Court Opinion

ID: 4416382
Source: CourtListenerOpinion
Date Created: 2019-07-12 16:00:48.279492+00
Date Added: 2024-06-11T14:51:08.618272
License: Public Domain

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-cv-
00422-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-cv-
01016-RGA, Judge Richard G. Andrews.
                ______________________

                Decided: July 12, 2019
                ______________________

    JEFFREY B. ELIKAN, Covington & Burling LLP, Wash-
ington, 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, Trout-
man 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, Wash-
ington, 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 repre-
sented by JAMIE LUCIA, San Francisco, CA.

    KEVIN PAUL MARTIN, Goodwin Procter LLP, Boston,
MA, argued for defendants-appellants Dr. Reddy's Labora-
tories, 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 An-
geles, CA, argued for defendants-appellants Watson Labor-
atories 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, Wash-
ington, 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 Labor-
atories 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 in-
valid as indefinite. Reckitt Benckiser Pharm. Inc. v. Wat-
son 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 pa-
tent. Indivior also appeals from a fourth decision by the
same court finding that Alvogen Pine Brook, LLC (“Al-
vogen”) does not infringe the ’514 patent. Indivior Inc. v.
Mylan Techs. Inc., 298 F. Supp. 3d 775 (D. Del. 2018) (“Al-
vogen 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 af-
firm 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 in-
gredients: the opioid buprenorphine and the opioid antag-
onist 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 inva-
lidity of four patents covering pharmaceutical films and
methods of making them. However, the parties’ substan-
tive disputes focus on only two patents, the ’514 and ’150
patents. Both patents claim pharmaceutical films and are
listed in the Orange Book 2 as covering Suboxone Film.
Representative claims of the two patents are set forth in
the Appendix. The ’497 patent is directed to film manufac-
turing 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 Evalua-
tions.”
    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 formula-
tions 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 be-
cause 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 sur-
face, 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 eliminat-
ing excessive air in the mixing process, selecting polymers
and solvents to provide a controllable viscosity and by dry-
ing 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 rep-
resentative 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 iden-
tifies two parameters—viscosity and drying—that contrib-
ute to film uniformity: (1) the viscosity of the matrix must
be “sufficient to aid in substantially maintaining non-self-
aggregating uniformity” of the active (the “viscosity limita-
tion”); 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 conven-
tional 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 un-
derlying aqueous composition builds, causing the film sur-
face 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 con-
tinues until drying is complete. Id. col. 3 ll. 49–52. Unde-
sirably, this cycle produces a dried film that is uneven and
nonuniform, which the patent refers to as the “ripple ef-
fect.” 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 micro-
wave drying, desirably in the absence of external air cur-
rents 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 Deci-
sion, 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 at-
mospheric conditions. Id. col. 32 ll. 38–67. The specifica-
tion does not specify whether the air comes from the top or
bottom during zone drying but does indicate that zone dry-
ing “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 af-
fecting viscosity and hence film uniformity. See id. col. 11
ll. 15–24.
    Similar to the ’514 patent, the ’497 patent claims pro-
cesses for making pharmaceutical films. Claim 24, the sole
asserted claim, depends from claim 1, which recites a dry-
ing limitation similar to claim 62 of the ’514 patent: a “dry-
ing” 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 substan-
tively similar to that of the ’514 patent.
                       2. ’150 Patent
    Like the ’514 patent, the ’150 patent is directed to uni-
form 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 as-
serted claims of the ’150 patent claim pharmaceutical films
by their components. Claim 1 is representative of the as-
serted claims and recites a film comprising an active ingre-
dient and a water-soluble polymer component containing
certain proportions of polyethylene oxide (“PEO”), includ-
ing both low molecular weight PEO (“L-PEO”) and high
molecular weight PEO (“H-PEO”), and a hydrophilic cellu-
losic polymer. ’150 patent col. 57 ll. 35–54. The specifica-
tion lists various “useful water[-]soluble polymers,”
including PEO, hydrophilic cellulosic polymers, and a sep-
arate 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 provi-
sional 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 infringe-
ment, 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 Al-
vogen 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 prod-
uct. 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 Wat-
son 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 judg-
ment. 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 spec-
ification 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 appli-
cation 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 recit-
ing that the film be “capable of being continuously cast . . .
without loss of substantial uniformity” and that “uni-
formity 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 dis-
claimed 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 In-
divior’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). Con-
sequently, 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 amend-
ments, 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. In-
divior 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 pri-
marily from the top and thus does not meet the drying lim-
itation 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 equiv-
alents. The district court held a separate trial on the ’150
patent and found that DRL does not infringe any of the as-
serted 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 in-
definite, that Watson infringes the ’514 patent, and that
Watson is not entitled to Rule 59 relief from the infringe-
ment judgment.
    Indivior cross-appeals from the district court’s determi-
nations that DRL does not infringe either the ’514 or the
’150 patent and that Alvogen does not infringe the ’514 pa-
tent. Indivior also requests vacatur of the court’s judgment
that certain claims of the ’832 patent would have been ob-
vious 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 con-
cerning 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.” Po-
laroid 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 in-
fringe the ’514 patent. We first consider Indivior’s cross-
appeal 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 con-
struction 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 re-
view 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 con-
struction 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 ex-
press statements of what the invention is, its repeated dis-
paragement 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 spec-
ification 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 “continu-
    ously cast” limitation in the ’305 claims as it lim-
    ited the scope of the “drying” limitation in the ’514
    claims. Specifically, films formed with conven-
    tional 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 (em-
phasis 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 pa-
tent 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 pa-
tent specification disclaimed drying methods that use
solely conventional convection air drying from the top. In-
stead, 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 con-
firmed 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 uni-
formity,” 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 uni-
form 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 repeat-
edly 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 con-
ventional top air drying because such drying does not pro-
duce uniform films, the central object of the claimed
invention. For example, the specification teaches that “the
conventional drying methods themselves are unable to pro-
vide uniform films.” ’514 patent col. 3 ll. 14–16. In the
section focused on “Drying Wet Cast Films,” the specifica-
tion 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 dry-
ing
    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 re-
    sults 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 sub-
stantially 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 ab-
sence of external air currents or heat on the top (exposed)
surface of the film . . . .”). “If top air is employed, it is bal-
anced with the bottom air drying to avoid non-uniformity
. . . .” Id. col. 29 ll. 1–3.
     The specification also provides examples that demon-
strate the failure of conventional drying methods to achieve
uniformity. Examples CH and CG examined whether un-
desirable particle aggregations occurred during conven-
tional 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 homog-
enous with no particle aggregations. Id. col. 52 ll. 60–62.
In contrast, when films were dried in an oven “by conven-
tional 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 uni-
form 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 pro-
cess 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 spec-
ification 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 conven-
tional 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 manu-
facturing 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. Like-
wise, 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 avoid-
ing . . . excessive air in the mixing process, selecting poly-
mers 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 dry-
ing the film, the polymer may be selected in order to pro-
vide 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 ex-
tend 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 argu-
ment by not raising it in the DRL case until post-trial brief-
ing.    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 re-
jected, Alvogen Decision, 298 F. Supp. 3d at 783.
    Even if we assume waiver does not apply, the specifi-
cation’s discussion of zone drying does not qualify its dis-
claimer 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 con-
ditions. ’514 patent col. 32 ll. 38–45; id. figs. 35–36. Con-
sistent 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 pa-
tent 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 em-
bodiments; it just excludes zone drying that uses solely con-
ventional convection air drying from the top, which is never
disclosed in the patent. We thus conclude that the disclo-
sure of zone drying does not qualify the specification’s re-
peated disparagement of solely top air drying.
    Consistent with our previous Indivior decision, we ul-
timately 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 dry-
ing limitation and proceed to the second step of the in-
fringement 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 as-
serted claims of the ’514 patent. Even under the court’s

     6 Because we conclude that the specification dis-
claims conventional top air drying, we need not decide
whether the prosecution history further supports that dis-
claimer.
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 bal-
anced 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 seri-
ously dispute the essential predicates of the court’s nonin-
fringement 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 conven-
tional top air drying, which is insufficient to meet the dry-
ing 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 insubstan-
tial bottom drying brings Alvogen’s process within the
reach of the asserted claims. We disagree. Indivior’s argu-
ment is largely repetitive of its claim construction argu-
ments, 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 in-
substantial 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 Al-
vogen’s dryer can be said to employ anything but ‘conven-
tional convection air drying from the top.’”); accord DRL
’514 Decision, 2017 WL 3837312, at *5 (finding that inci-
dental bottom drying did not infringe asserted claims). We
conclude that this finding is not clearly erroneous or prem-
ised on an improper claim construction, and therefore af-
firm 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. Wat-
son 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 vis-
cosity limitation of the asserted claims. We address each
argument in turn.
     Unlike DRL and Alvogen, Watson never requested con-
struction 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 re-
move bottom heating sources. It then moved under Rule
59 to reopen the court’s judgment.
    The district court denied Rule 59 relief. Rule 59 Deci-
sion, 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 nar-
rower 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. Addition-
ally, the court decided that Watson was a sophisticated lit-
igant 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 mani-
fest injustice. See United States ex rel. Schumann v. Astra-
Zeneca 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 dis-
trict court found that, while there is an interest in con-
sistency 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 De-
cision, 2016 WL 3186659, at *20.
     Watson argues that Indivior failed to show that viscos-
ity 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 vis-
cosity 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 vis-
cosity limitation requires that the viscosity of the matrix
be “sufficient to aid” in maintaining uniformity. ’514 pa-
tent col. 73 ll. 53–55. As both parties agree, viscosity is one
factor among several identified in the ’514 patent that con-
tributes to uniformity. E.g., id. col. 23 ll. 14–20. Specifi-
cally, 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 viscos-
ity limitation even if other factors than viscosity contribute
to film uniformity. Watson Decision, 2016 WL 3186659, at
*20. As previously discussed, the asserted claims them-
selves identify drying as an additional factor affecting uni-
formity. 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 va-
lidity 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 par-
ticularly 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 indefi-
niteness if its claims, read in light of the specification de-
lineating 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 In-
vents 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 dis-
pute focused on claim 62’s recitation of a “cast film compris-
ing a flowable water-soluble or water swellable film-
forming matrix.” ’514 patent col. 73 ll. 49–50. Watson al-
leged 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 prod-
uct 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 re-
cite 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 ma-
trix 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 refrigera-
tor shelf “comprising” a lower wall having a certain resili-
ence. 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 assem-
bly. 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 interpre-
tation 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 con-
tent 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. Mi-
crosoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011); Fer-
ring 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 In-
divior’s argument that the pharmaceutical film field was
nascent around the time of invention and in DRL’s argu-
ment 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 dry-
ers 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-phar-
maceutical films, citing in particular the more demanding
FDA requirements for drug content uniformity in pharma-
ceuticals. 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 pharmaceuti-
cal 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 Deci-
sion, 2017 WL 3837312, at *16. Schmidt also disclosed that
there was a regulatory requirement for drug content uni-
formity and that its processes yielded films with a repro-
ducible weight that varied within 10%. Id. at *17.
However, the district court found that Schmidt did not ex-
amine the uniformity of the film after drying, crediting In-
divior’s expert’s testimony. Id.
    Chen taught pharmaceutical films made by a casting
process and a drying oven that included top air drying noz-
zles 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 meas-
ured 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 ref-
erence disclosed a human study using its films, which im-
plicitly suggested that the films had uniform drug content.
Id. at *18. However, the court noted that Chen did not dis-
close that its films had the requisite uniformity and that
the defendants’ expert failed to produce uniform films us-
ing 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 tech-
niques, 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 tech-
niques in Strobush because Strobush did not address phar-
maceutical 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 consid-
erations supported nonobviousness. The court considered
evidence that obtaining pharmaceutical film content uni-
formity 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 ap-
proval for a pharmaceutical film. Id. Second, several pa-
pers 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 distribu-
tion of active,” “the advantageous factor which was not ap-
preciated 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 none-
theless 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 dismiss-
ing the teachings of Strobush. DRL also contends that sec-
ondary considerations do not compel nonobviousness.
    Indivior responds that the district court did not clearly
err in its factual findings and that secondary considera-
tions 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 in-
vention, 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 dry-
ing.” Id. at *15. Consequently, the court found that a per-
son 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 pharma-
ceutical 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 con-
strued, claim 62 requires a specific type of drying, i.e., with-
out solely top air drying, to achieve a specific uniformity
“subsequent to casting and drying.” Schmidt disclosed nei-
ther 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 testi-
mony that since film uniformity could be lost at the drying
step, a uniform wet film does not disclose the claimed uni-
form 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 uni-
formity 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 ra-
ther 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 bot-
tom-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 ad-
dressing a different problem.
    That finding is further supported by the court’s deter-
mination that a skilled artisan would not have had a rea-
sonable 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 manufac-
turing 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 phar-
maceutical film and received praise for its work in achiev-
ing 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 evi-
dence.
    Because we conclude that DRL has not shown clear er-
ror 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 pa-
tent as well.
            C. Infringement of the ’150 Patent
    We turn to the parties’ appeals concerning the ’150 pa-
tent, 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 prod-
uct. Id. at *3. Indivior argued that DRL’s product in-
fringed 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 in-
fringe 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 conclud-
ing that the disclosure-dedication rule applied. DRL disa-
grees 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 no-
tice function of claims. As the Supreme Court long ago ex-
plained, “[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 re-
captured 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 nonobvious-
ness 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 descrip-
tion of the invention.” The test for adequate written de-
scription “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 re-
cites a pharmaceutical film with: (1) “at least one water-
soluble polymer component consisting of [PEO] in combi-
nation 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 L-
PEO and at least one H-PEO; and (4) the L-PEO “com-
prises 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 mo-
     lecular weight PEOs with larger amounts of lower
     molecular weight PE[O]s. Desirably, such composi-
     tions contain about 60% or greater levels of the
     lower molecular weight PEO in the PEO-blend pol-
     ymer component.
     To balance the properties of adhesion prevention,
     fast dissolution rate, and good tear resistance, de-
     sirable film compositions may include about 50% to
     75% low molecular weight PEO, optionally com-
     bined with a small amount of a high molecular
     weight PEO, with the remainder of the polymer
     component containing a hydrophilic cellulosic poly-
     mer (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 ap-
plication, the court found that this passage provided ade-
quate 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 pa-
tent. According to DRL, the ’902 application fails to de-
scribe 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% L-
PEO, some H-PEO, and up to 25% HCP.
     Addressing only the examples, DRL argues that no em-
bodiment 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 cer-
tain sustained release ratio. Id. at 1322–23. However, the
specification never indicated that the ratio was “an im-
portant 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 inva-
lidity. Id. at 1327, 1329. Here, however, the ’902 applica-
tion does direct a skilled artisan to the claimed polymer
component. Consistent with the ’150 patent claims, the ap-
plication discloses that a polymer component with 60% L-
PEO 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 dis-
close 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% L-
PEO. DRL Appellant Br. 56–57 (emphasis added). DRL
indicates that the “PEO-blend polymer component” in-
cludes only PEO and not an HCP. But it provides no evi-
dence or reasoning in support of that interpretation, and
the application’s disclosure is to the contrary. For each ex-
ample formulation including an HCP, percentages for L-
PEO and H-PEO are shown for the entire polymer compo-
nent, 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 ex-
clusive of other ingredients. Accordingly, we conclude that
the district court did not clearly err in interpreting “poly-
mer component” to consistently include all the polymers in
the formulation.
    In sum, the ’902 application discloses films with vary-
ing 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 arti-
san 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 subse-
quent 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 va-
catur.
    Indivior argues that, “in general, when a claim is can-
celled, 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 moot-
ness 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 inap-
propriate 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 sta-
    tioned 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 con-
     sisting 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 mo-
     lecular 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 com-
     ponent.
’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-cv-
00422-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-cv-
01016-RGA, Judge Richard G. Andrews.
                  ______________________
MAYER, Circuit Judge, dissenting.
    There is no need for this court to reach the issue of in-
fringement 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 Thera-
peutics, 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 sublin-
gual 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 uni-
formity required in pharmaceutical films. Cross-Appel-
lants’ 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 dec-
ade prior to this date, others had achieved uniform distri-
bution 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 con-
stant weight [was] only +/-2.5% for 20 g/m² and approxi-
mately +/-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 ac-
tive 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 in-
hibit 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 ac-
tive 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 formula-
tion [i]s then coated on the non-siliconized side of a polyes-
ter 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 bot-
tom, 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-Appel-
lants’ Br. 57. In support, it contends that Schmidt only
teaches creating films with uniform weight, not with uni-
form active drug content. This argument is wholly without
merit. On its face, Schmidt asserts that the methods it dis-
closes 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 ac-
tive ingredient distribution,” J.A. 70217 (1:62), but that the
claimed invention does not suffer from the same “disad-
vantage[],” J.A. 70217 (2:14–15).
    Indivior suggests that Schmidt only measured weight
uniformity rather than drug content uniformity. Cross-Ap-
pellants’ 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 uni-
formity:
    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 compo-
    nents 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 con-
    tain 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. Cross-
Appellants 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 . . . lo-
cated 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 Stro-
bush 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 dry-
ing technique that reduces mottle could also be employed
to reduce non-uniformity.
    All the elements recited in the challenged claims of In-
divior’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 re-
quires 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), ob-
viousness demands a more “expansive and flexible ap-
proach,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415
(2007). In evaluating obviousness, the pertinent perspec-
tive 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 well-
known 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 Su-
preme Court criticized a rigid approach to determining ob-
viousness 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 ingre-
dient 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-recog-
nized 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 devel-
oping 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 facil-
itates uniform baking. See KSR, 550 U.S. at 419 (explain-
ing 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 preven-
tative 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 ap-
plication, U.S. Patent Application No. 60/473,902 (the “’902
application”). See J.A. 198. To obtain the benefit of a par-
ent 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 mat-
ter 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 later-
filed 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 no-
where conveys possession of the specific polymer compo-
nent recited in independent claim 1. That claim requires
low molecular weight polyethylene oxide (“PEO”), high mo-
lecular 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 compo-
nent and that the HCP can be no more than 25% of the
polymer component. J.A. 279 (57:36–54). The ’902 appli-
cation, 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 lim-
itations of claim 1. See J.A. 197.
    In concluding that the ’902 application supplied ade-
quate 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 preven-
    tion, fast dissolution rate, and good tear resistance,
    desirable film compositions may include about 50%
    to 75% low molecular weight PEO, optionally com-
    bined 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 molecu-
lar 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 fun-
damentally, 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 diffi-
cult 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 in-
cluding 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.