Court Opinion

ID: 4502549
Source: CourtListenerOpinion
Date Created: 2020-01-29 17:00:33.535158+00
Date Added: 2024-06-11T09:24:55.243852
License: Public Domain

Case: 19-2396    Document: 58     Page: 1   Filed: 01/29/2020

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

   GALDERMA LABORATORIES, L.P., GALDERMA
       S.A., GALDERMA SKIN HEALTH S.A.,
                Plaintiffs-Appellants

                             v.

        TEVA PHARMACEUTICALS USA, INC.,
              Defendant-Cross-Appellant
               ______________________

                   2019-2396, 2020-1213
                  ______________________

     Appeals from the United States District Court for the
 District of Delaware in No. 1:17-cv-01783-RGA, Judge
 Richard G. Andrews.
                 ______________________

                Decided: January 29, 2020
                 ______________________

     JAMIL ALIBHAI, Munck Wilson Mandala, LLP, Dallas,
 TX, for plaintiffs-appellants. Also represented by KELLY P.
 CHEN, CHASE COBERN, CHAD RAY, MICHAEL CRAIG WILSON;
 EVAN D. DIAMOND, GERALD J. FLATTMANN, JR., VANESSA
 YEN, King & Spalding LLP, New York, NY.

    JOHN C. O’QUINN, Kirkland & Ellis LLP, Washington,
 DC, for defendant-cross-appellant. Also represented by
 WILLIAM H. BURGESS; LEORA BEN-AMI, New York, NY.
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 2               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

                   ______________________

     Before MOORE, O’MALLEY, AND STOLL, Circuit Judges.
 O’MALLEY, Circuit Judge.
      This patent infringement suit arises from the filing of
 Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) Abbreviated
 New Drug Application (“ANDA”) No. 210019. In its ANDA,
 Teva seeks approval to market a generic version of
 Soolantra®, a pharmaceutical product marketed by Plain-
 tiffs Galderma Laboratories, L.P., Galderma S.A., and
 Nestlé Skin Health S.A. (collectively, “Galderma”). Follow-
 ing a bench trial, the U.S. District Court for the District of
 Delaware entered final judgment for Teva, holding that the
 asserted claims of U.S. Patent Nos. 9,089,587 (“the ’587 pa-
 tent”); 9,233,117 (“the ’117 patent”); and 9,233,118 (“the
 ’118 patent”) were invalid for anticipation under 35 U.S.C.
 § 102. Galderma appeals from the district court’s judg-
 ment. Following entry of judgment, Galderma sought and
 obtained from the district court an injunction pending ap-
 peal pursuant to Federal Rule of Civil Procedure 62(d).
 Teva cross-appeals from the district court’s injunction or-
 der. For the reasons discussed below, we reverse and re-
 mand the district court’s judgment and dismiss as moot
 Teva’s cross-appeal. 1

      1  Given the parties’ detailed briefing of these issues
 in connection with Teva’s motion to stay the injunction or-
 der (addressed below), the straightforward nature of the is-
 sues presented, and the need to resolve this dispute and
 return it to the district court expeditiously, we see no value
 in scheduling oral argument in this case. Accordingly, we
 proceed to rule on this appeal on the papers.
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.                 3

                        I. BACKGROUND
                 A. The Claimed Technology
     Galderma is the holder of approved New Drug Applica-
 tion (“NDA”) No. 206255 for Soolantra®, a topical pharma-
 ceutical    formulation    containing    1%     ivermectin.
 Soolantra® is indicated for the treatment of inflammatory
 lesions of rosacea, a skin disorder characterized by facial
 flushing and redness. The patents-in-suit are listed in the
 Orange Book for Soolantra® and are directed to methods of
 treating papulopustular rosacea (“PPR”), using topical
 ivermectin compositions. PPR, a subtype of rosacea, is a
 chronic inflammatory disorder that results in facial pap-
 ules and pustules and is characterized by the presence of
 inflammatory lesions. Soolantra®, approved by the FDA
 in 2014, is the first ever ivermectin-based treatment for
 rosacea.
     Galderma asserted the following claims at trial:
 claim 12 of the ’587 patent; claims 2, 3, and 6 of the ’117
 patent; and claims 6, 7, 10, and 11 of the ’118 patent. The
 asserted claims recite methods of treating inflammatory le-
 sions of rosacea through topical administration of 1% iver-
 mectin once daily to patients with inflammatory lesions of
 rosacea. The claims also recite certain efficacy benchmarks
 resulting from the treatment methods. These bench marks
 measure certain parameters, including: (1) lesion count re-
 duction, i.e., the difference in the number of inflammatory
 lesions before and after treatment; (2) Investigator’s Global
 Assessment (“IGA”) success rate, i.e., the percentage of pa-
 tients who achieve an IGA of 0 to 1 on a five-point scale of
 rosacea severity; 2 and, (3) relapse-free time, i.e., the time
 period between a patient’s IGA success rate of 0 or 1 to the

     2   The five-point scale characterizes rosacea severity
 as follows: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate),
 and 4 (severe). ’587 patent, Table 1.
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 4               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 patient’s first reoccurrence of an IGA of 2 or more. See
 ’587 patent, 6:63–7:25. The claimed efficacy benchmarks
 are:
     (1) ‘a significant reduction in inflammatory lesion
     count in the subject’ (’587 patent, claim 12; ’118 pa-
     tent, claims 6, 7, 10, 11);
     (2) ‘a significant improvement in at least one se-
     lected from the group consisting of a higher inves-
     tigator’s global assessment success rate and a
     delayed time to first relapse in the subject in com-
     parison to that achieved by topically administering
     to the subject, twice daily, a second pharmaceutical
     composition comprising 0.75% by weight metroni-
     dazole’ (’587 patent, claim 12);
     (3) ‘as early as 2 weeks after the initial administra-
     tion of the pharmaceutical composition, a signifi-
     cant reduction in inflammatory lesion count’ (’117
     patent, claims 2, 3, 6; ’118 patent, claims 7, 10, 11);
     (4) ‘as early as 2 weeks after the initial administra-
     tion of the pharmaceutical composition, a signifi-
     cant reduction in inflammatory lesion count,’
     ‘wherein the subject has moderate to severe pap-
     ulopustular rosacea before the treatment,’ and
     ‘wherein the subject has 15 or more of the inflam-
     matory lesions before the treatment’ (’117 patent,
     claim 6);
     (5) ‘more reduction in inflammatory lesion count in
     the subject in comparison to that achieved by topi-
     cally administering to the subject, twice daily, a
     second pharmaceutical composition comprising
     0.75% by weight metronidazole’ (’117 patent, claim
     2; ’118 patent, claim 10); and
     (6) ‘longer relapse-free time of the inflammatory le-
     sions of rosacea in the subject in comparison to that
     achieved by twice daily topically administering to
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.                 5

     the subject a second pharmaceutical composition
     comprising 0.75% by weight metronidazole’ (’117
     patent, claim 3; ’118 patent, claim 11).
 Galderma Labs. L.P. v. Teva Pharm. USA, Inc., 390 F.
 Supp. 3d 582, 590 (D. Del. 2019).
      The parties agreed that the terms “significant reduc-
 tion” or “significant improvement” meant “a reduction/im-
 provement that is statistically significant, not due to
 chance alone, which has a p-value of 0.05 or less.” J.A.
 4374. And they agreed that “time to first relapse” or “re-
 lapse-free time” meant “the time elapsed between initial
 successful treatment to an IGA of rosacea of 0 or 1 to the
 first reoccurrence of the IGA to 2 or more in a subject.” Id.
     It is undisputed that the Soolantra® formulation nec-
 essarily achieves the claimed efficacy limitations.
                   B. Procedural History
     On December 30, 2016, Teva filed its ANDA directed to
 a generic 1% ivermectin cream. In response to Teva’s par-
 agraph IV certification asserting that the claims of the pa-
 tents-in-suit were invalid, unenforceable, and/or not
 infringed, Galderma filed this suit against Teva, alleging
 infringement pursuant to 35 U.S.C. § 271(d)(2)(A). Teva
 stipulated to infringement of claim 6 of the ’118 patent.
 The district court held a bench trial in June 2019. Teva
 asserted that the claims at issue were invalid as antici-
 pated by U.S. Patent No. 5,952,372 (“McDaniel”) or U.S.
 Patent No. 7,550,440 (“Manetta”). Teva also argued that
 the asserted claims were invalid for obviousness over
 Manetta alone, or Manetta in combination with McDaniel
 and certain other prior art references. J.A. 6053–62. Teva
 further argued that the asserted claims lack written de-
 scription support. J.A. at 6042–43.
     Following post-trial briefing, the district court issued
 an opinion finding each of the asserted claims invalid for
 anticipation by McDaniel. Galderma Labs., 390 F. Supp.
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 6               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 3d at 584. The district court found that McDaniel expressly
 discloses: methods for treatment of rosacea, including in-
 flammatory lesions of PPR; a topical formulation contain-
 ing about 1–5% ivermectin; and, once-daily application of
 ivermectin. Id. at 586–89. It also found that McDaniel in-
 herently disclosed the claimed efficacy limitations. Id. at
 589–92. This finding of inherency was based on the parties’
 stipulation that “Manetta enables McDaniel in 2012 as to
 the formulation.” Id. at 591. The district court concluded
 that McDaniel discloses “the same ivermectin formulation
 as in the asserted claims.” Id. at 591–92. According to the
 district court, “as of 2012, before the critical dates of the
 asserted claims, a person of ordinary skill in the art would
 have been able to practice McDaniel’s disclosed treatment
 method with Manetta’s formulation without undue experi-
 mentation.” Id. at 591. It is undisputed that Manetta dis-
 closes the Soolantra formulation. J.A. 6015, ¶¶ 93–94;
 J.A. 15010–11.
     The district court did not address Teva’s anticipation
 challenge based on Manetta. And, because it found all as-
 serted claims invalid for anticipation, the court did not
 reach Teva’s arguments concerning obviousness and lack
 of written description. The district court entered judgment
 on August 29, 2019.
     On September 6, 2019, Galderma timely filed a notice
 of appeal. Shortly thereafter, Teva launched its generic
 drug product. In response, Galderma filed an emergency
 motion for a stay pending appeal pursuant to Federal Rule
 of Civil Procedure 62(d). At the hearing for this motion, the
 district court noted that Galderma had raised a substantial
 issue with the finding of anticipation, leaving the court
 without confidence that this decision would be affirmed.
 J.A. 15862–63. The court granted Galderma’s motion, en-
 joining Teva from marketing its generic product.
    Teva then filed a motion with this court pursuant to
 Federal Rule of Appellate Procedure Rule 8, asking us to
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.                 7

 stay or dissolve the injunction. Because Teva did not first
 file a notice of appeal from the injunction order, we asked
 the parties to address whether we had authority to grant
 Teva’s requested relief. In response, Teva timely filed a
 notice of cross-appeal. We granted Teva’s Rule 8 motion on
 December 12, 2019 and stayed the district court’s injunc-
 tion. See Order, Galderma Labs. L.P. v. Teva Pharm. USA,
 Inc., No. 19-2053 (Fed. Cir. Dec. 12, 2019), ECF No. 43.
     On appeal, Galderma challenges the district court’s
 finding of anticipation of the asserted claims. As to the
 cross-appeal, Teva does not intend to further brief the in-
 junction issue, noting that its requested relief has already
 been granted. We have jurisdiction under 28 U.S.C.
 § 1295(a)(1).
                        II. DISCUSSION
                    A. Standard of Review
      On appeal from a bench trial, we review a district
 court’s conclusions of law de novo and its findings of fact
 for clear error. SmithKline Beecham Corp. v. Apotex Corp.,
 403 F.3d 1331, 1337 (Fed. Cir. 2005). “Anticipation is a
 question of fact, and a district court’s findings on this issue
 are reviewed for clear error.” Braintree Labs., Inc. v. Novel
 Labs., Inc., 749 F.3d 1349, 1358 (Fed. Cir. 2014). A factual
 finding is clearly erroneous if, upon review of the evidence,
 a reviewing court is “left with the definite and firm convic-
 tion that a mistake has been made.” Spectrum Pharm., Inc.
 v. Sandoz Inc., 802 F.3d 1326, 1333 (Fed. Cir. 2015). “[I]f
 the trial court bases its findings upon a mistaken impres-
 sion of applicable legal principles, the reviewing court is
 not bound by the clearly erroneous standard.” Inwood
 Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 855 (1982).
                       B. Anticipation
     On appeal, Galderma challenges the district court’s
 (1) use of multiple references for its anticipation analysis;
 and (2) finding of inherency based on “a mere possibility.”
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 8               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 The parties also dispute whether McDaniel expressly dis-
 closes the claimed efficacy limitations. As explained below,
 we agree with Galderma that the district court erred in its
 inherent anticipation analysis. Moreover, we read the dis-
 trict court’s opinion to implicitly find that McDaniel lacks
 an express disclosure of the claimed efficacy limitations.
 We do not consider this finding to be clearly erroneous.
             1. Reliance on Multiple References
     A patent is invalid for anticipation if a single prior art
 reference discloses each and every limitation of the claimed
 invention, either expressly or inherently. Schering Corp.
 v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir.
 2003). An anticipatory prior art reference must also “ena-
 ble one with ordinary skill in the art to practice the inven-
 tion.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d
 1331, 1342 (Fed. Cir. 2005) (internal quotations and cita-
 tions omitted). “As long as the reference discloses all of the
 claim limitations and enables the ‘subject matter that falls
 within the scope of the claims at issue,’ the reference antic-
 ipates.” In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009)
 (emphasis added) (quoting Schering Corp., 339 F.3d at
 1380–81).
      Galderma argues that the district court erred by find-
 ing the asserted claims anticipated based on disclosures
 found in two references, in contravention of settled law
 that anticipation must be based on disclosure in a single
 reference. According to Galderma, although the district
 court was permitted to look to other references to interpret
 the allegedly anticipatory reference, it was strictly prohib-
 ited from using additional references “for a very specific
 teaching.” Galderma’s Br. 22 (citing Studiengesellschaft
 Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed.
 Cir. 1984)). Galderma argues that the district court erred
 by relying on Manetta for its teaching of the Soolantra for-
 mulation. Id. at 23. In Galderma’s view, based on the par-
 ties’ stipulation that McDaniel’s formulation was enabled
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.                 9

 by Manetta, the district court incorporated one of the
 Manetta formulations into McDaniel, erroneously finding
 the asserted claims anticipated.
     Galderma further contends that the district court con-
 fused enablement with anticipatory disclosure. Id. at 23–
 26. Galderma argues that we have looked to additional ref-
 erences “solely to show enablement of an anticipatory ref-
 erence,” not, as here, for “whether an enabled reference
 discloses all claim limitations.” Id. at 25 (citing Bristol-My-
 ers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368,
 1372 (Fed. Cir. 2001)). According to Galderma, Manetta’s
 enablement of McDaniel’s formulation only means that a
 person of ordinary skill in the art (“POSA”) could practice
 the general formulations disclosed in McDaniel. It cannot
 mean that McDaniel discloses the specific formulation dis-
 closed in Manetta.
      Teva, on the other hand, sees no error in the district
 court’s finding of anticipation. It argues that anticipation
 is evaluated from the perspective of a POSA and the
 knowledge of a POSA can be shown with extrinsic evidence,
 “without running afoul of the single-reference rule for an-
 ticipation.” Teva’s Br. 33. According to Teva, Galderma’s
 stipulation that “‘Manetta enables McDaniel in 2012 as to
 the formulation,’” is “directly relevant evidence” of the per-
 spective of a POSA. Id. at 34. Teva argues that there is no
 error because “[i]t follows [from the parties’ stipulation]
 that a skilled artisan with McDaniel in hand would envis-
 age” the specific formulation disclosed in Manetta. Id. at
 35.
      Teva further argues that the district court’s findings
 are consistent with our precedent. It argues that disclo-
 sure of a genus (here, McDaniel’s disclosure of a 1–5% iver-
 mectin formulation) can anticipate a claimed species if a
 POSA would discern or possess the species (here, the
 Soolantra formulation) upon reading the disclosure. Id.
 (citing Bristol-Myers, 246 F.3d at 1380). According to Teva,
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 10              GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 Manetta’s Soolantra is “undoubtedly a species within the
 scope of McDaniel’s disclosure,” and, given that this formu-
 lation necessarily achieves the claimed results, a POSA’s
 possession of the formulation before the critical date antic-
 ipates. Id. (citing Perricone v. Medicis Pharm. Corp., 432
 F.3d 1368 (Fed. Cir. 2005)).
     Teva’s arguments ignore the axiom that a patent claim
 can only be invalid for anticipation if a single reference dis-
 closes each and every limitation of the claimed invention.
 Turning to another reference “for a very specific teaching”
 runs afoul of these settled principles. See, e.g., Dart Indus.,
 726 F.2d at 727 (rejecting an anticipation challenge where
 the challenger relied on two additional articles “for a very
 specific teaching, not for any light they shed on what [the
 anticipatory reference] would have meant to those skilled
 in the art”). Here, the district court erred by finding the
 asserted claims anticipated by the disclosures of McDaniel
 and Manetta, in contravention of settled law.
       We reject Teva’s arguments that the doctrine of ena-
 blement justified the district court’s reliance on Manetta
 for a specific teaching. In so arguing, Teva confuses the
 concepts of anticipation and enablement, just as the dis-
 trict court did. Whether a prior art reference is enabled is
 a separate question from whether it discloses, expressly or
 inherently, the claimed limitations at issue. Here, the par-
 ties’ stipulation meant only one thing: in 2012, a POSA
 would have been able to practice the general formulations
 disclosed in McDaniel, i.e., 1–5% ivermectin, “formulated
 into a cosmetically-acceptable topical lotion, cream, or gel.”
 McDaniel at 2:66–3:10. The stipulation cannot mean, as
 Teva suggests, that McDaniel discloses the specific
 Soolantra formulation.
     Our decision in Bristol-Myers is instructive. In Bristol-
 Myers, we held that certain method of treatment claims di-
 rected to “premedicating” were anticipated by the prior art
 reference “Kris” suggesting premedicating generally, even
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.               11

 though Kris did not “actually employ premedication.” 246
 F.3d at 1378. We clarified that it was permissible to “look
 to any references that establish that Kris’s suggestion of
 [premedicating] would have been enabling to one of skill in
 the art more than one year prior to [the] earliest filing date
 of [the patent].” Id. at 1379. At the same time, we found
 that certain other claims, directed to specific classes of pre-
 medicaments (“steroids, antihistimines, H2-receptor an-
 tagonists, and combinations thereof”), were not anticipated
 by Kris, which disclosed “only the use of premedicaments
 generally.” Id. at 1372, 1380. For this second set of claims,
 we refused to turn to other prior art references disclosing
 the use of steroids and H2-histamine antagonists as pre-
 medicaments, because Kris did not contain this specific dis-
 closure. Id. at 1380.
     The difference between our finding of anticipation of
 the first set of claims in Bristol-Myers and the district
 court’s finding of anticipation in the present case, is that in
 Bristol-Myers, the asserted anticipatory reference con-
 tained the very disclosure that was found to be enabling
 based on other references (premedicating generally). By
 contrast, here, McDaniel does not contain the specific dis-
 closure that is necessary for a finding of anticipation: an
 ivermectin formulation (such as Soolantra®) that neces-
 sarily achieves the claimed efficacy limitations. We refuse
 to look to Manetta to incorporate a specific disclosure not
 found in McDaniel, just as we refused in Bristol-Myers to
 look beyond Kris for a disclosure of the specific premedica-
 ments claimed in the second set of claims at issue in that
 case.
     In suggesting that “[i]t follows [from the parties’ stipu-
 lation] that a skilled artisan with McDaniel in hand would
 envisage” the Soolantra® formulation, Teva’s Br. 35, Teva
 makes the impermissible leap from enablement to disclo-
 sure. The parties’ stipulation concerned the enablement of
 McDaniel. What a POSA “envisages,” on the other hand,
 is undoubtedly a question of disclosure, not enablement.
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 12               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 What a POSA “envisages” from reading a reference is rele-
 vant to whether a reference discloses the claim elements
 “arranged as in the claim.” Net MoneyIn, Inc. v. VeriSign,
 Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Though
 Manetta enables an embodiment of McDaniel, it does not
 necessarily follow that a POSA reading McDaniel would at
 once envisage the undisclosed specific Soolantra® formula-
 tion that satisfies the claimed efficacy limitations. In any
 event, we have previously rejected the proposition that “a
 reference missing a limitation can anticipate a claim if a
 skilled artisan viewing the reference would ‘at once envis-
 age’ the missing limitation.” See Nidec Motor Corp. v.
 Zhongshan Bd. Queen Motor Co. Ltd., 851 F.3d 1270, 1274–
 75 (Fed. Cir. 2017). Here, the district court was not per-
 mitted “to fill in missing limitations simply because a
 skilled artisan would immediately envision them.” Id.
      We also reject Teva’s arguments that possession of the
 Soolantra® formulation by a POSA before the critical date
 anticipates because Soolantra® is “undoubtedly a species
 within the scope of McDaniel’s disclosure.” Teva’s Br. 35.
 Teva has not established that McDaniel’s disclosure of 1–
 5% topical ivermectin is a small enough genus that the spe-
 cies is anticipated. To the contrary, Teva’s own expert tes-
 tified that a 1% ivermectin formulation can be achieved in
 “thousands and thousands of possible” ways. J.A. 6486–87.
      Accordingly, we conclude that the district court erred
 in looking outside McDaniel in its anticipation analysis.
           2. Inherency Based on Mere Possibility
     “[A] limitation or the entire invention is inherent and
 in the public domain if it is the ‘natural result flowing from’
 the explicit disclosure of the prior art.” Schering Corp., 339
 F.3d 1373 at 1379 (citations omitted). Inherency “may not
 be established by probabilities or possibilities.” Bettcher
 Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir.
 2011).
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.               13

     On appeal, Galderma argues that the district court er-
 roneously found that McDaniel inherently discloses the
 claimed efficacy limitations. Galderma’s Br. 28–32. Ac-
 cording to Galderma, the district court erroneously based
 this conclusion on the mere possibility that a POSA would
 have been able to practice McDaniel’s disclosed method
 with Soolantra®. Teva, on the other hand, argues that
 McDaniel “discloses” the Soolantra® formulation, and
 therefore it inherently anticipates the claimed efficacy lim-
 itations, regardless of any other formulations McDaniel
 also discloses. Teva’s Br. 38–39.
      We agree with Galderma that the district court’s find-
 ing of inherent anticipation is erroneous. As we have ex-
 plained, the district court’s conclusion that McDaniel
 discloses the Soolantra® formulation conflates the princi-
 ples of enablement and anticipation. The proper inquiry
 for inherent anticipation is whether the claimed efficacy
 limitations “necessarily result” from practicing McDaniel.
 See, e.g., Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 960–61
 (Fed. Cir. 2014) (affirming judgment that claims were not
 inherently anticipated where the prior art only showed
 that the limitation might occur, not that it inevitably oc-
 curred). What a POSA would have been able to practice
 based on Manetta’s disclosure is not at issue.
     The district court mistakenly relied on Perricone
 v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) to
 find inherent anticipation. In Perricone, the anticipatory
 reference “disclosed compositions includ[ing] all the vari-
 ous ingredients in the concentrations claimed by [the pa-
 tentee].” 432 F.3d at 1376. We found that “the district
 court correctly applied the inherency doctrine” because the
 prior art reference at issue “disclose[d] the very same com-
 position” as the claimed invention and taught its use in the
 manner claimed. Id. at 1379. We concluded that “[u]sing
 the same composition claimed by [the patentee] in the same
 manner claimed by [the patentee] naturally results in the
 same claimed . . . benefits.” Id.
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 14              GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

     Unlike Perricone, here, McDaniel does not disclose the
 “very same composition” as the patents-in-suit; it only dis-
 closes topical ivermectin formulations generally. The rec-
 ord does not show that practicing McDaniel’s general
 disclosure of 1% ivermectin, “formulated into a cosmeti-
 cally-acceptable topical lotion, cream, or gel,” necessarily
 achieves the claimed efficacy limitations. Teva did not
 demonstrate that the use of any such formulation inevita-
 bly results in the claimed efficacies. Notably, Teva’s own
 formulation expert testified that formulation parameters
 such as excipients can impact drug release, J.A. 6491,
 which affects whether a formulation has “any sort of ther-
 apeutic value.” J.A. 6481.
      This is not a case, as Teva suggests, of an anticipating
 reference disclosing non-anticipating alternatives. Teva’s
 Br. 39–40. It is true that anticipation is not defeated by a
 showing that the allegedly anticipating reference also dis-
 closes non-anticipating alternatives. See, e.g., Perricone,
 432 F.3d at 1376. But that is not the question before us.
 The inquiry here is whether the claimed efficacy limita-
 tions are an inherent result of practicing McDaniel’s dis-
 closed methods. The answer is no because: (1) McDaniel
 does not disclose the specific Soolantra® formulation; and
 (2) as Teva’s expert acknowledged, variation in formulation
 parameters will undoubtedly affect the results achieved
 from the use of McDaniel’s disclosed formulations. Teva
 has provided no basis for us to conclude with certainty that
 all 1% formulations within the scope of McDaniel’s disclo-
 sure will inevitably achieve the claimed efficacy limita-
 tions.
     Accordingly, we conclude that the district court’s inher-
 ent anticipation analysis was clearly erroneous.
             3. McDaniel’s Express Disclosures
     Finally, we address whether McDaniel expressly dis-
 closes the efficacy limitations. Galderma argues that the
 district court correctly found that McDaniel does not
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.                15

 expressly disclose the claimed efficacy limitations. Gal-
 derma’s Reply Br. 14–15. Teva, on the other hand, insists
 that the district court made no such finding. Teva’s Br. 41–
 42. Instead, Teva argues that McDaniel expressly discloses
 all the efficacy limitations. Id. at 43–55.
     As to whether the district court found that McDaniel
 lacks an express disclosure of the claimed efficacy limita-
 tions, we conclude that such a finding is implicit in the
 court’s analysis. The district court’s “Findings of Fact”
 Nos. 9–11 are reproduced below:
     9. McDaniel explicitly discloses a treatment
     method comprising (1) topically administering, (2)
     once daily, (3) to a skin area affected by the inflam-
     matory lesions of papulopustular rosacea, (4) a
     pharmaceutical composition comprising about 1%
     by weight ivermectin and a pharmaceutically ac-
     ceptable carrier.
     10. McDaniel inherently discloses the treatment
     results of its treatment method as enabled by the
     Manetta formulation.
     11. McDaniel anticipates claim 12 of the ’587 pa-
     tent, claims 2, 3, and 6 of the ’117 patent, and
     claims 6, 7, 10, and 11 of the ’118 patent.
 Galderma Labs., 390 F. Supp. 3d at 585. In its analysis,
 the district court first explained how McDaniel expressly
 discloses every element of “the claimed treatment method,”
 at the same time noting that it will “separately” address
 the “various efficacy limitations.” Id. at 586–87. When ad-
 dressing the claimed efficacy limitations, the district court
 stated that “the only remaining limitations are those relat-
 ing to efficacy. Therefore, McDaniel anticipates the as-
 serted claims if the efficacy limitations are inherent to the
 treatment method.” Id. at 589–90 (emphases added). This
 language makes clear that the district court concluded that
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 16               GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.

 McDaniel does not expressly disclose the efficacy limita-
 tions.
      We see no clear error in this finding. Based on our re-
 view of the record, including the expert testimony address-
 ing McDaniel’s disclosures, we conclude that the district
 court did not clearly err in finding that McDaniel lacks an
 express disclosure of the claimed efficacy limitations. See,
 e.g., J.A. 6819–23 (testimony of Dr. Thisted); J.A. 6841–46
 (testimony of Dr. Webster); J.A. 6693–99, 6759–64 (testi-
 mony of Dr. Gallo).
      Because the district court did not clearly err in finding
 that McDaniel lacks an express disclosure of the claimed
 efficacy limitations, and because the district court clearly
 erred in its inherent anticipation analysis, McDaniel does
 not anticipate. Accordingly, we reverse the district court’s
 finding of anticipation.
              C. Teva’s Obviousness Arguments
      The district court did not reach Teva’s obviousness de-
 fense because it found the asserted claims anticipated by
 McDaniel. Teva invites us to affirm the judgment of inva-
 lidity by considering, in the first instance, the issue of ob-
 viousness of the asserted claims. As a court of review, that
 is not our role. We have declined in the past to reach inva-
 lidity issues not decided by the district court. See, e.g., Bax-
 ter Healthcare Corp. v. Spectramed, Inc., 49 F.3d 1575,
 1585 (Fed. Cir. 1995). We see no reason to depart from that
 practice in this case.
                   D. Teva’s Cross-Appeal
     Because we have already granted the relief requested
 in Teva’s cross-appeal, see No. 19-2396, ECF No. 43, we dis-
 miss Teva’s cross-appeal as moot.
                       III. CONCLUSION
     For the foregoing reasons, we reverse and remand for
 the district court to consider Teva’s remaining invalidity
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 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC.               17

 defenses, and dismiss Teva’s cross-appeal as moot. We
 have considered the parties’ remaining arguments and find
 them unpersuasive.
   REVERSED AND REMANDED AS TO CASE NO.
  2019-2396; DISMISSED AS TO CASE NO. 2020-1213
                            COSTS
     No costs.