Case 1:22-cv-00061-TSK-JPM Document 78 Filed 09/29/22 Page 1 of 5 PageID #: 2180
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
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`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
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`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`Defendant.
`
`
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`Case No. 1:22-cv-00061-TSK
`
`JURY TRIAL DEMANDED
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`
`
`REGENERON’S RESPONSE TO MYLAN’S POST-HEARING SUPPLEMENT
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`Regeneron supplies this brief response to Mylan’s “Post-Hearing Supplement,” filed
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`following the Court’s September 29, 2022 scheduling conference. Though Mylan was forced to
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`acknowledge that the BPCIA governs this proceeding, Mylan’s submission again provides no
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`response regarding the statutory remedy provided for by the BPCIA in 35 U.S.C. § 271(e)(4)(D),
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`other than to ignore it and hope the Court enters a late trial date to render it a dead letter. That
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`statutory relief is an important component of the bargain that Congress struck in creating a path
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`for biosimilars to rely on innovators’ clinical data and develop products through an abbreviated
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`pathway.
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`The Court has ample case management tools to fashion a schedule that will allow
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`Regeneron to avail itself of that statutory relief, including through phased trial proceedings or
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`otherwise. E.g., Fed. R. Civ. P. 42(b); 54(b). Regeneron also has made clear that it is prepared
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`to take steps that will render the schedule feasible, such as committing to voluntary, early
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`document production and limiting the number of patents for trial. See ECF 7 (Motion for
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`Expedited Status Conference), 75 (Rule 26(f) Report). And, in an effort to accommodate
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`Mylan’s request for greater certainty, Regeneron also offered not to seek injunctive relief against
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`1
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 001
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`

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`Case 1:22-cv-00061-TSK-JPM Document 78 Filed 09/29/22 Page 2 of 5 PageID #: 2181
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`
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`the U.S. marketing or sales of Mylan’s current aBLA product (BLA No. 761274) on the patents
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`asserted in the Complaint but not tried during the first stage of litigation. That is a concrete
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`proposal, not a “vague[]” suggestion, as Mylan asserts. It is a way to give Mylan the certainty it
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`professes to seek and avoid the concern it raised repeatedly (ECF 26 at 3, 5, 9) regarding these
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`patents interfering with Mylan’s commercialization. As a practical matter, given that Regeneron
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`has agreed that it will not seek injunctive relief in connection with the patents not initially
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`litigated against the U.S. marketing or sales of Mylan’s current aBLA product (BLA No.
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`761274), it is unlikely that the second phase will proceed at all in the event that Regeneron
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`prevails as to any of the patents asserted in the first phase.
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`So that its proposal is not subject to mischaracterization as “vague,” Regeneron attaches a
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`proposed order that would effectuate Regeneron’s proposal, which provides:
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`(1)
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`Three days after the Scheduling Order setting the case for a June 2023 trial,
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`Regeneron will identify 6 patents from 3 patent families to proceed in the first
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`stage of litigation;
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`(2)
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`That same day, Regeneron will also stipulate that it will not seek injunctive relief
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`against the U.S. marketing or sales of Mylan’s current aBLA product (BLA No.
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`761274) on the other 18 patents asserted in the Complaint;
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`(3)
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`Upon the later of (a) seven days after the Court’s Markman order or (b) seven
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`days after the close of fact discovery, Regeneron will further narrow the first-
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`stage litigation to three patents and a maximum of 25 claims.
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`Mylan rejects even this framework, arguing that Regeneron could still seek damages for
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`infringement on the second-phase patents in the event Mylan launches. ECF 77 at 1-2. But that
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`would be the case even under Mylan’s proposed schedule. Specifically, Mylan has proposed to
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`2
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 002
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`

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`Case 1:22-cv-00061-TSK-JPM Document 78 Filed 09/29/22 Page 3 of 5 PageID #: 2182
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`litigate all 24 patents at a trial two years from now, in September 2024, well after the time when
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`Mylan’s product presumably will be approved and when Mylan may launch. ECF 75-2,
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`“Proposal 1.” And under that scenario, Mylan would face the uncertain prospect of both
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`injunctive relief and damages with respect to all 24 of the asserted patents. Regeneron’s
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`proposal, in contrast, would give Regeneron the opportunity to obtain statutory relief under
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`§ 271(e)(4)(D) on the first-stage patents while giving Mylan certainty against injunctive relief on
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`the second-stage patents with respect to the U.S. marketing or sales of its current aBLA product.
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`Even in the highly unlikely event that all 18 of the other patents were litigated in a second phase,
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`there is no reason that litigation could not also proceed to trial by late 2024—that is, when Mylan
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`has proposed it should take place anyway under its first proposed schedule. It could not be
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`clearer that, notwithstanding its professed need to avoid any risk of damages, Mylan’s true
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`objective is to achieve by scheduling procedure what it cannot achieve on the merits: depriving
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`Regeneron of a statutory injunction.
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`Regeneron thanks the Court for its attention to this matter, and respectfully requests entry
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`of the proposed scheduling order attached to this Response.
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`
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`Date: September 29, 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)
`
`
`
` 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
`
`
`
`3
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 003
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`

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`Case 1:22-cv-00061-TSK-JPM Document 78 Filed 09/29/22 Page 4 of 5 PageID #: 2183
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`
`
`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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`4
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 004
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`

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`Case 1:22-cv-00061-TSK-JPM Document 78 Filed 09/29/22 Page 5 of 5 PageID #: 2184
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`CERTIFICATE OF SERVICE
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`I hereby certify that on September 29, 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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`
`
`
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`
`
`
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`/s/ Steven R. Ruby
`Steven R. Ruby
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`5
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 005
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`

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`Case 1:22-cv-00061-TSK-JPM Document 78-1 Filed 09/29/22 Page 1 of 2 PageID #: 2185
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`Defendant.
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`JURY TRIAL DEMANDED
`
`
`
`[PROPOSED] SCHEDULING ORDER
`
`On September 28, 2022, this Court held a Scheduling Conference in the above-styled
`
`matter. Pursuant to Federal Rules of Civil Procedure 16(b) and 26(f), and the Local Rules of
`
`Civil Procedure, it is hereby ORDERED that the below listed dates be adopted:
`
`
`Regeneron identifies 6 patents from 3 patent
`families for initial proceedings. All deadlines herein
`apply only to those patents.
`Regeneron stipulates that it will not seek injunctive
`relief on the other 18 patents asserted in its
`Complaint (ECF 1) with respect to the United States
`marketing or sales of Mylan’s current aBLA Product
`(BLA No. 761274)
`Rule 26 Disclosures
`Submission of Protective Order or Disagreements
`concerning same
`Markman: exchange of proposed terms for
`construction
`Markman: exchange of preliminary constructions
`and intrinsic support
`Markman: File joint claim construction chart
`The parties may identify no more than 12 claim
`terms for construction (6 per side)
`
`DATE
`
`3 days after this Order
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`October 7, 2022
`
`October 7, 2022
`
`October 13, 2022
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`October 20, 2022
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`October 27, 2022
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`Markman: file positions regarding word limits
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`October 27, 2022
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`1
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 006
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`Case 1:22-cv-00061-TSK-JPM Document 78-1 Filed 09/29/22 Page 2 of 2 PageID #: 2186
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`
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`Markman: parties file joint opening claim
`construction briefs
`Markman: parties file joint responsive claim
`construction briefs
`Substantial completion of document production
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`Markman hearing
`Deadline to amend pleadings
`Parties serve final infringement and invalidity
`contentions
`Close of Fact Discovery
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`Regeneron narrows initial proceedings to 3 patents
`and 25 claims
`
`Opening Expert Reports on Issues for Which the
`Party Bears the Burden of Proof
`Responsive/Rebuttal Expert Reports
`Reply Expert Reports
`Motions for Summary Judgment (if any)
`Close of Expert Discovery
`Motions in Limine and Daubert Motions
`Responses to Motions in Limine and Daubert
`Motions
`Joint Stipulation of Facts
`Proposed Joint Pretrial Order, L.R. Civ. P. 16.04(b)
`Final Pretrial and Settlement Conference
`Trial
`
`It is so ORDERED.
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`November 10, 2022
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`November 23, 2022
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`November 30, 2022
`December 1, 2022, or at Court’s
`Convenience
`December 2, 2022
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`December 9, 2022
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`December 21, 2022
`7 days after Markman order or 7 days
`after close of fact discovery, whichever
`is later
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`January 26, 2023
`
`February 23, 2023
`March 23, 2023
`April 13, 2023
`April 20, 2023
`May 4, 2023
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`May 18, 2023
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`June 8, 2023
`June 8, 2023
`June __, 2023
`June __, 2023
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`The Clerk is directed to transmit copies of this Order to all counsel of record herein.
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`DATED: _________
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`THOMAS S. KLEEH, CHIEF JUDGE
`NORTHERN DISTRICT OF WEST VIRGINIA
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`2
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2016 PAGE 007
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