Sandoz Inc v. United Therapeutics Corporation
CourtCourt of Appeals for the Third Circuit
Date FiledOctober 7, 2026
Docket24-3067
StatusPublished
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Full Opinion
UNITED STATES COURT OF APPEALS FOR THE
THIRD CIRCUIT
Nos. 24-3067, 24-3116, and 24-3146
SANDOZ, INC.; RAREGEN, LLC, n/k/a Liquidia PAH, LLC
v.
UNITED THERAPEUTICS CORP.; SMITHS MEDICAL ASD, INC.
UNITED THERAPEUTICS CORP.,
Appellant in No. 24-3067
SANDOZ, INC.,
Appellant in No. 24-3116
RAREGEN, LLC,
Appellant in No. 24-3146
_________________________________
On Appeal from the U.S. District Court, D.N.J.
Judge Brian R. Martinotti, No. 2:19-cv-10170
Before: RESTREPO, MCKEE, AND AMBRO, Circuit Judges
Argued: Nov. 12, 2025; Filed: Oct. 7, 2026
_____________________________
OPINION OF THE COURT
RESTREPO, Circuit Judge. This case involves
competitive conduct between two pharmaceutical companies
that manufacture and sell the brand-name and generic versions
of the drug treprostinil. In 2002, United Therapeutics
Corporation (“UTC”) launched an injectable form of
treprostinil under the brand name Remodulin to treat
pulmonary arterial hypertension, a disease that causes high
blood pressure in the arteries running from the heart to the
lungs. In 2017, Sandoz, Inc. received approval to market
generic injectable treprostinil. Sandoz and its marketing
partner RareGen, LLC (together with Sandoz, “Plaintiffs”)
contend that, in connection with Sandoz’s launch of generic
treprostinil, UTC violated federal antitrust and state tort laws
and breached a patent settlement agreement with Sandoz.
Because the settlement agreement does not
unambiguously establish the interpretation that Sandoz
advances, we will reverse the grant of summary judgment in
favor of Sandoz as to liability on the breach-of-contract claim
and remand with instructions that the issue of liability proceed
to trial.1 We will also reverse the grant of summary judgment
in favor of UTC on the tortious interference claim and remand
for the District Court to analyze the tortious interference claim
separately from the antitrust claims. As UTC demonstrated
procompetitive justifications for its conduct, we will affirm the
dismissal of the antitrust and state tort claims against UTC.
Finally, we will affirm the denial of UTC’s motion to exclude
Plaintiffs’ damages expert.
I. FACTUAL AND PROCEDURAL BACKGROUND
A. UTC and Smiths Cartridge Agreements
UTC is a pharmaceutical drug company that designs
and manufactures the brand-name drug Remodulin for patients
with pulmonary arterial hypertension. Remodulin can be
administered either intravenously or subcutaneously.
Subcutaneous administration requires the use of a pump and
disposable cartridges. Smiths Medical ASD, Inc. (“Smiths”)
developed and manufactured the CADD-MS 3 pump and
cartridges used to administer Remodulin subcutaneously.
Smiths sold its pump and cartridges to two specialty pharmacy
distributors, Accredo Health Group (“Accredo”) and CVS
Specialty (“CVS” and with Accredo, the “Specialty
Pharmacies”), which sold the medication to patients.
In August 2015, Smiths informed the Specialty
Pharmacies it was discontinuing the CADD-MS 3 pumps and
that its supply of cartridges was projected to be available for at
least three years. In March 2016, UTC and Smiths contracted
1
As we reverse the District Court’s summary judgment order
as to liability on the breach-of-contract claim and on the tor-
tious interference claim, we deny as moot the pretrial eviden-
tiary challenges and damages challenges raised on appeal.
2
for a “life extension” for Smiths’ pumps and cartridges (the
“Supply Agreement”). UTC paid Smiths $2.5 million up front
to produce 7,000 pumps and 1.6 million cartridges, and it
agreed to purchase any unsold pumps after six years. Smiths
agreed to supply cartridges only to the Specialty Pharmacies in
the United States.
In March 2017, Smiths informed UTC that it had
produced 258,450 of the 1.6 million cartridges, and there was
sufficient resin to produce approximately 2.6 million
cartridges. In July 2017, UTC and Smiths amended the Supply
Agreement and UTC provided additional funding for Smiths’
production of 2.1 million cartridges. The amendment also
obligated Smiths to use commercially reasonable efforts to
amend its contract with the Specialty Pharmacies to include a
requirement that the cartridges only be used with Remodulin.
B. Sandoz and Generic Treprostinil
On September 29, 2015, UTC and Sandoz, a generic
drug company, entered into a settlement agreement (the
“Settlement Agreement”) arising from patent litigation, which
granted Sandoz a license to market treprostinil, the generic
form of Remodulin, for both subcutaneous and intravenous
administration. The Settlement Agreement included language
obligating UTC “[n]ot to take any action directly or indirectly
to prevent, delay, limit, or otherwise restrict the launch” of
Sandoz’s generic treprostinil and not to cause any third party
to “interfere with Sandoz’s efforts to launch” generic
treprostinil. App. 2781–82, 2784.
On May 17, 2016, a Sandoz executive contacted Smiths
regarding the CADD-MS 3 pump, and Smiths informed
Sandoz that it was discontinuing the pump. The FDA approved
Sandoz’s application for generic treprostinil in November
2017. Although the Settlement Agreement permitted Sandoz to
begin marketing generic treprostinil in June 2018, it waited to
launch the drug. In August 2018, Sandoz partnered with
RareGen—a company created by former UTC executives—to
market and sell generic treprostinil.
3
C. Cartridge Restrictions
In December 2018, UTC learned that Smiths had not
been able to obtain contract amendments with the Specialty
Pharmacies restricting its cartridges for use with Remodulin
only. UTC also learned that Sandoz was preparing to launch
generic treprostinil. At UTC’s request, Smiths placed the
cartridges on allocation status, which gave UTC approval
rights over every cartridge sale by Smiths to the Specialty
Pharmacies. UTC used the authority as “negotiating leverage”
over the Specialty Pharmacies, App. 1494, refusing to release
cartridges until they signed exclusivity agreements restricting
use of the cartridges to Remodulin only. Over the next few
months, the Specialty Pharmacies sent numerous emails to
Smiths, expressing concerns that their supplies were dwindling
and that they would be unable to service patients. These
shortages created serious risks for patients, who needed
continuous infusions of medication. With UTC’s approval,
Smiths permitted some shipments of cartridge, but warned the
Pharmacies that “this [would] be the process until the
amendments have been finalized.” App. 6739.
On February 14, 2019, CVS agreed to sell the cartridges
only to Remodulin users. On March 18, 2019, Accredo
followed suit. But Smiths never countersigned the agreements.
A Smiths employee later testified that Smiths was “no longer
comfortable signing” and that “it was placing an unfair burden
on Smiths Medical to try to dictate the supply chain flow of
this, so [Smiths] didn’t really want to be in the middle of that
anymore.” App. 1173.
In an April 8, 2019, amendment to the Supply
Agreement, Smiths sold its existing and future cartridge
inventory to UTC and agreed to distribute the pumps and
cartridges on UTC’s behalf. In April and May 2019, UTC
executed agreements directly with the Specialty Pharmacies,
prohibiting them from distributing the cartridges for use with
generic treprostinil.
Sandoz maintains that Accredo initially assured it that
cartridges would be available for use with generic treprostinil,
but then in January 2019 stated that cartridges could no longer
be provided for non-Remodulin use. On March 25, 2019,
4
lacking the cartridges for subcutaneous administration, Sandoz
launched its generic treprostinil for intravenous administration
only. In May 2019, RareGen contracted with a device
manufacturer to produce cartridges for use with Sandoz’s
generic treprostinil. The FDA approved the alternative
cartridge on March 26, 2021, and Sandoz launched its generic
subcutaneous treprostinil in May 2021. Sandoz’s generic
treprostinil underperformed relative to internal forecasts, and
Sandoz ultimately destroyed over $6 million of its product.
D. Procedural History
On April 16, 2019, Sandoz and RareGen filed their
complaint against UTC and Smiths, asserting federal antitrust,
state antitrust, and state tort claims.2 After the District Court
denied Plaintiffs’ motion for a preliminary injunction, Sandoz
added a breach of contract claim against UTC based on the
Settlement Agreement. The District Court granted summary
judgment against RareGen and Sandoz as to the antitrust and
state-law tort claims, dismissing RareGen from the case, and
granted summary judgment in favor of Sandoz as to liability
on its breach-of-contract claim. The court also denied UTC’s
motion to exclude the opinion of Sandoz’s damages expert, Dr.
Anupam Jena. After a bench trial on damages as to the breach-
of-contract claim, the court awarded Sandoz $61,643,251 in
damages.
On appeal, UTC challenges the District Court’s grant of
summary judgment in favor of Sandoz as well as certain
evidentiary rulings and aspects of the damages award. RareGen
cross-appeals the District Court’s grant of summary judgment
in favor of UTC on the antitrust and state law claims. Sandoz
adopts RareGen’s arguments and additionally challenges the
District Court’s damages award.
II. STANDARD OF REVIEW
The District Court had jurisdiction under 15 U.S.C. § 15
and 28 U.S.C. §§ 1331, 1332, 1337. We have jurisdiction
2
Prior to summary judgment, Plaintiffs and Smiths settled and
the District Court dismissed all claims against Smiths with
prejudice.
5
under 28 U.S.C. § 1291. We exercise plenary review over the
District Court’s grant of summary judgment, “applying the
same standard that the lower court should have applied.” Le
Pape v. Lower Merion Sch. Dist., 103 F.4th 966, 977 (3d Cir.
2024) (quoting Chisolm v. McManimon, 275 F.3d 315, 321 (3d
Cir. 2001)). Summary judgment is appropriate where there is
no genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law, drawing all inferences
and reviewing all facts in the light most favorable to the non-
moving party. Id. We review a district court’s decision to
exclude or admit expert testimony for abuse of discretion. See
ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254, 268 (3d Cir.
2012).
III. BREACH OF CONTRACT
UTC argues that the District Court erred in granting
partial summary judgment in favor of Sandoz as to liability on
its breach-of-contract claim because the meaning of the
challenged provisions in the Settlement Agreement is
ambiguous. As this case involves a question of contract
interpretation, summary judgment shall be granted only if the
contract language is unambiguous, meaning “subject to only
one reasonable interpretation.” Mylan Inc. v. SmithKline
Beecham Corp., 723 F.3d 413, 418 (3d Cir. 2013) (quoting
Arnold M. Diamond, Inc. v. Gulf Coast Trailing Co., 180 F.3d
518, 521 (3d Cir. 1999)). Whether a contract is ambiguous is
an issue of law subject to plenary review. Sumitomo Mach.
Corp. of Am. v. AlliedSignal, Inc., 81 F.3d 328, 332 (3d Cir.
1996). “If the non-moving party presents a reasonable
alternative reading of the contract, then a question of fact as to
the meaning of the contract exists which can only be resolved
at trial.” Newport Assocs. Dev. Co. v. Travelers Indem. Co. of
Ill., 162 F.3d 789, 792 (3d Cir. 1998). “Thus, the dispositive
question is whether [UTC] provided a reasonable reading of
the contract.” Id.
The Settlement Agreement is governed by New Jersey
law, which requires courts to consider “‘all of the relevant
evidence that will assist in determining the intent and meaning
of the contract’ when making ambiguity determinations.”
Mylan, 723 F.3d at 419 (quoting Conway v. 287 Corp. Ctr.
Assocs., 901 A.2d 341, 346 (N.J. 2006)). Even when a contract
appears to be unambiguous on its face, “[e]vidence of the
6
circumstances is always admissible in aid of the interpretation”
of an integrated contract. Id. (quoting Sumitomo Mach.
Corp., 81 F.3d at 332). Contracts should be read “as a whole”
and “in a fair and common sense manner” that is based on “the
intent of the parties, the express terms of the contract,
surrounding circumstances and the underlying purpose of the
contract.” Manahawkin Convalescent v. O’Neill, 85 A.3d 947,
958 (N.J. 2014) (citation modified). Therefore, we must
consider “all relevant evidence to determine if any ambiguity
exists,” and summary judgment is inappropriate “if the
contested provisions fall in that gray area.” Mylan, 723 F.3d at
419.
Plaintiffs alleged that UTC breached the Settlement
Agreement’s terms prohibiting it from impeding the launch of
treprostinil. Specifically, under Section 11(b), UTC agreed
“[n]ot to take any action directly or indirectly to prevent, delay,
limit, or otherwise restrict the launch, manufacture, use, sale,
offer for sale, importation or distribution of the Sandoz ANDA
Product in or for the Territory by Sandoz and its Affiliates as
permitted under the terms of this Agreement.” App. 2781–82.
Under Section 15(a), UTC additionally agreed that it “shall not
cause any Third Party to . . . initiate or otherwise undertake any
activity in the Territory, directly or indirectly, against the . . .
Sandoz ANDA Product to . . . interfere with Sandoz’s efforts
to launch the Sandoz ANDA Product in the Territory as of the
Effective Launch Date under the terms provided by this
Agreement.” App. 2784. Plaintiffs alleged that UTC’s
cartridge restrictions breached these provisions because they
prevented, delayed, and limited Sandoz’s efforts to launch
generic treprostinil.
In holding UTC liable for breach of contract, the District
Court ruled that UTC breached Sections 11(b) and 15(a) by
“locking up the existing inventory by taking title to all
commercially available cartridges as Sandoz was preparing to
launch its generic.” App. 93. The court held that “there is no
genuine dispute UTC unambiguously promised not to ‘prevent,
limit, delay, or otherwise restrict’ Sandoz’s generic launch.”
App. 92. However, context complicates an isolated reading of
Sections 11(b) and 15(a), which would seemingly restrict UTC
from taking any actions that would have the effect of impeding
its competitor Sandoz’s efforts to launch generic treprostinil.
7
First, both Sections 11(b) and 15(a) are limited by “the
terms” of the Settlement Agreement, which include other
provisions that UTC argues foreclose any obligation
concerning the cartridges. Specifically, the Settlement
Agreement’s definition of the product at issue, termed the
Sandoz ANDA Product, states that it “expressly [does] not
include . . . any technology associated with any UTC
product(s).” App. 2776. The Settlement Agreement also
provides that Sandoz’s license to make, market, sell, and
distribute generic treprostinil “expressly and specifically
excludes conferring any and all rights . . . to the use of any
device(s), pump(s), or equipment that may be used with the
Sandoz ANDA Product.” App. 2778. Finally, both parties
represented and warranted that “[n]othing in this agreement
shall be construed to grant any right to any Third Party
proprietary technology, including . . . any other pump or
delivery system for the Sandoz ANDA Product or any other
form of treprostinil.” App. 2782.
Further, UTC offers an alternative reading that Sections
11(b) and 15(a) are merely “catch-all provisions aimed at
reinforcing UTC’s agreement not to wield its intellectual
property rights against Sandoz.” UTC Br. 28. Indeed, the
surrounding context of 11(b) and 15(a)—provisions in a patent
litigation settlement agreement—suggest that those provisions
refer to UTC refraining from using its intellectual property
rights to derail Sandoz’s launch and FDA approval, rather than
a blanket ban on any conduct interfering with Sandoz’s launch.
Section 11(a), which immediately precedes Section 11(b) and
is the only other subsection in Section 11, obligates UTC not
to bring suit against Sandoz for patent infringement. Section
15 is titled “Regulatory Approval,” and 15(a) also restricts
UTC from “interfer[ing] with Sandoz’s efforts to obtain FDA
approval” of its product. App. 2784.
We thus cannot say there is “only one reasonable
interpretation” of the contract. Mylan, 723 F.3d at 418 (citation
modified). In light of the broader context, “the contested
provisions fall in that gray area” of ambiguity, and
consequently, “summary judgment is improper.” Id. at 419.
Instead, the breach-of-contract claim should proceed to trial
and the “fact-finder must attempt to discover what the
8
contracting parties . . . intended [the disputed provisions] to
mean.” Fed Cetera, LLC v. Nat’l Credit Servs., Inc., 938 F.3d
466, 470 (3d Cir. 2019) (quoting Wayne Land & Mineral Grp.
LLC v. Del. River Basin Comm’n, 894 F.3d 509, 534 (3d Cir.
2018)). Therefore, we will reverse the District Court’s grant of
summary judgment as to the breach-of-contract claim.
IV. SHERMAN ACT CLAIMS
A. Forfeiture
As a preliminary matter, we hold that Sandoz properly
adopted RareGen’s arguments regarding the antitrust and state
law claims. In its appellate brief, Sandoz adopted the Sherman
Act antitrust and state law arguments asserted in RareGen’s
cross-appeal under Federal Rule of Appellate Procedure 28(i).
Rule 28(i) provides that in cases involving multiple appellants
or appellees, “any party may adopt by reference a part of
another’s brief.” Fed. R. App. P. 28(i). UTC argues that Sandoz
has forfeited the antitrust and state law claims on appeal
because its “blanket statement” of incorporation does not
sufficiently identify the arguments incorporated and, even if
the statement were adequate, the incorporation would violate
the word count. UTC Resp. Br. 40 (citation omitted).
This Circuit encourages parties to adopt “portions of
already-filed briefs” under Rule 28(i) so long as the issues are
“specifically and explicitly identified” and not incorporated
under “general statements of adoption.” United States v.
Williams, 974 F.3d 320, 339 n.7 (3d Cir. 2020). Otherwise,
leaving the court to “scour the record” and “identify the issues
to be adopted” will result in the abandonment and waiver of
the unspecified issues. United States v. Fattah, 914 F.3d 112,
146 n.9 (3d Cir. 2019).
Sandoz’s statement of incorporation is not a general
statement of adoption. Sandoz specified it adopted RareGen’s
arguments related to the antitrust and state-law claims. Sandoz
Br. 1 n.1 (“RareGen . . . separately appeals the summary
judgment decision on the antitrust and related state-law claims.
Sandoz adopts RareGen’s arguments.”) Sandoz then further
detailed that it “adopts by reference the entirety of the Brief of
Appellee RareGen, LLC, including specifically argument
9
Sections I and II, which appeal the district court’s order
granting summary judgment in UTC’s favor on Plaintiffs’
antitrust and related state-law claims.” Sandoz Br. 3–4. Thus,
the adopted arguments are “specifically and explicitly
identified.” Williams, 974 F.3d at 339 n.7.
UTC also argues that Sandoz exceeded the word count
in Federal Rule of Appellate Procedure 28.1(e) by
incorporating RareGen’s arguments. In support, UTC cites to
Federal Circuit authority holding that a party may not exceed
the word limit when incorporating arguments by reference. See
Promptu Sys. Corp. v. Comcast Cable Commc’ns, LLC, 92
F.4th 1384, 1386 (Fed. Cir. 2024) (per curiam); Medtronic, Inc.
v. Teleflex Life Scis. Ltd., 86 F.4th 902, 906–07 (Fed. Cir.
2023).
We have not addressed this issue precedentially, but we
have rejected the related practice of a party incorporating on
appeal its own briefs filed in the district court, proscribing such
incorporation as “effectively nullify[ing] the page or word
limits.” Papp v. Fore-Kast Sales Co., 842 F.3d 805, 816 (3d
Cir. 2016). In so ruling, we cited to the Tenth Circuit, id. & n.9
(citing Gaines-Tabb v. ICI Explosives, USA, Inc., 160 F.3d
613, 623–24 (10th Cir. 1998)), which prohibits the adoption of
district court filings because the practice circumvents the
appellate page limitations and “unnecessarily complicate[s] the
task of an appellate judge.” Gaines-Tabb, 160 F.3d at 624.
However, the Tenth Circuit has held that adopted arguments
do not count toward the word limit when a party adopts by
reference arguments from a co-party’s appellate brief. United
States v. Butler, 141 F.4th 1136, 1149 (10th Cir. 2025). The
Eighth Circuit holds the same because “[p]ermitting unlimited
adoption of briefs will generally not cause the problems that
word limits are designed to avoid, since courts and parties
already have to read and respond to the briefs being adopted.”
In re Target Corp. Customer Data Sec. Breach Litig., 855 F.3d
913, 916–17 (8th Cir. 2017).
We agree that the concerns that arise when adopting
briefing below are not present when a party adopts a part of an
appellate brief in the same case. Unlike in the former context,
the federal appellate rules explicitly permit parties to adopt by
reference co-parties’ arguments raised in appellate briefs, with
10
no indication that the arguments should count toward the word
limit. And, because the relevant argument has already been
raised on appeal by one party, the court must review the
argument regardless of whether another party adopts it.
Therefore, we join the Eighth and Tenth Circuits in holding
that a party’s proper adoption of arguments pursuant to Rule
28(i) does not count toward the word limits prescribed by
Federal Rule of Appellate Procedure 28.1(e).3
B. The Sherman Act
Sandoz and RareGen brought claims under Sections 1
and 2 of the Sherman Act. Section 1 prohibits “[e]very
contract, combination in the form of trust or otherwise, or
conspiracy, in restraint of trade or commerce among the
several States.” 15 U.S.C. § 1. Section 1 applies only to
unreasonable restraints of trade. Race Tires Am., Inc. v.
Hoosier Racing Tire Corp., 614 F.3d 57, 74 (3d Cir. 2010). To
prevail on a Section 1 claim, a plaintiff must prove (1)
concerted action by the defendants; (2) that the concerted
actions produced anti-competitive effects within the relevant
product and geographic markets; (3) that the concerted actions
were illegal; and (4) that it was injured as a proximate result of
the concerted action. Gordon v. Lewistown Hosp., 423 F.3d
184, 207 (3d Cir. 2005).
3
We do not address UTC’s argument that RareGen lacks
antitrust standing to advance its Sherman Act claims because
we affirm the District Court’s dismissal of the antitrust claims.
Further, even if RareGen does not have antitrust standing, UTC
does not dispute that Sandoz has antitrust standing as a
competitor to UTC. Ethypharm S.A. France v. Abbott Lab’ys,
707 F.3d 223, 233 (3d Cir. 2013) (stating that a competitor in
the relevant market can establish antitrust injury). Because we
hold that Sandoz validly adopted RareGen’s Sherman Act
arguments, those claims are properly before us. Cf. In re Yellow
Corp., 152 F.4th 491, 500 n.2 (3d Cir. 2025) (holding that even
if appellants raising challenge lacked standing under prudential
standing doctrine, the issue “would remain properly before us”
where another appellant that “has standing unquestionably . . .
joins in [co-appellants’] challenge to the regulations”).
11
Section 2 prohibits monopolization, attempts to
monopolize, and conspiracies to monopolize any part of
interstate commerce. 15 U.S.C. § 2. To prevail on a Section 2
claim, a plaintiff must show “(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.” Broadcom Corp. v. Qualcomm
Inc., 501 F.3d 297, 307 (3d Cir. 2007) (quoting United States
v. Grinnell Corp., 384 U.S. 563, 570–71 (1966)). Both
Sections require plaintiffs to allege that the defendant engaged
in anticompetitive conduct and that the conduct caused the
plaintiff to suffer antitrust injury. See ZF Meritor, 696 F.3d at
281.
The parties do not dispute that the alleged
anticompetitive conduct should be evaluated through the “rule
of reason” analysis, which the District Court applied below.
The Supreme Court has described the rule of reason as a “three-
step, burden-shifting framework,” Ohio v. Am. Express Co.,
585 U.S. 529, 541 (2018), while advising that this framework
is not a “rote checklist” and is not “an inflexible substitute for
careful analysis,” Nat’l Collegiate Athletic Ass’n v. Alston, 594
U.S. 69, 97 (2021). First, the plaintiff must prove that “the
challenged restraint has a substantial anticompetitive effect
that harms consumers in the relevant market.” Am. Express,
585 U.S. at 541. Only a restraint that, “on its face, has no
purpose except stifling competition” is unreasonable per se.
Eisai, Inc. v. Sanofi Aventis U.S., LLC, 821 F.3d 394, 402 (3d
Cir. 2016) (quoting Burtch v. Milberg Factors, Inc., 662 F.3d
212, 221 (3d Cir. 2011)). All other restraints are evaluated
under the rule of reason. Am. Express, 585 U.S. at 541.
The parties and the District Court understood the
alleged anticompetitive conduct to involve an “exclusive
dealing arrangement,” where a buyer agrees to purchase certain
goods only from a particular seller for a certain period. ZF
Meritor, 696 F.3d at 270. Courts apply the rule of reason to
exclusive dealing arrangements because they may offer
economic benefits to consumers like “assuring them the
availability of supply and price stability,” and therefore are not
per se violations of the antitrust laws. Eisai, 821 F.3d at 403.
12
An exclusive dealing agreement will not satisfy the rule of
reason only if “the ‘probable effect’ of the arrangement is to
substantially lessen competition, rather than merely
disadvantage rivals.” ZF Meritor, 696 F.3d at 271 (quoting
Tampa Elec. Co. v. Nashville Coal Co., 365 U.S. 320, 329
(1961)).
Here, Plaintiffs identify the challenged restraint as
UTC’s 2019 agreements with Smiths and the Specialty
Pharmacies. To prevail under the rule of reason’s first step,
Plaintiffs must demonstrate that the restrictions resulted in
“substantial foreclosure of the market for the relevant product”
and had “likely or actual anticompetitive effects.” Eisai, 821
F.3d at 403. If Plaintiffs make this showing, the burden shifts
to UTC to show a procompetitive justification. Am. Express,
585 U.S. at 541. If UTC demonstrates such a justification, the
burden shifts back to Plaintiffs to show that “the
procompetitive efficiencies could be reasonably achieved
through less anticompetitive means.” Id. at 542; see ZF
Meritor, 696 F.3d at 271 (noting that exclusive dealing
agreements generally require an analysis of “likely or actual
anticompetitive effects considered in light of any
procompetitive effects”).
Even assuming Plaintiffs established substantial
foreclosure of the relevant market and anticompetitive effects
of the restrictions, UTC has demonstrated procompetitive
objectives that justify its conduct. A valid procompetitive
justification “relates directly or indirectly to the enhancement
of consumer welfare.” LePage’s Inc. v. 3M, 324 F.3d 141, 163
(3d Cir. 2003) (en banc) (quoting Data Gen. Corp. v.
Grumman Sys. Support Corp., 36 F.3d 1147, 1183 (1st Cir.
1994)). “Thus, pursuit of efficiency and quality control might
be legitimate competitive reasons[,] while the desire to
maintain a monopoly market share or thwart the entry of
competitors would not.” Id.
The District Court found that UTC offered “several
good faith procompetitive justifications for its 2019 cartridge
restriction.” App. 86. We agree that UTC proffered valid
justifications for its conduct: it was concerned there would not
be enough cartridges for Remodulin patients and it sought to
increase output, ensure supply, and discourage free riding
13
through its investment in Smiths’ cartridges, which would have
otherwise been discontinued. See Am. Express, 585 U.S. at 549
(describing “expanding output” as exemplary of
procompetitive conduct); Race Tires Am., 614 F.3d at 76
(explaining that exclusive dealing arrangements that assure
supply are often considered efficient). Smiths continued
producing the CADD-MS3 cartridges and pumps because of
UTC’s funding commitment, which undoubtedly did increase
output, ensure supply, and discourage free riding.
Plaintiffs argue these justifications are pretextual. We
do not deny that UTC understood—and even desired—that the
cartridge restrictions would hinder Plaintiffs’ launch.
Nonetheless, the record shows that UTC’s procompetitive
justifications are sincere, as UTC was consistently concerned
about securing a cartridge supply for its own product. There is
nothing pretextual about seeking to protect a procompetitive
investment and also seizing the opportunity to disadvantage a
competitor along the way. Indeed, we have encouraged the
“competition to be an exclusive supplier” and called such
competition “a vital form of rivalry.” ZF Meritor, 696 F.3d at
270 (quoting Race Tires Am., 614 F.3d at 83). And Plaintiffs
themselves restricted the alternative cartridges they developed
for exclusive use with Sandoz’s generic treprostinil.
Finally, Plaintiffs have not established that UTC can
achieve its legitimate objectives through a “viable” and
“substantially less restrictive alternative” that can provide
“comparable benefits” to the restraint. United States v. Brown
Univ., 5 F.3d 658, 679 (3d Cir. 1993). Plaintiffs propose that
“UTC could have encumbered only the cartridges necessary
for the procompetitive justification, or committed to purchase
a specific volume of cartridges (and pre-paying Smiths)
without imposing restrictions on the remainder.” RareGen Br.
54. However, Plaintiffs have not demonstrated these
alternatives are actually viable or provide comparable benefits
to the cartridge restrictions. It is far from clear that these
alternatives are “substantially less restrictive,” Brown, 5 F.3d
at 679, and “courts should not second-guess ‘degrees of
reasonable necessity’ so that ‘the lawfulness of conduct turn[s]
upon judgments of degrees of efficiency.’” Alston, 594 U.S. at
98 (alteration in original) (quoting Rothery Storage & Van Co.
v. Atlas Van Lines, Inc., 792 F.2d 210, 227 (D.C. Cir. 1986)).
14
Accordingly, we will affirm the District Court’s
dismissal of the Sherman Act claims on the basis that UTC
established procompetitive justifications for the restrictive
agreement and Plaintiffs failed to rebut these justifications.
V. STATE LAW CLAIMS
RareGen challenged the District Court’s entry of
summary judgment against Plaintiffs’ claims of unfair and
deceptive trade practices and tortious interference.4 Sandoz
adopted RareGen’s arguments on appeal.
A. Unfair and Deceptive Trade Practices
The District Court dismissed Plaintiffs’ unfair-and-
deceptive-trade-practices claim under North Carolina General
Statutes § 75-1.1 because it is “based on the same conduct as
their antitrust claims” and their antitrust claims failed. App. 89.
Plaintiffs argue that the District Court failed to consider that
the unfair-and-deceptive-trade-practices claim was not “based
solely” on the antitrust claims, but also on the “conduct giving
rise to the breach-of-contract claim.” RareGen Br. 56.
4
The District Court also dismissed Plaintiffs’ restraint-of-trade
claims, but Plaintiffs failed to address them in their appellate
brief. See RareGen Br. 56 (challenging only the “district
court’s decision on Plaintiffs’ unfair trade practices and
tortious interference claims”). They have thus forfeited any
challenge to the dismissal of these claims. See Montemuro v.
Jim Thorpe Area Sch. Dist., 99 F.4th 639, 646–47 (3d Cir.
2024). Regardless, we would affirm the District Court’s
dismissal because Plaintiffs’ restraint-of-trade causes of action
are identical to their federal antitrust causes of action, which
we have dismissed, and the state laws governing these claims
mirror federal antitrust laws and are analyzed using federal
antitrust jurisprudence. Compare App. 336–38 with App. 338–
40; see Kugler v. Koscot Interplanetary, Inc., 293 A.2d 682,
694 (N.J. Super. Ct. Ch. Div. 1972); Sykes v. Health Network
Sols., Inc., 2017 WL 3601347, at *6 (N.C. Super. Ct. Aug. 18,
2017), aff’d, 828 S.E.2d 467 (N.C. 2019).
15
When allegations of unfair and deceptive trade practices
“describe the same conduct that is the subject of plaintiffs’
[failed] antitrust claims,” dismissal is warranted “to the extent
that these allegations overlap.” Sykes v. Health Network Sols.,
Inc., 828 S.E.2d 467, 471–72 (N.C. 2019); see also R.J.
Reynolds Tobacco Co. v. Philip Morris Inc., 199 F. Supp. 2d
362, 396 (M.D.N.C. 2002) (“Because Plaintiffs do not allege
any facts that suggest that Defendant’s conduct is unlawful
beyond the conduct that is the basis for their failed federal
[antitrust] claims, Plaintiffs’ state common law and statutory
[unfair trade practices] claims fail as well.”), aff’d, 67 F. App’x
810 (4th Cir. 2003). Here, Plaintiffs do not specify any alleged
conduct distinct from the conduct underlying the antitrust
claims. Moreover, “a mere breach of contract, even if
intentional, is not sufficiently unfair or deceptive to sustain an
action under [the UTPA,] N.C.G.S. § 75-1.1,” and Plaintiffs
have not put forth the necessary “substantial aggravating
circumstances” to support such an action. Broussard v.
Meineke Disc. Muffler Shops, Inc., 155 F.3d 331, 347 (4th Cir.
1998) (alteration in original) (quoting Branch Banking & Trust
Co. v. Thompson, 418 S.E.2d 694, 700 (N.C. Ct. App. 1992)).
Accordingly, we will affirm summary judgment in favor of
UTC on the unfair-and-deceptive-trade-practices claim.
B. Tortious Interference
The District Court also dismissed Plaintiffs’ tortious
interference claim because it was based on the same conduct
underlying the antitrust causes of action. The court recognized
that “tortious interference claims can cover wrongful conduct
other than antitrust activity,” yet dismissed the claim because
Plaintiffs based their tortious interference claim only on UTC’s
anticompetitive activity. App. 88–89. We have rejected the
“premise that state tortious interference law and federal
antitrust law should be read in pari materia.” Brokerage
Concepts, Inc. v. U.S. Healthcare, Inc., 140 F.3d 494, 532 (3d
Cir. 1998). As relevant here, a New Jersey tortious interference
claim requires “[w]rongful conduct,” which encompasses
actions that are malicious but otherwise lawful. Avaya Inc., RP
v. Telecom Labs, Inc., 838 F.3d 354, 383 (3d Cir. 2016). Thus,
New Jersey tortious interference jurisprudence requires that the
“line must be drawn where one competitor interferes with
another’s economic advantage through conduct which is
16
fraudulent, dishonest, or illegal.” Id. (emphasis added)
(quoting Ideal Dairy Farms, Inc. v. Farmland Dairy Farms,
Inc., 659 A.2d 904, 936 (N.J. Super. Ct. App. Div. 1995)). In
other words, the fact that UTC did not violate the antitrust laws
does not alone foreclose a tortious interference claim, which
can still stand if UTC’s conduct is found to be malicious,
fraudulent, or dishonest. Accordingly, we will reverse and
remand for the District Court to consider whether the Plaintiffs
can sustain their tortious interference claim independently
from the merits of their antitrust claims.
VI. DAUBERT MOTION
In its summary judgment opinion, the District Court
also denied UTC’s motion under Daubert v. Merrell Dow
Pharms., Inc., 509 U.S. 579 (1993), to exclude the testimony
of Plaintiffs’ damages expert, Dr. Anupam Jena. Under Federal
Rule of Evidence 702, we have distilled two major
requirements governing the admission of expert testimony: (1)
the expert must be “qualified to express an expert opinion” and
(2) the expert opinion “must be reliable.” In re TMI Litig., 193
F.3d 613, 664 (3d Cir. 1999), amended, 199 F.3d 158 (3d Cir.
2000). Focusing on the second requirement, UTC argues that
Jena’s estimate of generic treprostinil’s performance absent
UTC’s alleged breach was not sufficiently reliable. Jena’s
model of a “but-for” world relied on an internal forecast
prepared by RareGen in April 2019. His model used the
RareGen forecast’s projected penetration rate of generic
treprostinil, its projected share of generic treprostinil sales that
Plaintiffs would capture, and the actual real-world price of
generic treprostinil.
It is permissible for an expert to “construct a reasonable
offense-free world as a yardstick for measuring what,
hypothetically, would have happened ‘but for’ the defendant’s
unlawful activities,” and in some circumstances, the expert
may rely on others’ estimates to build that hypothetical reality.
ZF Meritor, 696 F.3d at 292 (quoting LePage’s, 324 F.3d at
165). We have recognized that “‘internal projections for future
growth’ often serve as legitimate bases for expert opinions.”
Id. (quoting LePage’s, 324 F.3d at 165). Indeed, “experts
frequently use a plaintiff’s business plan to estimate the
plaintiff’s expected profits in the absence of the defendant’s
17
misconduct.” Id. This is because companies are “generally
well-informed about the industries in which they operate” and
incentivized “to develop accurate projections.” Id.
However, the expert “must explain why he relied on
such estimates and must demonstrate why he believed the
estimates were reliable.” Id. In ZF Meritor, we upheld the
exclusion of an expert report based on internal projections
where the expert “lacked critical information” about the
internal model, including “who initially calculated” the
projections, “the methodology used to create” the projections,
and “the assumptions on which [the] price and volume
estimates were based.” Id. at 293. UTC argues that Jena
similarly “lacked critical information” about, and thus
unreasonably relied on, the RareGen forecast—Jena was
unaware of who created and provided the data for the forecast,
why the forecast was created, or how it was used. And while
the expert in ZF Meritor was excluded despite knowing that
the forecast was presented to the board of directors, revised
several times in response to the board’s concerns, and relied
upon by the board in making business decisions, Jena had no
knowledge of the business uses for RareGen’s forecast. See id.
at 292.
We conclude the District Court did not abuse its
discretion in admitting Jena as an expert. The court
acknowledged that Jena did not know the identity or
qualifications of the person who prepared the RareGen forecast
and that this may weigh in favor of exclusion in certain cases.
Even so, it found that Jena’s testimony was reliable because,
unlike the expert in ZF Meritor, Jena ensured reliability by
comparing the forecasted rates aga