INDIVIOR INC., FKA RECKITT BENCKISER PHARMACEUTICALS INC., INDIVIOR UK LIMITED, FKA RB PHARMACEUTICALS LIMITED, AQUESTIVE THERAPEUTICS, INC., FKA MONOSOL RX, LLC, Plaintiffs-Cross-Appellants
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 INDIVIOR INC., FKA RECKITT BENCKISER PHARMACEUTICALS INC., INDIVIOR UK LIMITED, FKA RB PHARMACEUTICALS LIMITED, AQUESTIVE THERAPEUTICS, INC., Plaintiffs-Appellants
ALVOGEN PINE BROOK, LLC, Defendant-Cross-Appellant
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, 1:15-cv-00477-RGA, 1:15-cv-01016-RGA,
Judge Richard G. Andrews.
Jeffrey B. Elikan, Covington & Burling LLP, Washington,
DC, argued for all plaintiffs-cross-appellants in 2017-2587
and for all plaintiffs-appellants in 2018-1949. Indivior
Inc., Indivior UK Limited also represented by Erica Nicole
Andersen, Beth S. Brinkmann, Robert Jason Fowler, Matthew
Aaron Kudzin, Jeffrey Howard Lerner, Ashley Kwon; Dustin B.
Weeks, Troutman Sanders LLP, Atlanta, GA; Daniel Ladow, James
M. Bollinger, Magnus Essunger, Katherine Harihar, Timothy P.
Heaton, Gerald Eames Porter, New York, NY; Charanjit Brahma,
San Francisco, CA.
Francis Hibey, Steptoe & Johnson, LLP, Washington, DC,
for plaintiff-cross-appellant Aquestive Therapeutics, Inc. in
2017-2587 and for plaintiff-appellant Aquestive Therapeutics,
Inc. in 2018-1949. Also represented by Jamie Lucia, San
Paul Martin, Goodwin Procter LLP, Boston, MA, argued for
defendants-appellants Dr. Reddy's Laboratories, S.A., Dr.
Reddy's Laboratories Inc. in 2017-2587. Also represented
by Elaine Blais, Edwina Clarke, Robert Frederickson, III,
Alexandra Lu; Robert V. Cerwinski, Ira J. Levy, New York, NY.
Stephen R. Smerek, Winston & Strawn LLP, Los Angeles, CA,
argued for defendants-appellants Watson Laboratories Inc.,
Actavis Laboratories UT, Inc., Teva Pharmaceuticals USA, Inc.
in 2017-2587. Also represented by Jason Craig Hamilton;
George C. Lombardi, Michael Keenan Nutter, Chicago, IL;
Geoffrey P. Eaton, Washington, DC.
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.
Newman, Mayer, and Lourie, Circuit Judges.
LOURIE, CIRCUIT JUDGE.
Reddy's Laboratories, S.A. and Dr. Reddy's
Laboratories Inc. (collectively, "DRL"); Watson
Laboratories Inc. and Actavis Laboratories UT, Inc.
(collectively, "Watson"); and Teva Pharmaceuticals
USA, Inc. ("Teva") appeal from several decisions of
the United States District Court for the District of Delaware
pertaining to U.S. Patents 8, 603, 514 (the "'514
patent"), 8, 900, 497 (the "'497 patent"),
and 8, 017, 150 (the "'150 patent").
Specifically, DRL appeals from two decisions holding the
asserted claims of the '514, '497, and '150
patents not invalid as obvious. Reckitt Benckiser Pharm.
Inc. v. Dr. Reddy's Labs. S.A., Nos. 14-1451-RGA,
14-1573-RGA, 14-1574-RGA, 2017 WL 3837312 (D. Del. Aug. 31,
2017) ("DRL '514 Decision");
Reckitt Benckiser Pharm. Inc. v. Dr. Reddy's Labs.
S.A., No. 14-1451-RGA, 2017 WL 3782782 (D. Del. Aug. 31,
2017) ("DRL '150 Decision"). Watson
and Teva appeal from the court's judgment in a third
decision that the '514 patent is not invalid as
indefinite. Reckitt Benckiser Pharm. Inc. v. Watson
Labs., Inc., Nos. 13-1674-RGA, 14-422-RGA, 2016 WL
3186659 (D. Del. June 3, 2016) ("Watson
Decision"); J.A. 212-14. 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").
Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc.
(collectively, "Indivior") cross-appeal from the
district court's findings in the two DRL decisions that
DRL does not infringe either the '514 or the '150
patent. Indivior also appeals from a fourth decision by the
same court finding that Alvogen Pine Brook, LLC
("Alvogen") does not infringe the '514 patent.
Indivior Inc. v. Mylan Techs. Inc., 298 F.Supp.3d
775 (D. Del. 2018) ("Alvogen Decision").
Finally, Indivior requests that the court's judgment in
the Watson case of invalidity of claims 15-19 of U.S. Patent
8, 475, 832 (the "'832 patent") be vacated as
vacate as moot the district court's decision holding
claims 15-19 of the '832 patent invalid as obvious. We
affirm the court on all other issues.
markets and holds the New Drug Application ("NDA")
for Suboxone® sublingual film ("Suboxone
Film"), an opioid addiction treatment that combines two
active ingredients: the opioid buprenorphine and the opioid
antagonist naloxone. Suboxone Film is applied below a
patient's tongue, where it then rapidly dissolves to
release the active ingredients. In 2010, the Food and Drug
Administration ("FDA") approved Indivior's film
product, the first such product to gain FDA approval.
Previously, Indivior sold buprenorphine/naloxone only in a
appeals involve issues of infringement and invalidity of four
patents covering pharmaceutical films and methods of making
them. However, the parties' substantive disputes focus on
only two patents, the '514 and '150 patents. Both
patents claim pharmaceutical films and are listed in the
Orange Book as covering Suboxone Film. Representative
claims of the two patents are set forth in the Appendix. The
'497 patent is directed to film manufacturing methods,
and the parties do not distinguish it from the '514
patent with respect to the issues on appeal. Aquestive
Therapeutics, Inc. ("Aquestive") owns these three
patents and exclusively licenses them to
Indivior. The fourth patent, the '832 patent,
claims film formulations and is owned by Indivior.
Patents in Suit
'514 and '497 Patents
'514 patent claims pharmaceutical films with a uniform
distribution of active ingredient. As described in the
specification, drug content uniformity is required by
regulatory authorities yet difficult to achieve in practice
because of problems in manufacturing the films. '514
patent col. 2 ll. 18-21, 42-46, 57-59. Generally, a film may
be made by mixing an active compound with a solvent to form a
flowable matrix, casting the mixture onto a planar surface,
and then drying the film to produce a solid sheet.
Id. col. 5 ll. 41-54, col. 6 ll. 49-60.
factors in the film-making process can affect uniformity.
"By avoiding the introduction of and eliminating
excessive air in the mixing process, selecting polymers and
solvents to provide a controllable viscosity and by drying
the film in a rapid manner from the bottom up, such [uniform]
films result." Id. col. 23 ll. 16-20. Claim 62,
the sole independent claim at issue from the '514 patent,
is representative and recites "a cast film
comprising a flowable water-soluble or water swellable
film-forming matrix," "wherein the uniformity
subsequent to casting and drying of the matrix is
measured by . . . unit doses which do not vary by more than
10%" of the amount of active. Id. col. 73 ll.
49-50, col. 74 ll. 6-9 (emphases added). The claim identifies
two parameters-viscosity and drying-that contribute to film
uniformity: (1) the viscosity of the matrix must be
"sufficient to aid in substantially maintaining
non-self-aggregating uniformity" of the active (the
"viscosity limitation"); and (2) the matrix must be
"capable of being dried without loss of substantial
uniformity of the active" (the "drying
limitation"). Id. col. 73 l. 53-col. 74 l. 5.
The other asserted claims of the '514 patent all depend
from claim 62.
drying limitation is central to several of the issues on
appeal. The specification teaches that using conventional
drying methods, which apply hot air to the top of the film,
produces nonuniform films. E.g., id. col. 8
ll. 56-64, col. 22 ll. 41-60. As hot air strikes the surface
of the film, water at the surface evaporates, forming a
polymer skin that seals the aqueous composition below.
Id. col. 3 ll. 37- 42. But as heating continues, the
vapor pressure of the underlying aqueous composition builds,
causing the film surface to stretch and ultimately break to
allow the vapor to escape. Id. col. 3 ll. 45-49. The
polymer skin then reforms, and the cycle of surface
destruction and reformation continues until drying is
complete. Id. col. 3 ll. 49-52. Undesirably, this
cycle produces a dried film that is uneven and nonuniform,
which the patent refers to as the "ripple effect."
Id. col. 3 ll. 51-54.
produce a uniform film, the specification discloses
controlled drying processes that differ from conventional
techniques. In a section titled "Drying Wet Cast
Films," id. col. 28 l. 51, the specification
states that "[t]he wet film may be dried using
controlled bottom drying or controlled microwave
drying, desirably in the absence of external air currents or
heat on the top (exposed) surface of the film,"
id. col. 28 ll. 52-55 (emphasis added). Such methods
allow for vapor release without the disadvantages described
above. Id. col. 28 ll. 55-57. In contrast,
"[c]onventional convection air drying from the
top is not employed" because it produces 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.
addition to controlling the location of the source of air,
the specification teaches a "zone drying procedure"
in which the film is dried along a belt with different drying
zones that may vary in temperature, humidity, or other
atmospheric conditions. Id. col. 32 ll. 38-67. The
specification does not specify whether the air comes from the
top or bottom during zone drying but does indicate that zone
drying "dries the film without surface skinning."
Id. col. 32 ll. 49-50. Zone drying may be
supplemented with additional processes such as lamination
"so long as controlled drying is maintained in
accordance with the invention." Id. col. 33 ll.
62 also recites that the flowable matrix has a viscosity
"sufficient to aid" in maintaining film uniformity.
Id. col. 73 ll. 53-55. The specification provides
suitable ranges of matrix viscosity, which are
"generally" 400- 100, 000 centipoise,
"preferably" 800-60, 000 centipoise, and "most
preferably" 1, 000-40, 000 centipoise. Id. col.
11 ll. 26-29. The choice of polymer has an important role in
affecting viscosity and hence film uniformity. See
id. col. 11 ll. 15-24.
to the '514 patent, the '497 patent claims processes
for making pharmaceutical films. Claim 24, the sole asserted
claim, depends from claim 1, which recites a drying
limitation similar to claim 62 of the '514 patent: a
"drying" step to form a film "having a
substantially uniform distribution" of an active
compound. '497 patent col. 57 ll. 8-10. The specification
of the '497 patent is also substantively similar to that
of the '514 patent.
the '514 patent, the '150 patent is directed to
uniform pharmaceutical films, but it claims them somewhat
differently. Rather than identifying process parameters
relevant to film uniformity, as in the '514 patent, the
asserted claims of the '150 patent claim pharmaceutical
films by their components. Claim 1 is representative of the
asserted claims and recites a film comprising an active
ingredient and a water-soluble polymer component containing
certain proportions of polyethylene oxide ("PEO"),
including both low molecular weight PEO ("L-PEO")
and high molecular weight PEO ("H-PEO"), and a
hydrophilic cellulosic polymer. '150 patent col. 57 ll.
35-54. The specification lists various "useful
water[-]soluble polymers," including PEO, hydrophilic
cellulosic polymers, and a separate compound, polyvinyl
pyrrolidone. Id. col. 15 ll. 47- 52. The other
asserted claims-4, 5, 8, and 9-each depend from claim 1.
DRL '150 Decision, 2017 WL 3782782, at *1.
'150 patent claims priority from an earlier provisional
application, U.S. Patent Application 60/473, 902 (the
Decisions on Appeal
generic drug companies filed Abbreviated New Drug
Applications ("ANDAs") to market generic versions
of Suboxone Film prior to the expiration of the patents in
suit. Indivior then brought several actions for patent
infringement, accusing DRL of infringing the '514 and
'150 patents, and both DRL and Watson of infringing the
'497 patent; Watson of infringing the '514 and
'832 patents; and Alvogen of infringing the '514 and
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
Watson '514 Decision
first trial over the '514 patent involved Indivior's
claim that Watson infringed the '514 patent. Watson did
not request construction of the drying limitation. The court
found that Watson infringed the '514 patent and that
Watson did not meet its burden to prove the asserted claims
invalid as indefinite. Watson Decision, 2016 WL
3186659, at *16, *21.
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 Fed.Appx. 997 (Fed. Cir. 2016).
trial, Watson modified its film manufacturing process and
requested relief under Rule 59 from the district court's
infringement judgment. The court denied relief, finding no
manifest injustice in upholding its final judgment. Rule
59 Decision, 2017 WL 3820943, at *3.
'514 Decision and the Related Appeal
second trial over the '514 patent, the district court
considered Indivior's claims that DRL infringed the
'514 patent and that DRL and Watson infringed the
'497 patent. Unlike in the previous case, the parties
(including Watson) disputed the meaning of the drying
limitation. The court construed the drying limitation of the
'514 patent to mean "dried without solely employing
conventional convection air drying from the top,"
because it concluded that the specification disclaimed such
conventional top drying 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.
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.
the district court's judgment of noninfringement,
Indivior amended claims of a pending continuation application
that ultimately issued as U.S. Patent 9, 931, 305 (the
"'305 patent"). The amendment removed the words
"dried" and "drying" from the language of
claim 62, instead reciting that the film be "capable of
being continuously cast . . . without loss of
substantial uniformity" and that "uniformity of
the-continuously cast film is measured by . . . unit
doses cut from the continuously cast film which do
not vary by more than 10%" of the amount of the active.
'305 patent col. 73 ll. 21-29 (emphases added). The
'305 patent shares a specification with, and is
terminally disclaimed to, the '514 patent.
after the '305 patent issued, Indivior again sued DRL for
patent infringement, this time asserting the '305 patent
in the District of New Jersey. DRL had since launched its
competing generic product, and Indivior moved for a temporary
restraining order and preliminary injunction at the New
Jersey court. DRL argued that Indivior's New Jersey
action was barred as claim precluded by the Delaware
court's judgment. The New Jersey court concluded that
claim preclusion likely would not apply and that Indivior
would likely be able to prove infringement. Indivior Inc.
v. Dr. Reddy's Labs. S.A., No. 17-CV-7111, 2018 WL
3496643, at *8, *11 (D.N.J. July 20, 2018). Consequently, the
court entered a temporary restraining order and then a
preliminary injunction against DRL's generic product.
Id. at *14.
appealed to this court. Despite the claim amendments, the
panel majority held that the cast films claimed in the
'305 patent still had to be dried and were subject to the
same specification disclaimer as the '514 patent.
Indivior Inc. v. Dr. Reddy's Labs., S.A., 752
Fed.Appx. 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.
Alvogen '514 Decision
third trial over the '514 patent, the district court
considered Indivior's claim that Alvogen infringed the
'514 patent. The court construed the drying limitation as
it did in the DRL '514 Decision. Alvogen
Decision, 298 F.Supp.3d at 779. And as in the DRL case,
the court found that Alvogen's film manufacturing process
dries the films primarily from the top and thus does not meet
the drying limitation and does not infringe the asserted
claims. Id. at 784-85.
addition to the '514 patent, Indivior asserted that DRL
infringed the '150 patent under the doctrine of
equivalents. The district court held a separate trial on the
'150 patent and found that DRL does not infringe any of
the asserted claims. DRL '150 Decision, 2017 WL
3782782, at *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.
appeals from the district court's judgments that the
asserted claims of the '514, '497, and '150
patents are not invalid as obvious. Watson and Teva appeal
from the court's judgments that the '514 patent is
not invalid as indefinite, that Watson infringes the '514
patent, and that Watson is not entitled to Rule 59 relief
from the infringement judgment.
cross-appeals from the district court's determinations
that DRL does not infringe either the '514 or the
'150 patent and that Alvogen does not infringe the
'514 patent. Indivior also requests vacatur of the
court's judgment that certain claims of the '832
patent would have been obvious over the cited prior art.
jurisdiction over each appeal under 28 U.S.C. §
1295(a)(1). We first address the parties' disputes
concerning the '514 patent and then turn to the '150
and '832 patents.
appeal from a bench trial, we review a district court's
conclusions of law de novo and its findings of fact
for clear error. Braintree Labs., Inc. v. Novel Labs.,
Inc., 749 F.3d 1349, 1358 (Fed. Cir. 2014). A factual
finding is clearly erroneous if, despite some supporting
evidence, we are left with the definite and firm conviction
that a mistake has been made. United States v. U.S.
Gypsum Co., 333 U.S. 364, 395 (1948). "The burden
of overcoming the district court's factual findings is,
as it should be, a heavy one." Polaroid Corp. v.
Eastman Kodak Co., 789 F.2d 1556, 1559 (Fed. Cir. 1986).
Infringement of the '514 Patent
challenges the district court's judgments that DRL and
Alvogen do not infringe the '514 patent. Watson appeals
from the court's separate judgment that it does infringe
the '514 patent. We first consider Indivior's
cross-appeal and appeal and then turn to Watson's appeal.
infringement analysis has two steps. Clare v. Chrysler
Grp. LLC, 819 F.3d 1323, 1326 (Fed. Cir. 2016). First,
the court construes the asserted claims. Claim construction
is a question of law that may involve underlying factual
questions. Teva Pharm. USA, Inc. v. Sandoz, Inc.,
135 S.Ct. 831, 841 (2015). But when, as here, the court's
construction of the relevant limitation is based solely on
the intrinsic evidence, we review its construction de
novo. HTC Corp. v. Cellular Commc'ns Equip.,
LLC, 877 F.3d 1361, 1367 (Fed. Cir. 2017). Second, the
court determines whether the accused product meets each
limitation of the claim as construed, which is a question of
fact that we review for clear error. Wright Med. Tech.,
Inc. v. Osteonics Corp., 122 F.3d 1440, 1443 (Fed. Cir.
Indivior's Appeal and Cross-Appeal
challenges to the district court's judgments of
noninfringement largely turn on the proper construction of
the drying limitation. In the DRL and Alvogen cases, the
district court construed the drying limitation to mean
"dried without solely employing conventional convection
air drying from the top." Alvogen Decision, 298
F.Supp.3d at 779; DRL '514 Decision, 2017 WL
3837312, at *4; Claim Construction Order, 2016 WL
3621632, at *11. That construction rested on the court's
conclusion that the patentee disclaimed drying wet cast films
using solely conventional convection air drying from the top.
The court's disclaimer conclusion was based on the
'514 patent specification's express statements of
what the invention is, its repeated disparagement of
conventional top drying methods, and the patent
applicant's characterization of the invention during
prosecution. Claim Construction Order, 2016 WL
3621632, at *6, *11.
Indivior, we likewise concluded that the same
specification in the related '305 patent disclaimed
conventional top air drying. 752 Fed.Appx. at 1031-32. In
addressing whether Indivior's assertion of the '305
patent raised the same cause of action as the '514
patent, we concluded:
[T]he specification limits the scope of the
"continuously cast" limitation in the '305
claims as it limited the scope of the "drying"
limitation in the '514 claims. Specifically, films
formed with conventional top air drying methods are excluded
from the scope of both claim terms.
Id. at 1034-35 (emphasis added). We explained that
"[w]hile the language of the claim terms changed,
the scope of the claims did not materially
change." Id. at 1035 (emphasis added).
Even where different patents are asserted between two suits,
claim preclusion bars a patentee from bringing successive
suits accusing the defendant's same product of infringing
essentially the same patent claims. SimpleAir, Inc. v.
Google LLC, 884 F.3d 1160, 1167 (Fed. Cir. 2018);
see Acumed LLC v. Stryker Corp., 525 F.3d 1319, 1324
(Fed. Cir. 2008). Because-and only because- the asserted
claims of the '305 patent were materially the same as
those that were or could have been asserted in the '514
patent, we held that Indivior's action on the '305
patent was likely claim precluded and that the district court
abused its discretion in entering a preliminary injunction.
Indivior, 752 Fed.Appx. at 1035.
the DRL and Alvogen appeals, Indivior argues that the
district court erred in concluding that the '514 patent
specification disclaimed drying methods that use solely
conventional convection air drying from the top. Instead,
Indivior contends that the drying limitation should be given
its plain and ordinary meaning. To the extent that the
specification did disclaim ...