& (contract breach questions sent to trial)CivilCourt of AppealsAppeal
Sandoz Inc v. United Therapeutics Corporation
Court
Court of Appeals for the Third Circuit
Decided
Oct 7, 2026
Docket
24-3067
Judges
Not listed
đDetailed analysis & 3-line summary
AI breakdown
Analyzed Oct 7, 2026
Where this case stands
District court: granted in favor of Sandoz on breach-of-contract liability.
This decision ¡ Appeal
& (contract breach questions sent to trial)
TL;DR
1Sandoz accuses United Therapeutics of breaching their contract regarding the launch of a generic drug.
2The court a previous decision that ruled in favor of Sandoz, stating the contract's wording was ambiguous.
3The key issue is whether UTC's actions prevented Sandoz from launching its generic treprostinil as agreed.
Key issues
1
Did UTC breach the with Sandoz?
Holding ¡ The court found the terms were ambiguous and sent the issues back to trial.
2
Were UTC's actions harmful to Sandoz?
Holding ¡ The court will allow a trial to explore whether UTC's actions violated the agreement.
3
Did UTC's actions violate antitrust laws?
Holding ¡ The court the dismissal of antitrust claims, supporting UTC's justifications.
Why it matters
The decision impacts the competitive landscape for generic drug launches in the pharmaceutical industry, affecting pricing and availability.
If you were the judge?
Pharmaceutical companies clash over drug launch contract terms. Did UTC break the rules?
1United Therapeutics created a drug to treat high blood pressure, then Sandoz got approval for a generic version.
2Sandoz claims UTC violated their contract by limiting the availability of essential cartridges needed for their product.
3The court must decide if UTC's actions were a breach of contract based on their settlement agreement with Sandoz.
Did UTC break its agreement with Sandoz during the launch of the generic drug?
Parties
Appellant
Sandoz Inc
Appellee
United Therapeutics Corporation
Roles are inferred from the case caption.
Opinion of the court
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 (âUTCâ) 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, âPlaintiffsâ)
contend that, in connection with Sandozâs 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 UTCâs motion to exclude
Plaintiffsâ 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. (âSmithsâ)
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 (âAccredoâ) and CVS
Specialty (âCVSâ and with Accredo, the âSpecialty
Pharmaciesâ), 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 Courtâs 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 âlife extensionâ for Smithsâ pumps and cartridges (the
âSupply Agreementâ). 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 Smithsâ
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
âSettlement Agreementâ) 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 â[n]ot to take any action directly or indirectly
to prevent, delay, limit, or otherwise restrict the launchâ of
Sandozâs generic treprostinil and not to cause any third party
to âinterfere with Sandozâs efforts to launchâ generic
treprostinil. App. 2781â82, 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
Sandozâs 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
RareGenâa company created by former UTC executivesâto
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 UTCâs 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 ânegotiating leverageâ
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 UTCâs approval,
Smiths permitted some shipments of cartridge, but warned the
Pharmacies that âthis [would] be the process until the
amendments have been finalized.â 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 âno longer
comfortable signingâ and that âit was placing an unfair burden
on Smiths Medical to try to dictate the supply chain flow of
this, so [Smiths] didnât really want to be in the middle of that
anymore.â 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 UTCâs 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 Sandozâs
generic treprostinil. The FDA approved the alternative
cartridge on March 26, 2021, and Sandoz launched its generic
subcutaneous treprostinil in May 2021. Sandozâs 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 Plaintiffsâ 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 UTCâs
motion to exclude the opinion of Sandozâs 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 Courtâs 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 Courtâs grant of summary judgment
in favor of UTC on the antitrust and state law claims. Sandoz
adopts RareGenâs arguments and additionally challenges the
District Courtâs 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 Courtâs grant of summary judgment, âapplying the
same standard that the lower court should have applied.â 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 courtâs 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 âsubject to only
one reasonable interpretation.â 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). âIf 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.â Newport Assocs. Dev. Co. v. Travelers Indem. Co. of
Ill., 162 F.3d 789, 792 (3d Cir. 1998). âThus, the dispositive
question is whether [UTC] provided a reasonable reading of
the contract.â Id.
The Settlement Agreement is governed by New Jersey
law, which requires courts to consider ââall of the relevant
evidence that will assist in determining the intent and meaning
of the contractâ when making ambiguity determinations.â
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, â[e]vidence of the
6
circumstances is always admissible in aid of the interpretationâ
of an integrated contract. Id. (quoting Sumitomo Mach.
Corp., 81 F.3d at 332). Contracts should be read âas a wholeâ
and âin a fair and common sense mannerâ that is based on âthe
intent of the parties, the express terms of the contract,
surrounding circumstances and the underlying purpose of the
contract.â Manahawkin Convalescent v. OâNeill, 85 A.3d 947,
958 (N.J. 2014) (citation modified). Therefore, we must
consider âall relevant evidence to determine if any ambiguity
exists,â and summary judgment is inappropriate âif the
contested provisions fall in that gray area.â Mylan, 723 F.3d at
419.
Plaintiffs alleged that UTC breached the Settlement
Agreementâs terms prohibiting it from impeding the launch of
treprostinil. Specifically, under Section 11(b), UTC agreed
â[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.â App. 2781â82.
Under Section 15(a), UTC additionally agreed that it âshall 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 Sandozâs efforts
to launch the Sandoz ANDA Product in the Territory as of the
Effective Launch Date under the terms provided by this
Agreement.â App. 2784. Plaintiffs alleged that UTCâs
cartridge restrictions breached these provisions because they
prevented, delayed, and limited Sandozâs 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
âlocking up the existing inventory by taking title to all
commercially available cartridges as Sandoz was preparing to
launch its generic.â App. 93. The court held that âthere is no
genuine dispute UTC unambiguously promised not to âprevent,
limit, delay, or otherwise restrictâ Sandozâs generic launch.â
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 Sandozâs efforts to launch generic treprostinil.
7
First, both Sections 11(b) and 15(a) are limited by âthe
termsâ of the Settlement Agreement, which include other
provisions that UTC argues foreclose any obligation
concerning the cartridges. Specifically, the Settlement
Agreementâs definition of the product at issue, termed the
Sandoz ANDA Product, states that it âexpressly [does] not
include . . . any technology associated with any UTC
product(s).â App. 2776. The Settlement Agreement also
provides that Sandozâs license to make, market, sell, and
distribute generic treprostinil âexpressly 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.â App. 2778. Finally, both parties
represented and warranted that â[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.â App. 2782.
Further, UTC offers an alternative reading that Sections
11(b) and 15(a) are merely âcatch-all provisions aimed at
reinforcing UTCâs agreement not to wield its intellectual
property rights against Sandoz.â UTC Br. 28. Indeed, the
surrounding context of 11(b) and 15(a)âprovisions in a patent
litigation settlement agreementâsuggest that those provisions
refer to UTC refraining from using its intellectual property
rights to derail Sandozâs launch and FDA approval, rather than
a blanket ban on any conduct interfering with Sandozâs 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 âRegulatory Approval,â and 15(a) also restricts
UTC from âinterfer[ing] with Sandozâs efforts to obtain FDA
approvalâ of its product. App. 2784.
We thus cannot say there is âonly one reasonable
interpretationâ of the contract. Mylan, 723 F.3d at 418 (citation
modified). In light of the broader context, âthe contested
provisions fall in that gray areaâ of ambiguity, and
consequently, âsummary judgment is improper.â Id. at 419.
Instead, the breach-of-contract claim should proceed to trial
and the âfact-finder must attempt to discover what the
8
contracting parties . . . intended [the disputed provisions] to
mean.â Fed Cetera, LLC v. Natâl Credit Servs., Inc., 938 F.3d
466, 470 (3d Cir. 2019) (quoting Wayne Land & Mineral Grp.
LLC v. Del. River Basin Commân, 894 F.3d 509, 534 (3d Cir.
2018)). Therefore, we will reverse the District Courtâs 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 RareGenâs arguments regarding the antitrust and state
law claims. In its appellate brief, Sandoz adopted the Sherman
Act antitrust and state law arguments asserted in RareGenâs
cross-appeal under Federal Rule of Appellate Procedure 28(i).
Rule 28(i) provides that in cases involving multiple appellants
or appellees, âany party may adopt by reference a part of
anotherâs brief.â Fed. R. App. P. 28(i). UTC argues that Sandoz
has forfeited the antitrust and state law claims on appeal
because its âblanket statementâ 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 âportions of
already-filed briefsâ under Rule 28(i) so long as the issues are
âspecifically and explicitly identifiedâ and not incorporated
under âgeneral statements of adoption.â United States v.
Williams, 974 F.3d 320, 339 n.7 (3d Cir. 2020). Otherwise,
leaving the court to âscour the recordâ and âidentify the issues
to be adoptedâ 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).
Sandozâs statement of incorporation is not a general
statement of adoption. Sandoz specified it adopted RareGenâs
arguments related to the antitrust and state-law claims. Sandoz
Br. 1 n.1 (âRareGen . . . separately appeals the summary
judgment decision on the antitrust and related state-law claims.
Sandoz adopts RareGenâs arguments.â) Sandoz then further
detailed that it âadopts by reference the entirety of the Brief of
Appellee RareGen, LLC, including specifically argument
9
Sections I and II, which appeal the district courtâs order
granting summary judgment in UTCâs favor on Plaintiffsâ
antitrust and related state-law claims.â Sandoz Br. 3â4. Thus,
the adopted arguments are âspecifically and explicitly
identified.â 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 RareGenâs 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 Commcâns, LLC, 92
F.4th 1384, 1386 (Fed. Cir. 2024) (per curiam); Medtronic, Inc.
v. Teleflex Life Scis. Ltd., 86 F.4th 902, 906â07 (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 âeffectively nullify[ing] the page or word
limits.â 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, 623â24 (10th Cir. 1998)), which prohibits the adoption of
district court filings because the practice circumvents the
appellate page limitations and âunnecessarily complicate[s] the
task of an appellate judge.â 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-partyâs appellate brief. United
States v. Butler, 141 F.4th 1136, 1149 (10th Cir. 2025). The
Eighth Circuit holds the same because â[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.â
In re Target Corp. Customer Data Sec. Breach Litig., 855 F.3d
913, 916â17 (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-partiesâ 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 partyâs 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 â[e]very
contract, combination in the form of trust or otherwise, or
conspiracy, in restraint of trade or commerce among the
several States.â 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 UTCâs argument that RareGen lacks
antitrust standing to advance its Sherman Act claims because
we affirm the District Courtâs 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 Labâys,
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 RareGenâs 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 âwould remain properly before usâ
where another appellant that âhas standing unquestionably . . .
joins in [co-appellantsâ] challenge to the regulationsâ).
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 â(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.â Broadcom Corp. v. Qualcomm
Inc., 501 F.3d 297, 307 (3d Cir. 2007) (quoting United States
v. Grinnell Corp., 384 U.S. 563, 570â71 (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 ârule
of reasonâ analysis, which the District Court applied below.
The Supreme Court has described the rule of reason as a âthree-
step, burden-shifting framework,â Ohio v. Am. Express Co.,
585 U.S. 529, 541 (2018), while advising that this framework
is not a ârote checklistâ and is not âan inflexible substitute for
careful analysis,â Natâl Collegiate Athletic Assân v. Alston, 594
U.S. 69, 97 (2021). First, the plaintiff must prove that âthe
challenged restraint has a substantial anticompetitive effect
that harms consumers in the relevant market.â Am. Express,
585 U.S. at 541. Only a restraint that, âon its face, has no
purpose except stifling competitionâ 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 âexclusive
dealing arrangement,â 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 âassuring them the
availability of supply and price stability,â 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 âthe âprobable effectâ of the arrangement is to
substantially lessen competition, rather than merely
disadvantage rivals.â 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
UTCâs 2019 agreements with Smiths and the Specialty
Pharmacies. To prevail under the rule of reasonâs first step,
Plaintiffs must demonstrate that the restrictions resulted in
âsubstantial foreclosure of the market for the relevant productâ
and had âlikely or actual anticompetitive effects.â 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 âthe
procompetitive efficiencies could be reasonably achieved
through less anticompetitive means.â Id. at 542; see ZF
Meritor, 696 F.3d at 271 (noting that exclusive dealing
agreements generally require an analysis of âlikely or actual
anticompetitive effects considered in light of any
procompetitive effectsâ).
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 ârelates directly or indirectly to the enhancement
of consumer welfare.â LePageâs 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)). âThus, 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.â Id.
The District Court found that UTC offered âseveral
good faith procompetitive justifications for its 2019 cartridge
restriction.â 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 Smithsâ cartridges, which would have
otherwise been discontinued. See Am. Express, 585 U.S. at 549
(describing âexpanding outputâ 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
UTCâs 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 understoodâand even desiredâthat the
cartridge restrictions would hinder Plaintiffsâ launch.
Nonetheless, the record shows that UTCâs 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
âcompetition to be an exclusive supplierâ and called such
competition âa vital form of rivalry.â 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 Sandozâs generic treprostinil.
Finally, Plaintiffs have not established that UTC can
achieve its legitimate objectives through a âviableâ and
âsubstantially less restrictive alternativeâ that can provide
âcomparable benefitsâ to the restraint. United States v. Brown
Univ., 5 F.3d 658, 679 (3d Cir. 1993). Plaintiffs propose that
âUTC 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.â 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 âsubstantially less restrictive,â Brown, 5 F.3d
at 679, and âcourts should not second-guess âdegrees of
reasonable necessityâ so that âthe lawfulness of conduct turn[s]
upon judgments of degrees of efficiency.ââ 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 Courtâs
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 Courtâs entry of
summary judgment against Plaintiffsâ claims of unfair and
deceptive trade practices and tortious interference.4 Sandoz
adopted RareGenâs arguments on appeal.
A. Unfair and Deceptive Trade Practices
The District Court dismissed Plaintiffsâ unfair-and-
deceptive-trade-practices claim under North Carolina General
Statutes § 75-1.1 because it is âbased on the same conduct as
their antitrust claimsâ 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 âbased
solelyâ on the antitrust claims, but also on the âconduct giving
rise to the breach-of-contract claim.â RareGen Br. 56.
4
The District Court also dismissed Plaintiffsâ restraint-of-trade
claims, but Plaintiffs failed to address them in their appellate
brief. See RareGen Br. 56 (challenging only the âdistrict
courtâs decision on Plaintiffsâ unfair trade practices and
tortious interference claimsâ). They have thus forfeited any
challenge to the dismissal of these claims. See Montemuro v.
Jim Thorpe Area Sch. Dist., 99 F.4th 639, 646â47 (3d Cir.
2024). Regardless, we would affirm the District Courtâs
dismissal because Plaintiffsâ 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. 336â38 with App. 338â
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), affâd, 828 S.E.2d 467 (N.C. 2019).
15
When allegations of unfair and deceptive trade practices
âdescribe the same conduct that is the subject of plaintiffsâ
[failed] antitrust claims,â dismissal is warranted âto the extent
that these allegations overlap.â Sykes v. Health Network Sols.,
Inc., 828 S.E.2d 467, 471â72 (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) (âBecause Plaintiffs do not allege
any facts that suggest that Defendantâs conduct is unlawful
beyond the conduct that is the basis for their failed federal
[antitrust] claims, Plaintiffsâ state common law and statutory
[unfair trade practices] claims fail as well.â), affâd, 67 F. Appâx
810 (4th Cir. 2003). Here, Plaintiffs do not specify any alleged
conduct distinct from the conduct underlying the antitrust
claims. Moreover, âa 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,â and Plaintiffs
have not put forth the necessary âsubstantial aggravating
circumstancesâ 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 Plaintiffsâ tortious
interference claim because it was based on the same conduct
underlying the antitrust causes of action. The court recognized
that âtortious interference claims can cover wrongful conduct
other than antitrust activity,â yet dismissed the claim because
Plaintiffs based their tortious interference claim only on UTCâs
anticompetitive activity. App. 88â89. We have rejected the
âpremise that state tortious interference law and federal
antitrust law should be read in pari materia.â 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 â[w]rongful conduct,â 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
âline must be drawn where one competitor interferes with
anotherâs economic advantage through conduct which is
16
fraudulent, dishonest, or illegal.â 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 UTCâs 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 UTCâs motion under Daubert v. Merrell Dow
Pharms., Inc., 509 U.S. 579 (1993), to exclude the testimony
of Plaintiffsâ 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 âqualified to express an expert opinionâ and
(2) the expert opinion âmust be reliable.â 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
Jenaâs estimate of generic treprostinilâs performance absent
UTCâs alleged breach was not sufficiently reliable. Jenaâs
model of a âbut-forâ world relied on an internal forecast
prepared by RareGen in April 2019. His model used the
RareGen forecastâs 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 âconstruct a reasonable
offense-free world as a yardstick for measuring what,
hypothetically, would have happened âbut forâ the defendantâs
unlawful activities,â and in some circumstances, the expert
may rely on othersâ estimates to build that hypothetical reality.
ZF Meritor, 696 F.3d at 292 (quoting LePageâs, 324 F.3d at
165). We have recognized that ââinternal projections for future
growthâ often serve as legitimate bases for expert opinions.â
Id. (quoting LePageâs, 324 F.3d at 165). Indeed, âexperts
frequently use a plaintiffâs business plan to estimate the
plaintiffâs expected profits in the absence of the defendantâs
17
misconduct.â Id. This is because companies are âgenerally
well-informed about the industries in which they operateâ and
incentivized âto develop accurate projections.â Id.
However, the expert âmust explain why he relied on
such estimates and must demonstrate why he believed the
estimates were reliable.â Id. In ZF Meritor, we upheld the
exclusion of an expert report based on internal projections
where the expert âlacked critical informationâ about the
internal model, including âwho initially calculatedâ the
projections, âthe methodology used to createâ the projections,
and âthe assumptions on which [the] price and volume
estimates were based.â Id. at 293. UTC argues that Jena
similarly âlacked critical informationâ about, and thus
unreasonably relied on, the RareGen forecastâJena 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 boardâs concerns, and relied
upon by the board in making business decisions, Jena had no
knowledge of the business uses for RareGenâs 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 Jenaâs testimony was reliable because,
unlike the expert in ZF Meritor, Jena ensured reliability by
comparing the forecasted rates against a range of other sources.
He reviewed thirty-three forecast models and selected the
RareGen forecast because it did not account for the alleged
breach, it was the most up-to-date, and it provided specific
details about the projected penetration rate and share of sales.
Jena testified at his deposition that, despite not recalling who
specifically created the RareGen model or the creatorâs
qualifications, he found the model to be reliable because its
forecast was âreasonable,â âin line with what one would
expect,â and âat the mid-pointâ in comparison with other
models he reviewed. He also testified that, based on his
18
experience, the RareGen model is the sort of analysis that
would be produced in the ordinary course of business.5
As the District Court noted, Jena explained that the
forecast provided details about the assumptions made and he
validated the forecast by reviewing corroborating material. ZF
Meritor does not require courts to exclude an expert who
cannot provide the information that was lacking in ZF Meritor.
Rather, it requires themto âperform a case-by-case inquiry to
determine whether the expertâs reliance on the business plan in
a given case is reasonable.â ZF Meritor, 696 F.3d at 292. Here,
despite not knowing the particular indicia discussed in ZF
Meritor, Jena engaged in an in-depth comparative analysis
lacking in ZF Meritor. Therefore, the District Court did not err
in ruling that Jena could ârely on the estimates of others in
constructing a hypothetical realityâ after concluding, in its
discretion, that Plaintiffs met their burden to âexplain why
[Jena] relied on such estimatesâ and âdemonstrate why he
believed the estimates were reliable.â Id.
As the District Court did not abuse its discretion in
denying UTCâs motion to exclude Jenaâs testimony, we will
affirm its ruling.
*****
For the reasons discussed above, we will reverse the
grant of summary judgment in favor of Sandoz on the breach-
of-contract claim as to liability and the grant of summary
judgment in favor of UTC on the tortious interference claim;
affirm the dismissal of the Sherman Act claims and North
5
Jenaâs trial testimony corroborated his report and deposition
testimony. He explained that the model was reliable because
there were business incentives for the model to be accurate, it
was prepared closest in time to the launch of treprostinil, its
creatorsâformer UTC executives employed by RareGenâ
had specialized knowledge, and its forecast was in the middle
when compared to other forecasts he examined. Jena dismissed
concerns that the model, which was created after this litigation
commenced, was altered for litigation because there were
earlier versions with the same or higher generic penetration
rates.
19
Carolina unfair and deceptive trade practices claim; affirm the
denial of the Daubert motion against Plaintiffsâ damages
expert Dr. Anupam Jena; and dismiss the remaining
evidentiary and damages challenges as moot. Because we will
reverse the grant of Sandozâs motion for partial summary
judgment on Count VII, breach of contract, as to liability, we
will vacate the November 1, 2024 judgment and damages
award entered in favor of Sandoz and against UTC on Count
VII, and remand for further proceedings consistent with this
Opinion.
Counsel for Appellant United Therapeutics Corp.
Charles L. McCloud [Argued]
Edward J. Bennett
Jonathan B. Pitt
Sean Douglass
WILLIAMS & CONNOLLY LLP
Stephen M. Orlofsky
Michael R. Darbee
BLANK ROME LLP
Counsel for Appellant Sandoz, Inc.
Matthew D. Kent [Argued]
David A. Hatchett
Karla M. Doe
Jenny R. Kramer
Jonathan D. Parente
ALSTON & BIRD LLP
Counsel for Appellant RareGen, LLC.
Kathleen R. Hartnett [Argued]
Patrick J. Hayden
COOLEY LLP
Kevin H. Marino
MARINO TORTORELLA & BOYLE, P.C.
20