Case 1:23-cv-00089-TSK Document 66-1 Filed 01/11/24 Page 1 of 7 PageID #: 3883
`Case 1:23-cv-00089-TSK Document 66-1 Filed 01/11/24 Page 1of 7 PagelD #: 3883
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`EXHIBIT A
`EXHIBIT A
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`Case Pending No. 5 Document 1 Filed 01/11/24 Page 1 of 6Case 1:23-cv-00089-TSK Document 66-1 Filed 01/11/24 Page 2 of 7 PageID #: 3884
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`BEFORE THE UNITED STATES JUDICIAL PANEL
`ON MULTIDISTRICT LITIGATION
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`In re Aflibercept Patent Litigation
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`MDL No. ______________
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`MOTION OF PLAINTIFF FOR TRANSFER OF ACTION TO THE
`NORTHERN DISTRICT OF WEST VIRGINIA PURSUANT TO 28 U.S.C. § 1407
`FOR COORDINATED PRETRIAL PROCEEDINGS
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`Regeneron Pharmaceuticals, Inc. (“Regeneron”), by and through undersigned counsel,
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`respectfully moves the Judicial Panel on Multidistrict Litigation to enter an order pursuant to 28
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`U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Judicial Panel on Multidistrict
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`Litigation, transferring Regeneron Pharmaceuticals, Inc. v. Amgen Inc., C.A. No. 2:24-cv-00264,
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`currently pending in the United States District Court for the Central District of California (judge
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`not yet assigned), to Chief Judge Thomas S. Kleeh in the United States District Court for the
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`Northern District of West Virginia, for coordinated pretrial proceedings with the five cases filed
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`by Regeneron that are already pending before Chief Judge Kleeh in the Northern District of West
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`Virginia.
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`Transfer for pretrial coordination is proper and necessary for the following reasons, as set
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`forth more fully in the accompanying memorandum:
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`1.
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`Regeneron is the Plaintiff in six actions for patent infringement brought under the
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`patent laws of the United States, Title 35, United States Code, against six defendants:1
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`• Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. and Biocon
`Biologics Inc., C.A. No. 1:22-cv-00061 (N.D. W. Va.) (Kleeh, C.J.)
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`1 Mylan Pharmaceuticals Inc. (“Mylan”); Biocon Biologics Inc. (“Biocon”); Celltrion, Inc.
`(“Celltrion”); Formycon AG (“Formycon”); Samsung Bioepis Co. Ltd. (“Samsung”); and
`Amgen Inc. (“Amgen”) (collectively, “Defendants”).
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`1
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`• Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc.,
`C.A. No. 1:23-cv-00089 (N.D. W. Va.) (Kleeh, C.J.)
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`• Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis Co., Ltd.,
`C.A. No. 1:23-cv-00094 (N.D. W. Va.) (Kleeh, C.J.)
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`• Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis Co., Ltd.,
`C.A. No. 1:23-cv-00106 (N.D. W. Va.) (Kleeh, C.J.)
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`• Regeneron Pharmaceuticals, Inc. v. Formycon AG,
`C.A. No. 1:23-cv-00097 (N.D. W. Va.) (Kleeh, C.J.)
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`• Regeneron Pharmaceuticals, Inc. v. Amgen Inc.,
`C.A. No. 2:24-cv-00264 (C.D. Cal.) (judge not yet assigned)
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`This motion seeks coordination of these six actions by transferring the Amgen action to West
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`Virginia.
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`2.
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`Five of the six above-listed actions are pending before Chief Judge Kleeh in the
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`Northern District of West Virginia.
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`3.
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`In the sixth action, Regeneron sued Amgen Inc. in the Central District of California
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`(the “Amgen Action”); that case has not yet been assigned to a judge.
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`4.
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`All six actions arise out of Defendants’ filings of abbreviated Biologics License
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`Applications (“aBLAs”) with the United States Food and Drug Administration (“FDA”) seeking
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`approval to commercially manufacture, use, offer for sale, sell, or import biosimilar versions of
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`Regeneron’s Eylea® (aflibercept) product, prior to the expiration of patents owned by Regeneron.
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`Each action involves numerous asserted patents, 13 of which overlap across all six actions: U.S.
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`Patent Nos. 9,222,106; 9,254,338; 9,816,110; 10,130,681; 10,415,055; 10,464,992; 10,669,594;
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`10,888,601; 11,066,458; 11,084,865; 11,104,715; 11,253,572; and 11,306,135 (the “patents-in-
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`suit”).
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`5.
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`Each Defendant’s submission of its aBLA constitutes an act of patent infringement
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`under 35 U.S.C. § 271(e). Each Defendant has indicated that it disputes the validity and/or
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`infringement of all asserted patents and that it does not intend to await patent expiry to
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`commercialize its biosimilar product. Pursuant to 42 U.S.C. § 262(k)(7)(A), Defendants’ aBLAs
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`may be approved as soon as Eylea’s regulatory exclusivity expires on May 18, 2024.
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`6.
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`Regeneron filed the first of the above-listed actions, Regeneron Pharmaceuticals,
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`Inc. v. Mylan Pharmaceuticals Inc. and Biocon Biologics Inc. (the “Mylan Action”), in August
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`2022, after the FDA accepted Mylan’s aBLA filing and the parties completed the pre-suit
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`requirements set forth in 42 U.S.C. § 262(l). In June 2023, Chief Judge Kleeh presided over a
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`two-week bench trial involving the infringement and validity of three of Regeneron’s patents-in-
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`suit. The Court issued its post-trial decision on December 27, 2023, finding that one of
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`Regeneron’s patents-in-suit is valid and infringed by Mylan and Biocon.
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`7.
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`Regeneron filed suits against Celltrion, Formycon, and Samsung in the Northern
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`District of West Virginia in November 2023 after each sent notice letters to Regeneron indicating
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`that they would begin marketing and selling their respective biosimilar products upon receiving
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`approval from the FDA. 42 U.S.C. § 262(l)(8)(A). On December 27, 2023, Regeneron filed a
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`second suit against Samsung pursuant to 42 U.S.C. § 262(l)(6). On January 10, 2024, Regeneron
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`also filed a suit in the Central District of California against Amgen pursuant to 42 U.S.C.
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`§ 262(l)(6).
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`8.
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`All of the above-listed actions therefore involve the same core issue: whether, by
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`seeking approval of its Eylea biosimilar product, the Defendant has infringed and/or will infringe
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`any valid claim of Regeneron’s asserted patents.
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`9.
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`The above-listed actions present numerous common issues of fact and law,
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`including without limitation the technologies underlying the patents-in-suit; the prosecution
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`histories of the patents-in-suit; the proper construction of claim terms in the patents-in-suit; the
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`scope and content of the prior art; and any secondary indicia of non-obviousness associated with
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`the products embodying the patents-in-suit. The above-listed actions also present common issues
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`of fact and law with respect to issues of remedies, including injunctive relief.
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`10.
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`All of the above-listed actions except for the Mylan Action are in their earliest
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`stages. As of the filing of this motion, in all the actions other than the Mylan Action, only a single
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`scheduling conference has occurred, discovery is just beginning, and no substantive orders have
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`issued. On January 9, 2024, Chief Judge Kleeh issued an Order scheduling preliminary injunction
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`proceedings in the Celltrion, Formycon, and Samsung Actions, culminating in a combined
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`preliminary injunction hearing on May 2, 2024. That Order is attached as Exhibit 7 to this motion.
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`11.
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`In the Mylan Action, Regeneron provided extensive discovery as to six patents from
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`three patent families, and the Court issued a claim construction opinion on 12 claim terms of the
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`six patents and a decision following a two-week trial on 12 asserted claims from three of the
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`patents-in-suit. Four of the six patents construed by the Court in the Mylan Action are asserted in
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`all six actions.
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`12.
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`Regeneron intends to seek an injunction against each of the Defendants to prevent
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`them from marketing their proposed biosimilars before patent expiry in each of the above-listed
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`actions. As mentioned above, a preliminary injunction hearing has been scheduled for May 2,
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`2024, in four of the cases currently pending before Chief Judge Kleeh. Ex. 7. As the Mylan Action
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`has already proceeded to trial, Regeneron will seek permanent injunctive relief from Chief Judge
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`Kleeh in that case.
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`13.
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`Transfer and coordination of the above-listed action is necessary to: (a) eliminate
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`the potential for inconsistent rulings on pretrial motions, including but not limited to any claim
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`construction rulings; (b) eliminate the burden of duplicative discovery on common issues; (c) avoid
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`the unnecessary use of judicial resources; and (d) reduce the overall costs and burdens for all of
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`the parties.
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`14.
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`Because each of the above-listed actions asserts infringement through the
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`submission of an aBLA, the effect of having inconsistent rulings regarding FDA procedures, claim
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`construction, injunctions, validity, and aBLA-based infringement would be significant,
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`deleterious, and an unnecessary strain on judicial resources.
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`15.
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`Chief Judge Kleeh is already familiar with the issues in these cases, having presided
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`over more than a year of litigation and two weeks of trial in the Mylan Action, culminating in a
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`313-page opinion issued on December 27, 2023. The Court does not currently have any other
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`multidistrict litigations on its docket.
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`Based on the foregoing, Regeneron respectfully requests that the action against Amgen Inc.
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`pending in the Central District of California, Regeneron Pharmaceuticals, Inc. v. Amgen Inc., C.A.
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`No. 2:24-cv-00264, be transferred to Chief Judge Kleeh in the Northern District of West Virginia
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`for coordinated pretrial proceedings with the five other cases filed by Regeneron that are already
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`pending in that District.
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`Dated: January 11, 2024
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`OF COUNSEL:
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`Elizabeth S. Weiswasser
`Anish R. Desai
`Natalie C. Kennedy
`Tom Yu
`Yi Zhang
`Kathryn Leicht
`Rocco Recce
`Zhen Lin
`Kellie Van Beck
`WEIL GOTSHAL & MANGES LLP
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`WILLIAMS & CONNOLLY LLP
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`/s/ David I. Berl_________
`David I. Berl
`Ellen E. Oberwetter
`Thomas S. Fletcher
`Andrew V. Trask
`Teagan J. Gregory
`Shaun P. Mahaffy
`Kathryn S. Kayali
`Arthur J. Argall III
`Adam Pan
`Rebecca A. Carter
`Haylee N. Bernal Anderson
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`Case Pending No. 5 Document 1 Filed 01/11/24 Page 6 of 6Case 1:23-cv-00089-TSK Document 66-1 Filed 01/11/24 Page 7 of 7 PageID #: 3889
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`Renee M. Griffin
`Jennalee Beazley*
`680 Maine Avenue, SW
`Washington, DC 20024
`Tel.: (202) 434-5000
`Fax: (202) 434-5029
`dberl@wc.com
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`*Admitted only in Pennsylvania; practice
`Supervised by D.C. Bar members
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`
`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`
`767 5th Avenue
`New York, NY 10153
`(212) 310-8000
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`Christopher M. Pepe
`Priyata Y. Patel
`Matthew Sieger
`WEIL GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`(202) 682-7000
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`Andrew E. Goldsmith
`Jacob E. Hartman
`Evan T. Leo
`Mary Charlotte Y. Carroll
`Sven E. Henningson
`KELLOGG, HANSEN, TODD, FIGEL
`& FREDERICK, P.L.L.C.
`1615 M Street, NW, Suite 400
`Washington, DC 20036
`(202) 326-7900
`
`Steven R. Ruby
`David R. Pogue
`Raymond S. Franks II
`CAREY DOUGLAS KESSLER & RUBY, PLLC
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25353
`(304) 345-1234
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`Tony Bisconti
`BIENERT KATZMAN LITTRELL WILLIAMS LLP
`903 Calle Amanecer, Suite 350,
`San Clemente, CA 92673
`(949) 369-3700
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