Case 1:22-cv-00061-TSK-JPM Document 415 Filed 04/10/23 Page 1 of 12 PageID #: 24089
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`Civil Action No. 1:22-cv-00061-TSK
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S EMERGENCY MOTION TO
`MODIFY SCHEDULING ORDER AND FOR EMERGENCY STATUS CONFERENCE
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`Defendant Mylan Pharmaceuticals Inc. (“Mylan”), by its undersigned counsel, hereby
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`respectfully moves this Court to order Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) to
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`immediately narrow the scope of these initial proceedings to 3 patents and 12 claims in anticipation
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`of trial, currently set to commence in just two months, on June 12, 2023.
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`Despite Mylan’s repeated requests, Regeneron refuses to limit the scope of this litigation
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`commensurate with the expedited schedule it demanded. It insists on proceeding with four patents
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`and 60 asserted claims, even though Regeneron represented to this Court that it would take no
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`more than 12 patent claims to trial. Yet, trial is imminent. Expert discovery closes in ten days,
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`motions for summary judgment are also due in ten days, and the Proposed Joint Pretrial Order is
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`due in 38 days. Mylan—and the Court—should not be forced to contend with five times the
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`number of patent claims during pretrial exchanges and trial, a practical impossibility under the
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`current pretrial schedule and in the nine days the Court has allotted for trial. The time has come
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`for Regeneron to either play its hand or cede its expedited trial schedule.
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`Celltrion Exhibit 1062
`Page 1
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`

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`I.
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`BACKGROUND.
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`Regeneron filed this action just over eight months ago, on August 2, 2022, alleging
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`infringement of 24 patents on the basis of Mylan’s submission of a Biologics License Application
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`(“BLA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval of a biosimilar
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`aflibercept product. (See generally Dkt. 1, Complaint.) Three days later, Regeneron moved the
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`Court for an expedited status conference, seeking to “position this case for trial no later than June
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`2023,” on a subset of patents. (Dkt. 7, Mot. Requesting Expedited Status Conf. at 1.) Even then,
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`Regeneron acknowledged the importance of selecting “a manageable subset of the asserted
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`patents” to litigate. (Id. at 6.)
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`Mylan challenged the feasibility of proceeding to trial in June 2023 on even a subset of the
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`24 asserted patents. (See Dkt. 26, Mylan Resp. to Mot. Requesting Expedited Status Conf. at 11-
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`12.) On September 29, 2022, the Court held a Scheduling Conference, wherein Regeneron’s
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`counsel confirmed that it would “do further reduction with respect to the number of claims at an
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`appropriate time,” suggesting that “before trial, [Regeneron] will narrow it further.” (Dkt. 90,
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`Status Conf. Tr. at 22:16 – 23:8.) Regeneron told the Court that it was “not going to come before
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`Your Honor asking [the Court] to adjudicate even 24 claims,” “mak[ing] it manageable . . . in view
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`of the schedule.” (Id. at 23:8-13.) Regeneron’s counsel further represented that he “would be
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`shocked if we present more than a dozen claims to Your Honor for adjudication at trial.” (Id. at
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`9:9-11.)
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`Because of Regeneron’s representations that it would streamline the litigation in order to
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`proceed to trial in June 2023, on October 25, 2022, the Court adopted Regeneron’s proposed
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`Scheduling Order. The parties have therefore proceeded at an unusually brisk pace, engaging in
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`Markman proceedings, fact discovery, and expert report exchanges within approximately five
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`months. (See Dkt. 87, Scheduling Order.) The Scheduling Order contemplated two rounds of
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`2
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`Celltrion Exhibit 1062
`Page 2
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`claim narrowing in advance of motions for summary judgment, preparation of the Proposed Joint
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`Pretrial Order, and Trial. First, Regeneron was ordered to reduce its asserted patents to six within
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`three days following entry of the Order.1 (Id. at 1.) Second, the Scheduling Order (reflecting
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`Regeneron’s proposal) contemplates a further narrowing “to 3 patents and 25 claims” within “7
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`days after Markman order or 7 days after close of fact discovery, whichever is later.” (Id. at 2.)
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`Accordingly, on October 28, 2022, Regeneron filed a Stipulation Regarding Claim
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`Narrowing and Injunctive Relief, wherein it selected six patents to proceed. (See Dkt. 88 at 1.)
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`Regeneron did not, at that time, select a subset of claims from those six patents for adjudication.
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`(Id.) Thus, the parties’ proceeded to litigate well over 100 claims through nearly three (3) months
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`of discovery. Consequently, during Markman briefing, Mylan was forced to contend with well
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`over 100 claims. (Dkt. 122, Mylan Op. Claim Construction Br. at 3-4.) Despite the ongoing
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`prejudice to Mylan in proceeding on over 100 claims under an expedited schedule, Regeneron only
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`hinted at further claim narrowing in its Responsive Claim Construction Brief, served December
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`15, 2023, where it represented to Mylan and the Court that it “[would] not present more than a
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`dozen claims at trial.” (Dkt. 174, Regeneron Resp. Claim Construction Br. at 4 n.1.)
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`On January 24, 2023, the Parties appeared before the Court for a Markman hearing to
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`address claim construction issues on four patents and 68 claims. (See Dkt. 270, Markman Hrg. Tr.
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`at 163:18 – 164:7.) Following the hearing, on February 10, 2023, the parties filed their respective
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`Findings of Fact and Conclusions of Law on Claim Construction, addressing four patents and 63
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`patent claims. (See Dkt. 306, Mylan Findings of Fact and Conclusions of Law at 1, 9, 25 & 57.)
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`1 While that Scheduling Order required Regeneron to reduce the number of asserted patents to six
`within three days following entry of the Order, it placed no limits on the number of claims that
`Regeneron could assert from those six patents.
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`3
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`Celltrion Exhibit 1062
`Page 3
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`Simultaneously with the preparation of Findings of Fact and Conclusions of Law on Claim
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`Construction, the parties began expert discovery. In its Opening Expert Reports on February 2,
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`2023, Regeneron continued to assert infringement of 63 patent claims, requiring hundreds of pages
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`to address each of the elements of those asserted claims. (See Dkt. 287-89.) Similarly, due to the
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`large number of claims still at issue and the distinct elements of each of those 63 patent claims,
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`Mylan served over 1,200 pages of expert reports to adequately address invalidity issues relating to
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`the asserted claims. (See Dkt. 290-96.)
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`On February 27, 2023, counsel for Regeneron apprised Mylan via e-mail that it “will not
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`proceed with asserting in the first stage of the litigation claims 7 and 8 of U.S. Patent 10,888,601
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`and claim 15 of U.S. Patent 11,253,572.” (Ex. A, 2-27-23 E. Oberwetter e-mail.) Thus, as of
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`today, Regeneron is asserting four patents and 60 claims in this case, and as explained below,
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`Regeneron refuses to agree to a date certain to further reduce its asserted patents and claims in
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`advance of trial.
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`Faced with the completion of expert discovery, an imminent deadline for the parties to
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`serve any motions for summary judgment and a looming deadline to submit a Proposed Joint
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`Pretrial Order, Mylan sought some certainty that Regeneron would hold true to its representations
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`to the Court, and also sought to establish an orderly (if expedited) schedule for efficient pretrial
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`disclosures and preparation of the Proposed Joint Pretrial Order. Accordingly, on March 24, 2023,
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`counsel for Mylan proposed certain dates for pretrial disclosures, predicated on Regeneron
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`identifying, on April 14, 2023, the “3 patents and 12 claims it intends to take to trial,” consistent
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`with Regeneron’s repeated representations to the Court that it “will not present more than a dozen
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`claims at trial.” (Ex. B, 3-24-23 E. Hunt e-mail; Dkt. 174, Regeneron Resp. Claim Construction
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`Br. at 4 n.1.) One week later, on March 31, counsel for Regeneron proposed a modified schedule
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`4
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`Celltrion Exhibit 1062
`Page 4
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`for pretrial disclosures, but Regeneron entirely ignored Mylan’s request that it identify the patents
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`and claims it intends to present at trial. (Ex. C, 3-31-23 E. Oberwetter e-mail.) The next business
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`day, Mylan followed-up, requesting Regeneron’s prompt confirmation that it would “identify the
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`three (3) patents and twelve (12) claims that Regeneron intends to take to trial, on April 14th, or
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`provide a date certain on which Regeneron will make that identification.” (Ex. D, 4-3-23 E. Hunt
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`e-mail.) Thereafter, Regeneron refused to engage in further claim narrowing because “[t]he
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`scheduling order provides the timing for further claim narrowing . . . follow[ing] the Court’s order
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`on claim construction.” (Ex. E, 4-3-23 E. Oberwetter e-mail.)
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`II.
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`THE COURT SHOULD MODIFY THE SCHEDULING ORDER TO COMPEL
`REGENERON TO NARROW ISSUES FOR ITS EXPEDITED TRIAL.
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`Regeneron insists that the Court’s October 25, 2022 Scheduling Order (which adopted
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`Regeneron’s proposal) justifies its delay in narrowing the initial proceedings to three patents and
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`no more than twelve claims. (Ex. E, 4-3-23 E. Oberwetter e-mail.) But Regeneron is sitting on its
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`hands when the parties should be working to crystallize the issues for the Court and trial. While
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`Mylan acknowledges that this Court’s Scheduling Order predicates its compulsory claim
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`narrowing on issuance of the Markman order, good cause exists to modify the Scheduling Order
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`in furtherance of the goals of Rule 16, the practicalities of pretrial exchanges and trial, and in
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`recognition of Regeneron’s own insistence that this matter must proceed in an expedited manner.
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`Federal Rule of Civil Procedure 16(b)(4) gives the Court broad discretion to modify its
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`Scheduling Order upon a showing of “good cause.” FED. R. CIV. P. 16(b)(4). The Local Rules of
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`this District further provide that, among other things, “dates concerning pretrial conferences and
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`trial[] may be modified for cause by order.” L.R. CIV. P. 16.01(f)(1).
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`In the Fourth Circuit,
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`“good cause” requires “the party seeking relief [to] show that the deadlines cannot
`reasonably be met despite the party’s diligence,” and whatever other factors are
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`5
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`Celltrion Exhibit 1062
`Page 5
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`also considered, “the good-cause standard will not be satisfied if the [district] court
`concludes that the party seeking relief (or that party’s attorney) has not acted
`diligently in compliance with the schedule.” See 6A Charles Alan Wright, Arthur
`R. Miller, and Mary Kay Kane, Federal Practice and Procedure Civ.3d § 1522.2 (3d
`ed. 2010) (collecting cases)[.]
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`Cook v. Howard, 484 Fed. App’x 805, 815 (4th Cir. 2012); see also Harris v. Q&A Assocs., Inc.,
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`No. 2:16-CV-46, 2018 WL 8458206, at *1-*2 (N.D.W. Va. June 20, 2018); see also Selders v.
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`Megacorp Logistics, LLC, No. 2:14-cv-60, 2015 WL 12910711, at *2 (N.D.W. Va. Apr. 28, 2015).
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`Moreover, Rule 16 mandates that a court issue a Scheduling Order in furtherance of certain specific
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`goals, including “expediting disposition of the action” and “discouraging wasteful pretrial
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`activities.” FED. R. CIV. P. 16(a); see also FED. R. CIV. P. 16(b)(1). Evaluating these goals in view
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`of this case’s procedural posture establishes that good cause exists to modify the Scheduling Order.
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`Expediting Disposition of the Action. It is only because of Regeneron’s insistence on
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`expediting this litigation that the current Scheduling Order is unworkable. In a typical case, the
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`parties would have ample time to narrow issues for trial through dispositive motions and pretrial
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`exchanges. Yet this case is anything but typical. Ironically, Regeneron now refuses to narrow the
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`issues for trial, when it was adamant just months ago that it would do whatever necessary to ensure
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`the case proceeded to trial in June 2023. To the extent that the trial date will hold, and Regeneron
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`continues to insist on expedited disposition of the initial phase of this matter, good cause exists to
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`modify the Scheduling Order in furtherance of that goal.
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`Discouraging Wasteful Pretrial Activities. At present, Regeneron is proposing that the
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`parties engage in dispositive motion practice and preparation of the Proposed Joint Pretrial Order
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`on five times more patent claims than it intends to have tried. Further, Regeneron is also required
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`under the current Scheduling Order to drop one of the patents it is currently asserting, which could
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`result in substantial narrowing of the issues for trial, particularly to the extent that Regeneron drops
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`6
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`Celltrion Exhibit 1062
`Page 6
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`Case 1:22-cv-00061-TSK-JPM Document 415 Filed 04/10/23 Page 7 of 12 PageID #: 24095
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`either the 865 formulation patent or the 715 manufacturing patent.2 Modifying the Scheduling
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`Order to compel Regeneron to immediately narrow the scope of these initial proceedings to the no
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`more than three (3) patents and twelve (12) claims it already promised, (Dkt. 174, Regeneron Resp.
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`Claim Construction Br. at 4 n.1), is necessary to avoid wasteful pretrial activities, causes no
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`prejudice to Regeneron, and is indeed required if this case is to proceed to trial in June.
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`First, engaging in further pretrial activities before claim narrowing would only waste the
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`Court’s and the parties’ resources. To the extent that the parties file motions for summary
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`judgment—currently due just ten days from today—any such motions will necessarily address
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`claims that Regeneron does not intend to take to trial. Forcing the parties to prepare dispositive
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`motions on claims that will ultimately be dropped is an exercise in futility and clearly a wasteful
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`use of the Court’s and parties’ resources.
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`Second, if trial is to proceed in June, the parties must prepare the Proposed Joint Pretrial
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`Order in the next five weeks, addressing the requirements of Local Rule 16.04(b) for each asserted
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`patent claim, resulting in a pretrial order many times more voluminous than necessary or
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`contemplated under the current Scheduling Order. Recognizing this, Mylan proposed that
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`Regeneron agree to narrow the issues in advance of pretrial exchanges, (Ex. B, 3-24-23 E. Hunt e-
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`mail), but Regeneron insists on engaging in wasteful pretrial activities through the preparation of
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`a pretrial order addressing at least 48 patent claims—and likely hundreds of claim elements—that
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`Regeneron admits will not proceed to trial (Ex. E, 4-3-23 E. Oberwetter e-mail). As Regeneron
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`demanded this expedited schedule, it should bear the burden of reducing the claims to a
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`2 At present, the parties are relying on the opinions of fourteen (14) expert witnesses to support
`their claims and defenses with respect to the patents and claims currently at issue. If Regeneron
`were to drop either the 865 formulation patent or the 715 manufacturing patent, a minimum of
`three (3) expert witnesses would no longer testify at the trial because an entire technology area
`would no longer be at issue.
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`7
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`Celltrion Exhibit 1062
`Page 7
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`manageable amount—as it told the Court it would—and it should do so before motions for
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`summary judgment and preparation of the Joint Proposed Pretrial Order.
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`Third, Regeneron simply cannot reasonably take 60 claims to trial. It has repeatedly told
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`this Court that it will not present more than a dozen claims, and even if Regeneron were to move
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`forward with its unreasonable 60 claims, it is practically impossible for the parties and the Court
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`to litigate those claims within the nine (9) days that the Court has allotted for trial.
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`Through this emergency motion, Mylan does not seek to delay. To the contrary, Mylan
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`has established that good cause exists to alleviate any further delay in preparing this matter for
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`trial. Regeneron is the party injecting delay, and absent the relief requested by Mylan, there is a
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`real risk that Scheduling Order deadlines cannot be met.
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`Mylan Has Acted Diligently. Mylan made significant efforts to comply with the
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`Scheduling Order, including producing over one million pages of documents, conducting over 20
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`depositions during fact discovery, and serving over 1,200 pages of expert reports addressing the
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`invalidity of the claims at issue alone, all while repeatedly requesting that Regeneron reduce issues
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`for trial. Most recently, Mylan proposed that Regeneron identify its selected three patents and 12
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`claims by April 14, 2023, which Mylan views as imperative if this matter will proceed to trial in
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`June. (Ex. B, 3-24-23 E. Hunt e-mail.) Throughout, Regeneron has refused to limit the subject
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`matter at issue consistent with the schedule it demanded.
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`Regeneron Will Not Be Prejudiced. Regeneron chose to put this litigation on the fast
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`track, yet Regeneron is riding the brakes on the eve of trial to gain a strategic advantage and
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`prejudice Mylan. Mylan’s requested modification is not seeking to impart delay. To the contrary,
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`Mylan seeks to expedite the crystallization of issues for an imminent trial.
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`8
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`Celltrion Exhibit 1062
`Page 8
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`Should Regeneron assert that it would be prejudiced by Mylan’s requested modification,
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`ostensibly because it requires the Court to construe certain disputed terms found within the patent
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`claims currently at issue, Regeneron must then choose whether it wishes to maintain the expedited
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`schedule it imposed, or potentially forego an early trial in favor of strategic certainty. Months ago,
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`during the Markman hearing, Regeneron already had in mind the claims it was likely to take to
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`trial, and it now has the benefit of full expert discovery on over 60 patent claims—more than
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`enough to permit Regeneron to select patents and claims for trial, regardless of any outstanding
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`claim construction issues.
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`Regeneron alone is in control of the flow of traffic here: either it selects the three patents
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`and 12 claims it wishes to try in this litigation, or the race to the finish slows, and the parties
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`proceed to trial at some future point. Regeneron must select its line, and it must do so now.
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`*
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`*
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`*
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`For at least the above reasons, good cause exists to modify the Scheduling Order and to
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`compel Regeneron to narrow the scope of the litigation to three patents and 12 claims prior to the
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`filing of summary judgment motions and pretrial exchanges, in anticipation of a June trial.
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`III.
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`AN EMERGENCY STATUS CONFERENCE IS NECESSARY TO ASSESS THE
`FEASIBILITY OF PROCEEDING TO TRIAL ON JUNE 12TH.
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`As Mylan’s emergency motion to modify the Scheduling Order makes clear, Regeneron’s
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`refusal to limit the scope of this case in advance of trial calls into question the feasibility of
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`proceeding to trial on June 12, 2023. Absent the narrowing of issues that the Scheduling Order
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`contemplated would occur months ago, Mylan believes that the parties will be unable to submit a
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`Proposed Joint Pretrial Order on May 18, 2023 and, perhaps most importantly, the parties and the
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`Court will be forced to contend with five times the number of patent claims—totaling hundreds of
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`additional claim elements—which the parties must address in their proofs both prior to trial and
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`9
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`Celltrion Exhibit 1062
`Page 9
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`24098
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`during trial. Simply put, assuming Regeneron’s continued refusal to meaningfully limit the case,
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`it is a practical impossibility to maintain the current pretrial and trial schedule.
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`IV.
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`CONCLUSION
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`For the reasons set forth herein, Mylan respectfully requests that the Court grant Mylan’s
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`emergency motion to modify the Scheduling Order and convene an emergency status conference
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`to discuss preparations for trial, currently set for June 12, 2023.
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`10
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`Celltrion Exhibit 1062
`Page 10
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`

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`Case 1:22-cv-00061-TSK-JPM Document 415 Filed 04/10/23 Page 11 of 12 PageID #:
`24099
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`Dated: April 10, 2023
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`STEPTOE & JOHNSON PLLC
`
`Of Counsel (admitted pro hac vice):
`Of Counsel (admitted pro hac vice):
`William A. Rakoczy
`Deanne M. Mazzochi
`Heinz J. Salmen
`Eric R. Hunt
`Jeff A. Marx
`Neil B. McLaughlin
`Lauren M. Lesko
`L. Scott Beall
`Thomas H. Ehrich
`Steven J. Birkos
`Katie A. Boda
`Abraham J. Varon
`Jake R. Ritthamel
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 527-2157
`wrakoczy@rmmslegal.com
`dmazzochi@rmmslegal.com
`hsalmen@rmmslegal.com
`ehunt@rmmslegal.com
`jmarx@rmmslegal.com
`nmclaughlin@rmmslegal.com
`llesko@rmmslegal.com
`sbeall@rmmslegal.com
`tehrich@rmmslegal.com
`sbirkos@rmmslegal.com
`kboda@rmmslegal.com
`avaron@rmmslegal.com
`jritthamel@rmmslegal.com
`
` /s/ William J. O’Brien
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Attorneys for Defendant
`Mylan Pharmaceuticals Inc.
`
`11
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`Celltrion Exhibit 1062
`Page 11
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`

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`Case 1:22-cv-00061-TSK-JPM Document 415 Filed 04/10/23 Page 12 of 12 PageID #:
`24100
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`CERTIFICATE OF SERVICE
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`I certify that on the 10th day of April 2023, I filed the foregoing “DEFENDANT MYLAN
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`PHARMACEUTICALS INC.’S EMERGENCY MOTION TO MODIFY SCHEDULING
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`ORDER AND FOR EMERGENCY STATUS CONFERENCE” using the Court’s CM/ECF
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`system, which will send notification of the filing to all counsel of record.
`
` /s/ William J. O’Brien
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Attorneys for Defendant
`Mylan Pharmaceuticals Inc.
`
`12
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`Celltrion Exhibit 1062
`Page 12
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`