United States Court of Appeals 

for the Federal Circuit ______________________

INDIVIOR INC., FKA RECKITT BENCKISER 

PHARMACEUTICALS INC., INDIVIOR UK 

LIMITED, FKA RB PHARMACEUTICALS LIMITED, 

AQUESTIVE THERAPEUTICS, INC., FKA 

MONOSOL RX, LLC,

Plaintiffs-Cross-Appellants

v.

DR. REDDY'S LABORATORIES, S.A., DR. REDDY'S 

LABORATORIES INC., WATSON LABORATORIES 

INC., ACTAVIS LABORATORIES UT, INC., TEVA 

PHARMACEUTICALS USA, INC.,

Defendants-Appellants

PAR PHARMACEUTICAL, INC., INTELGENX 

TECHNOLOGIES CORP.,

Defendants

______________________

2017-2587, 2018-1010, 2018-1058, 2018-1062, 2018-1114, 

2018-1115, 2018-1176, 2018-1177

______________________

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:13-cv-01674-RGA, 1:14-cv00422-RGA, 1:14-cv-01451-RGA, 1:14-cv-01574-RGA, 1:16-

cv-00178-RGA, Judge Richard G. Andrews.

-------------------------------------------------------------
2 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

INDIVIOR INC., FKA RECKITT BENCKISER 

PHARMACEUTICALS INC., INDIVIOR UK 

LIMITED, FKA RB PHARMACEUTICALS LIMITED,

AQUESTIVE THERAPEUTICS, INC.,

Plaintiffs-Appellants

v.

ALVOGEN PINE BROOK, LLC,

Defendant-Cross-Appellant

______________________

2018-1949, 2018-2045

______________________

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:15-cv-00477-RGA, 1:15-cv01016-RGA, Judge Richard G. Andrews.

______________________

Decided: July 12, 2019

______________________

JEFFREY B. ELIKAN, Covington & Burling LLP, Washington, DC, argued for all plaintiffs-cross-appellants in 

2017-2587 and for all plaintiffs-appellants in 2018-1949. 

Indivior Inc., Indivior UK Limited also represented by 

ERICA NICOLE ANDERSEN, BETH S. BRINKMANN, ROBERT 

JASON FOWLER, MATTHEW AARON KUDZIN, JEFFREY 

HOWARD LERNER, ASHLEY KWON; DUSTIN B. WEEKS, Troutman Sanders LLP, Atlanta, GA; DANIEL LADOW, JAMES M.

BOLLINGER, MAGNUS ESSUNGER, KATHERINE HARIHAR,

TIMOTHY P. HEATON, GERALD EAMES PORTER, New York, 

NY; CHARANJIT BRAHMA, San Francisco, CA. 

 JAMES FRANCIS HIBEY, Steptoe & Johnson, LLP, Washington, DC, for plaintiff-cross-appellant Aquestive 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 3

Therapeutics, Inc. in 2017-2587 and for plaintiff-appellant

Aquestive Therapeutics, Inc. in 2018-1949. Also represented by JAMIE LUCIA, San Francisco, CA. 

 KEVIN PAUL MARTIN, Goodwin Procter LLP, Boston, 

MA, argued for defendants-appellants Dr. Reddy's Laboratories, S.A., Dr. Reddy's Laboratories Inc. in 2017-2587. 

Also represented by ELAINE BLAIS, EDWINA CLARKE,

ROBERT FREDERICKSON, III, ALEXANDRA LU; ROBERT V.

CERWINSKI, IRA J. LEVY, New York, NY.

 STEPHEN R. SMEREK, Winston & Strawn LLP, Los Angeles, CA, argued for defendants-appellants Watson Laboratories Inc., Actavis Laboratories UT, Inc., Teva

Pharmaceuticals USA, Inc. in 2017-2587. Also represented 

by JASON CRAIG HAMILTON; GEORGE C. LOMBARDI, MICHAEL 

KEENAN NUTTER, Chicago, IL; GEOFFREY P. EATON, Washington, DC. 

 STEVEN H. SKLAR, Leydig, Voit & Mayer, Ltd., Chicago, 

IL, argued for defendant-cross-appellant in 2018-1949. 

Also represented by DAVID AIRAN, GREGORY BAYS, NICOLE 

KOPINSKI, JAMES SANNER. 

 ______________________

Before NEWMAN, MAYER, and LOURIE, Circuit Judges.

Opinion for the court filed by Circuit Judge LOURIE.

Dissenting opinion filed by Circuit Judge MAYER.

LOURIE, Circuit Judge.

Dr. Reddy’s Laboratories, S.A. and Dr. Reddy’s Laboratories Inc. (collectively, “DRL”); Watson Laboratories Inc.

and Actavis Laboratories UT, Inc. (collectively, “Watson”); 

and Teva Pharmaceuticals USA, Inc. (“Teva”) appeal from 

several decisions of the United States District Court for the 

District of Delaware pertaining to U.S. Patents 8,603,514 

(the “’514 patent”), 8,900,497 (the “’497 patent”), and 
4 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

8,017,150 (the “’150 patent”). Specifically, DRL appeals 

from two decisions holding the asserted claims of the ’514, 

’497, and ’150 patents not invalid as obvious. Reckitt 

Benckiser Pharm. Inc. v. Dr. Reddy’s Labs. S.A., Nos. 14-

1451-RGA, 14-1573-RGA, 14-1574-RGA, 2017 WL 3837312 

(D. Del. Aug. 31, 2017) (“DRL ’514 Decision”); Reckitt 

Benckiser Pharm. Inc. v. Dr. Reddy’s Labs. S.A., No. 14-

1451-RGA, 2017 WL 3782782 (D. Del. Aug. 31, 2017) (“DRL 

’150 Decision”). Watson and Teva appeal from the court’s 

judgment in a third decision that the ’514 patent is not invalid as indefinite. Reckitt Benckiser Pharm. Inc. v. Watson Labs., Inc., Nos. 13-1674-RGA, 14-422-RGA, 2016 WL 

3186659 (D. Del. June 3, 2016) (“Watson Decision”); J.A. 

212–14.1 Watson also appeals from the court’s finding in 

that decision that Watson infringes the ’514 patent, as well 

as the court’s subsequent order denying it relief from the 

infringement judgment under Rule 59. Reckitt Benckiser 

Pharm. Inc. v. Watson Labs., Inc., Nos. 13-1674-RGA, 14-

422-RGA, 2017 WL 3820943 (D. Del. Aug. 31, 2017) (“Rule 

59 Decision”). 

Indivior Inc., Indivior UK Limited, and Aquestive 

Therapeutics, Inc. (collectively, “Indivior”) cross-appeal 

from the district court’s findings in the two DRL decisions 

that DRL does not infringe either the ’514 or the ’150 patent. Indivior also appeals from a fourth decision by the 

same court finding that Alvogen Pine Brook, LLC (“Alvogen”) does not infringe the ’514 patent. Indivior Inc. v. 

Mylan Techs. Inc., 298 F. Supp. 3d 775 (D. Del. 2018) (“Alvogen Decision”). Finally, Indivior requests that the court’s 

judgment in the Watson case of invalidity of claims 15–19 

of U.S. Patent 8,475,832 (the “’832 patent”) be vacated as 

moot. 

 

1 Unless otherwise noted, all J.A. citations are to the 

joint appendix filed in the DRL appeal. 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 5

We vacate as moot the district court’s decision holding 

claims 15–19 of the ’832 patent invalid as obvious. We affirm the court on all other issues.

I. BACKGROUND

Indivior markets and holds the New Drug Application 

(“NDA”) for Suboxone® sublingual film (“Suboxone Film”), 

an opioid addiction treatment that combines two active ingredients: the opioid buprenorphine and the opioid antagonist naloxone. Suboxone Film is applied below a patient’s 

tongue, where it then rapidly dissolves to release the active 

ingredients. In 2010, the Food and Drug Administration 

(“FDA”) approved Indivior’s film product, the first such 

product to gain FDA approval. Previously, Indivior sold 

buprenorphine/naloxone only in a tablet form. 

These appeals involve issues of infringement and invalidity of four patents covering pharmaceutical films and 

methods of making them. However, the parties’ substantive disputes focus on only two patents, the ’514 and ’150 

patents. Both patents claim pharmaceutical films and are 

listed in the Orange Book2 as covering Suboxone Film. 

Representative claims of the two patents are set forth in 

the Appendix. The ’497 patent is directed to film manufacturing methods, and the parties do not distinguish it from 

the ’514 patent with respect to the issues on appeal. 

Aquestive Therapeutics, Inc. (“Aquestive”) owns these 

three patents and exclusively licenses them to Indivior.3 

 

2 This publication is formally entitled “Approved 

Drug Products with Therapeutic Equivalence Evaluations.”

3 Indivior was formerly known as Reckitt Benckiser 

Pharmaceuticals Inc. Aquestive was formerly known as 

MonoSol Rx, LLC. For simplicity, we refer to the former 

entities by their present names. 
6 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

The fourth patent, the ’832 patent, claims film formulations and is owned by Indivior. 

A. The Patents in Suit

1. The ’514 and ’497 Patents

The ’514 patent claims pharmaceutical films with a 

uniform distribution of active ingredient. As described in 

the specification, drug content uniformity is required by 

regulatory authorities yet difficult to achieve in practice because of problems in manufacturing the films. ’514 patent 

col. 2 ll. 18–21, 42–46, 57–59. Generally, a film may be 

made by mixing an active compound with a solvent to form 

a flowable matrix, casting the mixture onto a planar surface, and then drying the film to produce a solid sheet. Id. 

col. 5 ll. 41–54, col. 6 ll. 49–60. 

Multiple factors in the film-making process can affect 

uniformity. “By avoiding the introduction of and eliminating excessive air in the mixing process, selecting polymers

and solvents to provide a controllable viscosity and by drying the film in a rapid manner from the bottom up, such 

[uniform] films result.” Id. col. 23 ll. 16–20. Claim 62, the 

sole independent claim at issue from the ’514 patent, is representative and recites “a cast film comprising a flowable 

water-soluble or water swellable film-forming matrix,” 

“wherein the uniformity subsequent to casting and drying

of the matrix is measured by . . . unit doses which do not 

vary by more than 10%” of the amount of active. Id. col. 73 

ll. 49–50, col. 74 ll. 6–9 (emphases added). The claim identifies two parameters—viscosity and drying—that contribute to film uniformity: (1) the viscosity of the matrix must 

be “sufficient to aid in substantially maintaining non-selfaggregating uniformity” of the active (the “viscosity limitation”); and (2) the matrix must be “capable of being dried 

without loss of substantial uniformity of the active” (the 

“drying limitation”). Id. col. 73 l. 53–col. 74 l. 5. The other 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 7

asserted claims of the ’514 patent all depend from claim 

62.4 

The drying limitation is central to several of the issues 

on appeal. The specification teaches that using conventional drying methods, which apply hot air to the top of the 

film, produces nonuniform films. E.g., id. col. 8 ll. 56–64, 

col. 22 ll. 41–60. As hot air strikes the surface of the film, 

water at the surface evaporates, forming a polymer skin 

that seals the aqueous composition below. Id. col. 3 ll. 37–

42. But as heating continues, the vapor pressure of the underlying aqueous composition builds, causing the film surface to stretch and ultimately break to allow the vapor to 

escape. Id. col. 3 ll. 45–49. The polymer skin then reforms, 

and the cycle of surface destruction and reformation continues until drying is complete. Id. col. 3 ll. 49–52. Undesirably, this cycle produces a dried film that is uneven and 

nonuniform, which the patent refers to as the “ripple effect.” Id. col. 3 ll. 51–54. 

To produce a uniform film, the specification discloses 

controlled drying processes that differ from conventional 

techniques. In a section titled “Drying Wet Cast Films,” id. 

col. 28 l. 51, the specification states that “[t]he wet film may 

be dried using controlled bottom drying or controlled microwave drying, desirably in the absence of external air currents or heat on the top (exposed) surface of the film,” id. 

col. 28 ll. 52–55 (emphasis added). Such methods allow for 

vapor release without the disadvantages described above. 

Id. col. 28 ll. 55–57. In contrast, “[c]onventional convection 

air drying from the top is not employed” because it produces 

 

4 Indivior asserted claims 62–65, 69, 71, and 73 

against DRL, DRL ’514 Decision, 2017 WL 3837312, at *2; 

claims 62, 64, 65, 69, and 73 against Watson, Watson Decision, 2016 WL 3186659, at *2; and claims 62, 63, 65, 69, 71, 

and 73 against Alvogen, Alvogen Decision, 298 F. Supp. 3d 

at 776. 
8 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

the ripple effect. Id. col. 28 ll. 57–64 (emphasis added). If 

some top air is used, “it is balanced with the bottom air 

drying to avoid non-uniformity.” Id. col. 29 ll. 1–3. 

In addition to controlling the location of the source of 

air, the specification teaches a “zone drying procedure” in 

which the film is dried along a belt with different drying 

zones that may vary in temperature, humidity, or other atmospheric conditions. Id. col. 32 ll. 38–67. The specification does not specify whether the air comes from the top or 

bottom during zone drying but does indicate that zone drying “dries the film without surface skinning.” Id. col. 32 ll. 

49–50. Zone drying may be supplemented with additional 

processes such as lamination “so long as controlled drying 

is maintained in accordance with the invention.” Id. col. 33 

ll. 1–4.

Claim 62 also recites that the flowable matrix has a 

viscosity “sufficient to aid” in maintaining film uniformity. 

Id. col. 73 ll. 53–55. The specification provides suitable 

ranges of matrix viscosity, which are “generally” 400–

100,000 centipoise, “preferably” 800–60,000 centipoise, and 

“most preferably” 1,000–40,000 centipoise. Id. col. 11 ll. 

26–29. The choice of polymer has an important role in affecting viscosity and hence film uniformity. See id. col. 11 

ll. 15–24. 

Similar to the ’514 patent, the ’497 patent claims processes for making pharmaceutical films. Claim 24, the sole

asserted claim, depends from claim 1, which recites a drying limitation similar to claim 62 of the ’514 patent: a “drying” step to form a film “having a substantially uniform 

distribution” of an active compound. ’497 patent col. 57 ll. 

8–10. The specification of the ’497 patent is also substantively similar to that of the ’514 patent. 

2. ’150 Patent

Like the ’514 patent, the ’150 patent is directed to uniform pharmaceutical films, but it claims them somewhat 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 9

differently. Rather than identifying process parameters 

relevant to film uniformity, as in the ’514 patent, the asserted claims of the ’150 patent claim pharmaceutical films 

by their components. Claim 1 is representative of the asserted claims and recites a film comprising an active ingredient and a water-soluble polymer component containing 

certain proportions of polyethylene oxide (“PEO”), including both low molecular weight PEO (“L-PEO”) and high 

molecular weight PEO (“H-PEO”), and a hydrophilic cellulosic polymer. ’150 patent col. 57 ll. 35–54. The specification lists various “useful water[-]soluble polymers,” 

including PEO, hydrophilic cellulosic polymers, and a separate compound, polyvinyl pyrrolidone. Id. col. 15 ll. 47–

52. The other asserted claims—4, 5, 8, and 9—each depend 

from claim 1. DRL ’150 Decision, 2017 WL 3782782, at *1.

The ’150 patent claims priority from an earlier provisional application, U.S. Patent Application 60/473,902 (the 

“’902 application”). 

B. The Decisions on Appeal

Several generic drug companies filed Abbreviated New 

Drug Applications (“ANDAs”) to market generic versions of 

Suboxone Film prior to the expiration of the patents in suit. 

Indivior then brought several actions for patent infringement, accusing DRL of infringing the ’514 and ’150 patents, 

and both DRL and Watson of infringing the ’497 patent; 

Watson of infringing the ’514 and ’832 patents; and Alvogen of infringing the ’514 and ’497 patents.5

 

5 DRL’s ANDA was originally owned by Teva, which 

transferred its interest to DRL but maintained an interest 

in a related product. Teva agreed to be bound by the court’s 

decision in the DRL ’514 patent case for the related product. J.A. 30001–06; see J.A. 210–14 (district court’s final 

judgments). 
10 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

The district court held four bench trials and decided 

multiple issues of infringement and validity concerning the 

asserted patents. We discuss only the issues pertinent to 

these appeals. 

1. Watson ’514 Decision

The first trial over the ’514 patent involved Indivior’s

claim that Watson infringed the ’514 patent. Watson did 

not request construction of the drying limitation. The court 

found that Watson infringed the ’514 patent and that Watson did not meet its burden to prove the asserted claims 

invalid as indefinite. Watson Decision, 2016 WL 3186659, 

at *16, *21.

Indivior also asserted the ’832 patent against Watson. 

The district court concluded that claims 15–19 of the ’832 

patent are invalid as obvious. Id. at *11. In a parallel inter 

partes review proceeding, the Patent Trial and Appeal 

Board held claims 15–19 unpatentable as anticipated and 

obvious. BioDelivery Scis. Int’l, Inc. v. RB Pharm. Ltd., No. 

IPR2014-00325, 2015 WL 4045328, at *16 (P.T.A.B. June 

30, 2015), aff’d, 667 F. App’x 997 (Fed. Cir. 2016). 

After trial, Watson modified its film manufacturing 

process and requested relief under Rule 59 from the district 

court’s infringement judgment. The court denied relief, 

finding no manifest injustice in upholding its final judgment. Rule 59 Decision, 2017 WL 3820943, at *3. 

2. DRL ’514 Decision and the Related Appeal

In a second trial over the ’514 patent, the district court 

considered Indivior’s claims that DRL infringed the ’514 

patent and that DRL and Watson infringed the ’497 patent. 

Unlike in the previous case, the parties (including Watson) 

disputed the meaning of the drying limitation. The court 

construed the drying limitation of the ’514 patent to mean 

“dried without solely employing conventional convection 

air drying from the top,” because it concluded that the specification disclaimed such conventional top drying 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 11

techniques. DRL ’514 Decision, 2017 WL 3837312, at *4; 

see Reckitt Benckiser Pharm. Inc. v. Teva Pharm. USA, 

Inc., Nos. 14-1451-RGA, 14-1573-RGA, 14-1574-RGA, 2016 

WL 3621632, at *10–11 (D. Del. June 29, 2016) (“Claim 

Construction Order”). The court found that DRL’s drying 

process uses dryers where the sole source of heat comes 

from the top and thus does not infringe the asserted claims 

of the ’514 patent. DRL ’514 Decision, 2017 WL 3837312, 

at *5–6. For similar reasons, the court found that neither 

DRL nor Watson infringed the asserted claim of the ’497 

patent. DRL ’514 Decision, 2017 WL 3837312, at *5–6, *9.

The court also held that DRL failed to prove by clear 

and convincing evidence that the asserted claims of either 

the ’514 or the ’497 patent would have been obvious over 

the cited prior art. Id. at *20.

After the district court’s judgment of noninfringement, 

Indivior amended claims of a pending continuation application that ultimately issued as U.S. Patent 9,931,305 (the 

“’305 patent”). The amendment removed the words “dried” 

and “drying” from the language of claim 62, instead reciting that the film be “capable of being continuously cast . . . 

without loss of substantial uniformity” and that “uniformity of the-continuously cast film is measured by 

. . . unit doses cut from the continuously cast film which do 

not vary by more than 10%” of the amount of the active. 

’305 patent col. 73 ll. 21–29 (emphases added). The ’305 

patent shares a specification with, and is terminally disclaimed to, the ’514 patent.

Soon after the ’305 patent issued, Indivior again sued 

DRL for patent infringement, this time asserting the ’305 

patent in the District of New Jersey. DRL had since 

launched its competing generic product, and Indivior 

moved for a temporary restraining order and preliminary 

injunction at the New Jersey court. DRL argued that Indivior’s New Jersey action was barred as claim precluded 

by the Delaware court’s judgment. The New Jersey court 
12 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

concluded that claim preclusion likely would not apply and 

that Indivior would likely be able to prove infringement. 

Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 17-CV-7111, 

2018 WL 3496643, at *8, *11 (D.N.J. July 20, 2018). Consequently, the court entered a temporary restraining order 

and then a preliminary injunction against DRL’s generic 

product. Id. at *14.

DRL appealed to this court. Despite the claim amendments, the panel majority held that the cast films claimed 

in the ’305 patent still had to be dried and were subject to 

the same specification disclaimer as the ’514 patent. Indivior Inc. v. Dr. Reddy’s Labs., S.A., 752 F. App’x 1024, 

1031–32 (Fed. Cir. 2018) (“Indivior”). Under the proper 

construction, we concluded that the asserted claims of the 

’305 patent were materially identical to those of the ’514 

patent already adjudicated. Id. at 1034–35. Accordingly, 

we held that Indivior’s New Jersey action was likely claim 

precluded, vacated the court’s preliminary injunction, and 

remanded for further proceedings. Id. at 1035. 

3. Alvogen ’514 Decision

In the third trial over the ’514 patent, the district court 

considered Indivior’s claim that Alvogen infringed the ’514 

patent. The court construed the drying limitation as it did

in the DRL ’514 Decision. Alvogen Decision, 298 F. Supp. 

3d at 779. And as in the DRL case, the court found that 

Alvogen’s film manufacturing process dries the films primarily from the top and thus does not meet the drying limitation and does not infringe the asserted claims. Id. at 

784–85. 

4. DRL ’150 Decision

In addition to the ’514 patent, Indivior asserted that 

DRL infringed the ’150 patent under the doctrine of equivalents. The district court held a separate trial on the ’150 

patent and found that DRL does not infringe any of the asserted claims. DRL ’150 Decision, 2017 WL 3782782, at 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 13

*4–5. The court also held that DRL did not prove that the 

asserted claims of the ’150 patent would have been obvious. 

Id. at *7–8.

C. The Appeals

DRL appeals from the district court’s judgments that 

the asserted claims of the ’514, ’497, and ’150 patents are 

not invalid as obvious. Watson and Teva appeal from the 

court’s judgments that the ’514 patent is not invalid as indefinite, that Watson infringes the ’514 patent, and that 

Watson is not entitled to Rule 59 relief from the infringement judgment. 

Indivior cross-appeals from the district court’s determinations that DRL does not infringe either the ’514 or the

’150 patent and that Alvogen does not infringe the ’514 patent. Indivior also requests vacatur of the court’s judgment 

that certain claims of the ’832 patent would have been obvious over the cited prior art.

We have jurisdiction over each appeal under 28 U.S.C. 

§ 1295(a)(1). We first address the parties’ disputes concerning the ’514 patent and then turn to the ’150 and ’832 

patents.

II. DISCUSSION 

On appeal from a bench trial, we review a district 

court’s conclusions of law de novo and its findings of fact 

for clear error. Braintree Labs., Inc. v. Novel Labs., Inc., 

749 F.3d 1349, 1358 (Fed. Cir. 2014). A factual finding is 

clearly erroneous if, despite some supporting evidence, we 

are left with the definite and firm conviction that a mistake 

has been made. United States v. U.S. Gypsum Co., 333 U.S. 

364, 395 (1948). “The burden of overcoming the district 

court’s factual findings is, as it should be, a heavy one.” Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1559 

(Fed. Cir. 1986).
14 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

A. Infringement of the ’514 Patent

Indivior challenges the district court’s judgments that 

DRL and Alvogen do not infringe the ’514 patent. Watson 

appeals from the court’s separate judgment that it does infringe the ’514 patent. We first consider Indivior’s crossappeal and appeal and then turn to Watson’s appeal. 

An infringement analysis has two steps. Clare v. 

Chrysler Grp. LLC, 819 F.3d 1323, 1326 (Fed. Cir. 2016). 

First, the court construes the asserted claims. Claim construction is a question of law that may involve underlying 

factual questions. Teva Pharm. USA, Inc. v. Sandoz, Inc., 

135 S. Ct. 831, 841 (2015). But when, as here, the court’s 

construction of the relevant limitation is based solely on 

the intrinsic evidence, we review its construction de novo. 

HTC Corp. v. Cellular Commc’ns Equip., LLC, 877 F.3d 

1361, 1367 (Fed. Cir. 2017). Second, the court determines 

whether the accused product meets each limitation of the 

claim as construed, which is a question of fact that we review for clear error. Wright Med. Tech., Inc. v. Osteonics 

Corp., 122 F.3d 1440, 1443 (Fed. Cir. 1997). 

1. Indivior’s Appeal and Cross-Appeal

Indivior’s challenges to the district court’s judgments 

of noninfringement largely turn on the proper construction 

of the drying limitation. In the DRL and Alvogen cases, 

the district court construed the drying limitation to mean 

“dried without solely employing conventional convection 

air drying from the top.” Alvogen Decision, 298 F. Supp. 3d 

at 779; DRL ’514 Decision, 2017 WL 3837312, at *4; Claim 

Construction Order, 2016 WL 3621632, at *11. That construction rested on the court’s conclusion that the patentee 

disclaimed drying wet cast films using solely conventional 

convection air drying from the top. The court’s disclaimer 

conclusion was based on the ’514 patent specification’s express statements of what the invention is, its repeated disparagement of conventional top drying methods, and the 

patent applicant’s characterization of the invention during 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 15

prosecution. Claim Construction Order, 2016 WL 3621632, 

at *6, *11. 

In Indivior, we likewise concluded that the same specification in the related ’305 patent disclaimed conventional 

top air drying. 752 F. App’x at 1031–32. In addressing 

whether Indivior’s assertion of the ’305 patent raised the 

same cause of action as the ’514 patent, we concluded:

[T]he specification limits the scope of the “continuously cast” limitation in the ’305 claims as it limited the scope of the “drying” limitation in the ’514 

claims. Specifically, films formed with conventional top air drying methods are excluded from the 

scope of both claim terms.

Id. at 1034–35 (emphasis added). We explained that 

“[w]hile the language of the claim terms changed, the scope 

of the claims did not materially change.” Id. at 1035 (emphasis added). Even where different patents are asserted 

between two suits, claim preclusion bars a patentee from 

bringing successive suits accusing the defendant’s same 

product of infringing essentially the same patent claims. 

SimpleAir, Inc. v. Google LLC, 884 F.3d 1160, 1167 (Fed. 

Cir. 2018); see Acumed LLC v. Stryker Corp., 525 F.3d 

1319, 1324 (Fed. Cir. 2008). Because—and only because—

the asserted claims of the ’305 patent were materially the 

same as those that were or could have been asserted in the 

’514 patent, we held that Indivior’s action on the ’305 patent was likely claim precluded and that the district court 

abused its discretion in entering a preliminary injunction. 

Indivior, 752 F. App’x at 1035.

In both the DRL and Alvogen appeals, Indivior argues 

that the district court erred in concluding that the ’514 patent specification disclaimed drying methods that use 

solely conventional convection air drying from the top. Instead, Indivior contends that the drying limitation should 

be given its plain and ordinary meaning. To the extent that 

the specification did disclaim certain top drying methods, 
16 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

Indivior alternatively argues that the disclaimer cannot 

encompass zone drying. 

Both DRL and Alvogen respond that the district court 

properly construed the drying limitation, as this court confirmed in Indivior. 

We agree with DRL and Alvogen that the district court 

correctly construed the drying limitation and that the ’514 

patent specification disclaims conventional top air drying. 

The specification “is the single best guide to the meaning 

of a disputed term,” Phillips v. AWH Corp., 415 F.3d 1303, 

1315 (Fed. Cir. 2005) (en banc) (internal quotation marks 

omitted), and where it “makes clear that the invention does 

not include a particular feature, that feature is deemed to 

be outside the reach of the claims of the patent,” SciMed 

Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 

F.3d 1337, 1341 (Fed. Cir. 2001); see Chi. Bd. Options 

Exch., Inc. v. Int’l Sec. Exch., LLC, 677 F.3d 1361, 1372 

(Fed. Cir. 2012). The asserted claims recite a film that is 

“capable of being dried without loss of substantial uniformity,” but, as we already concluded in Indivior, and as 

we again explain below, the specification repeatedly makes 

clear that conventional top air drying does not yield uniform films. ’514 patent col. 74 ll. 3–5. Such drying is thus 

outside the reach of the claims.

A specification may disclaim an embodiment by repeatedly disparaging it. See Openwave Sys., Inc. v. Apple Inc., 

808 F.3d 509, 513–14 (Fed. Cir. 2015); Chi. Bd., 677 F.3d 

at 1372. Here, the specification repeatedly disparages conventional top air drying because such drying does not produce uniform films, the central object of the claimed 

invention. For example, the specification teaches that “the 

conventional drying methods themselves are unable to provide uniform films.” ’514 patent col. 3 ll. 14–16. In the 

section focused on “Drying Wet Cast Films,” the specification likewise discloses that “[c]onventional convection air 

drying from the top is not employed.” Id. col. 28 ll. 51, 57–
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 17

58. And the patent explains why: conventional top air drying

initiates drying at the top uppermost portion of the 

film, thereby forming a barrier against fluid flow, 

such as the evaporative vapors, and thermal flow, 

such as the thermal energy for drying. Such dried 

upper portions serve as a barrier to further vapor 

release as the portions beneath are dried, which results in non-uniform films.

Id. col. 28 ll. 57–64. 

This undesirable phenomenon is described elsewhere 

as the ripple effect. Id. col. 3 ll. 33–54. The ripple effect is 

“avoided by the present invention” “by applying heat to the 

bottom surface of the film with substantially no top air 

flow” or by using controlled microwaves, “again with substantially no top air flow.” Id. col. 22 ll. 48–57, col. 28 ll. 

52–55 (“The wet film may be dried using controlled bottom 

drying or controlled microwave drying, desirably in the absence of external air currents or heat on the top (exposed) 

surface of the film . . . .”). “If top air is employed, it is balanced with the bottom air drying to avoid non-uniformity 

. . . .” Id. col. 29 ll. 1–3. 

The specification also provides examples that demonstrate the failure of conventional drying methods to achieve 

uniformity. Examples CH and CG examined whether undesirable particle aggregations occurred during conventional drying techniques as compared to “the uniform 

drying process of the present invention.” Id. col. 52 ll. 27–

28. In example CH, films were placed in an oven “on trays 

lined with furnace filters, which uniformly distribute heat.” 

Id. col. 52 ll. 57–59. The resulting dried films were homogenous with no particle aggregations. Id. col. 52 ll. 60–62. 

In contrast, when films were dried in an oven “by conventional top and bottom drying means,” particle aggregations 

occurred. Id. col. 53 ll. 1–3, 8–10. Similarly, example CG 

reports that when films were “dried according to 
18 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

conventional drying techniques, rather than via the uniform drying process of the present invention,” the resulting 

films had particle aggregations. Id. col. 52 ll. 26–28, 39–

40. And again, when films were instead dried “by the process of the present invention,” on trays lined with furnace 

filters, the resulting films were homogenous and lacked 

particle aggregations. Id. col. 52 ll. 43–50. Nowhere does 

the specification describe making a uniform film with only 

conventional convection air drying from the top. 

Indivior emphasizes that the specification describes 

other factors that affect film uniformity. Indivior Reply Br. 

5–7. We agree that both the asserted claims and the specification identify other factors, such as viscosity, that may 

contribute to uniformity. E.g., ’514 patent col. 73 ll. 53–55, 

col. 74 ll. 3–5 (claim 62 containing both viscosity and drying 

limitations); id. col. 23 ll. 14–20 (specification indicating 

likewise). But the unequivocal disparagement of conventional top air drying detailed above demonstrates that 

other factors may not substitute for controlled drying of a 

wet cast film to achieve uniformity. As Indivior’s expert 

explained, uniformity can be lost at any step of the manufacturing process, and once lost cannot be recovered. J.A. 

17209. 

Indivior nonetheless argues, first in its reply brief, that 

“polymer selection and the resulting viscosity may be used 

as an alternative to controlled drying.” Indivior Reply Br. 

7. This argument is inconsistent with Indivior’s own 

acknowledgement that uniformity can be lost throughout 

the manufacturing process, and that neither the drying nor 

the viscosity limitation of the asserted claims renders the 

other superfluous. Indivior Cross-Appellant Br. 47. Likewise, the specification indicates that no individual factor 

can guarantee uniformity of a wet cast film after drying. 

’514 patent col. 3 ll. 3–9 (“The long length of drying time 

aids in promoting the aggregation of the active and other 

adjuvant, notwithstanding the use of viscosity modifiers.” 

(emphasis added)), col. 23 ll. 14–20 (“The present invention 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 19

yields exceptionally uniform film products . . . . By avoiding . . . excessive air in the mixing process, selecting polymers and solvents to provide a controllable viscosity and

by drying the film in a rapid manner from the bottom up, 

such films result.” (emphasis added)). The lone statement 

purportedly to the contrary cited by Indivior, id. col. 4 ll. 

61–64 (“Alternatively, or in addition to controlling the drying the film, the polymer may be selected in order to provide a viscosity that maintains the non-self-aggregating 

uniform heterogeneity.”), does not change our conclusion in 

light of the specification’s unambiguous disparagement of 

conventional top air drying and its teachings as a whole. 

Even if the specification did disclaim certain drying 

methods, Indivior contends that the disclaimer cannot extend to zone drying. Indivior Cross-Appellant Br. 43. Zone 

drying, according to Indivior, is a preferred embodiment 

that can achieve uniform films and cannot be excluded 

from the claims.

Indivior plainly waived this limited disclaimer argument by not raising it in the DRL case until post-trial briefing. See, e.g., Power Integrations, Inc. v. Fairchild 

Semiconductor Int’l, Inc., 904 F.3d 965, 974 (Fed. Cir. 

2018). However, it did raise a claim construction argument 

resembling the one on appeal in a footnote in the Alvogen 

case, Alvogen J.A. 91990 n.20, which the district court rejected, Alvogen Decision, 298 F. Supp. 3d at 783. 

Even if we assume waiver does not apply, the specification’s discussion of zone drying does not qualify its disclaimer of conventional top air drying. Zone drying just 

refers to using a drying tunnel with multiple “drying zones” 

along the belt that may differ in various atmospheric conditions. ’514 patent col. 32 ll. 38–45; id. figs. 35–36. Consistent with the rest of the specification, the patent 

nowhere suggests that zone drying achieves uniform films 

by using solely conventional top air drying. Rather, the patent explains that zone drying may be supplemented with 
20 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

additional processes only “so long as controlled drying is 

maintained in accordance with the invention.” Id. col. 33 

ll. 1–4. And contrary to Indivior’s argument, the district 

court’s construction does not exclude any zone drying embodiments; it just excludes zone drying that uses solely conventional convection air drying from the top, which is never 

disclosed in the patent. We thus conclude that the disclosure of zone drying does not qualify the specification’s repeated disparagement of solely top air drying. 

Consistent with our previous Indivior decision, we ultimately agree with the district court that the ’514 patent 

specification unmistakably disclaimed conventional top air 

drying as unable to produce the claimed uniform films.6 

Accordingly, we affirm the court’s construction of the drying limitation and proceed to the second step of the infringement analysis, considering DRL’s and Alvogen’s 

distinct ANDA processes separately.

The district court found that DRL’s ANDA product does 

not infringe the asserted claims of the ’514 patent. DRL 

’514 Decision, 2017 WL 3837312, at *5–6. Although the 

court found that the drying process is controlled in certain 

ways to assure film uniformity, it determined that the sole 

source of heat in its drying process is hot air coming from 

above the film and that any bottom drying that occurred 

was incidental. Id. at *5. Consequently, the court found 

that DRL does not infringe the drying limitation and thus 

does not infringe any of the asserted claims. Id. at *6. 

Indivior argues that the district court clearly erred in 

finding that DRL’s ANDA product does not infringe the asserted claims of the ’514 patent. Even under the court’s 

 

6 Because we conclude that the specification disclaims conventional top air drying, we need not decide 

whether the prosecution history further supports that disclaimer. 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 21

construction, Indivior contends that DRL’s drying process 

is tightly controlled to maintain uniformity and uses balanced top air and bottom air drying. 

DRL responds that the district court did not clearly err 

in finding noninfringement because DRL’s drying process 

uses solely conventional top air drying. 

We agree with DRL that the district court did not 

clearly err in finding that DRL’s drying process does not 

meet the drying limitation and thus does not infringe the 

asserted claims of the ’514 patent. Indivior does not seriously dispute the essential predicates of the court’s noninfringement finding: that the sole source of heat in DRL’s 

drying process is hot air from above the film, and that any 

bottom drying is merely incidental. See id. at *5 (“DRL’s 

use of ‘bottom drying’ is essentially that the inside of the 

oven simply gets hot . . . .”). Indivior thus has not shown 

clear error in the court’s holding that DRL employs conventional top air drying, which is insufficient to meet the drying limitation as properly construed. Accordingly, we 

affirm the court’s finding that DRL does not infringe the 

asserted claims of the ’514 patent. 

We next address Indivior’s appeal concerning Alvogen’s 

ANDA product. The district court found that Alvogen’s 

ANDA product does not infringe the ’514 patent because it 

does not meet the drying limitation. Alvogen Decision, 298 

F. Supp. 3d at 785. The court credited Alvogen’s expert’s 

testimony that nozzles above the film supply all the hot air 

to dry the films, id. at 780–81, and found that any bottom 

drying in Alvogen’s process is insubstantial, id. at 784. 

Indivior argues that the district court clearly erred in 

its noninfringement finding because even some insubstantial bottom drying brings Alvogen’s process within the 

reach of the asserted claims. We disagree. Indivior’s argument is largely repetitive of its claim construction arguments, which we have rejected. The district court found 

that even solely conventional top air drying can result in 
22 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

some incidental drying from the bottom, but that such insubstantial bottom drying does not infringe the asserted 

claims as construed in light of the specification’s disclaimer 

of conventional top air drying. Id. (“Plaintiffs have not 

demonstrated ‘substantial’ bottom drying such that Alvogen’s dryer can be said to employ anything but ‘conventional convection air drying from the top.’”); accord DRL 

’514 Decision, 2017 WL 3837312, at *5 (finding that incidental bottom drying did not infringe asserted claims). We 

conclude that this finding is not clearly erroneous or premised on an improper claim construction, and therefore affirm the district court’s judgment that Alvogen does not 

infringe the asserted claims of the ’514 patent. 

2. Watson’s Appeal

We now consider Watson’s infringement appeal. Watson makes two arguments in its appeal from the district 

court’s judgment that Watson’s ANDA product infringes 

the asserted claims of the ’514 patent. Watson Decision, 

2016 WL 3186659, at *21. First, Watson argues that the 

court erred in not granting Watson Rule 59 relief after the 

amendment of its ANDA. Second, Watson argues that the 

court erred in finding that its ANDA product meets the viscosity limitation of the asserted claims. We address each 

argument in turn. 

Unlike DRL and Alvogen, Watson never requested construction of the drying limitation when it litigated the ’514 

patent against Indivior, although it joined DRL in arguing 

for the narrower construction of the similar limitation in 

the ’497 patent. After the district court entered judgment 

of infringement, Watson amended its ANDA process to remove bottom heating sources. It then moved under Rule 

59 to reopen the court’s judgment.

The district court denied Rule 59 relief. Rule 59 Decision, 2017 WL 3820943, at *3. The court found no manifest 

injustice in holding Watson to its decision not to request 

construction of the drying limitation. Id. at *2. According 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 23

to the court, Watson knew of and in fact proposed the narrower construction of that limitation alongside DRL in its 

case concerning the ’497 patent, yet never requested such 

a construction in Watson’s own ’514 patent case. Id. The 

court observed that the broader construction of the drying 

limitation potentially gave Watson a stronger invalidity 

position at the expense of noninfringement. Id. Additionally, the court decided that Watson was a sophisticated litigant that “should be bound by the litigation decisions [it]

make[s].” Id. 

On appeal, Watson argues that the district court 

abused its discretion in not reopening the judgment under 

Rule 59. Indivior responds that the court acted well within 

its discretion in denying Watson such relief.

We agree with Indivior that the district court did not 

abuse its discretion. While Rule 59 gives a court authority 

to alter or amend a judgment, that authority is exercised 

only in limited circumstances, such as to prevent a manifest injustice. See United States ex rel. Schumann v. AstraZeneca Pharm. L.P., 769 F.3d 837, 848–49 (3d Cir. 2014). 

Watson argues that it is manifestly unjust that different 

generic products will be treated differently depending on 

how their cases were litigated. But it is neither unusual 

nor unjust for a party to be bound by its litigation decisions, 

particularly here where Watson was fully aware of but did 

not request the claim construction it now seeks. The district court found that, while there is an interest in consistency across judgments, there is also a public interest in 

finality and judicial efficiency, Rule 59 Decision, 2017 WL 

3820943, at *2, and we discern no abuse of discretion in the 

court’s balancing of those factors in this particular case. 

Furthermore, Watson acknowledges that it can still seek a 

judgment of noninfringement based on the amended ANDA 

process even if it fails to secure Rule 59 relief. Under these 

circumstances, we conclude that the court acted within its 

discretion in declining to reopen its judgment based on a 
24 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

claim construction argument that Watson knew of yet 

failed to raise. 

Watson separately argues that the district court clearly 

erred in finding that Watson’s ANDA product meets the 

viscosity limitation of the ’514 patent claims. The court 

found that the viscosity range of Watson’s product was 

within the preferred range disclosed in the ’514 patent and 

thus was “sufficient to aid” in preventing aggregation of the 

active, as required by the viscosity limitation. Watson Decision, 2016 WL 3186659, at *20. 

Watson argues that Indivior failed to show that viscosity contributes to the uniformity of Watson’s films and that 

the district court improperly placed the burden on Watson 

to prove noninfringement. Further, Watson emphasizes 

the breadth of the preferred viscosity range and that no 

particular viscosity value can guarantee uniformity. 

Indivior responds that the district court did not clearly 

err in finding that Watson’s ANDA product meets the viscosity limitation because the ANDA requires a viscosity 

squarely within the most preferred range identified in the 

’514 patent. 

We agree with Indivior and conclude that the district 

court did not clearly err in finding infringement. The viscosity limitation requires that the viscosity of the matrix 

be “sufficient to aid” in maintaining uniformity. ’514 patent col. 73 ll. 53–55. As both parties agree, viscosity is one 

factor among several identified in the ’514 patent that contributes to uniformity. E.g., id. col. 23 ll. 14–20. Specifically, the patent explains that “[v]iscosity is one property 

of a liquid that controls the stability of the active” and that 

the viscosity of the matrix will “generally” be 400–100,000 

centipoise, “preferably” be 800–60,000 centipoise, and 

“most preferably” be 1,000–40,000 centipoise. Id. col. 11 ll. 

24–29. Watson’s ANDA specifies a viscosity of 5,800–

17,500 centipoise, J.A. 80020, 12578, which is, as the court 

correctly found, plainly encompassed by the most preferred 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 25

range disclosed in the ’514 patent. Further, the court did 

not clearly err in finding that a film may satisfy the viscosity limitation even if other factors than viscosity contribute 

to film uniformity. Watson Decision, 2016 WL 3186659, at 

*20. As previously discussed, the asserted claims themselves identify drying as an additional factor affecting uniformity. Since Watson demonstrates no clear error in the 

court’s infringement judgment, we affirm its finding that 

Watson’s ANDA product infringes the ’514 patent. 

B. Validity of the ’514 Patent

Watson, Teva, and DRL raise two challenges to the validity of the ’514 patent. Watson and Teva appeal from the 

court’s judgment that the asserted claims of the ’514 patent 

are not invalid as indefinite. DRL appeals from the court’s 

judgment that the claims have not been shown to be invalid 

as obvious. We consider the challenges separately. 

1. Indefiniteness

A patent must “conclude with one or more claims particularly pointing out and distinctly claiming the subject 

matter which the applicant regards as his invention.” 35 

U.S.C. § 112, ¶ 2 (2006).7 Because of the statute’s demand 

for particularity in claiming, “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to 

inform, with reasonable certainty, those skilled in the art 

about the scope of the invention.” Nautilus, Inc. v. Biosig 

Instruments, Inc., 572 U.S. 898, 901 (2014). 

We review a district court’s indefiniteness judgment as 

we do its claim construction, Sonix Tech. Co. v. Publ’ns 

 

7 Because the application of the ’514 patent was filed 

before March 16, 2013, the pre-Leahy-Smith America Invents Act version of § 112 applies. See Pub. L. No. 112-29, 

125 Stat. 284 (2011). 
26 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

Int’l, Ltd., 844 F.3d 1370, 1376 (Fed. Cir. 2017), which in 

this case is de novo. 

At the district court, the parties’ indefiniteness dispute focused on claim 62’s recitation of a “cast film comprising a flowable water-soluble or water swellable filmforming matrix.” ’514 patent col. 73 ll. 49–50. Watson alleged that this limitation is indefinite because a cast film 

in its final dosage form is not flowable, and the claim thus 

required a physical impossibility. While the court agreed 

that the final cast film could not be flowable, it reasoned 

that a product claim may recite elements “in the state in 

which they exist during manufacture, before the final product exists.” Watson Decision, 2016 WL 3186659, at *15–16. 

And because the intrinsic evidence made clear that the cast 

film was made from a matrix that was flowable only before 

drying, the court concluded that the defendants failed to 

prove that the claims were indefinite. Id. at *16. 

On appeal, Watson and Teva argue that the claims recite a physical impossibility—a flowable yet solid cast 

film—and are therefore indefinite. Indivior responds that 

the claims, understood in light of the specification, clearly 

recite a matrix that is flowable only before drying. 

We agree with Indivior that the claim is not indefinite. 

The only sensible reading of the claim is that the cast film 

is made from a matrix that is flowable before drying and is 

not simultaneously dry and flowable. For example, the matrix as claimed has a viscosity, which is a property of fluids, 

not solids. And the matrix is “capable of being dried,” 

which would be redundant if the matrix is already dried. 

The specification similarly explains that the wet matrix is 

“formed into a film . . . and then dried.” ’514 patent col. 25 

ll. 27–28. The claims and specification thus make quite 

clear that the flowable matrix is first flowable and then 

dried.

Having no support in the patent itself, Watson and 

Teva essentially rest on the argument that a product claim 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 27

“comprising” certain elements must contain those elements 

simultaneously. But the district court properly rejected 

this position based on our precedent. For example, in 

Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 

1375–76 (Fed. Cir. 2009), the patentee claimed a refrigerator shelf “comprising” a lower wall having a certain resilience. Since the specification made clear that the resilience 

only referred to resilience during assembly, we held that 

the lower wall only required that property during assembly. Id. at 1378–79, 1380–81. The ’514 patent likewise 

makes clear that the matrix is flowable only at a certain 

time—before drying. The word “comprising” in isolation 

does not sustain Watson and Teva’s nonsensical interpretation of a flowable dried film that is contrary to both the 

specification and the claim language. We thus affirm the 

district court’s judgment that the ’514 patent has not been 

shown to be invalid as indefinite.

2. Obviousness

We now consider DRL’s appeal from the district court’s 

judgment of nonobviousness. Obviousness is a question of 

law based on underlying facts, including the scope and content of the prior art, differences between the prior art and 

the claims at issue, the level of ordinary skill, and relevant 

evidence of secondary considerations. Graham v. John 

Deere Co. of Kan. City, 383 U.S. 1, 17–18 (1966). A patent 

is presumed valid, and overcoming that presumption at the 

district court requires clear and convincing evidence. Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011); Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1401, 1407 

(Fed. Cir. 2014). 

In its analysis of the Graham factors, the district court 

found that a person of ordinary skill would principally have 

a background in pharmaceutical science or chemistry but 

“would also be a member of a team, which would include 

an engineer or scientist with one to three years of relevant 

experience manufacturing and optimizing various types of 
28 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

film products using coating and drying processes.” DRL 

’514 Decision, 2017 WL 3837312, at *15. In reaching this 

determination, the court found some merit both in Indivior’s argument that the pharmaceutical film field was 

nascent around the time of invention and in DRL’s argument that a person of ordinary skill would have some 

knowledge relating to coating and drying films. Id. 

Turning to the prior art, the district court generally 

found that there was limited use of top air convection dryers in the context of pharmaceutical films at the time of 

invention. Id. at *16. The court also observed that there 

were differences between pharmaceutical and non-pharmaceutical films, citing in particular the more demanding 

FDA requirements for drug content uniformity in pharmaceuticals. Id. 

DRL asserted that the claims were obvious over U.S. 

Patents 4,849,246 (“Schmidt”), 6,552,024 (“Chen”), and 

5,881,476 (“Strobush”). The district court made findings on 

the teachings of the prior art, which we summarize below. 

Schmidt disclosed processes for making pharmaceutical films. Schmidt’s films were made through a roll-coating 

process with temperature-controlled rollers and a drying 

tunnel that was controllable in sections. DRL ’514 Decision, 2017 WL 3837312, at *16. Schmidt also disclosed that 

there was a regulatory requirement for drug content uniformity and that its processes yielded films with a reproducible weight that varied within 10%. Id. at *17. 

However, the district court found that Schmidt did not examine the uniformity of the film after drying, crediting Indivior’s expert’s testimony. Id. 

Chen taught pharmaceutical films made by a casting 

process and a drying oven that included top air drying nozzles and that had controllable temperature and air speed. 

Id. Chen further discussed a human pharmacokinetic 

study conducted with its films. Id. at *18.
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 29

Strobush disclosed a method for drying photographic 

and other non-pharmaceutical films without introducing a 

surface defect called “mottle.” Id. at *16. As Strobush was 

not directed to pharmaceutical films, it did not address 

drug content uniformity. Id.

The key dispute between the parties was whether the 

prior art’s teachings would motivate a skilled artisan to 

make a uniform pharmaceutical film according to the 

claimed invention with a reasonable expectation of success. 

The district court found that Schmidt did not directly 

measure drug content uniformity and only indirectly measured uniformity before drying. Id. at *17. Further, the 

court cited a subsequent peer-reviewed article indicating 

that Schmidt’s process did not produce uniform films. Id. 

The court thus found that Schmidt did not disclose how to 

achieve drug content uniformity. Id.

Turning to Chen, the district court found that the reference disclosed a human study using its films, which implicitly suggested that the films had uniform drug content. 

Id. at *18. However, the court noted that Chen did not disclose that its films had the requisite uniformity and that 

the defendants’ expert failed to produce uniform films using Chen’s protocol. Id. In light of this conflicting evidence, 

the court found that DRL failed to prove that Chen 

achieved drug content uniformity. Id. 

Given the nascent status of pharmaceutical films at the 

time of invention and the limited knowledge of drying techniques, the district court additionally found that a person 

of ordinary skill would not have been motivated to combine 

the prior art to achieve uniformity. Id. at *18. Moreover, 

the court found that a skilled artisan would not have been 

motivated to combine Schmidt and Chen with the techniques in Strobush because Strobush did not address pharmaceutical films or film uniformity, but rather the surface 

defect called mottle. Id. 
30 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

Finally, the district court found that secondary considerations supported nonobviousness. The court considered 

evidence that obtaining pharmaceutical film content uniformity was a long-felt need yet difficult to achieve, and the 

court gave some credit to Aquestive’s work related to the 

’514 patent in solving that need. Id. at *19. That credit 

was supported by several pieces of evidence. First, it was 

undisputed that Aquestive was the first to receive FDA approval for a pharmaceutical film. Id. Second, several papers cited the inventors’ work for demonstrating the value 

and viability of pharmaceutical films. Id. Third, DRL itself 

prepared an internal memorandum recognizing an 

Aquestive patent application that “yields uniform distribution of active,” “the advantageous factor which was not appreciated by the prior arts.” Id. The court considered that 

the praise did not specifically address the patents in suit 

and sometimes credited others as well, but the court nonetheless gave the evidence some weight because it referred 

to the claimed technology. Id. at *20. 

Considering all the evidence, the district court held 

that DRL failed to prove by clear and convincing evidence 

that the asserted claims of the ’514 patent would have been 

obvious. Id.. 

On appeal, DRL challenges several of the district 

court’s factual findings. First, DRL argues that the court 

clearly erred in finding the level of ordinary skill. Second, 

DRL alleges that the court clearly erred in finding that 

Schmidt and Chen do not teach drug content uniformity. 

Third, DRL argues that the court clearly erred in dismissing the teachings of Strobush. DRL also contends that secondary considerations do not compel nonobviousness. 

Indivior responds that the district court did not clearly 

err in its factual findings and that secondary considerations support nonobviousness.

We agree with Indivior that the district court did not 

clearly err in its factual findings or in its ultimate 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 31

judgment of nonobviousness. First, we see no clear error 

in the court adopting a compromise measure of the level of 

ordinary skill. Although the court found that the field of 

pharmaceutical films was just emerging at the time of invention, it also found “merit to [DRL’s] argument that one 

of ordinary skill would have a degree of access to some of 

the body of prior-art knowledge relating to coating and drying.” Id. at *15. Consequently, the court found that a person of ordinary skill would be on a team with an engineer 

or scientist with experience in manufacturing films. Id. 

DRL argues that the court clearly erred in settling on the 

particular amount of experience: 1–3 years according to 

the court, while DRL preferred 5–10 years. For its part, 

Indivior’s expert testified that a skilled artisan would have 

a lower amount of experience with films since the pharmaceutical film field was young and that, in his nearly 40 

years of experience, he had never seen a team assembled 

with the experience suggested by DRL. On this record, we 

conclude that DRL’s nitpicking over the experience level of 

the skilled artisan fails to demonstrate clear error. 

Next, we conclude that the district court did not clearly 

err in finding that Schmidt did not disclose uniform dried 

films according to the claimed invention. As properly construed, claim 62 requires a specific type of drying, i.e., without solely top air drying, to achieve a specific uniformity 

“subsequent to casting and drying.” Schmidt disclosed neither limitation. Indeed, DRL does not dispute that 

Schmidt only disclosed a uniform wet film. The court thus 

did not clearly err in relying on Indivior’s expert’s testimony that since film uniformity could be lost at the drying 

step, a uniform wet film does not disclose the claimed uniform dried films. 

We conclude likewise with respect to Chen. While the 

human study disclosed in Chen implicitly suggested that 

the films were uniform, Chen’s actual discussion of uniformity involved films lacking an active compound, J.A. 

70211–12, and the defendants’ expert failed to produce 
32 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

uniform films using Chen’s method, DRL ’514 Decision, 

2017 WL 3837312, at *17–18. The district court did not 

clearly err in its weighing of this evidence, some of which 

supported DRL’s position and some of which went against 

it.

Having found that neither Schmidt nor Chen taught 

the post-drying uniform films as claimed in the ’514 patent, 

the district court also found that a skilled artisan would 

not have been motivated to modify either reference in light 

of Strobush with a reasonable expectation of success. Id. 

at *18–19. DRL argues that this was also clear error. We 

disagree. Strobush did not address the uniformity of either 

pharmaceutical films or non-pharmaceutical films, but rather a surface defect called mottle. Mottle may relate to 

uniformity, but they are different properties. The court 

credited Indivior’s expert, who testified that lack of mottle 

would not imply that the film was uniform, id. at *18, and 

DRL points to no clear error in that finding. Further, while 

DRL emphasizes that Strobush taught bottom-drying, it 

does not point us to any recognition in Strobush that bottom-drying had any particularly advantageous features. 

While the motivation of the skilled artisan need not be the 

same as that of the patentee, KSR Int’l Co. v. Teleflex Inc., 

550 U.S. 398, 419 (2007), DRL’s proffered motivation is too 

tenuous. We conclude that the district court did not clearly 

err in finding that a skilled artisan would not have been 

motivated to make a bottom-dried uniform pharmaceutical 

film based on a teaching that was not emphasized in any 

meaningful way from a reference in a different field addressing a different problem.

That finding is further supported by the court’s determination that a skilled artisan would not have had a reasonable expectation of success. DRL ’514 Decision, 2017 

WL 3837312, at *19. In contrast to a “finite number of 

identified, predictable solutions,” KSR, 550 U.S. at 421, the 

court found that multiple factors throughout the manufacturing process contribute to the uniformity of 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 33

pharmaceutical films, that adjusting the various factors 

would have been unintuitive, and that the field was still 

emergent at the time of invention. DRL ’514 Decision, 2017 

WL 3837312, at *19. We also see no clear error in those 

findings. 

We last consider DRL’s challenge to the district court’s 

evaluation of the evidence of secondary considerations. 

“[E]vidence of secondary considerations may often be the 

most probative and cogent evidence in the record. It may 

often establish that an invention appearing to have been 

obvious in light of the prior art was not.” Stratoflex, Inc. v. 

Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983). 

Aquestive was the first to receive FDA approval for a pharmaceutical film and received praise for its work in achieving uniform films, including by DRL itself. Having 

considered DRL’s arguments, we conclude that the court 

did not clearly err in giving some weight to Indivior’s evidence.

Because we conclude that DRL has not shown clear error in the court’s findings, we affirm the district court’s 

judgment that the asserted claims of the ’514 patent, as 

properly construed, would not have been obvious. As DRL 

has not argued the ’497 patent separately, we affirm the 

court’s nonobviousness judgment with respect to that patent as well. 

C. Infringement of the ’150 Patent 

We turn to the parties’ appeals concerning the ’150 patent, beginning with Indivior’s appeal from the district 

court’s judgment that DRL does not infringe the asserted 

claims of the ’150 patent. DRL ’150 Decision, 2017 WL 

3782782, at *1, *5. Claim 1 recites that the film includes a 

hydrophilic cellulosic polymer (“HCP”). DRL substituted 

polyvinyl pyrrolidone (“PVP”) for HCP in its ANDA product. Id. at *3. Indivior argued that DRL’s product infringed under the doctrine of equivalents. 
34 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

The district court held that DRL’s product does not infringe under the doctrine of equivalents because the ’150 

patent disclosed PVP as an alternative to HCP but did not 

claim it, thereby dedicating it to the public. Id. at *4–5.

Indivior argues that the district court erred in concluding that the disclosure-dedication rule applied. DRL disagrees and contends that the district court’s analysis and 

judgment were correct.

We agree with DRL that the disclosure-dedication rule 

applies here and that the district court correctly found that 

DRL’s product does not infringe under the doctrine of 

equivalents. When a patentee discloses subject matter but 

does not claim it, the patentee dedicates the unclaimed 

subject matter to the public and cannot recapture it 

through the doctrine of equivalents. Johnson & Johnston 

Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed. Cir. 

2002) (en banc). The rule descends from the essential notice function of claims. As the Supreme Court long ago explained, “[t]he public is notified and informed, by the most 

solemn act on the part of the patentee, that his claim to 

invention is for such and such an element or combination, 

and for nothing more.” Mahn v. Harwood, 112 U.S. 354, 

361 (1884). 

Here, the patentee claimed a film comprising a polymer 

component made up of PEO and HCP but disclosed “useful 

water[-]soluble polymers,” including both HCP and other 

polymers such as PVP. ’150 patent col. 15 ll. 44–60. The 

specification further describes examples of successful films 

using polymeric blends of PEO and PVP without HCP. Id. 

col. 51 l. 49–col. 52 l. 36 (example EA); see also id. col. 54 l. 

51–col. 55 l. 11 (examples EI, EJ). These disclosures teach 

that PVP, an unclaimed embodiment, is an alternative to 

HCP and thus is dedicated to the public and cannot be recaptured through the doctrine of equivalents. See Johnson 

& Johnston, 285 F.3d at 1054. We affirm the district 

court’s judgment that DRL’s ANDA product, which 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 35

contains PVP but not HCP, does not infringe the asserted 

claims of the ’150 patent. 

D. Validity of ’150 Patent

DRL alleges that the ’150 patent is invalid as obvious. 

Its challenge to the district court’s judgment of nonobviousness focuses solely on whether the ’150 patent may 

properly claim priority from the earlier ’902 application. 

The priority question turns on whether the ’902 application 

provides an adequate written description of the claims of 

the ’150 patent. See Lockwood v. Am. Airlines, Inc., 107 

F.3d 1565, 1571–72 (Fed. Cir. 1997). Under 35 U.S.C. 

§ 112, “[t]he specification shall contain a written description of the invention.” The test for adequate written description “is whether the disclosure of the application relied 

upon reasonably conveys to those skilled in the art that the 

inventor had possession of the claimed subject matter as of 

the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 

F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The disclosure 

must demonstrate that the patentee truly invented the 

subject matter encompassed by the claims. Whether a 

claim satisfies the written description requirement is a 

question of fact. Id.. 

As relevant to this issue, claim 1 of the ’150 patent recites a pharmaceutical film with: (1) “at least one watersoluble polymer component consisting of [PEO] in combination with a[n] [HCP]”; wherein (2) “the water-soluble 

polymer component comprises greater than 75% [PEO] and 

up to 25% [HCP]”; (3) the PEO comprises at least one LPEO and at least one H-PEO; and (4) the L-PEO “comprises about 60% or more in the polymer component.” ’150 

patent col. 57 ll. 35–54. 

The district court held that the ’150 patent properly 

claimed priority from the ’902 application. In making that 

determination, the court relied primarily on the following 

passage from the ’902 application:
36 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

For instance, certain film properties, such as fast 

dissolution rates and high tear resistance, may be 

attained by combining small amounts of high molecular weight PEOs with larger amounts of lower 

molecular weight PE[O]s. Desirably, such compositions contain about 60% or greater levels of the 

lower molecular weight PEO in the PEO-blend polymer component.

To balance the properties of adhesion prevention, 

fast dissolution rate, and good tear resistance, desirable film compositions may include about 50% to 

75% low molecular weight PEO, optionally combined with a small amount of a high molecular 

weight PEO, with the remainder of the polymer 

component containing a hydrophilic cellulosic polymer (HPC or HPMC).

DRL ’150 Decision, 2017 WL 3782782, at *6 (emphases 

added) (quoting J.A. 70035). The court interpreted the 

term “polymer component” to refer to all polymers in the 

formulation, including L-PEO, H-PEO, and any HCP. Id. 

Together with example formulations listed in the ’902 application, the court found that this passage provided adequate support for the ’150 patent’s priority claim. Id. at *6.

On appeal, DRL argues that the district court clearly 

erred in finding that the ’902 application provided written 

description support for the asserted claims of the ’150 patent. According to DRL, the ’902 application fails to describe the claimed composition with the specificity of the 

’150 patent claims.

Indivior responds that the ’902 application reasonably 

conveys to a skilled artisan that the inventor invented and 

disclosed the claimed films as of the application’s filing 

date.

We agree with Indivior that the district court did not 

clearly err in finding that the ’902 application provides 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 37

adequate written description support for the asserted 

claims of the ’150 patent. To obtain certain desirable film 

properties, the ’902 application recommends that films 

should combine small amounts of H-PEO with larger 

amounts of L-PEO, and desirably the films should have at 

least 60% L-PEO “in the PEO-blend polymer component.” 

J.A. 70035. Considering a broader set of properties, the 

application prescribes 50–75% L-PEO with the balance of 

the “polymer component” being H-PEO and HCP. Id. The 

application also discloses multiple example formulations 

with varying levels of L-PEO, H-PEO, and HCP. The court 

did not clearly err in finding that these disclosures would 

convey to a skilled artisan the claimed films with a polymer 

component containing at least 75% PEO, at least 60% LPEO, some H-PEO, and up to 25% HCP. 

Addressing only the examples, DRL argues that no embodiment disclosed in the ’902 application has the precise 

combination of L-PEO, H-PEO, and HCP claimed in the 

’150 patent. It analogizes this case to Purdue Pharma L.P. 

v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000). There, we 

considered a claim to a formulation characterized by a certain sustained release ratio. Id. at 1322–23. However, the 

specification never indicated that the ratio was “an important defining quality of the formulation, nor d[id] the 

disclosure even motivate one to calculate the ratio.” Id. at 

1327. By claiming a characteristic of the formulation that 

was “not discussed even in passing in the disclosure,” the 

patentee ran afoul of the written description requirement, 

and we thus affirmed the district court’s judgment of invalidity. Id. at 1327, 1329. Here, however, the ’902 application does direct a skilled artisan to the claimed polymer 

component. Consistent with the ’150 patent claims, the application discloses that a polymer component with 60% LPEO has desirable properties and that the remainder of the 

component may include H-PEO and HCP. The district 

court did not clearly err in finding that these disclosures 

supported the ’150 patent claims.
38 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

DRL suggests that the ’902 application does not disclose that the polymer component comprises 60% L-PEO 

because the application in the relevant sentence refers only 

to the “PEO-blend polymer component” comprising 60% LPEO. DRL Appellant Br. 56–57 (emphasis added). DRL 

indicates that the “PEO-blend polymer component” includes only PEO and not an HCP. But it provides no evidence or reasoning in support of that interpretation, and 

the application’s disclosure is to the contrary. For each example formulation including an HCP, percentages for LPEO and H-PEO are shown for the entire polymer component, and never for just the PEO part. J.A. 70085. We 

think “PEO-blend polymer component” simply refers to a 

polymer component containing a PEO blend and is not exclusive of other ingredients. Accordingly, we conclude that 

the district court did not clearly err in interpreting “polymer component” to consistently include all the polymers in 

the formulation. 

In sum, the ’902 application discloses films with varying amounts of L-PEO, H-PEO, and HCP, describes films 

with 60% L-PEO as having desirable properties, and states 

that the remainder of the polymer component apart from 

L-PEO may include H-PEO and HCP. This disclosure of 

the ’902 application reasonably conveyed to a skilled artisan the films claimed in the ’150 patent. The specification 

need not recite the claimed invention in haec verba. Ariad, 

598 F.3d at 1352. We affirm the district court’s holding 

that the ’150 patent is entitled to the priority date of the 

’902 application. As DRL makes no other challenge to the 

court’s judgment of nonobviousness, we affirm that holding 

as well.

E. Validity of ’832 Patent

We last address Indivior’s challenge to the district 

court’s judgment that claims 15–19 are invalid as obvious. 

Watson Decision, 2016 WL 3186659, at *11. In a parallel 

inter partes review proceeding, the Patent Trial and Appeal 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 39

Board held claims 15–19 unpatentable as anticipated and 

obvious, BioDelivery, 2015 WL 4045328, at *16, which we 

affirmed, 667 F. App’x 997 (Fed. Cir. 2016). Indivior argues 

that the Board’s unpatentability decision and our subsequent affirmance moot the parties’ dispute over the validity 

of claims 15–19 and requests vacatur of the district court’s 

judgment of invalidity. No party raises any objection to vacatur.

Indivior argues that, “in general, when a claim is cancelled, the patentee loses any cause of action based on that 

claim, and any pending litigation in which the claims are 

asserted becomes moot.” Indivior Cross-Appellant Br. 89 

(quoting Fresenius USA, Inc. v. Baxter Int’l, Inc., 721 F.3d 

1330, 1340 (Fed. Cir. 2013)). We agree that the Board’s 

decision and our affirmance mooted any dispute over the 

district court’s decision regarding claims 15–19 of the ’832 

patent. We also agree that vacatur is proper because mootness was not caused by Indivior’s voluntary action. See 

U.S. Bancorp Mortg. Co. v. Bonner Mall P’ship, 513 U.S. 

18, 24–25 (1994). Indeed, Indivior opposed the inter partes 

review, appealed the decision, and sought review en banc. 

No party contends on appeal that vacatur would be inappropriate in these circumstances.

CONCLUSION

We have considered the parties’ remaining arguments 

but find them unpersuasive. For the foregoing reasons, we 

affirm the district court’s judgments that DRL and Alvogen 

do not infringe the ’514 patent, that Watson does infringe 

the ’514 patent, and that Watson, Teva, and DRL failed to 

prove that the ’514 patent is invalid. We likewise affirm 

the court’s judgment that DRL does not infringe the ’150 

patent, and that DRL failed to prove that the ’150 patent is 

invalid. We vacate the court’s decision that claims 15–19 

of the ’832 patent are invalid as obvious.

AFFIRMED-IN-PART, VACATED-IN-PART
40 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

COSTS

No costs.
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 41

APPENDIX

’514 Patent Claim 62

62. A drug delivery composition comprising:

(i) a cast film comprising a flowable water-soluble 

or water swellable film-forming matrix comprising 

one or more substantially water soluble or water 

swellable polymers; and a desired amount of at 

least one active;

wherein said matrix has a viscosity sufficient to aid 

in substantially maintaining non-self-aggregating 

uniformity of the active in the matrix;

(ii) a particulate active substantially uniformly stationed in the matrix; and

(iii) a taste-masking agent selected from the group 

consisting of flavors, sweeteners, flavor enhancers, 

and combinations thereof to provide taste-masking 

of the active;

wherein the particulate active has a particle size of 

200 microns or less and said flowable water-soluble 

or water swellable film-forming matrix is capable 

of being dried without loss of substantial uniformity

in the stationing of said particulate active therein; 

and

wherein the uniformity subsequent to casting and 

drying of the matrix is measured by substantially 

equally sized individual unit doses which do not 

vary by more than 10% of said desired amount of 

said at least one active.

’514 patent col. 73 l. 48–col. 74 l. 9 (emphasis added). 

’150 Patent Claim 1

1. A mucosally-adhesive water-soluble film product 

comprising:
42 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

an analgesic opiate pharmaceutical active; and

at least one water-soluble polymer component consisting of polyethylene oxide in combination with a 

hydrophilic cellulosic polymer;

wherein:

the water-soluble polymer component comprises 

greater than 75% polyethylene oxide and up to 25% 

hydrophilic cellulosic polymer;

the polyethylene oxide comprises one or more low 

molecular weight polyethylene oxides and one or 

more higher molecular weight polyethylene oxides, 

the molecular weight of the low molecular weight 

polyethylene oxide being in the range 100,000 to 

300,000 and the molecular weight of the higher molecular weight polyethylene oxide being in the 

range 600,000 to 900,000; and

the polyethylene oxide of low molecular weight 

comprises about 60% or more in the polymer component.

’150 patent col. 57 ll. 37–54.
United States Court of Appeals 

for the Federal Circuit ______________________

 

INDIVIOR INC., FKA RECKITT BENCKISER 

PHARMACEUTICALS INC., INDIVIOR UK 

LIMITED, FKA RB PHARMACEUTICALS LIMITED,

AQUESTIVE THERAPEUTICS, INC., FKA 

MONOSOL RX, LLC,

Plaintiffs-Cross-Appellants

v.

DR. REDDY'S LABORATORIES, S.A., DR. REDDY'S 

LABORATORIES INC., WATSON LABORATORIES 

INC., ACTAVIS LABORATORIES UT, INC., TEVA 

PHARMACEUTICALS USA, INC.,

Defendants-Appellants

PAR PHARMACEUTICAL, INC., INTELGENX 

TECHNOLOGIES CORP.,

Defendants

______________________

2017-2587, 2018-1010, 2018-1058, 2018-1062, 2018-1114, 

2018-1115, 2018-1176, 2018-1177

______________________

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:13-cv-01674-RGA, 1:14-cv00422-RGA, 1:14-cv-01451-RGA, 1:14-cv-01574-RGA, 1:16-

cv-00178-RGA, Judge Richard G. Andrews.

-------------------------------------------------------------
2 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

INDIVIOR INC., FKA RECKITT BENCKISER 

PHARMACEUTICALS INC., INDIVIOR UK 

LIMITED, FKA RB PHARMACEUTICALS LIMITED,

AQUESTIVE THERAPEUTICS, INC.,

Plaintiffs-Appellants

v.

ALVOGEN PINE BROOK, LLC,

Defendant-Cross-Appellant

______________________

2018-1949, 2018-2045

______________________

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:15-cv-00477-RGA, 1:15-cv01016-RGA, Judge Richard G. Andrews.

______________________

MAYER, Circuit Judge, dissenting.

There is no need for this court to reach the issue of infringement because the three patents—U.S. Patent Nos. 

8,017,150 B2 (the “’150 patent”), 8,603,514 B2 (the “’514 

patent”), and 8,900,497 B2 (the “’497 patent”)—asserted by 

Indivior Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. (collectively, “Indivior”) are invalid as obvious. 

I therefore respectfully dissent.

I. Invalidity of the ’497 and ’514 Patents

Indivior’s ’497 and ’514 patents are directed to sublingual films for delivering active ingredients. See J.A. 334–

51, 412–25. According to Indivior, its patents provide a 

novel solution for attaining the active ingredient uniformity required in pharmaceutical films. Cross-Appellants’ Br. 55–62. To the contrary, however, long before the 

priority dates of Indivior’s patents, multiple prior art 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 3

references taught both methods to manufacture sublingual 

films and techniques for achieving film content uniformity.

The earliest possible priority date for the ’497 and ’514 

patents is October 2001. See J.A. 170. For well over a decade prior to this date, others had achieved uniform distribution of active ingredients on mucosally-administered 

films. U.S. Patent No. 4,849,246 (“Schmidt”), for example, 

recognized that “hitherto known proposals” for producing 

drug delivery films had been unable to achieve the drug 

content uniformity required by regulators. J.A. 70217 

(1:60). Schmidt explained that with his claimed invention, 

which used a roll-coating method, “[t]he reproducible constant weight [was] only +/-2.5% for 20 g/m2 and approximately +/-10% for 1 g/m2 over [the] entire surface.” J.A. 

70219 (6:1–3). Schmidt further taught that by roll-coating 

with a “doctor blade,” it was “possible to achieve a weight 

tolerance per surface unit down to +/-1%.” J.A. 70219 

(6:37–42).

Schmidt focused on the importance of viscosity in 

achieving uniformity, explaining that “[c]oating materials 

with . . . a viscosity of approximately 30 to 10,000 cPs ha[d] 

proved particularly satisfactory” in ensuring “uniform active ingredient content.” J.A. 70218 (4:50–59). Indeed, 

Schmidt specifically taught that by making the viscosity of 

a wet matrix sufficiently thick, one could successfully inhibit the movement of particles during the time it takes to 

dry the coated film. J.A. 70218 (4:20–59).

U.S. Patent No. 6,552,024 B1 (“Chen”) likewise taught 

how to obtain uniform distribution of pharmacological active ingredients on a film. See J.A. 70210 (9:20–27), 70211 

(11:7–15, 12:1–28). Specifically, Chen disclosed a process 

for making mucoadhesive oral thin films, explaining that 

after mixing and degassing the ingredients, “[t]he formulation [i]s then coated on the non-siliconized side of a polyester film at a wet thickness of 10 [millimeters] and dried in 

a hot air circulating oven at 50° [Celsius] for 9 minutes.” 
4 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

J.A. 70211 (12:12–15). Notably, moreover, U.S. Patent No. 

5,881,476 (“Strobush”) disclosed drying a film from the bottom, see J.A. 70241 (9:44–51), and explained that the 

claimed method could be used to avoid introducing “mottle” 

into the final film product, J.A. 70239 (6:26).

Indivior’s efforts to evade the overwhelming evidence 

of obviousness are unavailing. Indivior first argues that 

Schmidt does not disclose a film having the drug content 

uniformity required by the ’514 patent. See Cross-Appellants’ Br. 57. In support, it contends that Schmidt only 

teaches creating films with uniform weight, not with uniform active drug content. This argument is wholly without 

merit. On its face, Schmidt asserts that the methods it discloses can be used to create films meeting the uniformity 

requirements for the active ingredient of a drug. See J.A. 

70217 (1:59–2:47). Schmidt specifically explains that the 

prior art was not able to achieve the requisite “uniform active ingredient distribution,” J.A. 70217 (1:62), but that the 

claimed invention does not suffer from the same “disadvantage[],” J.A. 70217 (2:14–15).

Indivior suggests that Schmidt only measured weight 

uniformity rather than drug content uniformity. Cross-Appellants’ Br. 57; see ante at 29. This argument falls flat, 

however, given that Indivior’s own patents acknowledge 

that weight uniformity is a proxy for active ingredient uniformity:

The additive weights of eight randomly selected 

dosage forms . . . are as shown in Table 2 below. . . . 

The individual dosages were consistently 0.04 gm, 

which shows that the distribution of the components within the film was consistent and uniform. 

This is based on the simple princip[le] that each 

component has a unique density. Therefore, when 

the components of different densities are combined 

in a uniform manner in a film, as in the present 

invention, individual dosage[] forms from the same 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 5

film of substantially equally dimensions[] will contain the same mass. J.A. 353 (41:50–42:33).

Indivior also complains that even if Schmidt teaches 

how to create a uniform wet matrix, it does not teach how 

to maintain uniformity during the drying process. CrossAppellants Br. 57; see ante at 29–32. But Strobush teaches 

the precise bottom drying methods that the ’497 and ’514 

patents rely upon to achieve uniform dried films. See J.A. 

70239 (6:24–27) (teaching high-speed drying), 70241 (9:44–

51) (describing an embodiment which uses “air foils . . . located below the coated substrate” to dry from the bottom).

According to Indivior, a skilled artisan would not have 

turned to Strobush’s bottom drying method because Strobush addresses “mottle,” which is a surface defect, rather 

than drug content uniformity. Cross-Appellants Br. 57; see 

ante at 32. To the contrary, however, Strobush defines 

“mottle” as “an irregular pattern or non-uniform density 

defect.” J.A. 70237 (1:59–60) (emphasis added). Given that 

“mottle” is defined as a non-uniform density defect, a 

skilled artisan would certainly have appreciated that a drying technique that reduces mottle could also be employed 

to reduce non-uniformity.

All the elements recited in the challenged claims of Indivior’s ’497 and ’514 patents are explicitly disclosed in the 

prior art. Even if they were not, however, obviousness and 

anticipation are different beasts. While anticipation requires that a single prior art reference disclose each and 

every element of the claimed invention, see, e.g., In re 

Smith Int’l, Inc., 871 F.3d 1375, 1381 (Fed. Cir. 2017), obviousness demands a more “expansive and flexible approach,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 

(2007). In evaluating obviousness, the pertinent perspective is that of an artisan endowed not only with “ordinary 

skill” and “ordinary creativity,” but also with the capacity 

to recognize and deploy “predictable solutions” to wellknown problems. Id. at 421; see also Randall Mfg. v. Rea, 
6 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

733 F.3d 1355, 1362 (Fed. Cir. 2013) (“In KSR, the Supreme Court criticized a rigid approach to determining obviousness based on the disclosures of individual prior-art 

references, with little recourse to the knowledge, creativity, 

and common sense that an ordinarily skilled artisan would 

have brought to bear when considering combinations or 

modifications.”).

Here, given that Schmidt teaches uniform active ingredient distribution, J.A. 70217, the only real dispute on the 

obviousness question is whether a skilled artisan would 

have been motivated to dry films from the bottom rather 

than from the top, as explicitly disclosed in Strobush, J.A. 

70241 (9:44–51). At the time of the purported invention 

described in the ’497 and ’514 patents, it was well-recognized that conventional drying methods—which shot hot 

air from the top of a drying oven—resulted in films that 

were overly dry and rippled, i.e., “overcooked,” on top and 

wet, i.e., “undercooked,” on the bottom. See J.A. 334 (3:33–

57), 346–47 (28:58–29:1). The district court determined 

that a person of ordinary skill “would possess a bachelor’s 

degree in pharmaceutical science, chemistry, or a related 

field, plus two to five years of relevant experience in developing drug formulations” and “would also be a member of 

a team, which would include an engineer or scientist with 

one to three years of relevant experience manufacturing 

and optimizing various types of film products using coating 

and drying processes.” J.A. 169. There can be no dispute 

that such a person would have readily recognized that 

switching the location of the heat source from the top to the 

bottom would likely ameliorate the problem of films that 

were overly dry on the top and overly wet on the bottom. 

Indeed, any person having basic familiarity with a kitchen 

oven would certainly appreciate that, since hot air rises, 

heating an item from the bottom rather than the top facilitates uniform baking. See KSR, 550 U.S. at 419 (explaining that “[g]ranting patent protection to advances that 

would occur in the ordinary course without real innovation 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 7

retards progress”); id. at 421 (stating that “[r]igid preventative rules that deny factfinders recourse to common 

sense” have no place in the obviousness analysis). 

II. Invalidity of the ’150 Patent

Indivior’s ’150 patent is likewise invalid as obvious. 

The district court erred in concluding that the ’150 patent 

can claim priority to the 2003 filing date of its parent application, U.S. Patent Application No. 60/473,902 (the “’902 

application”). See J.A. 198. To obtain the benefit of a parent application’s filing date, “the claims of the later-filed 

application must be supported by the written description 

in the parent in sufficient detail that one skilled in the art 

can clearly conclude that the inventor invented the claimed 

invention as of the filing date sought.” Anascape, Ltd. v. 

Nintendo of Am., Inc., 601 F.3d 1333, 1335 (Fed. Cir. 2010) 

(internal quotation marks omitted). In this regard, 

“[e]ntitlement to a filing date extends only to subject matter that is disclosed; not to that which is obvious.” Research 

Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 870 

(Fed. Cir. 2010). Accordingly, “the parent application must 

actually or inherently disclose the elements of the laterfiled claims.” Id.; see also PowerOasis, Inc. v. T–Mobile 

USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008).

The ’150 patent is not entitled to rely on the priority 

date of the ’902 application because that application nowhere conveys possession of the specific polymer component recited in independent claim 1. That claim requires 

low molecular weight polyethylene oxide (“PEO”), high molecular weight PEO, and a hydrophilic cellulosic polymer 

(“HCP”), and further specifies that the low molecular 

weight PEO must be at least 60% of the polymer component and that the HCP can be no more than 25% of the 

polymer component. J.A. 279 (57:36–54). The ’902 application, however, does not suggest possession of a polymer 

component including at least 60% low molecular weight 

PEO and at most 25% HCP. Indeed, as the district court 
8 INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A.

correctly acknowledged, the ’902 application provides over 

ninety examples, and yet not one of them satisfies the limitations of claim 1. See J.A. 197.

In concluding that the ’902 application supplied adequate written description support for claim 1, the district 

court relied primarily upon the following passage:

For instance, certain film properties, such as 

fast dissolution rates and high tear resistance, may 

be attained by combining small amounts of high 

molecular weight PEOs with larger amounts of 

lower molecular weight PEOs. Desirably, such 

compositions contain about 60% or greater levels of 

the lower molecular weight PEO in the PEO-blend 

polymer component.

To balance the properties of adhesion prevention, fast dissolution rate, and good tear resistance, 

desirable film compositions may include about 50% 

to 75% low molecular weight PEO, optionally combined with a small amount of a higher molecular 

weight PEO, with the remainder of the polymer 

component containing a[n] [HCP]. J.A. 70035.

On its face, however, this passage contradicts the 

court’s reading. As discussed above, claim 1 requires that 

the low molecular weight PEO constitute “about 60% or 

more [of] the polymer component,” J.A. 279 (57:54), but the 

passage relied upon by the district court states that the low 

molecular weight PEO can be as low as 50% of the polymer 

component. J.A. 70035. This passage further states that 

“[d]esirably” there should be “60% or greater levels of the 

lower molecular weight PEO in the PEO-blend polymer 

component,” i.e., there should be at least 60% low molecular weight PEO in the blend of high and low molecular 

weight PEO. J.A. 70035. Importantly, however, requiring 

60% or more low molecular weight PEO in the “PEO-blend 

polymer component” is very different from requiring 60% 

or more low molecular weight PEO in the component 
INDIVIOR INC. v. DR. REDDY'S LABORATORIES, S.A. 9

consisting of low molecular weight PEO, high molecular 

weight PEO, and HCP as claim 1 requires. Even more fundamentally, the passage relied upon by the district court 

says nothing about claim 1’s mandate that the HCP can be 

no more than 25% of the polymer component.

“Requiring a written description of the invention limits 

patent protection to those who actually perform the difficult work of ‘invention’—that is, conceive of the complete 

and final invention with all its claimed limitations—and 

disclose the fruits of that effort to the public.” Ariad 

Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353 (Fed. 

Cir. 2010) (en banc). Nothing in the ’902 application even 

arguably suggests possession of a polymer component including at least 60% low molecular weight PEO and at most 

25% HCP as required by claim 1. Because the district court 

erred in concluding that Indivior was entitled to rely on the 

2003 priority date of the ’902 application, the asserted 

claims of the ’150 patent are invalid as obvious.