INDIVIOR INC. et al v. DR. REDDY'S LABORATORIES S.A. et al
Filing
294
OPINION. Signed by Judge Kevin McNulty on 11/5/2019. (sms)
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
INDWIOR INC., INDWIOR UK
LIMITED, and AQUESTWE
THERAPEUTICS, INC.,
-
.
Civ. No. 17-7111 (KM) (CLW)
Civ. No. 18-1775 (KM) (CLW)
Civ. No. 18-5288 (KM) (CLW)
Plaintiffs,
V.
DR. REDDY’S LABORATORIES S.A.,
AND DR. REDDY’S LABORATORIES,
INC.,
Defendants.
INDWIOR INC., INDIWOR UK
LIMITED, and AQUESTIVE
THERAPEUTICS, INC.,
.
-
Civ. No. 17-7 106 (1cM) (CLW)
Civ. No. 18-8285 (KM) (CLW)
Plaintiffs,
OPINION
V.
ALVOGEN PINE BROOK, INC., AND
ALVOGEN PINE BROOK LLC,
Defendants.
KEVIN MCNULTY, U.S.D.J.:
This opinion contains the Court’s construction of key patent terms
following a Markman hearing. (Dkt. No. 7106 at DE 211; Dkt. No. 7111 at DE
290) The final section constitutes the Court’s opinion on the motion by Alvogen
Pine Brook, Inc. and Alvogen Pine Brook LLC (collectively, unless otherwise
specified, “Alvogen”) to recover on bonds posted in connection with my grant of
a temporary restraining order in the 17-cv-7 106 consolidated action. (See DE
148).
1
These consolidated patent infringement cases are brought by Indivior
Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. (collectively, unless
othenvise specified, “Indivior”), against Dr. Reddy’s Laboratories S.A. and Dr.
Reddy’s Laboratories, Inc. (collectively, unless othenvise specified, “DRL”) and
Alvogen.
The patents-in-suit are Patent Nos. 9,931,305 (“the ‘305 Patent”), issued
to Aquestive on April 3, 2018, and 9,687,454 (“the ‘454 Patent”), issued to
Indivior on June 27, 2017. Indivior’s Suboxone film is also covered by Patent
No. 8,603,514 (“the ‘514 Patent”). The ‘514 Patent shares the same
specification with the ‘305 Patent. As a result, the ‘305 Patent was filed with a
terminal disclaimer to synchronize its expiration with that of the ‘514 Patent.
This ‘514 Patent is not directly at issue here, but was at issue in a related
litigation involving these same parties filed in the United States District Court
for the District of Delaware (“the Delaware Litigation”).
Collectively, these patents describe formulations of Suboxone film, a
“rapidly dissolving film that adheres to the underside of a patient’s tongue” or
cheek. Indivior’s Suboxone film is used to treat opioid dependency; it works to
decrease a patient’s need for opioids while also deterring abuse. Its two active
ingredients are buprenorphine and naloxone. The films are created by 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 thin sheet that can be cut into individual
dosages.
Procedural History’
I.
I first briefly review the relevant opinions issued both in this action and
in the related Delaware Litigation.
Citations to the record will be abbreviated as follows. Citations to page numbers
refer to the page numbers assigned through the Electronic Court Filing system, unless
othenvise indicated:
=
Docket entry number in this case.
2
In broad strokes, Indivior previously moved in this action to enjoin DRL
from bringing its generic Suboxone film to market. In a prior decision, I granted
the motion. (Dkt. No. 7111 at DE 121). DRL subsequently appealed to the
Federal Circuit, which reversed and remanded. Indiuior Inc. v. Dr. Reddy’s
Labs., S.A., 752 F. App’x 1024 (Fed. Cir. 2018) (“Indiviorf). The parties also
appealed a number of decisions in the related Delaware Litigation. After the
parties filed their Markman briefs here, the Federal Circuit issued its opinion
concerning the Delaware Litigation appeal. Indivior Inc. v. Dr Reddy’s Labs.,
S.A., 930 F.3d 1325, 1339 (Fed. Cir. 2019) (“IndiviorH”).
“Dkt. No. 7106”
=
Civil Action No. 2:17-cv-7106-KM-CLW.
“Dkt. No. 7111”
=
Civil Action No. 2:17-cv-7111-KM-CLW.
“Dkt. No. 5285”
=
Civil Action No. 2: 18-cv-5285-KM-CLW.
“DId. No. 5288”
=
Civil Action No. 2:1S-cv-5288-KM-CLW.
“P1. Opening” = Plaintiffs Opening Markman Brief (Dkt. No. 7106 at DE 135;
01cc No. 7111 at DE 250).
“P1. Ex.” = Plaintiff’s Exhibits (Dkt. No. 7106 at DE 135-1; Dkt. No. 7111 at DE
250-1), attached to the Declaration of Philip S. May (Id.).
“P1. Response” = Plaintiffs Responsive Markman Brief (Dkt. No. 7106 at DE
146; Dkt. No. 7111 at DE 259).
“Def. Opening” = Defendants’ Opening Markman Brief (Dkt. No. 7106 at DE
136; Dkt. No. 7111 at 249).
“Def. Ex.” = Defendants’ Exhibits (Dkt. No. 7106 at DE 137 to 137-4; Dkt. No.
7111 at 249-1 to 249-5).
“Def. Response” = Defendants’ Responsive Markman Brief (Dkt. No. 7106 at DE
144; Dkt. No. 7111 at 256).
“Fassihi Declaration” = Declaration of Reza Fassihi, Ph.D. (Dkt. No. 7106 at
DE 136-1; Dkt. No. 7111 at 249-6).
“Fuller Declaration” = Declaration of Gerald 0. Fuller, Ph.D. (Dkt. No. 7106 at
DE 135-2; Dkt. No. 7111 at 250-2).
“‘305 Patent” = United States Patent No. 9,931,305, P1. Ex. A (Dkt. No. 7106 at
DE 135-1; Dkt. No. 7111 at DE 250-1).
“454 Patent” = United States Patent No. 9,687,454, P1. Ex. B (Dkt. No. 7106 at
DE 135-1; Dkt. No. 7111 at DE 250-1).
“514 Patent” = United States Patent No. 8,603,514, P1. Ex. C (Dkt. No. 7106 at
DE 135-1; Dkt. No. 7111 at DE 250-1).
3
A. The ‘514 Patent
Indivior initially entered the Suboxone market by introducing a tablet in
2002. It then began developing a film version with Aquestive. The patent for
that film, the ‘514 Patent, was issued on December 10, 2013.2 (‘514 Patent at
[45j, [54].).
DRL and others, including Alvogen, sought to enter the film market as
generic competitors and filed ANDAs with the FDA for generic versions of the
Suboxone film. Indivior responded by filing suit against a number of parties,
including DRL and Alvogen, in the Delaware Litigation. Ultimately, the
Delaware district court held that Indivior had failed to meet its burden of
showing that DRL’s and Alvogen’s generic versions infringed the claims of the
‘514 Patent for Suboxone film. Reckitt Benciciser Phann. Inc. v. Dr. Reddy’s
Labs. S.A., Nos. 14-1451, 14-1573, 14-1574, 2017 WL 3837312 (D. Del. Aug.
31, 2017); Reckitt Benckiser Phann. Inc. u. Dr. Reddy’s Labs. S.A., No. CV 141451-RGA, 2017 WL 3782782 (D. Del. Aug. 31, 2017); Indivior Inc. v. Mylan
Techs. Inc., 298 F. Supp. 3d 775 (D. Del. 2018).
With respect to DRL, District Judge Andrews had earlier construed one
of the claims in the ‘514 Patent to mean “dried without solely employing
conventional convection air drying from the top” and found that there was not
enough evidence to show that DRL’s procedures “amountLed] to an
unconventional process” for drying. See Reckitt Benckiser Phann. Inc. v. Teva
Phann. USA Inc., Nos. 14-1451, 14-1573, 141574,2016WL3621632,at*10_
*11 (D. Del. June 29, 2016). He found that Indivior had disclaimed
“conventional convection air drying from the top,” both through express
statements and repeated disavowal in the ‘514 Patent specification. Id. at *8,
*11 (noting that the ‘514 Patent contained identical language from process
patents that were construed earlier in the opinion and applying that same
reasoning to the claims in the ‘514 Patent). After reviewing the evidence
At the time, Aquestive was known as MonoSol Rx, LLC. (See, e.g., Dkt. No. 5285
atDE 1).
2
4
presented at trial, Judge Andrews concluded that Indivior did not prove that
DRL’s process of drying was unconventional, and hence infringing. Judge
Andrews later made similar findings with respect to Alvogen. See Mylan Techs.
Inc., 298 F. Supp. 3d at 785. (“Plaintiffs’ comparison between Alvogen’s exhibit
batch and commercial processes fails to demonstrate that Alvogen’s
commercial process does not ‘solely’ employ drying from the top. It does not
change my conclusion that Plaintiffs have not demonstrated ‘substantial’
bottom drying.”).
Indivior then appealed to the Federal Circuit. See Section I.E, infra,
discussing Indivior IL
B. The ‘305 Patent
Aquestive responded to the Delaware ruling by applying for the ‘305
Patent, which was issued on April 3, 2018. The ‘514 Patent and the ‘305 Patent
largely overlap, except as to the language of one claim—Claim 26 of the ‘305
Patent and Claim 62 of the ‘514 Patent. The two pertinent revisions are as
follows:
First, the ‘514 Patent claims “(i) a cast film.” The ‘305 Patent, however,
claims “(i) a continuously cast film produced on a manufacturing line.”
Second, the ‘514 Patent claims that
“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 dnjing of the matrix is
measured by substantially equally sized individual unit doses
which do not vary by more than 10% of said at least on active.”
The ‘305 Patent contains similar language, except that the italicized
“drying” language was dropped and references to “continuous casting” are
substituted. Thus ‘305’s Claim 26 now reads:
said flowable water-soluble or water swellable film-forming matrix is
capable of being continuously cast on the manufacturing line without
loss of substantial uniformity in the stationing of said particulate
active therein; and
5
wherein said uniformity of the-continuously cast film is measured by
substantially equally sized individual unit doses cut from the
continuously cast film which do not vary by more than lO% of a
desired amount of said at least one active.
(P1. Ex. A at 85; italicized emphasis added).
Indivior then brought these actions against DRL and Alvogen here in the
District of New Jersey, now claiming infringement of the new ‘305 Patent. (See
Dkt. No. 5288 at DE 1; Dkt. No. 5285 at DE 1). Upon learning of DRL’s plans to
launch the ANDA product “at risk,” Indivior moved for temporary restraints and
a preliminary injunction to prevent DRL from launching its generic product.
(Dkt. No. 7111 at DE 70). I granted a temporary restraining order enjoining
DRL from launching in order to preserve the status quo during the resolution
of the motions. (Id. at DE 78). After a hearing, on July 13, 2018, I granted
Indivior’s motion for a preliminary injunction. (Id. at DE 121). In essence, I
concluded that Indivior, in the ‘305 Patent, had succeeded in “claiming around”
the problem with the ‘514 Patent that was identified in the Delaware decision.
DRL then appealed that decision to the Federal Circuit, which disagreed.
C. Indivior I
On November 20, 2018, a divided Federal Circuit vacated the preliminary
injunction issued in this action and remanded. See Jnthvior I, 752 F. App’x
1024.
The Federal Circuit first examined the ‘305 Patent’s specification. The
court particularly noted the specification’s focus on drying processes:
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 11. 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 1. 48—col. 4 1. 3
The specification discloses controlled drying techniques that avoid
the “rippling” problems produced by conventional drying methods.
Id. at col. 23 11. 10—21. The specification explains that “[tihe objective
of the drying process is to provide a method of drying films that
avoids complications, such as the noted ‘rippling’ effect, that are
6
associated with conventional drying methods.” Id. at col. 23 II. 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 11. 22—39, col. 54 11. 20—21. These
techniques control heat distribution during the drying process and
produce content-uniform films. Id.
Id.
at
1026.
In light of that discussion, the Federal Circuit considered whether
Indivior was likely to succeed on the merits of its infringement claims,
ultimately answering that question in the negative. In the ‘305 specification,
the court found, Indivior expressly disclaimed “solely using conventional 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.” Id. at 1029. The Federal
Circuit relied heavily on SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys.,
Inc., 242 F.3d 1337, 1343—44 (Fed. Cir. 2001) and Openwave Sys., Inc. v. Apple
Inc., 808 F.3d 509, 513 (Fed. Cir. 2015), which instruct that disavowal of a
feature in the specification results in the exclusion of that feature from the
claim scope:
“Disavowal requires that ‘the specification make[ J clear that the
invention does not include a particular feature.’” Openwave Sys.,
Inc. v. Apple Inc., 808 F.Sd 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 thati its repeated derogatory statements about [a particular
embodimentj reasonably may be viewed as a disavowal.”’ Id. at
(quoting Chicago Bd. Options Exch., Inc. v. Int’l Sec. Exclt, LLC, 677
F.3d 1361, 1372 (Fed. Cir. 2012)).
In SciMed, we instructed that
7
[w]here the specification 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, even though the
language of the claims, read without reference to the
specification, might be considered broad enough to
encompass the feature in question.
SciMed, 242 F.3d at 1341. There, we determined that the patent
claims covered balloon dilation catheters with coaxial 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 *1030 lumens that were
the subject of the SciMed patents. Id. at 1342—43. The patent’s
characterization of the “present invention” also 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 arrangement.” Id.
In Openwove, we affirmed the district court’s construction of “mobile
device” to exclude devices containing computer modules. 808 F.3d
at 517. The patent specification was “rife with remarks that
disparage and, therefore, 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. 14. at 515—16. We concluded that “ft 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.” 14. at 517.
Indiviorl, 752 F. App’x at 1029—30.
Thus, based on SciMed and Openwave, the Federal Circuit found a
textual basis for continuing to impute a drying limitation to the ‘305 Patent’s
claims: “[T]he ‘305 patent is ‘rife with remarks that disparage, and therefore,
disclaim’ solely using conventional top air drying to form films. The
specification instructs that using such methods produces films without content
uniformity—a claim limitation and a key feature of the invention.” Id. at 1030.
The Court was persuaded that “continuously cast film” has an inherent drying
8
limitation because the film, which starts as a liquid, has to be dried to
ultimately become a solid film. Id. at 103 1—32. Moreover, “[t]he specification
makes clear that a film produced using only conventional top air drying cannot
satisfy the claim limitations
.
.
.
As such, the express disclaimer of conventional
top air drying in the 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.” Id. at 1032.
In sum, the Federal Circuit found that Indivior was unlikely to succeed
on the merits of infringement because the disavowals in the specification
placed DRL’s conventional, top air drying films outside the scope of the ‘305
Patent. Id. at 1031—34.
The Federal Circuit also examined the cases litigated between Indivior’s
predecessor (Reckitt Benckiser) and DRL in the Delaware Litigation. There,
“The Delaware Court determined that the patentee disavowed solely using
conventional air drying from the top to produce the claimed films” in the ‘514
Patent. Id. at 1027. In reviewing the ‘305 Patent and the ‘514 Patent, the
Federal Circuit found that the only difference between the two patents was that
the “305 claims contain the term ‘continuously cast’ in place of ‘dried’ and
‘drying.’ There is no dispute that there are no other material differences
between the claims
.
.
While the language of the claim terms changed, the
scope of the claims did not materially change.” Id. at 1034—35 (citations
omitted). Thus, the Federal Circuit also held that claim preclusion likely barred
Indivior’s suit as the ‘305 Patent was patentably indistinct from the ‘514
Patent. Id. at 1035.
Judge Newman issued a dissenting opinion in which she first criticized
the majority for failing to credit the district court’s “equitable discretion, and
instead mak[ing] appellate findings of the merits of infringement, although
there has been no trial of infringement.” Id. at 1036—37 (Newman, J.,
dissenting). Judge Newman also disagreed with the majority’s efforts to read a
drying limitation into the ‘305 Patent claims when that process limitation,
g
present in the ‘514 Patent, had been dropped for purposes of the ‘305 Patent.
Id. at 1037—38. Thus, in her view, it was improper for the majority “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.” Id. at 1037. The majority committed
further error, wrote Judge Newman, because it treated the Delaware court’s
decisions on a different patent, the ‘514 Patent, as barring suit in this action
on the ‘305 Patent. Id. at 1040.
Indivior then filed a petition for en banc rehearing, essentially espousing
the position of the dissent.
D. Mvogen
Meanwhile, on January 22, 2019, Indivior moved in this Court for
temporary restraints and a preliminary injunction to prevent Alvogen from
launching its generic product prior to the Federal Circuit’s issuance of its
mandate in Indiuiorf (Dkt. No. 7106 at DE 83). I granted a temporary’
restraining order (“TRO”) enjoining Alvogen from launching in order to preserve
the status quo pending the issuance of the mandate. (Id. at DE 88). I also
granted Alvogen the opportunity to apply by telephone for the posting of a
reasonable bond should it receive FDA approval for its Suboxone film. (Id.).
After a hearing on the preliminary injunction application, on January 24, 2019,
I entered an amended order to show cause that temporarily restrained and
enjoined Alvogen and ordered Indivior to post a bond or other security in the
amount of $18 million. (Id. at DE 102). On Febnia
1, 2019, the parties agreed
and stipulated, and I so ordered, that Alvogen would be enjoined from
“engaging in the use, offer to sell, or sale within the United States, or importing
into the United States its generic buprenorphine-and naloxone-containing
transmucosal film products.” (Id. at DE 105). The temporary restraints were
dependent on the final outcome of the Indiviorlappeal. (Id.). Indivior later
agreed to post. a second bond that increased the total value of the bonds posted
to $36 million. (Id.).
10
On February 4, 2019, the Federal Circuit denied rehearing. On February
19, 2019, the Federal Circuit issued its mandate vacating the DRL preliminary
injunction. The same day, I vacated the injunctive restraints. (Id. at DE 119).
Alvogen then proceeded to bring to market its Suboxone film.
Alvogen now moves for an order granting it an immediate recovery on the
bonds. (Dkt. No. 7106 at DE 148, 149, 171). Indivior opposes that motion. (Id.
at DE 156).
E. Indiviorli
Following the Indiviorldecision, and after the parties submitted their
Mark-man briefing here, on July 12, 2019, the Federal Circuit, this time with
Judge Newman in the majority, issued its opinion on the appeals taken in the
Delaware Litigation. In this opinion, here deemed Indivior II, the Federal Circuit
largely upheld the Delaware district court’s findings. 930 F.3d 1325. My
Mark-man findings here are guided, if not strictly compelled in every particular,
by the Federal Circuit’s decision in Indivior IL
As in its prior Indivior Idecision, the Federal Circuit here looked to the
manufacturing process and the role of drying: “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.”
Indiviorll, 930 F.3d at 1331. One way the specification achieves uniformity, the
court observed, is “by drying the film in a rapid manner from the bottom up.”
Id. The court went on to discuss the drying limitations in the specification,
which, it found, disclaimed conventional drying methods. See Id. at 1332.
On this appeal, Indivior challenged the Delaware district court’s findings
that DRL and Alvogen had not infringed the ‘514 Patent. In response, both DRL
and Alvogen argued that they employ (so-called “conventional”) drying
processes that use “dryers where the sole source of heat comes from the top
and thus does not infringe the asserted claims of the ‘514 Patent.” Id. at 1334—
35; see also Id. at 1335 (“And as in the DRL case, the court found that
Alvogen’s film manufacturing process dries the films primarily from the top and
11
thus does not meet the drying limitation and does not infringe the asserted
claims.”).
Mirroring the reasoning of Indivior I, the Federal Circuit in Indivior II held
“that the [Delaware] district court correctly construed the drying limitation and
that the ‘514 Patent specification disclaims conventional top air drying.” Id. at
1336. The Court incorporated the reasoning of Inthvior Ito conclude that the
change of language as between the claims of the ‘514 and ‘305 patents was not
sufficient to change the result. Both patents, the Court found, excluded
conventional top air drying methods:
In addressing whether Indivior’s assertion of the ‘305 patent raised
the same cause of action as the ‘514 patent, we concluded:
jT]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. Speczjically,filmsfonned
with conventional top air dnjing methods are excluded from the
scope of both claim terms.
[Indivior 1] 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. Stnjker Corp., 525 F.3d 1319, 1324 (Fed.
Cir. 2008). Because—and only because—the asserted claims of the
‘305 Patent were materially the same as those that were or could
have been asserted in the ‘514 Patent, we held that Indivior’s action
on the ‘305 Patent was likely claim precluded and that the district
court abused its discretion in entering a preliminary injunction.
Indivior, 752 F. App’x at 1035.
We agree with DRL and Alvogen that the [Delaware] district court
correctly construed the drying limitation and that the ‘514 patent
specification disclaims conventional top air drying
The asserted
claims recite a film that is “capable of being dried without loss of
substantial uniformity,” but, as we already concluded in Indivior,
and as we again explain below, the specification repeatedly makes
.
12
.
.
clear that conventional top air drying does not yield uniform films.
‘514 Patent col. 74 11. 3—5. Such drying is thus outside the reach of
the claims.
A specification may disclaim an embodiment by repeatedly
disparaging it. See Opeimuave Sys., Inc. v. Apple Inc., 808 F.3d 509,
513—14 (Fed. Cir. 2015); ChL Rd., 677 F.3d at 1372. Here, the
specification repeatedly disparages conventional top air drying
because such drying does not produce uniform films, the central
object of the claimed invention
Id. at 1336—37; see also Id. at 1340. Thus, in analyzing the ‘514 Patent in
Indiviorll, the Federal Circuit drew on its reasoning in Indiviorl, making it clear
that for these purposes, the claims of the ‘305 Patent are indistinct, or at least
not meaningfully distinct, from those of the ‘514 Patent.
II.
CLAIM CONSTRUCTION
A. Standards
“The purpose of claim construction is to ‘determin[ej the meaning and
scope of the patent claims asserted to be infringed.”’ 02 Micro Int’l Ltd. v.
Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008) (quoting
Mark-man v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en
banc), affd, 517 U.S. 370, 116 5. Ct. 1384 (1996)). “[T]he words of a claim are
generally given their ordinary and customary meaning.” Phillips v. AWH Corp.,
415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks and
citations omitted). Courts interpret claim terms according to an objective
standard: “[T]he ordinary and customary meaning of a claim term is the
meaning that the term would have to a person of ordinan’ skill in the art in
question at the time of the invention.” Id. at 1313. To make this determination,
courts may consider evidence intrinsic to the patent, i.e., “the words of the
claims themselves, the remainder of the specification, [and] the prosecution
history,” as well as “extrinsic evidence, which consists of all evidence external
to the patent and prosecution history, including expert and inventor testimony,
13
dictionaries, and learned treatises.” Id. at 1314, 1317 (internal quotation marks
and citations omitted).
In Phillips, the United States Court of Appeals for the Federal Circuit,
sitting en banc, explained that its prior case law had “attempted to explain
why, in general, certain types of evidence are more valuable than others.” Id. at
1324 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
(Fed.Cir.1996)). Phillips assigned significant value to intrinsic evidence and less
weight to extrinsic evidence, holding extrinsic evidence useful only to the extent
that “those sources are not used to contradict claim meaning that is
unambiguous in light of the intrinsic evidence.” Id. at
Thus, a court “first look[s] to the actual words of the claims and then
read[sj them in view of the specification.” Profectus Tech. LLC v.
Huawei
Techs.
Co., 823 F.3d 1375, 1380 (Fed. Cir. 2016). “ICilaims must be read in view of
the specification, of which they are a part” because the specification “is the
sing’e best guide to the meaning of a disputed term.” Phillips, 415 F.3d at
1315. “[I]f the specification reveals a special definition given to a claim term by
the inventor, then the inventor’s lexicography governs, even if it differs from the
terms ordinary meaning.” David Netzer Consulting Eng’r LLC v. Shell Oil Co.,
824 F.3d 989, 994 (Fed. Cir. 2016) (citing Phillips, 415 F.3d at 1316). The court
may also consider, where relevant, the patent’s prosecution history, “which
consists of the complete record of the proceedings before the PTO and j] the
prior art cited during the examination of the patent.” Phillips, 415 F.3d at
1317. Extrinsic evidence, considered in the context of the intrinsic evidence,
may “help educate the court regarding the field of the invention and
[1
help the
court determine what a person of ordinary skill in the art would understand
claim terms to mean.” Phillips, 415 F.3d at 1319.
14
B. Disputed Claims
1.
Term
“Continuously Cast Film” and “Continuously Cast Film
Produced on a Manufacturing Line”
Plaintiff
Defendant
‘
plain and ordinary meaning,
but if construction is
necessary, “continuous
sheet of cast film”
“a film formed by combining
components to form a wet
matrix, depositing the wet
matrix onto a substrate, and
drying the matrix without
solely employing conventional
convection air drying from the
top”
“continuously
cast film
produced on a
manufacturing
line”
plain and ordinary meaning,
but if construction is
necessary, “continuous
sheet of cast film produced
on a manufacturing line”
“a film formed by combining
components to form a wet
matrix, depositing the wet
matrix onto a substrate, and
drying the matrix without
solely employing conventional
convection air drying from the
top”
“continuously
cast film”
(‘305 PatentS
k
•
(‘305 Patent: 26)
(P1. Opening at 11; Def. Opening at 10).
The parties’ primary dispute is whether, with respect to the ‘305 Patent,
the claim “continuously cast film” has a drying limitation. No, says Indivior, for
several reasons. (P1. Opening at 11).
First, according to Indivior, “cast film” has a plain meaning
—
individual
doses are cast in one sheet. The word “continuous” does not alter this meaning;
it just refers to the fact that a sheet has not yet been cut into dosage-sized
pieces. (Id. at 12—13). Therefore, “continuously cast film” should be given the
same plain meaning that “cast film” was given in the related ‘514 Patent. (Id.).
These jointly submitted charts, summarizing the parties’ positions as to the
four disputed claims, are reproduced as relevant in connection with the discussion of
each claim.
3
15
Second, Indivior contends that during the patent prosecution, it
specifically amended the claim to remove drying limitations. Any construction
of the claim, it says, must account for this history. (Id. at 14—15).
Third, the patent specification does not disclaim “conventional
convection air drying from the top.” This is demonstrated by the specification’s
inclusion of examples illustrating that conventional drying ovens can be used
to make uniform films. (Id. at 15—20). Indivior points to the Fuller Declaration,
which highlights that “[t]he ‘305 Patent guides the practitioner in the selection
of the optimal choice of polymer and the use of viscosity to create uniform films
when conventional drying operations are used” and notes that polymer
selection, rather than the technique of drying, is the major determinant in the
viscosity of the solution. (Fuller Declaration
¶ 62—63; see also P1. Response at
13—19).
Fourth, Indivior alleges that defendants’ proposed construction is
improper because it imposes a process limitation onto a composition claim. (P1.
Opening at 2 1—22).
Fifth, Indivior contends that Indivior I, reversing the preliminary
injunction, is not binding on this court. (Id. at 23—29). Indivior claims that the
Indivior Iopinion was based on a “cold record” and did not have the benefit of,
e.g., the Fuller Declaration. (Id. at 24—25; see also P1. Response at 10—11).
Finally, Indivior contends that the ‘514 Patent is a different patent with a
different prosecution history and different claims, so that the findings from the
Delaware Litigation are not binding here. (P1. Response at 11—12).
DRL and Alvogen counter that claim construction in this case must
account for the findings in the Delaware Litigation and the Federal Circuit’s
opinions in hidivior I (and, now, Indivior Ii). (Def. Opening at 10)
.‘
Defendants
As noted above, the Federal Circuit’s opinion in Indivior II was decided after the
parties submitted their Markman briefing. Nevertheless, DRL and Alvogen likewise
argued at the Markman hearing that Indivior II also bears on these issues and requires
a finding in its favor. (Markman Hearing Transcript (Dkt. No. 7106 at DE 213, pp. 60—
61; Dkt. No. 7111 at DE 292, pp. 60—61)).
16
contend that these opinions already and unequivocally establish that
“continuously cast film” has a drying limitation because the specification
disclaimed films made using conventional, top air dn’ing. Thus, regardless of
Indivior deleting the word “dried” during the patent prosecution of the ‘305
Patent, Indivior is precluded by the doctrine of issue preclusion from arguing
otherwise here. (Id. at 13—15; Def. Response at 19—20). Defendants also point to
numerous examples in the specification that disparage conventional, top air
drying. (P1. Opening. 15—18). Finally, defendants contend that the Indiviorl
decision was not based on a “cold record”; the Federal Circuit had the benefit of
the Delaware Litigation over the ‘514 Patent, briefing containing all of Indivior’s
arguments here, expert declarations addressing the merits of the current
claims, the preliminary injunction hearing transcript, and oral argument. (Def.
Response at 13—14). In any event, say the defendants, Indivior has failed to
supply any new evidence here, not available before, that would change the
result. (Id. at 16—17). As noted above, I held a Mw-kman hearing in which both
sides were permitted to proffer whatever evidence they deemed appropriate.
To construe the claim here I must endeavor to give the claim terms their
“ordinary and customary meaning” in light of the words chosen, primarily
based on the specification, which “is the single best guide to the meaning of a
disputed term.” Phillips, 415 F.3d at 1315. I also am guided by both Federal
Circuit opinions in Inthvior land Inthvior II, which together suggest that the
‘305 Patent must be construed consistent with the ‘514 Patent.
Turning to the ‘305 Patent’s specification, I am constrained to find, as
did the Federal Circuit, that the specification discloses creation of uniform
films via certain controlled drying processes that differ from conventional topdown techniques:
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. 811. 56—64, col. 22 II. 4 1—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 11.
37—42. But as heating continues, the vapor pressure of the
17
underlying aqueous composition builds, causing the film surface to
stretch and ultimately break to allow the vapor to escape. Id. cal. 3
11. 45—49. The polymer skin then reforms, and the cycle of surface
is
drying
until
reformation
continues
destruction
and
cycle produces a
complete. Id. col. 3 11. 49—52. Undesirably, this
dried film that is uneven and nonuniform, which the patent refers
to as the “ripple effect.” Id. col. 3 11. 5 1—54.
In a section titled “Drying Wet Cast Films,” Id. cal. 28 1. 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 11. 52—55 (emphasis added). Such methods
allow for vapor release without the disadvantages described above.
Id. cal. 28 11. 55—57. In contrast, “Iclonventional convection air
drying from the top isnot employed” because it produces tbe ripple
effect. Id. col. 28 11. 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 11. 1—3.
In addition to controlling the location of the source of air, the
specification teaches a “zone drying procedure” in which the film is
dried along a belt with different drying zones that may vary in
temperature, humidity, or other atmospheric conditions. Id. col. 32
11. 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. cal. 32 11.
49—50. Zone dnning may be supplemented with additional processes
such as lamination “so long as controlled drying is maintained in
accordance with the invention.” Id. col. 33 11. 1—4.
Indivior II, 930 F.3d at 1332. In light of the patent’s specification, and giving
due regard to the reasoning of the Federal Circuit, I must reject Indivior’s
proposed claim construction. Rather, defendants’ proposed construction, which
construes “continuously cast film” to include “drying the matrix without solely
employing conventional convection air drying from the top” is consistent with
the claim language and the overall specification. I therefore find that
“continuously cast film” means a continuous sheet of cast film that has been
dried without solely employing conventional convection air drying from the top.
18
2.
“ParticLe Size of 200 Microns or Less” and “Particle
Size of 100 Microns or Less”5
Plaintiff
Term
Defendant
Indefinite
“particle size of 200
microns or less”
(‘305 Patent: 1, 26)
No construction necessary
(i.e., particle size of 200
microns or less)
“particle size of 200
microns or less”
No construction necessai-v Indefinite
(i.e., particle size of 100
microns or less)
(‘305 Patent: 27)
(P1. Opening at 29; Def. Opening at 22).
Here, Alvogen challenges the term “particle size,” stating that it is
indefinite because there are many ways to measure it. (Def. Opening at 22).
According to Alvogen, “particle size” is “highly dependent upon the particular
method used to make the measurement.” The patent, it says, is indefinite
because it does not specify what method should be used. (Id. at 23). In support,
Alvogen proffers the report of its expert, Dr. Reza Fassihi, who notes that there
are numerous methods for measuring particle size and that the specification
does not recognize or require a specific method of measurement. (Fassihi
Declaration
¶‘I
50—66; Def. Opening at 2 1—23). Although sieving is one such
method, Alvogen points to examples in the ‘305 Patent that it claims do not
support the use of a sieve: “[The ‘305 Patent] also includes an example of an
active agent having a ‘mean sphere diameter’ of 12 microns (40:50-51) and an
example of an active agent having an ‘approximated [sic]150 micron’ particle
size (40:38-40). Thus the specification, according to Alvogen, is at best
inconsistent in its description of particle size, and in many examples does not
describe how a reported particle size was determined at all.” (Def. Opening at
24). Alvogen maintains that its failure to challenge the meaning of “particle
DRL does not join Alvogen in this argument.
19
size” in prior litigation involving the related ‘514 Patent does not preclude it
from raising the issue here. (Del Response at 32).
Indivior maintains that no construction of these terms is necessary’ and
that, in any event, Alvogen is precluded from re-raising this issue here. (P1.
Opening at 29—3 1). I agree.
As to construction of the term “particle size,” unless a patentee
unequivocally imparts a novel meaning to terms in a claim, courts “indulge a
‘heavy presumption’ that claim terms carry their full ordinary and customary
meaning.” Omega Eng’g, mc, v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir.
2003). Here, I find no such novel meaning in the specification. Instead, the
patent explains that particle size is to be given its plain and ordinary meaning
—
as construed by a person of ordinary skill in the art
—
such that it means
where particles are able to pass through a sieve of a specified mesh size, the
particles are understood to be smaller than that size.
As to collateral estoppel, my analysis is shaped by the Federal Circuit’s
opinion that the claims of the two patents are patentably indistinct—and
indeed, virtually identical except for the “continuously cast” language:
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 element 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 Delaware Case is that the ‘305 claims contain
the term “continuously cast” in place of “dried” and “drying.”
Compare ‘514 patent col. 73 1. 48—col. 74 1. 9, with ‘305 patent col.
73 11. 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
20
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 “patentably 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-wpe 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 “continuously
cast.” J.A. 4344—45, 4354—55. It also filed a terminal disclaimer at
the same time. J.A. 4360—6 1, 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.
Indzviorl, 752 F. App5c 1034—1035; see also Indivior II, 930 F.3d at 1336 (“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.” (citation omitted)).
Apart from the “continuously cast” terminology, the ‘305 Patent has the
same specification as the ‘514 Patent. The absence of any other material
distinction between the two patents is underscored by the very examples
Alvogen points to in support of its “particle size” indefiniteness argument. As
noted above, Alvogen cites examples in the ‘305 Patent specification to argue
indefiniteness. (Def. Opening at 24). Those very examples, however, appear
verbatim in the ‘514 Patent. (See P1. Ex. C at 162). Moreover, the claims
containing the term “particle size” in the ‘305 Patent are identical to the ‘514
Patent. (Compare P1. Ex. A at 83 with P1. Ex. C at 179 (for example, the ‘514
Patent, like the ‘305 Patent, claims: “A drug deliven’ composition comprising.
• wherein the particulate active has a particle size of 200 microns or less
.
Whatever this language gives in terms of an argument for indefiniteness, it
takes away from any argument for claim preclusion.
21
.
Alvogen ultimately stipulated in the Delaware Litigation that particle size
in the ‘514 Patent had its plain and ordinary meaning, and a final judgment
was issued. (See P1. Ex. H; Ex. I). That judgment binds the parties in the
subsequent ‘305 litigation. Alvogen cannot revive the particle size argument
simply by filing a patentably indistinct second patent.
I therefore find likewise that “particle size” with respect to the ‘305
Patent is not indefinite and has its plain and ordinary meaning.
3.
“About 2 mg to About 16 mg of Buprenorphine or a
Pharmaceutically Acceptable Salt Thereof’
Term
.
“about 2 mg to
about 16 mg of
buprenorphine or a
pharmaceutically
acceptable salt
thereof’
( Exemplary of terms
concerning the
quantity of
buprenorphine or
naloxone)
Plaintiff
Defendant
plain and ordinary
meaning, but if
construction is necessary,
for example,
“approximately 2 mg to
approximately 16 mg of
buprenorphine or a
pharmaceutically
acceptable salt thereof’
“a dosage containing
buprenorphine that
provides buprenorphine
absorption levels
bioequivalent to a
comparable on dose
Suboxone® tablet, i.e., a
film containing 8 mg
buprenorphine compared
to a tablet containing 8
mg buprenorphine”
plain and ordinary
meaning, but if
construction is necessary,
for example
“buprenorphine Cmax
from approximately 0.624
ng/ml to approximately
5.638 ng/ml”
“buprenorphine Cmax
values that are
bioequivalent to a
comparable one dose
tablet, i.e., a
film containing 8 mg
buprenorphine compared
to a tablet containing 8
mg buprenorphine”
(‘454 Patent: 1)
“buprenorphine
Cmax from about
0.624 ng/ml to
about 5.638 ng/ml”
( Exemplary of terms
concerning Cmax or
AUC values)
(‘454 Patent: 1)
(P1. Opening at 32; Def. Opening at 26—27).
The parties agree that the term “about” means “approximately.” (See the
parties’ Joint Claims Construction and Preliminary Statement (Dkt. No. 7106
atDE 73; Dkt. No. 7111 atDE 182)). This dispute, then, is not about the
22
actual meaning of the term “about.” Rather, the parties disagree as to whether
the Suboxone film must provide buprenorphine and naloxone absorption levels
that are bioequivalent to a comparable dose of Suboxone tablets. (P1. Opening
at 32—35; Def. Opening at 27—29).
DRL contends that the specification for the ‘454 patent supports the
bioequivalence interpretations because it makes repeated reference to the
purpose of the invention: the production of a Suboxone film that is
bioequivalent to Suboxone tablets. (Def. Opening at 28—30). Indivior responds
that the term does not require construction because all of its words have a
clear and established meaning. (P1. Opening at 32—33). DRL’s “bioequivalence”
construction, says Indivior, is not sustainable, if only because it would exclude
disclosed embodiments. (Id. at 33—34; P1. Resp. 27—29).
I agree with Indivior. “[Ajbsent contravening evidence from the
specification or prosecution history, plain and unambiguous claim language
controls the construction analysis.” DSW, Inc. v. Shoe Pavilion, Inc., 537 F.Sd
1342, 1347 (Fed. Cir. 2008). Here, I find that the claim language is clear and
unambiguous. Moreover, DRL and Alvogen’s proposed construction cannot be
adopted here as it improperly limits the claim scope by excluding embodiments
referenced in the specification. (See P1. Ex. B, col. 14:59—63 (“In one
embodiment, the film composition provides an in vivo plasma profile having a
Cmax of less than about 6.4 ng/ml for the agonist and an in vivo plasma
profile having a Cmax of less than about 400 pg/mI for the antagonist.”); see
also Indivior Inc.
ji.
Actavis Labs. UT, Inc., No. CV 18-497-RGA, 2019 WL
2098841 (D. Del. May 14, 2019) (construing the same claim in the ‘454 Patent
and finding that “many of the sections that Defendant points to in the
specification do not support its claim construction. (Id. col. 3:32-39 (The
‘optimum’ absorption may be, for example, a level that provides a bioequivalent
absorption.
..
An ‘optimum’ Cmax of buprenorphine is about 0.67 to about 5.36
ng/ml’) (emphasis added); Id. col. 14:37-39 (‘[TIhe inventive film composition
preferably provides an AUC value so as to provide a bioequivalent result
23
The claim language is clear and unambiguous; it identifies a chemical
substance and states the range of permissible weights in milligrams. I construe
the term “about 2 mg to about 16 mg of buprenorphine or a pharmaceutically
acceptable salt thereof’ to have its plain and ordinary meaning and do not find
the term to be limited by bioequivalent dosages.
“A Polyethylene Oxide Alone”6
4.
Defendant
Plaintiff
Term
“a polyethylene
plain and ordinary meaning,
oxide alone or
but if construction is
plain and ordinary meaning,
or if a construction is
in combination
necessary, for example, “a
necessary, “a polyethylene
with
polyethylene oxide or a
oxide alone or in combination
hydrophilic
polyethylene oxide in
with a hydrophilic cellulosic
cellulosic
combination with a
polymer”
polymer”
hydrophilic cellulosic
a
polymer”
(‘454 Patent: 9
10, 11)
(P1.
Opening at
35; Def. Opening at 32).
The dispute with respect to this final claim is subtle. It concerns whether
DRL infringes the ‘454 Patent if its water-soluble matrix contains polyethylene
oxide
(“P0”) combined with a polymer other than a hydrophilic cellulosic
polymer (“HCP”).
The parties ask the court to the meaning of two alternatives: a watersoluble matrix comprised of either:
(1) P0
“alone”; or
(2) P0
+
HCP.
Everyone seems to agree that alternative (2) encompasses P0 plus HCP. The
rub is alternative (1): Does it include P0 in combination with polymers other
than HCP? Or does it include only 100% P0, not P0 combined with any other
polymer?
6
Alvogen does not join DRL in this
argument.
24
DRL takes the latter view. Thus, DRL says, its polymer matrix, which
includes a P0 plus a polymer that is not HCP, does not infringe the claim. (Id.
at 33). Indivior takes the former view. It points to the word “comprises,” which,
it contends, permits a more expansive interpretation of PU “alone.” (P1.
Response at 3 1—32). Thus, because DRL’s water-soluble matrix contains P0 in
conjunction with a polymer (even though the polymer is not HCP), it would
infringe under alternative (1).
In drafting its claim, Indivior chose the word “alone,” and “alone” is a
lonely word. In ordinary English, given a choice of “tea alone or tea with milk,”
we would not assume we were being offered tea with honey, or even tea with
cream. And in general, this seems like farfetched and convoluted drafting if
what the writer meant to convey was just “P0 in combination with a polymer.”
Because Indivior chose to use the word “alone,” it cannot then restore
disclaimed features by relying on the word “comprising.” Spectrum Int’l, Inc. v.
Sterilite Corp., 164 F.3d 1372 (Fed. Cir. 1998) acknowledges that “a transitional
term such as ‘comprising’
.
.
.
does not exclude additional unrecited elements,
or steps (in the case of a method claim).” Id. 1379—80 (quoting Moleculon
Research Corp. v. CBS, Inc., 793 F.2d 1261, 1271 (Fed. Cir. 1986)). As Spectrum
points out, “in the very same sentence, however, the [Moleculon] court limited
this broad view of ‘comprising’ to avoid altering the scope of the particular
claim step at issue.
.
.
.
‘Comprising’ is not a weasel word with which to
abrogate claim limitations.” Id. (citations omitted).
Absent some indication that the commonsense meaning of “alone” was
not intended, I am “powerless to rewrite the claims and must construe the
language of the claim at issue based on the words used.” SRAM Corp. v. AD-Il
Eng’g, Inc., 465 F.3d 1351, 1359 (Fed. Cir. 2006) (citation omitted). Of course,
a drafter may act as its own lexicographer and define terms any way it wishes.
But nothing in the record here supports Indivior’s counterintuitive construction
whereby DRL’s film infringes because it contains a matrix consisting of P0 and
25
a polymer that is not HCP. Here, P0 “alone” plainly and unambiguously limits
the alternative (1) water-soluble matrix to those that contain only P0.
Ill.
Recovery on the Bonds
Finally, Alvogen moves separately for an order granting immediate
recovery on the bonds posted in connection with the court’s injunction pending
the Court of Appeals’ mandate in IndiviorL (Dkt. No. 7106 at DE 148).
Rule 65(c) requires an injunction bond “in an amount that the court
considers proper to pay the costs and damages sustained by any party found to
have been wrongfully enjoined or restrained.” “The purpose of the bond
requirement is to protect the enjoined party in the event the injunction should
not have been imposed.” Howmethca Osteonics v. Zimmer Inc., 461 F. App’x
192, 198 (3d Cir. 2012). However, “[i]t is settled that one can recover on an
injunction bond only after a trial and final judgment on the merits.” Clark v. KMan Corp., 979 F.2d 965, 969 (3d Cir. 1992). Only an adverse final judgment
establishes that a party was wrongfully enjoined in the interim.
The Third Circuit has recently held that this rule applies to TRO bonds,
like the one here. See Nat’! Collegiate Athletic Ass’n v. Governor of New Jersey,
939 F.3d 597, 605 (3d Cir. 2019) (confirming in the context of TROs that
“whether a party’ was wrongfully enjoined depends upon the final judgment on
the merits”). “[T]he rule increases predictability of the law, ‘discourag[es
parties from requesting injunctions based on tenuous legal grounds,’ and
conserves judicial resources.” Id. at 607 (citations omitted). Our system is not
one in which, during the litigation, each party has to write the other a check
every time it falls behind on points.
Alvogen argues that Indivior made a strategic decision to seek an
injunction despite the Federal Circuit panel’s having previously ordered that an
n,
injunction against DRL must be lifted. Because of this choice, says Alvoge it
was wrongfully kept from proceeding to market. (Dkt. No. 7106 at DE 149).
Indivior responds, correctly in my view, that under settled Third Circuit law
26
Alvogen may not recover on the bonds before there is a final judgment on the
merits. (Id. at DE 156).
A determination as to whether Alvogen was unlawfully enjoined cannot
be made until “there is final judgment.” American Bible Soc., 446 F. 2d at 594.
Such a final judgment must take into account many factors that the Court
cannot properly adjudicate at this stage—for example, the likelihood of
Alvogen’s having been, as it now claims, the first generic to market but for this
litigation or this injunction. For this reason, too, even if not barred by Third
Circuit precedent, the equities would weigh against the grant of Alvogen’s
motion.
Alvogen’s motion to recover on the bond is denied without prejudice to a
later application, if and when appropriate, in connection with the final
resolution of this case. (Dkt. No. 7106 at DE 148).
N.
Conclusion
I construct the disputed terms, for the reasons and in the manner
detailed above, as follows:
1. “continuously cast film” means a continuous sheet of cast film
that has been dried without solely employing conventional
convection air drying from the top.
2. “particle size” requires no construction.
3. “about 2 mg to about 16 mg of buprenorphine or a
pharmaceutically acceptable salt thereof’ and its equivalent
claims have their plain and ordinary meaning.
4. “a polyethylene oxide alone” means a water-soluble matrix
comprised solely of PU.
Alvogen’s motion to recover on the bond pursuant to Rule 65 (Dkt. No.
7106 at DE 148) is denied without prejudice.
An appropriate order follows.
Dated: November 5, 2019
Kevin McNulty
United States District Judge
27
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