Court Opinion

ID: 9351401
Source: CourtListenerOpinion
Date Created: 2022-12-30 15:00:32.345841+00
Date Added: 2024-06-11T16:59:50.875894
License: Public Domain

Case: 22-1878    Document: 62     Page: 1   Filed: 12/30/2022

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

 ASTELLAS US LLC, ASTELLAS PHARMA US, INC.,
           GILEAD SCIENCES, INC.,
              Plaintiffs-Appellants

                             v.

                     HOSPIRA, INC.,
                    Defendant-Appellee
                  ______________________

                        2022-1878
                  ______________________

     Appeal from the United States District Court for the
 District of Delaware in No. 1:18-cv-01675-CFC-CJB, Chief
 Judge Colm F. Connolly.
                  ______________________

                Decided: December 30, 2022
                  ______________________

     PAUL WHITFIELD HUGHES, McDermott Will & Emery
 LLP, Washington, DC, argued for all plaintiffs-appellants.
 Plaintiffs-appellants Astellas US LLC, Astellas Pharma
 US, Inc. also represented by IAN BARNETT BROOKS; JASON
 ALBERT LEONARD, New York, NY.

     W. CHAD SHEAR, Fish & Richardson P.C., San Diego,
 CA, for plaintiff-appellant Gilead Sciences, Inc. Also rep-
 resented by ELIZABETH M. FLANAGAN, Minneapolis, MN;
Case: 22-1878     Document: 62      Page: 2    Filed: 12/30/2022

 2                             ASTELLAS US LLC   v. HOSPIRA, INC.

 ROBERT M. OAKES, Wilmington, DE; LISA M. FERRI,
 MANUEL JOSE VELEZ, Mayer Brown, LLP, New York, NY.

     CHARLES B. KLEIN, Winston & Strawn LLP, Washing-
 ton, DC, argued for defendant-appellee. Also represented
 by CLAIRE A. FUNDAKOWSKI, JOVIAL WONG; ALISON
 MICHELLE KING, Chicago, IL.
                  ______________________

     Before DYK, REYNA, and CUNNINGHAM, Circuit Judges.
 DYK, Circuit Judge

     Gilead Sciences, Inc., Astellas US LLC, and Astellas
 Pharma US, Inc. (together, “Astellas”) sued Hospira, Inc.,
 alleging that Hospira’s abbreviated new drug application
 (“ANDA”) infringed three patents that cover Form A re-
 gadenoson (U.S. Patent Nos. 8,106,183; RE47,301; and
 8,524,883), a monohydrate (hydrate that contains one mol-
 ecule of water in the crystal lattice for every molecule of the
 compound) form of regadenoson that can be used to in-
 crease blood flow to mimic a cardiac stress test. Astellas’s
 theory was not that Hospira intentionally created Form A
 regadenoson, but that this occurred inadvertently in the
 production process for an intermediate product made by a
 third party and incorporated by Hospira into its final prod-
 uct. Before trial, Hospira amended its ANDA, allegedly
 making it more difficult for Astellas to prove its original
 infringement theory. Astellas then sought to present a new
 and previously unasserted infringement theory (that Hos-
 pira’s own process created Form A regadenoson).
     The district court found this new theory to be untimely
 and granted Hospira’s motion to strike the new infringe-
 ment contentions and the related expert evidence. The
 trial went forward on Astellas’s original infringement the-
 ory, updated with supplemental evidence, and the district
 court found that Hospira did not infringe. Astellas appeals
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 ASTELLAS US LLC   v. HOSPIRA, INC.                           3

 only the district court’s exclusion of the new theory. We
 hold that the district court did not abuse its discretion in
 excluding the new infringement theory, and we affirm.
                         BACKGROUND
      This case concerns U.S. Patent Nos. 8,106,183;
 RE47,301; and 8,524,883 (the “Form A patents”), all of
 which are owned by Astellas. The asserted patent claims
 all recite, or depend from independent claims that recite,
 Form A regadenoson, the most stable and only known mon-
 ohydrate crystalline form of regadenoson. 1
      Hospira, Inc. is one generic manufacturer that filed an
 ANDA with a paragraph IV certification for a generic drug
 product with Form G regadenoson as the active pharma-
 ceutical ingredient (“API”), a compound not covered by the
 asserted patents. Hospira bought its API from Curia Mis-
 souri, Inc. (“Curia”), formerly Euticals, Inc., 2 meaning Hos-
 pira’s ANDA relied on and incorporated Curia’s Drug
 Master File (“DMF”). A DMF is a confidential submission
 to the FDA that provides detailed information about the
 processes used to manufacture a drug. Curia created the
 API by converting crude regadenoson to Form F re-
 gadenoson (also not covered by the asserted patents) and
 then to Form G regadenoson. However, when these forms
 “are exposed to a sufficient amount of water, including wa-
 ter in the air (i.e., humidity) and in reagents, they will con-
 vert to Form A.” J.A. 176. Hospira and Curia were aware
 of the risk of conversion and wanted to avoid conversion
 during Curia’s manufacturing process.

     1    Astellas owned other regadenoson patents covering
 a broader array of regadenoson compounds and structures.
 The last of these patents expired April 10, 2022.
     2    Because the distinction is immaterial, Euticals,
 Inc. will also be referred to as “Curia.”
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 4                            ASTELLAS US LLC   v. HOSPIRA, INC.

     Hospira’s ANDA product is created by a compounding
 process in which Curia’s intermediate Form G product is
 dissolved in a water-based solution. Again, there is a risk
 that water exposure could cause Form G regadenoson to
 convert to Form A regadenoson. However, Hospira claims
 that the introduction of water during the compounding pro-
 cess does not cause conversion to Form A regadenoson be-
 cause Form G dissolves directly in the compounding
 solution.
     This case involves two separate infringement theories
 provided by Astellas. The first is the intermediate theory
 which is that the Form A patents are infringed because
 Form A regadenoson is created during the manufacturing
 of the Form G intermediate by Curia. The second is the
 compounding theory which is that infringement of the
 Form A patents occurs when the Form G intermediate con-
 verts to Form A regadenoson during Hospira’s own com-
 pounding process.
     On June 30, 2020, shortly after Astellas was notified
 that Hospira filed its ANDA, Astellas sued Hospira for in-
 fringement of the Form A patents in the District of Dela-
 ware, and the case was consolidated with similar cases
 Astellas had brought against Apotex, Inc. and other generic
 manufacturers who had filed their own ANDAs. The AN-
 DAs were filed with a paragraph IV certification, which
 stated that the listed patents, the Form A patents in this
 case, are “invalid or will not be infringed by the manufac-
 ture, use, or sale of the [generic] drug . . . .” 21 U.S.C. §
 355(j)(2)(A)(vii)(IV); see also 35 U.S.C. § 271(e)(2)(A). As-
 tellas’s theory was that these filings were acts of infringe-
 ment.
     Proving infringement requires showing that the ANDA
 product proposed to be sold under the ANDA would in-
 fringe. Astellas’s original infringement theory as to Hos-
 pira was the intermediate theory which was, as the district
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 ASTELLAS US LLC   v. HOSPIRA, INC.                           5

 court found, “that crude and Forms F and G regadenoson
 have ‘a propensity’ to convert to Form A when exposed to
 water, and that water is introduced into Curia’s . . . manu-
 facturing process.” J.A. 225. During discovery, Astellas’s
 expert specifically disclaimed any theory that infringement
 occurred during Hospira’s compounding process. See J.A.
 1107.
      During the pendency of the infringement action, Curia
 amended its DMF to “optimize its manufacturing process
 to limit the presence of water.” J.A. 186 (internal quota-
 tion, alteration, and citations omitted). Hospira amended
 its ANDA with the only change being to incorporate the
 changes made by Curia. After Hospira amended its ANDA,
 the district court entered the order at issue here establish-
 ing supplemental fact discovery, supplemental expert dis-
 covery, and infringement contentions regarding Hospira’s
 amended ANDA.
     After supplemental fact discovery with Hospira was
 complete, Astellas filed supplemental infringement conten-
 tions articulating a new theory unrelated to the production
 of the intermediate (the API) (the compounding infringe-
 ment theory) and claiming, as summarized by the district
 court, that “[Hospira] infringe[s] the patents-in-suit be-
 cause the [API] used in [Hospira’s] proposed products con-
 verts to [Form A] during the manufacturing process of
 [Hospira’s] finished products.” J.A. 227–28 (emphasis
 omitted). Astellas also submitted expert evidence to sup-
 port this theory. Hospira filed a motion to strike the sup-
 plemental infringement contentions and supplemental
 expert reports related to the new theory. The magistrate
 judge granted the motion to strike, finding that the com-
 pounding infringement theory was untimely and that the
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 6                             ASTELLAS US LLC   v. HOSPIRA, INC.

 Pennypack factors 3 did not save the untimely disclosures.
 J.A. 228–29. Astellas filed objections to the magistrate
 judge’s order, which the district court overruled.
     Trial went forward on Astellas’s original intermediate
 infringement theory, and the court found that Hospira did
 not infringe the asserted patent claims. Astellas appealed
 only the district court’s grant of the motion to strike its new
 infringement theory. 4
     We have jurisdiction under 28 U.S.C. § 1295(a)(1).
                           DISCUSSION
      We review evidentiary rulings not unique to patent law
 for abuse of discretion under the law of the regional circuit,
 here the Third Circuit. See Del. Valley Floral Grp., Inc. v.
 Shaw Rose Nets, LLC, 597 F.3d 1374, 1379 (Fed. Cir. 2010);
 Centocor Ortho Biotech, Inc. v. Abbott Lab’ys., 636 F.3d
 1341, 1347 (Fed. Cir. 2011); ZF Meritor, LLC v. Eaton
 Corp., 696 F.3d 254, 268 (3d Cir. 2012).
                      I.     Untimeliness
     Astellas first argues that its new compounding in-
 fringement theory was not untimely. As noted, Astellas’s
 original infringement theory argued that crude, Form F,
 and/or Form G regadenoson transformed into Form A re-
 gadenoson during Curia’s API manufacturing process due
 to incidental exposure to water. After Curia modified its
 API manufacturing process to decrease the potential for
 water exposure, Astellas’s original infringement theory

     3   As discussed below, the Pennypack factors are fac-
 tors that the Third Circuit has directed district courts to
 weigh “[i]n considering whether to exclude evidence relat-
 ing to an untimely . . . disclosure.” J.A. 229 n.1.
     4   Astellas filed a Rule 8 motion for injunction pend-
 ing appeal, which we denied on December 6, 2022.
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 ASTELLAS US LLC   v. HOSPIRA, INC.                           7

 became harder to prove. This led Astellas to introduce a
 new infringement theory that the API converted to Form A
 regadenoson during Hospira’s own compounding process.
     During the original period of discovery, Astellas’s ex-
 pert testified that he had no opinion as to whether infringe-
 ment occurred during the compounding process. See J.A.
 1107 (“Q: . . . You’re not offering an opinion that when Hos-
 pira does its own manufacturing and takes the API and
 converts it to a liquid, that that is causing Form A conver-
 sion. Correct? A: Yeah, I think what you mean is, when
 they dissolve the regadenoson in water and—and the other
 excipients that are present, that doesn’t cause Form A to
 form. Is that what you’re asking? Q: Yes. You’re not offer-
 ing that opinion. Correct? A: I am not.”).
     Astellas did not reveal its new theory until October
 2021, close to a year after the original fact discovery period
 closed (October 2020), months after the original expert dis-
 covery period closed (April 2021), and shortly after supple-
 mental fact discovery closed. Because this theory was
 based on documents produced to Astellas in August 2020,
 Astellas could have raised this theory during the original
 period of discovery (which ended in October 2020 for fact
 discovery and April 2021 for expert discovery), after it
 knew Hospira was going to amend its ANDA (April 2021),
 or immediately after Astellas received Hospira’s ANDA
 amendments (August 2021). It chose not to.
     Rather, Astellas chose to wait to raise its compounding
 infringement theory during the supplemental discovery pe-
 riod, more than a month after the entry of the supple-
 mental discovery order. There was no reason, other than
 Astellas’s own litigation choices, that the compounding in-
 fringement theory could not have been asserted earlier.
 This is not a case where Astellas relied on new information
 disclosed in the ANDA amendment to craft a new theory of
 infringement. Instead, Astellas simply decided that the
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 8                            ASTELLAS US LLC   v. HOSPIRA, INC.

 ANDA amendment would make it harder to prove its orig-
 inal infringement theory and decided to try a new theory
 related to a process not changed by the amendment.
     Nonetheless, Astellas argues that the supplemental
 discovery and revised scheduling order permitted Astellas
 to develop a new theory of infringement and thus that it
 submitted its excluded infringement contentions and ex-
 pert opinions by the court-ordered deadline for supple-
 mental infringement contentions.
      On its face, the Hospira supplemental discovery order
 at issue does not state the scope of permitted discovery. See
 J.A. 1220–23. However, viewing the order in context
 makes it clear that the scope of discovery, and thus the
 scope of the supplemental infringement contentions and
 expert reports, was limited to the ANDA amendments.
     The Hospira supplemental discovery order at issue fol-
 lowed an earlier supplemental discovery order as to Apo-
 tex, another defendant accused of infringing the Form A
 patents. Apotex filed its ANDA amendment, produced to
 Astellas on April 6, 2021, to incorporate an amendment to
 the DMF of its API supplier. The district court scheduled
 a status conference for April 7, 2021, after Apotex produced
 its ANDA.
      At that conference, Hospira explained that, like Apo-
 tex, it also planned to amend its ANDA to incorporate Cu-
 ria’s forthcoming DMF amendment with more stringent
 requirements. 5 Astellas responded that it required an “op-
 portunity to take discovery about them [the ANDA amend-
 ments]” of both Apotex and Hospira. J.A. 1045.

     5   Other defendants also said they planned to simi-
 larly amend their ANDAs. For simplicity, we focus only on
 Hospira and Apotex.
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 ASTELLAS US LLC   v. HOSPIRA, INC.                           9

     After the status conference, Astellas and Apotex filed a
 joint status letter where Astellas asked for one supple-
 mental discovery schedule for all defendants who had
 amended or would be amending their ANDAs (including
 Hospira). The district court instead asked Astellas and
 Apotex to propose a schedule for supplemental fact discov-
 ery regarding Apotex only. Pursuant to that request, As-
 tellas and Apotex submitted a joint letter outlining
 competing discovery and case schedule proposals but
 agreeing as to the scope of discovery. Astellas proposed
 that discovery requests should be limited to “issues raised
 by the [ANDA] amendments.” See Joint Letter in Accord-
 ance with D.I. 709 at 1, Astellas US LLC v. Apotex Inc., No.
 18-1675 (D. Del. Apr. 28, 2021), ECF No. 722. Apotex noted
 that “[Astellas] proposed that the ‘scope of the supple-
 mental discovery’ would be the ‘DMF and ANDA amend-
 ments’” and that Apotex had agreed to this proposal. See
 id. at 2. The district court adopted Astellas’s proposed re-
 vised scheduling order in relevant part, including the pro-
 posed     deadlines     for    supplemental    infringement
 contentions and expert discovery. Although the order itself
 did not explicitly incorporate the parties’ agreement as to
 the scope of discovery, it noted that supplemental discovery
 “should not be expansive.” Oral Order, Astellas US LLC v.
 Apotex Inc., No. 18-1675 (D. Del. Apr. 30, 2021), ECF No.
 717.
     Thereafter, Hospira filed its own ANDA amendment,
 and Astellas and Hospira (together with Apotex) agreed to
 the second scheduling order, the order at issue here. It pro-
 vided deadlines for supplemental fact discovery requests
 regarding Hospira. It also provided the same deadlines re-
 garding both Apotex and Hospira for the close of expert dis-
 covery and Astellas’s final supplemental infringement
 contentions. Again, the second revised scheduling order
 did not explicitly state the scope of discovery. However, the
 parties had agreed that the Apotex discovery was limited
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 10                            ASTELLAS US LLC   v. HOSPIRA, INC.

 to Apotex’s ANDA amendments, and there is nothing to
 suggest broader discovery as to Hospira. Quite the con-
 trary, the same triggering event, the filing of a new ANDA,
 led to supplemental discovery against Hospira, and the sec-
 ond scheduling order covered both Hospira and Apotex as
 to supplemental infringement contentions and expert re-
 ports without distinction between the two. Further, the
 district court interpreted the second revised scheduling or-
 der when granting Hospira’s motion to strike and noted
 that it considered the supplemental discovery period to be
 limited to “address[ing] new, relevant facts that are related
 to the DMF/ANDA amendment processes.” J.A. 228–29,
 232. “[G]reat deference is given to a district court’s inter-
 pretation of its own order.” WRS, Inc. v. Plaza Entertain-
 ment, Inc., 402 F.3d 424, 428 (3d Cir. 2005).
     We conclude that the district court did not abuse its
 discretion in determining that Astellas’s supplemental in-
 fringement contentions and expert evidence were un-
 timely. Contrary to Astellas’s argument, nothing in our
 decision in Ferring B.V. v. Watson Lab’ys, Inc.-Fla., 764
 F.3d 1382 (Fed. Cir. 2014) suggests otherwise. There, we
 held that “[a]llowing an [ANDA] amendment is within the
 discretion of the district court, guided by principles of fair-
 ness and prejudice to the patent-holder.” Ferring B.V., 764
 F.3d at 1391. This hardly suggests that supplemental dis-
 covery unrelated to the ANDA amendment is required. 6

      6  Astellas argues that refusing to allow Astellas to
 amend its contentions creates undesirable litigation incen-
 tives. In fact, the litigation process is not adversely af-
 fected by having parties list multiple theories of
 infringement in their original contentions with the goal of
 whittling them down by the time of trial. Because it is not
 undesirable to have parties list all possible infringement
 contentions at the case’s outset, it is not unfair to expect
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 ASTELLAS US LLC   v. HOSPIRA, INC.                             11

      II.    Exclusion of Compounding Infringement
                      Theory and Evidence
      Astellas contends that its new evidence and infringe-
 ment theory, even if untimely, should not have been ex-
 cluded. In considering whether the district court abused
 its discretion in excluding evidence, the Third Circuit con-
 siders the five Pennypack factors:
     (1) “the prejudice or surprise in fact of the party
     against whom the excluded witnesses would have
     testified” or the excluded evidence would have been
     offered; (2) “the ability of that party to cure the
     prejudice”; (3) the extent to which allowing such
     witnesses or evidence would “disrupt the orderly
     and efficient trial of the case or of other cases in the
     court”; (4) any “bad faith or willfulness in failing to
     comply with the court’s order”; and (5) the im-
     portance of the excluded evidence.
 ZF Meritor, 696 F.3d at 298 (quoting Meyers v. Pennypack
 Woods Home Ownership Assn., 559 F.2d 894, 904–05 (3d
 Cir. 1977)). While there has been no finding here of bad
 faith or willfulness (factor (4)), factors (1), (2), (3), and (5)
 in this case support the district court’s decision.
     First, as to factors (1) and (2), as described above, Hos-
 pira was clearly surprised by the new infringement theory

 that all possible infringement contentions be presented at
 that time. Importantly, this case was not one where the
 information necessary to craft an infringement contention
 was uncovered by the ANDA amendment. The necessary
 information was revealed during the original period of dis-
 covery. Moreover, Astellas was permitted to—and did—
 update its original infringement theory with supplemental
 evidence related to testing on samples taken from Curia’s
 optimized API manufacturing process. See J.A. 199.
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 12                            ASTELLAS US LLC   v. HOSPIRA, INC.

 that was unrelated to the ANDA amendment and had no
 reason to suspect that Astellas would seek to assert the
 new compounding infringement theory. During the origi-
 nal discovery period, Astellas’s expert explicitly stated that
 he was not offering an opinion as to whether the compound-
 ing process causes infringement. 7 Hospira did not receive
 notice of the new theory until about four months before
 trial.
      The district court correctly concluded that Hospira
 would likely be prejudiced by the introduction of the com-
 pounding infringement theory at this late stage. Hospira
 argued there was not enough time remaining before expert
 reports were due and trial was to take place to conduct the
 tests necessary to show that no conversion occurred during
 the compounding process. It is not clear exactly how long
 it would take to run the necessary tests, but Astellas
 acknowledged that it could take “weeks.” Reply Br. 24–25
 (quoting Hospira’s expert at J.A. 2181). Astellas’s expert
 himself admitted that it would take “a lot more time” to run
 the best test to determine if there was Form A conversion
 during the compounding process. J.A. 1606–08. The dis-
 trict court concluded there was not sufficient time for Hos-
 pira to even “investigate[] whether to perform additional
 (and lengthy) testing procedures in order to assess the ac-
 curacy of [Astellas’s] new theory.” J.A. 230.

      7  See J.A. 1107 (“Q: . . . You’re not offering an opinion
 that when Hospira does its own manufacturing and takes
 the API and converts it to a liquid, that that is causing
 Form A conversion. Correct? A: Yeah, I think what you
 mean is, when they dissolve the regadenoson in water
 and—and the other excipients that are present, that
 doesn’t cause Form A to form. Is that what you’re asking?
 Q: Yes. You’re not offering that opinion. Correct? A: I am
 not.”).
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 ASTELLAS US LLC   v. HOSPIRA, INC.                          13

      To be sure, the trial date could have been moved yet
 again, but the trial date had already been postponed for
 over six months to enable the supplemental discovery and
 further delay would have prejudiced some other defendants
 in the case by effectively extending the presumed generic
 launch date. Once a patent owner brings a § 271(e)(2)(A)
 infringement action, the FDA generally suspends approval
 of the ANDA for a maximum of 30 months. If district court
 litigation extends beyond that 30-month window, the FDA
 can approve the ANDA, but the generic manufacturer is
 often reluctant to bring the generic to market before there
 is a district court decision. The 30-month stay for Apotex
 and another defendant expired in February 2021, but they,
 along with other defendants, agreed not to launch their ge-
 neric products until Astellas’s last compound patent ex-
 pired on April 10, 2022. See J.A. 1044. So, while Hospira
 itself might not have been prejudiced by moving the trial
 date, such a move would have been impractical and preju-
 dicial to other defendants in the case who sought resolution
 by April 2022. 8 Understandably, Astellas does not seri-
 ously argue that moving the trial date provided a viable
 solution.
     As to factor (3), the district court concluded that there
 was “not time to: (1) incorporate a new and significant in-
 fringement theory into the case; (2) allow Defendants to
 take relevant discovery; and (3) still keep the trial date.”
 J.A. 230. Astellas presents no persuasive evidence to the
 contrary and did not demonstrate that the district court’s
 determination in this respect was erroneous.
     As to factor (5), Astellas argues that under the Third
 Circuit’s decision in In re Paoli R.R. Yard PCB Litig., 35

     8     While Apotex and other defendants settled before
 trial, it was unknown that the settlements would occur at
 the time the motion to strike was decided.
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 14                          ASTELLAS US LLC   v. HOSPIRA, INC.

 F.3d 717 (3d Cir. 1994), evidence cannot normally be ex-
 cluded absent a showing of willfulness or bad faith if the
 evidence is critical. However, Astellas has not shown that
 the excluded evidence here is critical or of sufficient im-
 portance to outweigh the other factors. 9 The excluded evi-
 dence was merely an alternative theory of infringement,
 not the sole theory of infringement. This is in contrast to
 the Third Circuit case of ZF Meritor on which Astellas pri-
 marily relies.
     In ZF Meritor, an antitrust case, the district court
 found that ZF Meritor’s damages expert’s (DeRamus’s)
 analysis was unreliable insofar as he relied on Strategic
 Business Plan (SBP) market share and profit margin in-
 puts in making his damages calculations because DeRa-
 mus “did not know either the qualifications of the
 individuals who prepared the SBP estimates or the as-
 sumptions upon which the estimates were based.” 696 F.3d
 at 290–91. The district court excluded DeRamus’s testi-
 mony. Id. at 295. ZF Meritor asked the district court to
 allow DeRamus to revise his damages estimate by replac-
 ing SBP inputs with other inputs already included in the
 expert report. Id. Although the defendant would “have to

      9  Astellas was provided with samples from Curia
 produced under the more stringent requirements in July
 2021. Astellas ran tests on these samples in which it at-
 tempted to simulate the compounding process and show
 that Form A conversion occurred during the compounding
 process. This is the evidence that was excluded. Astellas
 now appears to complain that its evidence concerning
 whether the more stringently produced samples converted
 to Form A during intermediate manufacturing was ex-
 cluded. There is simply no basis in evidence for this asser-
 tion. The evidence that was stricken was evidence
 regarding the compounding process, not Curia’s intermedi-
 ate production.
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 ASTELLAS US LLC   v. HOSPIRA, INC.                          15

 respond to new calculations, it [would] not have to analyze
 any new data, or challenge any new methodologies.” Id. at
 298.
     The district court denied ZF Meritor’s request, leaving
 it without any damages estimate, and the district court
 awarded it $0 in damages because ZF Meritor lacked a
 damages theory. Id. at 295–97. The Third Circuit held
 that it was an abuse of discretion to not allow ZF Meritor
 to amend its damages projection. Id. at 298.
      Unlike ZF Meritor, Astellas here was asking to add an
 entirely new theory, relying on new test data concerning
 the conversion of the API to Form A regadenoson during
 conditions it claimed mimicked the compounding process.
 Here, also unlike ZF Meritor, excluding the compounding
 infringement theory did not leave Astellas without the abil-
 ity to pursue infringement. Astellas was still able to pur-
 sue its original infringement theory updated with
 supplemental evidence: that conversion occurs during API
 manufacturing.
      Also, when applying the Pennypack factors, the Third
 Circuit and this court have found that, when the value of
 the excluded evidence is in question, the excluded evidence
 does not rise to the level of importance required to reverse
 the district court’s exclusion. See Insite Vision Inc. v.
 Sandoz, Inc., 783 F.3d 853, 865 (Fed. Cir. 2015) (“[T]he dis-
 trict court was correct to at least question the relevance
 and probative value of the [European Patent Office] file
 history under United States law.”); Semper v. Santos, 845
 F.2d 1233, 1238 (3d Cir. 1988) (“[I]t is questionable
 whether the rebuttal testimony would have materially
 helped Semper.”).
     In this case, Astellas’s own expert clearly had stated
 that he had no opinion on whether Form A conversion oc-
 curred during the compounding process. See J.A. 1107. As-
 tellas’s expert also clearly admitted that a test other than
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 16                           ASTELLAS US LLC   v. HOSPIRA, INC.

 the test relied on by Astellas would have been the best test
 for determining if there was infringement under the com-
 pounding infringement theory. J.A. 1606. Additionally,
 Hospira’s expert testified that the tests Astellas’s expert
 used to show that Form A regadenoson forms during Hos-
 pira’s compounding process did not accurately reflect Hos-
 pira’s compounding process. J.A. 1955, 1958. Hospira’s
 expert further testified that Astellas’s expert’s experiment
 “provide[d] no credible evidence that Form G converts to
 Form A in Hospira’s manufacturing process.” J.A. 1958.
 The district court found Hospira’s expert to be credible at
 trial (though not addressing this specific evidence), see J.A.
 173, and, in at least some respects, more credible than As-
 tellas’s expert. J.A. 195–96. There is thus serious doubt
 whether the excluded evidence would ultimately have
 helped Astellas.
                        CONCLUSION
      In sum, “the District Court has considerable discretion
 in matters regarding expert discovery and case manage-
 ment.” ZF Meritor, 696 F.3d at 297. The district court here
 did not abuse its discretion in finding Astellas’s compound-
 ing infringement theory and related evidence untimely, nor
 did the district court abuse its discretion in concluding that
 the Third Circuit’s Pennypack factors supported the dis-
 trict court’s decision. Because we conclude that there was
 no abuse of discretion, we do not reach Astellas’s argu-
 ments as to whether any error was prejudicial or harmful.
 We therefore affirm the district court.
                         AFFIRMED