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

______________________ 

JAMES TRAINOR, Fenwick & West LLP, New York, NY, 

argued for appellant. Also represented by ADAM GAHTAN,

RICHARD SHEA; ELIZABETH B. HAGAN, Seattle, WA. 

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2 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

 DENNIES VARUGHESE, Sterne Kessler Goldstein & Fox, 

PLLC, Washington, DC, argued for appellees. Also represented by KRISTINA CAGGIANO KELLY, ADAM LAROCK. 

 ROBERT J. MCMANUS, Office of the Solicitor, United 

States Patent and Trademark Office, Alexandria, VA, for 

intervenor. Also represented by BENJAMIN T. HICKMAN,

THOMAS W. KRAUSE, FARHEENA YASMEEN RASHEED. 

 ______________________ 

Before LOURIE, CHEN, and CUNNINGHAM, Circuit Judges.

LOURIE, Circuit Judge. 

Almirall, LLC (“Almirall”) appeals from the final written decision of the U.S. Patent and Trademark Office Patent 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 reasons provided below, we affirm. 

BACKGROUND

Almirall owns the ’219 patent, which relates to methods of treating acne or rosacea with dapsone formulations 

that include an acrylamide/sodium acryloyldimethyl taurate 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 apply the version of 35 U.S.C. § 103 in effect before the adoption of the Leahy-Smith America Invents Act (“AIA”), Pub. 

L. No. 112-29, 125 Stat. 284 (2011).

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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 dermatological conditions, sometimes in combination with dapsone. 

See Decision at *18. The ’219 patent includes 62 generalized 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 described 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/sodium acryloyldimethyl taurate copolymer; 

and

water;

wherein the topical pharmaceutical composition does not comprise adapalene. 

Id. at col. 15 l. 40–col. 16 l. 13 (emphases added).

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4 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

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 acryloyldimethyl taurate copolymer; and

water;

wherein the topical pharmaceutical composition 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. Amneal 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 treating dermatological conditions including acne and rosacea. 

Garrett states that the dapsone may exist in “a microparticulate 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).

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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 including 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 preferred 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 “includes 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% dapsone in a microparticulate and dissolved state; and about 

0.1% to 2% sodium hydroxide solution.” Decision at *5 (citing 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. Unless otherwise designated, all reagents listed . . . are commonly 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. NadauCase: 20-2331 Document: 80 Page: 5 Filed: 03/14/2022
6 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

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 similar 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 acryloyldimethyl taurate copolymer in isohexadecane. J.A. 1688. 

Bonacucina reports that Sepineo® P 600 has self-gelling 

and thickening properties that are effective for topical administration. J.A. 1688–89 (explaining that “the possibility 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 NadauFourcade in combination teach or suggest every claim limitation and that a person of ordinary skill in the art would 

have been motivated, with a reasonable expectation of success, to incorporate Nadau-Fourcade’s A/SA gelling agent 

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ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 7

into Garrett’s dapsone formulations. Id. at *30. Specifically, the Board determined that it would have been obvious 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 interchangeable” 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 expectation of success, to incorporate Bonacucina’s A/SA gelling 

agent into Garrett’s dapsone formulations. Id. at *30. Specifically, the Board determined that it would have been obvious 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 Carbopol®. The Board relied on expert testimony that Garrett’s 

Carbopol® was known to have drawbacks, for example, requiring 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.

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8 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

The Board also found that a skilled artisan would have 

had a reasonable expectation of successfully replacing Garrett’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 Carbopol® with equal amounts of Sepineo® in Garrett’s formulations. 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 GarrettBonacucina 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 record supporting the conclusion that Garrett’s dapsone formulations for treating acne neither inherently included nor 

implicitly required adapalene.” Id. at *25. The Board explained that “it is not Garrett’s mere silence as to the presence 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 demonstrated 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).

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ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 9

DISCUSSION

Almirall raises two challenges on appeal. First, Almirall contends that the Board erred in presuming obviousness based on overlapping ranges. Second, Almirall argues 

that the Board’s obviousness determinations were unsupported 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 review the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 

1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence 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 determination 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 obviousness as to 

the claimed amounts.” Decision at *14. 

Almirall argues that the Board erred in presuming obviousness based on overlapping ranges because no single 

reference discloses all of the claimed ranges. First, Almirall argues that Garrett’s ranges for its polymeric viscosity 

builders do not create a presumption of obviousness because Garrett only discloses ranges for carbomer thickeners, 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 presumption of obviousness because the presumption applies only 

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10 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

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 thickener ranges is sufficient to support the rejection because 

disclosure of the precise, claimed composition is not necessary to show obviousness. Citing Valeant and Anacor, Amneal asserts that ranges for structurally and functionally 

similar compounds can establish a prima facie case of obviousness. 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 disclosed 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 disclosed in—and therefore obvious in light of—the prior art.” 

E.I. du Pont, 904 F.3d at 1008. A presumption of obviousness 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.

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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 support 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 obviousness 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 overlapping 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 interactions with the other ingredients of the compositions relative 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 conclusions supported by substantial evidence.

But even if we agreed with Almirall that the presumption 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 gelling agent for another. Each may be effective at a different 

concentration in different formulations, but that is just a 

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12 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

property of the particular known material, subject to conventional 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 determining 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 argues that although Garrett does not indicate that any of its 

formulations include adapalene, more is needed for a disclosure 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 contrary to our precedent. “[A] reference need not state a feature’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 formulation—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)

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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 formulations that lack adapalene. The Board thus did not err 

in concluding that Garrett discloses the negative adapalene 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-Fourcade was unsupported by substantial evidence. 

First, we consider Almirall’s argument that the Board 

failed to require evidence of a motivation to combine Garrett with Nadau-Fourcade. The presence or absence of a 

motivation to combine references in an obviousness determination is a question of fact. See In re Gartside, 203 F.3d 

at 1316. Almirall argues that the Board erred by substituting the alleged interchangeability of Sepineo® and Carbopol® for evidence of a motivation to combine NadauFourcade 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 motivated to replace Garrett’s gelling agent with an A/SA copolymer. 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 gelling 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 combined the references; on the contrary, it reviewed the context-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 

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14 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

as well as expert testimony. For example, the Board credited 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 water 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 combination was sufficient to support its obviousness determination. 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 cosmetic 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 ordinary 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 expectation of success in incorporating Nadau-Fourcade’s A/SA copolymer into Garrett’s formulations. Almirall argues that 

the evidence fails to show that Sepineo® and Carbopol® 

are interchangeable. Almirall asserts that a person of ordinary skill could not substitute an A/SA copolymer at the 

same amount and concentration as a carbomer. Almirall 

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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 determining that Nadau-Fourcade teaches that Sepineo® is 

interchangeable with Carbopol® as a gelling agent in topical pharmaceutical formulations containing water-insoluble drugs.

We agree with Amneal. A finding of a reasonable expectation 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 expectation of success analysis is supported by substantial evidence. 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 because the agents were known for use in topical compositions with water insoluble drugs. Furthermore, the Board 

found that a person of ordinary skill would not have expected any incompatibilities. The Board analyzed the record evidence and found that Carbopol® and Sepineo® were 

recognized to be interchangeable and equivalent gelling 

agents that could be used in topical formulations containing dapsone, and that they could be used in the same concentration 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 

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16 ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

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 neutralization step were not motivating factors, because grittiness 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 correctly 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 compositions 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 expectation of success in incorporating Bonacucina’s A/SA copolymers into Garrett’s formulations. Almirall argues that 

Bonacucina fails to suggest that Sepineo® could successfully replace a carbomer in any formulation. Amneal counters 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 resolved by Sepineo®.

We again agree with Amneal. The Board’s reasonable 

expectation of success analysis was supported by substantial evidence. The Board found that “[t]he reasonable expectation of success for using Sepineo[®] as a gelling agent 

Case: 20-2331 Document: 80 Page: 16 Filed: 03/14/2022
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 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.

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