United States Court of Appeals 

for the Federal Circuit ______________________ 

BRAINTREE LABORATORIES, INC.,

Plaintiff-Appellee,

v.

NOVEL LABORATORIES, INC.,

Defendant-Appellant.

______________________ 

2013-1438

______________________ 

Appeal from the United States District Court for the 

District of New Jersey in No. 11-CV-1341, Judge Peter G. 

Sheridan.

______________________ 

Decided: April 22, 2014

______________________ 

JOHN J. REGAN, Wilmer Cutler Pickering Hale and 

Dorr LLP, of Boston, Massachusetts, argued for plaintiffappellee. With him on the brief were MARK C. FLEMING,

NISHAT A. SHAIKH, JENNIFER C. BROWN, and MICHAEL A.

GREENE; and CHRISTOPHER R. NOYES, of New York, New 

York. 

RONALD M. DAIGNAULT, Robins, Kaplan, Miller & 

Ciresi L.L.P., of New York, New York, argued for defendant-appellant. With him on the brief were DAVID 

LEICHTMAN, MATTHEW B. MCFARLANE and OREN D.

LANGER. 
2 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

______________________ 

Before DYK, PROST, and MOORE, Circuit Judges.

Opinion for the court filed by Circuit Judge PROST. 

Opinion concurring in part, dissenting in part, and concurring in the result filed by Circuit Judge DYK. 

Dissenting opinion filed by Circuit Judge MOORE. 

PROST, Circuit Judge. 

This is a patent infringement case under the HatchWaxman Act. See 35 U.S.C. § 271(e)(2)(A). DefendantAppellant Novel Laboratories, Inc. (“Novel”) appeals the 

grant of summary judgment by the United States District 

Court for the District of New Jersey that U.S. Patent No. 

6,946,149 (“’149 patent”) held by Braintree Laboratories, 

Inc. (“Braintree”) is infringed by the composition covered 

by Novel’s abbreviated new drug application (“ANDA”). 

See Braintree Labs., Inc. v. Novel Labs., Inc., No. 11-CV1341, 2013 WL 211252 (D.N.J. Jan. 18, 2013) (“Infringement Opinion”). The district court entered summary 

judgment of infringement based on its construction of four 

disputed claim terms. See Braintree Labs., Inc. v. Novel 

Labs., Inc., No. 11-CV-1341, 2012 WL 4120907 (D.N.J. 

Sept. 19, 2012) (“Claim Construction Order”). Novel 

challenges the district court’s claim construction for two of 

those terms. Following a six-day bench trial on Novel’s 

invalidity defenses, the district found that Novel failed to 

prove that the asserted claims were invalid. See 

Braintree Labs., Inc. v. Novel Labs., No. 11-CV-1341, 2013 

WL 2970739 (D.N.J. June 4, 2013) (“Validity Opinion”). 

Novel also appeals those findings.

Because we agree with Novel that the district court 

erred in its construction of the claim term “clinically 

significant electrolyte shifts,” we reverse the district 

court’s claim construction of that term, vacate the district 

court’s grant of summary judgment of infringement, and 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 3

remand for further factual findings to determine whether 

the composition covered by Novel’s ANDA product infringes under the new claim construction articulated 

herein. Further, we affirm the district court’s findings 

that the asserted claims of the ’149 patent are not invalid.

I. BACKGROUND

Braintree is a pharmaceutical company that manufactures the SUPREP® Bowel Prep Kit (“SUPREP”), which 

helps to prepare patients for colonoscopies. The colon 

needs to be visually clear in order to successfully perform 

a colonoscopy, so prior to the examination patients typically drink several liters of a solution to induce diarrhea. 

By the late 1990s, two colon cleansing options existed, 

both of which had some disadvantages. The first option 

was considered the safest but required patients to drink 

large volumes of unappetizing isotonic prep formulas, 

resulting in low patient compliance. The second option 

was to administer a low-volume, hypertonic prep. However, this option caused severe electrolyte shifts, leading 

to heart failure, kidney failure, neurological impairment, 

and even death. 

Braintree’s ’149 patent discloses a combination of 

magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and 

effectively induce colonic purging without causing clinically significant electrolyte shifts. See, e.g., ’149 patent 

abstract.

Claim 15, which the parties agree is representative, 

recites: 

A composition for inducing purgation of the colon 

of a patient, the composition comprising from 

about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount 

of Na2SO4, an effective amount of MgSO4, and an 

effective amount of K2SO4, wherein the composi-
4 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

tion does not produce any clinically significant 

electrolyte shifts and does not include phosphate. 

Ex Parte Reexamination Certificate, ’149 patent col. 2

ll. 23-30 (emphases added). 

Braintree alleges that SUPREP is a commercial embodiment of the ’149 patent. Novel is a generic drug 

manufacturer. 

II. PROCEDURAL HISTORY

On November 8, 2010, Novel filed an ANDA for a proposed generic copy of SUPREP. A few months later, 

Novel sent Braintree a Paragraph IV certification of 

invalidity/noninfringement letter asserting that “each of 

the claims of the ’149 patent is either invalid or is not 

infringed” by Novel’s product. On March 9, 2011, 

Braintree filed this action seeking a declaration that 

Novel’s ANDA product infringes the ’149 patent. Novel 

asserted counterclaims of noninfringement and invalidity. 

After construing claim terms, the district court granted summary judgment of infringement in Braintree’s 

favor and denied Novel’s motion for reconsideration, 

ruling that SUPREP meets all limitations of the asserted 

claims. See Infringement Opinion at *10. Following a 

bench trial regarding validity, the district court found 

that Novel “did not show proof that met the clear and 

convincing standard” that the asserted claims were anticipated, nor were they obvious or indefinite. Validity 

Opinion at *25-26. 

III. DISCUSSION

This appeal concerns challenges to the district court’s 

claim constructions, its grant of summary judgment 

regarding infringement, and its findings following a bench 

trial regarding validity. Regarding claim construction, 

Novel argues that the district court misconstrued the 

claim terms “purgation” and “clinically significant electro-
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 5

lyte shifts.” Based on these erroneous claim constructions, Novel argues that the district court improperly 

granted Braintree’s motion for summary judgment on 

infringement. Regarding validity, Novel argues that the 

district court erred when it failed to find that (1) U.S. 

Patent No. 4,975,286 (“Hechter”) anticipates the asserted 

claims of the ’149 patent; (2) the prior art, as understood 

by a person of skill in the art, renders the asserted claims 

obvious; and (3) the asserted claims are invalid because 

the term “purgation” is indefinite under 35 U.S.C. 

§ 112, ¶ 2. We address each of Novel’s challenges in turn. 

A. Claim Construction

Claim construction is a question of law, Markman v. 

Westview Instruments, Inc., 52 F.3d 967, 976-79 (Fed. Cir. 

1995) (en banc), aff’d, 517 U.S. 370 (1996), that we review 

de novo without deference. Cybor Corp. v. FAS Techs., 

Inc., 138 F.3d 1448, 1454-55 (Fed. Cir. 1998) (en banc).

1. Purgation

The district court construed “purgation” to mean “an 

evacuation of a copious amount of stool from the bowels 

after oral administration of the solution.” Claim Construction Order at *6. In adopting this construction, the 

district court rejected Novel’s argument that “purgation 

means cleansing,” concluding that “[a]lthough cleansing is 

a term in the specification of the ’149 [p]atent, [the asserted claims] clearly adopt purgation as the methodology 

to improve visualization of the colon.” Id. at *3.

On appeal, the parties dispute the construction of the 

claim term “purgation” because the asserted claims cover 

compositions “comprising from about 100 mL to about 

500 mL of an aqueous hypertonic solution.” Ex Parte 

Reexamination Certificate, ’149 patent col. 2 ll. 24-26. 

Braintree sells SUPREP in a kit containing two six-ounce 

bottles of concentrated solution, along with a dilution cup. 

A patient must dilute each of the two six-ounce bottles
6 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

with ten ounces of water to form two sixteen-ounce solutions. Each of those half-dose sixteen ounce solutions has 

a total volume of 473 mL, which is within the range found 

in the asserted claims of the ’149 patent, but Braintree 

concedes that neither dose accomplishes a full cleansing. 

Thus, Braintree’s “one bottle” infringement theory asserts 

that one (half-dose) bottle of SUPREP, diluted with water

to become a sixteen ounce solution, falls within the asserted claims. This infringement theory can prevail if 

purgation means the “evacuation of a copious amount of 

stool from the bowels after oral administration of the 

solution,” which is something less than a full cleansing. 

Novel argues that SUPREP does not infringe the asserted claims if “purgation” means cleansing, because a 

full cleansing only occurs after ingesting 946 mL of solution (i.e., two doses). Pointing to the specification, Novel

alleges that the physiological event that the inventor 

contemplated was cleansing the colon for a colonoscopy. 

See, e.g., ’149 patent title, abstract. Novel also relies on a 

passage in the specification which indicates that a dosage

amount is “effective” only if it produces a clean colon in 

preparation for a colonoscopy or other surgical procedures. Id. at col. 5 ll. 19-24 (“Optimally, the effective dose 

may be divided and administered, to the patient in two, or 

more administrations over an appropriate time period. 

Generally, 2 doses administered of equal portions of the 

effective dose, separated by 6 to 24 hours produce satisfactory purgation.”). Thus, Novel argues that an effective 

amount of solution must cleanse the colon. 

Novel also points to Braintree’s 2010 patent term extension request, where Braintree represented to the U.S. 

Patent and Trademark Office (“PTO”) that “[t]he 

SUPREP product is an osmotic laxative for cleansing (i.e., 

purging) of the colon . . . .” J.A. 22172 (emphasis added). 

Therefore, Novel argues that Braintree’s representation 

that purgation is equivalent to cleansing reflects the 

proper construction of “purgation.” 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 7

While we have considered all of Novel’s arguments

supporting its proposed construction of “purgation,” we 

find them unpersuasive. “In construing claims, the analytical focus must begin and remain centered on the 

language of the claims themselves, for it is that language 

that the patentee chose to use to ‘particularly point[] out 

and distinctly claim[] the subject matter which the patentee regards as his invention.’” Interactive Gift Express, 

Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 

2001) (quoting 35 U.S.C. § 112, ¶ 2 (1975), amended by 35 

U.S.C. § 112(b)). The asserted claims here only require 

that the compositions “induce” (i.e., bring about or start) 

diarrhea. The claims do not contain language that requires achieving a fully cleansed colon for a colonoscopy. 

Thus, while cleansing is the goal specifically articulated 

in the specification, it is not a claim requirement. See 

Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. 

Cir. 2010) (citation omitted) (“There is an inference . . . 

that two different terms used in a patent have different 

meanings.”).

Novel’s reliance on the claim term “effective amount” 

is also misplaced. The district court construed “effective 

amount” as an amount of solution “necessary to produce a 

colonic purgation, while not producing clinically significant electrolyte shifts,” and Novel has not challenged this 

construction. Claim Construction Order at *5. Since an 

“effective amount” only requires purgation and not a full 

cleansing, it is consistent to construe purgation as an 

evacuation of a copious amount of stool. Although the 

specification contemplates a scenario in which an effective 

amount could produce a full cleansing, it does so only in 

terms of a preferred embodiment. See Enzo Biochem, Inc. 

v. Applera Corp., 599 F.3d 1325, 1342 (Fed. Cir. 2010) 

(citation omitted) (“‘[I]t is improper to read limitations 

from a preferred embodiment described in the specification—even if it is the only embodiment—into the claims 
8 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

absent a clear indication in the intrinsic record that the 

patentee intended the claims to be so limited.’”). 

Finally, we conclude that Braintree’s statement that 

SUPREP is a product for “cleansing (i.e., purging)” in its 

patent term extension request does redefine “purgation” 

as “cleansing.” Whether a statement to the PTO that 

includes “i.e.” constitutes a clear and unmistakable disavowal of claim scope depends on the context. See, e.g.,

Toshiba Corp. v. Imation Corp., 681 F.3d 1358, 1370-71 

(Fed. Cir. 2012). In this case, the post-issuance statement 

of the patentee does not modify the plain meaning of the 

word “purgation.” Thus, we hold that Braintree’s statement was not a clear and unmistakable disavowal. See 

SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1199-

1201 (Fed. Cir. 2013); Elbex Video, Ltd. v. Sensormatic 

Elecs. Corp., 508 F.3d 1366, 1371 (Fed. Cir. 2007). 

For the aforementioned reasons, we affirm the district 

court’s construction of the claim term “purgation.” 

2. Clinically Significant Electrolyte Shifts

The district court originally construed “clinically significant electrolyte shifts” to require “alterations in blood 

chemistry that are outside the normal upper or lower 

limits of their normal range or other untoward effects.” 

Claim Construction Order at *6. Later, in considering the 

parties’ summary-judgment motions, the district court 

amended its construction and re-defined “clinically significant electrolyte shifts” to be “alterations in blood chemistry that are both outside the normal upper or lower limits 

of their range and accompanied by or manifested as other 

untoward effects.” Infringement Opinion at *7 (emphases 

added). The district court explained that it modified its 

original construction to make it conjunctive because the 

specification refers to “electrolyte shifts leading to serious 

health problems for the patient.” Id. It further explained 

that the phrase “untoward effects” may refer to “those 

fatal side effects of the [prior art] solution because such 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 9

side effects are referred to in the specification” and “is 

meant to show that electrolyte abnormalities are not 

clinically significant unless they lead to serious adverse 

health effects, like those caused by [the prior art].” Id.

On appeal, Novel argues that in requiring both alterations in blood chemistry and other untoward effects, the 

district court ignored the inventor’s clear definition of the 

term “clinically significant electrolyte shifts” in the specification. See ’149 patent col. 2 ll. 47-51 (“The terms ‘clinically significant’ as used herein are meant to convey 

alterations in blood chemistry that are outside the normal 

upper or lower limits of their normal range or other 

untoward effects.”). 

In defending the district court’s final construction, 

Braintree argues that the preferred embodiment—

referred to as Solution D in the ’149 patent—caused 

alterations in some patients’ blood chemistry, but those 

alterations were found to be “clinically insignificant.” ’149 

patent col. 10 ll. 32-33. Thus, according to Braintree, the 

definition found in the specification would exclude Solution D, which is the preferred embodiment in the ’149 

patent. And “[a] claim construction that excludes the 

preferred embodiment ‘is rarely, if ever, correct and would 

require highly persuasive evidentiary support.’” Adams 

Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d 

1283, 1290 (Fed. Cir. 2010) (citation omitted). 

Under our precedent, the patentee’s lexicography 

must govern the claim construction analysis. See Phillips 

v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en 

banc). Therefore, we disagree with the district court’s 

modification of the clear language found in the specification. We reverse the district court’s claim construction 

and construe “clinically significant electrolyte shifts” to be

“alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other 

untoward effects.” 
10 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

B. Infringement

We review the grant of summary judgment under the 

law of the regional circuit. Lexion Med., LLC v. Northgate 

Techs., Inc., 641 F.3d 1352, 1358 (Fed. Cir. 2011). The 

Third Circuit reviews the grant of summary judgment de 

novo. Nicini v. Morra, 212 F.3d 798, 805 (3d Cir. 2000) 

(en banc). Summary judgment is appropriate if the 

movant “shows that there is no genuine dispute as to any 

material fact and the movant is entitled to judgment as a 

matter of law.” Fed. R. Civ. P. 56(a).

Based on its construction of “purgation,” which does 

not require a full cleanse, the district court found that one 

bottle of SUPREP meets the “purgation” claim limitation, 

as it will induce an evacuation of a copious amount of 

stool from the bowels and is a composition comprising 

473 mL of an aqueous hypertonic solution. Infringement 

Opinion at *9-10. We affirm the district court’s construction of this term, and we likewise affirm the district 

court’s finding that one (half-dose) bottle of SUPREP 

practices this claim limitation.

The district court also found that SUPREP practices 

the “wherein the composition does not produce any clinically significant electrolyte shifts” limitation. Id. at *6-8. 

It based its conclusion not only on its erroneous construction of the term “clinically significant electrolyte shifts” 

but also on its importation of the claim terms “a patient”

into this limitation. Id. at *8. The words “a patient” are 

found in the preamble. See Ex Parte Reexamination 

Certificate, ’149 patent col. 2 ll. 23-24. The district court 

explained that, based on its review of the record, “it 

appears that the administration of the composition and 

evaluation of the electrolyte levels in [the asserted claims] 

were meant to be done on a per patient basis.” Infringement Opinion at *8. It defined “a patient” to mean “one or 

more patients.” Id. It then found that “at least one 

patient to whom SUPREP is administered will experi-
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 11

ence, or has experienced, no clinically significant electrolyte shifts.” Id. 

“[I]f the claim preamble is ‘necessary to give life, 

meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim.” 

Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 

1305 (Fed. Cir. 1999) (citations omitted). Conversely, a 

preamble is not limiting “where a patentee defines a 

structurally complete invention in the claim body and 

uses the preamble only to state a purpose or intended use 

for the invention.” Rowe v. Dror, 112 F.3d 473, 478 (Fed.

Cir. 1997).

Neither party has argued on appeal that the district 

court erred in importing “a patient” into this limitation. 

However, the parties are at odds over whether the district 

court’s definition of “a patient” is correct. Novel argues 

that the district court’s definition limits the utility of the 

claimed compositions to administration in a single patient. Indeed, such an interpretation would allow a 

composition to meet the claims even if 99 patients out of 

100 experienced clinically significant electrolyte shifts, as 

long as one patient did not. 

In support of the district court’s definition of “a patient,” Braintree argues that “a patient” must mean one 

or more patients, as it cannot be the case that no infringement can occur if SUPREP causes a clinically 

significant electrolyte shift in a single patient. 

We agree with Novel and conclude that, in this case, 

the district court’s definition of “a patient” is incorrect. In 

view of the proper claim construction of “clinically significant electrolyte shifts,” the district court’s application of 

the claim terms “a patient” leads to the absurd result of 

infringement even if a composition causes clinically 

significant electrolyte shifts in a large percentage of 

patients. Therefore, we instead interpret “a patient” to 

mean the general class of persons to whom the patented 
12 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

compositions are directed, i.e., a patient population. This 

definition of a patient is consistent with the “invention 

the patentee intended to define and protect.” Rowe, 112 

F.3d at 478. Indeed, in the specification, the inventor 

states that his “objective was to find a well tolerated 

orally administered colonic purgative that . . . avoided the 

risks of upset or electrolyte balance in patients.” ’149 

patent col. 4 ll. 45-48 (emphasis added). In addition, the

inventor states that a preferred embodiment has been 

“well tolerated by normal people.” Id. at col. 11 ll. 43-44 

(emphasis added). And in the ’149 patent’s abstract, the 

inventor described his invention as “[a] compromise 

between convenient, distasteful, solid or low volume, 

hyperosmotic solutions which cause considerable fluid and 

electrolyte imbalances in patients and large volume, 

difficult to consume, iso-osmotic solutions . . . .” Id. at 

abstract (emphasis added). 

We note that there is evidence in the record that at 

least some patients experienced alterations in blood 

chemistry that are outside the normal upper or lower 

limits of their normal range. See, e.g., J.A. 924, 5059-71, 

6683, 6694, 6759, 6831, 6833, 6849, 6857. Therefore, we 

conclude that there remains a genuine dispute as to 

whether SUPREP avoids producing any clinically significant electrolyte shifts in a patient population. We vacate 

the district court’s grant of summary judgment of infringement, and we remand this matter to the district 

court for further factual findings concerning whether such 

alterations qualify as “clinically significant electrolyte 

shifts” in accordance with the proper claim construction

articulated here within. 

C. Invalidity

Invalidity must be proven by clear and convincing evidence. WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 

1339, 1355 (Fed. Cir. 1999). On appeal from a bench trial, 

we review the district court’s conclusions of law de novo 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 13

and findings of fact for clear error. Brown & Williamson 

Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1123 

(Fed. Cir. 2000). 

1. Anticipation by Hechter

Anticipation is a question of fact, and a district court’s 

findings on this issue are reviewed for clear error. See 

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 

(Fed. Cir. 2008). Below, the district court found that 

Novel “did not show proof that met the clear and convincing standard” that the asserted claims were anticipated 

by Hechter. Validity Opinion at *25. The district court 

credited Braintree’s expert witness’s opinion that Hechter 

does not disclose several limitations of the asserted 

claims. Id. at *24. On appeal Novel argues again that 

Hechter anticipates the asserted claims of the ’149 patent. 

Hechter teaches first mixing 60 grams of a dry powder 

composition with one-liter of water and then later adding 

three additional liters of water prior to administration. 

Hechter col. 3 ll. 52-62. Novel argues that Hechter expressly discloses the preparation of a one-liter hypertonic 

solution because during the first step, the composition in 

Hechter is mixed with one-liter of water. See id. at col. 3 

ll. 55-59. It alleges that Hechter further discloses that 1.6 

liters, or 40% of its four-liter solution, is capable of cleansing the colon (Id. at col. 4 ll. 13-16); 40% of one-liter is 400 

mL. Novel also claims that the initial solution in Hechter 

is inherently hypertonic. 

We note that during prosecution, the examiner initially rejected the claims over Hechter. See J.A. 21889. 

Braintree then added the word “hypertonic” to its claims,

explaining that Hechter taught administering 3 to 4 liters 

of an isotonic solution, while the claims were directed to 

hypertonic solutions. J.A. 21906, 21913-14. In response, 

the examiner withdrew the rejections. J.A. 21922.
14 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

After reviewing Hechter and the ’149 patent’s prosecution history, we conclude that Novel’s argument is 

flawed for at least three reasons. First, Hechter does not 

disclose administering this initial one-liter solution to a 

patient. And we find no clear error in the district court’s 

finding that skilled artisans would not have administered 

Hechter’s initial mixing solution because, as the ’149 

patent explains, “concentrating the large volume, [isotonic 

preparations] into smaller volumes does not achieve the 

same effectiveness, and is not as safe.” ’149 patent col. 3 

ll. 26-28. Second, although theoretically the initial oneliter solution described in Hechter could be hypertonic in 

a patient, both parties’ experts agreed that the only way 

to know whether Hechter’s initial mixing solution was 

hypertonic would be to test it. See J.A. 21251-52, 21422, 

21622. But Novel has no evidence to suggest that the 

initial mixture in Hechter has been tested in a patient 

population, let alone that it was found to be hypertonic. 

Id. Thus, Novel lacks clear and convincing evidence that 

Hechter teaches this limitation. Third, Hechter actually 

teaches away from administering a hypertonic solution, 

stating that its solution needs to be isotonic in order to 

avoid clinically significant electrolyte shifts. See Hechter 

col. 2 ll. 9-39, col. 2 ll. 60-67, col. 3 ll. 15-16, col. 3 ll. 38-40. 

For at least these three reasons, we affirm the district 

court’s finding that Hechter does not anticipate the asserted claims of the ’149 patent.

2. Obviousness

Obviousness is a question of law, reviewed de novo, 

based on underlying factual findings, reviewed for clear 

error. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). 

The district court found that Novel, which relied on 

sixteen prior art references, failed to prove obviousness by 

clear and convincing evidence. Validity Opinion at *24. 

“[D]iscount[ing] [Novel’s expert’s] testimony on credibility 

grounds because some of his conclusions did not appear to 

be as reasonable,” the district court found that the prior 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 15

art “did not direct a [skilled artisan] to combine sodium 

sulfate, magnesium sulfate, and potassium sulfate in a 

small volume hypertonic solution that causes purgation, 

does not produce clinically significant electrolyte shifts, 

and does not contain phosphate.” Id. at *22. The district 

court also found that the inventor’s “detailed experimentation” was far from the “tweaking” and “modifying” that 

Novel’s expert claimed. Id. at *23. 

Novel relies on many references as an attempt to 

demonstrate that, at the time of the invention, one of skill 

in the art knew that: (1) sulfate salts caused purgation of 

the colon; (2) hypertonic, low-volume colon-cleansing

solutions were preferable; (3) clinically significant electrolyte shifts should be avoided; (4) bowel preps should be 

administered in a split-dose regimen; and (5) bowel preps 

should typically avoid phosphates. It adds that the prior 

art consisted only of a limited number of known agents 

that may be combined to cleanse the colon without ingesting phosphate and without producing clinically significant 

electrolyte shifts. Further, Novel argues that all components in the asserted claims were known purgatives at 

the time of invention. Thus, Novel alleges that the asserted claims “‘simply arrange[] old elements with each 

performing the same function it had been known to perform’ and yields no more than one would expect from such 

an arrangement, [so] the combination is obvious.” KSR 

Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (citation 

omitted). Finally, Novel argues that before the ’149

patent’s priority date, there was a need to: (1) avoid the 

use of phosphates in particular patient populations; and 

(2) develop a low-volume solution to improve patient 

compliance and efficacy. Novel claims the district court 

failed to consider the limited number of choices to meet 

those market preferences and pressures. 

We disagree. As the district court correctly noted, 

Novel did not prove that one of skill in the art would have 

been motivated to combine so many references. In other 
16 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

words, it failed to prove a “plausible rational[e] as to why 

the prior art references would have worked together.” 

Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 

1352 (Fed. Cir. 2010). Further, in building its obviousness case, Novel relies on expert testimony which the 

district court found to be less credible. Validity Opinion

at *25. And the prior art, including Hechter, taught that 

safe bowel preps should be isotonic, not hypertonic like 

the claimed compositions. See, e.g., Hechter col. 2 ll. 60-

64. Therefore, we conclude that the district court did not 

err in finding that Novel failed to demonstrate that the 

asserted claims of the ’149 patent would have been obvious at the time of the invention. 

3. Indefiniteness

We review de novo the district court’s decision regarding indefiniteness, as it is a question of law. Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1363 

(Fed. Cir. 2012). The district court found that Novel 

failed to prove the claims indefinite by clear and convincing evidence. Validity Opinion at *25-26. It rejected 

Novel’s argument that a skilled artisan would not understand the word “copious”—a term not used in any claim 

and only found in the district court’s construction of 

“purgation.” Id. at *25. On appeal, Novel argues that the 

district court noted but then ignored the clear import of 

the testimony from the inventor, who admitted explicitly 

that the term purgation “does not have a defined volume.” 

J.A. 21048-49. It points to further testimony on the 

record from a Braintree employee, in which the employee 

admitted: “I don’t think there’s any clear definition about 

what copious diarrhea means.” J.A. 21304. 

We are not persuaded by Novel’s indefiniteness argument. It has failed to show why the word “copious,” a 

word that is not found in the claims but rather is used in 

the district court’s construction of “purgation,” is indefinite in this context. Descriptive words like “copious” are 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 17

commonly used in patent claims, to “avoid[] a strict numerical boundary to the specified parameter.” See Pall 

Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 

(Fed. Cir. 1995). Further, when asked what copious 

would mean to one of skill in the art, Braintree’s expert 

witness stated “[w]ell, copious is a lot. . . . I think anyone 

who has taken a bowel prep prior to [a] colonoscopy, 

knows that it’s quite a bit of diarrhea that comes out.” 

J.A. 20161. We agree, and therefore we conclude that one 

of skill in the art would understand what a “copious” 

amount of diarrhea is in this context. 

IV. CONCLUSION

For the foregoing reasons, we affirm the district 

court’s claim construction of “purgation.” However, we 

conclude that the district court erred in construing the 

claim term “clinically significant electrolyte shifts.” We 

reverse its claim construction and vacate its grant of 

summary judgment of infringement. Regarding validity, 

we affirm the district court’s findings that the asserted 

claims of the ’149 patent are not anticipated, not obvious, 

and not indefinite. We remand this case to the district 

court for further proceedings consistent with this opinion. 

AFFIRMED-IN-PART, REVERSED-IN-PART, 

VACATED-IN-PART, AND REMANDED
United States Court of Appeals 

for the Federal Circuit ______________________ 

BRAINTREE LABORATORIES, INC.,

Plaintiff-Appellee,

v.

NOVEL LABORATORIES, INC.,

Defendant-Appellant.

______________________ 

2013-1438

______________________ 

Appeal from the United States District Court for the 

District of New Jersey in No. 11-CV-1341, Judge Peter G. 

Sheridan.

______________________ 

DYK, Circuit Judge, concurring in part, dissenting in part, 

and concurring in the result. 

I agree with Judge Prost that the district court erred 

in its construction of “clinically significant electrolyte 

shifts” and that the correct construction of that term is 

“alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other 

untoward effects.” Op. of Prost, J., at 9. Although it 

seems to me that Novel established non-infringement as a 

matter of law under the correct “clinically significant 

electrolyte shifts” construction, I join the remand to the 
2 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

district court for further proceedings on that issue.1 I also 

agree that the asserted claims of the ’149 patent are not 

invalid. Thus I join parts I–II, III(A)(2), III(B) (except the 

second paragraph) and III(C). 

However, I respectfully dissent from the majority’s 

conclusion that Novel’s ANDA meets the volume limitation of the asserted claims. Under the proper interpretation of the volume limitation, Novel established noninfringement as a matter of law. In my view, the majority’s contrary conclusion is inconsistent with established 

authority under the Hatch-Waxman Act.

1 The sole evidence in the summary judgment record concerning the percentage of individuals experiencing 

such electrolyte shifts is data from two clinical studies of 

SUPREP, and those data are sufficient to show that the 

claim limitation was not met. The first, BLI800-202, a 

Phase II study of eighteen patients, showed that a majority of patients experienced clinically significant electrolyte 

shifts. J.A. 5059–69; 6642, 6683; 6756, 6759; 6831; 6912; 

7000, 7002; 7094, 7100; 7386; Def.’s Br. in Supp. of Mot. 

for Summ. J. 8, Braintree Labs., Inc. v. Novel Labs., Inc., 

No. 3:11-cv-1341 (D.N.J. Oct. 9, 2012), ECF No. 159-1. 

The second, BLI800-303, a Phase III study of sixty-three 

patients, showed that a significant minority or about onethird of patients experienced clinically significant electrolyte shifts. J.A. 9679 (expert report of Dr. Goldfarb (Novel’s expert witness) summarizing BLI800-303 data). 

Braintree’s expert witness Dr. Peura also testified that 

“abnormal electrolyte values have been observed in some 

patients taking SUPREP.” J.A. 10322 (emphasis removed). 

 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 3

I 

I agree with the majority that the district court’s 

construction of “purgation” was correct. But even under 

that construction, Novel’s ANDA does not meet the 

claimed volume limitation. The asserted claims include a 

volume limitation that requires that the solution be 

between 100-500 mL, as seen in representative claim 15:

A composition for inducing purgation of the colon 

of a patient, the composition comprising from 

about 100 ml to about 500 ml of an aqueous hypertonic solution . . . wherein the composition does 

not produce any clinically significant electrolyte 

shifts . . . . 

Ex Parte Reexamination Certificate No. 6,946,149C1 col.

2 ll. 23–30 (emphasis added). The asserted claims also 

include claims 18–20, and 23. Claims 19–20 and 23 are 

method of use claims.

In ANDA litigation, because a generic company seeking FDA approval does not yet “make[], use[], offer[] to 

sell, or sell[]” the product and therefore cannot infringe 

under 35 U.S.C. § 271(a), pharmaceutical companies must 

rely on 35 U.S.C. § 271(e)(2)(A), which creates an “artificial” act of infringement when the generic company submits an ANDA seeking approval “‘for a drug claimed in a 

patent or the use of which is claimed in a patent.’” Eli 

Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675, 676 

(1990) (quoting § 271(e)(2)(A)). The infringement occurs 

only if the generic company seeks approval for a patented 

composition or use that has been approved by the FDA. 

Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 

1319 (Fed. Cir. 2012) (citing Warner-Lambert Co. v. 

Apotex Corp., 316 F.3d 1348, 1356 (Fed. Cir. 2003) (“‘[T]he 

use’ in § 271(e)(2)(A) refers to the use for which the FDA 

has granted an NDA.”)); Glaxo, Inc. v. Novopharm, Ltd., 
4 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

110 F.3d 1562, 1567–68 (Fed. Cir. 1997) (composition is 

determined by the composition in the ANDA).2 

Under the Hatch-Waxman Act, the infringement inquiry “must focus on what the ANDA applicant will likely 

market if its application is approved.” Id. at 1569. Novel’s ANDA does not cover administration of the drug for 

purgation sufficient for “evacuation of a copious amount of 

stool from the bowels.” Claim Construction Order at *6. 

Rather, Novel’s ANDA states specifically that the drug “is 

indicated for cleansing of the colon as a preparation for 

colonoscopy in adults.” J.A. 5280. The ANDA limits its

dose regimen (the SUPREP regimen) as follows: “The dose

for colon cleansing requires administration of two bottles

of [oral solution]. Each bottle is administered as 16 oz 

[i.e., 473 mL] of [oral solution] . . . .” J.A. 5280 (emphases 

added). Therefore, the volume of the dose in Novel’s 

ANDA is 946 mL.3 Braintree’s infringement argument, 

2 Section 271(e)(2)(A) reads as follows:

(2) It shall be an act of infringement to submit— 

(A) an application under [21 U.S.C. § 355(j)] or described in [21 U.S.C. § 355(b)(2)] for a drug 

claimed in a patent or the use of which is claimed 

in a patent.

35 U.S.C. § 271(e)(2)(A).

3 See also J.A. 22172 (Braintree’s Patent Term Extension Request) (“The SUPREP product . . . contains only 

2 x 16 ounces of solution (i.e., approximately 2 x 0.47 L = 

.94L of solution), as indicated in the approved label . . . .”); 

J.A. 4262 (Jack A. Di Palma et al., A Randomized Clinical 

Study Evaluating the Safety and Efficacy of a New, Reduced-Volume, Oral Sulfate Colon-Cleansing Preparation 

for Colonoscopy, 104 Am. J. Gastroenterology 2275, 2276 

 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 5

adopted by the district court and by the majority here, is 

the “one bottle” infringement theory, which asserts that 

because one (half-dose) bottle of Novel’s proposed generic

falls within the 100-500 mL volume range and would 

cause a “purgation,” the ANDA infringes. 

Here, “one bottle” consisting of 473 mL is not the dose 

approved by the FDA. The approved NDA for SUPREP 

does not permit a dose regimen of only one 16 oz bottle 

(473 mL), but requires both administrations of the “splitdose” regimen of two bottles (946 mL). Nor does the NDA 

recommend a one bottle dose to induce purgation as a 

possible alternative. Since no clinical studies have been 

conducted to support a one bottle regimen for purgation, 

the FDA has not approved such a use. See 21 U.S.C. 

§ 355(d)(1). Because there is no underlying NDA approval 

for a one bottle regimen for purgation, Novel is precluded 

from seeking an ANDA for such a regimen.4 Instead, 

Novel’s ANDA properly seeks approval for a 946 mL, two 

bottle regimen to induce colon cleansing, based on 

Braintree’s approved NDA. Therefore, Novel’s ANDA 

does not infringe the ’149 patent, which claims a composition with a volume of 100-500 mL for inducing purgation

and a method of using the same. 

(2009)) (“The total preparation volume [of SUPREP] is 

960 ml.”). 4 A generic may not file an ANDA that differs from 

the approved NDA in “route of administration, dosage 

form, or strength” unless it has obtained special permission from the FDA to do so, 21 U.S.C. § 355(j)(2)(C), and

Novel neither sought nor received such permission here. 

A generic may not seek approval for a use that differs 

from the approved NDA under any circumstances. See 

Warner-Lambert, 316 F.3d at 1356 (citing 

§ 355(j)(2)(A)(i)).

 
6 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

The majority’s contrary interpretation is inconsistent 

with this court’s longstanding precedent. An ANDA 

cannot infringe an asserted patent when the FDAapproved dose is not the dose claimed in the patent. As 

we held in Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 

1322, 1332 (Fed. Cir. 2003), “a method of use patent 

holder may not sue an ANDA applicant for induced infringement of its patent, if the ANDA applicant is not 

seeking FDA approval for the use claimed in the patent 

and if the use claimed in the patent is not FDA-approved.” 

(emphasis added) (citing Warner-Lambert, 316 F.3d at 

1354–55). While the patent here includes both composition and method of use claims, all claims are limited to 

the use of a specified volume of the composition.

In particular, the majority’s decision is contrary to our 

decision in Bayer Schering, where we held that because

“the FDA has not approved [the use claimed in the patent] . . . the defendants cannot be held liable for infringement of the patent.” 676 F.3d at 1326. There, the 

patent claimed the use of a particular drug to achieve 

three effects simultaneously, “a contraceptive effect, an 

antiandrogenic effect, and an antialdosterone effect.” Id.

at 1319 (quoting U.S. Patent No. 5,569,652). But the 

FDA-approved NDA and label indicated the use of the 

branded drug only “for oral contraception.” Id. (internal 

quotation marks omitted). We held that the accused 

ANDAs did not infringe because they did not seek approval for two of the claimed uses. Id. at 1326. There was 

no infringement under § 271(e)(2)(A) because “the defendants’ ANDAs [sought] approval to market the generic 

[drug] for contraceptive use, and there is no valid patent 

on the use of the drug for that purpose alone.” Id. 

Crucially, we found it irrelevant that the drug did, in 

fact, cause the three claimed effects simultaneously—

simply because a patient could practice the claims by 

using the drug to achieve all three effects did not mean 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 7

that the corresponding ANDA infringed. Id. at 1325–26. 

“[Nothing] on the [approved] label provide[d] any safety or 

efficacy information associated with the possible use of 

[the drug] in treating patients who are in need of those 

[claimed] effects.” Id. at 1322. As we noted there:

[T]he point is not simply that the method of use 

[claimed in the patent] was not described in the 

Indications and Usage section that shows lack of 

FDA approval; the point is that the label, taken in 

its entirety, fails to recommend or suggest to a 

physician that [the drug] is safe and effective for 

inducing the claimed combination of effects in patients in need thereof. 

Id. at 1324. So too here—just because a patient could

ingest only one bottle of Novel’s generic to achieve a 

purgation does not make Novel’s ANDA infringing. It is 

undisputed that Novel’s proposed label fails to recommend or suggest to a physician that the solution should be 

taken to achieve purgation, rather than cleansing, or that 

it suggests taking a dosage below the 946 mL level for any 

purpose. 

Similarly, in Warner-Lambert, 316 F.3d at 1356, we 

held that “because an ANDA may not seek approval for an 

unapproved or off-label use of a drug . . . it necessarily 

follows that 35 U.S.C. 271(e)(2)(A) does not apply to a use 

patent claiming only such [an unapproved or off-label] 

use.” See also AstraZeneca LP v. Apotex, Inc., 633 F.3d 

1042, 1059–60 (Fed. Cir. 2010) (assuming that an ANDA 

seeking approval for a twice-daily dose regimen could not 

infringe a patent claiming a once-daily dose regimen). In 

short, Braintree’s patent claims a composition and a 

method, both of which require using a 100-500 mL solution. Novel’s ANDA seeking FDA approval for a 946 mL 

solution cannot infringe the ’149 patent. 
8 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

II

Even if there were no Hatch-Waxman issue, 

Braintree’s theory would be unsupportable. Braintree’s 

“one bottle” theory rests on a demonstrably incorrect 

claim construction. Here, “volume” refers to the total 

volume of the recommended dosage and not some portion 

of that total volume—whether or not the recommended 

dosage is given in one bottle or two bottles. 

The ’149 patent specification describes the two categories of bowel cleansing options in the prior art to the ’149 

patent, each with its own disadvantages. The first were 

“large volume” isotonic solutions that did not cause electrolyte shifts in patients. ’149 patent col. 1 ll. 31, 48–53. 

The second were “small volume” hypertonic preparations 

that caused severe electrolyte shifts in many patients, 

often with life-threatening results. Id. col. 2 ll. 41–44, col. 

4 ll. 23–26. The inventors of the ’149 patent further 

recognized that although “[c]linical trials have shown use 

of the 4 liter [i.e., large volume] [isotonic] solution to be 

safe and efficacious [i.e., did not cause electrolyte shifts],” 

that patient “compliance [with ingesting such solutions] is 

poor because of the large volume of solution.” Id. col. 4 ll. 

1–5. The ’149 patent attempted to address both issues by 

creating a small volume solution for patient ingestion that 

did not cause clinically significant electrolyte shifts. The 

volume limitation was critical to distinguish the ’149 

patent from the prior art. The specification explains that 

the prior art solutions were customarily ingested in 

multiple administrations, such that a solution with a total

volume of 4 liters would be divided into administrations of 

500 mL or less.5 The specification suggested the same 

5 See, e.g., ’149 patent col. 1 ll. 53–56 (“Because the 

[large] solutions are isotonic, patients are required to 

ingest a significant amount of volume of these solutions, 

 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 9

method of dividing the total volume for ingesting the 

claimed solution: 

Optimally, the effective dose may be divided and 

administered, to the patient in two, or more administrations over an appropriate time period. 

Generally, 2 doses administered of equal portions 

of the effective dose, separated by 6 to 24 hours 

produce satisfactory purgation. 

Id. col. 5 ll. 19–24 (emphasis added). The specification 

thus makes clear that the total volume is the combination 

of the divided doses. Under the correct construction as 

envisioned by drafters of the ’149 patent, “volume” referred to the total claimed 100-500 mL volume of solution 

ingested by the patient as the recommended dose to 

induce purgation, even if this total volume has been 

divided into smaller administrations of unspecified size. 

This ensured that the claimed volume limitation did not 

run afoul of the prior art solutions such as Hechter, which 

suggested dividing a “large volume” solution of 4 liters 

into individual administrations of about eight ounces or 

237 mililiters. Hechter col. 4 ll. 2–12, col. 6 ll. 14–35.

Indeed, Braintree’s own arguments that Hechter does 

not anticipate the ’149 patent focus on the total volume of 

the disclosed Hechter solution and are inconsistent with 

its “one bottle” infringement theory. Hechter disclosed a 

4 liter isotonic solution that would be created from a 1 

liter hypertonic stock solution. Hechter col. 3 ll. 55–62. 

up to one eight ounce glass [i.e., 237 mL] every ten 

minutes for a total of one gallon of fluid [i.e., about 4 L] to 

achieve effective purging.” (emphasis added)); id. col. 2 ll. 

32–34 (“Patients are typically required to take two (2) 

three ounce doses of [Fleets Phospho-Soda] separated by a 

three to 12 hour interval for a total of six ounces (180 

ml).”).

 
10 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

Novel argued that because Hechter taught that only 40% 

of the 4 liter isotonic solution must be ingested to achieve 

colon-cleansing, it inherently disclosed a 400 mL hypertonic stock solution capable of colon-cleansing. Appellant’s Br. 47–49. But Braintree’s expert witness in this 

case disagreed, objecting that there could be no anticipation from consuming only a portion of the recommended 

dose. See J.A. 21624 (Peura direct testimony) at 962:7–13 

(explaining that he disagreed with Novel’s inherent 

disclosure theory, because “[w]ell, a liter is a liter. You 

know, there may be two 500 milliliters components to a 

liter or four 250, or ten 100; there’s no teaching in Hechter that would suggest that . . . this liter would ever be 

administered to anybody, and there’s surely no teaching 

that you can divide this liter into component parts.”). 

Braintree’s own argument that Hechter does not anticipate the claimed invention depends, in part, on an assumption that the relevant volume is the total amount of 

a disclosed solution, not the volume of individual administrations or separate components of that solution. 

In short, the specification of the ’149 patent and 

Braintree’s own expert made clear that the invention was 

directed at “small volume” solutions of 100-500 mL total—

not large volume solutions that could be divided into 100-

500 mL administrations. Braintree’s “one bottle” theory 

of infringement therefore leads to the surprising result 

that although large volume solutions of 4 liters are derogated in the specification, if administered in 500 mL 

increments, such solutions would infringe the ’149 patent. 

Therefore, the entire premise of the ’149 patent—that a 

recommended dosage of a small volume would improve 

patient compliance—is ignored by Braintree’s one bottle 

theory. 

 Because Novel’s ANDA does not meet the volume 

limitation of the asserted claims, under this court’s ANDA 

infringement precedent and under the language of the 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 11

specification, it cannot infringe the ’149 patent. I respectfully dissent from the contrary conclusion reached by the 

majority. 
United States Court of Appeals 

for the Federal Circuit ______________________ 

BRAINTREE LABORATORIES, INC.,

Plaintiff-Appellee,

v.

NOVEL LABORATORIES, INC.,

Defendant-Appellant.

______________________ 

2013-1438

______________________ 

Appeal from the United States District Court for the 

District of New Jersey in No. 11-CV-1341, Judge Peter G. 

Sheridan.

______________________ 

MOORE, Circuit Judge, dissenting. 

I join the majority opinion except for Part III-B because I disagree with the majority’s construction of “a 

patient.” I agree with the district court that “a patient” 

means “one or more patients” in accordance with the plain 

language of the asserted claims and with our precedent. I 

would affirm the district court’s summary judgment of 

infringement because undisputed evidence shows that at 

least one patient who was treated with the accused composition has experienced “clinically significant electrolyte 

shifts” within the meaning of the claims. Therefore, I 

respectfully dissent. 

Reexamined claim 15 of U.S. Patent No. 6,946,149

(’149 patent), which is representative of the asserted 
2 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

claims, recites “[a] composition for inducing purgation of 

the colon of a patient, . . . wherein the composition does 

not produce any clinically significant electrolyte shifts

. . . .” Everyone agrees that the preamble term “a patient” 

limits the scope of the claim. The disagreement centers 

on the meaning of “a patient.” The district court held that 

it meant one or more patients. The majority concludes 

that it means “a general class of persons,” or “a patient 

population.” Maj. Op. at 11–12. 

The plain and ordinary meaning of “a patient” is one 

or more patients. We have, on many occasions, construed 

the article “a.” Not surprisingly, this word appears in 

many patent claims. We have repeatedly held that “a,” 

when used in a “comprising” claim, means one or more. 

“As a general rule, the words ‘a’ or ‘an’ in a patent claim 

carry the meaning ‘one or more.’ The exceptions to this 

rule are extremely limited: a patentee must evince a clear 

intent to limit ‘a’ or ‘an’ to ‘one.’” 01 Communique Lab., 

Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 

2012); see also SanDisk Corp. v. Kingston Tech. Co., Inc., 

695 F.3d 1348, 1360–61 (concluding that “a” means “one 

or more”); Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 

F.3d 1338, 1342 (Fed. Cir. 2008) (“[T]his court has repeatedly emphasized that the indefinite article ‘a’ or ‘an’ in 

patent parlance carries the meaning of ‘one or more’ in 

open-ended claims containing the transitional phrase 

‘comprising.’”). In the few instances where we have ever 

deviated from this general rule, we concluded that the 

intrinsic evidence made it clear that the patentee intended “a” to mean one and only one. See Tivo, Inc. v. EchoStar Commc’ns Corp., 516 F.3d 1290, 1303–04 (Fed. Cir. 

2008); Insituform Techs., Inc. v. Cat Contracting, Inc., 99 

F.3d 1098, 1105–06 (Fed. Cir. 1996). 

Strangely, the majority does not conclude that “a patient” means “one or more,” consistent with our general 

rule, or that it means “only one,” consistent with the only 

exception that we have allowed. “A patient,” according to 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 3

the majority, requires multiple patients, a patient population, or patient class. But there is no plain meaning of “a” 

that excludes the singular. We give claim terms their 

plain and ordinary meaning unless the patentee acted as 

its own lexicographer or there was a disavowal of claim 

scope. Thorner v. Sony Computer Entm’t Am. LLC, 669 

F.3d 1362, 1365 (Fed. Cir. 2012). Neither of these circumstances is present here. Although the majority is 

correct that the specification sometimes uses the plural 

“patients,” at other places it uses the singular “patient.” 

See ’149 patent col. 2 ll. 43–44, col. 2 l. 65, col 3 l. 3, col. 5 

l. 21. The patentee obviously knew how to refer to “patients” generally or as a class, but chose to draft the 

claims to recite only “a patient.” Nothing in the specification of the ’149 patent or its prosecution history defines 

the singular “a patient” as a plural “patient population” 

contrary to the words of the claims. In fact, the patent 

lists only one object of the invention—and it is described 

in terms of impact on a single patient: “One purpose of 

the present research was to develop a safe, effective, and 

well tolerated small volume solution made up of a high 

concentration of poorly absorbable salts that induce colon 

cleansing catharsis after oral ingestion without clinically 

significant alternation [sic] of sodium, chloride, bicarbonate, potassium, calcium, and phosphate level and 

balance or other untoward effects on the recipient.” Id.

col. 3 ll. 32–38. 

I agree with the majority that the patent defines “clinically significant electrolyte shifts” as “alterations in blood 

chemistry that are outside the normal upper or lower 

limits of their normal range or other untoward effects.” 

Id. col. 2 ll. 47–51. According to the patent, clinical 

significance is measured in an individual patient. Namely, are the electrolyte shifts in an individual patient 

clinically significant, i.e., are they outside the normal 

range? “Clinical significance” can sometimes refer to a 

measure of statistical significance and other times to a 
4 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

measure of deviation from normal in an individual patient. This patent, as discussed above, expressly defines 

it as a measure in an individual patient. See also id. col. 

2 ll. 43–44 (the invention avoids electrolyte shifts that are 

“clinically significant to the patient”); id. col. 3 ll. 66–67

(“clinically significant electrolyte shifts on bodily chemistry”); id. col. 3 ll. 35–38 (“clinically significant alternation 

[sic] . . . or other untoward effects on the recipient”). 

Extrinsic evidence of record likewise demonstrates that 

clinical significance is a measure applied to a single 

patient. For example, the record includes a laboratory 

report on an individual patient that directs the analyst to 

indicate whether the test results were “Clinically Significant” or “Not Clinically Significant” for that patient, J.A. 

6756, and expert reports confirm this single-patient 

meaning of the term, see J.A. 5059; J.A. 5153–54. Indeed, 

the use of the term “clinical significance” to refer to individual patients is well-established in the medical arts. 

See, e.g., Alan E. Kazdin, The Meanings and Measurement 

of Clinical Significance, 67 J. Consulting & Clinical 

Psychol. 332, 332–33 (1999) (asking whether “the criterion of clinical significance may not be met” when “the client

improves, but at the end of treatment the client’s behavior

has not changed enough for it to fall within the normative 

range”). I see no basis in the specification or the prosecution history to rewrite the patent claims. 

This claim covers “[a] composition for inducing purgation of the colon of a patient . . . wherein the composition 

does not produce any clinically significant electrolyte 

shifts . . . .” To infringe, the composition must induce 

purgation in the colon of a patient without producing 

clinically significant electrolyte shifts (i.e., shifts outside 

the normal range) in that patient. Infringement is proven 

if the composition causes these reactions in a single 

patient. The majority believes this to be an “absurd 

result” because it would allow “a composition to meet the 

claims even if 99 patients out of 100 experienced clinically 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 5

significant electrolyte shifts, as long as one patient did 

not.”1 Maj. Op. 11. I understand the majority’s concern. 

But this is a question of damages, not infringement. 

Infringement, whether on a large or small scale, is 

still infringement.2 See, e.g., Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1318 (Fed. Cir. 2009). Lucent

makes clear that there is no “rare infringement” exception 

to liability, and that even one instance of infringement is 

adequate to support a judgment of infringement. Id.

(affirming a finding of direct infringement where a jury 

“could have reasonably concluded that . . . more likely 

than not one person somewhere in the United States had 

performed the claimed method”); see also Broadcom Corp. 

v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013) (“It 

is well settled that an accused device that sometimes, but 

not always, embodies a claim nonetheless infringes.”). 

The law responds to rare infringement not by eliminating 

liability, but by providing for a correspondingly low award 

of damages. See Lucent, 580 F.3d at 1334 (“The damages 

award ought to be correlated, in some respect, to the 

extent the infringing method is used by consumers.”). 

Likewise, the decision whether to award injunctive relief

in a patent infringement suit, which is at the discretion of 

the district court, includes consideration of the extent of 

infringement or harm to the patentee. See Robert Bosch 

LLC v. Pylon Mfg. Corp., 659 F.3d 1142, 1148–50 (Fed. 

Cir. 2011).

1 To be sure, there is evidence in the record in this 

case that the claimed composition infringes in numerous 

instances, not just one. See Maj. Op. at 12. 

2 It may be that the FDA would not approve a drug 

that has efficacy in a small percentage of the patients who 

take it, but that is not the standard we use in assessing 

infringement of patent claims. 

 
6 BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 

And here lies the heart of the majority’s problem. 

This is an ANDA case. In ANDA cases in which the 

accused product has not yet been marketed, a damages 

remedy is of course not available. Instead, the district 

court “shall order the effective date of any approval of the 

drug . . . involved in the infringement to be a date which 

is not earlier than the date of the expiration of the patent 

which has been infringed,” and the court “may” grant 

“injunctive relief.” 35 U.S.C. § 271(e)(4)(A), (B). Thus, 

while the injunction remedy rests within the discretion of 

the district court, the order to delay the approval of the 

ANDA until patent expiration is not discretionary. Id. I 

don’t like this result either, but this is exactly what the 

statutory language commands. The statute requires the 

court to delay approval until expiration of the patent, 

even if there is only a single infringement. And since the 

generic can’t launch without FDA approval, the statute

creates a de facto injunction. 

In an effort to avoid this outcome, the majority rewrites the claim language to allow infringement only if 

the drug works in a patient population rather than a 

patient.3 But this we cannot do. Chef Am., Inc. v. LambWeston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (“[W]e 

construe the claim as written . . . .”); Process Control Corp. 

v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999) 

3 Changing “a patient” to “a patient population” is 

pernicious for practical reasons as well. Infringement will 

now be measured by whether a patient population experiences purgation without abnormal shifts in electrolytes. 

What percentage of people constitutes a patient population? Is the patient population everyone who takes the 

drug? A statistically significant number of people who 

take the drug—which would be 99.5%? A majority? And 

have we now written an indefinite or unsupported claim 

for the patentee? 

 
BRAINTREE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. 7

(“[A] nonsensical result does not require the court to 

redraft the claims . . . .”). If the result commanded by the 

statute is unsatisfactory, the proper response is for Congress to amend the statute, making the delayed approval 

discretionary rather than mandatory, not for us to redraft 

the patent to avoid such a result. For these reasons, I 

respectfully dissent. I would affirm the district court’s 

summary judgment of infringement.