Almirall, LLC v. Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC

United States Court of Appeals
for the Federal Circuit
______________________
ALMIRALL, LLC,
Appellant
v.
AMNEAL PHARMACEUTICALS LLC, AMNEAL
PHARMACEUTICALS OF NEW YORK, LLC,
Appellees
ANDREW HIRSHFELD, PERFORMING THE
FUNCTIONS AND DUTIES OF THE UNDER
SECRETARY OF COMMERCE FOR
INTELLECTUAL PROPERTY AND DIRECTOR OF
THE UNITED STATES PATENT AND TRADEMARK
OFFICE,
Intervenor
______________________
2020-2331
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2019-
00207, IPR2019-01095.
______________________
Decided: March 14, 2022
______________________
J AMES T RAINOR, Fenwick & West LLP, New York, NY,
argued for appellant. Also represented by ADAM G AHTAN,
RICHARD SHEA; ELIZABETH B. HAGAN, Seattle, WA.
Case: 20-2331 Document: 80 Page: 1 Filed: 03/14/2022

-- 1 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 2
D ENNIES VARUGHESE , Sterne Kessler Goldstein & Fox,
PLLC, Washington, DC, argued for appellees. Also repre-
sented by K RISTINA C AGGIANO K ELLY , ADAM L AROCK.
ROBERT J. MCMANUS , Office of the Solicitor, United
States Patent and Trademark Office, Alexandria, VA, for
intervenor. Also represented by BENJAMIN T. HICKMAN,
T HOMAS W. K RAUSE, F ARHEENA Y ASMEEN RASHEED.
______________________
Before L OURIE, CHEN, and CUNNINGHAM , Circuit Judges.
L OURIE, Circuit Judge.
Almirall, LLC (“Almirall”) appeals from the final writ-
ten decision of the U.S. Patent and Trademark Office Pa-
tent Trial and Appeal Board (the “Board”) holding that
claims 1–8 of U.S. Patent 9,517,219 (the “’219 patent”)
would have been obvious over the cited prior art at the time
the alleged invention was made.1 See Amneal Pharms.
LLC v. Almirall, LLC, No. IPR2019-00207, 2020 WL
2833274 (P.T.A.B. May 29, 2020) (“Decision”). For the rea-
sons provided below, we affirm.
BACKGROUND
Almirall owns the ’219 patent, which relates to meth-
ods of treating acne or rosacea with dapsone formulations
that include an acrylamide/sodium acryloyldimethyl tau-
rate copolymer (“A/SA”) thickening agent and the solvent
diethylene glycol monoethyl ether (“DGME”). Dapsone can
be used for treating various dermatological conditions.
1 Because the challenged claims of the ’219 patent
have an effective filing date before March 16, 2013, we ap-
ply the version of 35 U.S.C. § 103 in effect before the adop-
tion of the Leahy-Smith America Invents Act (“AIA”), Pub.
L. No. 112-29, 125 Stat. 284 (2011).
Case: 20-2331 Document: 80 Page: 2 Filed: 03/14/2022

-- 2 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 3
’219 patent, col. 1 ll. 19–23. DGME allows compositions to
be prepared with increased solubilized concentrations of
dapsone. Id. at col. 2 ll. 48–50. A polymeric viscosity
builder such as an A/SA agent can minimize the intensity
of yellowing of the composition. Id. at col. 2, ll. 54–61. It
can also influence dapsone crystallization by reducing the
particle size and minimizing a gritty feel upon application.
See id.
Adapalene is a compound used for treating dermatolog-
ical conditions, sometimes in combination with dapsone.
See Decision at *18. The ’219 patent includes 62 general-
ized composition embodiments, ’219 patent, col. 6 l. 58–
col. 12 l. 40, and eight specific example formulations, id. at
col. 12 l. 42–col. 15 l. 33. Several of the examples are de-
scribed as including adapalene.
Independent claims 1 and 6 read as follows:
1. A method for treating a dermatological condition
selected from the group consisting of acne vulgaris
and rosacea comprising administering to a subject
having the dermatological condition selected from
the group consisting of acne vulgaris and rosacea a
topical pharmaceutical composition comprising:
about 7.5% w/w dapsone;
about 30% w/w to about 40% w/w diethylene glycol
monoethyl ether;
about 2% w/w to about 6% w/w of a polymeric
viscosity builder comprising acrylamide/so-
dium acryloyldimethyl taurate copolymer;
and
water;
wherein the topical pharmaceutical composi-
tion does not comprise adapalene.
Id. at col. 15 l. 40–col. 16 l. 13 (emphases added).
Case: 20-2331 Document: 80 Page: 3 Filed: 03/14/2022

-- 3 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 4
6. A method for treating a dermatological condition
selected from the group consisting of acne vulgaris
and rosacea comprising administering to a subject
having the dermatological condition selected from
the group consisting of acne vulgaris and rosacea a
topical pharmaceutical composition comprising:
about 7.5% w/w dapsone;
about 30% w/w diethylene glycol monoethyl ether;
about 4% w/w of a polymeric viscosity builder
comprising acrylamide/sodium acryloyldime-
thyl taurate copolymer; and
water;
wherein the topical pharmaceutical composi-
tion does not comprise adapalene.
Id. at col. 16 ll. 23–36 (emphases added).
Amneal filed a petition for inter partes review of
claims 1–8 of the ’219 patent. J.A. 120. Amneal argued
that claims 1–8 would have been obvious over Int’l Patent
Pub. WO 2009/061298 (“Garrett”) and Int’l Patent Pub.
WO 2010/072958 (“Nadau-Fourcade”). J.A. 117–18. Am-
neal also argued that claims 1–8 would have been obvious
over Garrett and a publication titled “Characterization and
Stability of Emulsion Gels Based on Acrylamide/Sodium
Acryloyldimethyl Taurate Copolymer” (“Bonacucina”).2 Id.
Garrett describes topical dapsone treatments for treat-
ing dermatological conditions including acne and rosacea.
Garrett states that the dapsone may exist in “a micropar-
ticulate form, a dissolved form, or both.” J.A. 1475. Garrett
2 Giulia Bonacucina, et al., Characterization and
Stability of Emulsion Gels Based on Acrylamide/Sodium
Acryloyldimethyl Taurate Copolymer, 10(2) AAPS
PHARMSCITECH 368–75 (2009).
Case: 20-2331 Document: 80 Page: 4 Filed: 03/14/2022

-- 4 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 5
does not disclose any formulations that include adapalene.
For example, Garrett identifies a commercial product,
Aczone®, that lacks adapalene. J.A. 1482.
Garrett’s formulations include thickening agents. J.A.
1486. Garrett describes suitable thickening agents as in-
cluding polymer thickeners such as hydrophilic gelling
agents used in the cosmetic and pharmaceutical industries.
J.A. 1485. Garrett explains that a gelling agent preferably
comprises between about 0.2% to about 4% by weight of the
composition. Id. Garrett identifies Carbopol® as a pre-
ferred thickening agent. Id. Carbopol® is one of numerous
cross-linked acrylic acid polymers that are given the name
“carbomer.” Id. Garrett’s preferred compositional weight
percent range for Carbopol® is between about 0.5% to
about 2%.
Garrett discloses a preferred embodiment that “in-
cludes about 0.5% to 4.0% carbomer . . .; about 53.8% to
84.2% water; about 10% to 30% ethoxydiglycol [i.e.,
DGME]; about 0.2% methylparaben; about 5% to 10% dap-
sone in a microparticulate and dissolved state; and about
0.1% to 2% sodium hydroxide solution.” Decision at *5 (cit-
ing J.A. 1476). But Garrett also contemplates adjustments
for optimization. “The relative percentages for each of the
reagents used . . . may vary depending upon the desired
strength of the target formulation, gel viscosity, and the
desired ratio of microparticulate to dissolved dapsone. Un-
less otherwise designated, all reagents listed . . . are com-
monly known by one of ordinary skill in the art and are
commercially available from pharmaceutical or cosmetic
excipient suppliers.” Id. at *6 (citing J.A. 1490, 1495).
Nadau-Fourcade describes topical pharmaceutical
compositions with a water-sensitive active pharmaceutical
ingredient in dissolved form. J.A. 1529. The compositions
are for dermatologic use for conditions including acne and
rosacea. J.A. 1578. Nadau-Fourcade’s compositions may
include a hydrophilic gelling agent. J.A. 1574. Nadau-
Case: 20-2331 Document: 80 Page: 5 Filed: 03/14/2022

-- 5 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 6
Fourcade lists exemplary thickeners including carbomers
(e.g., Carbopol® products) and A/SA agents (e.g., Sepineo®
or Simulgel® products) in a range of concentrations, but
preferentially ranging from 0.01% to 5%. J.A. 1574–75.
Two formulations shown in Examples 6 and 13 utilize sim-
ilar components but different gelling agents. J.A. 1587,
1589 (containing carbomer 0.1% and Simulgel® 600 0.20%,
respectively).
Bonacucina presents research on Sepineo® P 600, a
concentrated dispersion of acrylamide/sodium acrylo-
yldimethyl taurate copolymer in isohexadecane. J.A. 1688.
Bonacucina reports that Sepineo® P 600 has self-gelling
and thickening properties that are effective for topical ad-
ministration. J.A. 1688–89 (explaining that “the possibil-
ity of obtaining stiff and stable gelled phases with this
polymer makes it a good candidate for the formulation of
emulsion gels”). Testing revealed that Sepineo® P 600
“thickens and gels well, a property that depends strongly
on polymer concentration.” J.A. 1694. Bonacucina’s gels
included a Sepineo® P 600 concentration of 0.5% to 5%.
J.A. 1694; see also J.A. 1690 (Table I, showing examples
with 0.5%, 1%, 3%, and 5% (w/w) Sepineo®).
Relevant to this appeal, the Board’s decision hinged on
whether a person of ordinary skill in the art would have
found it obvious to substitute an A/SA agent taught by
Nadau-Fourcade or Bonacucina for the carbomer gelling
agent in Garrett’s formulations to arrive at the claimed
composition. See Decision at *16. Garrett does not teach
using an A/SA agent as its polymeric viscosity builder. Id.
Instead, Garrett identifies five other preferred gelling
agents, including Carbopol®. J.A. 1485.
First, the Board determined that Garrett and Nadau-
Fourcade in combination teach or suggest every claim lim-
itation and that a person of ordinary skill in the art would
have been motivated, with a reasonable expectation of suc-
cess, to incorporate Nadau-Fourcade’s A/SA gelling agent
Case: 20-2331 Document: 80 Page: 6 Filed: 03/14/2022

-- 6 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 7
into Garrett’s dapsone formulations. Id. at *30. Specifi-
cally, the Board determined that it would have been obvi-
ous to substitute Nadau-Fourcade’s Sepineo® for Garrett’s
Carbopol®. Id. at *16. The Board found that the class of
hydrophilic gelling agents and the specific examples in the
concentrations disclosed in Garrett overlap with the gelling
agents taught by Nadau-Fourcade. Id. Nadau-Fourcade
pairs Carbopol® and Sepineo® in a small set of especially
preferred gelling agents. Id. at *17. The Board also relied
on expert testimony explaining that a person of skill would
have been able to immediately appreciate that Carbopol®
and Sepineo® “perform the same function and are inter-
changeable” and that “such a substitution was routine and
predictable because such thickening agents were known for
use in topical compositions with water insoluble drugs.” Id.
Second, the Board determined that Garrett and
Bonacucina in combination also teach or suggest every
claim limitation and that a person of ordinary skill in the
art would have been motivated, with a reasonable expecta-
tion of success, to incorporate Bonacucina’s A/SA gelling
agent into Garrett’s dapsone formulations. Id. at *30. Spe-
cifically, the Board determined that it would have been ob-
vious to substitute Bonacucina’s Sepineo® for Garrett’s
Carbopol®. Id. at *20.
The Board found that a person of ordinary skill would
have had good reasons to pursue a replacement for Carbo-
pol®. The Board relied on expert testimony that Garrett’s
Carbopol® was known to have drawbacks, for example, re-
quiring neutralization to achieve maximum viscosity and
producing grittiness and possible agglomeration. Id. at
*21. The Board also credited expert testimony in finding
that Sepineo®’s advantages would have motivated a person
of skill to replace Carbopol® with Sepineo®. For example,
Sepineo® is self-gelling, is pre-neutralized, and reduces
grittiness. Id.
Case: 20-2331 Document: 80 Page: 7 Filed: 03/14/2022

-- 7 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 8
The Board also found that a skilled artisan would have
had a reasonable expectation of successfully replacing Gar-
rett’s gelling agents with Bonacucina’s Sepineo®, in the
same amounts, to arrive at the composition recited in the
claims. Id. The Board determined that overlapping ranges
support the conclusion that a person of ordinary skill in the
art would have been expected to successfully replace Car-
bopol® with equal amounts of Sepineo® in Garrett’s formu-
lations. Id. The Board concluded that replacing Garrett’s
Carbopol® with Bonacucina’s Sepineo® would have been a
mere substitution of one gelling agent for another known
in the field, and that each component of the Garrett-
Bonacucina combination, once Sepineo® was substituted
for Carbopol®, was used for the same function it is known
to perform. Id.
The Board also agreed with Amneal that Garrett
teaches the negative adapalene claim limitation. Id. at
*18. The Board found that “there is ample evidence of rec-
ord supporting the conclusion that Garrett’s dapsone for-
mulations for treating acne neither inherently included nor
implicitly required adapalene.” Id. at *25. The Board ex-
plained that “it is not Garrett’s mere silence as to the pres-
ence of adapalene, but its disclosure of complete dapsone
formulations to treat acne in its absence that suggests that
adapalene is not included in Garrett’s formulations.” Id. at
*18. The Board noted that “the commercial Aczone® 5%
product referenced in Garrett did not include adapalene.”
Id. Relying on Garrett’s teachings and expert testimony,
the Board determined that Almirall failed to show that a
person of ordinary skill in the art would have viewed
adapalene as included in Garrett’s dapsone formulations.
Id.
The Board ultimately concluded that Amneal demon-
strated by a preponderance of the evidence that claims 1–
8 of the ’219 patent are unpatentable. Id. at *33. Almirall
appealed. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A).
Case: 20-2331 Document: 80 Page: 8 Filed: 03/14/2022

-- 8 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 9
D ISCUSSION
Almirall raises two challenges on appeal. First, Almi-
rall contends that the Board erred in presuming obvious-
ness based on overlapping ranges. Second, Almirall argues
that the Board’s obviousness determinations were unsup-
ported by substantial evidence.
We review the Board’s legal determinations de novo, In
re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we re-
view the Board’s factual findings underlying those deter-
minations for substantial evidence, In re Gartside, 203 F.3d
1305, 1316 (Fed. Cir. 2000). A finding is supported by sub-
stantial evidence if a reasonable mind might accept the ev-
idence as adequate to support the finding. Consol. Edison
Co. v. NLRB, 305 U.S. 197, 229 (1938).
I
We first consider Almirall’s challenge to the Board’s de-
termination that “Garrett discloses a range for each of the
various components of the composition that either fully en-
compasses or overlaps/abuts the ranges and amounts for
those components recited in the challenged claims, and this
is sufficient to create a presumption of obviousness as to
the claimed amounts.” Decision at *14.
Almirall argues that the Board erred in presuming ob-
viousness based on overlapping ranges because no single
reference discloses all of the claimed ranges. First, Almi-
rall argues that Garrett’s ranges for its polymeric viscosity
builders do not create a presumption of obviousness be-
cause Garrett only discloses ranges for carbomer thicken-
ers, not A/SA thickeners as claimed. Second, Almirall
argues that the Board erred by looking to the overlapping
range for the A/SA element in Nadau-Fourcade and
Bonacucina to provide that missing limitation. Almirall
argues that Nadau-Fourcade and Bonacucina cannot be
used in combination with Garrett to establish a presump-
tion of obviousness because the presumption applies only
Case: 20-2331 Document: 80 Page: 9 Filed: 03/14/2022

-- 9 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 10
when a single reference discloses all claimed ranges. See
Appellant’s Br. 27–28 (citing Iron Grip Barbell Co. v. USA
Sports, Inc., 392 F.3d 1317 (Fed. Cir. 2004)).
Amneal responds that the Board did not err in applying
a presumption of obviousness of overlapping ranges. First,
Amneal argues that Garrett’s disclosure of carbomer thick-
ener ranges is sufficient to support the rejection because
disclosure of the precise, claimed composition is not neces-
sary to show obviousness. Citing Valeant and Anacor, Am-
neal asserts that ranges for structurally and functionally
similar compounds can establish a prima facie case of obvi-
ousness. See Appellee’s Br. 24–26 (citing Valeant Pharms
Int’l Inc. v. Mylan Pharms Inc., 955 F.3d 25 (Fed. Cir.
2020); Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372 (Fed.
Cir. 2018)). Second, Amneal argues that the Board did not
err in looking to Nadau-Fourcade and Bonacucina because
the obviousness inquiry is flexible and does not require
that all elements be shown in a single reference.
“A prima facie case of obviousness typically exists when
the ranges of a claimed composition overlap the ranges dis-
closed in the prior art.” In re Peterson, 315 F.3d 1325, 1329
(Fed. Cir. 2003) (citing In re Geisler, 116 F.3d 1465, 1469
(Fed. Cir. 1997)); see also E.I. du Pont de Nemours & Co. v.
Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018); Iron
Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322
(Fed. Cir. 2004). “The point of our overlapping range cases
is that, in the absence of evidence indicating that there is
something special or critical about the claimed range, an
overlap suffices to show that the claimed range was dis-
closed in—and therefore obvious in light of—the prior art.”
E.I. du Pont, 904 F.3d at 1008. A presumption of obvious-
ness does not shift the burden of persuasion to the patentee
to prove nonobviousness, but a presumption establishes
that, “absent a reason to conclude otherwise, a factfinder is
justified in concluding that a disclosed range does just
that—discloses the entire range.” Id.
Case: 20-2331 Document: 80 Page: 10 Filed: 03/14/2022

-- 10 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 11
We agree with Amneal that the Board did not err in
applying a presumption of obviousness of overlapping
ranges. The Board’s decision sets forth factual findings of
similarity between carbomers and A/SA agents that sup-
port its conclusion that “Garrett discloses a range for each
of the various components of the composition that either
fully encompasses or overlaps/abuts the ranges and
amounts for those components recited in the challenged
claims, and this is sufficient to create a presumption of ob-
viousness as to the claimed amounts.” Decision at *14. For
example, Amneal’s expert explained that Garrett’s gelling
agents and Nadau-Fourcade’s gelling agents have overlap-
ping characteristics. Id. at *17. The Board also credited
expert testimony that a person of ordinary skill in the art
would have been able to immediately appreciate that the
carbomers and A/SA agents at issue perform the same
function and are interchangeable. Id. Moreover, there was
no evidence that A/SA agents would have different interac-
tions with the other ingredients of the compositions rela-
tive to carbomer. Indeed, the Board credited expert
testimony that a skilled artisan “would not have expected
any incompatibilities in substituting” the gelling agents.
Id. Thus, the Board found that Garrett’s gelling agents and
A/SA agents are “used in very similar concentrations for
similar formulations.” Id.
The Board also found that the presumption was not
overcome because Almirall’s evidence of unexpected results
and failure of others was unpersuasive. We find those con-
clusions supported by substantial evidence.
But even if we agreed with Almirall that the presump-
tion does not apply in this case, the outcome would be the
same. Ultimately, despite Almirall’s attempts to argue
otherwise, this case does not depend on overlapping
ranges. It is simply a case of substituting one known gel-
ling agent for another. Each may be effective at a different
concentration in different formulations, but that is just a
Case: 20-2331 Document: 80 Page: 11 Filed: 03/14/2022

-- 11 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 12
property of the particular known material, subject to con-
ventional experimentation.
It is undisputed that Nadau-Fourcade and Bonacucina
each separately disclose an A/SA thickener within the
claimed range. As further discussed below, despite deter-
mining that there was a presumption of obviousness, the
Board also analyzed whether a person of ordinary skill in
the art would have been motivated to combine Garrett with
Nadau-Fourcade or Bonacucina to arrive at the claims with
a reasonable expectation of success.
II
We therefore next consider Almirall’s arguments that
the Board erred in determining that claims 1–8 would have
been obvious over Garrett and Nadau-Fourcade
(Ground 1), as well as over Garrett and Bonacucina
(Ground 2).
As a preliminary matter relevant to both obviousness
grounds, Almirall argues that the Board failed to account
for the negative adapalene claim limitation. Almirall ar-
gues that although Garrett does not indicate that any of its
formulations include adapalene, more is needed for a dis-
closure of a negative claim limitation. Amneal responds
that substantial evidence supports the Board’s finding that
Garrett effectively teaches the negative adapalene claim
limitation.
We agree with Amneal. Almirall’s argument is con-
trary to our precedent. “[A] reference need not state a fea-
ture’s absence in order to disclose a negative limitation.”
AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367
(Fed. Cir. 2019). Instead, it was reasonable for the Board
to find that, in the context of Garrett, a skilled artisan
would recognize that the reference discloses a complete for-
mulation—excluding the possibility of an additional active
ingredient. See, e.g., Novartis Pharms. Corp. v. Accord
Healthcare, Inc., 21 F.4th 1362, 1373 (Fed. Cir. 2022)
Case: 20-2331 Document: 80 Page: 12 Filed: 03/14/2022

-- 12 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 13
(recognizing that for negative limitations, “the disclosure
must be read from the perspective of a person of skill in the
art”). It is undisputed that Garrett discloses dapsone for-
mulations that lack adapalene. The Board thus did not err
in concluding that Garrett discloses the negative adapa-
lene claim limitation.
Ground 1: Garrett and Nadau-Fourcade
Almirall argues that the Board’s holding that claims 1–
8 would have been obvious over Garrett and Nadau-Four-
cade was unsupported by substantial evidence.
First, we consider Almirall’s argument that the Board
failed to require evidence of a motivation to combine Gar-
rett with Nadau-Fourcade. The presence or absence of a
motivation to combine references in an obviousness deter-
mination is a question of fact. See In re Gartside, 203 F.3d
at 1316. Almirall argues that the Board erred by substi-
tuting the alleged interchangeability of Sepineo® and Car-
bopol® for evidence of a motivation to combine Nadau-
Fourcade with Garrett. Amneal responds that the Board
properly placed the burden on Amneal to show that the
prior art provided reasons to combine the references.
The record amply supports the Board’s conclusion that
a person of ordinary skill in the art would have been moti-
vated to replace Garrett’s gelling agent with an A/SA copol-
ymer. The Board relied on prior art and expert testimony
in determining that a person of ordinary skill would have
recognized Carbopol® and Sepineo® as closely related gel-
ling agents that could be interchangeably used in dapsone
formulations in the same concentration range. The Board
did not rely on a conclusory rationale of “design choice” as
sufficient to find that a skilled artisan would have com-
bined the references; on the contrary, it reviewed the con-
text-specific evidence for the soundness of Amneal’s
rationale. In explaining why a person of ordinary skill
would have made the choice to use an A/SA copolymer, the
Board relied on Garrett and Nadau-Fourcade’s teachings
Case: 20-2331 Document: 80 Page: 13 Filed: 03/14/2022

-- 13 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 14
as well as expert testimony. For example, the Board cred-
ited Amneal’s expert’s testimony that “such a substitution
was routine and predictable because such thickening
agents were known for use in topical compositions with wa-
ter insoluble drugs” and that a person of ordinary skill
“would not have expected any incompatibilities.” Decision
at *17.
We conclude that the Board’s rationale for the combi-
nation was sufficient to support its obviousness determina-
tion. The Board noted that Garrett explicitly states that
“[p]olymer thickeners that may be used include those
known to one skilled in the art, such as hydrophilic and
hydroalcoholic gelling agents frequently used in the cos-
metic and pharmaceutical industries.” Id. (citing J.A.
1485). The record demonstrates that A/SA copolymers
would have been predictable design choices that a person
of ordinary skill would have considered for development of
topical dapsone formulations. See KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007) (“When there is a design need
or market pressure to solve a problem and there are a finite
number of identified, predictable solutions, a person of or-
dinary skill has good reason to pursue the known options
within his or her technical grasp.”); id. at 416 (“[W]hen a
patent claims a structure already known in the prior art
that is altered by the mere substitution of one element for
another known in the field, the combination must do more
than yield a predictable result.”); id. at 417 (“If a person of
ordinary skill can implement a predictable variation, § 103
likely bars its patentability.”).
Second, we consider Almirall’s argument that a person
of ordinary skill would not have had a reasonable expecta-
tion of success in incorporating Nadau-Fourcade’s A/SA co-
polymer into Garrett’s formulations. Almirall argues that
the evidence fails to show that Sepineo® and Carbopol®
are interchangeable. Almirall asserts that a person of or-
dinary skill could not substitute an A/SA copolymer at the
same amount and concentration as a carbomer. Almirall
Case: 20-2331 Document: 80 Page: 14 Filed: 03/14/2022

-- 14 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 15
contends that Nadau-Fourcade’s Examples 6 and 13
demonstrate that different formulations require different
thickeners at different concentrations. Amneal counters
that the Board relied on expert testimony in correctly de-
termining that Nadau-Fourcade teaches that Sepineo® is
interchangeable with Carbopol® as a gelling agent in topi-
cal pharmaceutical formulations containing water-insolu-
ble drugs.
We agree with Amneal. A finding of a reasonable ex-
pectation of success does not require absolute predictability
of success. See OSI Pharms., LLC v. Apotex Inc., 939 F.3d
1375, 1385 (Fed. Cir. 2019). The Board’s reasonable expec-
tation of success analysis is supported by substantial evi-
dence. The Board credited Amneal’s expert’s testimony
that a person of ordinary skill would have understood that
use of Nadau-Fourcade’s A/SA gelling agents in Garrett’s
formulation would have been routine and predictable be-
cause the agents were known for use in topical composi-
tions with water insoluble drugs. Furthermore, the Board
found that a person of ordinary skill would not have ex-
pected any incompatibilities. The Board analyzed the rec-
ord evidence and found that Carbopol® and Sepineo® were
recognized to be interchangeable and equivalent gelling
agents that could be used in topical formulations contain-
ing dapsone, and that they could be used in the same con-
centration range. We are therefore not persuaded that the
Board erred in analyzing the evidence provided by Amneal
and its impact on whether a skilled artisan would have had
a reasonable expectation of success in combining these
prior art teachings to achieve the claimed invention.
Ground 2: Garrett and Bonacucina
Almirall argues that the Board’s holding that claims 1–
8 would have been obvious over Garrett and Bonacucina
was unsupported by substantial evidence.
First, we consider Almirall’s argument that Amneal
failed to provide evidence of a motivation to combine
Case: 20-2331 Document: 80 Page: 15 Filed: 03/14/2022

-- 15 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 16
Garrett with Bonacucina. Almirall argues that Bonacucina
does not suggest which active pharmaceutical ingredients
or excipients may be compatible with Sepineo®. Almirall
contends that mitigating grittiness and eliminating a neu-
tralization step were not motivating factors, because grit-
tiness was not a concern for Garrett’s formulations and
that A/SA copolymers still require neutralization. Amneal
counters that the Board relied on expert testimony in cor-
rectly determining that a person of ordinary skill would
have been motivated to use Bonacucina’s A/SA copolymer
because of its advantages.
We agree with Amneal that the Board’s analysis was
supported by substantial evidence. The evidence supports
the finding that dapsone compositions with carbomer could
be gritty and require neutralization. Bonacucina teaches
that Sepineo®, in contrast, forms stiff and stable composi-
tions and is pre-neutralized. We find no error in the
Board’s determination that Bonacucina suggests Sepineo®
as a gelling agent for topical applications like Garrett’s
dapsone formulations.
Second, we consider Almirall’s argument that a person
of ordinary skill would not have had a reasonable expecta-
tion of success in incorporating Bonacucina’s A/SA copoly-
mers into Garrett’s formulations. Almirall argues that
Bonacucina fails to suggest that Sepineo® could success-
fully replace a carbomer in any formulation. Amneal coun-
ters that the Board relied on expert testimony in correctly
determining that a person of ordinary skill would have had
a reasonable expectation of success because Bonacucina
taught using Sepineo® at overlapping concentrations and
because carbomers had known drawbacks which were re-
solved by Sepineo®.
We again agree with Amneal. The Board’s reasonable
expectation of success analysis was supported by substan-
tial evidence. The Board found that “[t]he reasonable ex-
pectation of success for using Sepineo[®] as a gelling agent
Case: 20-2331 Document: 80 Page: 16 Filed: 03/14/2022

-- 16 of 17 --

ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 17
in Garrett’s dapsone formulations stems from the fact that
Sepineo[®] was a well-known gelling agent that had been
successfully used for other similar topical formulations.”
Decision at *27. We are not persuaded that the Board erred
in analyzing the evidence provided by Amneal and its im-
pact on whether a skilled artisan would have had a reason-
able expectation of success in combining these prior art
teachings to achieve the claimed invention.
CONCLUSION
We have considered Almirall’s remaining arguments,
but we find them unpersuasive. The Board’s decision was
supported by substantial evidence and not erroneous as a
matter of law. For the foregoing reasons, the decision of
the Board is affirmed.
AFFIRMED
Case: 20-2331 Document: 80 Page: 17 Filed: 03/14/2022

-- 17 of 17 --