United States Court of Appeals 

for the Federal Circuit ______________________ 

GLAXOSMITHKLINE LLC

(formerly known as SmithKline Beecham 

Corporation),

Plaintiff-Appellee,

v.

BANNER PHARMACAPS, INC. AND

IMPAX LABORATORIES, INC.,

Defendants-Appellants,

AND

ROXANE LABORATORIES, INC.,

Defendant-Appellant,

AND

MYLAN INC. AND

MYLAN PHARMACEUTICALS INC.,

Defendants-Appellants,

AND

WATSON LABORATORIES, INC. FLORIDA,

Defendant-Appellant.

______________________ 

2013-1593, -1594, -1595, -1598

______________________ 
2 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

Appeals from the United States District Court for the 

District of Delaware in Nos. 11-CV-0046, 11-CV-0542 and 

11-CV-0789, Judge Richard G. Andrews. 

______________________ 

Decided: February 24, 2014 

______________________ 

WILLIAM F. LEE, Wilmer Cutler Pickering Hale and 

Dorr, LLP, of Boston, Massachusetts, argued for plaintiffappellee. With him on the brief were LISA J. PIROZZOLO

and SARAH R. FRAZIER, of Boston, Massachusetts; 

WILLIAM G. MCELWAIN, THOMAS G. SAUNDERS and 

MATTHEW GUARNIERI, of Washington, DC; and 

CHRISTOPHER R. NOYES, of New York, New York. 

DEANNE E. MAYNARD, Morrison & Foerster, LLP, of 

Washington, DC, argued for all defendants-appellants. 

With her on the brief for defendants-appellants Banner 

Pharmacaps, Inc., et al., were MARC A. HEARRON, of 

Washington, DC and PARISA JORJANI, of San Francisco, 

California. Of counsel on the brief were C. KYLE 

MUSGROVE and MICHAEL M. SHEN, Haynes and Boone, 

LLP, of Washington, DC. On the brief for Roxane Laboratories, Inc. were KENNETH G. SCHULER and MARC N.

ZUBICK, Latham & Watkins LLP, of Chicago, Illinois; and 

DARRYLL H. STEENSMA, of San Diego, California. On the 

brief for Watson Laboratories, Inc. – Florida were GARY E.

HOOD and MARK T. DEMING, Polsinelli, PC, of Chicago, 

Illinois. On the brief for Mylan Inc., et al. were JAMES H.

WALLACE, JR., MARK A. PACELLA, and LUCY M. STARK, 

Wiley Rein, LLP, of Washington, DC. 

______________________ 

Before O’MALLEY, WALLACH, and TARANTO, Circuit 

Judges.
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 3

TARANTO, Circuit Judge. 

Plaintiff GlaxoSmithKline LLC (“GSK”) sued Banner 

Pharmacaps, Inc., Impax Laboratories, Inc., Roxane 

Laboratories, Inc., Mylan Inc., Mylan Pharmaceuticals, 

Inc., and Watson Laboratories, Inc.–Florida (collectively, 

“Defendants”). Invoking 35 U.S.C. § 271(e)(2), GSK 

alleged that drug products containing the molecule dutasteride that Defendants propose to market fall within 

claims of U.S. Patent No. 5,565,467, which covers dutasteride and its pharmaceutically acceptable solvates. All 

Defendants stipulated to infringement, which is no longer 

an issue, but alleged that the asserted claims were invalid 

for anticipation, lack of utility, lack of enablement, and 

inadequacy of the written description. After a three-day 

bench trial, the district court issued an opinion concluding 

that Defendants did not prove the asserted claims invalid. 

GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 

11-CV-046, 2013 WL 4082232 (D. Del. Aug. 9, 2013). 

Defendants appeal the rejection of their writtendescription challenge. Their appeal presents only one 

contention—that “solvate” is not adequately described, 

whether construed as Defendants urge or as the district 

court construed it. We affirm, without resolving the 

claim-construction dispute. 

BACKGROUND

This case involves claims to the chemical compound 

dutasteride and its pharmaceutically acceptable solvates. 

Claim 1 of the ’467 patent, the only independent claim, 

reads, “17β-N-(2,5-bis(Trifluoromethyl))phenylcarbamoyl4-aza-5α-androst-1-en-3-one or a pharmaceutically acceptable solvate thereof.” ’467 patent, col. 16, lines 4-6. 

The parties agree that dutasteride is the molecule identified before “or a pharmaceutically acceptable solvate 

thereof.” The other asserted claims all recite “[a] pharmaceutical formulation comprising” the “compound of 

claim 1,” subject to further restrictions having no effect on 
4 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

the issue presented here. See id. at col. 16, lines 7-20

(dependent claims 2 through 5). 

Dutasteride “is useful in the treatment of androgen 

responsive diseases.” ’467 patent, col. 10, lines 19-20. 

Androgens are a class of hormones—with testosterone 

“the major circulating androgen”—implicated in a number 

of diseases, including “benign prostatic hyperplasia, 

prostate cancer, acne, male pattern baldness and hirsutism.” Id. at col. 1, lines 18-19, 55-60. In some target 

tissues, including prostate and skin tissue, testosterone 

produces certain effects by first being converted to dihydrotestosterone. See id. at col. 1, lines 15-25. Dutasteride 

inhibits the enzymes that catalyze the conversion and

thus mitigates some of testosterone’s physiological effects, 

which is sometimes medically desirable. See id. 

The asserted claims cover not only dutasteride, but 

also any “pharmaceutically acceptable solvate thereof.” A 

“solvate,” by definition, is something that originates in a 

“solution,” which is a mixture of two substances: a “solute” 

dissolved in a “solvent.” Salt water is a solution, in which 

salt is the solute and water the solvent. A solvate is a 

molecule (a) consisting of a complex made up of solute 

molecules and solvent molecules (b) resulting from the 

solution. The parties agree on that much, and also on the 

proposition that, at least frequently, a solvate complex is 

“crystalline,” a purely structural description referring to 

the regular, periodic arrangement of the constituent 

molecules or atoms. The parties disagree about whether 

“solvate” (in the context of this patent) means only such 

crystalline complexes—a dispute we need not resolve. 

Dutasteride has been proven effective in treating benign prostatic hyperplasia, otherwise known as enlargement of the prostate gland. GSK markets Avodart® and 

JalynTM, which contain dutasteride and are approved by 

the Food and Drug Administration to treat symptoms of 

benign prostatic hyperplasia. Each Defendant filed at 
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 5

least one Abbreviated New Drug Application under 21 

U.S.C. § 355(j), seeking FDA approval to market a generic 

version of Avodart® or JalynTM. Each ANDA included a 

certification under § 355(j)(2)(A) that the ’467 patent is 

invalid, is unenforceable, or would not be infringed by 

marketing of the proposed generic product. As authorized 

by 35 U.S.C. § 271(e)(2), GSK responded by suing Defendants for infringement of its ’467 patent. 

The district court construed “pharmaceutically acceptable” to mean “[s]uitable for use when administered 

to the recipient thereof as a pharmaceutical.” Claim 

Construction Opinion at 8, GlaxoSmithKline LLC, No. 11-

CV-046 (D. Del. Nov. 15, 2012). The court also construed 

“solvate” (of dutasteride), which is the claim term at issue 

here. GSK and Defendants disagreed about whether the 

term refers only to crystalline complexes of solute and 

solvent molecules—that is, of dutasteride (the solute) and 

some solvent—or, instead, also includes non-crystalline 

complexes. GSK argued for the broader construction, 

Defendants for the narrower. The district court acknowledged Defendants’ “considerable extrinsic evidence” that, 

in the pharmaceutical field, “solvate” is limited to crystalline complexes, no matter how created, but it concluded 

that the specification of this particular patent “direct[ly]

contradict[s]” any such narrow usage. See id. at 7-8 

(relying on ’467 patent, col. 3, line 58, through col. 4, line 

12). The court construed a “solvate” of dutasteride to 

mean 

[a] complex formed by dutasteride with a solvent 

in which dutasteride is reacted or from which it is 

precipitated or crystallized.

Id. at 4. Despite potential confusion about the meaning of 

this language, including about what “it” refers to, the 

parties agree in interpreting the district court’s construction to refer to three processes of forming dutasteride 

solvates—by a reaction of dutasteride with a solvent; by 
6 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

precipitation of a complex from a solution of dutasteride 

and a solvent; by crystallization of a complex from a 

solution of dutasteride and a solvent—with the resulting 

complex not required to be crystalline. 

Defendants stipulated to infringement and have not 

raised any infringement issue on appeal (not even conditionally, should we reverse the district court’s claim 

construction in deciding the issue they do raise on appeal). The only issue before us is Defendants’ invalidity 

challenge asserting the inadequacy of the written description, a challenge that the district court rejected—along 

with invalidity challenges asserting anticipation, lack of 

utility, and lack of an enabling disclosure—after a threeday bench trial held after the stipulation of infringement. 

Defendants did not dispute that dutasteride is adequately 

described: it is precisely identified by structure. Instead, 

they argued that “solvates” of dutasteride, a limitation in 

all asserted claims, lacked adequate support in the written description. Specifically, Defendants argued that the 

written description failed to describe the crystalline form 

of solvate or, more generally, a wide enough range of the 

solvates included in the district court’s construction, 

which need not be crystalline and could be produced 

through reaction, precipitation, or crystallization. 

Addressing the adequacy of the written description, 

the district court made various findings, some focused on 

solvate formation and some on determining which solvates were therapeutically effective. See GlaxoSmithKline 

LLC v. Banner Pharmacaps, Inc., No. 11-CV-046, 2013 

WL 4082232, at *2-3 (D. Del. Aug. 9, 2013) (findings of 

fact). It found that dutasteride is “the key structural 

feature of the solvate” and what “distinguish[es] the ’467 

[p]atent from the prior art.” Id. at *2, 8. It found that 

solvate formation “has been known in the art for over 100 

years,” that dutasteride is a steroid, that “[s]teroids in 

particular have been known to be prone to solvate formation since 1983,” and that “the universe of solvents 
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 7

thought to be pharmaceutically acceptable was wellknown and relatively small.” Id. at *2, 6. The court noted 

that “it [was] difficult or even impossible to predict

whether a particular solvate form will offer bioavailability, at least prior to the solvate’s actual formation,” but 

found that methods to determine the solubility of an 

already formed solvate “were well-known and routine in 

the art” and “could be done in less than a week.” Id. at 

*6-7 (emphasis added). 

The district court concluded that Defendants failed to 

prove the inadequacy of the written description. According to the district court, “[t]here is no reason why a person 

skilled in the art would not credit a patentee with possession of a solvate merely because the patentee did not 

disclose solvates formed by each solvation process,” i.e., reaction, precipitation, crystallization. Id. at 

*5. The district court characterized Example 3D—which 

describes dissolving dutasteride in liquid propylene 

glycol, see ’467 patent, col. 15, lines 21-25—as identifying 

a “reacted” solvate. Id. at *7-8. The court found the

example, in addition to what was known in the art, “sufficient to meet the written description requirement.” Id. 

The district court rejected not only Defendants’ written-description challenge but also their remaining invalidity arguments. In particular, based on extensive 

findings of fact, the court concluded that the patent 

enables a person of ordinary skill in the art to make and 

to use the full range of the claimed molecules. Id. at *8-

13. Defendants do not appeal that ruling.

Defendants timely appealed, raising only a writtendescription issue here. We have jurisdiction under 28 

U.S.C. § 1295(a)(1). 

DISCUSSION

This appeal presents a single issue: whether, under 

what is now 35 U.S.C. § 112(a), the written description of 
8 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

the ’467 patent adequately supports the claims to “solvates” of dutasteride. Adequacy of the written description 

is a question of fact. Ariad Pharm., Inc. v. Eli Lilly & Co., 

598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). After a 

bench trial, we review the district court’s findings of fact 

for clear error. Pozen Inc. v. Par Pharm., Inc., 696 F.3d 

1151, 1166 (Fed. Cir. 2012). 

Defendants have presented a limited issue. Although

noting that the claimed solvates must be “pharmaceutically acceptable,” Defendants’ brief does not argue that, 

even if the specification adequately describes “solvates,” it 

inadequately describes the pharmaceutically acceptable 

ones. There is no such contention, and there is no mention of the “pharmaceutically acceptable” language, in the 

statement of issues, in the (argument-summarizing) 

introduction and statement of the case, in the summary of 

the argument, or in any heading or subheading of the 

argument section of the brief. The only argument actually developed in the brief is that there is no adequate 

description of “solvates,” whether that term is limited to 

crystalline structures (as Defendants argue) or covers 

crystalline and non-crystalline structures, produced 

through reaction with a solvent or precipitation or crystallization from a solution (as the parties understand the 

district court’s construction). We conclude that Defendants have not properly presented any other contention in 

this court, especially given the lack of elaboration on the 

distinct issues that would be raised by a writtendescription challenge to the phrase “pharmaceutically 

acceptable.” 

On the sole issue properly presented, we reject Defendants’ challenge. Under either the district court’s 

claim construction or Defendants’ claim construction, the 

claim term “solvate” refers to a molecular complex defined 

by structure and by the process of creating it, not by what 

the molecule does. Under the district court’s construction, 

the structure is any complex of dutasteride and solvent, 
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 9

not necessarily a crystalline complex, resulting from any 

of three processes: reaction with a solvent or precipitation

or crystallization from a solution. Under Defendants’ 

construction, the structure is a complex of dutasteride and 

a solvent in which the arrangement is crystalline, resulting from crystallization out of a solution. In either event, 

the written description, which presents materially the 

same interpretive choice, describes the same class by

identifying a particular structure obtained by particular 

processes. No matter which construction is adopted, the 

term “solvate” involves no performance property (the 

claimed compound need not perform an identified function or produce an identified result) and hence raises no 

issue of insufficient structural, creation-process, or other

descriptions to support such a property. In this situation, 

we affirm the district court’s finding that “solvate” is 

adequately described, without needing to choose between 

the offered constructions of “solvate.” 

The Detailed Description provides a description by 

structure and process of creation that matches the 

claimed term, whichever construction is preferable. It 

declares: 

Those skilled in the art of organic chemistry will 

appreciate that many organic compounds can 

form complexes with solvents in which they are 

reacted or from which they are precipitated or 

crystallized. These complexes are known as “solvates”. For example, a complex with water is 

known as a “hydrate”. Solvates of [dutasteride]

are within the scope of the invention.

It will also be appreciated by those skilled in organic chemistry that many organic compounds 

can exist in more than one crystalline form. For 

example, crystalline form may vary from solvate 

to solvate. Thus, all crystalline forms of [dutasteride] or the pharmaceutically acceptable solv-
10 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

ates thereof are within the scope of the present 

invention.

’467 patent, col. 3, line 58, through col. 4, line 12. That 

language defines the claimed genus by two properties. 

First, a solvate is a complex of dutasteride molecules and

solvent molecules, with dutasteride being, as the district 

court found, “the key structural component.” GlaxoSmithKline LLC, 2013 WL 4082232, at *2. Second, the 

structure is one that is created by an identified process—

specifically, by dissolving dutasteride (the solute) in a 

solvent. Just as they dispute the claim construction, the 

parties dispute the precise meaning of this passage, 

including whether the resulting complex must be crystalline and whether it must be produced by just one process 

or any of three (crystallization only, or any of reaction, 

precipitation, or crystallization). But under each side’s 

construction and reading of the specification, the description matches the claim, and regardless of which side is 

right, the description remains entirely based on structure 

of the compound and its process of creation.

We have no precedent under which this two-condition 

description, matching the claim scope, would be insufficient. To the contrary, this court has repeatedly “explained that an adequate written description requires a 

precise definition, such as by structure, formula, chemical 

name, physical properties, or other properties, of species 

falling within the genus sufficient to distinguish the 

genus from other materials.” Ariad, 598 F.3d at 1350

(emphasis added). Describing a complex of dutasteride

and solvent molecules is an identification of “structural 

features commonly possessed by members of the genus 

that distinguish them from others,” allowing one of skill 

in the art to “visualize or recognize the identity of the 

members of the genus.” Regents of the Univ. of California 

v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); cf.

Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 

1353, 1366-67 (Fed. Cir. 2011) (holding written descrip-
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 11

tion inadequate “[g]iven the absence of information regarding structural characteristics of” the claimed genus). 

The structural identification here is further narrowed by 

requiring that the structure result from (one or any of 

three) identified processes. On the (related, though 

distinct) question of establishing conception, i.e., a definite and permanent idea of the complete and operative 

invention, we have indicated that it can be enough to 

identify a compound “by its method of preparation.” 

Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 

(Fed. Cir. 1991); see Fiers v. Revel, 984 F.2d 1164, 1169 

(Fed. Cir. 1993); id. at 1171 (written-description analysis 

referring to earlier conception analysis).

In this case, the claim is no broader in scope than the 

written description: the above-quoted passage from the 

written description matches the claim scope (whether 

they are narrow or broad, as the parties dispute). It is 

therefore quite different from the claims in Eli Lilly & Co. 

v. Teva Pharmaceuticals USA, Inc., 619 F.3d 1329, 1344-

45 (Fed. Cir. 2010), where the claim covered particle sizes 

before and after formulation into tablets, but the specification addressed only pre-formulation size. Critically, 

moreover, the claim term at issue, “solvate,” is not functional: to be a “solvate,” a compound need not produce a 

desired result or otherwise perform a certain function. 

The claim term and its corresponding description, however broad, identify certain structures produced by certain 

processes. We have not required more for an adequate 

written description that matches claim scope. And we see 

no basis for doing so in the present context, where “the 

concept of solvation . . . has been known in the art for over 

100 years” and “[s]teroids in particular [such as dutasteride] have been known to be prone to solvate formation 

since 1983,” GlaxoSmithKline LLC, 2013 WL 4082232, at 

*2, 6, and it is now undisputed that the written description enables a person of skill in the art to make and use 

the full claimed range of “solvates” of dutasteride.
12 GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 

The claims in this case, not involving functional claim 

language, do not present the fundamental difficulty 

presented by the claims in virtually all of the precedents 

on which Defendants rely. The claims in those cases used 

functional language: they “cover[ed] any compound later 

actually invented and determined to fall within the 

claim’s functional boundaries”; such language may “merely recite a description of the problem to be solved [how to 

produce a desired result] while claiming all solutions to 

it.” Ariad, 598 F.3d at 1353. In the field of genetic inventions, our precedents have addressed claims that seek to 

distinguish members of the claimed genus by the shared 

performance property of encoding a particular enzyme or 

other product. See, e.g., Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1123-24 (Fed. Cir. 

2008) (claiming “recombinant plasmids that contain a 

DNA coding sequence that is broadly defined, and only by 

its function, viz., encoding DNA polymerase I”); Eli Lilly, 

119 F.3d at 1562-63 (claiming genetic material capable of 

“encod[ing] insulin” or “coding for human proinsulin”); 

Fiers, 984 F.2d at 1171 (claiming all DNA “that achieve[s]

a result without defining what means will do so”). In 

other cases, the claimed performance property has been a 

compound’s ability to inhibit the action of a particular 

protein, see Ariad, 598 F.3d at 1340-41; Univ. of Rochester 

v. G.D. Searle & Co., 358 F.3d 916, 918 (Fed. Cir. 2004), a 

compound’s ability to inhibit a particular medical complication, see Boston Scientific Corp., 647 F.3d at 1364, or an 

antibody’s ability to bind to a particular antigen, see

Noelle v. Lederman, 355 F.3d 1343, 1349-50 (Fed. Cir. 

2004); In re Alonso, 545 F.3d 1015, 1018 (Fed. Cir. 2008). 

Here, in contrast, under any of the parties’ preferred 

claim constructions, “solvates” of dutasteride are not 

distinguished by a particular performance property. The

claim term does not assert coverage of yet-unidentified 

ways of achieving a desired result; it does not “attempt to 

preempt the future before it has arrived.” Fiers, 984 F.2d 
GLAXOSMITHKLINE LLC v. BANNER PHARMACAPS, INC. 13

at 1171. This case thus sharply differs from those Defendants invoke. In the circumstances of this case, we 

have no basis for reversing the district court’s finding that

the written description conveys to the relevant skilled 

artisan that “the inventor[s] actually invented the invention claimed.” Ariad, 598 F.3d at 1351. 

CONCLUSION

For the foregoing reasons, we affirm the district 

court’s rejection of Defendants’ written-description challenge to the validity of the asserted claims of the ’467 

patent.

AFFIRMED