`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`CELLTRION, INC.,
`
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`SAMSUNG BIOEPIS CO., LTD.,
`
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`FORMYCON AG,
`
`
`
`
`Plaintiff,
`
`
`v.
`
`
`
`Defendant.
`
`Plaintiff,
`
`
`v.
`
`
`
`Defendant.
`
`Plaintiff,
`
`
`v.
`
`
`
`Defendant.
`
`
`
`Case No. 1:23-cv-00089-TSK
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`Case No. 1:23-cv-00094-TSK
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`
`Case No. 1:23-cv-00097-TSK
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 1 of 23 PageID #: 3688
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`PLAINTIFF’S MEMORANDUM IN SUPPORT OF ITS
`MOTION FOR ALTERNATIVE SERVICE
`
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 2 of 23 PageID #: 3689
`
`
`TABLE OF CONTENTS
`
`
`Page(s)
`
`TABLE OF AUTHORITIES .......................................................................................................... ii 
`
`NATURE AND STATE OF PROCEEDINGS ................................................................................1 
`
`SUMMARY OF ARGUMENT .......................................................................................................4 
`
`STATEMENT OF FACTS ..............................................................................................................4 
`
`ARGUMENT .................................................................................................................................10 
`
`I. 
`
`II. 
`
`Legal Standard ...................................................................................................................10 
`
`Regeneron Should Be Permitted to Serve Defendants by Email to their U.S. Counsel ....11 
`
`A. 
`
`B. 
`
`C. 
`
`Service on U.S. Counsel Is Reasonably Calculated to Apprise Each
`Defendant of This Action and Satisfies Due Process ............................................11 
`
`Service by Email Is Not Prohibited by International Law .....................................12 
`
`Requiring Service Only Via Hague Convention Procedures May Delay
`This Litigation, Prejudicing Regeneron .................................................................13 
`
`CONCLUSION ..............................................................................................................................15 
`
`
`
`i
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 3 of 23 PageID #: 3690
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`
`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
`
`

`

`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
`
`35 U.S.C. § 271(e) .................................................................................................................. 5, 6, 7
`
`42 U.S.C. § 262(k)-(l) ..................................................................................................................... 1
`
`42 U.S.C. § 262(l) ........................................................................................................................... 5
`
`42 U.S.C. § 262(l)(8)(C) ................................................................................................................. 1
`
`RULES
`
`Fed. R. Civ. P. 4 ............................................................................................................................ 11
`
`Fed. R. Civ. P. 4(d) ....................................................................................................................... 11
`
`iii
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 5 of 23 PageID #: 3692
`
`
`Fed. R. Civ. P. 4(d)(1)................................................................................................................... 11
`
`Fed. R. Civ. P. 4(e) ....................................................................................................................... 11
`
`Fed. R. Civ. P. 4(f) .................................................................................................................. 10, 12
`
`Fed. R. Civ. P. 4(f)(2) ..................................................................................................................... 9
`
`Fed. R. Civ. P. 4(f)(3) ............................................................................................. 3, 10, 12, 13, 15
`
`Fed. R. Civ. P. 4(h)(1)..................................................................................................................... 9
`
`Fed. R. Civ. P. 4(h)(2)......................................................................................................... 3, 10, 15
`
`Fed. R. Civ. P. 4(k) ....................................................................................................................... 11
`
`
`
`iv
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 6 of 23 PageID #: 3693
`
`
`
`NATURE AND STATE OF PROCEEDINGS
`
`On November 8, 2023 Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an
`
`action against Celltrion, Inc. (“Celltrion”), a Korean company, under the Biologics Price
`
`Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262(k)-(l). Regeneron then filed suit
`
`against Samsung Bioepis, Co., Ltd. (“Bioepis”), a Korean company, on November 21, and
`
`against Formycon AG (“Formycon”), a German company, on November 29, also under the
`
`BPCIA. Regeneron filed its suit against Celltrion in response to its provision of a notice of
`
`commercial marketing by and through its counsel, pursuant to the BPCIA, notifying Regeneron
`
`that it may commercialize its proposed biosimilar product in no less than 180 days. The statute
`
`envisages that such notice may—as here—trigger a lawsuit and an ensuing motion for
`
`preliminary injunction to prevent commercialization of the biosimilar product, for which the
`
`parties must “reasonably cooperate” and conduct “expedite[d] . . . discovery.” 42 U.S.C. §
`
`262(l)(8)(C).
`
`Celltrion, Bioepis, and Formycon (collectively “Defendants”) had other plans. Rather
`
`than permit this Court to adjudicate the patent infringement on the merits, Defendants are
`
`erecting a series of wasteful and baseless procedural roadblocks in an effort to consume the
`
`limited 180-day time period that the statute allocates to preliminary injunction proceedings.
`
`Each of the Defendants has submitted a U.S. Food & Drug Administration (“FDA”) application
`
`seeking approval to market its biosimilar product nationwide—the very act that, the Federal
`
`Circuit has confirmed, confers personal jurisdiction in all fifty states. See Acorda Therapeutics,
`
`Inc. v. Mylan Pharms., Inc., 817 F.3d 755 (Fed. Cir. 2016). Nevertheless, in a desperate effort to
`
`avoid this Court—in particular its knowledge of the asserted patents obtained during the course
`
`of Regeneron’s co-pending litigation against Mylan and Biocon—Defendants’ counsel indicated
`
`their intent to contest personal jurisdiction. But the procedural gambits have not stopped there.
`
`1
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 7 of 23 PageID #: 3694
`
`
`
`After the filing of each complaint, Regeneron promptly provided via email a copy of the
`
`complaint to each Defendant’s U.S. counsel—Gemini Law LLP (“Gemini”) for Celltrion,1 Quinn
`
`Emanuel Urquhart & Sullivan, LLP (“Quinn Emanuel”) for Bioepis, and Jenner & Block LLP
`
`(“Jenner & Block”) for Formycon. Regeneron asked each counsel to accept service of its
`
`complaint on behalf of their client. Defendants’ counsel were not strangers to these cases; each
`
`had repeatedly (and recently) conferred with Regeneron’s counsel and served papers frequently
`
`on their respective Defendant’s behalf.
`
`Remarkably, each U.S. counsel has declined to accept service, often after weeks of
`
`silence. Bioepis’s counsel Quinn Emanuel, for example, failed to respond to the simple request
`
`to accept service by email for more than two weeks before declining. Quinn Emanuel’s stated
`
`basis for forgoing this formality—and it is just that, a formality, given that Bioepis and its
`
`counsel long had notice of the dispute—was that accepting service may waive Bioepis’s ability
`
`to challenge personal jurisdiction. But Bioepis knows that position is baseless, because it
`
`previously agreed to a stipulation accepting service while preserving its defenses as to
`
`jurisdiction and venue in a prior BPCIA case. See Genentech, Inc. v. Samsung Bioepis Co. Ltd.,
`
`Case 1:20-cv-00859-CFC-JLH, Dkt. 5 (D. Del. July 6, 2020).
`
`Nevertheless, in an attempt to avoid this motion, Regeneron agreed to meet and confer
`
`with Bioepis on December 13, 2023. But Bioepis’s counsel remained unwilling to accept
`
`service. On December 15, Regeneron provided caselaw to confirm that Bioepis’s concerns were
`
`unwarranted and proposed a stipulation nearly identical to the one Bioepis previously accepted in
`
`the Genentech matter.
`
`
`1 Celltrion is also represented by Wilkie Farr & Gallagher LLP, but Gemini has been responsible for all
`relevant communication with Regeneron.
`
`2
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 8 of 23 PageID #: 3695
`
`
`
`Celltrion’s U.S. counsel, Gemini, proceeded in even more egregious fashion. After
`
`negotiating for weeks on a proposed preliminary injunction schedule and agreeing to accept
`
`service if Regeneron would extend the date for Celltrion to respond to the complaint (which
`
`Regeneron offered to do), see Ex. A (Nov. 13, 2023 Email from A. Zalcenstein to P. Patel),
`
`Celltrion stopped engaging in those discussions. When Celltrion’s counsel finally responded to
`
`Regeneron’s latest draft of the proposed schedule—weeks later—it became clear that Gemini
`
`had determined it would stand shoulder to shoulder with the other Defendants in refusing to
`
`accept service, thereby obstructing this litigation. Celltrion ultimately reneged on its month-old
`
`commitment to accept service in a December 21 email in which it permitted Formycon’s counsel
`
`to speak on its behalf.
`
`Formycon’s U.S. counsel, Jenner & Block, ignored Regeneron’s request to accept service
`
`for weeks. After finally stating that they were “working through [the service] issue with our
`
`client,” Ex. B (Dec. 12, 2023 Email from S. Van Horn to A. Trask), Formycon continued to
`
`negotiate a potential preliminary injunction schedule, making no further mention of concerns
`
`about service. Indeed, during a meet and confer between Regeneron and all Defendants on
`
`December 19, Formycon’s counsel suggested it was still awaiting approval from its client on
`
`whether to accept service. Two days later, Formycon’s counsel, writing on behalf of all the
`
`Defendants, also refused.
`
`Defendants’ deliberate, and now coordinated, delay tactics have already hindered
`
`progress in these litigations. Given the urgency of the 180-day time period set by statute to
`
`adjudicate the preliminary injunction, Regeneron thus moves for entry of an order authorizing
`
`alternative service on each of the Defendants. See Fed. R. Civ. P. 4(h)(2), 4(f)(3).
`
`3
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 9 of 23 PageID #: 3696
`
`
`
`SUMMARY OF ARGUMENT
`
`Alternative service on Defendants via email to their U.S. counsel is proper, because such
`
`service is reasonably calculated to apprise Defendants of the actions, is not barred by
`
`international agreement, and is necessary to ensure timely progression of this matter to litigation
`
`on the merits. Defendants are already aware of this litigation, and have each been
`
`communicating with their counsel and with Regeneron for months about the underlying subject
`
`matter of this litigation—Defendants’ EYLEA® biosimilar products and Regeneron’s
`
`infringement allegations. The Hague Convention does not address or prohibit service by email.
`
`Finally, the circumstances of these cases, in particular the congressionally acknowledged need
`
`for expedited discovery and a timely adjudication of Regeneron’s forthcoming motion for
`
`preliminary injunction, especially in light of the impending potential FDA approval and launch
`
`of Defendants’ biosimilar products, necessitate expeditious service. Numerous courts have
`
`authorized service on foreign defendants via email to U.S. counsel in analogous situations.
`
`STATEMENT OF FACTS
`
`Regeneron invented, developed, and sells EYLEA®, the market-leading treatment for
`
`several serious eye diseases. See Celltrion Compl. ¶ 2. Defendants are each in the process of
`
`seeking approval to commercialize a biosimilar of EYLEA® in the United States. A brief
`
`recitation of Regeneron’s interactions with each, conducted entirely with or through Defendants’
`
`U.S. counsel, follows.
`
`Celltrion
`
`On June 30, 2023, Celltrion—a company organized under the laws of the Republic of
`
`Korea—publicly announced that it had applied for approval from the FDA to commercialize
`
`“CT-P42,” a biosimilar of EYLEA®. See id. ¶ 3. In September 2023, Celltrion provided
`
`Regeneron with a copy of its abbreviated Biologics License Application or “aBLA” for CT-P42
`
`4
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 10 of 23 PageID #: 3697
`
`
`
`and later provided its notice of commercial marketing, indicating its intent to begin marketing
`
`and selling the biosimilar immediately upon receiving approval from the FDA. See id. ¶¶ 23, 25.
`
`Because Celltrion’s submission of its aBLA constitutes an act of patent infringement under 35
`
`U.S.C. § 271(e), Regeneron filed the above-captioned action for patent infringement to obtain
`
`relief before Celltrion launches CT-P42 in the United States.
`
`Regeneron has been in communication with Celltrion’s U.S. counsel since September
`
`2023 as the parties followed the “patent dance” 2 procedures of the BPCIA and prepared for this
`
`litigation. See Celltrion Compl. ¶ 2. All of Regeneron’s contact with Celltrion about its aBLA
`
`has occurred through its U.S. counsel, Gemini. In early November, prior to the filing of the
`
`complaint, counsel for Regeneron reached out to Celltrion’s U.S. counsel to discuss a proposed
`
`preliminary injunction schedule and confidentiality agreement to govern this infringement
`
`litigation. Counsel for Celltrion responded and acknowledged they were aware Regeneron
`
`planned to file an action. Shortly thereafter, on November 8, 2023, Regeneron filed its
`
`complaint, and the same day Regeneron’s counsel emailed Gemini a copy of the complaint and
`
`requested that they confirm whether they would accept service of process on behalf of Celltrion.
`
`When Celltrion’s counsel failed to respond, Regeneron followed up two days later, and on
`
`November 13, Gemini “agree[d] to accept service of the complaint on behalf of Celltrion”
`
`provided Regeneron agreed to an extension of Celltrion’s time to respond. Ex. A (Nov. 13, 2023
`
`Email from A. Zalcenstein to P. Patel).
`
`In the weeks that followed, Celltrion’s U.S. counsel continued to discuss the preliminary
`
`injunction schedule with Regeneron, and the parties traded drafts of a proposed stipulated
`
`
`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).
`
`5
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 11 of 23 PageID #: 3698
`
`
`
`preliminary injunction schedule. In every iteration of the draft stipulation, counsel for Celltrion
`
`agreed to accept service of process.
`
`With the parties close to a final stipulation as to service and schedule, counsel for
`
`Regeneron requested a December 1 meet and confer. Celltrion’s counsel asserted they were
`
`unavailable, so Regeneron shared another set of proposed revisions via email and followed up on
`
`the meet-and-confer request. Counsel for Celltrion did not respond. A week later, counsel for
`
`Regeneron again requested a call to discuss the schedule and service issues, but counsel for
`
`Celltrion was again unavailable. Regeneron would not hear from Celltrion again until its
`
`December 19, 2023 meet and confer with all Defendants, during which Celltrion would no
`
`longer commit to accepting service. Prior to that meeting, Celltrion gave no indication that it
`
`might refuse service. Two days later, in a December 21 email from all Defendants (sent by
`
`Formycon’s counsel), Celltrion finally and conclusively retracted its earlier commitment and
`
`refused to accept service.
`
`Samsung Bioepis
`
`Bioepis—a company organized under the laws of the Republic of Korea—applied for
`
`approval from FDA to commercialize “SB15,” a biosimilar of EYLEA®. Regeneron filed its
`
`action for patent infringement to obtain relief before Bioepis launches SB15 in the United States
`
`under 35 U.S.C. § 271(e).
`
`Regeneron has been in communication with Bioepis’s U.S. counsel as the parties
`
`prepared for this litigation. All of Regeneron’s contact with Bioepis about its aBLA has
`
`occurred through Quinn Emanuel.
`
`On November 21, 2023, Regeneron filed the above-captioned action. The following day,
`
`Regeneron emailed Bioepis’s in-house legal counsel and Quinn Emanuel a copy of the complaint
`
`6
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 12 of 23 PageID #: 3699
`
`
`
`and docket entry and requested that they confirm whether Bioepis would agree to accept service
`
`by email. Having received no response whatsoever from Bioepis for more than two weeks,
`
`Regeneron’s counsel wrote to Quinn Emanuel again on December 8 in follow-up, again
`
`requesting confirmation that Quinn Emanuel would accept service on behalf of Bioepis.
`
`Nineteen days after Regeneron’s initial email, on December 11, Quinn Emanuel replied that
`
`counsel was unable to accept service of the complaint via email, citing concerns about Bioepis’s
`
`intended personal jurisdiction defense.
`
`The parties met and conferred on December 13. During the meet and confer, Quinn
`
`Emanuel asserted that it was reluctant to accept service because of concern that doing so might
`
`waive Bioepis’s ability to challenge the Court’s personal jurisdiction. To alleviate those
`
`concerns, on December 15, Regeneron provided caselaw confirming that acceptance of service
`
`would not threaten Bioepis’s right to contest personal jurisdiction and proposing a stipulation
`
`explicitly preserving Bioepis’s personal jurisdiction defense. Bioepis’s counsel nevertheless
`
`again refused to accept service.
`
`Formycon
`
`On June 29, 2023, Formycon—a company organized under German law—publicly
`
`announced that it had applied for approval from FDA to commercialize “FYB203,” a biosimilar
`
`of EYLEA®. See Formycon Compl. ¶¶ 3, 7. In August 2023, Formycon announced that FDA
`
`had accepted its aBLA for FYB203. See id. ¶ 4. Because Formycon’s submission of its aBLA
`
`constitutes an act of patent infringement under 35 U.S.C. § 271(e), Regeneron filed its action for
`
`patent infringement to obtain relief before Formycon launches FYB203 in the United States.
`
`Regeneron has been in communication with Formycon’s U.S. counsel, Jenner & Block,
`
`as the parties prepared for this litigation. All of Regeneron’s contact with Formycon about its
`
`7
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 13 of 23 PageID #: 3700
`
`
`
`aBLA has occurred through Jenner & Block. In early November, counsel for Regeneron reached
`
`out to Formycon’s U.S. counsel to discuss a proposed preliminary injunction schedule in
`
`anticipation of this infringement action. Formycon’s counsel responded that they had “discussed
`
`the issue with Formycon” and indicated they were aware Regeneron planned to file this action.
`
`Ex. C (Nov. 10, 2023 Email from S. Van Horn to T. Fletcher). In the ensuing days, the parties
`
`met and conferred via videoconference and communicated by email numerous times to discuss
`
`the preliminary injunction schedule.
`
`On November 29, 2023, Regeneron filed its complaint, and shortly thereafter
`
`Regeneron’s counsel emailed Jenner & Block a copy of the sealed complaint. Formycon’s
`
`counsel acknowledged receipt and a few days later, Regeneron’s counsel followed up, providing
`
`a further revision of the proposed preliminary injunction schedule and requesting confirmation
`
`that Jenner & Block would accept service on Formycon’s behalf. When Jenner & Block failed to
`
`respond, counsel for Regeneron followed up again to request confirmation that Jenner & Block
`
`would accept service. Counsel for Formycon finally replied that they were “working through
`
`this issue with our client” and “[were] not in a position to accept service at this time.” Ex. B
`
`(Dec. 12, 2023 Email from S. Van Horn to A. Trask).
`
`In the days that followed, the parties continued to discuss the preliminary injunction
`
`schedule, but the service issue remained unresolved. As with Celltrion, Formycon’s U.S.
`
`counsel ultimately confirmed that it would not accept service via Defendants’ joint
`
`correspondence on December 21.
`
`*****
`
`8
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 14 of 23 PageID #: 3701
`
`
`
`Because Celltrion and Bioepis are Korean companies, and Formycon a German company,
`
`effectuating service through Rule 4(f)(2) would require the Hague Convention process.3 This
`
`would take a significant amount of time. For Celltrion and Bioepis, the Convention would
`
`require Regeneron first to transmit a request for service and each complaint (in English and
`
`Korean translation) to the Republic of Korea’s Director of International Affairs within the
`
`National Court Administration, the country’s designated “Central Authority.”4 The Korean
`
`Director of International Affairs would then send the request to a “competent court,” which in
`
`turn would serve Celltrion and Bioepis, respectively.5 Once the Korean court had served
`
`Celltrion and Bioepis, Regeneron would need to wait for the Korean central authority to send a
`
`certificate of service back to Regeneron. See Theodore J. Folkman, International Judicial
`
`Assistance § 2.3.4(d) (2012). As to Formycon, the Convention would require that Regeneron
`
`first transmit a request for service and the complaint (in English and German translation) to the
`
`President of the appropriate Regional Court,6 which would in turn attempt to effectuate service
`
`via the postal service, after which time Regeneron would need to wait for the return of a
`
`certificate of service from that Regional Court.
`
`
`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).
`
`9
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 15 of 23 PageID #: 3702
`
`
`
`In each case, the process is likely to take several months to complete, meaning that
`
`Defendants could potentially avoid service until mid-2024, when Regeneron’s regulatory
`
`exclusivity expires (on May 18, 2024).
`
`ARGUMENT
`
`I.
`
`Legal Standard
`
`The Federal Rules of Civil Procedure permit a Court to order service on a foreign
`
`corporation by any “means not prohibited by international agreement as may be directed by the
`
`court.” See Fed. R. Civ. P. 4(f)(3), (h)(2); see also Enovative Techs., LLC v. Leor, 622 F. App’x
`
`212, 214 (4th Cir. 2015) (quoting Fed. R. Civ. P. 4(f)(3)); 7 Williams v. Advert. Sex LLC, 231
`
`F.R.D. 483, 486-87 (N.D.W. Va. 2005) (same). This broad discretion is limited only by Due
`
`Process considerations, which require that the method of service be “reasonably calculated,
`
`under all the circumstances, to give notice to defendant.” Enovative Techs., 622 F. App’x at 214
`
`(internal quotations omitted). “Rule 4(f) does not denote any hierarchy or preference for one
`
`method of service over another,” Id., citing Rio Properties, Inc. v. Rio International Interlink,
`
`284 F.3d 1007, 1016 (9th Cir. 2002), and a plaintiff need not attempt to serve a foreign defendant
`
`abroad before seeking alternative service, see, e.g., In re OnePlus Tech. (Shenzhen) Co., Ltd.,
`
`2021 WL 4130643, at *3 (Fed. Cir. Sept. 10, 2021) (declining to find abuse of discretion by
`
`District Court in ordering service via email to U.S. counsel, notwithstanding that plaintiff had
`
`“made no showing that service under the Hague Convention had been tried and failed, would
`
`
`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.”)
`
`
`10
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 16 of 23 PageID #: 3703
`
`
`
`have been unlikely to succeed, or was otherwise impracticable”); see also Celgard, LLC. v.
`
`Shenzen Senior Tech. Material Co., 2020 WL 2575561, at *2 (W.D.N.C. May 21, 2020)
`
`(permitting service on foreign corporation via email to U.S. counsel despite Plaintiff not
`
`attempting service via Hague Convention).
`
`II.
`
`Regeneron Should Be Permitted to Serve Defendants by Email to their U.S. Counsel
`A.
`
`Service on U.S. Counsel Is Reasonably Calculated to Apprise Each
`Defendant of This Action and Satisfies Due Process
`
`The Court should permit service on Defendants through email service on their U.S.
`
`counsel, because doing so will ensure that each Defendant receives actual notice of the claims
`
`against it. Due Process requires that an ordered method of alternative service be “reasonably
`
`calculated, under all circumstances, to apprise interested parties of the pendency of the action
`
`and afford them an opportunity to present their objections.” Rio Properties, Inc., 284 F.3d at
`
`1016. This is consistent with the accepted “goal of Rule 4”—to provide actual notice. Hanna v.
`
`Plumer, 380 U.S. 460, 463 (1965) (“Actual notice is of course also the goal of Rule 4(d)(1)”);
`
`Moore v. K-Mart Corp., 1994 WL 824518, at n.2 (W.D. Va. Dec. 15, 1994) (“[T]he revised
`
`Federal Rules of Civil Procedure, Rule 4, indicates that actual notice is the goal of service of
`
`process.” (citing Fed. R. Civ. P. 4(d), (e), & (k))).
`
`Service through Defendants’ counsel is reasonably calculated to apprise them of this
`
`litigation because each Defendant already has actual notice of the litigation. Regeneron
`
`provided a copy of the complaint to each Defendant’s U.S. counsel via email weeks ago. That
`
`message, and indeed the filing of the complaints, occurred after months of regular and
`
`substantive communication and negotiation with each Defendant through U.S. counsel. It strains
`
`credulity to suggest that any Defendant has not been made aware of the litigation by that same
`
`counsel; no Defendant has ever asserted otherwise. At a minimum, each Defendant has
`
`11
`
`

`

`Case 1:23-cv-00089-TSK Document 43-1 Filed 12/22/23 Page 17 of 23 PageID #: 3704
`
`
`
`necessarily been apprised of the suit by their U.S. counsel to the extent necessary to