Case 1:22-cv-00061-TSK-JPM Document 7 Filed 08/05/22 Page 1 of 8 PageID #: 1748
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Case No. 1:22-cv-00061-TSK
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`JURY TRIAL DEMANDED
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`REGENERON PHARMACEUTICALS, INC.,
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`MYLAN PHARMACEUTICALS INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`MOTION REQUESTING EXPEDITED STATUS CONFERENCE
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`This is a patent case concerning Eylea®, a market-leading drug for treating certain serious
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`eye diseases that, if left untreated, can lead to permanent blindness. The plaintiff, Regeneron
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`Pharmaceuticals, Inc. (“Regeneron”), invented and developed Eylea® and markets it in the
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`United States, along with other life-transforming medicines for diseases including Ebola,
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`COVID-19, cancer, and other cardiovascular and metabolic diseases. Compl. ¶ 1. The
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`defendant, Mylan Pharmaceuticals Inc. (“Mylan”), is a generic drug company seeking to market
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`a “biosimilar” copy of Eylea®.
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`To vindicate its patent rights, Regeneron seeks a statutory permanent injunction under 35
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`U.S.C. § 271(e)(4)(D). That statutory provision, which is unique to biosimilar patent litigation,
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`contains a critical timing limitation: relief under § 271(e)(4)(D) requires resolving the parties’
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`disputes through final judgment and appeal before the date on which FDA may approve the
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`biosimilar product for marketing. Because FDA could approve Mylan’s proposed Eylea®
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`biosimilar in May 2024, Regeneron moves for an expedited status conference under Rule 40 and
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`28 U.S.C. § 1567 to position this case for trial no later than June 2023, so that Regeneron may
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`avail itself of the relief provided by § 271(e)(4)(D).
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`1
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`Regeneron has conferred with Mylan regarding this request for an expedited status
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`conference. Mylan has not stated its position.
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`I.
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`BACKGROUND
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`Although Regeneron filed its Complaint just days ago on August 2, 2022, Dkt. No. 1,
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`over the past several months the parties have exchanged their infringement and validity
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`contentions regarding the twenty-four asserted patents as part of a statutorily-mandated process
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`known informally as the “patent dance.” Mandated by the Biologics Price Competition and
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`Innovation Act (“BPCIA”), the patent dance requires a series of information exchanges between
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`the parties, with the goal of identifying the issues for subsequent biosimilar patent litigation and
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`thus facilitating adjudication of remaining disputes before commercialization of the proposed
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`biosimilar product. See 42 U.S.C. § 262(l).
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`In October 2021, Mylan submitted a regulatory application seeking approval of a
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`biosimilar version of Regeneron’s Eylea® product. Pursuant to the BPCIA, 42 U.S.C.
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`§ 262(l)(2), Mylan was required to share information about its proposed biosimilar with
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`Regeneron. That information revealed that any marketing of Mylan’s biosimilar copy of Eylea®
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`will infringe numerous Regeneron patents.
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`Mylan’s regulatory filing also set in motion the parties’ statutory patent dance exchanges,
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`which have advanced the parties’ understanding of what will be at issue in this case far beyond
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`what would be achieved through the ordinary filing of a complaint. Pursuant to that statutory
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`regime for exchanges of information, Mylan made available its regulatory application describing
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`various aspects of its proposed biosimilar product. In response, Regeneron identified the patents
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`that it believes Mylan’s proposed biosimilar would infringe. The parties then exchanged detailed
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`contentions containing their positions as to the infringement and validity of those patents.
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`2
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`The parties, thus, are not starting this case from scratch. On the contrary, prior to the
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`filing of this lawsuit, the parties exchanged thousands of pages of information about their
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`positions concerning the patents listed in Regeneron’s Complaint. As such, the parties have
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`already been working toward identifying and narrowing the issues for litigation pursuant to a
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`statutory scheme intended to facilitate swift adjudication of patent disputes before
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`commercialization of a proposed biosimilar product. 42 U.S.C. § 262(l); Compl. ¶¶ 17-22.
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`As part of the patent dance, Regeneron proposed litigating at this juncture only a subset
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`of the patents it alleges Mylan infringes. Mylan, however, proposed litigating 25 patents in this
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`case. Regeneron explained that attempting to litigate that many patents in a single proceeding
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`would be inefficient for the parties and burdensome on the Court. But Mylan refused to narrow
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`its list, and by the terms of the BPCIA, the biosimilar’s list of patents dictates the scope of the
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`Complaint. 42 U.S.C. §§ 262(l)(5), 262(l)(6). Accordingly, Regeneron was compelled by
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`statute to bring suit on each of the patents on Mylan’s list. Compl. ¶ 22. Regeneron did so.1
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`II.
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`AN EXPEDITED STATUS CONFERENCE IS WARRANTED
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`Pursuant to Rule 40, Regeneron respectfully requests an expedited status conference to
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`put in place a case schedule that will enable Regeneron to obtain the statutory relief it seeks
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`under 35 U.S.C. § 271(e)(4)(D). Rule 40 requires courts to “give priority to actions entitled to
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`priority by a federal statute.” Fed. R. Civ. P. 40. One such priority statute, 28 U.S.C. § 1657,
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`directs courts to expedite an action upon a showing of “good cause,” which exists where a
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`federal statutory right “would be maintained in a factual context that indicates that a request for
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`expedited consideration has merit.” Id. As the legislative history explains, “the ‘good cause’
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`1 During the patent dance, Regeneron did not contend infringement on one of the patents on its
`list and thus did not bring suit on that patent. The Complaint thus asserts 24 patents in total.
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`3
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`standard could properly come into play, for example, in a case in which failure to expedite would
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`result in mootness or deprive the relief requested of much of its value.” H.R. REP. 98-985, 1984
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`U.S.C.C.A.N. 5779, at 5784. Good cause exists here because without an expeditious case
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`schedule, Regeneron could be deprived of the relief it seeks under § 271(e)(4)(D)—a form of
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`injunctive relief created by statute specifically for biologic innovators in biosimilar patent actions
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`like this one. See Compl. Prayer for Relief (b).
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`Section 271(e)(4)(D) provides that a court “shall order a permanent injunction” against a
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`proposed biosimilar product upon issuance of “a final court decision” of patent infringement—
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`provided that “the biological product has not yet been approved”:
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`(4) For an act of infringement described in paragraph (2)—
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`. . .
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`(D) the court shall order a permanent injunction prohibiting any
`infringement of the patent by the biological product involved in the
`infringement until a date which is not earlier than the date of the
`expiration of the patent that has been infringed under paragraph
`(2)(C), provided the patent is the subject of a final court decision,
`as defined in section 351(k)(6) of the Public Health Service Act, in
`an action for infringement of the patent under section 351(l)(6) of
`such Act, and the biological product has not yet been approved
`because of section 351(k)(7) of such Act.
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`A “final court decision” under § 271(e)(4)(D) is “a final decision of a court from which no
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`appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been
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`or can be taken.” 42 U.S.C. § 262(k)(6)(C)(ii). Here, that “final court decision” in all likelihood
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`will require a decision from the United States Court of Appeals for the Federal Circuit, which
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`has jurisdiction over appeals in patent cases. 28 U.S.C. § 1295(a)(1).
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`In addition, § 271(e)(4)(D) requires that at the time of the “final court decision,” “the
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`biological product has not yet been approved because of section 351(k)(7).” Section 351(k)(7)
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`provides that approval of a biosimilar product “may not be made effective by the Secretary until
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`the date that is 12 years after the date on which the reference product was first licensed under
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`subsection (a),” plus certain additional time conferred for regulatory exclusivities. Here, that
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`date is at the latest May 18, 2024,2 which includes an additional six months of exclusivity that
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`Regeneron is seeking based on clinical trials to obtain approval for use of Eylea® in pediatric
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`patients. 42 U.S.C. § 262(k)(7); Compl. ¶ 2.
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`Taken together, for Regeneron to avail itself of the statutory relief provided under
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`§ 271(e)(4)(D), a judgment must be issued by this Court in sufficient time for the Federal Circuit
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`to issue a “final court decision” in advance of May 18, 2024. As a practical matter, Regeneron
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`submits that doing so requires a trial no later than June 2023.
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`A prolonged trial schedule in this case, by contrast, would render Regeneron’s claim for
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`relief under § 271(e)(4)(D) a nullity, contrary to Rule 40 and the text and statutory design of the
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`BPCIA. That the plain text of § 271(e)(4)(D) premises relief on a “final court decision” before
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`biosimilar approval demonstrates that Congress contemplated such decision to precede approval,
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`where possible. And the legislative history confirms that the BPCIA was designed to facilitate
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`“litigat[ing] patent disputes quickly and efficiently.” Assessing the Impact of a Safe and
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`Equitable Biosimilar Policy in the United States: Hearing Before the Subcomm. on Health of the
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`H. Comm. on Energy & Commerce, 110th Cong. 119 (2007) (statement of Bruce Downey,
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`chairman of the Generic Pharmaceutical Association and CEO of Barr Pharmaceuticals, Inc.),
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`available at https://www.govinfo.gov/app/details/CHRG-110hhrg40500/context; see also Amgen
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`Inc. v. Apotex Inc., 827 F.3d 1052, 1062 n.3 (Fed. Cir. 2016) (citing Downey statement as
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`evidence of design of BPCIA). That is precisely what should happen here: in accordance with
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`2 Regeneron expects to obtain pediatric exclusivity in the near future. Absent such exclusivity,
`Regeneron’s regulatory exclusivity would expire six months earlier, which would make a fast
`trial even more critical.
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`5
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`Case 1:22-cv-00061-TSK-JPM Document 7 Filed 08/05/22 Page 6 of 8 PageID #: 1753
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`Rule 40 and the purpose of the BPCIA, Regeneron’s infringement claims should be tried quickly,
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`rather than allowing the clock to run out on the statutorily prescribed relief.
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`To prepare this case for trial in June 2023, Regeneron respectfully proposes two
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`solutions: (1) to select for a first trial a manageable subset of the asserted patents, and (2) to
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`accelerate discovery. On (1), it would be virtually impossible to litigate “quickly and efficiently”
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`a case involving twenty-four patents. Accordingly, Regeneron proposes that the case’s initial
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`stage involve a reasonable subset consisting of no more than the following twelve patents: U.S.
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`Patent Nos. 10,857,205, 10,888,601, 10,927,342, 11,053,280, 11,066,458, 11,084,865,
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`11,104,715, 11,174,283, 11,186,625, 11,253,572, 11,299,532, and 11,306,135. As courts have
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`done in similar circumstances, this “first phase” of litigation would “focus[] . . . on certain
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`contested patents for expeditious litigation.” See AbbVie Inc. v. Alvotech hf., No. 21-cv-2899,
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`2022 WL 225881, at *1, *6 (N.D. Ill. Jan. 26, 2022) (“The BPCIA creates a procedure by which
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`the parties can litigate the most contested and consequential patents immediately, see § 262(l)(6),
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`giving both parties what is likely a definitive answer, with lower costs and on an expedited
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`schedule.”); see also, e.g., In re Omeprazole Patent Litig., 536 F.3d 1361, 1366 (Fed. Cir. 2008)
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`(sever and stay of patent and antitrust claims); Datatreasury Corp. v. Wells Fargo & Co., 490 F.
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`Supp. 2d 749, 751-52 (E.D. Tex. 2006) (severing and staying claims on some patents). On (2),
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`the parties have already exchanged voluminous contentions; Regeneron has already received
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`access to portions of Mylan’s regulatory application; and promptly upon entry of a protective
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`order Regeneron is prepared to make an immediate substantial document production to Mylan
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`including the patents and file histories, Regeneron’s regulatory filings, key laboratory notebooks,
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`and other scientific and inventor documents. Limited to the proposed subset of patents, the
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`remaining fact discovery that Regeneron intends to seek from Mylan will be tailored and can be
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`conducted consistent with a trial date in June 2023.
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`Accordingly, Regeneron respectfully requests a status conference at the Court’s earliest
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`convenience to position this case for a fast trial. Regeneron thanks the Court for its attention to
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`this matter.
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`Date: August 5, 2022
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`Of Counsel:
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`David I. Berl (pro hac vice forthcoming)
`Ellen E. Oberwetter (pro hac vice forthcoming)
`Thomas S. Fletcher (pro hac vice forthcoming)
`Andrew V. Trask (pro hac vice forthcoming)
`Teagan J. Gregory (pro hac vice forthcoming)
`Shaun P. Mahaffy (pro hac vice forthcoming)
`Kathryn S. Kayali (pro hac vice forthcoming)
`Arthur J. Argall III (pro hac vice forthcoming)
`Adam Pan (pro hac vice forthcoming)
`Nicholas Jordan (pro hac vice forthcoming)
`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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` 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)
`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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`Case 1:22-cv-00061-TSK-JPM Document 7 Filed 08/05/22 Page 8 of 8 PageID #: 1755
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`CERTIFICATE OF SERVICE
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`I certify that on this 5th day of August 2022, I electronically filed the foregoing “MOTION
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`REQUESTING EXPEDITED STATUS CONFERENCE,” with the Clerk of the Court using the
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`CM/ECF system and deposited same in the United States Mail, postage prepaid to the following:
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`Mylan Pharmaceutical Inc.
`3711 Collins Ferry Road
`Morgantown, WV 26505
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
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