Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 1 of 30 PageID #: 3899
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`REGENERON PHARMACEUTICALS, INC.
`
`Plaintiff,
`
`v.
`
`CELLTRION, INC.,
`
`Defendant.
`
`
`
`
`CIVIL CASE NO. 1:23-CV-89
`Judge Kleeh
`
`
`JURY TRIAL DEMANDED
`
`MEMORANDUM IN SUPPORT OF MOTION TO DISMISS FOR LACK OF
`PERSONAL JURISDICTION, OR ALTERNATIVELY, TO TRANSFER VENUE
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 2 of 30 PageID #: 3900
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`
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`TABLE OF CONTENTS
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`INTRODUCTION ...........................................................................................................................1
`STATEMENT OF FACTS ..............................................................................................................3
`ARGUMENT ...................................................................................................................................6
`I.
`The Court Should Dismiss All of Plaintiff’s Claims Under Rule 12(b)(2) .........................6
`A.
`Rule 12(b)(2) Legal Standard ..................................................................................6
`B.
`This Court Lacks Personal Jurisdiction Over Celltrion ...........................................8
`1.
`This Court Lacks General Jurisdiction Over Celltrion ................................8
`2.
`This Court Lacks Specific Jurisdiction Over Celltrion ................................9
`3.
`It Would Offend Traditional Notions of Fair Play and Substantial Justice
`to Subject Celltrion to Personal Jurisdiction in West Virginia ..................13
`Federal Rule of Civil Procedure 4(k)(2) does not apply ............................15
`4.
`In the Alternative, the Court Should Transfer This Case to Delaware Pursuant to 28
`U.S.C. § 1404(a) ................................................................................................................16
`A.
`28 U.S.C. § 1404(a) Legal Standard ......................................................................16
`B.
`Numerous Factors Strike in Favor of Trial in Delaware ........................................17
`The Discretionary Factors Considered by This Court Weight In Favor of
`1.
`Transfer. .....................................................................................................17
`Based on Regeneron’s Strategic Legal Maneuvers, the Consideration of
`Guarding Against Forum Shopping Weighs Heavily in Favor of Transfer.
`....................................................................................................................20
`CONCLUSION ..............................................................................................................................23
`
`
`II.
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`2.
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 3 of 30 PageID #: 3901
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`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Acorda Therapeutics Inc. v. Mylan Pharms. Inc.,
`817 F.3d 755 (Fed. Cir. 2016)............................................................................................11, 14
`
`In re: Aflibercept Patent Litgiation,
`MDL No, 3103 (JPML 2024) ....................................................................................................6
`
`In re Air Crash Over Hudson River Near New York, New York,
`716 F. Supp. 2d 1360 (J.P.M.L. 2010) .....................................................................................23
`
`Apple Inc. v. Zipit Wireless, Inc.,
`30 F.4th 1368 (Fed. Cir. 2022) ................................................................................................13
`
`Autogenomics, Inc. v. Oxford Gene Tech. Ltd.,
`566 F.3d 1012 (Fed. Cir. 2009)..................................................................................................6
`
`Avocent Huntsville Corp. v. Aten Int’l Co.,
`552 F.3d 1324 (Fed. Cir. 2008)..................................................................................................9
`
`In re: Best Buy Co., Inc., California Song-Beverly Credit Card Act Litig.,
`804 F. Supp. 2d 1376 (J.P.M.L. 2011) .....................................................................................22
`
`Beverly Hills Fan Co. v. Royal Sovereign Corp.,
`21 F.3d 1558 (Fed Cir. 1994)...................................................................................................12
`
`Burger King Corp. v. Rudzewicz,
`471 U.S. 462 (1985) ...............................................................................................................7, 8
`
`Celgard, LLC v. SK Innovation Co.,
`792 F.3d 1373 (Fed. Cir. 2015)..................................................................................................7
`
`In re Celotex Corp.,
`124 F.3d 619 (4th Cir. 1997) .....................................................................................................7
`
`Daimler AG v. Bauman,
`571 U.S. 117 (2014) ...................................................................................................................8
`
`Eclipse IP, LLC v. ECCO USA, Inc.,
`No. 5:12CV160, 2013 WL 5838675 (N.D.W. Va. Oct. 30, 2013) .......................14, 18, 19, 20
`
`In re Genentech, Inc.,
`566 F.3d 1338 (Fed. Cir. 2009)................................................................................................19
`
`Goodyear Dunlop Tires Operations, S.A. v. Brown,
`564 U.S. 915 (2011) ...................................................................................................................9
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`- 2 -
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 4 of 30 PageID #: 3902
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`
`
`Hanson v. Denckla,
`357 U.S. 235 (1958) ...................................................................................................................8
`
`Info. Prot. & Authentication of W. Virginia, LLC v. McAfee, Inc.,
`No. CIV.A. 1:09CV76, 2009 WL 3672861 (N.D.W. Va. Oct. 30, 2009) ....................... passim
`
`International Shoe Co. v. Washington,
`326 U.S. 310 (1945) .............................................................................................................7, 13
`
`Keith Nicholson Servs., LLC v. Am. Petroleum Partners Operating, LLC,
`No. 5:19-CV-205, 2019 WL 4580046 (N.D.W. Va. Sept. 20, 2019) ......................................17
`
`Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach,
`523 U.S. 26 (1998) ...................................................................................................................22
`
`Marcinkowska v. IMG Worldwide, Inc.,
`342 F. App’x 632 (Fed. Cir. 2009) ............................................................................................8
`
`In re Michaels Stores, Inc. Pin Pad Litig.,
`844 F. Supp. 2d 1368, 2012 WL 432605 (J.P.M.L. Feb. 7, 2012) ..........................................23
`
`Patent Rights Prot. Grp., LLC v. Video Gaming Techs., Inc.,
`603 F.3d 1364 (Fed. Cir. 2010)................................................................................................14
`
`Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc.,
`148 F.3d 1355 (Fed. Cir. 1998)..................................................................................................6
`
`Regeneron Pharmaceuticals, Inc. v. Amgen Inc.,
`C.A. No. 2:24-cv-00264 (Jan. 1, 2024) ..............................................................................21, 22
`
`Stover v. O’Connell Assocs., Inc.,
`84 F.3d 132 (4th Cir. 1996) .......................................................................................................8
`
`Synthes (U.S.A.) v. G.M. Dos Reis Jr. Ind. Com de Equip. Medico,
`563 F.3d 1285 (Fed. Cir. 2009)................................................................................................16
`
`Teva Pharms. USA, Inc. v. Mylan Pharms., Inc.,
`No. 1:17CV7, 2017 WL 958324 (N.D.W. Va. Mar. 10, 2017) .........................................17, 18
`
`Touchcom, Inc. v. Bereskin & Parr,
`574 F.3d 1403 (Fed. Cir. 2009)................................................................................................16
`
`Trustees of the Plumbers and Pipefitters Nat’l Pension Fund v. Plumbing Servs.,
`791 F.3d 436 (4th Cir. 2015) ...................................................................................................17
`
`World–Wide Volkswagen Corp. v. Woodson,
`444 U.S. 286 (1980) ...................................................................................................................8
`
`- 3 -
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 5 of 30 PageID #: 3903
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`Statutes
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`28 U.S.C. § 1404(a) .......................................................................................................................17
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`Other Authorities
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`JPML Rule 2.1(d)...........................................................................................................................22
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 6 of 30 PageID #: 3904
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`INTRODUCTION
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`This patent infringement action has no connection to West Virginia. It concerns (1) a New
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`York plaintiff who is seeking remedies from a Korean defendant in a West Virginia court regarding
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`a product that has yet to be marketed, (2) future acts of alleged infringement that may be committed
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`by a distributor incorporated in Delaware, and (3) past acts of alleged infringement that occurred
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`outside of West Virginia. Regeneron Pharmaceuticals Inc. (“Regeneron” or “Plaintiff”) sued
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`Celltrion, Inc. (“Celltrion” or “Defendant”) in this district based on the filing of Celltrion’s
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`abbreviated Biologics Drug Application (“aBLA”) with the FDA on June 29, 2023, through which
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`Celltrion seeks approval for an aflibercept biosimilar. Under Acorda, the Federal Circuit case that
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`all parties agree is controlling here, Celltrion does not have sufficient contacts with West Virginia
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`that put it within the reach of this Court’s jurisdiction. Celltrion’s headquarters and operations are
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`outside of West Virginia (and this country), it has no employees or offices in the state, it is not
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`registered to do business in the state, and it has never been a party to litigation or accepted
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`jurisdiction in West Virginia. Celltrion will also never sell any aflibercept products in the United
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`States.
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`Notably, Regeneron chose not to sue Celltrion USA, Inc. (“Celltrion USA”), the distributor
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`that is and will be solely responsible for offering to sell, and selling Celltrion’s aflibercept product
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`in the United States. Before filing its complaint, Regeneron knew this but purposefully chose not
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`to sue Celltrion USA. Why? Because Celltrion USA cannot be sued in West Virginia under the
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`patent venue statute: Celltrion USA is a corporation organized and existing under the laws of the
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`State of Delaware with its principal place of business in Jersey City, New Jersey.
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`Plaintiff has also sued other foreign corporations for patent infringement in this Court,
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`based on the allegation that they have also filed aBLAs for their own respective biosimilars. Like
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`Celltrion, those defendants have also made clear to Regeneron that they will not be selling
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`1
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 7 of 30 PageID #: 3905
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`aflibercept in the United States and have their own commercial partners that will be responsible
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`for this task. Those commercial partners are also notably absent from the case, as they too cannot
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`be sued for patent infringement in this Court under the venue statute. But like Celltrion USA, those
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`commercial partners are also incorporated in Delaware and could be gathered there into one
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`efficient proceeding.
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`More recently, Regeneron sued Amgen in California, where Amgen is headquartered, but
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`immediately moved to bring the case to West Virginia under the multi-district litigation statute.
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`Notably, Amgen, like Celltrion’s and the other defendants’ respective marketing partners, is also
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`incorporated in Delaware and can be sued there.
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`Given the availability of Delaware as an incontestable, efficient venue for these suits, why
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`has Regeneron exerted itself to avoid bringing suit there? The clear answer is that Plaintiff
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`strategically chose to pursue its suits in this Court (1) knowing that the Delaware judges—who are
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`among the most experienced in biosimilar patent litigation—have repeatedly declined to award the
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`extraordinary relief of a preliminary injunction in biosimilar cases just like this one, and (2) hoping
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`that the Court would view its claims more favorably after its narrow victory in the Mylan litigation.
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`That is blatant forum shopping.1
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`Despite Regeneron’s improper forum shopping, under the applicable case law and Federal
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`Rules of Civil Procedure, Celltrion—and the rest of this amalgam of very foreign defendants—do
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`not belong in West Virginia. Pursuant to Rule 12(b)(2), and under Acorda, this action against
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`1 To be clear, Celltrion is confident that, regardless of the forum, the evidence will show that Celltrion has not
`infringed, and will not infringe, any valid patent claims of Regeneron’s, and that Regeneron cannot come close to
`meeting its burden to establish that it is entitled to the extraordinary relief of a preliminary injunction, i.e., that it
`would suffer irreparable harm absent such relief. In fact, over one hundred claims across numerous patents directed
`to EYLEA® dosing regimens and formulations have already been invalidated by this Court, held unpatentable by
`the PTAB, or voluntarily surrendered by Regeneron in just the past year. And the formulation claims previously
`upheld by this Court are invalid in view of prior art that has not yet been presented to this Court.
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`2
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 8 of 30 PageID #: 3906
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`Celltrion should be dismissed for lack of personal jurisdiction. General and specific personal
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`jurisdiction over Celltrion would be improper because of Celltrion’s complete lack of contacts
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`with the state of West Virginia. Celltrion does not sell, offer to sell, market, or distribute CT-P42
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`in West Virginia; Celltrion is not licensed to do business in West Virginia; all of Celltrion’s
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`manufacturing activities for CT-P42 have and will continue to take place outside of the United
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`States; and Celltrion has never litigated in West Virginia. Further, Rule 4(k)(2) does not apply
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`because, for purposes of this dispute, Celltrion could be subject to specific personal jurisdiction
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`in, e.g., Delaware by virtue of its relationship with its commercial partner. Thus, this case should
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`be dismissed. In the alternative, under 28 U.S.C. § 1404(a), the case should be transferred to
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`Delaware, which is more convenient and appropriate given that district’s proximity to crucial
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`witnesses and vital documents, its local interest in a dispute involving its corporate citizens, and
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`given the enormous judicial efficiencies to be gained by having all defendants proceed in a single
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`court that has jurisdiction over all of the claims and parties.
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`For these reasons, Celltrion’s motion to dismiss for lack of personal jurisdiction, or
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`alternatively, to transfer venue, should be granted.
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`STATEMENT OF FACTS
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`In response to worldwide need, Celltrion has been committed to promoting the health and
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`well-being of patients at an affordable cost for over twenty years. Declaration of Dongik Shin
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`(“Shin Decl.”) at ¶ 3. Celltrion is a global biopharmaceutical company that focuses on the research,
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`development, and manufacture of high quality biosimilars and novel biopharmaceuticals. Id. at ¶
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`3. Its biosimilar medicines are available in approximately 110 countries around the world. Id. In
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`furtherance of its goal to make life-changing medicines accessible to all, Celltrion filed aBLA No.
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`761377 seeking approval to market CT-P42 with the FDA on June 29, 2023. Id. at ¶ 4. The active
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`3
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 9 of 30 PageID #: 3907
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`ingredient in CT-P42 is aflibercept and it is a proposed biosimilar to Regeneron’s EYLEA®
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`product. Id.
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`Defendant Celltrion is a corporation organized and existing under the laws of the Republic
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`of Korea with its principal place of business located in Incheon, Korea. Id. at ¶ 2. It does not have
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`any employees in West Virginia. Id. at ¶ 6. Nor does it own, lease, or operate any offices or other
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`facilities in West Virginia. Id. Celltrion does not design, manufacture, sell, or offer to sell any drug
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`product in the United States. Id. at ¶ 7. Celltrion does not ship any drug products to West Virginia,
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`nor does it conduct any marketing or advertising in, or directed toward, West Virginia. Id.
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`Celltrion USA—which is not a party to this lawsuit—is and will be solely responsible for
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`offering to sell, and selling Celltrion’s aflibercept products in the United States. Id. at ¶ 9. It is, in
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`other words, Celltrion’s commercial partner and distributor of Celltrion’s aflibercept product.
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`Celltrion USA is a corporation organized and existing under the laws of the State of Delaware with
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`its principal place of business in Jersey City, New Jersey. Id. at ¶ 10. Following the merger of
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`Celltrion with Celltrion Healthcare Co. Ltd. on December 28, 2023—after the complaint against
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`Celltrion was filed—nonparty Celltrion USA became a wholly owned subsidiary of Celltrion. Id.
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`at ¶ 15. Celltrion USA does not have any employees in West Virginia. Id. at ¶ 18. Nor does it own,
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`lease, or operate any offices or other facilities in West Virginia. Id. at ¶ 19.
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`On November 8, 2023, Regeneron—a corporation incorporated and with its principal place
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`of business in New York—sued Celltrion in the Northern District of West Virginia for patent
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`infringement, on the basis of Celltrion’s filing aBLA No. 761377 for CT-P42. See Compl. ¶ 5.
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`Plaintiff alleges that this Court possesses personal jurisdiction over Celltrion because “Celltrion
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`intends to—by itself or through others—market, distribute, offer for sale, and/or sell [CT-P42] in
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`the United States, including in the State of West Virginia.” Id. ¶ 17. Plaintiff further alleges that
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`4
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 10 of 30 PageID #: 3908
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`alternatively, this Court has personal jurisdiction over Celltrion, Inc. on the basis of Celltrion’s
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`other biosimilar activities unrelated to EYLEA® and CT-P42, “because it does business in West
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`Virginia, either directly or indirectly.” Id. ¶ 18. Finally, Plaintiff alleges that “[a]lternatively, this
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`Court has personal jurisdiction over Celltrion pursuant to Federal Rule of Civil Procedure 4(k)(2).”
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`Id. ¶ 19. However, neither the actual facts at the time of filing, nor Plaintiff’s allegations if accepted
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`as true, are sufficient to establish personal jurisdiction. At a minimum, in view of the facts
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`referenced above, the case should be transferred to Delaware.
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`In addition to Celltrion, at least three other corporations have filed aBLAs for aflibercept
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`biosimilar products, of which two are foreign corporations (Formycon AG (“Formycon”) and
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`Samsung Bioepis Co., Ltd. (“Samsung”)) and one domestic (Amgen Inc. (“Amgen”)). Formycon
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`is a company organized and existing under the laws of Germany, with its principal place of
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`business located in Germany. Samsung is a company organized and existing under the laws of the
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`Republic of Korea with its principal place of business located in the Republic of Korea. Samsung’s
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`distributor of its aflibercept product, Biogen Inc. (“Biogen”),2 is a Delaware company with its
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`principal place of business in Massachusetts.3 Formycon’s distributor of its aflibercept product,
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`Coherus BioSciences, Inc. (“Coherus”),4 is a Delaware company with its principal place of
`
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`2 Biogen News Release, FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS®
`Biosimilar (ranibizumab-nuna) (Sept. 20, 2021), https://investors.biogen.com/news-releases/news-release-
`details/fda-approves-samsung-bioepis-and-biogens-byooviztm-
`sb11#:~:text=Samsung%20Bioepis%20and%20Biogen%20entered,)%20vi%2C%20in%20November%202019.
`3 Biogen Inc., Annual Report (Form 10-K) (Dec. 31, 2016),
`https://www.sec.gov/Archives/edgar/data/875045/000087504517000009/biib-20161231x10k.htm
`4 Formycon AG In Ad-Hoc Releases, Formycon Announces Binding Term Sheet Between Klinge Biopharma and
`Coherus BioSciences For the Exclusive Commercialization of FYB203, A Biosimilar Candidate to Eylea®1, in the
`United States (Jan. 9, 2023), https://www.formycon.com/en/blog/press-release/formycon-announces-binding-term-
`sheet-between-klinge-biopharma-and-coherus-biosciences-for-the-exclusive-commercialization-of-fyb203-a-
`biosimilar-candidate-to-eylea1-in-the-united-states/
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`5
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 11 of 30 PageID #: 3909
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`business in California.5 Amgen, a Delaware company with its principal place of business in
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`California, has also filed an aBLA for an aflibercept biosimilar product.
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`Subsequent to the lawsuit filed against Celltrion, Regeneron also sued Formycon and
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`Samsung in West Virginia for patent infringement. In those complaints, Plaintiff alleged similar
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`claims that jurisdiction and venue were proper in West Virginia. But on January 10, 2024, after
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`this Court entered its Order setting a schedule, Regeneron sued Amgen in California for patent
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`infringement. Notably, Regeneron did not sue Amgen in West Virginia given Amgen’s Delaware
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`incorporation and principal place of business in California. Instead, Regeneron sought to bring
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`Amgen within the ambit of this Court by filing, with the United State Judicial Panel on
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`Multidistrict Litigation (the “JPML”), a Motion to Transfer its California action against Amgen to
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`this Court. See In re: Aflibercept Patent Litigation, MDL No, 3103, ECF No. 1 (JPML 2024). The
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`JPML has not adjudicated that transfer motion, however, it has denied Regeneron’s request to
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`expedite consideration of that motion. The one common theme is that none of these defendants has
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`any connection to West Virginia.
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`ARGUMENT
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`I.
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`The Court Should Dismiss All of Plaintiff’s Claims Under Rule 12(b)(2)
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`A.
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`Rule 12(b)(2) Legal Standard
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`Federal Circuit law is to be applied in patent cases on the issue of jurisdiction. See Red
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`Wing Shoe Co. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355, 1358 (Fed. Cir. 1998) (“This court
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`applies the law of the Federal Circuit, rather than that of the regional circuits, to determine personal
`
`jurisdiction in a patent infringement case.”); Autogenomics, Inc. v. Oxford Gene Tech. Ltd., 566
`
`F.3d 1012, 1016 (Fed. Cir. 2009) (“Personal jurisdiction is a question of law that we review de
`
`
`5 Coherus BioSciences, Inc., Annual Report (Form 10-K) (Dec. 31, 2022),
`https://www.sec.gov/Archives/edgar/data/1512762/000155837023002917/chrs-20221231x10k.htm
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`6
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 12 of 30 PageID #: 3910
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`novo. (citations omitted) ‘Moreover, we apply Federal Circuit law because the jurisdictional issue
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`is ‘intimately involved with the substance of the patent laws.’” (citations omitted) ‘Under
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`[jurisdictional] circumstances such as these, we have held we owe no special deference to regional
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`circuit law.’”).
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`The Federal Circuit’s “determination of whether a defendant is subject to specific personal
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`jurisdiction in the forum state involves two inquiries: first, whether the forum state’s long-arm
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`statute permits service of process and, second, whether the assertion of jurisdiction is consistent
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`with due process.” Celgard, LLC v. SK Innovation Co., 792 F.3d 1373, 1377 (Fed. Cir. 2015)
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`(citing Elecs. for Imaging, Inc. v. Coyle, 340 F.3d 1344, 1349 (Fed. Cir. 2003)). “Because the West
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`Virginia long-arm statute is coextensive with the full reach of due process (citation omitted), it is
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`unnecessary [ ] to go through the normal two-step formula for determining the existence of
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`personal jurisdiction (citations omitted). Rather, the statutory inquiry necessarily merges with the
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`Constitutional inquiry.” In re Celotex Corp., 124 F.3d 619, 627–28 (4th Cir. 1997).
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`A court’s exercise of personal jurisdiction over a non-resident defendant is consistent with
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`the Due Process Clause if the defendant has sufficient “minimum contacts” with the forum such
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`that requiring the defendant to defend its interests in the forum does not “offend ‘traditional notions
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`of fair play and substantial justice.’” International Shoe Co. v. Washington, 326 U.S. 310, 316
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`(1945) (quoting Milliken v. Meyer, 311 U.S. 457, 463 (1940)). Later cases have clarified that the
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`minimum contacts must be “purposeful.” Burger King Corp. v. Rudzewicz, 471 U.S. 462, 474
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`(1985). This “purposeful” requirement rests on the basic premise that traditional notions of fair
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`play and substantial justice are offended by requiring a non-resident to defend itself in a forum
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`when the non-resident never purposefully availed itself of the privilege of conducting activities
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`within the forum, thus never invoking the benefits and protections of its laws. See Hanson v.
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`7
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 13 of 30 PageID #: 3911
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`Denckla, 357 U.S.
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`235,
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`253
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`(1958); Stover
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`v. O’Connell
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`Assocs.,
`
`Inc.,
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`84 F.3d 132, 136 (4th Cir. 1996). Moreover, this “purposeful” requirement helps ensure that non-
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`residents have fair warning that a particular activity may subject them to litigation within the
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`forum. See Burger King, 471 U.S. at 472; see also World–Wide Volkswagen Corp. v. Woodson,
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`444 U.S. 286, 297 (1980).
`
`“Personal jurisdiction over an out-of-state defendant takes the character of either ‘general’
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`or ‘specific.’ ‘Specific’ jurisdiction means that a cause of action arises out of or is related to a
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`defendant’s activities in the forum state. ‘General’ jurisdiction arises from a defendant’s
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`‘continuous and systematic’ activities in the forum state.” Marcinkowska v. IMG Worldwide, Inc.,
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`342 F. App’x 632, 635 (Fed. Cir. 2009) (citing Helicopteros Nacionales de Colombia, S.A. v.
`
`Hall, 466 U.S. 408, 415–16 (1984)).
`
`B.
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`This Court Lacks Personal Jurisdiction Over Celltrion
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`1.
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`This Court Lacks General Jurisdiction Over Celltrion
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`This Court does not have general jurisdiction over Celltrion because it is not “at home” in
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`West Virginia. The “paradigm bases for general jurisdiction” where a corporation is “at home” are
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`“the place of incorporation and principal place of business.” Daimler AG v. Bauman, 571 U.S.
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`117, 137 (2014). Celltrion is not incorporated in West Virginia, and does not have its principal
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`place of business in West Virginia.
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`Regeneron suggests in its Complaint that this Court has general jurisdiction over Celltrion
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`because “Celltrion develops, manufactures, distributes, sells, and/or imports drug products for the
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`West Virginia market, including other biosimilar products … and because it does business in West
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`Virginia, either directly or indirectly” and that “[t]hese activities are so continuous and systematic
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`as to render Celltrion essentially at home in West Virginia.” Compl. ¶ 18. As an initial matter,
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`Celltrion has not manufactured, offered for sale, or marketed any drugs in West Virginia. Other
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`8
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 14 of 30 PageID #: 3912
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`companies, in particular Celltrion USA, Pfizer Inc., and Teva Pharmaceutical Industries Ltd., have
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`been responsible for marketing, advertising, offering to sell, selling, and distributing certain of
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`Celltrion’s now-marketed FDA approved products in the United States, including Vegzelma®
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`(bevacizumab-adcd), Yuflyma® (adalimumab-aaty), ZymfentraTM (infliximab-dyyb), Inflectra®
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`(infliximab-dyyb), Truxima® (rituximab-abbs), and Herzuma® (trastuzumab-pkrb).6 Regardless,
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`as a matter of law, manufacturing or selling goods in a state does not subject a party to general
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`jurisdiction there. See Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 927
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`(2011) (“Flow of a manufacturer’s products into the forum . . . may bolster an affiliation germane
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`to specific jurisdiction. . . . But ties serving to bolster the exercise of specific jurisdiction do not
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`warrant a determination that, based on those ties, the forum has general jurisdiction over a
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`defendant.”). For these reasons, and those discussed further below, Celltrion’s lack of contacts
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`with West Virginia falls far short of the requirement for being “so ‘continuous and systematic’ as
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`to render [it] essentially at home in the forum State.” Id. at 919; see infra pp. 9-11.
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`2.
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`This Court Lacks Specific Jurisdiction Over Celltrion
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`With respect to specific jurisdiction, the Federal Circuit employs a three-prong test, in
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`which it evaluates whether: “(1) the defendant purposefully directed its activities at residents of
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`the forum, (2) the claim arises out of or relates to those activities, and (3) assertion of personal
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`jurisdiction is reasonable and fair.” Avocent Huntsville Corp. v. Aten Int’l Co., 552 F.3d 1324,
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`1332 (Fed. Cir. 2008).
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`Regeneron has not sufficiently alleged and cannot demonstrate that Celltrion “purposefully
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`directed” its activities at residents of West Virginia. In its complaint, Regeneron alleges that
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`jurisdiction is proper because by virtue of having sought FDA approval for its aflibercept product,
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`6 Celltrion USA is responsible for Vegzelma®, Yuflyma®, and ZymfentraTM (infliximab-dyyb); Pfizer Inc. is
`responsible for Inflectra® (infliximab-dyyb), and Teva is responsible for Truxima® and Herzuma®.
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`9
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 15 of 30 PageID #: 3913
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`Celltrion seeks to “engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of CT-P42 in the United States, including in the State of West Virginia” and “intends
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`to—by itself or through others—market, distribute, offer for sale, and/or sell it in the United States,
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`including in the State of West Virginia.” Compl. ¶ 17. These conclusory allegations fail to establish
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`purposeful direction or availment with regard to West Virginia.
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`As an initial matter, as the declaration supporting this motion makes clear, Celltrion does
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`not and will not “engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of CT-P42,” or “market, distribute, offer for sale, and/or sell” the product, in West
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`Virginia. All manufacturing activities for CT-P42 have and will continue to take place outside of
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`the United States. Shin Decl. at ¶ 5. Celltrion does not sell, offer to sell, market, or distribute any
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`products in the United States, or ship products to West Virginia. Id. at ¶ 7. As it does for other
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`products (supra pp. 8-9), Celltrion uses a domestic corporation for the sale of CT-P42 in the United
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`States. In particular, nonparty Celltrion USA will be solely responsible for any marketing,
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`advertising, offers to sell, and sales of CT-P42 in the United States. Shin Decl. at ¶ 9.
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`Notably, Celltrion USA—a Delaware corporation with its principal place of business in
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`New Jersey, id. at ¶ 10—cannot be sued in West Virginia for the alleged acts of patent
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`infringement, since such a suit would lack proper venue under 28 U.S.C. § 1400(b). Without more,
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`the attenuated contacts that Regeneron alleges are insufficient to ascribe personal jurisdiction
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`under the law.
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`Regeneron has pointed to Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755
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`(Fed. Cir. 2016) to argue that a West Virginia court would have personal jurisdiction over
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`Celltrion. Dkt. 45, at 2. By claiming that “submitt[ing] an FDA application seeking approval to
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`market [a] biosimilar product nationwide” is “an act that confers personal jurisdiction in all fifty
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`10
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`Case 1:23-cv-00089-TSK Document 69 Filed 01/17/24 Page 16 of 30 PageID #: 3914
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`states,” Regeneron twists the true holding of Acorda in a way that offends due process and
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`important policies that disfavor forum shopping. Id. Regeneron ignores that the Acorda court relied
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`on a host of forum-specific contacts that are not present in this case. Additionally, Regeneron fails
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`to acknowledge that the Federal Circuit specifically addressed personal jurisdiction in the context
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`of claims for infringement under 35 U.S.C. § 271(e), which applies, at most, to less than half of
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`the claims here.
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`Per Regeneron’s illogical theory, any of the 94 United States district courts would have
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`personal jurisdiction over a drug c