Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 1 of 6 PageID #: 276
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`IN RE: AFLIBERCEPT PATENT
`LITIGATION
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`This Document Relates to All Cases
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`MDL No. 1:24-MD-3103-TSK
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`REGENERON PHARMACEUTICALS, INC.’S MOTION FOR GUIDANCE
`REGARDING TEMPORARY RESTRAINING ORDERS IN VIEW OF THE MAY 18,
`2024 EXPIRATION OF REGULATORY EXCLUSIVITY FOR EYLEA®
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`Fifteen days remain until May 18, 2024, the date on which FDA may approve biosimilar
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`copies of Eylea®. Unless the four biosimilar manufacturers against whom Regeneron has sought
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`injunctive relief—i.e., Mylan/Biocon, Formycon, Samsung Bioepis, and Celltrion—provide
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`assurances to Regeneron and the Court that they will not disturb the status quo by launching their
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`products before the Court adjudicates Regeneron’s pending motions, Regeneron may suffer
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`irreparable harm if that date passes without resolution of those motions. Regeneron has sought
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`such assurances from each of those four Defendants; the Defendants have not yet provided them.
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`Accordingly, Regeneron seeks guidance from the Court regarding the timing of temporary
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`restraining order (“TRO”) motions while the Court considers Regeneron’s pending motions for
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`permanent and preliminary injunctions.
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`As the Court noted in January, the clock is counting down to the expiry of Regeneron’s
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`regulatory exclusivity. When the clock hits zero on May 18, 2024, FDA may approve one or more
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`of Defendants’ biosimilar products. Dkt. 61 (Case No. 1:23-cv-00089-TSK) at 2.1 FDA does not
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`consider patent infringement in its approval decisions under the BPCIA; the statute instead
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`presumes such matters will be resolved through litigation—either fully on the merits, or
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`1 An identical order was filed in each of the Samsung, Celltrion, and Formycon cases.
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`Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 2 of 6 PageID #: 277
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`temporarily in the form of preliminary injunction proceedings—before FDA approval occurs. 42
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`U.S.C. § 262(k)(7)(B), id. at § 262(l)(8)(B); Amgen v. Apotex, 827 F.3d 1052, 1063 (Fed. Cir.
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`2016) (noting the BPCIA “give[s] the parties and the district court time” to adjudicate issues ahead
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`of “immediate market entry that could cause irreparable injury.”). Thus, absent an injunction, one
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`or more Defendants may begin marketing their infringing products on or after May 18, 2024—
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`notwithstanding the Court’s December 2023 opinion upholding the validity of Regeneron’s ’865
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`patent that is asserted as a basis for injunction against every Defendant here. Indeed, even
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`Biocon—an adjudged infringer of the ’865 patent—will be free to launch its product if it receives
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`FDA approval and no current order of this Court prevents it from doing so. Any launch of an
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`infringing product would alter the market irreversibly.
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`In order to ensure the preservation of the status quo, Regeneron contacted each of
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`Biocon, Samsung, Celltrion, and Formycon to confirm that they will not launch their infringing
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`products until this Court has had time to decide the pending motions for injunctive relief. None
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`has agreed. Without assurances from all four Defendants, or a Court order providing injunctive
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`relief, Regeneron anticipates it will need to file TRO motions no later than Tuesday, May 14,
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`2024—or on a date that the Court directs—to preserve the status quo and prevent harm while the
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`Court considers Regeneron’s motions for injunctive relief.2
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`In adjudicating the fully briefed injunction motions against these four Defendants, the
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`Court need not await the forthcoming briefing of an injunction motion against Amgen, the fifth
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`defendant in this MDL. Due in part to a pre-transfer order from the court in California, injunction
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`briefing against Amgen has not yet occurred. Amgen, therefore, is differently situated from the
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`2 The Court has authority to grant TROs without waiting for oppositions from Defendants or holding oral
`argument. See ClearOne Advantage, LLC v. Kersen, 2024 WL 69918, at *2 (D. Md. Jan. 5, 2024) (“A
`court may enter a TRO ‘without full notice, even, under certain circumstances, ex parte.’” (quoting Hoechst
`Diafoil Co. v. Nan Ya Plastics Corp., 174 F.3d 411, 422 (4th Cir. 1999))).
`2
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`Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 3 of 6 PageID #: 278
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`other four Defendants. Indeed, both Regeneron and Amgen have agreed there is no need for a
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`hearing on injunction proceedings against Amgen until August 2024, and none of the other four
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`Defendants have asserted that adjudication of Regeneron’s pending motions should await
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`injunction briefing involving Amgen. A TRO, in the first instance, cannot exceed fourteen days
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`in duration, Fed. R. Civ. P. 65(b)(2), so Regeneron respectfully submits that even with a TRO, it
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`will be necessary to adjudicate the motions against Biocon/Mylan, Samsung, Celltrion, and
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`Formycon before a motion against Amgen can be briefed.
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`Resolving the fully briefed motions for injunctive relief before adjudicating a later motion
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`against Amgen fully accords with the JPML’s Order. That Order does not address whether any
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`Defendant may launch its product before the Court adjudicates Regeneron’s requests for injunctive
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`relief, and does not require that all hearings in all cases take place at the same time. Instead, it
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`recognizes the importance of ensuring consistency of “rulings as to claim construction, patent
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`validity, and other issues,” Dkt. 112-1 (Case No. 1:24-cv-39) at 2, a goal that is assured by the fact
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`that this Court will now preside over all hearings, even if they do not take place on the same day.
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`MDL scheduling orders routinely designate certain cases as “Track 1” cases and others as “Track
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`2” cases, to reflect differences in factual issues or procedural posture. See, e.g., In re: Insulin
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`Pricing Litigation, 2:23-md-03080, Dkt. 34 at 2-5 (D.N.J. December 6, 2023); In re: National
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`Prescription Opiate Litigation, 1:17-md-2804, Dkt. 232, Slip op. at 6-8 (N.D. Ohio April 11,
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`2018). Here, the Defendants’ respective timelines necessitate injunction hearings against
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`Biocon/Mylan, Samsung, Celltrion, and Formycon on a first track, and Amgen on a second. After
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`injunctive proceedings resolve the immediate threat of the launch of infringing products,
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`Regeneron is not aware of any reason why all five cases could not proceed on the same schedule
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`for ensuing discovery and other pre-trial matters.
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`Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 4 of 6 PageID #: 279
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`Accordingly, Regeneron respectfully requests guidance from the Court regarding its
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`preferred timing for TRO motions against Biocon/Mylan, Samsung, Celltrion and Formycon.
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`Absent further instruction, Regeneron will plan to file TRO motions on Tuesday, May 14, 2024,
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`but is happy to file the motions on any schedule that would better facilitate the Court’s resolution
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` CAREY DOUGLAS KESSLER & RUBY, PLLC
`
`/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
`drpogue@cdkrlaw.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`by Friday, May 17, 2024.
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`Date: May 3, 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)
`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
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`Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 5 of 6 PageID #: 280
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`jbeazley@wc.com
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`*Admitted only in Pennsylvania; practice
`supervised by D.C. Bar members
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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
`
`Christopher M. Pepe (admitted PHV)
`WEIL, GOTSHAL & MANGES
`2001 M Street, NW
`Suite 600
`Washington, DC 20036
`Christopher.Pepe@weil.com
`
`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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`Case 1:24-cv-00039-TSK Document 131 Filed 05/03/24 Page 6 of 6 PageID #: 281
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`CERTIFICATE OF SERVICE
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`I hereby certify that on May 3, 2024, I electronically transmitted the foregoing with the
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`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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