Galderma Laboratories v. Teva Pharmaceuticals USA

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NOTE: This disposition is nonprecedential.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.
Case: 19-2396 Document: 58 Page: 2 Filed: 01/29/2020
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.Case: 19-2396 Document: 58 Page: 14 Filed: 01/29/2020
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
Case: 19-2396 Document: 58 Page: 16 Filed: 01/29/2020
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
Case: 19-2396 Document: 58 Page: 17 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.