Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 1 of 13 PageID #: 3906
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`Plaintiff,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
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`CELLTRION, INC.,
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`Plaintiff,
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`SAMSUNG BIOEPIS, CO., LTD.,
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`REGENERON PHARMACEUTICALS, INC.,
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`v.
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`SAMSUNG BIOEPIS, CO., LTD.,
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`REGENERON PHARMACEUTICALS, INC.,
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`FORMYCON AG,
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`Defendant.
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`Plaintiff,
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`v.
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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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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 2 of 13 PageID #: 3907
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`Defendant.
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`PLAINTIFF REGENERON PHARMACEUTICALS, INC.’S EMERGENCY MOTION
`FOR ENTRY OF A SCHEDULE FOR PRELIMINARY INJUNCTION PROCEEDINGS
`OR IN THE ALTERNATIVE AN EMERGENCY STATUS CONFERENCE
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 3 of 13 PageID #: 3908
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) respectfully requests that the
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`Court enter the attached schedule to ensure the orderly conduct of impending preliminary
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`injunction proceedings in the above-captioned matters, precipitated by the impending expiration
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`of regulatory exclusivity protecting Eylea on May 17, 2024. The facts necessitating this
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`emergency motion and entry of the schedule attached hereto are set forth below. Should the
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`Court prefer not to enter the requested schedule at this time, Regeneron respectfully requests an
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`emergency status conference after the New Year holiday to discuss the impending preliminary
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`injunction proceedings.
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`I.
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`BACKGROUND
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`Regeneron markets the vision-saving product Eylea®, a medication injected into a
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`patient’s eyeball in order to treat angiogenic eye disorders like age-related macular degeneration,
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`diabetic macular edema, and diabetic retinopathy. Each of Defendants Samsung Bioepis Co.,
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`Ltd. (“Samsung”), Celltrion, Inc. (“Celltrion”), and Formycon AG (“Formycon”) (collectively,
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`“Defendants”) has filed an application with FDA seeking to market a biosimilar copy of Eylea®
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`pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). In each of the
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`above-captioned matters, Regeneron alleges that the respective Defendant would infringe
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`Regeneron patents by engaging in the commercial manufacture or sale of its proposed biosimilar
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`product before the relevant patents expire.
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`Non-patent, statutory protections currently prohibit any Defendant from obtaining FDA
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`approval or launching its product, as explained further below. Those protections will begin to
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`expire on May 17, 2024. Regeneron therefore intends to seek a preliminary injunction (“PI”)
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`prohibiting each of Defendants from marketing its biosimilar copy of Eylea® until this Court has
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`decided issues of patent infringement and validity.
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`Regeneron accordingly reached out to each of Defendants to discuss potential PI
`1
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 4 of 13 PageID #: 3909
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`schedules, in some cases even before complaints were filed.1 In particular, Regeneron sent each
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`Defendant a proposed PI schedule designed to ensure orderly submissions culminating in a
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`hearing sufficiently before May 17, 2024. No Defendant responded to suggest PI proceedings
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`would be unnecessary. Instead, Regeneron engaged productively over the course of multiple
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`calls and emails with Celltrion and Formycon, in an effort to arrive at a mutually agreeable
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`schedule in this Court. Regeneron made every effort to engage equally with Samsung, but was
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`repeatedly rebuffed.
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`Negotiations continued until mid-December, when Defendants asked that Regeneron
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`convene a call with Defendants collectively, so that the parties could discuss scheduling concerns
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`en masse. That call appeared to be a productive one. Defendants, however, now have
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`announced—in concert by a single email—that they will each seek to flee the Northern District
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`of West Virginia by filing spurious motions to dismiss for lack of personal jurisdiction. Indeed,
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`counsel for each Defendant, with whom Regeneron had been communicating for months about
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`this very litigation both before and after complaints were filed, announced they would not even
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`accept service of the Complaints on behalf of their foreign clients. See D.I. 43 (Celltrion, 23-cv-
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`89); D.I. 31 (Formycon, 23-cv-97); D.I. 38 (Samsung, 23-cv-94).
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`To be clear: this Court does not lack personal jurisdiction over any Defendant. Each
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`Defendant has submitted an FDA application seeking approval to market its biosimilar product
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`nationwide, an act that confers personal jurisdiction in all fifty states. Acorda Therapeutics, Inc.
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`v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2018). Defendants plan is nothing more
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`than a transparent effort to escape this Court, and in particular, to escape this Court’s knowledge
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`of many of the asserted patents obtained during Regeneron’s co-pending litigation against Mylan
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`1 Regeneron’s ability to file a complaint is limited by the BPCIA, as described below.
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`2
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 5 of 13 PageID #: 3910
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`and Biocon. No Defendant has yet filed a motion to dismiss; presumably, Defendants were
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`awaiting this Court’s decision in the Mylan and Biocon case. In view of the Court’s decision
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`that Mylan/Biocon infringed Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”) and
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`that the ’865 patent is not invalid, D.I. 665 (1:22-cv-00061-TSK), Regeneron expects those
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`motions to be forthcoming.
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`The BPCIA—that is, the same act that allowed Defendants to submit applications to
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`market a biosimilar product—expressly guarantees 180 days for PI proceedings before a
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`biosimilar applicant may launch its product, and demands cooperation regarding expedited
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`discovery. 42 U.S.C. § 262(l)(8)(C). Defendants’ manufactured procedural roadblocks reflect a
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`desperate attempt to dodge their obligations and run out the clock. Accordingly, Regeneron
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`respectfully requests this Court convene a status conference after the New Year holiday to
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`discuss a PI schedule, including document discovery, that can proceed while Defendants’
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`motions to dismiss are litigated. In the absence of prompt discovery, adjudicating a PI before the
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`expiration of regulatory exclusivity will become impossible.
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`II.
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`STATUTORY AND REGULATORY BACKGROUND
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`Regeneron’s Eylea® is an innovative biologic drug, and the ability of other
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`pharmaceutical companies to market “biosimilar” copies of Eylea® is governed by the Biologics
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`Price Competition and Innovation Act (“BPCIA”), Pub. L. No. 111-148, §§ 7001-7003, 124 Stat.
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`119, 804-21. The BPCIA created an abbreviated process by which follow-on drug
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`manufacturers can seek to market copies of innovative drugs that have already been approved by
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`FDA. Sandoz Inc. v. Amgen Inc., 582 U.S. 1, 7 (2017) (citing 42 U.S.C. § 262(k)). Instead of
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`proving that its drug is “safe, pure, and potent”—like Regeneron had to do in order to obtain
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`approval for Eylea®—a company seeking to market a biosimilar copy of an existing drug can
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`“piggyback” on the innovator’s data, and need only prove that there are no “‘clinically
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 6 of 13 PageID #: 3911
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`meaningful differences’ between the [biosimilar drug and innovator drug] in terms of ‘safety,
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`purity, and potency.’” Id. Thus, the BPCIA allows biosimilar manufacturers to take a cheaper
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`and faster route to regulatory approval. On the other side of the scale, Congress granted
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`innovator companies a period of exclusivity before biosimilar drugs could be marketed. FDA
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`may not approve an application for a biosimilar product until 12 years after the innovator product
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`was first approved. Id. (citing 42 U.S.C. §§ 262(k)(7)(A), (B)).
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`Of course, an innovator company “may hold multiple patents covering the biologic, its
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`therapeutic uses, and the processes used to manufacture it. Those patents may constrain an
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`applicant’s ability to market its biosimilar even after the expiration of the 12–year exclusivity
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`period contained in § 262(k)(7)(A).” Id. The BPCIA is designed to “facilitate[] litigation during
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`the period preceding FDA approval so that the parties do not have to wait until commercial
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`marketing to resolve their patent disputes.” Id. To that end, the BPCIA prescribes a series of
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`iterative disclosures from both the biosimilar applicant and the innovator company. Id. at 8-11.
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`These exchanges have come to be known colloquially as the “Patent Dance.”
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`One requirement of the Patent Dance is that “[t]he [biosimilar] applicant shall provide
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`notice to the [innovator company] not later than 180 days before the date of the first commercial
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`marketing of the biological product licensed under subsection (k).” 42 U.S.C. § 262(l)(8)(A).
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`The “Notice of commercial marketing” or “NCM” plays an important role in structuring
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`biosimilar patent litigation. Once a biosimilar applicant enters the Patent Dance, the BPCIA
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`limits the ability of the innovator company to sue before certain steps of the dance are complete.
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`42 U.S.C. § 262(l)(9). Those limitations are lifted when the biosimilar applicant serves its NCM.
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`Id. §§ 262(l)(8),(9). In fact, the BPCIA expressly contemplates that service of an NCM may
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`necessitate PI proceedings, because—depending on any remaining regulatory exclusivity for the
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`4
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 7 of 13 PageID #: 3912
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`innovator and status of FDA review for the biosimilar applicant—the parties may have only 180
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`days left to adjudicate patent issues before the biosimilar applicant is entitled to launch. Id.
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`§ 262(l)(8)(B),(C). In view of that exigency, the BPCIA mandates that “[i]f the [innovator] has
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`sought a preliminary injunction under subparagraph (B), the [innovator] and the [biosimilar]
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`applicant shall reasonably cooperate to expedite such further discovery as is needed in
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`connection with the preliminary injunction motion.” Id. § 262(l)(8)(C).
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`III.
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`PROCEDURAL POSTURE
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`This Court is no stranger to Eylea®. In June 2023, this Court held trial in Regeneron
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`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. and Biocon Biologics Inc., Case No. 1:22-
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`cv-00061-TSK. That case arose from Mylan’s application under the BPCIA to market a
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`biosimilar copy of Eylea® before the expiration of several Regeneron patents. Regeneron and
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`Mylan completed the full Patent Dance exchanges, Regeneron sued Mylan as contemplated in
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`§ 262(l)(6), and the parties proceeded quickly to a trial on the merits. On December 28, 2023,
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`this Court issued a judgment finding that Mylan/Biocon’s biosimilar aflibercept product would
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`infringe Regeneron’s ’865 patent, and that the ’865 patent is not invalid. D.I. 665 (1:22-cv-
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`00061-TSK).
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`The above-captioned matters will involve the same ’865 patent, but the timing is
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`different. Like Mylan/Biocon, Defendants each have filed their own applications with FDA,
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`seeking to market their own biosimilar copies of Eylea®. Like Mylan/Biocon, each Defendant
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`will infringe the ’865 patent if and when they market their biosimilar product. But unlike
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`Mylan/Biocon, Defendants in the above-captioned matters filed their biosimilar applications with
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`FDA late enough to ensure that there would not be enough time to go to trial before Regeneron’s
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`regulatory exclusivity expires.
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`Defendant Celltrion served its NCM during the Patent Dance. Receipt of Celltrion’s
`5
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 8 of 13 PageID #: 3913
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`NCM allowed Regeneron to file a complaint against Celltrion without waiting for the rest of the
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`Patent Dance to take place. Regeneron subsequently filed complaints against Samsung and
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`Formycon as well. In view of the limited time before its regulatory exclusivity expires,
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`Regeneron promptly filed the above-captioned cases in this Court and reached out to Defendants
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`to discuss schedules for PI hearings, as described above.
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`IV.
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`PROMPT ENTRY OF A SCHEDULE IS NECESSARY TO PERMIT
`RESOLUTION OF A PRELIMINARY INJUNCTION BEFORE EXPIRY OF
`REGULATORY EXCLUSIVITY
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`Regeneron has been in contact with each of Defendants regarding the need for a PI
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`schedule for more than six weeks. As described above, Defendants do not disagree that PI
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`proceedings should take place. Defendants just do not want to hold those proceedings in West
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`Virginia. No Defendant has yet filed the promised motion to dismiss, likely in hopes this Court’s
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`decision in the Mylan/Biocon case would give them cause to reconsider. That is not what
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`happened. This Court’s decision upholding the ’865 patent will have strengthened Defendants’
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`desire to flee the Mountain State. Nothing has strengthened their legal basis to do so—
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`Defendants’ jurisdictional arguments remain as weak as ever. Acorda, Inc., 817 F.3d 755.
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`Unchecked, Defendants’ procedural gamesmanship will consume Regeneron’s BPCIA-
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`guaranteed 180 days to seek a PI.
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`Regeneron’s goal is simple: ensure an orderly process that will result in resolution of its
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`forthcoming motion for PI before May 17, 2024. In order to achieve that goal, Regeneron needs
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`to obtain modest but expedited discovery from each of Defendants. The BPCIA expressly
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`requires “reasonab[e] cooperat[ion] to expedite such further discovery as is needed in connection
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`with the preliminary injunction motion.” 42 U.S.C. § 262(l)(8)(C). To that end, and as the
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`attached schedule reflects, Regeneron has already served a short list of targeted requests for
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`production on Defendants and has offered to produce a large tranche of Regeneron’s documents
`6
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 9 of 13 PageID #: 3914
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`as soon as counsel confirm they will be maintained on an outside-counsel only basis pending
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`entry of a protective order. Prompt access to the requested documents from Defendants will
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`permit Regeneron to file a motion on a timeline that makes resolution before May 17, 2024
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`attainable. The remaining entries in Regeneron’s proposed schedule reflect a straightforward
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`effort to work backwards from the date by which a decision is needed and sensibly allocate the
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`available time to Regeneron’s motion, Defendants’ opposition, and Regeneron’s reply, along
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`with accompanying declarations and depositions of those declarants.
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`V.
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`CONCLUSION
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`Regeneron remains willing to work cooperatively with Defendants throughout the
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`coming months, but the short time between now and May 2024 does not permit further delay.
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`Regeneron therefore respectfully requests this Court enter the schedule attached hereto in the
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`above-captioned matters, or in the alternative convene a status conference on an expedited basis
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`following the New Year holiday.
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`Date: December 28, 2023
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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
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`7
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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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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 10 of 13 PageID #: 3915
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`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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`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
`
`8
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 11 of 13 PageID #: 3916
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`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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`9
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 12 of 13 PageID #: 3917
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`CERTIFICATE OF SERVICE
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`The undersigned counsel hereby certifies that on the 28th day of December 2023, service
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`of the foregoing “PLAINTIFF REGENERON PHARMACEUTICALS, INC.’S EMERGENCY
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`MOTION FOR ENTRY OF A SCHEDULE FOR PRELIMINARY
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`INJUNCTION
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`PROCEEDINGS OR IN THE ALTERNATIVE AN EMERGENCY STATUS CONFERENCE”
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`was made by U.S. Mail to the following counsel:
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`Robert Cerwinski, Esq.
`Aviv Zalcenstein, Esq.
`Gemini Law LLP
`40 W. 24th Street, Suite 6N
`New York, NY 10010
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`Counsel for Defendant Celltrion, Inc.
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`Laura Fairneny, Esq.
`Matthew Traupman, Esq.
`Quinn Emanuel Urquehart & Sullivan, LLP
`51 Madison Ave, 22nd floor
`New York, NY 10010
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`Zach Summers, Esq.
`Quinn Emanuel Urquehart & Sullivan, LLP
`865 S. Figueroa St., 10th Floor
`Los Angeles, California 90017
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`Counsel for Defendant Samsung Bioepis, Co., Ltd.
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`Louis E. Fogel
`Shaun M. Van Horn
`Jenner & Block LLP
`353 N. Clark Street
`Chicago, IL 60654
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`Haley B. Tuchman
`Jenner & Block LLP
`1099 New York Avenue, NW, Suite 900
`Washington, DC 20001
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`Counsel for Defendant Formycon AG
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`10
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`Case 1:23-cv-00106-TSK Document 9 Filed 12/28/23 Page 13 of 13 PageID #: 3918
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`
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
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`11
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