Case 1:22-cv-00061-TSK-JPM Document 26 Filed 08/19/22 Page 1 of 16 PageID #: 1904
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`Case No.: 1:22-cv-00061-TSK
`
`MYLAN PHARMACEUTICALS INC.’S RESPONSE TO
`MOTION REQUESTING EXPEDITED STATUS CONFERENCE
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`For at least the reasons set forth below, the Court should (1) deny Regeneron’s motion for
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`an expedited status conference (and trial date) in its entirety, and (2) permit this case to proceed
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`on an appropriate schedule that does not prejudice Mylan or the Court. Regeneron provides no
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`valid reason that would justify its extraordinary proposal to set trial for 10 months, let alone a plan
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`to conduct discovery and otherwise resolve the complex scientific and legal issues in dispute. As
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`ordered, Mylan will confer with Regeneron on an appropriate schedule and submit the parties’
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`meeting report on September 23, 2022. First Order and Notice Regarding Discovery and
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`Scheduling Conference (Dkt. No. 19) (Aug. 10, 2022). Mylan is prepared to discuss these issues
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`with the Court at a scheduling conference in the normal course as necessary.
`
`I.
`
`INTRODUCTION.
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`Based on an erroneous premise regarding permanent injunctive relief, Regeneron seeks an
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`unprecedented schedule in a complex biopharmaceutical matter in which Regeneron chose to
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`assert 24 patents. Regeneron’s premise is that “in all likelihood” it will lose any right to permanent
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`injunctive relief unless it receives an appellate decision prior to May 18, 2024. Regeneron’s
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`claimed need does not exist. Rushing to trial in fewer than 10 months on a complex, 24 patent
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`case⸺which even Regeneron concedes is not possible⸺is not only legally unnecessary, but
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`transparently designed to prejudice Mylan’s ability to engage in meaningful discovery, and will
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`unduly burden both the parties and the Court.
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`First, practically speaking, Regeneron’s proposed trial date of June 2023 is simply not
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`feasible—indeed, Regeneron’s Complaint puts at issue 566 patent claims across 24 asserted
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`patents stemming from 11 separate patent families with a collective 33 unique inventors, across a
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`wide range of non-overlapping technology areas (e.g., cell culture process patents, protein
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`purification patents, assay patents, cell line patents, method of treatment patents, formulation
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`patents, among others). Even if Regeneron’s justification for such an expedited schedule is correct
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`(it’s not), it would not justify denying the parties a reasonable time to conduct fact and expert
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`discovery in a complex biosimilar patent infringement action like this one.
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`What’s more, the problem would not be solved by Regeneron’s proposal for a unilateral
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`and self-serving selection of 12 patents for the case’s initial stage, at least because Regeneron’s
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`so-called “reasonable subset” includes patents from only 4 of the 11 families. Regeneron does not
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`propose to waive its claims as to the 12 remaining “unselected” patents and does not even offer a
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`proposal to timely resolve these patents, thus leaving the door open for Regeneron to assert those
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`patents against Mylan at any time in the future, including on the eve of trial or a potential product
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`launch. Accordingly, Regeneron’s so-called “solutions” only serve to delay patent clarity and
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`resolution on the merits in addition to increasing the likelihood of rushed motion practice.
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`Second, Regeneron’s premise is simply wrong. Contrary to Regeneron’s assertion, it will
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`not be deprived of any opportunity for injunctive relief absent a “final court decision” (e.g., a
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`Federal Circuit decision) before May 18, 2024, as explained in more detail below. Regardless of
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`when Mylan’s biosimilar is approved by FDA, Regeneron can seek injunctive relief to the extent
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`it can satisfy the requirements for such extraordinary relief, just as any litigant can do. Simply put,
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`Congress intentionally designed the biosimilar regulatory pathway to be independent from the
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`patent dispute framework—the resolution of patent disputes does not affect the timing of FDA
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`approval and vice versa.
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`Third, Regeneron’s proposal is not only unrealistic and contrary to the statute, it also
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`disrupts the careful balance created by Congress that was designed, in part, to allow the biosimilar
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`applicant to control the scope and timing of litigation. Regeneron essentially seeks to rob Mylan
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`of one of the benefits of availing itself of the optional patent dispute provisions of the Biologics
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`Price Competition and Innovation Act (BPCIA). Regeneron’s proposal skews the balanced
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`incentives for biosimilar applicants to make substantial pre-suit disclosures of their regulatory
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`application, manufacturing information, and defenses—all the while delaying patent certainty for
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`potentially 8+ months.
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`To be clear, a protracted litigation provides no benefit to the parties or to the Court. Mylan
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`has every incentive to litigate the present patent disputes “quickly and efficiently,” but disagrees
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`that either party must sacrifice its respective ability to reasonably litigate this case under the
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`Federal Rules. For the reasons set forth herein, Regeneron fails to show that the June 2023 trial
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`date it seeks is necessary, equitable, or otherwise justified, and thus, its motion should be denied,
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`allowing the parties to engage in the ordinary case-scheduling process leading to a reasonable trial
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`date.
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`II.
`
`BACKGROUND.
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`A.
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`The “Patent Dance” Under The BPCIA.
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`Through the BPCIA, Congress amended the Public Health Service Act and the Patent Act
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`in an effort to balance the goals of competition and innovation. BPCIA § 7001(b), Pub. L. No.
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`3
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`111-148. To expedite competing “biosimilars” to market, Congress created an abbreviated
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`regulatory approval pathway that allows a biosimilar applicant (here, Mylan) to rely, in part, on
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`the data supporting the previous approval of a reference biologic product (here, EYLEA®
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`(aflibercept)). 42 U.S.C. § 262(i)(2), (k). In exchange, Congress granted the reference product
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`sponsor (RPS) (here, Regeneron) 12 years of marketing exclusivity, independent of any patent
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`protection to which it is entitled.
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`In addition to the new regulatory pathway, Congress also created a flexible patent
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`resolution framework through which the biosimilar applicant and the RPS could identify patents
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`to be litigated in connection with the proposed biosimilar. By way of an optional multi-stage
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`process commonly referred to as the “patent dance,” the biosimilar applicant and RPS may
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`exchange information and negotiate a final patent list that is either generated by agreement or
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`through the simultaneous exchange of patent lists. 42 U.S.C. § 262(l)(2)-(l)(6). Each biosimilar
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`applicant must also provide advance notice to the RPS at least 180 days before the first commercial
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`marketing of the biosimilar. 42 U.S.C. § 262(l)(8)(A).
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`B.
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`Mylan And Regeneron Engaged In The “Patent Dance.”
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`Mylan submitted its biologics license application (BLA) for its aflibercept biosimilar on
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`October 29, 2021. Following FDA acceptance of Mylan’s BLA, Mylan and Regeneron engaged
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`in a series of information exchanges and negotiations in which Mylan attempted to narrow the list
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`of patents to be litigated from the list of 31 patents initially identified by Regeneron pursuant to
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`42 U.S.C. § 262(l)(3)(A). Despite several attempts, the parties failed to agree on a final and
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`complete list of patents which would be the subject of an action for patent infringement under
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`Section 262(l)(6)(A).
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`During negotiations, Regeneron suggested asserting 12 of the patents in a first litigation,
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`but refused to provide any clarity on how it intended to proceed with respect to the remaining set
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`4
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`of patents⸺effectively holding the remaining patents over Mylan’s head to be asserted in yet later
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`litigations. Mylan made clear that it wanted to efficiently litigate and/or resolve the disputes
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`between the parties, but also needed some level of certainty that Regeneron was not holding back
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`patents from immediate litigation only to later assert them on the eve of trial or launch as the basis
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`for emergency relief. Mylan expressed concern that reserving patents until an unspecified later
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`date would result in hurried and disorderly motion practice that would unnecessarily burden the
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`Court by forcing the Court and the parties to adjudicate complex legal and scientific concepts
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`instantaneously, on anywhere from 1 to 19 additional patents.
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`To narrow the issues, Mylan made representations about its product; produced information
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`from a third-party cell culture vendor; offered to waive any damages limitations with respect to
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`certain patents; and requested covenants-not-to-sue on any patents Regeneron did not intend to
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`immediately assert. Regeneron not only rejected these proposals, it threatened to immediately sue
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`on all 31 patents if Mylan pushed to litigate more than the 12 patents Regeneron unilaterally
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`identified. Notably, at no point during these negotiations did Regeneron ever disclose its plans to
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`seek a trial date in ten (10) months.
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`Since Mylan and Regeneron were unable to reach agreement, on July 5, 2022, Mylan and
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`Regeneron engaged in a simultaneous exchange of patent lists under 42 U.S.C. § 262(l)(5)(A).
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`Despite the fact that Regeneron’s identified patents are not infringed and/or invalid, Mylan was
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`compelled to identify 25 of those patents on its list in order to obtain the certainty that it seeks
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`because Regeneron refused to drop them from its “patent dance” list.1 Mylan believes a subset of
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`these patents could be prioritized for trial, provided that Mylan receives actual certainty that the
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`1 Mylan did not include 6 patents from Regeneron’s list of 31, because, as Regeneron itself
`admitted, those patents do not cover the current Mylan BLA product that is undergoing FDA
`review.
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`5
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`remaining patents cannot be asserted against Mylan, as well as reasonable limits as to which
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`patents may be the subject of a preliminary injunction motion.
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`As Regeneron notes and expects, in the event it obtains “pediatric exclusivity” in the near
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`future, the earliest Mylan’s BLA is eligible for FDA approval is May 18, 2024. Regeneron Motion
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`(Dkt. No. 7) at 5. Mylan has not yet provided its advance 180-day notice of commercial marketing.
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`III.
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`AN EXPEDITED SCHEDULE IS NEITHER NECESSARY NOR WARRANTED.
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`A.
`
`An Expedited Schedule Is Not Appropriate Nor Feasible Given The Size And
`Complexity Of The Disputed Issues.
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`Simply put, a June 2023 trial date would inevitably and improperly constrain Mylan’s
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`ability to engage in the discovery process and identify relevant information from all parties to the
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`dispute. That is reason enough to deny Regeneron’s motion in its entirety.
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`Mylan is entitled, under the Federal Rules, to take discovery commensurate in scope with
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`Regeneron’s legal claims. The anticipated scope of discovery here is significant considering that
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`there are 33 unique inventors, 24 asserted patents (which collectively comprise a total of 566
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`claims), and 11 patent families. This case will likely also require that the parties obtain overseas
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`discovery, including discovery subject to the Hague Convention, and discovery from third parties
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`(i.e., unrelated parties), including, but not limited to, cell culture media vendors. The asserted
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`patents also cover a broad array of non-overlapping subject matter, including isolated nucleic acid
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`molecules and methods for manufacturing recombinant proteins (the ’959 patent); recombinant
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`host cell lines (the ’106, ’110, and ’055 patents); protein purification methods (the ’280, ’715, and
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`’283 patents); treatment methods for multiple different indications (e.g., macular degeneration (the
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`’338, ’069, ’681, ’601 and ’572 patents), retinal vein occlusion (the ’205 patent), and diabetic
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`macular edema/retinopathy (the ’879 and ’601 patents)); cell culturing/cultivating methods (the
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`’771 and ’342 patents); formulations (the ’992, ’226, ’458, and ’865 patents); detection methods
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`6
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`(the ’594 patent); and compositions (the ’625 and ’135 patents). Accordingly, Mylan expects to
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`identify at least one expert witness for each of the above technology areas, possibly more,
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`depending on the claims that are at issue. And given Regeneron’s use of 5 expert witnesses in a
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`currently pending inter partes review challenge to a single patent (the ’338 patent), it is very likely
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`that Regeneron will be employing a large number of expert witnesses in this litigation. Moreover,
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`Regeneron does not even purport to address how a June 2023 trial date could be workable in view
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`of the extensive claim construction that will be required and/or dispositive motion practice.
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`Additionally, while Regeneron acknowledges in its motion that it has “already received
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`access to portions of Mylan’s regulatory application” and is “prepared to make an immediate
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`substantial document production to Mylan,”2 it fails to take into account that Mylan is also entitled
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`to conduct discovery. Regeneron Motion (Dkt. No. 7) at 6. For example, Regeneron’s proposal
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`does not appear to contemplate the full scope of the many factual and legal issues potentially at
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`issue, including at least the following:
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` whether the claims of the asserted patents are invalid, including based on at least
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`anticipation, obviousness, double patenting, indefiniteness, lack of written description
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`and enablement;
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`
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`
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`the scope and construction of the claims of the asserted patents;
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`if necessary, whether Regeneron has engaged in inequitable conduct that would
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`preclude enforcement of any valid claims; and
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` whether Mylan has infringed and/or is infringing, directly or indirectly, any one of the
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`2 Regeneron has provided no indication as to how many documents it intends on producing, stating
`only that its forthcoming document production will be “substantial,” “including the patents and
`file histories, Regeneron’s regulatory filings, key laboratory notebooks, and other scientific and
`inventor documents.” Regeneron Motion (Dkt. No. 7) at 6.
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`7
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`566 potential claims at issue, and if so, whether such infringement is willful.
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`Importantly, many of the above issues may require judicial intervention, whether motions to
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`compel and/or dispositive motion practice. As such, this case will require significant preparation
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`time and judicial involvement before trial.
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`Without prioritizing 12 of the patents (the problems inherent in this proposal are discussed
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`above), even Regeneron admits its proposed schedule is not feasible. Regeneron, moreover, offers
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`no reasonable mechanism by which a June 2023 trial might possibly occur even with prioritized
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`patents. Is Regeneron willing to agree to limits on written discovery and/or depositions? Is
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`Regeneron willing to voluntarily dismiss patents that it knows to not be infringed and/or knows to
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`be invalid? Will Regeneron forego the opportunity to amend and/or supplement the hundreds of
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`pages of detailed contentions it served during the patent dance?
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`Contrary to Regeneron’s (erroneous) suggestion that its proposed June 2023 trial date is
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`somehow essential to its ability to vindicate its patent rights, Regeneron’s true motivation in
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`seeking an expedited trial schedule on less than all patents is three-fold: One, such an unreasonably
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`expedited pace would inevitably prejudice Mylan’s ability to obtain all necessary discovery
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`relevant to pursue its defenses in response to Regeneron’s complaint allegations (to Regeneron’s
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`advantage). Two, Regeneron can hold the remaining patents over Mylan’s head, like a modern-
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`day sword of Damocles, effectively threatening to assert them in piecemeal fashion on the eve of
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`trial or product launch⸺essentially turning one case into several. And three, a highly abbreviated
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`schedule in the current district court litigation could be used by Regeneron to argue that Mylan’s
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`currently-pending inter partes review challenges to the ’681 and ’601 patents should be denied
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`review. (IPR2022-01225; IPR2022-01226; see also IPR2021-00880 and IPR2021-00881 (late-
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`stage IPRs challenging the ’069 and ’338 patents, with final written decision anticipated by Nov.
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`8
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`2022)).3 None of these motivations are proper, and they certainly do not warrant the highly
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`prejudicial and burdensome relief that Regeneron seeks.
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`As such, even if Regeneron had shown a need for a more expedited schedule (it has not),
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`Regeneron has cited no supporting authority demonstrating how this purported need would trump
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`Mylan’s due process rights to reasonable discovery for a fair trial. Regeneron cannot
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`simultaneously choose to bring a massive collection of disparate claims and truncate Mylan’s
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`rights to discovery and reasonable trial preparation in the face of those claims.
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`B.
`
`Regeneron’s Ability To Obtain Injunctive Relief Is Not Dependent On The
`Timing Of FDA’s Approval Of Mylan’s Biosimilar.
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`Regeneron’s purported need for an expedited trial for permanent injunctive relief prior to
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`FDA approval is not only overstated, but legally baseless.
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`Unlike the patent disputes arising under the Hatch-Waxman Act, Congress did not link
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`FDA approval of biosimilar products to the pendency or outcome of any patent dispute. Critically,
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`under the BPCIA’s patent resolution scheme, the filing of an infringement suit does not result in
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`an automatic stay of FDA approval. Instead, Congress created a defined 180-day window during
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`which an RPS, such as Regeneron, could move to enjoin the commercial manufacture or sale of a
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`competing biosimilar upon making the requisite showing for a patent-based injunction. 42 U.S.C.
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`§ 262(l)(8)(A) (statutory 180-day period for the patent owner to seek an injunction that is triggered
`
`3 Regeneron’s request for expedited scheduling is a thinly veiled tactic Regeneron intends to use
`to request that the Patent Trial and Appeal Board (PTAB) exercise its discretion to deny institution
`of two inter partes reviews recently filed by Mylan, challenging claims of the currently asserted
`’681 and ’601 patents. Mylan anticipates that Regeneron will ask the PTAB to deny institution
`under an argument that the district court will reach a decision on the merits before the Board will.
`See Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel
`District Court Litigation (June 21, 2022); Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11
`(P.T.A.B. Mar. 20, 2020). Regeneron hopes to adjudicate the ’681 and ’601 patents’ invalidity in
`district court, rather than the PTAB, given the lower “preponderance of the evidence standard”
`applied in PTAB challenges. See 35 U.S.C. § 316(e). Notably, Regeneron does not even
`acknowledge the existence of these PTAB proceedings in its motion.
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`by a biosimilar’s notice of commercial marketing). Furthermore, in contrast to the remedies
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`available under the Hatch-Waxman Act, a court has no authority under Section 271(e)(4)(A) to
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`order FDA to delay the effective approval of a biosimilar as a remedy for patent infringement. 35
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`U.S.C. § 271(e)(4)(A) (limited to a drug or veterinary biological product). In other words, in
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`enacting the BPCIA, Congress created a patent resolution scheme that is wholly separate from
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`FDA’s regulatory review—there simply is no mechanism to alter the timing of FDA approval of a
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`biosimilar based on the filing of a patent infringement suit.
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`Nonetheless, Regeneron seems to suggest that without an expedited schedule that would
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`allow a “final court decision” (e.g., a Federal Circuit appellate decision) prior to approval of
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`Mylan’s biosimilar, it would somehow be deprived of the opportunity to seek injunctive relief.
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`Not so. If Regeneron wants to enjoin Mylan prior to any biosimilar launch, Regeneron should use
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`the procedure contemplated by the BPCIA—a motion for preliminary injunction filed within 180
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`days of Mylan’s notice of commercial marketing based on a showing of possible infringement of
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`a valid patent and consideration of the traditional factors for an injunction. 42 U.S.C. §
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`262(l)(8)(B); 35 U.S.C. § 271(e)(4)(B). Likewise, once infringement and validity have been
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`adjudicated, nothing prevents Regeneron from seeking a permanent injunction to enjoin
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`infringement until patent expiry. See 35 U.S.C. § 283; eBay Inc. v. MercExchange, L.L.C., 547
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`U.S. 388, 393-94 (2006).
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`Moreover, as Regeneron conveniently neglects to mention, examples from previous
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`BPCIA cases demonstrate that Regeneron would not lose any substantive rights under a more
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`realistic trial schedule, particularly when there is no risk of Mylan launching prior to May 2024
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`(assuming pediatric exclusivity is granted as Regeneron anticipates). In the majority of BPCIA
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`patent decisions to date, the biosimilar applicant has obtained FDA approval prior to the district
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`court’s decision, which is typically received years in advance of a Federal Circuit decision.4
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`Moreover, in 2 of the 3 cases where a court has found infringement liability, a permanent injunction
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`was entered years after approval of the biosimilar. Immunex Corp. v. Sandoz Inc., No. 16-cv-
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`01118, Final Judgment and Order of Permanent Injunction (Dkt. No. 719) (D.N.J. Oct. 8, 2019)
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`(Sandoz’s etanercept biosimilar (Erelzi®, BLA No. 761042) was approved on August 30, 2016);
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`see also Immunex Corp. v. Samsung Bioepis Co., No. 19-cv-11755, Final Judgment and Order of
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`Permanent Injunction (Dkt. No. 128) (D.N.J. Nov. 3, 2021) (Samsung’s etanercept biosimilar
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`(Eticovo®, BLA No. 761066) was approved on Apr. 25, 2019).5
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`Furthermore, Regeneron’s purported need for expedited scheduling stands in direct
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`contradiction to its approach in the patent dance and filing this suit. Regeneron took nearly the
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`full statutory period (60 days) to produce its § 262(l)(3)(C) statements, and took nearly the entire
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`statutory period (30 days) under § 262(l)(6) to file suit. If Regeneron were genuinely interested in
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`4 See, e.g., Janssen Biotech, Inc. v. Celltrion Healthcare Co., Nos. 15-cv-10698, 17-cv-11008 (D.
`Mass.) (district court decisions 9/29/2016 (211 F. Supp. 3d 364) and 7/30/2018 (2018 WL
`10910845); Federal Circuit decisions 1/23/2018 (2018 WL 2072723) and 3/5/2020 (796 F. App’x
`741), respectively; Celltrion’s infliximab biosimilar (Inflectra®, BLA No. 125544) approved
`4/5/2016); Amgen Inc. v. Sandoz Inc., No. 14-cv-04741 (N.D. Cal.) (district court decision
`12/19/2017 (295 F. Supp. 3d 1062); Federal Circuit decision 5/8/2019 (923 F.3d 1023); Sandoz’s
`filgrastim biosimilar (Zarxio®, BLA No. 125553) approved 3/6/2015); Amgen Inc. v. Hospira,
`Inc., No. 15-cv-00839 (D. Del.) (district court decision 8/27/2018 (336 F. Supp. 3d 333); Federal
`Circuit decision 12/16/2019 (944 F.3d 1327); Hospira’s epoetin biosimilar (Retacrit®, BLA No.
`125545) approved 5/15/2018); Immunex Corp. v. Sandoz Inc., No. 16-01118 (D.N.J.) (district
`court decision 8/9/2019 (395 F. Supp. 3d 366); Federal Circuit decision 7/1/2020 (964 F.3d 1049);
`Sandoz’s etanercept biosimilar (Erelzi®, BLA No. 761042) approved 8/30/2016); Amgen Inc. v.
`Mylan Inc., No. 17-cv-01235 (W.D. Pa.) (district court decision 8/21/2019; Mylan’s pegfilgrastim
`biosimilar (Fulphila®, BLA No. 761075) approved 6/4/2018).
`5 No permanent injunction was entered in the third case as the patents-in-suit had expired by the
`time of trial. Amgen Inc. v. Hospira, Inc., No. 15-cv-00839, Final Judgment (Dkt. No. 393) (D.
`Del. Sept. 11, 2018) (Retacrit®, BLA No. 125545) (a jury trial was held in September 2017
`involving two patents-in-suit, the latest of which expired on January 5, 2016); see also id., Final
`Jury Instructions (redacted) (Dkt. No. 300) (D. Del. Sept. 7, 2017).
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`more quickly adjudicating this matter, it would have expedited any of those actions. The Court
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`should not reward a party that purposefully wasted 3 months with an expedited schedule.
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`But there is more. As noted above, Regeneron offers no particulars regarding how the
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`parties could realistically proceed to trial on up to 12 patents by June 2023, and obtain a district
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`court decision and an appellate decision by May 2024.6 And for good reason⸺to date, no district
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`court in any BPCIA action has ever resolved a litigation in 10 months in the first instance, even
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`when the disputed issues were resolved through dispositive motion practice and/or involve fewer
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`than 12 patents-in-suit.7 The bottom line is that there is no need for Regeneron to manufacture
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`this urgency when it will have the opportunity to seek a preliminary injunction, and could seek a
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`permanent injunction, regardless of when Mylan’s biosimilar is approved.
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`6 In 2021, the median time from docketing to disposition of a Federal Circuit appeal was 12 months.
`Federal Circuit, Median Time to Disposition in Cases Terminated After Hearing or Submission
`(Table),
`https://cafc.uscourts.gov/wp-content/uploads/reports-stats/disposition-
`time/06_Med_Disp_Time_MERITS_table.pdf. Thus, even with a June 2023 trial, it is unlikely
`there will be an appellate decision prior to approval of Mylan’s biosimilar.
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`7 Amgen Inc. et al v. Mylan Inc. et al., No. 17-cv-01235 (W.D. Pa.) (nearly 23 months from Sept.
`22, 2017 complaint to Aug. 21, 2019 district court decision on 1 patent-in-suit and nearly 24
`months from complaint to Sept. 17, 2019 stipulation of dismissal for other patent-in-suit following
`Federal Circuit decision in related case) (two patents-in-suit resolved by motion for judgment on
`the pleadings and stipulation of dismissal); Immunex Corporation et al. v. Sandoz Inc. et al., No.
`16-cv-01118 (D.N.J.) (41.5 months from Feb. 26, 2016 complaint to August 9, 2019 district court
`decision) (bench trial involving 2 patents-in-suit); Amgen Inc. et al v. Hospira, Inc., No. 15-cv-
`00839 (D. Del.) (over 35 months from Sept. 18, 2015 complaint to Aug. 27, 2018 district court
`decision) (jury trial involving 2 patents-in-suit); Amgen Inc. et al. v. Coherus Biosciences, Inc.,
`No. 17-cv-00546 (D. Del.) (10.5 months from May 10, 2017 complaint to Mar. 26, 2018 district
`court decision) (1 patent-in-suit resolved by a motion to dismiss); Amgen Inc. et al. v. Sandoz Inc.
`et al., No. 14-cv-04741 (N.D. Cal.) (nearly 38 months from Oct. 24, 2014 complaint to Dec. 19,
`2017 district court decision) (1 patent-in-suit resolved by summary judgment); Janssen Biotech,
`Inc. et al. v. Celltrion Healthcare Co. et al., Nos. 15-cv-10698, 17-cv-11008 (D. Mass.) (over 18.5
`months from Mar. 6, 2015 complaint to Sept. 28, 2016 district court decision on 1 patent-in-suit
`and over 40 months to July 30, 2018 district court decision on other patent-in-suit) (2 patents-in-
`suit resolved by motions for summary judgment); Amgen Inc. et al. v. Apotex Inc. et al., No. 15-
`cv-61631 (S.D. Fla.) (13 months from Aug. 6, 2015 complaint to Sept. 9, 2016 district court
`decision) (bench trial involving 1 patent-in-suit).
`
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`Case 1:22-cv-00061-TSK-JPM Document 26 Filed 08/19/22 Page 13 of 16 PageID #: 1916
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`C.
`
`By Participating In The Patent Dance, Mylan Has The Statutory Right To
`Control The Timing And Scope Of Litigation Under The BPCIA.
`
`The result here is entirely consistent with the BPCIA system that Congress designed. There
`
`are several options for resolving patent disputes under the BPCIA’s patent resolution framework
`
`that are primarily dictated by the biosimilar applicant. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664,
`
`1671-72 (2017) (recognizing that BPCIA was designed to provide the biosimilar applicant with
`
`“substantial control” over the timing and scope of patent litigation). Indeed, the Supreme Court
`
`recognized that the biosimilar applicant only cedes control of the scope and timing of the litigation
`
`when an applicant elects not to initiate the patent dance. Id. at 1675 (when the applicant chooses
`
`to not turn over its application and manufacturing information, “[the statute] vests in the [RPS] the
`
`control that the applicant would otherwise have exercised over the scope and timing of the patent
`
`litigation. It also deprives the applicant of the certainty that it could have obtained by bringing a
`
`declaratory-judgment action prior to the marketing its product”). Thus, when the biosimilar
`
`applicant elects to participate in the patent dance, as Mylan did here, it controls the number of
`
`patents to immediately litigate and the number of patents to reserve for later litigation, if any. 42
`
`U.S.C. § 262 (l)(5)(A).
`
`Regeneron’s self-selection of which patents to litigate now and which patents to reserve
`
`for later is contrary to the design of the BPCIA. Regeneron cannot benefit from Mylan’s pre-suit
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`disclosures only to then unilaterally block Mylan’s statutory right to control the timing and scope
`
`of litigation after suit is filed⸺and worse, hold a substantial number of patents over Mylan’s head
`
`to assert later. Over the past 8 months, Mylan has produced confidential and proprietary
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`information about its biosimilar and manufacturing information, as well as detailed contentions
`
`setting forth Mylan’s non-infringement and invalidity defenses on a patent-by-patent, claim-by-
`
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`Case 1:22-cv-00061-TSK-JPM Document 26 Filed 08/19/22 Page 14 of 16 PageID #: 1917
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`claim basis.8 Among other reasons, Mylan subjected itself to such onerous pre-suit information
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`disclosures to control the timing and scope of litigation and to best position itself to make informed
`
`judgments at the time of launch. Regeneron’s decision to hold back patents now, only to
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`potentially assert them later as the basis for emergency relief, not only increases the risk and
`
`uncertainty for Mylan, but also heightens the likelihood that this Court would be forced to decide
`
`complex legal and scientific issues in a pressurized context without the benefit of a fulsome
`
`evidentiary record.
`
`Despite the foregoing, Mylan will make all reasonable efforts to work with Regeneron to
`
`prioritize a subset of patents for trial provided that Mylan receives certainty with respect to the
`
`remaining patents, as well as reasonable limits as to which patents may be the subject of a
`
`preliminary injunction motion. Mylan is also open to discussing proposals to streamline the issues
`
`for the Court and timely resolution.
`
`IV.
`
`CONCLUSION.
`
`The Court should deny Regeneron’s motion in its entirety, and allow this case to proceed
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`in the normal course and in a fashion that does not prejudice Mylan’s right to fully and fairly
`
`defend itself.
`
`Date: August 19, 2022
`
`/s/ William J. O’Brien
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`STEPTOE & JOHNSON PLLC
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`8 Notably, neither Regeneron’s Complaint (Dkt. No. 1) nor its Motion Requesting Expedited Status
`Conference (Dkt. No. 7) contain any allegations of deficiencies related to Mylan’s information
`disclosures. None.
`
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`Case 1:22-cv-00061-TSK-JPM Document 26 Filed 08/19/22 Page 15 of 16 PageID #: 1918
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`Of Counsel (pro hac vices forthcoming):
`William A. Rakoczy
`Heinz J. Salmen
`Eric R. Hunt
`Neil B. McLaughlin
`Lauren M. Lesko
`RAKOCZY MOLINO