`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`
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`Plaintiff,
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`
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
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`
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`
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`CELLTRION, INC.,
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`
`
`
`
`Defendant.
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`
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`Civil Action No. 1:23-cv-89-TSK
`
`
`
`Civil Action No. 1:23-cv-94-TSK
`
`
`
`Civil Action No. 1:23-cv-106-TSK
`
`
`Civil Action No. 1:23-cv-97-TSK
`
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`Plaintiff,
`
`v.
`
`
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`
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`Defendant.
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`Plaintiff,
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`SAMSUNG BIOEPIS, CO., LTD.,
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`
`
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`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`v.
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`SAMSUNG BIOEPIS, CO., LTD.,
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`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`
`FORMYCON AG,
`
`
`Defendant.
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`Plaintiff,
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`
`
`
`
`v.
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`1
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`Case 1:23-cv-00106-TSK Document 9-1 Filed 12/28/23 Page 2 of 4 PageID #: 3920
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`Defendant.
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`CASE MANAGEMENT AND SCHEDULING ORDER
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`Pursuant to Federal Rules of Civil Procedure 16(b) and 26(f) and the Local Rules of Civil
`
`Procedure and 42 U.S.C. § 262(l)(8)(C), the Court enters the following Case Management and
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`Scheduling Order.
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`WHEREAS Plaintiff Regeneron Pharmaceuticals, Inc. initiated this civil action with the
`
`filing of a Complaint against each of Defendants Samsung Bioepis Co., Ltd. (“Samsung”),
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`Celltrion, Inc. (“Celltrion”), and Formycon AG (“Formycon”) (the “Actions”);
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`WHEREAS the United States Food and Drug Administration is currently reviewing each
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`of Defendants’ Biologic License Applications seeking approval to market a biosimilar version of
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`Regeneron’s aflibercept (Defendant’s “Aflibercept aBLA”);
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`WHEREAS Regeneron commits not to file a motion for preliminary injunction on any
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`patents other than those identified pursuant to the schedule below;
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`WHEREAS the Parties shall reasonably cooperate to expedite these proceedings and
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`facilitate the Court’s resolution of the Parties’ disputes.
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`Event
`
`Deadline
`
`Regeneron delivers targeted requests for
`production
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`December 22, 2023 (completed)
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`Regeneron identifies no more than eight
`patents that may be included in a Motion for
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`Within two business days of the entry of this
`order.
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`2
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`
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`Case 1:23-cv-00106-TSK Document 9-1 Filed 12/28/23 Page 3 of 4 PageID #: 3921
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`Preliminary Injunction; Defendants deliver
`targeted requests for production
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`Regeneron makes initial production of
`documents
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`Within one business day of agreement by
`counsel for a Defendant to maintain such
`documents on an outside-attorney’s-eyes-only
`basis until a protective order has been entered.
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`Defendant’s deadline to answer or otherwise
`respond to the Complaint, e.g., by filing a
`motion for lack of personal jurisdiction and/or
`improper venue
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`January 12, 2024
`
`Defendant produces documents responsive to
`Regeneron’s requests
`
`January 26, 2024
`
`Regeneron completes production of
`documents related to preliminary injunction,
`including documents related to patents it may
`assert in preliminary injunction motion
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`February 2, 2024
`
`Regeneron identifies patents it may assert in
`preliminary injunction motion
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`February 2, 2024
`
`Regeneron to file opposition to any motion
`for lack of personal jurisdiction and/or
`improper venue
`
`Regeneron to file motion for preliminary
`injunction and single supportive
`memorandum against all Defendants in case
`Nos. 1:23-cv-89-TSK, 1:23-cv-94-TSK, 1:23-
`cv-97-TSK, and 1:23-cv-106-TSK.
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`February 19, 2024
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`February 22, 2024
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`Defendant may file a reply ISO motion for
`personal jurisdiction and/or improper venue
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`March 6, 2024
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`Depositions of any Regeneron declarants1
`complete
`
`Defendants in case Nos. 1:23-cv-89-TSK,
`1:23-cv-94-TSK, 1:23-cv-97-TSK, and 1:23-
`cv-106-TSK file single opposition to motion
`for preliminary injunction
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`March 13, 2024
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`March 21, 2024
`
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`1 The parties shall present any declarant for deposition in the continental United States.
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`3
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`
`
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`Case 1:23-cv-00106-TSK Document 9-1 Filed 12/28/23 Page 4 of 4 PageID #: 3922
`
`Deposition of Defendants’ declarants
`complete
`
`April 10, 2024
`
`Regeneron files single reply ISO preliminary
`injunction
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`April 18, 2024
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`Proposed hearing on Regeneron’s motion for
`preliminary injunction
`
`In-person status conference with lead counsel
`ahead of May 18, 2024 expiration of
`regulatory exclusivity
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`
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`_____________ [week of April 29, 2024]
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`May 13, 2024
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`To the extent that the Parties have any discovery disputes, such disputes will be resolved on an
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`expedited basis consistent with the principles outlined in 42 U.S.C. § 262(l)(8)(C).
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`SO ORDERED this ______ of January, 2024.
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`
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`________________________________________
`
`United States District Judge
`
`
`
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`4
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`
`
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