Case 1:23-cv-00089-TSK Document 59 Filed 01/08/24 Page 1 of 5 PageID #: 3843
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`REGENERON PHARMACEUTICALS, INC.,
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`v.
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`CELLTRION, INC.,
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`Plaintiff,
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`Defendant.
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`Civil Action No. 1:23-cv-00089
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`DEFENDANT CELLTRION, INC.’S RESPONSE TO PLAINTIFF’S
`EMERGENCY MOTION FOR ENTRY OF A SCHEDULE FOR PRELIMINARY
`INJUNCTION PROCEEDINGS 1
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`There are various issues with Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) proposed
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`schedule. See ECF No. 45.2 Given the serious concerns about personal jurisdiction and venue in
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`this action (a motion to dismiss on those grounds is forthcoming), this Court should allot time to
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`hear those issues before setting a schedule for preliminary injunction proceedings. Such a path
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`forward is even more appropriate in light of Regeneron’s disclosure at last week’s Scheduling
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`Conference that it may sue additional defendant(s).
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`But even if this Court believes it should set preliminary injunction deadlines in addition to
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`motion to dismiss deadlines, it should not adopt the schedule proposed by Regeneron. Among
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`other things, Regeneron’s schedule puts the cart before the horse: it provides for discovery prior
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`1 By filing this Response, as with its response to Regeneron’s other pre-service motion, see ECF No. 52,
`Celltrion makes only a special appearance before the Court. It does not waive any objections or defenses,
`including any of those identified in Rule 12 of the Federal Rules of Civil Procedure, and specifically
`objections and defenses based on the lack of personal jurisdiction and/or improper venue. See Fed. R. Civ.
`P. 12(b)(2) & (3). In its forthcoming motion to dismiss, Celltrion will address, among other matters, the
`lack of personal jurisdiction over it and improper venue in this matter.
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`2 In the interest of judicial efficiency, Celltrion joins in and incorporates the positions taken by Formycon
`AG (“Formycon”) in its response to Regeneron’s motion filed in its parallel litigation against Formycon,
`see ECF No. 43, Case No. 1:23-cv-00097.
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`Case 1:23-cv-00089-TSK Document 59 Filed 01/08/24 Page 2 of 5 PageID #: 3844
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`to the filing of its motion for preliminary injunction, which runs contrary to the governing statutory
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`scheme and the practical reality of the compressed timeline here. See 42 U.S.C. § 262(l)(8)(C)
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`(providing, under the Biologics Price Competition and Innovation Act, that expedited discovery may
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`be available once (and if) a preliminary injunction has been sought).
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`Celltrion’s proposed schedule for preliminary injunction proceedings (to the extent the
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`Court finds that a schedule is necessary at this time) is a more efficient path forward. Regeneron’s
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`regulatory exclusivity over Eylea expires in May 2024. During the Scheduling Conference,
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`Celltrion explained that it wishes to wrap up Regeneron’s potential preliminary injunction motion
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`proceedings prior to that deadline. That is why Celltrion’s proposed schedule contemplates
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`Regeneron filing its potential preliminary injunction motion early in this action (by January 17,
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`2024). That possible motion is the trigger for all of the necessary proceedings to follow. And
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`Regeneron has had months to prepare that motion. To delay that filing by over a month from now
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`— as proposed by Regeneron — does not make sense and will only put additional onus on the
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`parties and this Court.
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`Celltrion’s proposed schedule also recognizes the reality of the compressed timeframe: it
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`is not feasible to accomplish discovery, briefing, and an evidentiary hearing on Regeneron’s
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`possible motion for preliminary junction by May unless Regeneron narrows the patents and claims
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`at issue at the outset and files its preliminary injunction motion soon. Patent-related discovery is
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`voluminous. Indeed, Celltrion has already provided Regeneron with hundreds of thousands of
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`pages of detailed technical information about its proposed product and manufacturing process
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`during the “patent dance” and will provide Regeneron with more information today in the form of
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`detailed contentions concerning non-infringement and invalidity of the 39 patents asserted in
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`Regeneron’s complaint. Given that May is only four months away, a narrowing of Regeneron’s
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`Case 1:23-cv-00089-TSK Document 59 Filed 01/08/24 Page 3 of 5 PageID #: 3845
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`patents and claims at the outset is necessary. Requiring Regeneron to file its motion promptly also
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`cannot prejudice it, since Regeneron has had the detailed technical information about Celltrion’s
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`product and process for over three months.
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`It is also crucial that Regeneron file its motion promptly so that Celltrion can be given a
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`fair opportunity to oppose that motion. If Regeneron is required to file its motion on January 17,
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`it will have had almost four months to assemble its papers. Regeneron’s proposed schedule would
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`give Celltrion only one month to assemble an opposition to what will likely be a complex set of
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`arguments supported by a multitude of fact and expert declarations. This would be patently unfair,
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`counter to the typical cadence of litigation on serious matters such as this, and highly prejudicial
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`to Celltrion.
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`Regeneron’s decisions to delay suit and refuse Celltrion’s offer of waiver of service created
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`this highly compressed timeline. Yet, Regeneron’s schedule fails to properly account for that
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`compression. The Court should thus decline to enter the schedule proposed in Regeneron’s Motion
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`and, if it is inclined to enter a schedule beyond just the briefing the forthcoming motion to dismiss,
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`enter a schedule like that proposed by Celltrion. See Exhibit A.
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`Respectfully Submitted,
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`CELLTRION, INC., specially appearing by counsel,
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`/s/ Max C. Gottlieb
`Michael B. Hissam (WVSB #11526)
`Max C. Gottlieb (WVSB #13201)
`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
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`Case 1:23-cv-00089-TSK Document 59 Filed 01/08/24 Page 4 of 5 PageID #: 3846
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`304-982-8056 fax
`mhissam@hfdrlaw.com
`mgottlieb@hfdrlaw.com
`arobey@hfdrlaw.com
`cshaffer@hfdrlaw.com
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`Case 1:23-cv-00089-TSK Document 59 Filed 01/08/24 Page 5 of 5 PageID #: 3847
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`v.
`
`CELLTRION, INC.,
`
`
`
`
`Plaintiff,
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`Defendant.
`
`Civil Action No. 1:23-cv-00089
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`CERTIFICATE OF SERVICE
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`The undersigned counsel does hereby certify that on the 8th day of January, 2024, he
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`electronically filed Defendant Celltrion, Inc.’s Response to Plaintiff’s Emergency Motion For
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`Entry of a Schedule For Preliminary Injunction Proceedings with the Clerk of Court using the
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`CM/ECF system, which will send notice of same to counsel of record.
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`/s/ Max C. Gottlieb
`Max C. Gottlieb (WVSB #13201)
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