Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 1 of 8 PageID #: 4058
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`v.
`CELLTRION, INC.,
`
`
`
`Defendant.
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`v.
`SAMSUNG BIOEPIS CO., LTD.,
`Defendant.
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`v.
`FORMYCON AG,
`
`
`
`Defendant.
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`v.
`SAMSUNG BIOEPIS CO., LTD.,
`
`
`Defendant.
`
`
`
`Civil Action No. 1:23-cv-00089-TSK
`
`
`
`Civil Action No. 1:23-cv-00094-TSK
`
`
`
`
`
`
`
`Civil Action No. 1:23-cv-00097-TSK
`
`
`
`Civil Action No. 1:23-cv-00106-TSK
`
`
`
`
`
`DEFENDANTS CELLTRION, INC., SAMSUNG BIOEPIS CO., LTD.,
`AND FORMYCON AG’S EXPEDITED MOTION FOR STATUS CONFERENCE
`
`
`
`
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 2 of 8 PageID #: 4059
`
`
`Defendants Celltrion, Inc. (“Celltrion”), Samsung Bioepis Co., Ltd. (“SB”), and Formycon
`
`AG (“Formycon”) (collectively, the “PI Defendants”)1 jointly submit this Expedited Motion for
`
`Status Conference to address disputes that have arisen between the parties in interpreting the
`
`Court’s January 9, 2024 Order Setting Briefing Schedule on Motions to Dismiss and Setting
`
`Schedule for Preliminary Injunction Proceedings (ECF No. 61 in 1:23-CV-89, ECF No. 69 in Case
`
`No. 1:23-CV-94, ECF No. 45 in 1:23-CV-97, and ECF No. 40 in Case No. 1:23-CV-106) (“PI
`
`Scheduling Order”).2 The PI Defendants respectfully submit that the requested status conference
`
`could be held remotely, via teleconference or Zoom, if that is the Court’s preference.
`
`Briefly, the current disputes center on two issues: (1) whether Regeneron can file one
`
`omnibus preliminary injunction brief across its separate actions against SB, Celltrion, and
`
`Formycon; and (2) whether Regeneron may file declarations with its reply brief and, if so, whether
`
`the reply declarants must be made available for deposition. To address both issues, the PI
`
`Defendants prepared a proposed schedule and sent it to Regeneron last week. (See Ex. B.) That
`
`proposed schedule is attached to this Motion as Exhibit A. Regeneron thus far has not directly
`
`responded to this proposed schedule, but its subsequent emails have made clear it intends to
`
`continue to pursue its own interpretation of the existing schedule. (See, e.g., Ex. C.) Given the
`
`upcoming deadlines, the PI Defendants respectfully request that the Court schedule a status
`
`
`1 The PI Defendants’ counsel have appeared specially for the limited purpose of contesting
`jurisdiction and have already has filed their respective motions to dismiss pursuant to Fed. R. Civ.
`P. 12(b)(2). This brief, which is limited to procedural aspects of the case, is similarly being
`submitted to facilitate early and prompt resolution of the PI Defendants’ jurisdictional challenge.
`2 In the interest of efficiency, the PI Defendants have filed this identical motion in each of their
`respective actions.
`
`
`
`- 1 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 3 of 8 PageID #: 4060
`
`
`conference as soon as the Court’s schedule permits so that the parties can receive the Court’s
`
`guidance regarding these procedural issues.3
`
`I.
`
`REGENERON SHOULD FILE SEPARATE MOTIONS FOR PRELIMINARY
`INJUNCTION AGAINST ALL DEFENDANTS TO AVOID DISCLOSURE OF
`EACH PI DEFENDANT’S COMPETITIVELY-SENSITIVE INFORMATION
`
`The Court’s PI Scheduling Order provides that Regeneron is “to file motion(s) for
`
`preliminary injunction and supportive memoranda against all defendants.” (emphasis added). The
`
`PI Defendants understand this deadline to require Regeneron to file separate preliminary injunction
`
`motions against each of SB, Celltrion, and Formycon. This understanding is based, in part, on the
`
`fact that Regeneron’s emergency motion that led to the Court’s PI Scheduling Order had sought a
`
`schedule under which Regeneron would “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.” (ECF No. 45-1 in 1:23-CV-89, ECF No. 40-1 in Case
`
`No. 1:23-CV-94, ECF No. 33-1 in 1:23-CV-97, and ECF No. 9-1 in Case No. 1:23-CV-106.) But
`
`the Court’s PI Scheduling Order does not include Regeneron’s proposed language, opting instead
`
`to refer to “motion(s)” and “memoranda.”
`
`Regeneron nevertheless has insisted during the parties’ meet and confers that the Court’s
`
`PI Scheduling Order does not require separate motions against the three defendants, but rather that
`
`the PI Scheduling Order gives Regeneron the option, in its sole discretion, to decide how many
`
`motions it wishes to file. (Ex. B at 5.) That position is not only inconsistent with the Court’s PI
`
`
`3 Earlier today, Regeneron filed an Emergency Motion for Clarification of the Court’s January 9,
`2024 Order, which deals primarily with that Order’s upcoming deadlines related to the PI
`Defendants’ motions to dismiss for lack of personal jurisdiction. (ECF No. 95 in 1:23-CV-89,
`ECF No. 96 in Case No. 1:23-CV-94, ECF No. 80 in 1:23-CV-97, and ECF No. 77 in Case No.
`1:23-CV-106.) This Expedited Motion, in contrast, addresses the Court-ordered deadlines for the
`preliminary injunction briefing. The PI Defendants will separately respond to Regeneron’s
`Emergency Motion shortly.
`
`
`
`- 2 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 4 of 8 PageID #: 4061
`
`
`Scheduling Order, but it would also lead to an abuse of the protections surrounding the PI
`
`Defendants’ confidential information.
`
`To support its preliminary injunction motion against each PI Defendant, Regeneron will
`
`necessarily use highly confidential technical information related to each PI Defendant’s individual
`
`products in an effort to establish infringement. To argue irreparable harm, Regeneron will
`
`necessarily rely on highly sensitive commercial information related to each PI Defendant’s
`
`respective planned marketing, sales, and launch plans. The PI Defendants are direct competitors.
`
`Because Regeneron’s preliminary injunction motions are likely to involve some of their most
`
`sensitive information, such as their planned launch dates and specific product compositions, the
`
`PI Defendants want to ensure that this highly confidential information is not shared with their
`
`direct competitors. Consistent with these concerns, the parties’ earlier confidentiality agreements
`
`and the draft protective order the parties are negotiating preclude any party from using another
`
`party’s confidential information outside of their respective actions. By filing an omnibus
`
`preliminary injunction brief across four cases, Regeneron would violate those protections and use
`
`each PI Defendants’ confidential information across all of the actions. Additionally, to serve any
`
`such omnibus brief on the PI Defendants, Regeneron would have to either disclose each of the PI
`
`Defendants’ most sensitive confidential information to the others or redact huge swaths of
`
`information such that each defendant’s counsel cannot review the entirety of Regeneron’s opening
`
`preliminary injunction brief. The better solution is to require Regeneron to file separate motions
`
`for preliminary injunction, specific to each defendant, which is consistent with the Court’s PI
`
`Scheduling Order.
`
`
`
`- 3 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 5 of 8 PageID #: 4062
`
`
`II.
`
`IF REGENERON FILES REPLY DECLARATIONS, THE PI DEFENDANTS
`MUST HAVE AN OPPORTUNITY TO DEPOSE ANY DECLARANTS AND FILE
`A SUR-REPLY
`
`The Court’s PI Scheduling Order does not permit Regeneron to file any declarations with
`
`its replies in support of its preliminary injunction motions. While the Order specifically provides
`
`for deadlines for the depositions of Regeneron’s declarants in connection with the opening motions
`
`and the PI Defendants’ declarants in connection with their oppositions, the PI Scheduling Order is
`
`silent as to depositions of reply declarants, with the natural implication being that there will be no
`
`reply declarations.
`
`Even though reply declarations are not contemplated by the PI Scheduling Order,
`
`Regeneron has indicated its intent to submit them anyway.4 While disagreeing that Regeneron is
`
`entitled to any such declarations, in the interest of compromise, the PI Defendants have proposed
`
`a schedule that allows for reply declarations limited to the issue of validity, while providing the PI
`
`Defendants an opportunity to depose the reply declarants and submit a sur-reply in further
`
`opposition. To fit these additional events into the schedule, the PI Defendants have proposed to
`
`slightly move up some of the previous deadlines such that the proposed hearing date of May 2,
`
`2024 would not change.
`
`
`4 In correspondence between the parties and during the parties’ meet and confers, Regeneron has
`argued that it must be permitted to file reply declarations because the PI Defendants have not
`provided invalidity contentions for the preliminary injunction patents. This is a problem of
`Regeneron’s own making. As an initial matter, Regeneron did not propose a deadline for invalidity
`contentions when it submitted its proposal to the Court with its emergency motion for entry of a
`schedule for preliminary injunction proceedings. (ECF No. 45-1 in 1:23-CV-89, ECF No. 40-1 in
`Case No. 1:23-CV-94, ECF No. 33-1 in 1:23-CV-97, and ECF No. 9-1 in Case No. 1:23-CV-106.)
`Further, Regeneron has refused to identify the claims of the preliminary injunction patents it
`intends to assert in its preliminary injunction motion, and it has refused to provide infringement
`contentions for the asserted preliminary injunction claims. Without this information, the PI
`Defendants cannot provide their invalidity contentions.
`
`
`
`- 4 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 6 of 8 PageID #: 4063
`
`
`The PI Defendants’ proposal is fair. It gives each party one round of declarations for each
`
`of the issues to be presented in the preliminary injunction proceedings. Regeneron’s opening
`
`declarations would address alleged infringement and irreparable harm. The PI Defendants’
`
`responsive declarations in opposition would address those issues as well as invalidity defenses.
`
`And Regeneron’s reply declarations would respond to the PI Defendants’ invalidity arguments.
`
`The PI Defendants’ proposal would also permit depositions of the declarants after each
`
`round of declarations, with time to prepare a brief that, among other things, incorporates any
`
`admissions gained through those depositions. Regeneron, in contrast, has proposed that the PI
`
`Defendants should collectively get only one seven-hour deposition of each of Regeneron’s
`
`declarants, even where those declarants submit multiple rounds of declarations and/or address
`
`issues specific to individual defendants. (Ex. C.) Worse still, Regeneron has not agreed to permit
`
`the PI Defendants to file any sur-reply on invalidity issues, on which the PI Defendants bear the
`
`burden of proof. Thus, Regeneron’s proposal would force the PI Defendants to choose whether to
`
`(1) depose Regeneron’s declarants before the deadline for opposition briefs but forfeit any
`
`opportunity for a deposition on Regeneron’s reply declarations; or (2) wait to depose Regeneron’s
`
`declarants without any opportunity to brief the substance of those depositions to the Court.
`
`Regeneron’s proposal is inherently unfair and should not be allowed in the face of the PI
`
`Defendants’ reasonable alternative proposal.
`
`
`
`
`
`
`
`
`
`
`
`- 5 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 7 of 8 PageID #: 4064
`
`
`Dated: February 13, 2024
`
`
`
`
`
`
`
`
`
`/s/ Max C. Gottlieb
`Max C. Gottlieb (WVSB #13201)
`Michael B. Hissam (WVSB #11526)
`Andrew C. Robey (WVSB #12806)
`Carl W. Shaffer (WVSB #13260)
`HISSAM FORMAN DONOVAN RITCHIE PLLC
`P.O. Box 3983
`Charleston, WV 25339
`681-265-3802 office
`304-982-8056 fax
`mhissam@hfdrlaw.com
`mgottlieb@hfdrlaw.com
`arobey@hfdrlaw.com
`cshaffer@hfdrlaw.com
`
`Attorneys for Defendant Celltrion, Inc. appearing for
`the limited purpose of contesting jurisdiction
`
`/s/ Sandra K. Law
`Sandra K. Law (WVSB No. 6071)
`SCHRADER COMPANION, DUFF & LAW, PLLC
`401 Main Street
`Wheeling, West Virginia 26003
`(304) 233-3390 (phone)
`(304) 233-2769 (fax)
`skl@schraderlaw.com
`
`Attorney for Defendant Samsung Bioepis Co., Ltd.
`appearing for the limited purpose of contesting
`jurisdiction
`
`/s/ M. David Griffith, Jr.
`M. David Griffith, Jr. (WVSB No. 7720)
`THOMAS COMBS & SPANN PLLC
`300 Summers Street, Suite 1380
`Charleston, West Virginia 25301
`(304) 414-1800 (phone)
`(304) 414-1801 (fax)
`dgriffith@tcspllc.com
`
`Attorney for Defendant Formycon AG appearing for
`the limited purpose of contesting jurisdiction
`
`- 6 -
`
`

`

`Case 1:23-cv-00089-TSK Document 97 Filed 02/13/24 Page 8 of 8 PageID #: 4065
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on February 13, 2024, I electronically filed the foregoing with the
`
`Clerk of the Court by using the Court’s CM/ECF system. Counsel of record for all parties will be
`
`served by the Court’s CM/ECF system.
`
`
`
`
`
`
`
`
`
`/s/ Max C. Gottlieb
`Max C. Gottlieb (WVSB #13201)
`
`- 7 -
`
`