INDIVIOR INC. et al v. DR. REDDY'S LABORATORIES S.A. et al

Filing 142

AMENDED OPINION; etc. Signed by Judge Kevin McNulty on 07/13/2018. (sms)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

INDflROR INC., INDIWOR UK
LIMITED, and AQUESTWE
THERAPEUTICS, INC.,

Civ. No. 17-7111 (KM) (CLW)

Civ. No. 18-1775 (1CM) (CLW)
Civ. No. 18-5288 (1CM) (CLW)

Plaintiffs,

(Consolidated)
V.

DR. REDDY’S LABORATORIES S.A.,
AND DR. REDDY’S LABORATORIES,
INC.,

OPINION
(Amended: see Order, ECF no. 134;
Redacted for Public Filing

Defendant.

KEVIN MCNULTY, U.S.D.J.:
In this patent infringement suit, the plaintiffs, Indivior Inc., Indivior UK
Limited, and Aquestive Therapeutics, Inc. (collectively, unless otherwise
specified, “Indivior”), seek a preliminary injunction against defendants, Dr.
Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (collectively,
unless otherwise specified, “DRL”). Indivior holds and practices a patent on
Suboxone film, a “rapidly dissolving film that adheres to the underside of a
patient’s tongue or the inside of a patient’s cheek.” The film contains and is a
means of administering buprenorphine and naloxone, drugs used in the
treatment of opioid addiction. DRL recently received approval from the Food
and Drug Administration (“FDA”) for an Abbreviated New Drug Application
(“ANDA”) for a generic version of Suboxone and plans to launch this generic “at
risk.” Indivior claims that this generic will infringe a continuation patent
(known as the ‘305 patent”) granted to Aquestive by the Patent Office in April
2018, and seeks to enjoin DRL’s launch of the generic. For the reasons
explained below, I will grant the preliminary injunction.
1

ESSENTIAL FINDINGS OF FACT
1. The ‘514 “parent” patent contained a “dried/drying” limitation and was
found not to claim a device that solely used °conventionaj” drying
methods, i.e., drying by convection from the top.
2. The ‘305 continuation patent now before the Court does not expressly or
impliedly contain the “dried/drying” language of the ‘514 patent.
3. The claims and issues in the prior action and in this action are not
identical.
4. The ‘305 patent claims the invention, and states embodiments thereof,
without respect to drying methods used to manufacture it.
5. The ‘305 patent provides an adequate written description to a person
skilled in the art of a device without respect to drying methods.
6. The record at present does not overcome the presumption of nonobviousness or validity.
7. The record adequately establishes infringement, particularly of Claim 26
of the ‘305 patent.
8. Entry of a generic would cause Indivior to lose market share and the
suboxone film’s advantageous formulaiy status, and would impair
research and development.
9. DRL knowingly invested “at risk” and has not shown that the balance of
harms/equities weighs in its favor. (See redacted portion of opinion,)
10.

Although the suboxone film is an efficacious means of
administering buprenorphine, it is not the only means, and the
disadvantages of having no generic alternative does not outweigh the
public benefit of maintaining Indivior’s rights as a patent holder while
this action is pending.

ESSENTIAL CONCLUSIONS OF LAW

1. Indivior has demonstrated a likelihood of success on the merits.
2. Indivior has demonstrated irreparable harm
3. The balance of the equities is at best neutral
4. The public interest does not weigh against entry of a preliminary
injunction.
The remainder of the discussion in this Opinion expands upon and
supports the foregoing findings of fact and conclusions of law.
2

FACTS1
The following facts were developed at a one-day hearing on June 28,
2018. Both sides declined to present live testimony. They presented their cases
by means of oral argument, supplemented by PowerPoint presentations citing
For ease of reference, I will cite to the following items as:
P1. Br.

Def.

Memorandum of Law in Support of Plaintiffs’ Motion
for a Temporary Restraining Order and Preliminary
Injunction (ECF no. 71)

=

Opp.

P1. Reply

DRL’s Opposition to Plaintiffs’ Motion for a
Preliminary Injunction and Temporary Restraining
Order (ECF no. 88)

=

Reply in Support of Plaintiffs’ Motion for a
Preliminary Injunction (ECF no. 96)

=

Simkin Decl.

Declaration of Richard Simldn (ECF no. 70)

Patent ‘305

=

Patent ‘514

United States Patent No. 9,931,305, Exhibit B to
Declaration of Philip S. May (ECF no. 71)

=

United States Patent No. 8,693,514, Exhibit E to
Declaration of Philip S. May (ECF no. 71)

Hofmann Decl.

Expert Declaration of Ivan T. Hofmann (ECF no. 88)

=

PI/TRO Hrg. Tr.

=

Transcript of Motion for Preliminary Injunction
Hearing on June 28, 2018 (ECF no. 110)

Langer Decl.

Expert Declaration of Robert S. Langer, ScD (ECF no. 71)

Amiji Decl.

Expert Declaration of Mansoor Amiji, PhD (ECF no. 91)

=

Langer Supp.
Bennis Deci.

Supplemental Expert Declaration of Robert S. Langer
ScD (ECF no. 96)

Crossley Dccl.
Navarro DecI.

=

Declaration of Mark Crossley (ECF no. 71)

=

Declaration of Robert P. Navarro, Pharm.D. (ECF no. 72)

=

Rosenthal Deci.
Sonig Decl.

Declaration of Melissa A. Bennis (ECF no. 72)

=

=

Expert Declaration of Richard Rosenthal, M.D. (ECF no. 90)
Declaration of Alok Sonig (ECF no. 88)
3

to the filed affidavits and exhibits. Many of the underlying historical facts were
not in dispute.
Indivior, along with Aquestive, developed Suboxone film, a type of
buprenorphine-containing transmucosal product for opioid dependence
(“BTOD9 (Simkin

¶ 7.) It is essentially a rapidly dissolving film that adheres to

the underside of a patient’s tongue or the inside of a patient’s cheek and
combines two active pharmaceutical ingredients: (1) buprenorphine, a partial
opioid agonist that decreases a patient’s need for opioids, and (2) naloxone, an
opioid antagonist that deters abuse. (Id.) Suboxone competes with several other
drugs in the BTOD market, including tablets and buccal films. It maintains its
position in that market partly because its generic competitors are not AB
rated—that is, pharmacies cannot substitute generics at the point of sale when
a patient is prescribed Suboxone. (Id.

¶ 9.)

]ndivior initially participated in the tablet market, having received
approval from the FDA to market Suboxone in tablet form in 2002. (Hoffman
Decl.

¶ 45.) It had “orphan drug exclusivity” for the drug in tablet form until

October 2009. (Id.)
During this time, Indivior developed the film version of Suboxone with
Aquestive. On December, 10, 2013, the Patent Office issued Patent No.
8,603,514 (“‘514 Patent”) for “Uniform Films for Rapid Dissolve Dosage Form
Incorporating Taste-Making Compositions” to Aquestive.2 (‘514 Patent at

[451,

[54).) Once it received approval from the FDA, Indivior marketed the new drug
with the objective of switching patients over from tablets to film. (See id.

46—

53.) By the time of the launch of the first generic tablet version of Suboxone,
Indivior had successfully migrated 85% of patients on the drug to the film
version. (Id. ¶ 5343
At the time, Aquestive was known as MonoSol Rx, LLC. (P1. Br. at 2.)
That program to induce the switch to the film form of the drug landed Indivior
in legal difficulty. In 2012, the Federal Trade Commission (FTC) initiated an
investigation into the business practices of Invidior regarding Suboxone; the
investigation remains pending. (Hofmann Decl. ¶ 61) Invidior also faces a class action
antitrust lawsuit, as well as a lawsuit filed by more than 40 states, relating to the
2

4

DRL (as well as several other pharmaceutical companies, including

Watson Laboratories, Par Pharmaceudcai, Inc., Alvogen Pine Brook, Inc., Teva
Pharmaceutical, Inc., Sandoz Inc. and Mylan Technologies, Inc.), sought to
enter the film market as a generic competitor. They submitted ANDAS to the
FDA for generic versions of the Suboxone film. (Hoffman Deci. ¶ 14.) In 2015,
Indivior responded by filing actions against these companies under the Hatch
Waxman Act in the United States District Court for the District of Delaware.
(Id.) In August 2017, Judge Richard Andrews held that Indivior failed to meet

its burden of showing that DRL’s generic version infringed the claims of the
‘514 Patent for Suboxone film. See infra. Judge Andrews had earlier construed
the 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 infra.
Indivior responded to that decision by returning to the Patent Office. On
April 3, 2018, the Patent Office issued Patent No. 9,931,305 (“‘305 Patent”) to
Aquestive. (Patent ‘305 at [45].) According to the ‘305 patent:
The present invention relates to rapid dissolve thin film drug
delivery compositions for the oral administration of active components.
The active components are provided as taste-masked or controlledrelease particles uniformly distributed throughout the film composition.
The composition may be formed by wet casting methods, where the film
is cast and controllably dried, or alternatively by an extrusion method.
(Id. at [57j (Abstract).)
This ‘305 continuation patent is a “child” of the ‘514 patent, the one that
was the subject of the previous Delaware litigation between DRL and Indivior.
marketing and sales of Suboxone. (Id. ¶ 62—63.) These allegations generally involve
deals with Aquestive to create the Suboxone film in order to extend Indivior’s market
exclusivity with the drug, Inthvior’s marketing of the film to physicians, payers, and
pharmacists as safer and superior to the tablet version, and the lowering of the price
for the film to incentivize sales. (See id. 9 64—65.) On top of that, the Department of
Justice has initiated a grand jury investigation relating to these practices, including
claims about pediatric safety and the overprescribing of Suboxone tablets and film. (Id.
¶ 66.) Several states have also initiated civil investigations against Indivior over the
marketing and promotion of Suboxone. (Id. ¶ 67.)
5

The two largely overlap, except as to the language of 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,” but the ‘305 Patent claims
“(i) a continuously cast film produced on a manufacturing line.” Second, the
‘514 Patent makes 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 vasy by more
than 10% of said at least on active.” The ‘305 patent contains the same
language, except that the italicized language became “continuously cast on the
manufacturing line” and “continuously cast film,” respectively.4

Below is a reproduction of a red-line of the language of Claims 26 and 62 of the
‘305 and ‘514 patents. (P1. Br, at 5—6.)
Limitation

I
2

3
4

5
6

Claim 26 of the ‘305 Patent (Ex. B)
A drug delivery composition
comprising:
(i) a continuously cast film produced
on a manufacturing 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;

comprising a flowable water-soluble
or water swellable film-forming
matrix comprising one or more
substantially water soluble or water
swellable polymers; and
a desired amount of at least one active;

wherein said matrix has a viscosity
sufficient to aid in substantially
maintaining non-self-aggregating
uniformity of the active in the matrix;
(ii) a particulate active substantially
uniformly stationed in the matrix; and
(iii) a taste-masking agent selected
from the group consisting of flavors,
sweeteners, flavor enhancers, and
combinations thereof to provide tastemasking of the active;

wherein said matrix has a viscosity
sufficient to aid in substantially
maintaining non-self-aggregating
uniformity of the active in the matrix;
(ii) a particulate active substantially
uniformly stationed in the matrix; and
(iii) a taste-masking agent selected
from the group consisting of flavors,
sweeteners, flavor enhancers, and
combinations thereof to provide tastemasking of the active;

6

Claim 62 of the ‘514 Patent (Ex. E)
A drug delivery composition
comprising:
(i) a cast film

In the District of Delaware, Plaintiffs and DRL had earlier litigated the
validity and potential infringement of the ‘514 Patent (as well as similar patents
held by plaintiffs) by DRL’s ANDA product. See Recklu Benckiser Phamz. Inc.

is.

TevaPharrn. USA Inc., (“Reckittr) Nos. 14-1451, 14-1573, 14-1574, 2016WL

3621632 (1). Del. June 29, 2016) (construing the claims of multiple terms of
several patents, including the ‘514 patent pursuant to Markman v. Westuiew
Instmments, Inc., 52 F.3d 967 (1996)); Reckitt Benckiser Phann. Inc. a Dr.

Reddy’s Labs. S.A.,rReckittlf) Nos. 14-1451, 14-1573, 14-1574, 2017WL
3837312 (D. Del. Aug. 31, 2017), appeal docketed, No. 18-1115 (Fed. Cir. Oct.
27, 2017) (addressing the allegations of infringement and invalidity with
respect to the ‘514 Patent after a four-day bench thai).
In Reckitt H, Judge Richard Andrews, after a four-day bench trial, found
that the defendants had failed to demonstrate by clear and convincing evidence
that the asserted claims in the ‘514 patents were invalid as obvious. He also
found, however, that Indivior failed to meet its burden to show that DRL’s
product infringed certain claims of the ‘514 patent. 2017 WL 3837312, at *20,
In an earlier opinion, Judge Andrews had construed the claim in the ‘514
patent, “dried,” to mean “dried without solely employing conventional
wherein the particulate active has a
particle size of 200 microns or less
and
said flowable water-soluble or water
said flowable water-soluble or water
swellable film-forming matrix is
swellable film-forming matrix is
capable of being dried without loss of
capable of being continuously cast on
the na,zesfactuthzg line without loss of substantial uniformity in the stationing
substantial uniformity in the stationing of said particulate active therein; and
of said particulate active therein; and
wherein the uniformity subsequent to
wherein said uniformity of the
casting and drying ofthe ,natrLt is
continuously cast fit,,: is measured by
measured by substantially equally
sized individual
substantially equally
sized individual unit doses which do
unit doses cut from the continuously
not vary by more than 10% of said
cast film which do not vary by more
desired amouni of said at least one
than 10% of a desired amount of said at active.
least_one_active.
wherein the particulate active has a
particle size of 200 microns or less and

—

‘

8

7

convection air drying from the top.”5 Reckitt I, 2016 WL 3621632, at *10_*1 1.
He found that Indivior had disclaimed “conventional convection air drying from
the top,” both through express statements and repeated disavowal in the ‘514
Patent specifications. 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. He was not persuaded “that evidence of a controlled process
that [did] not result in rippling and that achievejd] drug content uniformity
automatically amount[ed) to an unconventional process.” Reckitt II, 2017 WL
3837312, at 6. Indivior initially appealed those decisions by Judge Andrews
but later dismissed the appeal. Indiuior Inc. u. Watson Laboratories Inc., 2018

WL 3139436 (Fed. Cir. June 8, 2018).
Instead, Indivior obtained the continuation ‘305 patent, in which it
sought to claim around the “drying” problem. The “dried/drying language” was
dropped from the continuation patent, which was intended to have a broader
scope in that it would no longer disclaim “conventional” drying methods.
Indivior then brought this action against DRL here in the District of New
Jersey, this time claiming infringement of the new ‘305 patent. (See ECF no, I
(“Complaint for Patent Infringement9.) Upon learning of DRL’s plans to launch
the ANDA product “at risk,” Tndivior moved for temporary restraints and a
preliminary injunction to prevent DRL from launching its generic product. (ECF
no. 70.) (This application was made on an emergent basis, because the 30month stay granted by Hatch-Waxman had already been exhausted.)
I granted a temporary restraining order enjoining DRL from launching in
order to preserve the status quo during the resolution of this motion. (ECF no.

That decision was focused on arguments made by Teva Pharmaceuticals USA,
Inc., DRL’s predecessor in interest.
5

S

78.) On June 28, 2018, 1 conducted a hearing on the preliminary injunction
application.6
II.

Discussion
a. Standard of Review
A preliminary injunction has been called “a drastic and extraordinary

remedy.” Bayer CropScience AG v. Dow AgroSciences LLC, 851 F.3d 1302, 1308
(Fed. Cir. 2017) (quoting Nat’l Steel Car, Ltd. u. Canadian Pacific Railway, 357

F.3d 1319, 1324—25 (Fed. Cir. 2004)) “A plaintiff seeking a preliminary
injunction must establish (1) that he is likely to succeed on the merits, (2) that
he is likely to suffer irreparable harm in the absence of preliminary relief, (3)
that the balance of equities tips in his favor, and (4) that an injunction is in the
public interest.” Winter u. Natural Res. Def Council, Inc., 55 U.S. 7, 20 (2008)
(numbering added); accord Am. Express Thavel Related Sen’s. v. Sidamon
Edst off, 669 F.3d 359, 366 (3d Cir. 2012); I<os Phann., Inc. z.’. Andrx. Cop., 369

F.3d 700, 708 (3d Cir. 2004); see Adams u. Freedom Forge Corp., 204 F.3d 475,
486 (3d Cir. 2000) (movant bears the burden of establishing these elements).
A patentee need not address invalidity, an affirmative defense, as an
initial matter in filing for a preliminary injunction. Gaymar Industries, Inc. u.
Cincinnati Sub-Zero Products, Inc., 790 F.3d 1369, 1375 n.7 (Fed. Cir. 2015).
However, when the alleged infringer “raise[sJ substantive issues respecting the
validity and enforceability of the [patent-in-suit],” then the patentee carries the
burden of showing likelihood of success on the merits with respect to the
patent’s validity, enforceability, and infringement. Id. (quoting and
distinguishing Nutrition 21

t.’.

United States, 930 F.2d 867, 869 (Fed. Cir.

1991)).

The hearing largely consisted of oral argument by counsel for both parties as to
whether plaintiffs met the elements for the issuance of preliminary injunction. No oral
testimony was proffered. Instead, the parties have cited declarations and exhibits in
support of their arguments.
6

9

b. Likelihood of Success on the Merits
1. Claim Preclusion

DRL believes that the path to defeating this application for a preliminary
injunction has been smoothed by rulings in prior proceedings. It contends that
Indivior is barred from asserting these patent claims by the doctrines of claim
preclusion and issue preclusion.7 Indeed, that is the thrust of its presentation.
According to DRL, Indivior is barred by claim preclusion from asserting
in this District the “same cause of action” it earlier asserted against DRL under
the ‘514 patent, and lost, in the U.S. District Court for the District of Delaware.
(DeL Opp. at 8.) Further, DRL argues, Indivior is estopped by the Delaware
proceedings from relitigating the issue of whether DRL’s methods for drying its
film are “conventional” and, by extension, whether those methods infringe
Indivior’s ‘305 patent. (Id. at 14.)
I will address the question of claim preclusion first, In generai, the
Federal Circuit applies the claim preclusion law of the regional circuit in which
the district court sits. SimpleAir, Inc.

ii.

Google LLC, 884 F.3d 1160, 1165 (Fed.

Cir. 2018). Claim preclusion bars a suit where there has been: “(1) a final
judgment on the merits in a prior suit involving (2) the same parties or their
privies and (3) a subsequent suit based on the same cause of action.” Walthour
it.

Hen-on, 720 F. App’x 130, 132 (3d Cir. 2017) (quoting Lubrizol Corp. v. Exxon

Corp., 929 F.2d 960, 963 (3d Cir. 1991)). The first two requirements are met, in
that I have before me a final judgment on the merits from the District of
Delaware between the same two parties. See Reckitt II, 2017 WL 3837312. The
third requirement—that the prior judgment concern the ‘tsame cause of action”
as the one now before this court—is peculiar to patent law and is therefore
governed by Federal Circuit precedent. Acumed LLC

ii.

Stryker Corp., 525 F.3d

Though they are related, the two concepts are distinct. Claim preclusion
(sometimes known as resjudicata) bars the relitigating of claims between parties and
their privies, while issue preclusion (sometimes known as collateral estoppel) prevents
a party from relitigating a specific issue or question in a subsequent lawsuit where it
had the opportunity to fully argue that issue before a fact-finder in a previous lawsuit.
Confusingly, both terms are sometimes referred to by the umbrella term “resjudicata.”
7

10

1319, 1323 (Fed. Cir. 2008) (“Whether two claims for patent infringement are
identical” is governed by the law of the Federal Circuit, because this question is
“particular to patent law.”)
In SimpleAir, Inc. u. Qoogle LLC, 884 F.3d 1160 (Fed. Cir. 2018), the
Federal Circuit Court of Appeals addressed the issue of what constitutes the
“same cause of action” with respect to actions involving separate patents.
SimpleAir initiated a series of patent infringement lawsuits against Google and
its cloud messaging services. SimpleAir, 894 F.3d at 1163. The patents held by
SimpleAir consisted of a parent patent and several child patents which all
shared a common specification. Id. Google succeeded in obtaining three
separate judgments in its favor. Id. Its fourth complaint, however, was
dismissed by the district court on grounds of claim preclusion. Id. at 1164. The
district court reasoned that “because the [patents] shared the same title and
specification with the previously adjudicated continuation patents, and the
filing of a terminal disclaimer to overcome the VfO’s obviousness-type double
patenting rejections indicated that the PTO believed the content of the patents
in suit to be patentably indistinct from the earlier patents.” Id.
The Federal Circuit vacated the decision of the district court and
remanded. Id. at 1171. The district court, it reasoned, never actually compared
the claims of the patents involved in the fourth complaint to those of the
previously adjudicated patents. Id. at 1164. It was necessary to perform such a
comparison to determine whether the causes of action in current and prior
actions were identical. Id. at 1166. What defined a cause of action, held
SimpleAir, were the transactional facts from which the cause of action arose Id.
at 1165 (citing Restatement (Second) of Judgments (1982); Senju Phann. Co.,
Ltd. v Apotex Inc., 746 F.3d 1344, 1349 (Fed. Cfr. 2014)). The facts that make
up a “transaction” in a given case, it acknowledged, are not capable of a
mathematically precise definition. Id. (citing Restatement

§ 24 cmt. b.).

SimpleAir propounded a standard and method of analysis of claim
preclusion in connection with continuation patents:

11

As the accused activity between two cases must be “essentially the same”
for claim preclusion to apply, we adopt that standard for comparison of
the claims between asserted patents as well. Thus, where 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 asserted patent
claims in the two suits is essentially the same. In applying that standard
to the particular context here, we conclude that claims which are
patentably indistinct are essentially the same. Id. (citations omitted and
emphasis added).
The filing of a terminal disclaimer poses particular issues in connection
with continuation patents. Id. at 1167. Terminally disclaimed continuation
patents, the Court reasoned, could actually “provide larger claim scope to a
patentee than the patentee had under” the parent patent. Id. (citing Senju, 746
F.3d at 1353). A terminal disclaimer, said the SimpleAir Court, did not wholly
foreclose the question of claim preclusion, and could not be treated as rising to
the level of a presumption. SimpleAir held that such a disclaimer is
nevertheless relevant, however, and provides a “strong clue” that the claims are
essentially the same, or patentably indistinct. Id. at 1168.8
SimpleAir further held that the claims were not barred by the doctrine of
Kessler

1’.

Eldred, 206 U.S. 285 (1907). Id. at 1170. Under Kessler, assertions

of a patent against post-judgment activity are precluded if the earlier judgment
held that “essentially the same” accused activity did not infringe the patent.
SimpleAir, 864 F.3d at 1170 (citing Brian Life, LLC v. Elekta Inc., 746 F.Sd
1045, 1057—58 (Fed. Cir. 2014), and noting that this doctrine was meant to
prevent repeated post-judgment harassment of the judgment winner). This
issue, too, Simple Air remanded to the district court, with the following

8
The Federal Circuit limited its opinion to the error made by the district court—
that is, presuming without further inquiry that a terminally-disclaimed continuation
patent presents the same cause of action as a parent patent. SimpleAir, 884 F.3d at
1169. It noted that while the policy considerations—like whether SimpleAir made a
strategic delay in bringing its fourth suit against Google and SimpleAir’s assurance to
the jury in the previous case that it would not engage in duplicative and burdensome
litigation—were important, the presumption made by the district court was
inconsistent with precedent. Id.

12

instruction: “[I]f, on remand, the district court determines that the claims
are patentably indistinct from those previously adjudicated, and are therefore
claim-precluded

.

.

.

,

then the Kessler doctrine would also bar SimpleAir’s

assertions of those patents against Google’s provision of essentially the same
services post-judgment.” Id. at 1170. Thus the claim preclusion and Kessler
issues tended to merge, at least under the circumstances of that case.
The underlying inventions in SimpleAir (cloud technology) arid in this
case (vehicles for opioid addiction medication) could not be any more different.
The procedural histories of that action and this case, however, are similar.9
Invidior (like SimpleAir) holds a parent patent and a child patent with a
terminal disclaimer. As in Simple Air, a prior judgment has held that a device
did not infringe the parent patent. Like the plaintiff in SimpleAir, Invidior now
brings suit accusing the same allegedly infringing product, this time asserting
its rights under a child patent that contains language differing from that of the
parent. Like the Court in SimpleAir, then, I will look at the claims of both the
child and the parent patent, as well as the patent prosecution history, to see if
the claims are patentably indistinct, and thus “essentially the same.” See also
Acumed, 525 F.3d at 1324 rAccused devices are ‘essentially the same’ where
the differences between them are merely ‘colorable’ or ‘unrelated to the
limitations in the claim of the patent. ‘9. “If the overlap between the
transactional facts of the suits is substantial,” plaintiffs’ action in this case
“should.

.

.

be precluded.” SimpleAir, 884 F.3d at 1165.

In SimpleAir, the substantive dispute in the fourth complaint by SimpleAir
concerned the construction of the patent claim, “whether the selected remote
computing devices are online or offline to the information providers of the received
data,” compared with the claim, “whether said computing devices are online or offline
from a data channel associated with each device,” (the subject of the previous
litigation). SimpleAir, 884 F.3d at 1168. Though the Federal Circuit noted the
similarity of those claims, it left it to the district court on remand to resolve whether
the claims are essentially the same—in other words, patentably indistinct. Id. at 1168—
69. As of the date of this opinion, the district court in the Eastern District of Texas has
not published an opinion determining whether those claims are “patentably indistinct”
and resolving the issue of claim preclusion in that case.
13

A terminal disclaimer was filed with the ‘305 patent. (‘305 Patent at

(9.)

Under SimpleAir, I must take this into account, but it is not in itself dispositive.
A tenninal disclaimer is not an automatic, implied concession that thq two
patents are the same; it is, however, a “strong clue that a patent examiner and,
by concession, the applicant, thought the claims in the continuation lacked a
patentable distinction over the patent.” SimpleAir, 884 F.3d at 1168. The
existence of the terminal disclaimer, then, tilts in favor of DRL, but I must
consider it in tight of the claims of the relevant patents.
The ‘305 and ‘514 patents make many claims, which for the most part
overlap, and I do not consider them in detail. This case centers around a single
point of distinction: the meaning of the removal of the terms “drying! dried”
from the ‘514 parent patent and their replacement with the term “continuously
cast on the manufacturing line” in the ‘305 child patent. Indivior says that the
claim language in the ‘305 patent is clear, and that it does include a limitation
of “unconventional” drying. Such a limitation, says Indivior, if it was ever
present in the ‘514 patent, has now been removed, and should not be read
back into the text of the claims of the ‘305 patent. (PI/TRO Hrg. Tr. at 40:25—
41:15.) DRL argues that this was a change of wording, but not of substance;
the process by which Suboxone film is manufactured under the ‘305 patent,
and particularly the drying process, remains unchanged. (Def. Opp. at 9.)
“Courts are required

.

.

.

to ‘look at the words of the claims themselves

to define the scope of the patented invention.tm Aventis Pimmi. Inc. z1’. Amino
Chemicals Ltd., 715 F.3d 1362, 1373 (Fed. Cir. 2013) (quoting Vitronies Coip. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the ‘305 patent
clearly does not contain the terms “dried” or “drying.” Can Judge Andrews’s
construction of those terms as “dried without solely employing conventional
*4,
convection drying from the top,” Reckittll, 2017 WL 3837312, at
nevertheless be deemed to be present in the term “continuously cast” in the
‘305 patent? I must answer that question in the negative. I find that I cannot
automatically carry over this construction from the earlier ‘514 patent. Such a

14

limitation on a claim must be anchored in some textual reference in the ‘305
patent claims to the method by which the film is dried. See MBQ Labs., Inc. u.
Becton, Dickinson & Co., 474 F.3d 1323, 1330—3 1 rHowever, we cannot
endorse a construction analysis that does not identify a ‘textual reference in
the actual language of the claim with which to associate a proffered claim
construction. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 P.3d 985,
990 (Fed Cir. 19g9)

.

.“).

Within the relevant claim of the ‘305 patent, there is

no such textual reference, and no express limitation of how the film is dried,
whether conventionally or unconventionally.
I observe parenthetically that “conventional” vs. “unconventional,” while
employed as a useful shorthand, is not precisely the distinction drawn by
Judge Andrews. Ne referred, rather, to “conventional convection drying from
the top,” and found that it had been disavowed, leaving other claimed methods
intact.
DRL stresses that “drying is incorporated within the concept of
continuously cast film or continuously cast film on a manufacturing line” and
that “if drying is occurring, .

all the disavowals on which Judge Andrews

relied would apply to the drying which is available in this process.” (PI/TRO
Hrg. Tr. 66:1—11.) In other words, drying is still necessary to the process of the
‘305 patent, and Indivior therefore has not really changed its claims. (See id. at
66:12—20.) To find a limitation, however, it is not enough to find that certain
methods or characteristics are functionally required. See Markem-Imaje Corp. v.
Zipher Ltd., 657 F.3d 1293, 1301 (Fed. Cir. 2011) rThat a device will only
operate if certain elements are included is not grounds to incorporate those
elements into the construction of those claims.”). Similarly, patent
specifications do not automatically translate to limitations within the claims,
though they may be useful in understanding them. See Phillips

t’.

AI4W Corp.,

415 F.3d 1303, 1323 (Fed Cir. 2005). The court’s focus must be “on
understanding how a person of ordinary skill in the art would understand the
claim terms. For instance, although the specification often describes very

15

specific embodiments of the invention, we have repeatedly warned against
confining the claims to those embodiments.” Id. (citations omitted).
The parties have submitted competing expert declarations on that
subject According to DRL’s expert, “a person of ordinary skill in the art would
understand that drying and rheology (including viscosity) are essential aspects
of the invention [and that) that the invention provides for unconventional drying
85); according to Indivior’s expert, the
specifications merely describe a number of ways to making uniform films using
conventional and unconventional methods and “do not recite a particular

and viscosity” (see, e.g., Amiji

¶

drying method.” (See, e.g., Langer Supp. ¶117—21.)
The parties did not offer up their experts for live testimony or an
assessment of credibility. On a cold record, for purposes of this preliminary
prediction of likelihood of success, I am persuaded by Indivior’s interpretation.
Indivior is likely to prevail on its contention that neither the practicalities of
production nor the ‘305 patent language import such an implied “drying”
limitation into the “continuously cast” claim.
The cause of action here involves a continuation patent with a terminal
disclaimer. Nevertheless, the terms of that ‘305 patent do not include
“dried/drying.” That was the at the core of the claim decided by the Reckitt
decisions, which was distinct from the claim presented here. Therefore, I
believe that it is likely that plaintiffs will be able to show that the claims of the
‘305 patent are not “patentably indistinct” from the ‘514 patent and that this
cause of action is not barred by the doctrine of claim preclusion.
2. Issue Preclusion

“Collateral estoppel, also known as issue preclusion, prohibits relitigation
of an issue that has been fully and fairly litigated previously.” Kams ii.
Shanahan, 879 F.3d 504, 514 n.3 (3d Cir. 2018). The elements of issue
preclusion are that (1) the issue to be precluded is the same as that involved in
the prior action; (2) the issue was actually litigated; (3) the issue was
determined by a finai and valid judgment; and (4) the determination was
16

essential to the prior judgment. Id. (quoting Nat’! R.R. Passenger Corp. ii. Pa.
Pub. Lid!. Comm’n, 342 F.3d 242, 232 (3d Cir. 200Sf)0 DRL’s issue preclusion
argument has much in common with its claim preclusion argument, and I
resolve it similarly
In Reckitt land Reckitt H, Judge Andrews defined the term “dried/diying’
as “dried without solely employing conventional convection air drying from the
top” and found alter a bench trial that the drying methods employed by DRL
*jQ_
were non-infringing as to the ‘514 patent. Reckittl, 2016 WL 3621632, at
*11; Reckitt 11 2017 WL 3837312, at *6. This finding, DRL believes, estops
Indivior from relitigating in connection with the ‘305 patent the issue of
whether Indivior disclaimed films dried using conventional methods. The
problem is that the previous litigation construed the “dried/drying” language of
the ‘514 patent, language which is not present in the ‘305 patent. That earlier
language was critical to Judge Andrews’s decision to find that DRL did not
infringe the ‘514 patent.
DRL attempts to get around this problem by arguing, through evidence
in the declarations, that drying is still part of the process of “mak[ing] a
continuously cast film” and that the specification in the patent “repeatedly
states that drying is part of ‘the present invention.tm (Def. Opp. at 15.) Because
of this, ORL argues, Judge Andrews’s determination binds Indivior in this case
as well, and DRL’s ANDA product should be deemed non-infringing.
I am unpersuaded. An apparatus claim need not recite every method of
manufacturing the device, see Research Corp. Techs., Inc. v. Microsoft Corp.,
627 F.3d 859, 873 (Fed, Cir. 2010), and I am wary of ureading specific process
limitations into an apparatus claim” unless they are truly present, Baldwin
Graphic Sys., Inc. u. Sieben, ma, 512 F.3d 1338, 1344 (Fed. Cir. 2008). The
DRL is attempting to invoke defensive mutual collateral estoppel against the
same adversary it faced in the earlier litigation. Thus DRL does not seek to push the
boundaries of “the modem doctrine of non-mutual issue preclusion, [under which) a
litigant may also be estopped from advancing a position that he or she has presented
and lost in a prior proceeding against a different adversary.” Peloro ii. United States,
488 F.3d i63, 175 (3d Cfr. 2007).
10

17

‘305 patent does not contain the terms “drying/dried” in the relevant part of
the claim language. This fails the first element of the issue preclusion test: that
the issue to be precluded in this case be the same as the issue in the previous
case. The precise words of the claim are paramount; the inquiry into claim
construction “begins and ends in all cases with the actual words of the claim.”
Renishaw PLC u. Marposs Sodeta’ per A2ioni, 158 F.3d 1243, 1248 (Fed. Cir.
1998). The ‘305 patent and its claims contain different language and that
language requires its own distinct construction. For many of the same reasons
discussed above in relation to claim preclusion, the ‘305 patent language
presents a different issue from the one that was litigated under the ‘514 patent.
Because DRL fails to establish that the issue to be decided in this case is
the same as the one in the previous action, plaintiffs are likely to succeed in
showing that they are not precluded/estopped from litigating whether ORL’s
product infringes on the ‘315 patent.
3. Written Description
DRL next argues that Indivior, through this litigation, is attempting to
broaden what the specification says the inventors invented, in a manner
prohibited by the “written description” requirement.
Under 35 U.S.C.

§ 112, “[t]he specification [of a patent] shall contain a

written description of the invention, and the manner and process of making
and using it, in such full, clear, concise, and exact terms as to enable any
to make and use the same, and shall set forth the
best mode contemplated by the inventor or joint inventor of carrying out the
invention.” This is known as the “written description requirement.” See, e.g.,
person skilled in the art.

.

.

AriadPhann., Inc. v. Eli Lilly & Co., 598 F.3d 1136, 1351 (Fed. Cir. 2010)
rsince its inception, this court has consistentiy held that § 112, first
paragraph, contains a written description requirement separate from
enablement, and we have articulated a ‘fairly uniform standard,’ which we no
affirm.”). The test for sufficiency of this provision is “whether the disclosure of
the application relied upon reasonably conveys to those skilled in the art that
18

the inventor had possession of the claimed subject matter as of the filing date.”
Id. (citing Vas-Cath Inc. v. Ivfahurkar, 935 F.2d 1555, 1562—63 (Fed. Cir. 1991)).
DRL argues that the ‘305 patent does not describe the use of
conventional drying to retain the claimed levels of uniformity in a cast film.
(Del. Opp. at 17.) In fact, DRL says, the examples discussed in the patent’s
specification “reveal that when the inventors tried to achieve drug content
uniformity using ‘conventional’ drying, they failed.” (Id.) It claims that plaintiffs,
through this litigation, are attempting to broaden what the specification says
the inventors invented; the ‘305 patent, they say, lacks a written description of
an invention that would encompass production by conventional means of
drying. (Id.)”
Indivior, on the other hand, observes that its ‘305 patent makes
extensive disclosures about the films formed without regard to how they were
dried, and discloses embodiments and ways of making films that possess the
necessary uniformity. (Langer Supp. ¶1! 7—12, 21) A person of ordinary skill in
the art would understand that Indivior possessed the resulting invention. (P1.
Reply at 7.)
Indivior points to two examples in the ‘305 patent (CO and CH) which do
not specify a drying process. (P1. Reply at 7 (citing ‘305 Patent, 53:39—55:8))
Indivior’s expert, Dr. Robert Langer, states that “the (‘3051 Patent is clear that
using any one particular drying method is only one option that can be used to
create the desired uniform films” and that “(aj person of ordinary skill in the art
would therefore understand that a particular type of controlled drying is not
required to create the drug content unifonnity in the Patent.” (P1. Reply. at 7;
Langer. Supp.

¶

14).12

Dr. Langer also cites the ‘305 Patent’s description of a

Once again, it is important to remember that “conventional” drying is a term
used by the parties, not one construed as part of the patent. Judge Andrews used the
word to mean “convection air drying from the top.” and ruled that it had been
disavowed in the ‘514 patent.
12
“Thus, the ‘305 Patent discloses not only a number of uniform film
embodiments, but also a number of ways of making uniform films. A person of
ordinary skifi in the art would therefore understand that the inventors possessed the
II

19

“zone drying procedure” as suitable to make the films, and notes that this is in
fact the very type of drying employed by DRL. (Langer Supp. ¶ 19 (referencing
‘305 Patent, 33:23—35; 33:36—56).)

DRL, in contrast, cites to particular sections of the specifications of the
‘305 patent which state that uconventiona1 methods of drying would not be
able to retain uniformity (Del. app, at 17 (citing ‘305 Patent 3:29—30; 29:38—
39)). ORL’s expert, Dr. Mansoor Amiji, opines that, based on the evidence of the
‘305 patent, plaintiffs were not in possession of the invention, i.e., a uniform
film produced by means of conventional drying. (Del. Opp. at 17 (e.g., Amiji
Deci.

90 (“As these passages make clear, a person of ordinary skill in the art

reviewing the specification would not understand the inventors to have
invented uniform films that were manufactured using ‘conventional’
drying.”) 13.)
Two experts have advanced contradictory interpretations, but once again
their live testimony has not been offered and I am not equipped to assess their
credibility. Thrown back on the inherent plausibility of those opinions, I find
that, in this preliminary posture, the opinion of Indivior’s expert is more
persuasive in that it is tied more closely to the patent language. The primary
basis for my conclusion, however, is the face of the ‘305 patent itself, which, I
find, has disclosed films without regard to how they were dried. While a full

trial record could demonstrate otherwise, I find that plaintiffs have put forward
sufficient preliminary evidence to show that they are likely to prove that they
were in possession of the invention described in the patent and have thus
satisfied the written description requirement.

claimed uniform cast films. Accordingly, it is my opinion that the written description
requirement is satisfied.” (Langer Supp. ¶ 21.)
13
“Instead, a person of ordinary skill in the an would understand that the
inventors had reached the opposite conclusion; that conventional drying techniques
could not result in the claimed uniform films. Nowhere in the ‘305 patent is there any
description of how to achieve particulate ingredient uniformity in a final, dried film
using conventional drying techniques.” (Amiji Dccl. ¶ 90.)
20

4. Validity and Infringement of ‘305 Patent
DRL argues that, should Indivior be correct that the claims of the ‘305
patent do not require unconventional drying (or rule out conventional drying)
as part of the process of making the film, DRL would have “strong anticipation,
non-infringement, and written description defenses.” (Def. Opp. at 19.) That, of
course, is the other side of the continuation-patent coin; by claiming more
broadly, Indivior may have exposed its claims to further challenges.
.The parties have touched only lightly on the issue of obviousness.
(PI/TRO Hrg. Tr. at 82:11—15 r[DRL:J We didn’t raise an obviousness argument
because we think this claim, if it’s as broad as they say it is, [it’s] anticipated
by the Schmidt reference.”).) Relying on Reckitt II and the declaration of Dr.
Amiji, DRL argues that a previous patent (“Schmidt”) “disclose[d] most other
limitations of the ‘305 Patent’s independent claims,” and that the only way past
this prior art would be to read a “solid” limitation into the claims, and that
assuming “solid” simply means “dried,” then the patent was anticipated, (Id.
(citing Amiji ¶1] 93—133); P1/TRO Hrg. Tr. 82:21—83:3.) Plaintiffs dispute this
and say that DRL, by not challenging novelty or nonobviousness, has not
sufficiently questioned the patent’s validity: “Because the cast films of the ‘305
Patent are solid films, not a wet matrix, DRL’s contingent arguments about
alleged anticipation of the claims if directed to wet matrices is inapposite.” (Id.
P1. Reply at 7 & n.3.)
Patents enjoy a presumption of validity at every stage of litigation and the
burden rests on the party asserting invalidity, Canon Computer Sys., Inc. v. Nu
Kate Int’l, Inc., 134 F.3d 1085, 1088 (Fed Cir. 1998). Even assuming that DRL’s
spare arguments were enough to shift the burden, I find on the current record
that lnthvior is likely to show that the ‘305 patent is not anticipated or obvious.
As to non-infringement, Indivior puts forward a detailed explanation of
how DRL’s ANDA product infringes each of eight limitations set out in Claim 26
of the ‘305 patent. (P1. Br. at 10—13 (citing evidence from the litigation over the
‘514 patent and noting that “dried” is no longer a limitation). See also Langer

21

Dccl.

¶ 66—105 (matching features of ANDA product to Claim 26 of’305

patent).) DRL offers little in response. It merely states that it “does not ‘cut’
undried ‘continuously cast films.tm (Def.

Opp.

at 19 (citing Amiji

¶ 136.).) At this

point in the litigation, the patent claim and the description of the allegedly
infringing product sufficiently match; I find it likely on this record that Indivior
will be able to show that the DRL’s ANDA product would infringe the ‘305
patent.
The likelihood of success factor, then, tips in favor of Indivior.
c. Irreparable Harm
Should DRL be permitted to launch its ANDA product, Indivior says it
would be harmed irreparably in four ways: (1) Indivior would lose the market
share currently held by Suboxone film in the BTOD market; (2) Suboxone film
would irretrievably lose favorable formulaiy status among insurance plans; (3)
Indivior would suffer from delays in research and development and lose talent;
and (4) Indivior would suffer reputational harm and a loss of goodwill. (P1. Br.
at 2 1—26.) Plaintiffs also argue that Aquestive in particular would suffer
irreparable harm by losing an “important part of (its] business.” (Id. at 27.)
Suboxone film leads the market in BTODs. From January 2013 to
December 2017, Suboxone film maintained a 55.8% to nearly 70% share of the
BROD market, despite the existence of generic non-film BTOD products in that

¶ 15.) That position is maintained, in part, because
generic BTOD tablets’4 are not “AB-rated” to the film. (Simkin ¶ 9.) This means

market. (Bennis Decl.

that pharmacies are not allowed to substitute generic tablets at the point of
sale when a patient is specifically prescribed Suboxone film. (Id.)

“Tablets” by the way, are not ordinary pills to be swallowed with water. Counsel
clarified at the hearing that these tablets, like the film, are placed beneath the tongue
and left to dissolve.
11

22

Plaintiffs also claim that the launch threatens Suboxone film’s
advantageous formulaxy status. Formularies are lists of covered drugs
prepared by insurance plans and third-party payers that divide drugs into
“tiers.” These tiers dictate that how the drug is reimbursed for the patient and
correlate with the type of drug covered within a tier (e.g., low cost generic
drugs, preferred brand name drugs, non-preferred brand name drugs).
4.) As of May 2018, more than 64% of individuals covered by
insurance plans have access to Suboxone film as a Tier 1 (low cost generic) or
Tier 2 (preferred brand name drug), (Simldn ¶ 16.) Plaintiffs credit this status
(Navarro

¶

to (what they say) are the film’s superior features and their willingness to
extend financial incentives when strategically helpful. (Id,) They predict,
however, that Suboxone film would likely be relegated to a lower tier status or
omitted from the tiers altogether. (Id.) They also claim that even if Suboxone
film were able to maintain this status, the existence of an AB-rated generic
BTOD film would make pharmacies more likely to dispense only the generic
form of the drugs, as those pharmacies could lose money by dispensing the
brand form because of reimbursement incentives from the insurance plans and
third-party payers. (Id. 117.) Indivior also claims that if DRL’s ANDA product is
launched but later removed from the market, confusion and frustration among
patients, physicians, pharmacies, and the insurance plans would ensue, and
the market would be conditioned to favor the cheaper generic alternatives to
Suboxone film. (Navarro Deci.

¶

28.)

23

lending covenants

•a

Despite this, in 2017, Indivior spent $89 million on
development of their product pipeline. (Simkin ¶ 6.) This includes developing
drugs for the treatment of alcohol use disorders and schizophrenia. (Id.)
I

Finally, Indivior fears that its reputation as a pharmaceutical company
would suffer and it could lose the goodwill it has developed over the years. (P1.
Br. at 26.) Indivior has dedicated clinical liaisons who promote awareness of
opioid dependency and educate healthcare providers about treatment options
(not specific to Indivior’s products) and methods for obtaining the certifications
to prescribe BTODs, something which Indivior says that generic competitors do
28, 34.) Indivior has also donated millions of dollars to
foundations which provide opioid addiction medication to those who cannot
afford it and to programs oriented around awareness to addiction and
not do. (Simkin

¶J

prevention, treatment, recovery, and criminal justice reform. (Id. ¶ 3 1—32.)
Indivior expects it will have to make substantial cuts to these programs upon
DRL’s ANDA product launch. (Id.

¶

35.)

DRL believes that these claims of harm are exaggerated. (Def. Opp. at
20.) First, DRL argues that Indivior took on its debt obligations knowing that
generic competition was “looming.” (Id. at 20—2 1.) They point to the fact that
Suboxone film was initially sold by a larger company, Reckitt Benickser, which

24

had a much more diversified portfolio, and that Recldtt opted to spin off
Indivior as a one-product company once the initial lawsuits over Suboxone
began. (Hofmann

9’ 92—93.)

I
DRL also cites to Indivior’s recent launch of its “next generation” BTOD
product, Sublocade, a once-monthly injectable product, which is part of
Indivior’s “robust contingency plan” for an anticipated generic entry. (Id. ¶ 70.)
DRL says that Indivior expects peak net revenues of at least $1 billion from this
product and expects Sublocade to become “a new standard of care” for the
treatment of moderate to severe opioid use disorder.’5 (Id. ¶11 7 1—72.)
DRL also argues that Indivior’s claims of irreparable harm are
quantifiable and not imminent. DRL says that “while there may be some
uncertainty today as to the exact actions that will be taken by various parties,”
the impact on the BTOD market and its financial consequences for Indivior,
given the passage of time, will ailow damages to be quantified and assessed
with a reasonable degree of certainty. (Id. at 96.) In fact, it says that Indivior
has already quantified the potential impact of a generic entry. (See Crossley

¶

DRL insists that Indivior’s claims of loss of goodwill and reputation are
merely speculative and not irreparable, (Def. Opp. at 25.)
(Id.) Indivior will still have the money,
DRL says, to continue these programs. (Id.)

Finally, DRL argues that Aquestive’s claims of irreparable harm are
purely financial, as it merely receives a payment from Indivior tied to the sale of
Suboxone, and that any loss in licensing revenue is clearly calculable and
compensable. (Hofmann

¶ 104.)

I find that Indivior will likely suffer irreparable harm from the launch of
DRL’s ANDA product. Loss of market share “constitutes irreparable injury
because market share is so difficult to recover.” Henkel Corp. v. Coral, Inc., 754
F. Supp. 1280, 1322 (N.D. Ill, 1991), affd, 945 F.2d 416 (Fed. Cir. 1991).
Moreover, “[t]he 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.” Fresenius Kabi USA, USC
*13 (D.N.J. Sept. 23,
ii. Fera Phann., LLC, No. 15-3654, 2016 WL 5348866, at
2016) (citing Systemation, Inc. u. Engel Indus., Inc., 194 F.3d 1331 (Fed Cir.
1999)). ft 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
formulazy status and a change in tier pricing, constitutes irreparable harm.
Medac Phamta, Inc., 55 F. Supp. 3d 526, 536—
537 (11 Del. 2014) (finding the launch of a competing product that would force
the renegotiating of the current tier and pricing structure to carry the burden
See, e.g., Antares Pharma, Inc.

ii.

of demonstrating irreparable harm).
I am less moved by the other claims of harm. Claim of lost revenue
requiring cutbacks in, e.g., research, would not necessarily move the Court if it
found the likelihood of success to be weak. See Eli Lilly & Co. v. Am. Cyanamid
Co., 82 F.3d 1568. 1578 (Fed. Cir. 1996). At least as a makeweight, however,
Indivior’s potential cuts to research and development, in conjunction with its
large potential loss of market share, further support a finding of irreparable

harm. This factor favors Indivior.

26

d. Balance of the Equities

Indivior argues that, while it faces “devastating” harm if relief is denied,
DRL has a large portfolio of generic products and that the only harm facing
DRL would be deferred potential revenue. (Pt. Br. at 27.) ORES counters that its
ANDA product is not just “another generic product” in its portfolio. (Def. app.
at 28.)
DRL acquired the Suboxone ANDA from Teva Pharmaceuticals in 2016
for $70 million. (Sonig Decl.

¶ 13.) This (along with seven other products from

Teva) was a large acquisition made by DRL (e.g., it was two-thirds as large as
DRL’s 2006 purchase of an entire pharmaceutical company to enter the
European market). (See Id.) Suboxone was one of the key drivers of the Teva
purchase. (Id.

¶ 14.) DRL purchased in the belief “that there was a possibility

that DRL would be the first in the market with a generic version of Suboxone,”
particularly after the product was deemed non-infringing as to the ‘514 Patent
in the District of Delaware. (Id.

¶ 17.) After that decision, ORL prepared for a

commercial launch and engaged in a “time- and resource- intensive” ramp-up,
which included the purchasing of buprenorphine, naloxone, and foil packaging
to prepare for the manufacture of

for the films and the spending of

¶ 2 1—22.) This represented about
of DRL over the past three years. (Id. ¶ 20.)

commercial batches of the generic films. (Id.

DRL also takes issue with Indivior’s attempts to move patients in the
BTOD market off of film and onto Sublocade. (Def. Opp. at 29; Hofmann

¶ 111.)

It says that DRL’s product will not be a substitutable generic equivalent to
Sublocade and that generic products generally rely on substitution for the
reference listed drug. (Hofmann

¶ 111.)

—I
I find that the balance of equities nevertheless tips in favor of Indivior.
There is no doubt that DRL may lose months of potential revenue from the sale

27

of its ANDA product should it be enjoined from entering the STOD market
during this litigation. Still, it is not a current market player and it has no
market share to lose; its losses would more easily be calculated in damages,

and Indivior will be required to bond the injunction. Indivior, on the other
hand, faces substantial and irreparable harms in the form of erosion of its
position as the leader in the BTOD market, a potential loss of formulary status,
and damage to its goodwill and reputation among patients, physicians,
pharmacies, and insurance plans. These losses would be difficult to recoup
even if DRL’s ANDA product were eventually found to infringe the ‘305 Patent.
See supra Section II.c.
DRL’s losses stem from a market it seeks to enter, not one that it is
already in. DRL chose to enter the market “at risk” and took the chance it
could face a potential injunction against its product. The balance of harms and
equities appears to favor Indivior, and is at best neutral.
e. Public Interest
The country faces a recognized opioid addiction epidemic. (Rosenthal

¶

21.) Buprenorphine, the active ingredient in Suboxone film, is an effective
treatment for opioid addiction which does not have some of the disadvantages
associated with other opioid treatment medications, such as naltrexone and
methadone. (Id.

¶1J

3 1—32.) Of the over 2.5 million people who suffer from

opioid use disorder, only 30% receive medication. (Hofmann, ex. 28 at 4.) DRL
ascribes the under-utilization of medication to Suboxone’s high cost and
certain insurance plans’ unwillingness to cover such costs. (See Rosenthal

¶

41—42.) A generic version of Suboxone, says DRL, would change those
numbers. Prices would go down and more insurance plans would be willing to
cover a lower-cost generic. (Hofmann ¶3j 12 1—22.)
Indivior replies that the public interest would be disserved by the lack of
an injunction in two ways. First, they argue that the public interest generally
weighs in favor of protecting property rights in the absence of countervailing
factors. It is always true, of course, that a generic would likely be cheaper. But
28

the patent owner’s right to exclusivity encourages innovation and provides
incentives for drug companies to continue costly development efforts. (Pt. Br. at
28 (citing Apple, Inc. v. Samsung Elecs. Cc., 809 F.3d 663, 647 (Fed. Cir. 2015);
Syntex (US.A.) v. Apotex, Inc., 407 F.3d 1371, 1383—84 (Fed. Cir. 2005).)

Second, Indivior states that a reduction in revenue will cause Indivior to scale
back its outreach, educational, and charitable programs in the field of opioid
addiction and would, in turn, reduce access to opioid addiction treatment. (See
P1. Br. at 28—30,) It also warns that research and development by Indivior in
that field would be reduced. (Id. at 30.)
I find that the public interest will be served by the issuance of a
preliminary injunction in this case. True, the relief requested by plaintiffs
would prevent the entry of ORL’s generic film—a means of delivery of
thedication—into the market. It will not, however, deny access to the active
ingredient, which may be administered by other means. There still remain
other non-film generics on the market, and neither side has stated that the
issuance of injunctive relief (or the lack thereof) would prevent access to these
alternatives. DRL offers only that the ease of use of the film, as opposed to, e.g.,
the under-tongue tablet, would naturally result in better compliance. That is
not a negligible consideration, but it is not enough to tilt the balance.
Under these circumstances, the public interest tilts in favor of protecting
the exclusive rights held by the patent holder, see Apple, 809 F.3d at 647. This
factor, too, favors Indivior.

2.9

UI.

Conclusion

I have assessed the four injunctive factors, and also weighed them. For
the reasons set forth above, I will grant Indivior’s motion for a preliminary

injunction. For the immediate present, the restraints contained in the
temporary restraining order shall continue. On or before Monday, July 16,
2018, the parties shall submit an agreed form of preliminary injunction, with
required security, or shall individually submit competing forms of order for the
Court to consider.
An appropriate order follows.
Dated: July 13, 2018

United States District Judge

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