Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 1 of 10 PageID #: 1934
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Plaintiff,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
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`MYLAN PHARMACEUTICALS INC.,
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`Defendant.
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`Case No. 1:22-cv-00061-TSK
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`JURY TRIAL DEMANDED
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`PLAINTIFF’S REPLY IN SUPPORT OF
`MOTION REQUESTING EXPEDITED STATUS CONFERENCE
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`Regeneron seeks an expedited status conference to position this case for trial next
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`summer so that Regeneron may avail itself of statutory injunctive relief set forth in 35 U.S.C.
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`§ 271(e)(4)(D). Congress created that relief precisely for biosimilar patent cases like this one,
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`and the availability of that relief is central to Regeneron’s request for an expedited status
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`conference. Mylan’s opposition, however, says not one word about § 271(e)(4)(D). Mylan thus
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`does not dispute that Regeneron is entitled to seek § 271(e)(4)(D) relief in this case, nor does it
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`dispute that such relief requires a final court decision in advance of any approval of Mylan’s
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`biosimilar product. Mylan’s tacit acknowledgement that a primary basis for relief in this case
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`necessitates a rapid case schedule alone justifies an expedited status conference. Notably, while
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`Mylan quibbles with Regeneron’s proposed schedule, it does not dispute that an expedited status
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`conference is warranted.
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`Mylan argues that a rapid case schedule would “delay[] patent certainty” (Opp. 3), but
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`precisely the opposite is true. Regeneron’s proposal provides certainty to both parties regarding
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`the entitlement to relief under § 271(e)(4)(D). Because Regeneron seeks such relief only as to
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`the twelve patents listed in its motion, a case schedule designed to try those patents in time for a
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`1
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`Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 2 of 10 PageID #: 1935
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`final appellate decision before approval of Mylan’s biosimilar product will achieve complete
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`certainty—for both Regeneron and Mylan—as to those twelve patents and to Regeneron’s entire
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`claim for § 271(e)(4)(D) injunctive relief. Mylan itself recognizes that an early trial date for all
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`patents in the Complaint “is simply not feasible” (Opp. 2), and yet Mylan provides no alternative
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`plan for achieving the “patent certainty” that it desires for any patent before its biosimilar is
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`approved. Mylan’s apparent strategy is to run out the proverbial clock on Regeneron’s primary
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`requested relief, rather than contesting Regeneron’s entitlement to that relief on the merits.
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`An expedited status conference will enable the Court and the parties to fashion a plan for
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`positioning this case for a prompt trial and for achieving certainty for both parties’ benefit.
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`Although the Court set several initial case deadlines after Regeneron filed this motion (see ECF
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`19), Regeneron respectfully requests that the Court schedule a status conference at its earliest
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`possible convenience.
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`In the meantime, Regeneron is making every effort to prepare this case to be litigated
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`swiftly: Regeneron already has contacted Mylan about scheduling the Court-ordered Initial
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`Planning Meeting; Regeneron has transmitted to Mylan a draft Protective Order and draft
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`discovery requests for review; and in response to Mylan’s request for an “indication as to how
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`many documents [Regeneron] intends on producing” (Opp. 7 n.2), Regeneron provides in this
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`Reply an indication of the volume and contents of its initial document production, which
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`Regeneron will deliver to Mylan immediately upon entry of a Protective Order.
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`Because the parties agree that the relief sought in this case requires a rapid case schedule,
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`and because a rapid case schedule will provide both parties with certainty as to that requested
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`relief, Regeneron respectfully requests that the Court schedule an expedited status conference at
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`its earliest convenience.
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`2
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`I.
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`REGENERON HAS A VIABLE CLAIM UNDER § 271(e)(4)(D)
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`Mylan cannot and does not contest that Regeneron has a viable claim under
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`§ 271(e)(4)(D). Instead, Mylan focuses its arguments on other statutory provisions and forms of
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`relief, none of which is a substitute for § 271(e)(4)(D).
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`Mylan first attempts to deny the need for an expedited schedule by rewriting the
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`biosimilar patent statute. Mylan asserts, without citation, that “Congress created a patent
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`resolution scheme that is wholly separate from FDA’s regulatory review.” Opp. at 10. But that
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`is facially untrue—§ 271(e)(4)(D), by its express terms, requires particular relief in
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`circumstances where “the [biosimilar] product has not yet been approved” by FDA. The
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`connection between “the patent resolution scheme” and “FDA’s regulatory review” could not be
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`plainer. And it is the express connection between the two that necessitates an expedited status
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`conference to discuss case scheduling and enter a schedule that facilitates the relief Congress
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`provided, rather than negating it.
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`Next, Mylan contends that Regeneron can seek an injunction through other means
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`provided it “satisf[ies] the requirements for such extraordinary relief, just as any litigant can do.”
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`ECF 26 (“Opp.”) at 2-3. But the general ability of a litigant to seek an injunction under the
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`principles of equity is no substitute for the specific, mandatory statutory relief provided by
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`§ 271(e)(4)(D). Equitable injunctive relief involves consideration of the four traditional
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`equitable factors. See eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006) (“[1]
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`[plaintiff] has suffered an irreparable injury; (2) that remedies available at law, such as monetary
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`damages, are inadequate to compensate for that injury; (3) that, considering the balance of
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`hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the
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`public interest would not be disserved by a permanent injunction”). By contrast, the injunctive
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`relief Congress enacted in § 271(e)(4)(D) requires that a court “shall order a permanent
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`3
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`injunction prohibiting any infringement of the patent” by the biosimilar while the patent is in
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`force and before the biosimilar has been approved. An injunction under § 271(e)(4)(D) is thus
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`mandatory, not “extraordinary,” and it is specifically created for an innovator biopharmaceutical
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`company whose product a biosimilar company seeks to copy.
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`Similarly, Mylan wrongly suggests that “the procedure contemplated by the BPCIA” is a
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`motion for preliminary injunction. Opp. at 10. But a preliminary injunction, unlike relief under
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`§ 271(e)(4)(D), is subject to similar equitable considerations as a permanent injunction. See
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`Winter v. Nat. Res. Def. Council, 555 U.S. 7 (2008). Relatedly, Mylan misreads the BPCIA,
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`which stages preliminary injunction proceedings later in litigation. A preliminary injunction is a
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`remedy available after the biosimilar provides its notice of commercial marketing, which has not
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`yet occurred here. 42 U.S.C. § 262(l)(8)(B); see Opp. at 6 (“Mylan has not yet provided its
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`advance 180-day notice of commercial marketing.”). That notice initiates the “second phase” of
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`BPCIA litigation, which includes the possibility for a preliminary injunction. AbbVie Inc. v.
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`Alvotech hf., 2022 WL 225881, at *2 (N.D. Ill. Jan. 26, 2022). Here, however, the parties are in
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`the “first phase,” “i.e., before the biosimilar goes to market” and before the biosimilar has been
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`approved. Id. A preliminary injunction is thus not a substitute for the specific, congressionally
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`mandated relief provided under § 271(e)(4)(D).
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`Mylan cites several prior biosimilar cases but elides a crucial distinction from this case.
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`In those cases (Opp. at 11 n.4), FDA approval of the biosimilar product preceded the district
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`court’s decision in related patent litigation, because the regulatory exclusivity for each innovator
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`product had already expired by the time the lawsuit was filed.1 In those cases, there was no
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`1 The BPCIA was enacted as part of the Affordable Care Act in 2010. The products at issue in
`the first wave of BPCIA cases had been approved many years earlier—most in the 20th
`century—so that their regulatory exclusivities (and attendant proscriptions against FDA approval
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`4
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`Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 5 of 10 PageID #: 1938
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`possible path to a “final court decision”—and thus no possibility of any § 271(e)(4)(D) relief—
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`prior to FDA approval of the biosimilar.2 In the present case, by contrast, Regeneron expects its
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`regulatory exclusivity for Eylea to remain in force through May 2024, thereby permitting the
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`final appellate decision to predate FDA approval, as Congress envisioned in § 271(e)(4)(D). See
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`Mot. at 5. In fact, this is the first biosimilar patent case that will proceed while the innovator
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`product’s regulatory exclusivity remains in place. That timing makes Regeneron’s claim under
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`§ 271(e)(4)(D) viable, provided that this case proceeds expeditiously to trial. And Mylan’s cases
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`provide no support for its argument that Regeneron “would not lose any substantive rights
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`under” a less expedited schedule. Opp. at 10 & n.4. On the contrary, there can be no dispute
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`that Mylan’s proposed schedule necessarily would deprive Regeneron of statutory relief—that is
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`the animating principle behind Mylan’s proposal.
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`Mylan also suggests, without support, that the biosimilar applicant enjoys “[t]he statutory
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`right to control the timing and scope of litigation under the BPCIA.” Opp. at 13. A biosimilar
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`applicant does control the patent dance exchanges—as Mylan did here by forcing the parties to
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`litigate twenty-four patents in this action, Mot. at 3—and when to provide its notice of
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`commercial marketing. See Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1666 (2017).3 But there
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`is no statutory authority permitting a biosimilar company to extend the litigation and expunge,
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`without prevailing on the merits, the innovator’s right to relief under § 271(e)(4)(D).
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`of a biosimilar) had expired by the time biosimilar litigation began. In this case, by contrast, the
`litigation is occurring while the regulatory exclusivity remains in place.
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`2 As Mylan notes, unlike in the Hatch-Waxman context, the filing of an infringement suit does
`not stay FDA approval of a biosimilar. Opp. at 9.
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`3 Mylan observes that the biosimilar cedes control under the BPCIA when it fails to comply with
`the patent dance, Sandoz, 137 S. Ct. at 1666, but that is irrelevant here. There is no dispute that
`both parties complied with the patent dance.
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`5
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`Lacking a response to the urgency required by Regeneron’s § 271(e)(4)(D) claim, Mylan
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`also accuses Regeneron of other supposed “true motivation[s]” to advance this case quickly to
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`trial. Opp. at 8. None is accurate.
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`First, Mylan suggests that Regeneron seeks to deprive Mylan of discovery, id., but Mylan
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`admits that Regeneron has already provided “hundreds of pages of detailed contentions”
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`providing Mylan notice of Regeneron’s claims. Additionally, Regeneron is also prepared to
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`make a substantial document production immediately upon entry of a protective order, so that
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`fact discovery may begin imminently. In response to the request in Mylan’s opposition for “an
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`indication as to how many documents [Regeneron] intends on producing,” Regeneron provides
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`the following information in an effort to further the parties’ discovery preparedness. Within 48
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`hours after entry of a protective order, Regeneron intends to produce:
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` 65 lab notebooks pertaining to relevant research and development.
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` Over 3,000 internal, technical documents relating to research and development on
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`aflibercept formulations.
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` Custodial email data from 21 inventors of the patents-in-suit, including each
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`inventor from Regeneron’s proposed twelve patents for whom email data are
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`available.
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` Modules 1 through 4 of the Biologics License Application for Eylea, along with
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`relevant portions of Module 5.
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` The certified patents, file histories, and assignment histories for each of the 24
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`patents asserted in the complaint.
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` Regeneron’s annual reports from 2008 through 2021, and Regeneron's Form 10-K
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`for fiscal years 1999 through 2021.
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`6
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` Employment agreements for multiple inventors of the patents-in-suit.
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`Second, Mylan suggests that a fast trial date will increase the likelihood that the Patent
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`Trial and Appeal Board (“PTAB”) will exercise its discretion to deny two of Mylan’s inter
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`partes review challenges. Opp. at 8-9. However, Regeneron does not even seek to litigate one
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`of these two patents in the first-stage litigation (see Mot. at 6). Regardless, Mylan chose to delay
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`strategically the filing of its two recent petitions—instead of filing them at the same time as its
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`earlier-filed petitions last May, it filed them only last month—and thus any alleged prejudice is
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`of Mylan’s own making. Mylan’s provisional concern about one factor (among many) that
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`might affect one inter partes review is hardly a basis to delay the trial.4
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`Third, Mylan asserts that the second-stage patents are tantamount to a “sword of
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`Damocles” over Mylan while the first-stage patents are litigated. Opp. at 8. But as Regeneron
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`explained (see Mot. at 6), severing and staying claims on certain patents is hardly unprecedented
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`in complex patent ligation, and is particularly appropriate in the biosimilar context where the
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`statute contemplates litigating a “first phase” with a narrower set of patents “before the
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`biosimilar goes to market.” AbbVie, 2022 WL 225881, at *2. That is precisely what Regeneron
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`proposes here. More fundamentally, under Mylan’s proposed schedule, litigation through appeal
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`as to all 24 patents would not be completed before FDA approval, making whatever sword of
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`Damocles Mylan conjures more menacing, not less.
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`4 In view of the PTAB’s recent guidance, a district court trial schedule is only one among several
`factors relevant to the PTAB’s decision to institute. Katherine K. Vidal Memorandum, Interim
`Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District
`Court Litigation, United States Patent and Trademark Office (June 21, 2022),
`https://www.uspto.gov/about-us/news-updates/director-vidal-provides-clarity-patent-trial-and-
`appeal-board-practice.
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`7
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`Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 8 of 10 PageID #: 1941
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`II.
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`RELIEF UNDER § 271(e)(4)(D) IS FEASIBLE
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`Mylan asserts that a June 2023 trial is not feasible, Opp. at 6, largely by ignoring
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`Regeneron’s proposal to narrow this case and begin discovery quickly and the requirement in
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`Rule 40 to prioritize actions involving federal statutory rights at risk of being mooted through
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`delay. Mot. at 3-4, 6. The parties are apparently in agreement that keeping all twenty-four
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`patents in the case is incompatible with a fast schedule. Opp. at 6-7; Mot. at 6. Where the
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`parties differ is whether an expedited schedule could comport with the discovery necessary in
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`this case. Id. Regeneron is committed and able to begin fact discovery immediately upon
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`agreement of a protective order (Mylan already has Regeneron’s proposed Order), including by
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`producing within 48 hours of an Order the substantial document production outlined above.
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`Likewise, Regeneron has contacted Mylan to schedule a Rule 26(f) meeting and has provided
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`notice of the discovery Regeneron seeks from Mylan. A fast schedule will not deprive Mylan (or
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`Regeneron) of reasonable discovery, and Regeneron intends to work cooperatively with Mylan
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`to achieve a fast schedule while treating both parties fairly. While Mylan asserts that
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`Regeneron’s proposal fails to contemplate the “full scope of the many factual and legal issues,”
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`the ones listed by Mylan, such as “whether the claims of the asserted patents are invalid” and
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`“the scope and construction of the claims” are typical issues in patent litigation and do not
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`foreclose a fast schedule. Opp. at 7. Likewise, Regeneron obviously does not seek to assert the
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`“566 potential claims at issue” among twenty-four patents at trial, but rather seeks to limit the
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`number of patents now (Mot. at 6) and further narrow claims substantially as the case progresses.
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`Regeneron appreciates Mylan’s offer to “make all reasonable efforts to work with
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`Regeneron to prioritize a subset of patents for trial” and to discuss proposals to streamline the
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`issues for the Court. Opp. at 14. Regeneron will do likewise, including to discuss proposals so
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`that “Mylan receives certainty.”
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`8
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`Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 9 of 10 PageID #: 1942
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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)
`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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`Date: August 23, 2022
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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)
`Nicholas Jordan (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
`njordan@wc.com
`
`
`
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`Counsel for Plaintiff Regeneron Pharmaceuticals, Inc.
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`9
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`Case 1:22-cv-00061-TSK-JPM Document 41 Filed 08/23/22 Page 10 of 10 PageID #: 1943
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`CERTIFICATE OF SERVICE
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`I hereby certify that on August 23, 2022, I electronically filed the foregoing with the
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`Clerk of the Court by using the Court’s CM/ECF system. Counsel of record for all parties will
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`be served by the Court’s CM/ECF system.
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`/s/ Steven R. Ruby
`Steven R. Ruby
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`10
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