United States District Court, D. New Jersey
INDIVIOR INC., INDIVIOR UK LIMITED, and AQUESTIVE THERAPEUTICS, INC., Plaintiffs,
DR. REDDY'S LABORATORIES S.A., AND DR. REDDY'S LABORATORIES, INC., Defendants. INDIVIOR INC., INDIVIOR UK LIMITED, and AQUESTIVE THERAPEUTICS, INC., Plaintiffs,
ALVOGEN PINE BROOK, INC., AND ALVOGEN PINE BROOK LLC, Defendants.
McNulty United States District Judge.
opinion contains the Court's construction of key patent
terms following a Markman hearing. (Dkt. No. 7106 at
¶ 211; Dkt. No. 7111 at ¶ 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-7106 consolidated action.
(See DE 148).
consolidated patent infringement cases are brought by
Indivior Inc., Indivior UK Limited, and Aquestive
Therapeutics, Inc. (collectively, unless otherwise specified,
"Indivior"), against Dr. Reddy's Laboratories
S.A. and Dr. Reddy's Laboratories, Inc. (collectively,
unless otherwise specified, "DRL") and Alvogen.
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").
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
briefly review the relevant opinions issued both in this
action and in the related Delaware Litigation.
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
¶ 121). DRL subsequently appealed to the Federal
Circuit, which reversed and remanded. Indivior Inc. v.
Dr. Reddy's Labs., S.A., 752 Fed.Appx. 1024 (Fed.
Cir. 2018) ("Indivior F). 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) ("Indivior II").
The '514 Patent
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. ('514 Patent at , .).
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 Benckiser Pharm. 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 Pharm. Inc. v.
Dr. Reddy's Labs. S.A., No. CV 14-1451-RGA, 2017 WL
3782782 (D. Del. Aug. 31, 2017); Indivior Inc. v. Mylan
Techs. Inc., 298 F.Supp.3d 775 (D. Del. 2018).
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 "amount[ed]
to an unconventional process" for drying. See
Reckitt Benckiser Pharm. Inc. v. Teva Pharm. USA Inc.,
Nos. 14-1451, 14-1573, 14-1574, 2016 WL 3621632, 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 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.").
then appealed to the Federal Circuit. See Section
I.E, infra, discussing Indivior U.
The '305 Patent
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:
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 drying 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
'305 Patent contains similar language, except that the
italicized "drying" language was dropped and
references to "continuous casting" are substituted.
Thus '3O5'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 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 10% of a desired amount of
said at least one active.
(PI. Ex. A at 85; italicized emphasis added).
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 ¶ 1;
Dkt. No. 5285 at ¶ 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 ¶ 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.
then appealed that decision to the Federal Circuit, which
November 20, 2018, a divided Federal Circuit vacated the
preliminary injunction issued in this action and remanded.
See Indivior I, 752 Fed.Appx. 1024.
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 "[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
11. 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.
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[ ]
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. at (quoting Chicago
Bd. Options Exch., Inc. v. Int'l Sec. Exch., LLC,
677 F.3d 1361, 1372 (Fed. Cir. 2012)).
SciMed, we instructed that
[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."
In Openwave, 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. 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.
Indiviorl, 752 Fed.Appx. at 1029-30.
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 limitation because the film, which starts as
a liquid, has to be dried to ultimately become a solid film.
Id. at 1031-32. 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.
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.
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.
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, 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.
then filed a petition for en banc rehearing, essentially
espousing the position of the dissent.
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 Indivior
I. (Dkt. No. 7106 at ¶ 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 February 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 Indivior I appeal. (Id.). Indivior
later agreed to post a second bond that increased the total
value of the bonds posted to $36 million. (Id.).
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.
now moves for an order granting it an immediate recovery on
the bonds. (Dkt. No. 7106 at ¶ 148, 149, 171). ...