Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-20-01213/USCOURTS-ca13-20-01213-0/pdf.json

Parties Involved:
Galderma Laboratories, L.P.
Appellee
Galderma S.A.
Appellee
Galderma Skin Health S.A.
Appellee
Teva Pharmaceuticals USA, Inc.
Appellant

Document Text:

NOTE: This disposition is nonprecedential.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 Plaintiffs Galderma Laboratories, L.P., Galderma S.A., and 

Nestlé Skin Health S.A. (collectively, “Galderma”). Following 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 patent”); 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 judgment. Following entry of judgment, Galderma sought and 

obtained from the district court an injunction pending appeal pursuant to Federal Rule of Civil Procedure 62(d). 

Teva cross-appeals from the district court’s injunction order. For the reasons discussed below, we reverse and remand 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 order (addressed below), the straightforward nature of the issues 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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I. BACKGROUND

A. The Claimed Technology

Galderma is the holder of approved New Drug Application (“NDA”) No. 206255 for Soolantra®, a topical pharmaceutical 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 papules 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 lesions of rosacea through topical administration of 1% ivermectin 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 reduction, 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 patients 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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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 patent, claims 6, 7, 10, 11);

(2) ‘a significant improvement in at least one selected from the group consisting of a higher investigator’s global assessment success rate and a 

delayed time to first relapse in the subject in comparison to that achieved by topically administering 

to the subject, twice daily, a second pharmaceutical 

composition comprising 0.75% by weight metronidazole’ (’587 patent, claim 12);

(3) ‘as early as 2 weeks after the initial administration of the pharmaceutical composition, a significant 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 administration of the pharmaceutical composition, a significant reduction in inflammatory lesion count,’ 

‘wherein the subject has moderate to severe papulopustular rosacea before the treatment,’ and 

‘wherein the subject has 15 or more of the inflammatory lesions before the treatment’ (’117 patent, 

claim 6);

(5) ‘more reduction in inflammatory lesion count in 

the subject in comparison to that achieved by topically 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 lesions of rosacea in the subject in comparison to that 

achieved by twice daily topically administering to 

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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 reduction” or “significant improvement” meant “a reduction/improvement 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 “relapse-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 necessarily 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 paragraph IV certification asserting that the claims of the patents-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 anticipated 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 description 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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3d at 584. The district court found that McDaniel expressly 

discloses: methods for treatment of rosacea, including inflammatory lesions of PPR; a topical formulation containing about 1–5% ivermectin; and, once-daily application of 

ivermectin. Id. at 586–89. It also found that McDaniel inherently 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 experimentation.” Id. at 591. It is undisputed that Manetta discloses 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 asserted 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, enjoining 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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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 injunction. 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 injunction 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 conviction 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 impression 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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The parties also dispute whether McDaniel expressly discloses 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 district 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 “enable one with ordinary skill in the art to practice the invention.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 

1331, 1342 (Fed. Cir. 2005) (internal quotations and citations 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 anticipates.” 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 finding 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 prohibited 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 formulation. Id. at 23. In Galderma’s view, based on the parties’ stipulation that McDaniel’s formulation was enabled 

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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 confused enablement with anticipatory disclosure. Id. at 23–

26. Galderma argues that we have looked to additional references “solely to show enablement of an anticipatory reference,” not, as here, for “whether an enabled reference 

discloses all claim limitations.” Id. at 25 (citing Bristol-Myers 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 disclosed 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 anticipation.” 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 perspective 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 envisage” 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 disclosure of a genus (here, McDaniel’s disclosure of a 1–5% ivermectin 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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Manetta’s Soolantra is “undoubtedly a species within the 

scope of McDaniel’s disclosure,” and, given that this formulation necessarily achieves the claimed results, a POSA’s 

possession of the formulation before the critical date anticipates. 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 discloses 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 enablement 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 district 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 parties’ 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 BristolMyers, we held that certain method of treatment claims directed to “premedicating” were anticipated by the prior art 

reference “Kris” suggesting premedicating generally, even 

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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 premedicaments (“steroids, antihistimines, H2-receptor antagonists, 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 premedicaments, because Kris did not contain this specific disclosure. 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 contained the very disclosure that was found to be enabling

based on other references (premedicating generally). By 

contrast, here, McDaniel does not contain the specific disclosure that is necessary for a finding of anticipation: an 

ivermectin formulation (such as Soolantra®) that necessarily 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 premedicaments claimed in the second set of claims at issue in that 

case. 

In suggesting that “[i]t follows [from the parties’ stipulation] 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 disclosure. 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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What a POSA “envisages” from reading a reference is relevant 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® formulation 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 envisage’ 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 permitted “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 species is anticipated. To the contrary, Teva’s own expert testified 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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On appeal, Galderma argues that the district court erroneously found that McDaniel inherently discloses the 

claimed efficacy limitations. Galderma’s Br. 28–32. According 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 limitations, regardless of any other formulations McDaniel 

also discloses. Teva’s Br. 38–39. 

We agree with Galderma that the district court’s finding of inherent anticipation is erroneous. As we have explained, the district court’s conclusion that McDaniel 

discloses the Soolantra® formulation conflates the principles 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 occurred). 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 various ingredients in the concentrations claimed by [the patentee].” 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 composition” 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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Unlike Perricone, here, McDaniel does not disclose the 

“very same composition” as the patents-in-suit; it only discloses topical ivermectin formulations generally. The record does not show that practicing McDaniel’s general 

disclosure of 1% ivermectin, “formulated into a cosmetically-acceptable topical lotion, cream, or gel,” necessarily

achieves the claimed efficacy limitations. Teva did not 

demonstrate that the use of any such formulation inevitably 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 therapeutic 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 discloses 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 limitations are an inherent result of practicing McDaniel’s disclosed 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 disclosure will inevitably achieve the claimed efficacy limitations. 

Accordingly, we conclude that the district court’s inherent anticipation analysis was clearly erroneous. 

3. McDaniel’s Express Disclosures

Finally, we address whether McDaniel expressly discloses the efficacy limitations. Galderma argues that the 

district court correctly found that McDaniel does not 

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expressly disclose the claimed efficacy limitations. Galderma’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 limitations, 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 inflammatory lesions of papulopustular rosacea, (4) a 

pharmaceutical composition comprising about 1% 

by weight ivermectin and a pharmaceutically acceptable 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 patent, 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 addressing the claimed efficacy limitations, the district court 

stated that “the only remaining limitations are those relating to efficacy. Therefore, McDaniel anticipates the asserted 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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McDaniel does not expressly disclose the efficacy limitations. 

We see no clear error in this finding. Based on our review of the record, including the expert testimony addressing 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 (testimony 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 defense because it found the asserted claims anticipated by 

McDaniel. Teva invites us to affirm the judgment of invalidity by considering, in the first instance, the issue of obviousness of the asserted claims. As a court of review, that

is not our role. We have declined in the past to reach invalidity issues not decided by the district court. See, e.g., Baxter 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 dismiss 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 

Case: 20-1213 Document: 4 Page: 16 Filed: 01/29/2020
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.

Case: 20-1213 Document: 4 Page: 17 Filed: 01/29/2020