Indivior Inc. v. Dr. Reddy's Laboratories, S.A. ( 2018 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
INDIVIOR INC., INDIVIOR UK LTD., AQUESTIVE
THERAPEUTICS, INC.,
Plaintiffs-Appellees
v.
DR. REDDY'S LABORATORIES, S.A., DR. REDDY'S
LABORATORIES, INC.,
Defendants-Appellants
______________________
2018-2167, 2018-2169
______________________
Appeals from the United States District Court for the
District of New Jersey in Nos. 2:17-cv-07111-KM-CLW,
2:18-cv-01775-KM-CLW, 2:18-cv-05288-KM-CLW, Judge
Kevin McNulty.
______________________
Decided: November 20, 2018
______________________
JEFFREY B. ELIKAN, Covington & Burling LLP, Wash-
ington, DC, argued for all plaintiffs-appellees. Plaintiffs-
appellees Indivior Inc., Indivior UK Limited also repre-
sented by ERICA NICOLE ANDERSEN, BETH S. BRINKMANN,
MATTHEW AARON KUDZIN, JEFFREY HOWARD LERNER;
JAMES M. BOLLINGER, MAGNUS ESSUNGER, KATHERINE
HARIHAR, TIMOTHY P. HEATON, DANIEL LADOW, GERALD
2 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
EAMES PORTER, SUJATHA VATHYAM, Troutman Sanders
LLP, New York, NY; CHARANJIT BRAHMA, San Francisco,
CA; WILLIAM CHARLES BATON, CHARLES M. LIZZA, Saul
Ewing Arnstein & Lehr LLP, Newark, NJ.
JAMES FRANCIS HIBEY, Steptoe & Johnson, LLP,
Washington, DC, for plaintiff-appellee Aquestive Thera-
peutics, Inc. Also represented by JAMIE LUCIA, San Fran-
cisco, CA; WILLIAM CHARLES BATON, CHARLES M. LIZZA,
Saul Ewing Arnstein & Lehr LLP, Newark, NJ.
KEVIN PAUL MARTIN, Goodwin Procter LLP, Boston,
MA, argued for defendants-appellants. Also represented
by ELAINE BLAIS, EDWINA CLARKE, ROBERT FREDERICKSON,
III, ALEXANDRA LU; ROBERT V. CERWINSKI, IRA J. LEVY,
ALEXANDRA D. VALENTI, New York, NY.
______________________
Before NEWMAN, LOURIE, and STOLL, Circuit Judges.
Opinion for the court filed by Circuit Judge STOLL.
Dissenting Opinion filed by Circuit Judge NEWMAN
STOLL, Circuit Judge.
Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Labor-
atories, Inc. (collectively, “DRL”) appeal from the district
court’s order granting Indivior Inc., Indivior UK Ltd., and
Aquestive Therapeutics Inc.’s (collectively, “Indivior”)
preliminary injunction in this patent infringement case.
Because the district court’s conclusion that Indivior was
likely to succeed on the merits was based on an erroneous
interpretation of claim scope, we vacate the preliminary
injunction.
BACKGROUND
Indivior developed and now markets Suboxone Film, a
leading treatment for opioid dependency. Suboxone Film
contains two active ingredients: buprenorphine, which
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 3
decreases a patient’s need for opioids, and naloxone,
which deters abuse. Suboxone Film is a rapidly dissolv-
ing film formulation that adheres to the underside of a
patient’s tongue. One of the challenges in developing
pharmaceutical films is maintaining drug content uni-
formity. These films are initially produced as large sheets
that are then cut into individual dosage units. It is criti-
cal to ensure that the sheets have content uniformity so
that the individual doses contain equal amounts of drug.
Content uniformity is therefore essential to the safety of a
pharmaceutical film and is a prerequisite to regulatory
approval.
Indivior’s Suboxone Film is covered by U.S. Patent
Nos. 9,931,305 and 8,603,514. The ’305 patent is the only
patent at issue in this case. It is related to the ’514 pa-
tent, sharing the same specification. The patents’ shared
specification discloses various methods of producing films
that have drug content uniformity. ’305 patent col. 1
ll. 55–59. These methods generally involve mixing a
pharmaceutically active ingredient with a polymer in a
solvent, casting the mixture onto a planar carrier surface
to form a wet film, and then controllably drying the film
to produce a solid sheet having less than ten percent
variance in active ingredient throughout any given area.
Id. at col. 7 ll. 1–11. The resulting sheet of thin film can
then be cut into individual dosage units. Id. at col. 4
ll. 50–52.
The specification teaches that conventional drying
methods—which only apply warm air to the top of the wet
film—produce films that do not have the claimed content
uniformity. Id. at col. 9 ll. 13–18. The specification
explains that conventional methods that apply heat only
to the top of the film cause the water on the surface to
evaporate. Id. at col. 3 l. 48–col. 4 l. 3. This creates a
polymer skin barrier on the surface of the film. Id. As
the temperature outside the film continues to increase,
water vapor pressure builds up underneath the barrier,
4 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
ultimately ripping the surface open allowing the water
vapor to escape. Id. The polymer skin then reforms and
the process repeats until the film is completely dry. Id.
This repeated destruction and reformation of the film
surface produces uneven, non-uniform films and is known
as “rippling.” Id. at col. 23 ll. 10–14.
The specification discloses controlled drying tech-
niques that avoid the “rippling” problems produced by
conventional drying methods. Id. at col. 23 ll. 10–21. The
specification explains that “[t]he objective of the drying
process is to provide a method of drying films that avoids
complications, such as the noted ‘rippling’ effect, that are
associated with conventional drying methods.” Id.
at col. 23 ll. 10–14. The invention’s controlled drying
techniques include applying heat to the bottom of the
film, introducing controlled microwaves, controlling the
air flow above and beneath the film, and employing
furnace filters. Id. at col. 23 ll. 22–39, col. 54 ll. 20–21.
These techniques control heat distribution during the
drying process and produce content-uniform films. Id.
The Delaware Case
DRL’s predecessor in interest had previously submit-
ted two Abbreviated New Drug Applications (“ANDA”) to
market a generic version of Suboxone Film. In response,
Indivior filed suit under the Hatch-Waxman Act in the
District Court for the District of Delaware (“Delaware
Court”) (the “Delaware Case”), alleging infringement of
several patents, including the ’514 patent. Claim 62 of
the ’514 patent reads:
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 so substantially water soluble or wa-
ter swellable polymers; and a desired amount of at
least one active;
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 5
wherein said matrix has a viscosity sufficient
to aid in substantially maintaining non-self-
aggregating uniformity of the active in the matrix;
(ii) a particulate active substantially uniformly
stationed in the matrix; and
(iii) a taste-masking agent selected from the group
consisting of flavors, sweeteners, flavor enhanc-
ers, 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 wa-
ter-soluble or water swellable film-forming matrix
is capable of being dried without loss of substan-
tial uniformity in the stationing of said particulate
active therein; and
wherein the uniformity subsequent to casting
and drying of the matrix is measured by substan-
tially 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 (emphases added).
The Delaware Court determined that the patentee
disavowed solely using conventional air drying from the
top to produce the claimed films. See Reckitt Benckiser
Pharm. Inc. v. Teva Pharm. USA, Inc., No. 14-CV-1451-
RGA, 2016 WL 3621632, at *6, *11 (D. Del. June 29,
2016). It noted that the ’514 patent’s specification ex-
pressly disclaimed and disparaged these methods, and
that Indivior was “unable to point to a single portion of
the specification contemplating the use of top air drying
alone.” Id. at *6–7, *11. The Delaware Court therefore
construed “dried” to mean “dried without solely employing
conventional convection air drying from the top.” Id.at *10–11.
6 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
The Delaware Court conducted a four-day bench trial
and determined that DRL’s ANDA process does not
infringe the asserted ’514 patent claims. Reckitt Benck-
iser Pharm. Inc. v. Dr. Reddy’s Labs. S.A., No. 14-CV-
1451-RGA, 2017 WL 3837312, at *6 (D. Del. Aug. 31,
2017) (“Delaware Decision”). The Delaware Court found
that DRL’s process employs “dryers where the sole source
of heat is hot air coming from air nozzles over the liner.”
Id. at *5. It was unpersuaded that this process was
unconventional. Id. at *6. Based on this, the Delaware
Court concluded that Indivior failed to meet its burden of
showing that DRL infringes the asserted ’514 patent
claims. Id. at *20. The Delaware case is currently on
appeal to this court. See Indivior Inc. v. Dr. Reddy’s
Labs., S.A., No. 17-2587 (Fed. Cir. filed Oct. 13, 2017).
The Current Case
After the Delaware Court entered its judgment of non-
infringement, Indivior amended certain claims of a then-
pending application that ultimately issued as the ’305
patent. Indivior amended the claims to remove the words
“dried” and “drying,” and to add “continuously” and “con-
tinuously cast” in their place. It also filed a terminal
disclaimer to overcome obviousness-type double patenting
rejections based on the claims of the ’514 patent. J.A.
6551–52. The application issued as the ’305 patent on
April 3, 2018. Claim 26 reads:
26. A drug delivery composition comprising:
(i) a continuously cast film produced on a manu-
facturing line comprising a flowable water-soluble
or water swellable film-forming matrix comprising
one or more substantially water soluble or water
swellable polymers; and 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;
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 7
(ii) a particulate active substantially uniformly
stationed in the matrix; and
(iii) a taste-masking agent selected from the group
consisting of flavors, sweeteners, flavor enhanc-
ers, 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 wa-
ter-soluble or water swellable film-forming matrix
is capable of being continuously cast on the manu-
facturing line without loss of substantial uni-
formity in the stationing of said particulate active
therein; and
wherein said uniformity of the continuously
cast film is measured by substantially equally
sized individual unit doses cut from the continu-
ously cast film which do not vary by more than
10% of a desired amount of said at least one ac-
tive.
’305 patent col. 73 ll. 4–29 (emphases added).
That same day, Indivior accused DRL’s same ANDA
process of infringing the ’305 patent in the District Court
for the District of New Jersey. A few months later, the
FDA approved DRL’s ANDAs for its generic Suboxone
Film and DRL launched the same day. J.A. 11068.
Indivior immediately moved for a temporary restraining
order and a preliminary injunction, seeking to enjoin DRL
from selling its product. J.A. 516. The TRO was granted
on the same day after a telephone conference. The dis-
trict court then conducted a hearing on the preliminary
injunction motion. Indivior Inc. v. Dr. Reddy’s Labs. S.A.,
No. 17-CV-7111, 2018 WL 3496643, at *2 (D.N.J. July 20,
2018) (“Decision”). It granted the preliminary injunction
shortly after. Id. at *14.
8 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
In granting the preliminary injunction, the district
court concluded that Indivior was likely to succeed on the
merits of its infringement claim. Id. at *11. The district
court’s decision was largely based on its interpretation of
the ’305 patent’s claim scope. It considered the Delaware
Court’s determination of specification disclaimer and
declined to apply it to the ’305 claims. It concluded that
the claims, which lack an express “drying” limitation, do
not exclude any particular drying method. Id. at *7. The
district court credited Indivior’s expert over DRL’s and
declined to import a drying step into the “continuously
cast” limitation—the limitation that Indivior added
during prosecution to replace the terms “drying” and
“dried.” Id. at *8. According to the district court, the ’305
claims do not include a drying limitation. Id.
Based largely on this reasoning, it determined that
Indivior’s suit was not barred by claim preclusion in light
of the Delaware Case. Id. The district court considered it
likely that Indivior would be able to show that the
’305 claims are not “patentably indistinct” from the
’514 claims, and thus would likely show that the suit was
not barred by claim preclusion under SimpleAir, Inc. v.
Google LLC, 884 F.3d 1160 (Fed. Cir. 2018). It further
determined that Indivior would likely be able to show that
DRL’s ANDA would infringe the ’305 patent. Id. at *9–
11. It then weighed the remaining preliminary injunction
factors in favor of Indivior and granted the preliminary
injunction. Id. at *11–14.
DRL appeals the district court’s grant of the prelimi-
nary injunction. We have jurisdiction pursuant to
28 U.S.C. § 1292.
DISCUSSION
“To obtain a preliminary injunction, a party must
show ‘that [it] is likely to succeed on the merits, that [it] is
likely to suffer irreparable harm in the absence of prelim-
inary relief, that the balance of equities tips in [its] favor,
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 9
and that an injunction is in the public interest.’” Lumina-
ra Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343,
1352 (Fed. Cir. 2016) (quoting Winter v. Nat. Res. Def.
Council, Inc., 555 U.S. 7, 20 (2008)).
We review a district court’s grant of a preliminary in-
junction for an abuse of discretion. Abbott Labs. v.
Sandoz, Inc., 544 F.3d 1341, 1345 (Fed. Cir. 2008). In
reviewing a district court’s reasoning justifying a prelimi-
nary injunction, “we review factual findings for clear
error, conclusions of law de novo, and the exercise of a
district court’s discretion for a clear error of judgment in
weighing relevant factors.” Nat’l Steel Car, Ltd. v. Cana-
dian Pac. Ry., Ltd., 357 F.3d 1319, 1325 (Fed. Cir. 2004).
Likelihood of Success: Specification Disclaimer
We conclude that the district court abused its discre-
tion in granting the preliminary injunction. The
’305 patent specification disclaims solely using conven-
tional top air drying to produce films with the claimed
content uniformity. Because the ’305 claims thus do not
cover such films, Indivior has not shown that it is likely to
succeed on the merits of its infringement claim.
The inventors of the ’305 patent expressly disclaimed,
through remarks in the specification, solely using conven-
tional top air drying to produce films with the claimed
content uniformity. The patent distinguishes these
conventional methods from the present invention and
disparages their use, stating that these methods result in
films that do not have content uniformity—a key feature
of the invention. Under our case law on specification
disclaimer, such statements exclude from the scope of the
’305 claims films formed using these drying methods.
When construing claims, the specification “is the sin-
gle best guide to the meaning of a disputed term” and is
usually “dispositive.” Phillips v. AWH Corp., 415 F.3d
1303, 1315 (Fed. Cir. 2005) (en banc). In particular, “the
10 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
specification may reveal an intentional disclaimer, or
disavowal, of claim scope by the inventor. In that in-
stance as well, the inventor has dictated the correct claim
scope, and the inventor’s intention, as expressed in the
specification, is regarded as dispositive.” Id. at 1316
(citing SciMed Life Sys., Inc. v. Advanced Cardiovascular
Sys., Inc., 242 F.3d 1337, 1343–44 (Fed. Cir. 2001)).
“Disavowal requires that ‘the specification make[ ]
clear that the invention does not include a particular
feature.’” Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509,
513 (Fed. Cir. 2015) (quoting SciMed, 242 F.3d at 1341).
“To find disavowal of claim scope through disparagement
of a particular feature, we ask whether ‘the specification
goes well beyond expressing the patentee’s preference
. . . [such that] its repeated derogatory statements about
[a particular embodiment] reasonably may be viewed as a
disavowal.’” Id. (quoting Chicago Bd. Options Exch., Inc.
v. Int’l Sec. Exch., LLC, 677 F.3d 1361, 1372 (Fed. Cir.
2012)).
In SciMed, we instructed that
[w]here the specification makes clear that the in-
vention does not include a particular feature, that
feature is deemed to be outside the reach of the
claims of the patent, even though the language of
the claims, read without reference to the specifica-
tion, might be considered broad enough to encom-
pass the feature in question.
SciMed, 242 F.3d at 1341. There, we determined that the
patent claims covered balloon dilation catheters with co-
axial lumens and excluded catheters with dual lumens,
even though no language in the claims expressly provided
for such an exclusion. Id. at 1340. The specification cited
the disadvantages of prior art dual lumens and pointed
out the advantages of the co-axial lumens that were the
subject of the SciMed patents. Id. at 1342–43. The
patent’s characterization of the “present invention” also
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 11
included several references to an annular, i.e. coaxial
lumen. Id. at 1343. Further, the specification disclosed
that an annular sleeve structure “is the basic sleeve
structure for all embodiments of the present invention
contemplated and disclosed herein.” Id. We held that the
specification language “defines SciMed’s invention in a
way that excludes the dual, or side-by-side, lumen ar-
rangement.” Id.In Openwave, we affirmed the district court’s con-
struction of “mobile device” to exclude devices containing
computer modules. 808 F.3d at 517. The patent specifi-
cation was “rife with remarks that disparage and, there-
fore, disclaim mobile devices that incorporate computer
modules.” Id. at 514. The patent detailed the many
problems of incorporating a computer module into a
mobile device, and distinguished the present invention
from prior art devices that did just that. Id. at 515–16.
We concluded that “it is difficult to envisage how, in light
of the repeated disparagement of mobile devices with
‘computer modules’ discussed above, one could read the
claims of the patents-in-suit to cover such devices.” Id.
at 517.
Similar to SciMed and Openwave, the ’305 patent is
“rife with remarks that disparage, and therefore, dis-
claim” solely using conventional top air drying to form
films. Id. at 514. The specification instructs that using
such methods produces films without content uniformi-
ty—a claim limitation and a key feature of the invention.
The patent specification states that “conventional dry-
ing methods themselves are unable to provide uniform
films.” ’305 patent col. 3 ll. 29–31. Conventional drying
methods that dry only the top of the film produce a “ripple
effect” that results in “an uneven, and therefore non-
uniform film.” Id. at col. 3 l. 57–col. 4 l. 3. The specifica-
tion teaches that the rippling effect produced by conven-
tional drying methods can be “avoided by the present
12 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
invention,” by “applying heat to the bottom surface of the
film with substantially no top air flow,” or by introducing
“controlled microwaves.” Id. at col. 23 ll. 18–29. In its
discussion of drying wet cast films, the patent discloses
that a “wet film may be dried using controlled bottom
drying . . . desirably in the absence of external air cur-
rents or heat on the top.” Id. at col. 29 ll. 30–33. Notably,
an embodiment in the specification discloses that
“[c]onventional convection air drying from the top is not
employed because it initiates drying at the top uppermost
portion of the film . . . Such dried upper portions serve as
a barrier to further vapor release as the portions beneath
are dried, which results in non-uniform films.” Id.
at col. 29 ll. 36–43 (emphasis added). The specification
further explains that “[i]f top air is employed, it is bal-
anced with the bottom air drying to avoid non-uniformity
and prevent film lift-up on the carrier belt.” Id. at col. 29
ll. 48–50.
The ’305 patent also discloses two examples that
further disparage the use of conventional drying. In
Example CG, the films were dried “according to conven-
tional drying techniques, rather than via the uniform
drying process of the present invention.” Id. at col. 53
l. 67–col. 54 l. 2. The resulting films showed imprints of
the wire rack after drying, indicating aggregations at the
points of contact with the wires and non-uniformity. Id.
at col. 54 ll. 6–14. In contrast, employing a furnace filter
to uniformly distribute heat produced a uniform film. Id.
at col. 54 ll. 19–24. In Example CH, the films were dried
in an air oven “by conventional top and bottom drying
means,” which resulted in aggregations and non-
uniformity similar to that in Example CG. Id. at col. 54
ll. 42–54.
Like SciMed and Openwave, the specification distin-
guishes conventional methods from the present invention:
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 13
In a further aspect of the present invention,
methods of forming the films of this invention are
provided, by wet casting methods and hot melt ex-
trusion methods. In a wet casting method, the
film product is formed by combining a polymer
and a polar solvent, forming the combination into
a film, and drying the film in a controlled manner.
Preferably, the film is dried initially only applying
heat to the bottom side of the film, in order to
maintain a non-self-aggregating uniform hetero-
geneity.
Id. at col. 4 ll. 59–67 (emphasis added).
In still other embodiments, there is provided a
method of preparing a thin film drug delivery ve-
hicle having a substantially uniform distribution
of components including . . . (e) forming a wet film
from the matrix; (f) rapidly forming a visco-elastic
film by applying hot air currents to the bottom side
of the wet film with substantially no top air
flow . . .
Id. at col. 7 ll. 11–29 (emphasis added).
For the purposes of the present invention the term
non-self-aggregating uniform heterogeneity refers
to the ability of the films of the present invention
to provide a substantially reduced occurrence of,
i.e. little or no, aggregation or conglomeration of
components within the film as is normally experi-
enced when films are formed by conventional dry-
ing methods such as a high-temperature air-bath
using a drying oven, drying tunnel, vacuum drier,
or other such drying equipment.
Id. at col. 9 ll. 10–18 (emphasis added).
The above passages show that the patentee expressly
disclaimed the sole use of conventional top air drying to
produce the claimed films. Such disavowal places films
14 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
formed by these methods outside the scope of the
’305 claims.
Indivior argues that the ’305 claims are not limited to
any particular drying method because “dried/drying has
no textual basis” in the claims. Appellee Br. 25. Accord-
ing to Indivior, the specification disclaimer found by the
Delaware Court in its analysis of the ’514 patent was
“rooted in the meaning of the claim language ‘dried’ and
‘drying,’” and does not apply to the ’305 claims because
those terms are absent. Id. at 24–26. Indivior further
argues that removal of the drying terms during prosecu-
tion removes any limitation on how the film is dried. Id.
at 30–31.
We disagree with Indivior and conclude that the
’305 claims exclude conventional top air drying. First of
all, the drying limitation has a textual basis in the term
“continuously cast film,” which appears in claims 1 and 26
of the ’305 patent. ’305 patent col. 68 l. 53, col. 69 l. 14,
col. 73 l. 5, 25. These claims recite films formed by wet
casting, one of the two film forming methods disclosed by
the patent. See id. at Abstract. They state that the film
is initially produced as a “flowable” matrix and that the
content uniformity of the film is measured by “individual
unit doses cut from the continuously cast film.” Id.
at col. 68 ll. 53–56, col. 69 ll. 11–14, col. 73 ll. 5–7, 25–27
(emphasis added). The patent instructs that “[i]n a wet
casting method, the film product is formed by combining a
polymer and a polar solvent, forming the combination into
a film, and drying the film in a controlled manner.” Id.
at col. 4 ll. 61–64 (emphasis added). The parties submit-
ted expert declarations with their briefing on the prelimi-
nary injunction motion before the district court. Indivior’s
expert, Dr. Langer, explained in his declaration that:
[t]o make a continuously cast film, the flowable
coating matrix is then continuously deposited, or
coated, onto a substrate . . . . The coating matrix
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 15
is deposited on the moving substrate and is car-
ried through an oven where the solvent is largely
removed, resulting in a continuously cast film on
the substrate that is rolled for further processing
(i.e., cutting into individual dosage units and
packaging).
J.A. 1313 ¶ 47 (emphasis added). The “continuously cast
film” in claims 1 and 26 thus requires drying as the film
starts out as a liquid and ends up as a solid that can be
cut into individual dosages.
In any event, even if the claims did lack a textual
hook for drying, we do not read our precedent as requiring
such a hook under the circumstances in this case. As we
have explained,
[w]here the specification makes clear that the in-
vention does not include a particular feature, that
feature is deemed to be outside the reach of the
claims of the patent, even though the language of
the claims, read without reference to the specifica-
tion, might be considered broad enough to encom-
pass the feature in question.
SciMed, 242 F.3d at 1341. Here, the specification makes
clear that the invention does not include films that were
dried using conventional top air drying.
Indivior agrees that the claimed films are solid and
have been dried, however, it disagrees that a dried film
limits the ’305 claims by how the film is dried. Appellee
Br. 34. We disagree. The specification makes clear that a
film produced using only conventional top air drying
cannot satisfy the claim limitations. In particular, the
specification warns that one cannot obtain the claimed
level of drug content uniformity in the final cast film by
using only conventional top air drying. See ’305 patent
col. 3 ll. 29–31, col. 29 ll. 36–43, 48–50. As such, the
express disclaimer of conventional top air drying in the
16 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
specification disavows not just a process step from process
claims, but also films produced by these drying methods
from the scope of the ’305 composition claims.
Indivior nonetheless argues that it is improper to
import drying, a process limitation, into the ’305 patent’s
composition claims because there is an absence of “specific
process language.” Appellee Br. 33–34. As a general rule,
product claims are not limited to the method of manufac-
ture disclosed in the specification. “The method of manu-
facture, even when cited as advantageous, does not of
itself convert product claims into claims limited to a
particular process.” Vanguard Prod. Corp. v. Parker
Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000).
However, “process steps can be treated as part of a prod-
uct claim if the patentee has made clear that the process
steps are an essential part of the claimed invention.”
Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361,
1375 (Fed. Cir. 2007).
In Andersen, we held that claims in a group of patents
directed to a “composite structural member” included a
pelletizing process, even though the claims themselves did
not “contain an explicit process-based limitation.” Id.at 1371–74. The patents’ specification disclosed that the
manufacture of the composite members “requires two
important steps. A first blending step and a second
pelletizing step.” Id. at 1372. It also disclosed that these
steps are necessary to obtain the “intimate mixing” that
the “specification identifies as critical to the strength of
the composite and ultimately, the claimed structural
members.” Id. We noted that “the specifications thus
make clear that the inventors regarded the pelletization
process as an essential step in producing the ultimate
products—the structural members that were claimed in
the Group II patents.” Id. at 1375. After considering the
specification and the prosecution history, we construed
the asserted claims to be limited to composite structural
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 17
members produced with “an intermediate step of pelleti-
zation or linear extrusion.” Id.In Medicines Co. v. Mylan, Inc., we construed a claim
term “batches” to require that the product be made by an
“efficient mixing” process. 853 F.3d 1296, 1302 (Fed. Cir.
2017). The specification defined “batches” as either “all
batches prepared by a same compounding process” or “a
single batch . . . wherein the levels of [Asp9 -bivalirudin]
represent levels for all potential batches made by said
processes.” Id. at 1303. The parties agreed that the
“batches” must be made by a particular compounding
process. Id. at 1303–04. The patentee argued, however,
that “the claims do not require the use of a particular
process that achieves batch consistency.” Id. at 1303. We
rejected that argument and held that the prosecution
history and the specification of the patents “demonstrate
that the invention disclosed by the . . . patents is a com-
pounding process that achieves batch consistency,” which
the specification taught could only be achieved using
“efficient mixing.” Id. at 1304. We noted that “our deci-
sion does not impermissibly add a process limitation to a
product claim that does not require a process because the
specification’s definition of ‘batches’ by itself injects a
compounding process as a limitation in the asserted
claims.” Id.
As in Medicines, we are not “impermissibly add[ing] a
process limitation to a product claim that does not require
a process” because here, the claim term “continuously cast
film” does require a process—the film is made through
continuous casting. Id. The ’305 patent discloses only
two methods of forming the films: wet casting and extru-
sion. Claims 1 and 26 clearly describe films that are
formed by a wet casting method, which the specification
describes as “combining a polymer and a polar solvent,
forming the combination into a film, and drying the film
in a controlled manner.” ’305 patent col. 4 ll. 61–64. The
claims themselves describe “continuously cast film” in
18 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
terms of processes as well. The “continuously cast film” is
“produced on a manufacturing line comprising a flowa-
ble . . . film-forming matrix,” which is “capable of being
continuously cast on the manufacturing line without loss
of substantial uniformity.” Id. at col. 73 ll. 5–23 (empha-
sis added). The uniformity of the “continuously cast film”
is measured by “individual unit doses cut from the con-
tinuously cast film which do not vary by more than 10%”
of a desired amount of active ingredient. Id. at col. 73
ll. 25–29. The “continuously cast film” thus describes a
film formed by the wet casting method described in the
specification, which necessarily requires drying.
Further, similar to Andersen, Indivior’s patent specifi-
cation makes clear that the drying process is an essential
part of the ’305 claimed invention. See Andersen,
474 F.3d at 1375. The claims require content uniformity
such that the desired amount of active ingredient does
“not vary by more than 10%” in the individual unit doses.
’305 patent col. 73 ll. 25–29. As we discussed above,
Indivior expressly disavowed the sole use of conventional
top air drying, warning that these methods cannot form
content uniform films. See e.g., id. at col. 3 ll. 29–31
(“[T]he conventional drying methods themselves are
unable to provide uniform films.”), col. 29 ll. 36–43 (“Con-
ventional convection air drying from the top is not em-
ployed because it initiates drying at the top uppermost
portion of the film, thereby forming a barrier against fluid
flow. . . which results in non-uniform films.”), col. 29
ll. 48–50 (“If top air is employed, it is balanced with the
bottom air drying to avoid non-uniformity and prevent
film lift-up on the carrier belt.”). Content uniformity is an
express claim limitation and is described as a problem in
the prior art that the ’305 patent aims to solve. Id.at col. 4 ll. 23–39, col. 69 ll. 14–15, col. 73 ll. 28–29. If, as
the specification explains, content uniformity cannot be
achieved using conventional drying methods, then using
non-conventional drying methods is necessarily a part of
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 19
the claimed invention—it is essential. A drying process
limitation is therefore properly read into the claims
through the operation of specification disclaimer.
We hold that the ’305 claims exclude films produced
solely by conventional top air drying methods. We con-
clude that Indivior has not shown that it is likely to
succeed on the merits of its infringement claim under this
construction.
Likelihood of Success: Claim Preclusion
We further hold that claim preclusion likely bars In-
divior’s suit as the ’514 claims and the ’305 claims are
patentably indistinct.
In determining whether claim preclusion applies, “we
apply the law of the regional circuit in which the district
court sits,” here the Third Circuit. SimpleAir, 884 F.3d
at 1165. Claim preclusion requires “(1) a final judgment
on the merits in a prior suit involving; (2) the same par-
ties or their privities; and (3) a subsequent suit based on
the same cause of action.” CoreStates Bank, N.A. v. Huls
Am., Inc., 176 F.3d 187, 194 (3d Cir. 1999). We compare
the claims to determine whether there is “the same cause
of action.” SimpleAir, 884 F.3d at 1165.
[W]here different patents are asserted in a first
and second suit, a judgment in the first suit will
trigger claim preclusion only if the scope of the as-
serted patent claims in the two suits is essentially
the same. In applying that standard to the partic-
ular context here, we conclude that claims which
are patentably indistinct are essentially the same.
Id. at 1167. Regarding continuation patents, we instruct-
ed that a terminal disclaimer does not conclusively show
that the claim scope of a parent patent and a child patent
is the same. Id. at 1168. But, “a terminal disclaimer is a
strong clue that a patent examiner and, by concession, the
20 INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A.
applicant, thought the claims in the continuation lacked a
patentable distinction over the parent.” Id.
The parties and the accused products are the same
here as in the Delaware Case, where there was a final
judgment on the merits. See Delaware Decision, 2017 WL
3837312 at *1 n.1, *20. The only claim preclusion ele-
ment at issue here is whether this case is “based on the
same cause of action” as the Delaware Case. CoreStates,
176 F.3d at 194. We thus examine whether the
’514 patent claims are “patentably indistinct” from the
’305 patent claims. See SimpleAir, 884 F.3d at 1167. We
conclude that they are and that claim preclusion likely
applies.
The ’305 patent has the same specification as the
’514 patent. The only difference between the ’305 claims
asserted here and the ’514 claims asserted in the Dela-
ware Case is that the ’305 claims contain the term “con-
tinuously cast” in place of “dried” and “drying.” Compare
’514 patent col. 73 l. 48–col. 74 l. 9, with ’305 patent
col. 73 ll. 4–29. There is no dispute that there are no
other material differences between the claims. As we
discussed above, the 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. While the language of the claim terms
changed, the scope of the claims did not materially
change. The claims of the ’305 patent are thus “patenta-
bly indistinct” from those of the ’514 patent.
Our conclusion is furthered by Indivior’s filing of a
terminal disclaimer. During prosecution of the
’305 patent, Indivior received obviousness-type double
patenting rejections over the claims of the ’514 patent.
J.A. 4360–61. In response, Indivior amended its claims to
replace the “drying” and “dried” limitations with “contin-
INDIVIOR INC. v. DR. REDDY’S LABORATORIES., S.A. 21
uously cast.” J.A. 4344–45, 4354–55. It also filed a
terminal disclaimer at the same time. J.A. 4360–61,
6556. While not dispositive, the filing of a terminal
disclaimer here is a “strong clue” that the claims of the
’305 patent are patentably indistinct from those of the
’514 patent. SimpleAir, 884 F.3d at 1168.
We hold that the ’305 claims are patentably indistinct
from the ’514 claims and that claim preclusion is likely to
apply. As a result, Indivior has not shown that it is likely
to succeed on the merits of its infringement claim against
DRL.
IV
Based on the record with the proper interpretation of
claim scope, we conclude that Indivior has not shown that
it is likely to succeed on the merits of its infringement
claim. The district court thus abused its discretion in
granting the preliminary injunction. Having held that
the district court’s likelihood of success analysis was an
abuse of discretion, we need not reach the other prelimi-
nary injunction factors. Accordingly, we vacate the pre-
liminary injunction and remand to the district court for
further proceedings.
VACATED AND REMANDED
COSTS
Costs to Appellants.
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
INDIVIOR INC., INDIVIOR UK LIMITED,
AQUESTIVE THERAPEUTICS, INC.,
Plaintiffs-Appellees
v.
DR. REDDY’S LABORATORIES, S.A., DR. REDDY’S
LABORATORIES, INC.,
Defendants-Appellants
______________________
2018-2167, 2018-2169
______________________
Appeals from the United States District Court for the
District of New Jersey in Nos. 2:17-cv-07111-KM-CLW,
2:18-cv-01775-KM-CLW, 2:18-cv-05288-KM-CLW, Judge
Kevin McNulty.
______________________
NEWMAN, Circuit Judge, dissenting.
The district court, on full and careful analysis of law
and equity, imposed a preliminary injunction pending
trial. 1 The court held that the enjoined party, Dr. Reddy’s
Laboratories, could readily be made whole by monetary
payment if the injunction was imposed in error, whereas
1 Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 17–
7111, 2018 WL 3496643 (July 19, 2018) (“D.N.J. Op.”).
2 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
Indivior could not recover its reputation and market share
if the injunction was erroneously denied. D.N.J. Op. at
*1, *12–13. The court required an injunction bond of $72
million, which the record states has been posted. My
colleagues ignore this reasoning, disregard the requisite
appellate standard of review, lift the injunction, and
authorize Dr. Reddy’s to make an “at risk” launch of its
counterpart of Indivior’s Suboxone®. I respectfully dis-
sent, for on the applicable standards of law and proce-
dure, the district court’s ruling should be sustained.
The preliminary injunction is an act of equi-
ty and is reviewed accordingly
“The purpose of a preliminary injunction is to pre-
serve the relative positions of the parties until a trial on
the merits can be held.” Univ. of Tex. v. Camenisch, 451
U.S. 390, 395 (1981); see also Smith Int’l, Inc. v. Hughes
Tool Co., 718 F.2d 1573, 1578 (Fed. Cir. 1983) (“A prelim-
inary injunction will normally issue only for the purpose
of preserving the status quo and protecting the respective
rights of the parties pending final disposition of the
litigation.”). The district court’s injunction was for this
purpose; it is a discretionary act, and is required to be
reviewed accordingly.
The district court reviewed the equities and recog-
nized the irreparable harm that would befall Indivior in
the absence of an injunction, noting that Dr. Reddy’s
knowingly risked the district court’s grant of such interim
relief. The district court found that Dr. Reddy’s “chose to
enter the market ‘at risk’ and took the chance it could face
a potential injunction against its product.” D.N.J. Op. at
*13. The district court concluded that the balance of
harms “appears to favor Indivior.” Id. at *1.
My colleagues do not consider the district court’s equi-
table discretion, and instead make appellate findings of
the merits of infringement, although there has been no
trial of infringement. My colleagues erroneously apply a
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 3
decision of the district court in Delaware on a different
patent with different claims, although that decision is
pending on appeal. While that appeal has not yet been
heard, my colleagues rely on the Delaware court’s ruling
to overturn the New Jersey district court’s equitable
action, an injunction pendente lite. With all respect to my
colleagues, they err in fundamental ways.
As the Court has related, “the decision whether to
grant or deny injunctive relief rests within the equitable
discretion of the district courts.” eBay, Inc. v. Mer-
cExchange, L.L.C., 547 U.S. 388, 394 (2006). “[S]uch
discretion must be exercised consistent with traditional
principles of equity, in patent disputes no less than in
other cases governed by such standards.” Id.The New Jersey district court considered the prelimi-
nary arguments related to patent validity, for the only
noteworthy invalidity argument related to the written
description; there was no prior art of significance. D.N.J.
Op. at *9–11. This aspect, together with other prelimi-
nary injunction factors, supports the district court’s
discretionary ruling to preserve the status quo pending
trial. Id. at *11–14. The only issue before us is whether
the district court had discretionary authority to preserve
the status quo during the litigation.
The majority errs in its finding of “specifica-
tion disclaimer”
The panel majority “read[s]” a “drying process limita-
tion” from the specification of the ’305 patent into the
claims “through the operation of specification disclaimer.”
Maj. Op. at 19. However, the invention claimed in the
’305 patent is not a drying method: it is a film for trans-
mucosal administration of an active ingredient. See, e.g.,
’305 patent, claim 26 (claiming a “drug delivery composi-
tion” as defined); Maj. Op. 6–7 (setting forth claim 26 in
full). As the courts have repeatedly stated: “It is the
claims that define the metes and bounds of the patentee’s
4 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
invention.” Thorner v. Sony Comput. Entm’t Am. LLC,
669 F.3d 1362, 1367 (Fed. Cir. 2012).
The ’305 specification states that the drying should
avoid agglomeration of the solid ingredients, and that
bottom-up drying is preferred over solely top-down drying;
however, the ’305 patent also states that bottom-up
drying is not the only method of drying and that it can be
combined with top-down drying, or replaced with viscosity
control by polymer composition and other film-forming
methods:
The films may be formed with a polar solvent
which may be water, a polar organic solvent, or a
combination thereof. An active ingredient may be
added to the polymer and water combination prior
to the drying step. Alternatively, or in addition to
controlling the drying the film, the polymer may
be selected in order to provide a viscosity that
maintains the non-self-aggregating uniform het-
erogeneity.
’305 patent, col. 5 ll. 7–13.
The claims are for the films, not the drying method.
The Supreme Court and this court have consistently
reaffirmed the primacy of the claims in defining the
patent right. See Cimiotti Unhairing Co. v. Am. Fur Ref.
Co., 198 U.S. 399, 410 (1905) (“In making his claim the
inventor is at liberty to choose his own form of expression,
and while the courts may construe the same in view of the
specifications and the state of the art, they may not add to
or detract from the claim.”); Kara Tech. Inc. v.
Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009)
(“The claims, not specification embodiments, define the
scope of patent protection. The patentee is entitled to the
full scope of his claims, and we will not limit him to his
preferred embodiment or import a limitation from the
specification into the claims.”); Phillips v. AWH Corp., 415
F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (“[T]he Su-
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 5
preme Court made clear that the claims are ‘of primary
importance, in the effort to ascertain precisely what it is
that is patented.’” (quoting Merrill v. Yeomans, 94 U.S.
568, 570 (1876))); Raytheon Co. v. Roper Corp., 724 F.2d
951, 957 (Fed. Cir. 1983) (“In arguing that claims must be
read in light of the specification, that prevention of back-
flow is the ‘essence’ of Torrey’s invention, and that all
claims must therefore be read as including the quoted
limitation of claim 1, Raytheon confuses the respective
roles of the specification and claims.”).
My colleagues select the drying method claimed in a
different patent (the ’514 parent patent) and place that
limitation in the claims of the ’305 patent, although the
patentee expressly amended the ’305 claims to remove the
drying method. See J.A. 4343–62 (Amendment and
Response to Office Action of July 21, 2017 (Nov. 30,
2017)). My colleagues give the amended ’305 claims
identical scope to the claims of the ’514 patent, the patent
previously litigated in Delaware. My colleagues then
conclude that the ’305 claims would have the same in-
fringement position as the ’514 claims were found to have
in Delaware. This is improper. It is improper for a court
to rewrite a product claim to contain a process limitation
from the specification—here contained in a preferred but
not sole embodiment—for it confounds the roles of the
specification and the claims. See Raytheon, 724 F.2d at
957. “[I]f we once begin to include elements not men-
tioned in the claim, in order to limit such claim . . . , we
should never know where to stop.” Phillips, 415 F.3d at
1312 (omission in original) (quoting McCarty v. Lehigh
Valley R.R. Co., 160 U.S. 110, 116 (1895)).
Precedent is replete with such warning: “It is the
claims that define the metes and bounds of the patentee’s
invention. The claims, not specification embodiments,
define the scope of patent protection.” Kara Tech. Inc.,
582 F.3d at 1341; see also Thorner, 669 F.3d at 1366 (“It is
[ ] not enough that the only embodiments, or all of the
6 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
embodiments, contain a particular limitation. We do not
read limitations from the specification into claims; we do
not redefine words.”); E.I. du Pont de Nemours & Co. v.
Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir.
1988) (it is improper to impose “a limitation read into a
claim from the specification wholly apart from any need to
interpret what the patentee meant by particular words or
phrases in the claim”).
The panel majority errs in requiring that the claims of
the ’305 patent be read as including the “drying process
limitation” that was cancelled from the claims. Maj. Op.
at 19. “In examining the specification for proper context,
however, this court will not at any time import limitations
from the specification into the claims.” CollegeNet, Inc. v.
ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005).
The majority blurs the “distinction between using the
specification to interpret the meaning of a claim and
importing limitations from the specification into the
claim.” Phillips, 415 F.3d at 1323.
The majority uses the term “specification disclaimer.”
Specification disclaimer requires the clear and explicit
intent by the patentee to limit the claims. See Thorner,
669 F.3d at 1366–67 (“To constitute disclaimer, there
must be a clear and unmistakable disclaimer.”); In re Am.
Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir.
2004) (“We have cautioned against reading limitations
into a claim from the preferred embodiment described in
the specification, even if it is the only embodiment de-
scribed, absent clear disclaimer in the specification.”
(citing Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898,
906 (Fed. Cir. 2004))); see also Omega Eng’g, Inc. v. Ray-
tek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003) (“We
indulge a ‘heavy presumption’ that claim terms carry
their full ordinary and customary meaning unless the
patentee unequivocally imparted a novel meaning to
those terms or expressly relinquished claim scope during
prosecution.” (internal citation omitted) (quoting CCS
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 7
Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366
(Fed. Cir. 2002)); Epistar Corp. v. Int’l Trade Comm’n, 566
F.3d 1321, 1334 (Fed. Cir. 2009).
Here the contrary intent is explicit: the ’305 patent
was amended to present claims that are not limited to any
drying method. The patentee eliminated “drying/dried”
limitations from the ’305 claims, unlike the ’514 claims.
See J.A. 4343–62 (Amendment and Response to Office
Action of July 21, 2017 (Nov. 30, 2017)) (removing “dry-
ing” and “dried” limitations from the claims). Reading
these terms back into the claims is contrary to the patent-
ee’s clear intent.
This action is dispositive of patentee intent to remove
such claim limitations. See Laryngeal Mask Co. Ltd. v.
Ambu, 618 F.3d 1367, 1372–73 (Fed. Cir. 2010) (“The
applicant deleted this requirement from the claims. . . .
Regardless of why LMA amended its claims, we agree
with LMA that it would be improper to read [that re-
quirement] back into the [claim].”); id. at 1373(“[D]efendant’s insistence upon this court’s reading back
into the claims limitations which were originally there
and were removed during prosecution of the application
through the Patent Office cannot be permitted.” (internal
quotation marks omitted) (alteration in original) (quoting
Kistler Instrumente AG v. United States, 628 F.2d 1303,
1308 (Ct. Cl. 1980))).
Specification disclaimer requires the opposite of what
the majority presents, for the intrinsic evidence negates
any intent to include in the claims any drying limitation
from the specification. See Teleflex, Inc. v. Ficosa N. Am.
Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002) (requiring
“expressions of manifest exclusion or restriction, repre-
senting a clear disavowal of claim scope”). My colleagues
contravene precedent.
The majority’s theory of disclaimer is not supported by
the cases to which they cite. In SciMed Life Systems, Inc.
8 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
v. Advanced Cardiovascular Systems, Inc., the specifica-
tion described two types of known catheter configura-
tion—dual lumen catheters and coaxial lumen catheters—
and then explicitly excluded dual lumen catheters from
the claim scope, whereby the court stated: “It is difficult
to imagine how the patents could have been clearer in
making the point that the coaxial lumen configuration
was a necessary element of every variant of the claimed
invention.” 242 F.3d 1337, 1343 (Fed. Cir. 2001). The
specification in SciMed stated: “The intermediate sleeve
structure defined above [coaxial design] is the basic sleeve
structure for all embodiments of the present invention
contemplated and disclosed herein . . . .” Id. The ’305
patent, in contrast, does not contain such unequivocal
language of exclusion.
The majority points to Medicines Co. v. Mylan, Inc.,
853 F.3d 1296 (Fed. Cir. 2017) as an example where this
court added a process limitation to a product claim based
on the specification. Maj. Op. at 17. But as the panel
majority notes, “[t]he specification defined ‘batches’ as
either ‘all batches prepared by a same compounding
process’ or ‘a single batch . . . wherein the levels of [Asp9 -
bivalirudin] represent levels for all potential batches
made by said processes.’” Id. (omission in original) (quot-
ing Medicines Co., 853 F.3d at 1303).
In contrast to the ’305 patent, the patents at issue in
Medicines Co. provided an express process definition for
the term “batches.” See 853 F.3d at 1300 (“As used here,
‘batch’ or ‘pharmaceutical batch’ refers to material pro-
duced by a single execution of a compounding process of
various embodiments of the present invention. ‘Batches’
or ‘pharmaceutical batches’ as defined herein may include
. . . .” (quoting U.S. Patent No. 7,582,727, col. 5 ll. 24–36;
U.S. Patent No. 7,598,343, col. 5 ll. 24–36)). Such an
express definition is not present in the ’305 specification.
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 9
The panel majority also cites Openwave Sys., Inc. v.
Apple Inc., although the standard for specification dis-
claimer, reiterated therein, is: “To find disavowal we must
find that the specification is ‘both so clear as to show
reasonable clarity and deliberateness, and so unmistaka-
ble as to be unambiguous evidence of disclaimer.’”
808 F.3d 509, 513 (Fed. Cir. 2015) (quoting DealerTrack,
Inc. v. Huber, 674 F.3d 1315, 1322 (Fed. Cir. 2012)). The
requisite “unmistakable evidence” is not met by the usage
of “preferably,” “substantially,” “normally,” or “desirably,”
in the relevant portions of the ’305 specification. See Maj.
Op. at 12–14 (quoting, for example, ’305 patent, col. 4
ll. 64–67 (“Preferably, the film is dried initially only
applying heat to the bottom side of the film, in order to
maintain a non-self-aggregating uniform heterogenei-
ty.”)).
The panel majority lastly relies on Andersen Corp. v.
Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007) as
an example of disclaimer of claim scope based on lan-
guage in the specification and prosecution history. Maj.
Op. at 16–17. The court read a “pelletizing” process
limitation into product claims, based on both the specifi-
cation and patentee statements during prosecution to
distinguish the claims over prior art. 474 F.3d at 1371–75
(“[W]e conclude that the prosecution history of the Group
II patents definitively resolves the question with a clear
disavowal and confirms the role of pelletization in the
production of the claimed structural members.”). In
contrast, during prosecution of the ’305 patent, the appli-
cant amended the claims to eliminate any drying method.
The panel majority’s theory of specification disclaimer
is devoid of support in law or precedent.
10 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
The majority erroneously treats the Delaware
decision on the ’514 parent patent as barring
this infringement suit on the different claims
of the ’305 continuation patent
The panel majority further errs in its ruling that
“claim preclusion likely bars Indivior’s suit as the ’514
claims and the ’305 claims are patentably indistinct.”
Maj. Op. at 19. The majority writes that under Sim-
pleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018),
and in view of regional circuit law, the claims at issue in
this New Jersey action, and those in the Delaware case,
are “patentably indistinct” and that “claim preclusion
likely applies.” Id. at 19–20. The majority presents two
reasons: (1) the importation of the “drying/dried” limita-
tion into the ’305 claims; and (2) the “strong clue” that
“claim preclusion is likely to apply” in view of Indivior’s
filing a terminal disclaimer for the ’305 patent. Id. at 20–
21. Again, law and precedent do not support the majority.
“In legal principle, the filing of a terminal disclaimer
simply serves the statutory function of removing the
rejection of double patenting, and raises neither presump-
tion nor estoppel on the merits of the rejection. It is
improper to convert this simple expedient of ‘obviation’
into an admission or acquiescence or estoppel on the
merits.” Quad Envtl. Techs. Corp. v. Union Sanitary
Dist., 946 F.2d 870, 874–75 (Fed. Cir. 1991). Moreover, in
Ventana Medical Systems, Inc. v. Biogenex Laboratories,
Inc., this court rejected the argument that “the filing of
the terminal disclaimer represents an admission by the
inventors ‘equating all claims of the [second application]
to all claims of the [first patent].’” 473 F.3d 1173, 1184
n.4 (Fed. Cir. 2006) (quoting argument).
This court has recognized, “Dating back at least to
Butler v. Eaton, 141 U.S. 240, 242–44 (1891), a bedrock
principle of preclusion law has been that a reversed
judgment cannot support preclusion; indeed, ‘a second
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 11
judgment based upon the preclusive effects of the first
judgment should not stand if the first judgment is re-
versed.’” Levi Strauss & Co. v. Abercrombie & Fitch
Trading Co., 719 F.3d 1367, 1372 (Fed. Cir. 2013) (quot-
ing 18A Charles A. Wright, et al., Federal Practice and
Procedure § 4433 (2d ed. 2002)). Imposing irreparable
harm on Indivior looms over the panel majority’s vacatur
of the preliminary injunction based in part on a judgment
currently pending appeal. The likelihood of such harm is
supported by extensive factual findings made by the
district court. D.N.J. Op. at *1, *12–13. “[A]n initial
reliance on preclusion must be reversed once the underly-
ing judgment is reversed.” Levi Strauss, 719 F.3d at
1372. This possibility supports the district court’s deci-
sion to preserve the status quo.
Other factors also support the preliminary
injunction, as the district court found
The majority explicitly declines to review the tradi-
tional equitable factors, such as the balance of harms, and
omits any discussion of equity and discretion. The district
court found that the harm to Dr. Reddy’s can be mone-
tized and compensated and that the harm to Indivior
cannot be fully remedied. D.N.J. Op. at *1, *12–13. The
district court explained its reasoning at careful length.
My colleagues hold that they “need not reach” these
aspects of the district court’s discretionary action, based
on their conclusion that Indivior “has not shown that it is
likely to succeed on the merits of its infringement claim.”
Maj. Op. at 21. However, the balancing of all factors is
the foundation of a discretionary ruling. When one side is
subject to substantially greater harm, this may outweigh
other factors believed to favor the opponent. “In each
case, courts ‘must balance the competing claims of injury
and must consider the effect on each party of the granting
or withholding of the requested relief.’” Winter v. Nat.
12 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
Res. Def. Council, 555 U.S. 7, 24 (2008) (quoting Amoco
Prod. Co. v. Gambell, 480 U.S. 531, 545 (1987)).
The district court made extensive factual findings, de-
tailing the likelihood of irreparable harm to Indivior in
the absence of an injunction while the issues are litigated.
D.N.J. Op. at *12. The district court found that “[e]ntry of
a generic would cause Indivior to lose market share and
the [S]uboxone film’s advantageous formulary status, and
would impair research and development.” Id. at *1. The
district court cited precedent that the “right to exclude
direct competition in a limited sphere, a right inherent in
the grant of a patent, is irreparably harmed by the loss of
sales and the competitive foothold that the infringer will
gain.” Id. at *12 (internal quotation marks and citation
omitted).
“Price erosion, loss of goodwill, damage to reputation,
and loss of business opportunities are all valid grounds for
finding irreparable harm.” Celsis in Vitro, Inc. v. CellzDi-
rect, Inc., 664 F.3d 922, 930 (Fed. Cir. 2012). The district
court found this case to fit these conditions:
It comports with common sense, and Indivior has
shown, that Indivior will likely lose market share
to DRL’s ANDA product once it is launched and
will be unlikely to recover that share, even if that
product is pulled from the market. Courts have
found that a reduction of market share due to the
loss of formulary status and a change in tier pric-
ing, constitutes irreparable harm.
D.N.J. Op. at *12.
The district court determined that the balance of eq-
uities “appears to favor Indivior.” D.N.J. Op. at *1, *13.
The district court found that Dr. Reddy’s “knowingly
invested ‘at risk,’” id. at *1, and its projected “losses stem
from a market it seeks to enter, not one that it is already
in.” Id. at *13. As in Sanofi-Synthelabo v. Apotex, Inc.,
INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A. 13
“the court did not clearly err in finding that [the accused
infringer’s] harms were ‘almost entirely preventable’ and
were the result of its own calculated risk to launch its
product pre-judgment.” 470 F.3d 1368, 1383 (Fed. Cir.
2006).
The district court also determined that the “public in-
terest will be served by the issuance of a preliminary
injunction in this case.” D.N.J. Op. at *14. The court
found that “[a]lthough the Suboxone film is an efficacious
means of administering buprenorphine, it is not the only
means, and the disadvantages of having no generic alter-
native does not outweigh the public benefit of maintaining
Indivior’s rights as a patent holder while this action is
pending.” Id. at *1. The district court found that the
injunction would not “deny access to the active ingredient,
which may be administered by other means. There still
remain other non-film generics on the market . . . .” Id. at
*14. The public interest in the discovery and provision of
new products is an important aspect of the court’s exer-
cise of equity.
None of these findings are reviewed by the majority.
Neither law nor equity supports removal of the prelimi-
nary injunction and allowing market entry during the
litigation. “It is well settled that the granting of a tempo-
rary injunction, pending final hearing, is within the sound
discretion of the trial court; and that, upon appeal, an
order granting such an injunction will not be disturbed
unless contrary to some rule of equity, or the result of
improvident exercise of judicial discretion.” Deckert v.
Independence Shares Corp., 311 U.S. 282, 290 (1940)
(internal quotation marks and citation omitted). The
district court’s action is fully in accord with precedent,
and is within its judicial discretion.
14 INDIVIOR INC. v. DR. REDDY’S LABORATORIES, S.A.
CONCLUSION
I do not discern abuse of the district court’s discretion.
From my colleagues’ contrary decision, I respectfully
dissent.