Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 1 of 10 PageID #: 4120
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Civil Action No. 1:23-cv-89-TSK
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`Civil Action No. 1:23-cv-94-TSK
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`Civil Action No. 1:23-cv-106-TSK
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`Civil Action No. 1:23-cv-97-TSK
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`REGENERON PHARMACEUTICALS, INC.,
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`CELLTRION, INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`SAMSUNG BIOEPIS, CO., LTD.,
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`SAMSUNG BIOEPIS, CO., LTD.,
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`FORMYCON AG,
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`Plaintiff,
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`Defendant.
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 2 of 10 PageID #: 4121
`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 2 of 10 PagelD #: 4121
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`REGENERON’S RESPONSE TO DEFENDANTS’
`REGENERON’S RESPONSE TO DEFENDANTS’
`MOTION FOR EXPEDITED STATUS CONFERENCE
`MOTION FOR EXPEDITED STATUS CONFERENCE
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 3 of 10 PageID #: 4122
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`Defendants have moved for an expedited status conference seeking (1) to preclude
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`Regeneron from filing an omnibus preliminary injunction brief addressing common issues between
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`the Defendants and (2) to revise substantially the Court’s schedule for preliminary injunction
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`proceedings on the eve of Regeneron’s opening brief. D.I. 100. As to the first issue, Regeneron
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`disagrees with Defendants’ position, which will create unnecessary repetition in the briefing of
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`issues common to multiple Defendants. Regeneron would accept a solution analogous to the one
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`set forth in Defendants’ recent response (No. 23-cv-97, D.I. 89) to “serve on each PI Defendant a
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`copy of its omnibus [brief] redacting confidential and OCEO information from the other PI
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`Defendants simultaneously with Regeneron’s filing of its [brief] under seal.” D.I. 89 at 5. This
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`solution has the advantages of streamlining the presentation of issues to the Court with all the
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`evidence and argument for each issue in one place, rather than distributed across three briefs.
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`Regeneron—subject to the Court’s preference—is also willing to file separate motions against
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`each Defendant.
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`As to the second issue, however, Regeneron opposes Defendants’ belated effort to alter the
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`schedule the Court entered and restructure the Court’s schedule to Regeneron’s prejudice.
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`Defendants had an opportunity to propose a preliminary injunction schedule last month (e.g., No.
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`23-cv-89, D.I. 59) in response to Regeneron’s motion regarding the issue (id., D.I. 45), but their
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`proposed schedule was rejected. Now, just over a week before Regeneron intends to file its
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`motions for preliminary injunction and more than a month after the Court entered the schedule
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`(id., D.I. 83), is too late. Moreover, Defendants’ proposal to restructure preliminary injunction
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`briefing is supported by no authority and badly misapprehends the standard for a preliminary
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`injunction in seeking to deprive Regeneron of the opportunity to address validity in its opening
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`brief.
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 4 of 10 PageID #: 4123
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`I.
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`DEFENDANTS’ BELATED EFFORT TO REVISE THE PRELIMINARY
`INJUNCTION SCHEDULE SHOULD BE DENIED
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`Citing no authority, Defendants propose a new schedule seeking to limit Regeneron to the
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`issues of infringement and irreparable harm in its opening brief and to grant themselves advanced
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`leave to file a surreply. D.I. 100 at 4-5. Unbelievably, Defendants do so without acknowledging
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`that they previously proposed (without prior notice to Regeneron, during the course of the hearing)
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`a schedule that included a surreply, No. 23-cv-89, D.I. 59-1, which this Court rejected in favor of
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`the schedule Defendants seek to avert again. Beyond its untimeliness and the prejudice
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`Defendants’ proposed schedule would create by limiting unduly the arguments Regeneron may
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`advance in its principal brief, Defendants also seek, arbitrarily and unfairly, to reduce the time for
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`Regeneron to depose Defendants’ declarants and prepare its reply. The Court should reject
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`Defendants’ drastic and untimely revisions to its duly considered schedule.
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`Defendants’ proposed new schedule is premised on their assertion that they “bear the
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`burden of proof” on “invalidity issues.” D.I. 100 at 5. While Defendants do bear the ultimate
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`burden of proving invalidity, in the relevant preliminary injunction context here, “a patentee must
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`show that it will likely prove infringement of the asserted claims and that its infringement claim
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`will likely withstand the alleged infringer's challenges to patent validity and enforceability.”
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`Metalcraft of Mayville, Inc. v. Toro Co., 848 F.3d 1358, 1363-64 (Fed. Cir. 2017) (emphasis
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`added). Accordingly, opening briefs seeking preliminary injunctions regularly address validity.
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`E.g., Ex. 1, Automated Merch. Sys. Inc. v. Crane Co., No. 08-cv-97-JPB-JES, D.I. 19, at 15
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`(N.D.W. Va. July 29, 2008); Ex. 2, Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 17-cv-7111, D.I.
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`156, at 16 (D.N.J. July 31, 2018); Ex. 3, BlephEx, LLC v. Myco Indus., Inc., No. 19-cv-13089, D.I.
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`10, at 17 (E.D. Mich. Nov. 7, 2019). Regeneron intends to meet its burden to show that it is likely
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`to succeed at trial, including by addressing the relevance of the Court’s decision in Regeneron
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`2
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 5 of 10 PageID #: 4124
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`Pharm., Inc. v. Mylan Pharm. Inc., 2024 WL 382495 (N.D.W. Va. Jan. 31, 2024) upholding the
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`validity of U.S. Patent 11,084,865, which Regeneron asserts here against each Defendant.
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`Defendants’ untimely effort to hamstring Regeneron’s opening brief should thus be denied on this
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`basis alone.
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`The propriety of addressing validity at the outset is even more appropriate here than in a
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`typical patent case, both because the validity of the ’865 patent already has been adjudicated by
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`this Court in the Mylan action and because the Defendants already have served contentions
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`regarding infringement and validity for each patent on which Regeneron may seek a preliminary
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`injunction. Under the BPCIA’s pre-suit provisions, applicants seeking approval of a biosimilar
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`product (e.g., Defendants) are required to provide the owner of the reference product (e.g.,
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`Regeneron) with “a detailed statement that describes, on a claim by claim basis, the factual and
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`legal basis of the opinion of the [Defendant] that such patent is invalid, unenforceable, or will not
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`be infringed” by its proposed biosimilar product.” 42 U.S.C. § 262(l)(3)(B)(ii) (emphasis added).
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`While Defendants’ pre-suit contentions are not technically binding, they are doubtlessly
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`informative of the validity issues the Court may address in resolving Regeneron’s injunction
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`motions; indeed, when Regeneron asked Defendants to identify the validity arguments they
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`intended to advance in opposing injunctive relief, they all refused. See Ex. 4 at 2 (Email to
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`Celltrion); Ex. 5 at 1–2 (Email to Formycon); Ex. 6 at 3 (Email to Samsung).
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`Accordingly, Regeneron intends to address the validity allegations Defendants have
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`advanced, on the basis of the contentions Regeneron possesses—the pre-suit contentions.
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`Remarkably, in order to shield their own assertions from the Court, Defendants have taken the
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`position—never adopted by any Court and contrary to the clear language of the statute—that the
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`BPCIA somehow prevents Regeneron from submitting Defendants’ BPCIA validity contentions,
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`3
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 6 of 10 PageID #: 4125
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`even under seal.1 The BPCIA restricts—at most—use or disclosure of “Confidential information.”
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`42 U.S.C. § 262(l)(1)(C-D). Defendants do not—and cannot—argue that their allegations of which
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`prior art references anticipate or render obvious Regeneron’s patents are confidential. Indeed, the
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`only Court (to undersigned counsel’s knowledge) that ever has addressed the argument that the
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`BPCIA contentions are confidential rejected it conclusively. AbbVie Inc. v. Boehringer Ingelheim
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`Int’l GmbH, 2019 WL 1571666, at *2 (D. Del. Apr. 11, 2019) (explaining that the BPCIA “does
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`not provide for separate or additional confidentiality for the contentions required under
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`§ 262(l)(3)(B) and (C)”); see also 87 Fed. Reg. 45764-02 (not only permitting, but requiring, that
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`pre-suit contentions under the Hatch-Waxman Act “be submitted directly to the USPTO”).
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`Accordingly, Regeneron intends to address in its principal briefs the validity of the asserted
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`patents, in view of this Court’s opinion in the Mylan case and the Defendants’ contentions.
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`Defendants may respond on validity and infringement in their principal briefs, and Regeneron will
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`then submit a reply. That is the briefing schedule that comports with this district’s rules and
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`practices, L.R. Civ. P. 7.02, with appropriate adjustments to the deadlines. That structure—a
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`principal brief for each party, and a reply for the moving party, with no surreply—governed each
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`of the preliminary injunction motions referenced above (and many others), including in this
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`District. That is the briefing schedule and structure this Court entered after the parties had
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`conferred regarding an appropriate preliminary injunction schedule for months and then presented
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`their dispute to the Court. That is the schedule this Court entered after Defendants proposed a
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`different schedule that included a surreply. D.I. 59-1. And that is the schedule that the parties
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`have operated under, and relied on, for more than a month. The notion that the schedule should
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`1 When Regeneron proposed to furnish, under seal, Defendants’ BPCIA contentions to the Judicial Panel
`on Multidistrict Litigation, Defendants not only refused, but went so far as to threaten Regeneron with
`injunctive relief and, in one case (Samsung), threatened to seek a temporary restraining order to prevent
`Regeneron from doing so. Ex. 6 at 1-2; see also Ex. 4 at 1; Ex. 5 at 1.
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`4
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 7 of 10 PageID #: 4126
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`be changed drastically at this juncture, to limit the arguments in Regeneron’s principal briefs,
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`curtail its time to conduct expert depositions and submit a reply, and add another round of briefing,
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`is unnecessary and unfair. This court rejected Defendants’ schedule that included a surreply
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`previously (D.I. 59-1), and it should do so again.
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`Notwithstanding the impropriety of Defendants’ request to modify the schedule, in an
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`effort to avoid a dispute, Regeneron will accommodate Defendants’ complaint that they would be
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`“force[d] . . . to choose” between deposing Regeneron’s declarants after an opening declaration
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`or, if applicable, a reply declaration. D.I. 100 at 5. To the extent Regeneron submits declarations
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`in support of its reply brief, Regeneron has informed Defendants it will make its declarants
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`available for a single day (7 hour) deposition in advance of the injunction hearing, during which
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`the parties will have the opportunity to address the deposition testimony.2
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`For the foregoing reasons, Defendants’ motion to revise the Court’s preliminary injunction
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`CONCLUSION
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`scheduling order should be denied.
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`Date: February 14, 2024
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`Of Counsel:
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`David I. Berl (admitted PHV)
`Ellen E. Oberwetter (admitted PHV)
`Thomas S. Fletcher (admitted PHV)
`Andrew V. Trask (admitted PHV)
`Teagan J. Gregory (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Kathryn S. Kayali (admitted PHV)
`Arthur J. Argall III (admitted PHV)
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` CAREY DOUGLAS KESSLER & RUBY, PLLC
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`Raymond S. Franks II (WVSB No. 6523)
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25323
`(304) 345-1234
`sruby@cdkrlaw.com
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`2 Late Wednesday evening, as Regeneron was filing its response, Defendants responded to Regeneron’s
`proposed compromise set forth in this submission by accepting the portions of Regeneron’s proposals they
`deemed favorable while rejecting the portions they deemed unfavorable.
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`5
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 8 of 10 PageID #: 4127
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`drpogue@cdkrlaw.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`Adam Pan (admitted PHV)
`Rebecca A. Carter (admitted PHV)
`Haylee N. Bernal Anderson (admitted PHV)
`Renee M. Griffin (admitted PHV)
`Jennalee Beazley* (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`(202) 434-5000
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`rebeccacarter@wc.com
`handerson@wc.com
`rgriffin@wc.com
`jbeazley@wc.com
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`*Admitted only in Pennsylvania; practice
`supervised by D.C. Bar members
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`6
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 9 of 10 PageID #: 4128
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`Elizabeth Stotland Weiswasser (admitted PHV)
`Anish R. Desai (admitted PHV)
`WEIL, GOTSHAL & MANGES
`767 Fifth Avenue
`New York, NY 10153
`Elizabeth.Weiswasser@weil.com
`Anish.Desai@weil.com
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`Christopher M. Pepe (admitted PHV)
`WEIL, GOTSHAL & MANGES
`2001 M Street, NW
`Suite 600
`Washington, DC 20036
`Christopher.Pepe@weil.com
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`Andrew E. Goldsmith (admitted PHV)
`Evan T. Leo (admitted PHV)
`Jacob E. Hartman (admitted PHV)
`Mary Charlotte Y. Carroll (admitted PHV)
`Sven E. Henningson (admitted PHV)
`KELLOGG, HANSEN, TODD, FIGEL &
` FREDERICK, P.L.L.C.
`1615 M Street, N.W., Suite 400
`Washington, D.C. 20036
`TEL: (202) 326-7900
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`7
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`Case 1:23-cv-00089-TSK Document 100 Filed 02/14/24 Page 10 of 10 PageID #: 4129
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`CERTIFICATE OF SERVICE
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`I hereby certify that on February 14, 2024, I electronically transmitted the foregoing with
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`the Court. Counsel of record for all parties will be served by electronic mail.
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`/s/ Steven R. Ruby
`Steven R. Ruby
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`8
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