INDIVIOR INC. et al v. DR. REDDY'S LABORATORIES S.A. et al
Filing
413
OPINION. Signed by Judge Kevin McNulty on 8/24/2020. (sm)
Case 2:17-cv-07111-KM-CLW Document 413 Filed 08/24/20 Page 1 of 24 PageID: 23735
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
INDIVIOR INC., INDIVIOR UK
LIMITED, and AQUESTIVE
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.
INDIVIOR INC., INDIVIOR UK
LIMITED, and AQUESTIVE
THERAPEUTICS, INC.,
Civ. No. 17-7106 (KM) (CLW)
Civ. No. 18-8285 (KM) (CLW)
Plaintiffs,
v.
OPINION
ALVOGEN PINE BROOK, INC., AND
ALVOGEN PINE BROOK LLC,
Defendants.
KEVIN MCNULTY, U.S.D.J.:
These consolidated patent infringement cases are brought by Indivior
Inc., Indivior UK Limited (collectively, “Indivior”), and Aquestive Therapeutics,
Inc. (“Aquestive”), against Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s
Laboratories, Inc. (collectively, unless otherwise specified, “DRL”) and Alvogen
Pine Brook, Inc. and Alvogen Pine Brook LLC (collectively, unless otherwise
specified, “Alvogen”).
1
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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.
Likewise, the ’454 Patent shares the same specifications with another patent,
U.S. Patent No. 8,475,832 (“the ’832 Patent”). This ’514 Patent and the ’832
Patent are not directly at issue here, but were at issue in a related litigation
involving similar parties filed in the United States District Court for the District
of Delaware (“the Delaware Litigation”).
Collectively, these patents describe formulations of Suboxone film1, 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. Defendants are
manufacturers and developers of generic competitors to Suboxone film.
This matter has been extensively litigated for a number of years.
Currently before the Court are several motions: (1) Plaintiffs’ appeal of
Magistrate Judge Waldor’s Opinion and Order granting Defendants’ motion to
amend their answer to add counterclaims; (2) Aquestive’s motion to dismiss
Alvogen’s and DRL’s counterclaims; and (3) Defendants’ motion for a Rule 54(b)
entry of a partial final judgment of noninfringement.2
For the reasons outlined herein, I will:
1. Deny Plaintiffs’ appeal of Judge Waldor’s Opinion and Order;
2. Deny Aquestive’s motion to dismiss; and
Suboxone film is Plaintiffs’ brand name for co-formulated
buprenorphine/naloxone sublingual film.
1
I am also in receipt of a number of letters filed in both actions (See, e.g., 7106
Action, DE 316, 318, 319) concerning these motions and whether to administratively
terminate certain motions in favor of granting Plaintiffs leave to file a motion for
summary judgment. These scheduling matters will be referred to the Magistrate Judge
for decision.
2
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3. Deny Defendants’ motion for a Rule 54(b) entry of partial final
judgment.
I.
Relevant Procedural History3
I write for the parties and assume they are familiar with the key facts of
this matter. Nevertheless, I will first briefly review the relevant procedural
history surrounding the litigation of the at-issue patents, both in this district
and elsewhere.
In 2014, Indivior’s predecessor, Reckitt Benckiser, brought suit in the
District of Delaware against a number of parties alleging infringement of
several patents, including the ’832 Patent and the ’514 Patent. After two bench
trials, 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 and found the ’832 patent invalid
for obviousness and indefiniteness. Reckitt Benckiser Pharm. Inc. v. Watson
Labs., Inc., No. CV 13-1674-RGA, 2016 WL 3186659, at *27 (D. Del. June 3,
2016); 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
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
otherwise indicated:
3
“DE” = Docket entry number in this case.
“7106 Action” = Civil Action No. 2:17-cv-7106-KM-CLW.
“7111 Action” = Civil Action No. 2:17-cv-7111-KM-CLW.
“’305 Patent” = United States Patent No. 9,931,305, Pl. 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, Pl. 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, Pl. Ex. C (Dkt. No. 7106 at
DE 135-1; Dkt. No. 7111 at DE 250-1).
“’832 Patent” = United States Patent No. 8,475,832.
3
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(D. Del. Aug. 31, 2017); Indivior Inc. v. Mylan Techs. Inc., 298 F. Supp. 3d 775
(D. Del. 2018). Indivior then appealed to the Federal Circuit.
While the Delaware Litigation was proceeding, in 2016, dozens of states
filed antitrust lawsuits against Indivior concerning its Suboxone products.
Plaintiffs responded to the Delaware rulings by applying for two
additional patents. First, the ’454 Patent issued to Indivior on June 27, 2017.
Second, the ’305 Patent4 issued to Aquestive on April 3, 2018. Following the
issuance of these patents, on September 14, 2017, Plaintiffs filed the 7106 and
7111 Actions, alleging infringement of the ’454 Patent.5 On April 3, 2018,
Plaintiffs then filed suit against DRL and Alvogen claiming infringement of the
new ’305 Patent. (See 2:18-cv-5288 at DE 1; 2:18-cv-5285 at DE 1). Ultimately
all of these actions were consolidated.
Upon learning of DRL’s plans to launch the ANDA product “at risk,” in
June 2018 Indivior moved to enjoin DRL from bringing its generic Suboxone
film to market. (7111 Action at DE 70, 71)
On July 13, 2018, I granted the motion for a preliminary injunction,
believing that Indivior had successfully “claimed around” the problem that
produced the Delaware rulings. (Id. at DE 121). DRL then appealed to the
Federal Circuit, which disagreed. On November 20, 2018, the Federal Circuit,
over a dissent, reversed and remanded, finding that Indivior was unlikely to
succeed on the merits of its infringement claim. Indivior Inc. v. Dr. Reddy’s
Labs., S.A., 752 F. App’x 1024 (Fed. Cir. 2018) (“Indivior I”).
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 Indivior I. (7106 Action at DE 83). I granted a temporary restraining
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.
4
The ’832 Patent and the ’454 Patent have the same specifications, but the ’454
Patent is directed to a bioequivalent film version of Suboxone tablets.
5
4
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order (“TRO”) enjoining Alvogen from launching in order to preserve the status
quo pending the issuance of the mandate. (Id. at DE 88)
On February 4, 2019, the Federal Circuit denied rehearing in Indivior I.
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). DRL and Alvogen then proceeded to bring to market their
generic versions of Suboxone films.
On April 9, 2019, the Department of Justice announced that Indivior had
been indicted for “engaging in an illicit nationwide scheme to increase
prescriptions of Suboxone Film, an opioid drug used in the treatment of opioid
addiction.” U.S. v. Indivior Inc. et al, No. 19-cr-16 (W.D. Va. Apr. 9, 20190).
On July 11, 2019, the U.S. Federal Trade Commission (“FTC”) filed a
complaint against Indivior alleging anticompetitive conduct. F.T.C. v. Reckitt
Benckiser Group PLC et al, No. 19-28 (W.D. Va. July 11, 2019).
On July 12, 2019, the Federal Circuit, 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. Indivior
Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1339 (Fed. Cir. 2019) (“Indivior
II”). In analyzing the ’514 Patent in Indivior II, the Federal Circuit made clear
that for these purposes, the claims of the ’305 Patent are indistinct from those
of the ’514 Patent.
On November 5, 2019, I entered an Opinion construing key terms of the
patents in suit here following a Markman hearing. (7106 Action at DE 215;
7111 Action at DE 294)
On November 19, 2019, Judge Waldor issued an Opinion and Order
permitting Alvogen and DRL to file their first amended answer with affirmative
defenses and counterclaims. (7106 Action at DE 217; 7111 Action at DE 296)
DRL’s first amended answer asserts two counterclaims:
Count 1: Monopolization and Conspiracy to Monopolize in violation of
Section 2 of the Sherman Act; and
Count 2: Recovery of Damages for wrongful injunction against sureties.
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(7111 Action at DE 218)
Alvogen’s answer asserts two counterclaims:
Count 1: Monopolization and Conspiracy to Monopolize in violation of
Section 2 of the Sherman Act; and
Count 2: Monopolization and Conspiracy to Monopolize in violation of the
New Jersey Antitrust Act.
(7106 Action at DE 297)
On December 4, 2019, Plaintiffs filed an appeal of Judge Waldor’s
Opinion and Order to this Court. Defendants oppose the appeal. (7106 Action
at DE 220, DE 229; 7111 Action at DE 300, DE 311)
On January 9, 2020, I so-ordered the parties’ stipulation of noninfringement as to the ’305 Patent. (7106 Action at DE 240; 7111 Action at DE
323) The stipulation was entered subject to the parties’ reservation of rights on
appeal.
On January 17, 2020, Aquestive then moved to dismiss Defendants’
counterclaims. (7106 Action at DE 250; 7111 Action at DE 330) Indivior did
not join in this motion and instead filed an answer to the counterclaims. (7106
Action at DE 251; 7111 Action at DE 331)
On January 21, 2020, DRL moved for entry of partial judgment under
Rule 54(b) in the 7111 Action. (DE 334) Three days later, on January 24, 2020,
Alvogen filed a similar motion. (DE 261)
II.
Appeal of Ruling on Motion to Amend and Motion to Dismiss
Because of the largely overlapping issues presented by Plaintiffs’ appeal
and by Aquestive’s motion to dismiss, I will address these motions together in
Section II of this Opinion. I will separately address Defendants’ motion for
partial judgment under Rule 54(b) in Section III.
A.
Applicable Standards
i. Standard of Review of a Magistrate Judge’s Decision
If a party objects to a magistrate judge’s order regarding a
nondispositive matter, the district court “must consider timely
objections and modify or set aside any part of the order that is
clearly erroneous or is contrary to law.” Id.; 28 U.S.C. §
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636(b)(1)(A). This standard requires the District Court to review
findings of fact for clear error and to review matters of law de novo.
Haines v. Liggett Grp. Inc., 975 F.2d 81, 91 (3d Cir. 1992).
Equal Employment Opportunity Comm’n v. City of Long Branch, 866 F.3d 93, 99
(3d Cir. 2017). See also Fed. R. Civ. P. 72(a); L. Civ. R. 72.1(c)(1)(A). This Court
has frequently spoken of the discretion granted to the Magistrate Judge in nondispositive matters. Where the appeal seeks review of a matter within the core
competence of the Magistrate Judge, such as a discovery dispute, the court will
defer to the Magistrate Judge’s discretion. See Cooper Hospital/Univ. Med. Ctr. v.
Sullivan, 183 F.R.D. 119, 127 (D.N.J. 1998); Deluccia v. City of Paterson, No. 09703, 2012 WL 909548, at *1 (D.N.J. March 15, 2012). “This deferential standard
is especially appropriate where the Magistrate Judge has managed this case from
the outset and developed a thorough knowledge of the proceedings.” Lithuanian
Commerce Corp., Ltd. v. Sara Lee Hosiery, 177 F.R.D. 205, 214 (D.N.J. 1997)
(internal quotations omitted); see Deluccia, 2012 WL 909548, at *1 (same).6
A report and recommendation on a dispositive issue, though, requires
plenary review:
The product of a magistrate judge, following a referral of a
dispositive matter, is often called a “report and recommendation.”
Parties “may serve and file specific written objections to the
proposed findings and recommendations” within 14 days of being
served with a copy of the magistrate judge’s report and
recommendation. Fed. R. Civ. P. 72(b)(2). If a party objects timely
to a magistrate judge’s report and recommendation, the district
court must “make a de novo determination of those portions of the
report or specified proposed findings or recommendations to which
objection is made.” 28 U.S.C. § 636(b)(1); see also Fed. R. Civ. P.
72(b)(3).
The standard of review of nondispositive matters has sometimes been referred
to as abuse of discretion. As a practical matter, it makes little difference, because
abuse-of-discretion review incorporates plenary review of legal questions and clearerror review of factual questions. See Koon v. United States, 518 U.S. 81, 100 (1996) (a
court “by definition abuses its discretion when it makes an error of law”); Doeblers’
Pennsylvania Hybrids, Inc. v. Doebler, 442 F.3d 812, 819 (3d Cir. 2006) (abuse of
discretion may encompass “a clearly erroneous finding of fact, an errant conclusion of
law, or an improper application of law to fact”).
6
7
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Equal Employment Opportunity Comm’n v. City of Long Branch, 866 F.3d at 99–
100.
A dispositive motion, if denied, is in a trivial sense non-dispositive. Still,
these particular motions were potentially dispositive, not of a routine
amendment, but of the addition of new and significant counterclaims not
previously available. Thus, in an abundance of caution, I give Judge Waldor’s
decision, and the motion to dismiss, see infra, the same plenary level of review.
ii. Motion to Dismiss Standard
Federal Rule of Civil Procedure 8(a) does not require that a complaint
contain detailed factual allegations. Nevertheless, “a plaintiff’s obligation to
provide the ‘grounds’ of his ‘entitlement to relief’ requires more than labels and
conclusions, and a formulaic recitation of the elements of a cause of action will
not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007); see Phillips v.
Cnty. of Allegheny, 515 F.3d 224, 232 (3d Cir. 2008) (Rule 8 “requires a
‘showing’ rather than a blanket assertion of an entitlement to relief.” (citation
omitted)). Thus, the complaint’s factual allegations must be sufficient to raise a
plaintiff’s right to relief above a speculative level, so that a claim is “plausible
on its face.” Twombly, 550 U.S. at 570; see also West Run Student Hous.
Assocs., LLC v. Huntington Nat. Bank, 712 F.3d 165, 169 (3d Cir. 2013).
That facial-plausibility standard is met “when the plaintiff pleads factual
content that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009) (citing Twombly, 550 U.S. at 556). While “[t]he plausibility standard
is not akin to a ‘probability requirement’ . . . it asks for more than a sheer
possibility.” Id.
Rule 12(b)(6) provides for the dismissal of a complaint if it fails to state a
claim upon which relief can be granted. The defendant, as the moving party,
bears the burden of showing that no claim has been stated. Animal Science
Products, Inc. v. China Minmetals Corp., 654 F.3d 462, 469 n.9 (3d Cir. 2011).
For the purposes of a motion to dismiss, the facts alleged in the complaint are
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accepted as true and all reasonable inferences are drawn in favor of the
plaintiff. New Jersey Carpenters & the Trustees Thereof v. Tishman Const. Corp.
of New Jersey, 760 F.3d 297, 302 (3d Cir. 2014).
For the purposes of a motion to dismiss, the facts alleged in the
counterclaim-complaint are accepted as true and all reasonable inferences are
drawn in favor of the plaintiff. New Jersey Carpenters & the Trustees Thereof v.
Tishman Const Corp. of New Jersey, 760 F.3d 297, 302 (3d Cir. 2014).
B.
Discussion
i. The Appeal and Motion to Dismiss7
Plaintiffs appeal from Magistrate Judge Waldor’s November 19, 2019
decision (DE 217) granting Defendants’ motion to file a first amended answer
with counterclaims pursuant to Fed. R. Civ. P. 72(a) and Local Rule 72.1(c). As
to the antitrust counterclaims, Aquestive also moves to dismiss. For the
reasons stated herein, I will affirm Magistrate Judge Waldor’s decision and
deny the motion to dismiss. Subsection 1 addresses DRL’s wrongful-injunction
counterclaim; subsection 2 addresses the antitrust arguments.
1. DRL’s Second Counterclaim
As part of its amended answer, DRL asserts a second counterclaim
seeking to recover damages from a Surety for a wrongful injunction. (7111
Action, DE 297 at 67) Plaintiffs assert that DRL lacks Article III standing to
assert such a claim. DRL’s injury, they say, is not actual because it is based on
speculation that Indivior will be unable to satisfy any final judgment against it.
(DE 220-1 at 23-25) Plaintiffs add that the wrongfulness, or not, of the
injunction cannot be determined until there is a final judgment.
DRL responds that it has standing to pursue its claims based on the
numerous rulings in this case, Indivior I, and Indivior II. (DE 229 at 24-25) The
parties moreover have stipulated that DRL did not infringe the ’305 Patent.
Because identical briefing was filed in both actions, unless otherwise indicated,
I will refer to the docket entry numbers for the briefing filed in the 7106 Action
throughout Section II of this Opinion.
7
9
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That is enough, says DRL, to establish that it was wrongfully enjoined and is
entitled to recover under the bond. I agree, at least insofar as the claims as to
the ’305 Patent have been finally decided. (See 7106 Action at DE 240; 7111
Action at DE 323)
Rule 65 allows a successful defendant to collect on a bond if it is “found
to have been wrongfully enjoined or restrained.” Fed. R. Civ. P. 65(c); Atomic Oil
Co. of Okl. v. Bardahl Oil Co., 419 F.2d 1097, 1101 (10th Cir. 1969) (“Rule 65(c)
creates a cause of action for the costs and damages incurred by the enjoined
party should it later be determined that that party was wrongfully enjoined or
restrained.”).8 Indeed, that is the purpose of posting a bond. The Third Circuit
has held that Rule 65(c) “strongly implies” that a prevailing defendant is
entitled to damages on the injunction bond, and has adopted the stance of the
“clear majority of our sister circuits” that “have held that there is a rebuttable
presumption that a wrongfully enjoined party is entitled to recover provable
damages up to the bond amount.” Nat’l Collegiate Athletic Ass’n v. Governor of
New Jersey, 939 F.3d 597, 606-07 (3d Cir. 2019), cert. denied, 206 L. Ed. 2d
938 (May 18, 2020). As I held in connection with the Markman Opinion,
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. K-Mart Corp., 979 F.2d 965,
969 (3d Cir. 1992); Nat’l Collegiate Athletic Ass’n, 939 F.3d at 605 (confirming
in the context of TRO that “whether a party was wrongfully enjoined depends
upon the final judgment on the merits”). Only an adverse final judgment
definitively establishes that a party was wrongfully enjoined in the interim.
Accordingly, should a final judgment establish that DRL was wrongfully
enjoined, it is presumptively entitled to recover on the injunction bond.
The full text of Rule 65(c) reads: “The court may issue a preliminary injunction
or a temporary restraining order only if the movant gives security 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 United States, its officers, and its
agencies are not required to give security.”
8
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In a sense, DRL’s counterclaim, considered as such, is therefore
superfluous. Nevertheless, DRL can choose what claims to bring, and it
appears that courts have permitted such claims to be pled independently. The
elements of a claim for recovery on a bond posted pursuant to Rule 65(c) of the
Federal Rules of Civil Procedure are “(1) existence of the bond; (2) wrongful
issuance of the restraining order; and (3) damage to the restrained party
resulting from the restraining order.” Qualcomm, Inc. v. Motorola, Inc. 185
F.R.D. 285, 287 (S.D. Cal. 1999) (citing Buddy Systems, Inc. v. Exer–Genie, Inc.,
545 F.2d 1164, 1169 n. 10 (9th Cir. 1976), cert. denied, 431 U.S. 903 (1977)).
Here, DRL has pled facts that sufficiently establish all three elements.
Elements 1 and 3 are not controversial: A bond has been posted, and DRL has
plausibly alleged damages as a result of being prohibited from entering the
generic market.
As for Element 2, however, it remains to be finally determined whether
DRL was wrongfully enjoined as to all claims at issue here. It is true, of course,
that the preliminary injunction has been dissolved. It is also true that a final
determination of wrongfulness and entitlement to recovery must await entry of
a final judgment. Something similar might be said, however, of virtually any
claim a party might assert in a complaint; it does not undermine standing or
require dismissal of a claim that is plausibly asserted.
Accordingly, I will deny Plaintiffs’ appeal (7106 Action at DE 220; 7111
Action at DE 300) of Judge Waldor’s Opinion and Order insofar as it seeks to
overturn the decision to permit DRL to assert its second counterclaim for
recovery under the bond.
ii. Antitrust Arguments
As to the antitrust counterclaims, Plaintiffs’ appeal from Judge Waldor’s
Opinion and Aquestive’s motion to dismiss present overlapping arguments,
which I address together. For the reasons stated below, I will affirm Judge
Waldor’s Opinion permitting Defendants to assert antitrust counterclaims, and
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deny Aquestive’s motion (7106 Action at DE 250; 7111 Action at DE 330) to
dismiss them.
1. Section 2 of the Sherman Act
“The offense of monopoly under § 2 of the Sherman Act has two
elements: (1) the possession of monopoly power in the relevant market and (2)
the willful acquisition or maintenance of that power as distinguished from
growth or development as a consequence of a superior product, business
acumen, or historic accident.” Queen City Pizza v. Domino’s Pizza, 124 F.3d
430, 437 (3d Cir. 1997) (quoting Aspen Skiing Co. v. Aspen Highlands Skiing
Corp., 472 U.S. 585, 596 n. 19 (1985)). An attempted monopolization claim has
three elements: “a plaintiff must prove that the defendant (1) engaged in
predatory or anticompetitive conduct with (2) specific intent to monopolize and
with (3) a dangerous probability of achieving monopoly power.” Id. at 442.
Under either section 1 or 2, the plaintiff bears the burden of pleading the
relevant geographic and product markets. Id. at 436-37.
A patentee can attempt to establish element 1, predatory or
anticompetitive conduct, by pleading facts that establish “(1) that the asserted
patent was obtained through knowing and willful fraud within the meaning of
Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U.S.
172, 177 (1965), or (2) that the infringement suit was ‘a mere sham to cover
what is actually nothing more than an attempt to interfere directly with the
business relationships of a competitor. Eastern R.R. Presidents Conference v.
Noerr Motor Freight, Inc., 365 U.S. 127, 144 (1961).’” Nobelpharma AB v.
Implant Innovations, Inc., 141 F.3d 1059, 1069 (Fed. Cir. 1998) (additional
internal citations omitted)).
The “sham litigation” theory is the one at issue here.9 Defendants allege
that Indivior’s patent litigation was part of an anticompetitive scheme.
Alvogen additionally asserts a second counterclaim for violations of the New
Jersey Antitrust Act. New Jersey’s Antitrust Act is essentially a replica of the federal
Sherman Antitrust Act, see, e.g., N.J. Stat. § 56:9-1, et seq, and must be interpreted
in accordance with federal antitrust principles. “This act shall be construed in
9
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A Section 2 conspiracy claim, like the one Defendants assert against
Aquestive, has four elements: (1) an agreement to monopolize; (2) an overt act
in furtherance of the conspiracy; (3) a specific intent to monopolize; and (4) a
causal connection between the conspiracy and the injury alleged.” Howard
Hess Dental Labs. Inc. v. Dentsply Int’l, Inc., 602 F.3d 237, 253 (3d Cir. 2010).
2. Noerr-Pennington Doctrine10
Any antitrust claim based on a party’s pursuit of litigation must
negotiate the potential bar of the Noerr-Pennington doctrine. “Rooted in the
First Amendment and fears about the threat of chilling political speech,” the
Noerr–Pennington doctrine provides immunity from antitrust liability for parties
who petition the government for redress. In re Lipitor Antitrust Litig., 868 F.3d
231, 264 (3d Cir. 2017) (quoting AD. Bedell Wholesale Co. v. Phillip Morris Inc.,
263 F.3d 239, 250 (3d Cir. 2001)). The doctrine extends to “actions which
might otherwise violate the Sherman Act because ‘[t]he federal antitrust laws
do not regulate conduct of private individuals in seeking anticompetitive action
from the government.” Id. More broadly, “[g]overnment advocacy is protected by
Noerr–Pennington immunity; seeking governmental approval of a private
agreement is not.” Id. The scope of Noerr–Pennington immunity depends on the
source, context, and nature of the competitive restraint at issue. Id. Noerr–
Pennington has been extended to provide immunity to private efforts to
influence courts and agencies, whether federal or state, Bristol–Myers Squibb
Co. v. IVAX Corp., 77 F. Supp. 2d 606, 611 (D.N.J. 2000), and has been held to
shield plaintiffs from liability for pursuing state common law claims such as
harmony with ruling judicial interpretations of comparable Federal antitrust statutes
and to effectuate, insofar as practicable, a uniformity in the laws of those states which
enact it.” N.J. Stat. Ann. § 56:9-18. Accordingly, my analysis in Section II.B.ii
additionally applies to Alvogen’s counterclaim asserting violations of the New Jersey
Antitrust Act.
The titular cases are Eastern Railroad Presidents Conference v. Noerr Motor
Freight, Inc., 365 U.S. 127 (1961) and United Mine Workers of America v. Pennington,
381 U.S. 657 (1965).
10
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tortious interference with contract and tortious interference with prospective
economic gain. Santana Products, Inc. v. Bobrick Washroom Equipment, Inc.,
401 F.3d 123, 140 (3d Cir. 2005) (declining to decide whether a marketing
campaign is petitioning activity that could be immunized by the doctrine).
However, Noerr–Pennington is not an absolute shield that covers all
litigation and petitioning activity. Hanover 3201 Realty, LLC v. Village
Supermarkets, Inc., 806 F.3d 162, 178 (3d Cir. 2015). The immunity ends
where the litigation “is a mere sham to cover what is actually nothing more
than an attempt to interfere directly with the business relationships of a
competitor and the application of the Sherman Act would be justified.” Id.
(quoting Noerr Motor Freight, Inc., 365 U.S. at 144). In determining whether
litigations are a sham, the Third Circuit has adopted the approach that governs
in the Second, Fourth, and Ninth Circuits when applying California Motor
Transportation Co. v. Trucking Unlimited, 404 U.S. 508 (1972) and Professional
Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49
(1993). See Hanover 3201 Realty, LLC., 806 F.3d at 180. First, the court must
determine whether there has been a single filing or a series of filings. Id. If
there has been just a single filing, there must be “a showing of objective
baselessness before looking into the subjective motivations” of the party alleged
to have engaged in anti–competitive behavior. Id. (noting that Professional Real
Estate’s “exacting two-step test” puts a heavy thumb on the scale in favor of
the party who has had a claim made against it). On the other hand, when faced
with a “series or pattern of lawsuits,” a more flexible approach is warranted. Id.
In that scenario, even if some of the petitions turn out to have objective merit,
the claimant is not automatically immunized from liability. Id.
A court may decide the applicability of the Noerr–Pennington doctrine on
a motion to dismiss under Fed. R. Civ. P. 12(b)(6) if no factual issues are
present. Trustees of Univ. of Pa. v. St. Jude Children’s Res. Hosp., 940 F. Supp.
2d 233, 242–43 (E.D. Pa. 2013) (“To be sure, the question of whether litigation
is a sham can be a fact question for the jury. But as the Supreme Court
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explained in PRE, when there is no dispute over the predicate facts of the
underlying legal proceeding, a court may decide probable cause [and thus
Noerr–Pennington applicability] as a matter of law.” (citations omitted and
emphasis added)); Asphalt Paving Sys. v. Asphalt Maint. Sols., LLC, No. 12–
2370, 2013 WL 1292200, at *7–*8 (E.D. Pa. Mar. 28, 2013) (deciding only that
Noerr–Pennington immunity applied in its grant of dismissal); Bristol–Myers
Squibb Co. v. WAX Corp., 77 F. Supp. 2d 606, 616 (D.N.J. 2000) (same).).
As Chief Judge Wolfson recently noted when surveying cases in this
district, the issue is a fact-intensive one, generally not suitable for resolution at
the pleading stage:
Notably, district courts within this Circuit have routinely prohibited
parties from invoking the protections of Noerr-Pennington at the dismissal
stage of a case in the context of patent suits, at which time the factual
record remains undeveloped and insufficient for the purpose of
determining whether a “sham litigation” has been filed. FTC v. Shire
ViroPharma, Inc., No. 17-131, 2018 WL 1401329, at *7, 2018 U.S. Dist.
LEXIS 45727, at *18 (D. Del. March 20, 2018) (“[W]hether [the patent
holder's] activity was in fact a sham under either standard is a factual
inquiry, which cannot be resolved at the motion to dismiss stage.”);
Otsuka Pharm. Co., 118 F.Supp.3d at 657 (“Moreover, even assuming the
allegations proved insufficient, the inquiry into whether [the plaintiffcounter-defendant] maintains in this action ‘objectively and subjectively
baseless’ infringement claims turns upon issues of reasonableness and
intent—issues which are premature to consider upon the present
record.”); S3 Graphics Co. v. ATI Techs. ULC, No. 11-1298, 2014 WL
573358, at *3, 2014 U.S. Dist. LEXIS 16928, at *9 (D.N.J. Feb. 11, 2014)
(holding that the issue of Noerr-Pennington immunity is “not proper
before discovery”); Shionogi Pharma, Inc. v. Mylan, Inc., No. 10-1077,
2011 WL 3860680, at *6, 2011 U.S. Dist. LEXIS 98547, at *6 (D. Del.
Aug. 31, 2011) (“Whether the underlying litigation is baseless is a factual
issue not to be determined on a motion to dismiss.”); In re Metoprolol
Succinate Direct Purchaser Antitrust Litig., No. 06-52, 2010 WL 1485328,
at *10, 2010 U.S. Dist. LEXIS 36303, at *34 (D. Del. April 13, 2010) *395
(“The court, however, cannot [determine whether Noerr-Pennington
applies] at the motion to dismiss stage, because it is fact intensive”);
Hoffman La Roche Inc. v. Genpharm Inc., 50 F.Supp.2d 367, 380 (D.N.J.
1999) (“Reasonableness is a question of fact, and the Court cannot make
such factual determinations on a factual controversy roiled by a motion
to dismiss.”).
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Takeda Pharm. Co. Ltd. v. Zydus Pharm. (USA) Inc., 358 F. Supp. 3d 389, 394–
95 (D.N.J. 2018).
3. Analysis of the Antitrust Claims
a. Appeal
On appeal, Plaintiffs (as counterclaim defendants) argue that Judge
Waldor’s Opinion and Order contained clear error. (DE 220) Plaintiffs assert
that, under Noerr-Pennington, their actions here—particularly, filing these
Hatch-Waxman suits and obtaining preliminary injunctions—are
presumptively shielded from antitrust liability. The facts pled, in Defendants’
view, are not sufficient to overcome this presumption, and Judge Waldor
should have rejected any claim based on the narrow “sham litigation” exception
to the Noerr-Pennington Doctrine. (Id. at 6) At this, the pleading stage, I must
disagree.
I pause briefly to consider the threshold issue of the timeliness of this
amendment, which was asserted after the deadline to amend pleadings. Rule
16 imbues Magistrate Judges with wide discretion in determining whether
“good cause” to warrant amendment has been presented.11 Judge Waldor cited
the discovery of emails and documents attached to the Indivior Indictment,
which came to light after the deadline to amend pleadings. (DE 217 at 4) I
agree with Judge Waldor that there was good cause to permit a belated
amendment.
Judge Waldor then turned to the substance of whether the Rule 15
motion to amend should be granted. Plaintiffs argued before Judge Waldor, and
continue to do so in their motion here, that the sham litigation exception to
Recent Third Circuit guidance confirms the aptness of Judge Waldor’s
approach. Before considering whether Rule 15’s standard for amendment governed,
Judge Waldor appropriately considered whether Defendants’ motion met Rule 16’s
more demanding requirements. “When a party moves to amend or add a party after
the deadline in a district court’s scheduling order has passed, the “good cause”
standard of Rule 16(b)(4) of the Federal Rules of Civil Procedure applies. A party must
meet this standard before a district court considers whether the party also meets Rule
15(a)’s more liberal standard.” Premier Comp Sols., LLC v. UPMC, No. 19-1838, 2020
WL 4668235, at *2 (3d Cir. Aug. 12, 2020).
11
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Noerr-Pennington had not been adequately pled and that Defendants’
amendments should therefore be rejected as futile. (DE 217 at 5) Judge Waldor
rejected these arguments and I do as well.
“Futility,” in this context, means that the proposed amended complaint
“would not withstand a motion to dismiss.” Massarsky v. Gen. Motors Corp.,
706 F.2d 111, 125 (3d Cir. 1983); see also Brown v. Philip Morris Inc., 250 F.3d
789, 796 (3d Cir. 2001); Jablonski, 863 F.2d at 292; Adams v. Gould Inc., 739
F.2d 858, 864 (3d Cir. 1984). Therefore, “[i]n assessing ‘futility,’ the District
Court applies the same standard of legal sufficiency as applies under Rule
12(b)(6).” Shane v. Fauver, 213 F.3d 113, 115 (3d Cir. 2000); see also Section
II.A.ii, supra (motion to dismiss standards). “[I]f the proposed amendment ‘is
frivolous or advances a claim or defense that is legally insufficient on its face,
the court may deny the motion to amend. If a proposed amendment is not
clearly futile, then denial of leave to amend is improper.” Harrison Beverage Co.
v. Dribeck Importers, Inc., 133 F.R.D. 463, 468 (D.N.J. 1990).
The analysis therefore merges with the motion to dismiss, discussed in
the next section. For the reasons outlined there, Defendants’ proposed
amendments are not futile, because they would withstand a motion to dismiss.
b. Motion to Dismiss
In moving to dismiss, Aquestive reasserts the “sham litigation”
arguments it presented in its appeal of Judge Waldor’s decision. (DE 250 at 20)
Aquestive adds that Defendants’ allegations fail because (1) there are no facts
that establish Aquestive is a competitor in the relevant market (MTD Br. at 1316); (2) the allegations improperly allege a shared monopoly (Id. at 16-18); and
(3) Defendants efforts at group pleading fail to specifically address Aquestive’s
individual conduct (Id. at 18-19).
First, I reject Plaintiffs’ argument that Defendants have failed to
sufficiently allege that they engaged in anticompetitive “sham litigation.” This is
not a case of a single filing. The antitrust allegations in the first instance assert
that Plaintiffs’ claims were objectively baseless and part of a larger strategic
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effort by Plaintiffs to take steps that they knew would delay or inhibit FDA
authorization for generic competitors. (See, e.g., 7106 Action, DE 218 ¶¶ 71-74,
87, 90) The counterclaims allege some particulars of that overall strategic
anticompetitive effort. For example, “when faced with imminent generic
competition, Indivior engaged in an elaborate corporate marketing strategy to
mislead physicians and patients in order to eliminate generic competition for
its products.” (Id. ¶ 106) Moreover, Indivior “fabricated [a] safety story that
Suboxone Film was safer, namely that the film would protect against diversion
and accidental child exposure as compared to the tablets” to get patients to
switch to using the films and to undermine the market for tablets. (Id. ¶ 110).
Indivior likewise is alleged to have developed a marketing strategy to extend its
monopoly power by, for example, increasing the cost of its tablets to encourage
patients to switch. (Id. ¶¶ 113, 156–66) Aquestive was allegedly part and parcel
of this strategy, as it owned the ’305 Patent and agreed with Indivior to
continue to file for new patents, then file lawsuits here and elsewhere, which
included seeking injunctions based on new patents that were patentably
indistinct from the patents at issue in Indivior II. (Id. ¶¶ 115-145)
Second, the counterclaims assert that Plaintiffs controlled pricing and
output of products in that they controlled 100% of the Suboxone market in the
US and used this power to harm competition. (Id. ¶¶ 196-99) Defendants allege
that Plaintiffs, including Aquestive, collectively leveraged their patents to
develop marketing and legal strategies that enabled Indivior to manipulate the
market for Suboxone products and decrease competition for their Suboxone
Film. (Id. ¶¶ 196-99)
The patent litigation, the counterclaim asserts, was part of this
anticompetitive strategy. Now of course, under Noerr-Pennington, it is not
enough that the underlying patent claims did not succeed. I expect Plaintiffs
will have much to say about the colorable, good faith basis for their patent
claims, irrespective of whether they ultimately prevailed. See, e.g., Takeda,
supra. Two judges have seen things Plaintiffs’ way, at least on certain issues.
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But the Defendants have sufficiently alleged that the underlying litigation was
baseless and was intended to stifle competition. The rest must await summary
judgment or a trial. Accordingly, I find that the allegations in the counterclaims
sufficiently plead the sham litigation exception.
In so holding I am mindful that, as this court recently held, “the inquiry
into whether [Plaintiff] maintains in this action ‘objectively and subjectively
baseless’ infringement claims turns upon issues of reasonableness and intentissues which are premature to consider upon the present record. Indeed,
resolution of these inherently factual issues requires consideration of whether
[Plaintiff] undertook a reasonable investigation in advance of pursuing its
infringement claims, whether [Plaintiff] undertook this action for an improper
and anticompetitive purpose, and whether a reasonable litigant could have
realistically expected success on the merits at the time of filing.” Otsuka Pharm.
Co. v. Torrent Pharm. Ltd., Inc., 118 F. Supp. 3d 646, 657 (D.N.J. 2015). None
of these issues are ripe for a determination at this stage of the proceedings.
Aquestive’s remaining arguments—(1) that there are no facts that
establish Aquestive is a competitor in the relevant market (MTD Br. at 13-16);
and (2) that the allegations improperly allege a shared monopoly (Id. at 1618)—fare no better. These arguments address a purported claim that Aquestive
had monopoly power in the relevant market. But these arguments are ancillary
to Defendants’ claim, which is that Aquestive conspired with Indivior to further
Indivior’s monopoly power. It is well established that “a claim of conspiracy to
monopolize requires only that a company agree with another company to assist
the first in its attempt to monopolize the relevant market.” In re Suboxone
(Buprenorphine Hydrochloride & Naloxone) Antitrust Litig., No. 13-MD-2445,
2017 WL 4910673, at *11 (E.D. Pa. Oct. 30, 2017); Carpet Grp. Int’l v. Oriental
Rug Importers Ass’n, Inc., 256 F. Supp. 2d 249, 283 (D.N.J. 2003) (“[T]he proof
required to demonstrate a conspiracy to monopolize does not require a proof of
market power in a relevant market.”). Defendants assert that Aquestive helped
conspire with Indivior to impermissibly protect Indivior’s market power and
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monopoly. Aquestive contributed to this conspiracy by applying for new
patents, filing lawsuits and multiple motions in conjunction with Indivior, and
by manufacturing the film for Indivior to then market. (See, e.g., 7111 Action,
DE 297 ¶¶ 17, 82, 96-99, 266-67) These allegations are sufficient to establish a
claim for conspiracy to monopolize at the motion to dismiss stage.
Accordingly, Aquestive’s motion to dismiss Defendants’ antitrust claims
is denied.
III.
Motion for a Rule 54(b) Entry of Partial Final Judgment
In the 7111 Action, DRL moved for an entry of final partial judgment of
non-infringement as to the ’305 Patent. (7111 Action at DE 334) Alvogen then
joined in the motion (7106 Action at DE 261), which Plaintiffs oppose. (7111
Action at DE 350)
Generally, an order which terminates fewer than all claims, or claims
against fewer than all parties to an action, does not constitute a “final” decision
for purposes of 28 U.S.C. § 1291. Under Rule 54(b), however, a district court
may convert such a partial order to a final decision over which a court of
appeals may then exercise jurisdiction.
Federal Rule 54(b) provides as follows:
When an action presents more than one claim for relief-whether as a
claim, counterclaim, crossclaim, or third-party claim-or when multiple
parties are involved, the court may direct entry of a final judgment as to
one or more, but fewer than all, claims or parties only if the court
expressly determines that there is no just reason for delay. Otherwise,
any order or other decision, however designated, that adjudicates fewer
than all the claims or the rights and liabilities of fewer than all the
parties does not end the action as to any of the claims or parties and
may be revised at any time before the entry of a judgment adjudicating
all the claims and all the parties’ rights and liabilities.
Fed. R. Civ. P. 54(b). Certification under Rule 54(b) is the exception, not the
norm. “Not all final judgments on individual claims should be immediately
appealable, even if they are in some sense separable from the remaining
unresolved claims. The function of the district court under the Rule is to act as
a ‘dispatcher.’ It is left to the sound judicial discretion of the district court to
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determine” when an action may be certified as final. Curtiss–Wright Corp. v.
Gen. Elec. Co., 446 U.S. 1, 8-9 (1980) (citations omitted). “The power which this
Rule confers upon the trial judge should be used only in the infrequent harsh
case as an instrument for the improved administration of justice and the more
satisfactory disposition of litigation in the light of the public policy indicated by
statute [28 U.S.C. § 1291] and rule.” Panichella v. Pa. R.R. Co., 252 F.2d 452,
455 (3d Cir.1958).
The Supreme Court has set forth the steps a court must take in making
determinations under Rule 54(b). First, a district court must determine that it
is dealing with a “final judgment” as to the particular claim at issue. “It must
be a ‘judgment’ in the sense that it is a decision upon a cognizable claim for
relief, and it must be ‘final’ in the sense that it is ‘an ultimate disposition of an
individual claim entered in the course of a multiple claims action.’” Curtiss–
Wright, 446 U.S. at 7 (quoting Sears, Roebuck & Co. v. Mackey, 351 U.S. 427
(1956)). Having made a finding of finality, the court must then determine
whether there is “any just reason for delay.” Id. at 8.
Here, there appears to be no dispute that there has been a final
resolution (subject to appeal, of course) of the claims concerning the ’305
Patent. Indeed, Plaintiffs have entered into a stipulated judgment that
Defendants did not infringe the ’305 Patent as construed in my Markman
Opinion and Order. (See 7111 Action at DE 323)
The parties disagree, however, as to whether there is “any just reason”
for delaying entry of a Rule 54(b) final judgment on the ’305 claims. “This latter
requirement, that a district court ‘must go on to determine whether there is
any just reason for delay,’ is not merely formalistic.” Elliott v. Archdiocese of
New York, 682 F.3d 213, 220 (3d Cir. 2012). The Third Circuit has set forth
several factors to be considered when assessing if there is a “just reason for
delay” under Rule 54(b):
(1) the relationship between the adjudicated and unadjudicated claims;
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(2) the possibility that the need for review might or might not be mooted
by future developments in the district court;
(3) the possibility that the reviewing court might be obliged to consider
the same issue a second time;
(4) the presence or absence of a claim or counterclaim which could result
in set-off against the judgment sought to be made final;
(5) miscellaneous factors such as delay, economic and solvency
considerations, shortening the time of trial, frivolity of competing claims,
expense, and the like.
Berckeley Inv. Grp., Ltd. v. Colkitt, 455 F.3d 195, 203 (3d Cir. 2006) (citing
Allis–Chalmers Corp. v. Philadelphia Elec. Co., 521 F.2d 360, 364 (3d Cir.
1975)).
Here I find good reason to delay entry of a final judgment as to the ’305
Patent claims. Although the Rule 54(b) motion cites case law severing patent
claims from antitrust claims, there is here the complicating factor of the yetunadjudicated claims under the ’454 patent. I take the Defendants’ point that
the claims are separate, but I nevertheless find as a matter of case
management that any final judgment should at least await the resolution of all
the patent issues.
Factor 1, the relationship between the adjudicated and unadjudicated
claims, counsels delay in entry of judgment. “Where the adjudicated and
unadjudicated claims share significant similarities, such as involving the same
parties, the same legal issues, or the same evidence, Rule 54(b) certification is
disfavored.” Ortho-McNeil Pharm., Inc. v. Kali Labs., Inc., No. CIV A 02-5707
DMC, 2007 WL 1814080, at *3 (D.N.J. June 20, 2007). The parties focus
generally on the overlap between the claims concerning the ’305 Patent and the
antitrust counterclaims. My concern is more generally with the overlap between
the ’305 Patent, the ’454 Patent, and the antitrust claims, and what would be
the most efficient way to resolve these issues. Certainly the parties in the
adjudicated and unadjudicated patent claims are identical and the legal and
factual issues, while not wholly identical, are intertwined and related. Factual
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issues resolved under the ’305 Patent overlap with those concerning the
remaining claim as to the ’454 Patent. My Markman Opinion and Order
construed the bioequivalence language under claim 1 of the’454 Patent and the
“a polyethylene oxide alone or in combination with a hydrophilic cellulosic
polymer” language in claims 9, 10, and 11. However, the primary issues and
defenses concerning whether DRL’s and Alvogen’s generic films infringe the
’454 Patent will largely overlap with the issues concerning the ’305 Patent.
Factors 3 and 4, too, suggest that Rule 54(b) certification should be
denied. Certification of the ’305 issues would likely result in a piecemeal appeal
to the Federal Circuit. If the claims as to the ’305 Patent were deemed final and
Plaintiff were to appeal, the Federal Circuit would have to evaluate the
correctness of the basis for finding the ’305 Patent was infringed. Regardless of
the outcome of that decision, the parties will inevitably appeal the Court’s
decision of the issues concerning the ’454 Patent and Defendants’
counterclaims. This second appeal would involve much of the same evidence
and many of the same legal issues as the first appeal. It would be far more
efficient for the Federal Circuit to review all of these issues, especially as they
relate to the ’305 Patent and the ’454 Patent, collectively rather than in
successive appeals that would turn largely on identical and interrelated facts.
Factor 2 slightly favors entry of a final judgment now. This Court has
already issued its definitive Markman opinion. Predictions are perilous, but it
seems unlikely that resolution of additional issues concerning the ’454 Patent
or Defendants’ antitrust claims would reach back to alter or moot the rulings
made thus far as to the ’305 Patent.
As to Factor 5, DRL points to the financial burden of being denied the
present ability to collect on the outstanding bond. I understand DRL’s
complaint that it deserves to collect on this bond (I set aside speculative issues
concerning a bonded stay pending appeal). This financial prejudice, however,
does not differ fundamentally from the usual course of litigation, in which a
plaintiff must generally await final judgment to be awarded damages. I note
also that DRL has now been allowed to bring their products to market. I
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therefore find that the financial cost of delay, though real, does not outweigh
the procedural cost of piecemeal appeals that would depend on resolution of
similar facts and legal issues.
Accordingly, Defendants’ Rule 54(b) motion for entry of partial final
judgment as to non-infringement of the ’305 Patent is denied. I will, however,
deny this motion without prejudice to a renewed application to sever the patent
claims from the antitrust counterclaims after the ’454 Patent claims are
resolved.
IV.
Conclusion
For the reasons set forth above, Plaintiffs’ appeal of Judge Waldor’s
December 4, 2019 Opinion and Order permitting Defendants to amend their
answer to add counterclaims (7106 Action DE 220; 7111 Action DE 300) is
denied.
Aquestive’s motion to dismiss Defendants’ counterclaims (7106 Action
DE 250; 7111 Action DE 330) is denied.
Defendants’ motion for entry of a partial final judgment (7106 Action DE
261; 7111 Action DE 334) is denied without prejudice.
An appropriate order follows.
Dated: August 24, 2020
/s/ Kevin McNulty
____________________________________
Kevin McNulty
United States District Judge
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