Court Opinion

ID: 4519341
Source: CourtListenerOpinion
Date Created: 2020-03-25 16:00:36.173187+00
Date Added: 2024-06-11T11:53:11.788042
License: Public Domain

Case: 19-1021    Document: 90     Page: 1   Filed: 03/25/2020

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

  GALDERMA LABORATORIES, L.P., NESTLE SKIN
      HEALTH S.A., TCD ROYALTY SUB LLC,
               Plaintiffs-Appellees

                             v.

   AMNEAL PHARMACEUTICALS LLC, AMNEAL
   PHARMACEUTICALS CO. (I) PVT. LTD., NKA
    AMNEAL PHARMACEUTICALS PVT. LTD.,
             Defendants-Appellants
            ______________________

                        2019-1021
                  ______________________

     Appeal from the United States District Court for the
 District of Delaware in No. 1:16-cv-00207-LPS, Chief Judge
 Leonard P. Stark.
                   ______________________

                 Decided: March 25, 2020
                 ______________________

     GERALD J. FLATTMANN, JR., King & Spalding LLP, New
 York, NY, argued for plaintiffs-appellees. Also represented
 by EVAN D. DIAMOND, VANESSA YEN.

    GEORGE C. LOMBARDI, Winston & Strawn LLP, Chi-
 cago, IL, argued for defendants-appellants.  Also
Case: 19-1021     Document: 90     Page: 2    Filed: 03/25/2020

 2                GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 represented by MAUREEN L. RURKA, KEVIN E. WARNER;
 EIMERIC REIG-PLESSIS, San Francisco, CA.
                ______________________

     Before LOURIE, MOORE, and STOLL, Circuit Judges.
 MOORE, Circuit Judge.
      Appellees Galderma Laboratories, L.P., Nestle Skin
 Health S.A., and TCD Royalty Sub LLC (collectively, Gal-
 derma) sued Amneal Pharmaceuticals, LLC and Amneal
 Pharmaceuticals Co. (I) Pvt. Ltd. (n/k/a Amneal Pharma-
 ceuticals Pvt. Ltd.) (collectively, Amneal) for infringement
 of U.S. Patent Nos. 8,206,740, 8,394,405, and 8,470,364
 (collectively, the Chang Patents) and U.S. Patent Nos.
 8,603,506 and 9,241,946 (collectively, the Ashley II Pa-
 tents). The Chang and Ashley II Patents relate to low-dose
 doxycycline formulations to treat, among other diseases,
 acne or rosacea. Following a bench trial, the district court
 found that Amneal’s product infringes the asserted claims
 under the doctrine of equivalents. Amneal appeals. We
 have jurisdiction under 28 U.S.C. § 1295(a)(1). For the rea-
 sons discussed below, we affirm the district court’s judg-
 ment as to infringement of the Chang Patents and reverse
 the district court’s judgment as to infringement of the Ash-
 ley II Patents.
                         DISCUSSION
     Following a bench trial, we review a district court’s con-
 clusions of law de novo and factual findings for clear error.
 Senju Pharm. Co., v. Lupin Ltd., 780 F.3d 1337, 1341 (Fed.
 Cir. 2015). Prosecution history estoppel and claim vitiation
 are issues of law we review de novo. Trading Techs. Int’l
 v. Open E Cry, LLC, 728 F.3d 1309, 1318 (Fed. Cir. 2013);
 Cadence Pharm. Inc. v. Exela Pharmsci Inc., 780 F.3d 1364,
 1368 (Fed. Cir. 2015). Prosecution history estoppel “may
 be subject to underlying facts,” which we review for clear
 error. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
 567 F.3d 1314, 1324 (Fed. Cir. 2009).            We review
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                  3

 infringement under the doctrine of equivalents for clear er-
 ror. Conoco, Inc. v. Energy & Envtl Int’l, 460 F.3d 1349,
 1357 (Fed. Cir. 2006).
                               I
                     The Chang Patents
     The Chang Patents describe compositions of doxycy-
 cline with an Immediate Release (IR) component and a De-
 layed Release (DR) component, combined into one unit for
 once-daily dosing. Claim 1 of the ’740 patent is illustrative:
     1. An oral pharmaceutical composition of doxycy-
     cline, which at a once-daily dosage will give steady
     state blood levels of doxycycline of a minimum of
     0.1 μg/ml and a maximum of 1.0 μg/ml, the compo-
     sition consisting of (i) an immediate release (IR)
     portion comprising 30 mg doxycycline; (ii) a de-
     layed release (DR) portion comprising 10 mg
     doxycycline; and optionally, (iii) one or more phar-
     maceutically acceptable excipients.
 “Immediate release” or IR is defined by the ’740 patent as
 “a dosage form that is intended to release substantially all
 of the active ingredient on administration with no en-
 hanced, delayed or extended release effect.” ’740 patent at
 4:5–8. “Delayed release” or DR is not expressly defined.
     In June 2013, Amneal filed a petition for inter partes
 review of the Chang ’740 and ’405 patents, which the Board
 instituted in December 2013. During the inter partes re-
 view, Patent Owner 1 sought to distinguish the claimed DR
 portion from the prior-art secondary loading portion of

     1    The inter partes review proceedings were between
 Amneal Pharmaceuticals, LLC and Supernus Pharmaceu-
 ticals, Inc., the previous assignee of the Chang patents.
 The proceedings as to the ’740 and ’405 patents were con-
 solidated. We refer to the ’740 proceeding throughout.
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 4                 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 slow-release pellets that begin dissolving in the stomach as
 disclosed in U.S. Patent No. 5,348,748 (Sheth). It argued
 that “‘a DR portion’ as claimed in the Chang ’740 patent
 requires no substantial release from the portion until
 some time other than promptly after administration – and
 in particular, until after the DR portion passes through the
 acidic stomach and sections of the GI tract below pH 4.5.”
 J.A. 2560 (emphasis in original); see also J.A. 16958–61,
 J.A. 2749. It further argued that Sheth’s “secondary load-
 ing” portion was “intentionally designed to be ‘leaky’ in the
 stomach,” but that “the Chang ’740 patent expressly states
 that for the ‘DR portion’ described and claimed therein,
 ‘there is no substantial release of doxycycline in the
 acidic stomach environment of approximately below pH
 4.5.’” J.A. 16957–58 (emphasis in original). Patent Owner
 argued that “the approach taught by Sheth is substantially
 different from the claimed IR/DR formulations of the
 Chang ’740 patent, and in fact would teach away from the
 claimed formulations of the Chang ’740 patent.” J.A. 16953
 ¶ 170 (emphasis in original); J.A. 2189 at 53:22–24 (Sheth
 “shows a substantial portion is dissolving in the acidic en-
 vironment of the stomach. The point is that’s not delayed
 release.”).
      The Board rejected Patent Owner’s argument and in-
 stead agreed with Amneal “that the broadest reasonable
 construction of ‘delayed release,’ in light of the specification
 of the ’740 patent, is not limited to formulations requiring
 that there be no substantial release in the stomach.” J.A.
 17023. It stated that “[t]he portion of the ’740 patent spec-
 ification upon which [Patent Owner] relies to support its
 narrower construction addresses properties of ‘enteric
 coated pellets,’ not a delayed-release component.” Id. Be-
 cause the ’740 patent discloses formats other than enteric
 coated pellets as being delayed-release components, the
 Board would “not read the limitations of an embodiment,
 even a preferred embodiment, into the construction of a
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                  5

 claim term that is plainly used elsewhere in the specifica-
 tion more broadly.” Id. (citing In re Bigio, 381 F.3d 1320,
 1325 (Fed. Cir. 2004)). After reviewing “other evidence of
 how the term is understood and used by persons of ordinary
 skill in the art,” the Board construed “delayed release” to
 mean “release of a drug at a time other than immediately
 following oral administration.” J.A. 17024. The Board ul-
 timately found that Sheth did not disclose a “delayed re-
 lease” format under the proper construction. J.A. 17029.
     Galderma sued Amneal in March 2016, alleging, inter
 alia, infringement of the Chang Patents. Like the Board,
 the district court construed “delayed release” or “DR” as
 “release of a drug at a time other than immediately follow-
 ing oral administration.” Based on this construction, the
 district court found, after a bench trial, that Amneal’s prod-
 uct contained the equivalent of the claimed 10 mg DR por-
 tion and entered judgment of infringement against
 Amneal. Amneal appeals this judgment, arguing that Gal-
 derma is precluded from asserting infringement under the
 doctrine of equivalents due to argument-based estoppel,
 amendment-based estoppel, and claim vitiation. Alterna-
 tively, it argues its product does not infringe the Chang Pa-
 tents under the doctrine of equivalents. We first address
 the parties’ arguments with respect to argument-based es-
 toppel. We conclude that the district court did not err in
 concluding that Galderma “did not disclaim particular DR
 formulations.” J.A. 70.
     Amneal argues that Patent Owner’s arguments during
 the ’740 inter partes review proceedings clearly and unmis-
 takably surrendered subject matter and therefore preclude
 a finding that Amneal’s products infringe the Chang pa-
 tents under the doctrine of equivalents. Based on Patent
 Owner’s statements, Amneal argues that competitors
 would interpret a DR portion as not encompassing a drug
 that begins dissolving or “leaking” in the stomach. Gal-
 derma argues that Amneal has not shown any statements
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 6                 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 that, when considered within the context of the complete
 inter partes review record, amount to a “clear and unmis-
 takable surrender.”
     We have held that “statements made by a patent owner
 during an IPR proceeding can be considered during claim
 construction and relied upon to support a finding of prose-
 cution disclaimer” so long as the statements are “both clear
 and unmistakable.” Aylus Networks, Inc. v. Apple Inc., 856
F.3d 1353, 1361–62 (Fed. Cir. 2017). Prosecution dis-
 claimer “promotes the public notice function of the intrinsic
 evidence and protects the public’s reliance on definitive
 statements made during prosecution.” Id. at 1360 (citing
 Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324
 (Fed. Cir. 2003)). The doctrine is rooted in the understand-
 ing that “[c]ompetitors are entitled to rely on those repre-
 sentations when determining a course of lawful conduct,
 such as launching a new product or designing-around a pa-
 tented invention.” Id. (citing Biogen Idec, Inc. v. Glax-
 oSmithKline LLC, 713 F.3d 1090, 1095 (Fed. Cir. 2013)).
     Statements by the patent owner are not considered in
 a vacuum; rather, the skilled artisan would look at the rec-
 ord as a whole in assessing claim scope. See Wang Labs.,
 Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993)
 (“The prosecution history must be examined as a whole in
 determining whether estoppel applies.”). There is no doubt
 that the Board rejected the Patent Owner’s attempt to limit
 the meaning of delayed release. See J.A. 17023 (“[W]e
 agree with Amneal that the broadest reasonable construc-
 tion of ‘delayed release,’ in light of the specification of the
 ’740 patent, is not limited to formulations requiring that
 there be no substantial release in the stomach.”). Because
 the Board rejected the Patent Owner’s arguments regard-
 ing the meaning of delayed release, the record before the
 Patent Office clearly put the public on notice that the
 meaning of delayed release with respect to the Chang Pa-
 tents is not limited to formulations requiring that there be
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                  7

 no substantial release in the stomach. While clear and lim-
 iting statements made by the patent owner can give rise to
 disclaimer, they do not in this case where those statements
 were clearly and expressly rejected by the Patent Office.
 Because the record makes clear to a skilled artisan that
 Patent Owner’s arguments were rejected, those arguments
 do not impact claim scope. Accordingly, we see no error in
 the district court’s conclusion that Galderma was not pre-
 cluded by these statements from asserting the doctrine of
 equivalents. 2 J.A. 70. 3
     Contrary to Amneal’s assertion, our decision in Ameri-
 can Piledriving does not compel a different result. In that
 case, we held that a patentee was bound by arguments that
 it made to an examiner to distinguish prior art. Am.
 Piledriving Equip., Inc. v. Geoquip, Inc., 637 F.3d 1324,
 1336 (Fed. Cir. 2011). We explained that the patentee had

     2   Amneal further argues that Patent Owner disa-
 vowed compositions that exhibit a “substantially constant
 rate” of release by arguing that their dissolution profiles
 “cannot be achieved with an IR/DR-only formulation as
 claimed in the Chang ’740 patent.” See J.A. 2552; J.A.
 2545–46, 2553–54, 2562, 16910–12. We agree with Gal-
 derma that Amneal did not raise this estoppel argument
 before the district court. While Amneal did compare its
 product’s dissolution profile to that of Sheth, it did not ar-
 gue that Galderma disavowed products exhibiting a “sub-
 stantially constant rate.” See J.A. 5393–94 (arguing that
 its later-releasing portion “[a]chieves a different result
 than DR”) (emphasis in original). The argument is there-
 fore waived.
     3   Amneal also argues that the district court erred in
 determining that Galderma’s doctrine of equivalents argu-
 ment was not precluded due to the doctrines of amend-
 ment-based estoppel and claim vitiation. We see no error
 in the district court’s decisions as to these doctrines.
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 8                GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 “unambiguously argued” a particular construction during
 reexamination and, “regardless of whether the examiner
 agreed with American Piledriving’s arguments concerning
 [the claim term], its statements still inform the proper con-
 struction.” Id. American Piledriving is distinguishable for
 multiple reasons including that the statements were not
 made during inter partes review, the statements were used
 to inform claim construction not prosecution history dis-
 claimer and our court did not find that the examiner had
 clearly and expressly rejected the patentee’s proposed con-
 struction.
     A prosecution history statement may inform the proper
 construction of a term without rising to the level of a clear
 and unmistakable disclaimer. See, e.g., Shire Dev., LLC v.
 Watson Pharm., Inc., 787 F.3d 1359, 1366 (Fed. Cir. 2015)
 (“Although the prosecution history statements do not rise
 to the level of unmistakable disavowal, they do inform the
 claim construction.”). In American Piledriving, the claim
 language and specification compelled a particular con-
 struction and the statements made during prosecution
 merely served as additional support that “remove[d] all
 doubt” about the correct construction. See 637 F.3d
 at 1334–36. Here, in contrast, the claim construction is un-
 disputed and the only question is whether a clear and un-
 mistakable disclaimer bars a finding of infringement under
 the doctrine of equivalents. A person of ordinary skill in
 the art would not read the prosecution history in this case
 and conclude that the patent owner’s claim construction
 that the Board expressly rejected was a clear and unmis-
 takable surrender.
     Having determined that the district court did not err in
 considering Galderma’s doctrine of equivalents arguments,
 we now turn to the merits of the court’s infringement find-
 ing. Amneal argues that Patent Owner’s arguments dur-
 ing inter partes review preclude a finding of infringement
 as its theory contradicts every “substantial” difference it
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                   9

 identified during inter partes review. For example, Patent
 Owner argued that (1) release of the drug in the stomach
 from “leaky” SR portions was “substantially different” from
 the claimed DR portion, and (2) “substantially constant re-
 lease” from SR-containing formulations was “significantly
 different” from the two-pulse dissolution of the claimed
 “IR/DR only” formulations. Amneal argues that its product
 has both. Galderma argues that Amneal’s product is at
 least equivalent to the claimed invention under the district
 court’s construction of DR as “release of a drug at a time
 other than immediately following oral administration.” It
 argues that Amneal’s product contains a portion of doxycy-
 cline that performs substantially the same function, in sub-
 stantially the same way, to achieve substantially the same
 result as the DR portion claimed.
      We review the district court’s fact findings for clear er-
 ror, and are not free to make a different finding on appeal. 4
 See Rolls-Royce Ltd. v. GTE Valeron Corp., 800 F.2d 1101,
 1110 (Fed. Cir. 1986) (“This court does not sit to reweigh
 the evidence presented to the district court, nor will it draw
 its own inferences, nor make its own fact findings. It will
 not reverse unless the inferences drawn and facts found by
 the trial court are on the full record so unsupported as to
 have been the result of clear error.”). The district court
 found that Amneal’s product contains a DR portion of
 doxycycline and a separate portion of doxycycline that is
 not available for release until a time “other than

     4   The district court considered the importance of the
 application of the correct burden of proof by the factfinder
 and concluded that “Galderma has proven infringement by
 a preponderance of the evidence.” J.A. 75–76 n.8 (“[T]he
 Court, when sitting as factfinder, is called upon to make a
 determination based on the evidence presented, applying
 the appropriate burden of proof, even when there is strong
 evidence on both sides of the dispute.”).
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 10               GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 immediately following oral administration.” J.A. 78. The
 district court found that these portions together satisfy the
 DR limitation. Id. Because the record evidence supports
 the district court’s finding, we conclude that the district
 court did not clearly err in finding infringement under the
 doctrine of equivalents. Amneal’s product is manufactured
 by layering doxycycline such that doxycycline releases at
 various intervals. See J.A. 5619–20 at B-61:1-B-64:5; J.A.
 5621 at B-67:7–19; J.A. 5625 at B-83:21–84:11; J.A. 5627
 at B-92:8–93:2; J.A. 5642 at B-153–54; J.A. 14524, 14531.
 Because a portion is prevented from releasing immedi-
 ately, such later-releasing portion of doxycycline occurs “at
 a time other than immediately following oral administra-
 tion.” See J.A. 76 (citing J.A. 41 ¶ 85); see also J.A. 5658–
 59 at B-218:6–219:4. Therefore, this later-releasing por-
 tion, “in combination with [the DR portion of doxycycline],
 is insubstantially different from the 10 mg DR portion
 claimed in Chang.” J.A. 78; see also J.A. 80–81 (concluding
 that Amneal’s product’s combination “performs the same
 function in the same way to achieve the same result as the
 10 mg DR portion claimed in Chang.”). In view of the evi-
 dence, we hold that the district court did not clearly err in
 finding infringement under the doctrine of equivalents
 with respect to the Chang Patents.
                              II
                     The Ashley II Patents
     The district court further concluded that Amneal’s
 product infringes the asserted claims of the Ashley II Pa-
 tents under the doctrine of equivalents. Following argu-
 ment in this court, Galderma filed a letter pursuant to
 Federal Rule of Appellate Procedure 28(j) alleging that this
 court lacks jurisdiction as to the Ashley II Patents based
 on actions taken by Amneal regarding its ANDA after filing
 its Notice of Appeal. We instructed the parties to submit
 supplemental briefing limited to this issue. Galderma al-
 leges that this court should dismiss the appeal because
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                   11

 Amneal’s actions divested this court of jurisdiction over the
 Ashley II Patents. Amneal argues that there remains a
 justiciable controversy between Galderma and Amneal
 concerning infringement of the Ashley II Patents.
                                A
      We hold that Amneal’s actions did not divest this court
 of subject matter jurisdiction. There is no dispute that the
 district court had subject matter jurisdiction when the ac-
 tion was filed. There is also no dispute that Amneal’s ap-
 peal is from a “final decision of a district court . . . in a[]
 civil action arising under . . . an[] Act of Congress relating
 to patents . . .” and therefore that this court had jurisdiction
 at the time the Notice of Appeal was filed. 28 U.S.C.
 § 1295(a)(1). As the Supreme Court stated in Caraco Phar-
 maceutical Laboratories, Ltd. v. Novo Nordisk, A/S, “[t]he
 want of an infringing act is a merits problem, not a juris-
 dictional one.” 566 U.S. 399, 412 n.5 (2012) (concluding
 that jurisdiction existed because the suit “‘ar[ose] under
 a[n] Act of Congress relating to patents.’ 28 U.S.C.
 § 1338(a).”). As such, this court retains jurisdiction over
 the judgment with respect to the Ashley II patents.
     We further conclude that there remains a justiciable
 controversy between the parties such that the action is not
 moot. An action is moot when “events have eradicated the
 effects of a defendant’s act or omission, and there is no rea-
 sonable expectation that the alleged violation will recur.”
 Ferring B.V. v. Watson Labs, Inc.-Fla., 764 F.3d 1382, 1391
 (Fed. Cir. 2014). “In cases where a defendant voluntarily
 ceases the challenged practice, it is necessary for the court
 to determine whether ‘there is no reasonable expectation
 that the wrong will be repeated.’” Id. (quoting United
 States v. W.T. Grant Co., 345 U.S. 629, 633 (1953)). We
 have reviewed the parties’ supplemental briefing and the
 current status of Amneal’s ANDA. Because there is no
 question that the allegedly infringing conduct could
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 12               GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 “reasonably be expected to recur,” we have not been di-
 vested of jurisdiction and the action is not moot. See
 Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc., 528
U.S. 167, 189 (2000). We therefore consider the issue of
 infringement under the doctrine of equivalents.
                               B
      The Ashley II Patents are related to methods of treat-
 ing acne or rosacea by oral administration of a low-dose
 doxycycline. Galderma asserted infringement of claims 3,
 4, 5, 15, and 16 of the ’506 patent and claims 13, 14, 15, and
 16 of the ’946 patent. Claim 15 of the ’506 patent is illus-
 trative:
      15. A method for treating papules and pustules of
      rosacea in a human in need thereof, the method
      comprising administering orally to said human
      doxycycline, or a pharmaceutically acceptable salt
      thereof, in an amount of 40 mg per day, wherein
      the amount results in no reduction of skin micro-
      flora during a six-month treatment, without ad-
      ministering a bisphosphonate compound.
     The district court construed “wherein the amount re-
 sults in no reduction of skin microflora during a six-month
 treatment” as “wherein the amount results in no reduction
 of skin microflora vis-à-vis a placebo control during a six-
 month treatment, with microbiological sampling at base-
 line and month six.” It found that Amneal’s product in-
 fringes the asserted claims of the Ashley II Patents under
 the doctrine of equivalents and entered a judgment of in-
 fringement against Amneal.
     Amneal appeals this judgment, arguing that Galderma
 presented no argument or evidence regarding the doctrine
 of equivalents as to the Ashley II Patents. It argues that
 allegations of infringement under the doctrine of equiva-
 lents require “particularized testimony and linking argu-
 ment as to the ‘insubstantiality of the differences’ between
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC                  13

 the claimed invention and the accused . . . process, or with
 respect to the function, way, result test . . . evidence must
 be presented on a limitation-by-limitation basis.” Appel-
 lants’ Br. 57 (citing Texas Instruments Inc. v. Cypress Sem-
 iconductor Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996)).
 Galderma argues that it asserted infringement under the
 doctrine of equivalents in the pretrial order. It further ar-
 gues that it presented evidence on why Amneal’s product
 would not reduce skin microflora, and “particularized tes-
 timony and argument under the ‘function-way-result’ test
 as to why the ‘sub-antibacterial amount’ terms . . . were
 infringed under the doctrine of equivalents,” which “ap-
 plied equally to the overlapping subject matter of the ‘skin
 microflora’ terms.” Appellees’ Br. 54. Amneal responds
 that any argument was related to the “sub-antibacterial
 amount” limitation of the Ashley I patents 5 and the record
 does not support an assertion that Galderma’s case on the
 “sub-antibacterial amount” limitations of other patents
 “applie[s] equally to the overlapping subject matter of the
 ‘skin microflora’ terms” here. Appellants’ Reply Br. 23.
     Galderma did not present particularized testimony and
 linking argument as to the reduction in skin microflora
 term. See J.A. 5477 (219:10–220:9, e.g., Q: So do you have
 an opinion as to whether Amneal’s ANDA product has sub-
 stantially the same function as a sub-antibacterial
 amount? A: Yes, it does . . . [b]ecause it functions the same
 way. It’s not inhibiting organisms, not selecting flora re-
 sistance, not affecting the flora.”). Rather, it presented tes-
 timony with respect to the “sub-antibacterial amount”
 limitation of the Ashley I patents and, now attempting to
 find support for the district court’s finding, it alleges that

     5   The Ashley I Patents are related patents. Alt-
 hough they were asserted in the district court below, they
 are not presently on appeal.
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 14               GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC

 such testimony provides the necessary particularized testi-
 mony for the skin microflora terms as well. Because the
 record wholly lacked the requisite particularized testimony
 required to find infringement under the doctrine of equiv-
 alents, we reverse the district court’s judgment. 6
                         CONCLUSION
      We have considered the parties’ remaining arguments
 and find them unpersuasive. For the foregoing reasons, we
 affirm the district court’s judgment as to infringement of
 the Chang Patents and reverse the district court’s judg-
 ment as to infringement of the Ashley II Patents.

      6   Alternatively, Galderma argues that in view of the
 substantial evidence and court’s factual findings, we can
 affirm the district court’s judgment because Amneal’s prod-
 uct literally infringes. It argues, for example, that the as-
 serted claims and specification (including the results of
 Example 38 from which the “no reduction of skin micro-
 flora” term was derived) expressly identify a 40 mg/day
 doxycycline dosage as an amount meeting the limitation.
 It further argues that Skidmore and Example 38 is “the
 strongest intrinsic evidence of what the patentee intended
 to convey with the skin microflora limitation.” Amneal ar-
 gues that Skidmore reports clinical results of a different
 twice-daily 20 mg formulation, not Amneal’s once-daily
 product, and was limited to the forehead, while the “skin
 microflora” limitation requires no reduction on the skin
 generally. We see no clear error in the district court’s find-
 ing that “it may be impossible to prove that absolutely no
 microflora in any part of the body is inhibited by admin-
 istration of 40 mg doxycycline once daily,” but “Skidmore,
 which reports on one area of the body . . . is insufficient to
 prove ‘no reduction of skin microflora vis-à-vis a placebo’ in
 all parts of the body and, thus, does not prove literal in-
 fringement.” J.A. 89.
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 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC               15

   AFFIRMED-IN-PART AND REVERSED-IN-PART
                           COSTS
     Each party shall bear its own costs.