed its
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`action for patent infringement to obtain relief before Bioepis launches SB15 in the United States
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`under 35 U.S.C. § 271(e).
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`Regeneron has been in communication with Bioepis’s U.S. counsel as the parties
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`prepared for this litigation. All of Regeneron’s contact with Bioepis about its aBLA has
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`occurred through Quinn Emanuel.
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`On November 21, 2023, Regeneron filed the above-captioned action. The following day,
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`Regeneron emailed Bioepis’s in-house legal counsel and Quinn Emanuel a copy of the complaint
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`6
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 12 of 23 PageID #: 3699
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`
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`and docket entry and requested that they confirm whether Bioepis would agree to accept service
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`by email. Having received no response whatsoever from Bioepis for more than two weeks,
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`Regeneron’s counsel wrote to Quinn Emanuel again on December 8 in follow-up, again
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`requesting confirmation that Quinn Emanuel would accept service on behalf of Bioepis.
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`Nineteen days after Regeneron’s initial email, on December 11, Quinn Emanuel replied that
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`counsel was unable to accept service of the complaint via email, citing concerns about Bioepis’s
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`intended personal jurisdiction defense.
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`The parties met and conferred on December 13. During the meet and confer, Quinn
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`Emanuel asserted that it was reluctant to accept service because of concern that doing so might
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`waive Bioepis’s ability to challenge the Court’s personal jurisdiction. To alleviate those
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`concerns, on December 15, Regeneron provided caselaw confirming that acceptance of service
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`would not threaten Bioepis’s right to contest personal jurisdiction and proposing a stipulation
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`explicitly preserving Bioepis’s personal jurisdiction defense. Bioepis’s counsel nevertheless
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`again refused to accept service.
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`Formycon
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`On June 29, 2023, Formycon—a company organized under German law—publicly
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`announced that it had applied for approval from FDA to commercialize “FYB203,” a biosimilar
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`of EYLEA®. See Formycon Compl. ¶¶ 3, 7. In August 2023, Formycon announced that FDA
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`had accepted its aBLA for FYB203. See id. ¶ 4. Because Formycon’s submission of its aBLA
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`constitutes an act of patent infringement under 35 U.S.C. § 271(e), Regeneron filed its action for
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`patent infringement to obtain relief before Formycon launches FYB203 in the United States.
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`Regeneron has been in communication with Formycon’s U.S. counsel, Jenner & Block,
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`as the parties prepared for this litigation. All of Regeneron’s contact with Formycon about its
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`7
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 13 of 23 PageID #: 3700
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`
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`aBLA has occurred through Jenner & Block. In early November, counsel for Regeneron reached
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`out to Formycon’s U.S. counsel to discuss a proposed preliminary injunction schedule in
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`anticipation of this infringement action. Formycon’s counsel responded that they had “discussed
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`the issue with Formycon” and indicated they were aware Regeneron planned to file this action.
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`Ex. C (Nov. 10, 2023 Email from S. Van Horn to T. Fletcher). In the ensuing days, the parties
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`met and conferred via videoconference and communicated by email numerous times to discuss
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`the preliminary injunction schedule.
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`On November 29, 2023, Regeneron filed its complaint, and shortly thereafter
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`Regeneron’s counsel emailed Jenner & Block a copy of the sealed complaint. Formycon’s
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`counsel acknowledged receipt and a few days later, Regeneron’s counsel followed up, providing
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`a further revision of the proposed preliminary injunction schedule and requesting confirmation
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`that Jenner & Block would accept service on Formycon’s behalf. When Jenner & Block failed to
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`respond, counsel for Regeneron followed up again to request confirmation that Jenner & Block
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`would accept service. Counsel for Formycon finally replied that they were “working through
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`this issue with our client” and “[were] not in a position to accept service at this time.” Ex. B
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`(Dec. 12, 2023 Email from S. Van Horn to A. Trask).
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`In the days that followed, the parties continued to discuss the preliminary injunction
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`schedule, but the service issue remained unresolved. As with Celltrion, Formycon’s U.S.
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`counsel ultimately confirmed that it would not accept service via Defendants’ joint
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`correspondence on December 21.
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`*****
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`8
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 14 of 23 PageID #: 3701
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`
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`Because Celltrion and Bioepis are Korean companies, and Formycon a German company,
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`effectuating service through Rule 4(f)(2) would require the Hague Convention process.3 This
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`would take a significant amount of time. For Celltrion and Bioepis, the Convention would
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`require Regeneron first to transmit a request for service and each complaint (in English and
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`Korean translation) to the Republic of Korea’s Director of International Affairs within the
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`National Court Administration, the country’s designated “Central Authority.”4 The Korean
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`Director of International Affairs would then send the request to a “competent court,” which in
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`turn would serve Celltrion and Bioepis, respectively.5 Once the Korean court had served
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`Celltrion and Bioepis, Regeneron would need to wait for the Korean central authority to send a
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`certificate of service back to Regeneron. See Theodore J. Folkman, International Judicial
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`Assistance § 2.3.4(d) (2012). As to Formycon, the Convention would require that Regeneron
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`first transmit a request for service and the complaint (in English and German translation) to the
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`President of the appropriate Regional Court,6 which would in turn attempt to effectuate service
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`via the postal service, after which time Regeneron would need to wait for the return of a
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`certificate of service from that Regional Court.
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`3 Regeneron also is pursuing service via Rule 4(h)(1) and will file proofs of service if it succeeds. Such a
`proof of service would not moot this motion to the extent Defendants contend that service via Rule 4(h)(1) was
`improper.
`4 Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial
`Matters, Nov. 15, 1965, art. 5, 20 U.S.T. 361, available at https://assets hcch.net/docs/f4520725-8cbd-4c71-b402-
`5aae1994d14c.pdf.
`5 Republic of Korea – Central Authority and Practical Information, Hague Conference on Private
`International Law, https://www hcch.net/en/states/authorities/details3/?aid=262 (last visited Dec. 21, 2023).
`6 Germany’s “Central Authority” is decentralized such that the appropriate authority is located in the
`district where the party designated for service resides. See Germany – Central Authority and Practical Information,
`Hague Conference on Private International Law, https://www.hcch net/en/states/authorities/details3/?aid=257 (last
`visited Dec. 21, 2023).
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`9
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`In each case, the process is likely to take several months to complete, meaning that
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`Defendants could potentially avoid service until mid-2024, when Regeneron’s regulatory
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`exclusivity expires (on May 18, 2024).
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`ARGUMENT
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`I.
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`Legal Standard
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`The Federal Rules of Civil Procedure permit a Court to order service on a foreign
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`corporation by any “means not prohibited by international agreement as may be directed by the
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`court.” See Fed. R. Civ. P. 4(f)(3), (h)(2); see also Enovative Techs., LLC v. Leor, 622 F. App’x
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`212, 214 (4th Cir. 2015) (quoting Fed. R. Civ. P. 4(f)(3)); 7 Williams v. Advert. Sex LLC, 231
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`F.R.D. 483, 486-87 (N.D.W. Va. 2005) (same). This broad discretion is limited only by Due
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`Process considerations, which require that the method of service be “reasonably calculated,
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`under all the circumstances, to give notice to defendant.” Enovative Techs., 622 F. App’x at 214
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`(internal quotations omitted). “Rule 4(f) does not denote any hierarchy or preference for one
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`method of service over another,” Id., citing Rio Properties, Inc. v. Rio International Interlink,
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`284 F.3d 1007, 1016 (9th Cir. 2002), and a plaintiff need not attempt to serve a foreign defendant
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`abroad before seeking alternative service, see, e.g., In re OnePlus Tech. (Shenzhen) Co., Ltd.,
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`2021 WL 4130643, at *3 (Fed. Cir. Sept. 10, 2021) (declining to find abuse of discretion by
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`District Court in ordering service via email to U.S. counsel, notwithstanding that plaintiff had
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`“made no showing that service under the Hague Convention had been tried and failed, would
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`7 As this issue involves interpretation of the Federal Rules of Civil Procedure, Fourth Circuit law applies.
`See Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298, 1306 (Fed. Cir. 2003) (“We generally
`apply the law of the pertinent regional circuit when the precise issue to be addressed involves an interpretation of the
`Federal Rules of Civil Procedure.”); See also Xilinx, Inc. v. Godo Kaisha IP Bridge 1, 246 F. Supp. 3d 1260, 1263
`(N.D. Cal. 2017) (ordering service on a foreign corporation’s U.S. counsel pursuant to Rule 4(f)(3), and noting that
`“[w]hen, as here, the issue to be addressed involves an interpretation of the Federal Rules of Civil Procedure, the
`law of the regional circuit applies even if the subject of the lawsuit is patent-related.”)
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`10
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 16 of 23 PageID #: 3703
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`have been unlikely to succeed, or was otherwise impracticable”); see also Celgard, LLC. v.
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`Shenzen Senior Tech. Material Co., 2020 WL 2575561, at *2 (W.D.N.C. May 21, 2020)
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`(permitting service on foreign corporation via email to U.S. counsel despite Plaintiff not
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`attempting service via Hague Convention).
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`II.
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`Regeneron Should Be Permitted to Serve Defendants by Email to their U.S. Counsel
`A.
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`Service on U.S. Counsel Is Reasonably Calculated to Apprise Each
`Defendant of This Action and Satisfies Due Process
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`The Court should permit service on Defendants through email service on their U.S.
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`counsel, because doing so will ensure that each Defendant receives actual notice of the claims
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`against it. Due Process requires that an ordered method of alternative service be “reasonably
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`calculated, under all circumstances, to apprise interested parties of the pendency of the action
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`and afford them an opportunity to present their objections.” Rio Properties, Inc., 284 F.3d at
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`1016. This is consistent with the accepted “goal of Rule 4”—to provide actual notice. Hanna v.
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`Plumer, 380 U.S. 460, 463 (1965) (“Actual notice is of course also the goal of Rule 4(d)(1)”);
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`Moore v. K-Mart Corp., 1994 WL 824518, at n.2 (W.D. Va. Dec. 15, 1994) (“[T]he revised
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`Federal Rules of Civil Procedure, Rule 4, indicates that actual notice is the goal of service of
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`process.” (citing Fed. R. Civ. P. 4(d), (e), & (k))).
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`Service through Defendants’ counsel is reasonably calculated to apprise them of this
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`litigation because each Defendant already has actual notice of the litigation. Regeneron
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`provided a copy of the complaint to each Defendant’s U.S. counsel via email weeks ago. That
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`message, and indeed the filing of the complaints, occurred after months of regular and
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`substantive communication and negotiation with each Defendant through U.S. counsel. It strains
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`credulity to suggest that any Defendant has not been made aware of the litigation by that same
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`counsel; no Defendant has ever asserted otherwise. At a minimum, each Defendant has
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`11
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`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 17 of 23 PageID #: 3704
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`necessarily been apprised of the suit by their U.S. counsel to the extent necessary to