Johnson & Johnson, a New Jersey corporation v. Samsung Bioepis Co. Ltd., a Korean corporation. Appeal from the U.S. District…

U.S. COURT OF APPEALS FOR THE
THIRD CIRCUIT
No. 25-1831
JOHNSON & JOHNSON, a New Jersey corporation;
JANSSEN BIOTECH, INC., a Pennsylvania corporation,
Appellants
v.
SAMSUNG BIOEPIS CO. LTD., a Korean corporation.
________________
Appeal from the U.S. District Court, D.N.J.
Judge Georgette Castner, No. 3:25-cv-01439
Before: HARDIMAN, KRAUSE, and FREEMAN,
Circuit Judges
Argued Sept. 9, 2025; Decided Apr. 14, 2026
________________
OPINION OF THE COURT
KRAUSE, Circuit Judge. Rarely do courts grant injunctive
relief before the plaintiff secures a judgment. And even more
rarely is that relief granted in contract cases, where it is usually
the case that monetary damages can later be quantified, so the
plaintiff’s alleged injury does not qualify as “irreparable
harm.” Nevertheless, in some contexts, we have recognized
that the complexity or risk of permanent alteration of a given

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market can make ascertaining legal loss impossible and thus
render monetary damages impractical. Such is the case here,
according to Appellants Johnson & Johnson and Janssen
Biotech, Inc. (together Janssen). Janssen claims that Appellee
Samsung Bioepis Co., Ltd. (Samsung) issued a license to a
subsidiary of the Cigna Group in violation of Samsung’s
contract with Janssen, and that a preliminary injunction should
issue against Samsung because the harms to Janssen would
otherwise be irreparable. Because we agree with the District
Court that Janssen failed to establish irreparable harm, we will
affirm its denial of relief.
I. BACKGROUND
A. Factual Background
This case concerns the marketplace for “biologics,” a “class
of medications that derive from natural sources, such as living
cells and entities.” App. 2 (citation modified). Because these
medications are “far more costly to manufacture than
traditional small molecule pharmaceuticals,” id. (citation
modified), patents that cover them are closely guarded, and
those that are effective and popular can generate significant
profits. But patents expire, and though they are typically
enforceable for a twenty-year term after the filing date, see 35
U.S.C. § 154(a)(2), the “effective patent life” of a biologic—
the period of actual market exclusivity from the time a
medication clears the post-filing clinical trials and regulatory
approvals and reaches the marketplace until the expiration of
the patent, see Proveris Sci. Corp. v. Innovasystems, Inc., 536

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F.3d 1256, 1260-61 (Fed. Cir. 2008)—is typically far shorter,
see In re Forest, 134 F.4th 1198, 1200 n.3 (Fed. Cir. 2025). At
the end of a biologic’s effective patent life, manufacturers of
generic versions of the medication, called “biosimilars,” can
enter the biologics market. Not surprisingly then, patent
holders typically seek to enforce their rights for as long as
possible, often obtaining related or overlapping patents so they
can still require biosimilar manufacturers to obtain a license
even after the original patent expires.1
That was the strategy pursued by Janssen after it developed
and patented ustekinumab, a biologic generally referred to and
marketed under the brand name “Stelara.” Stelara is used to
treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and
ulcerative colitis, and over its fifteen-year effective patent life,
Stelara generated sales of over $70 billion. In September 2023,
however, Janssen’s patent on the composition of
ustekinumab—U.S. Patent No. 6,902,734 (the ’734 Patent)—
expired, opening the door for other manufacturers, like
Samsung, to obtain FDA approval for their ustekinumab
biosimilars—in Samsung’s case, called ustekinumab-ttwe or
“SB17.” Janssen, however, claimed that SB17 would still
infringe various of the patents it had obtained related to
ustekinumab that were still in effect. The resulting litigation
1 This phenomenon of obtaining multiple, overlapping patents
to cover a single product or technology has been termed a
“patent thicket.” See Jeffrey Wu & Claire W. Cheng, Into the
Woods: A Biologic Patent Thicket Analysis, 19 Chi.-Kent J.
Intell. Prop. 93, 109-10 (2020).

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ended with a Settlement Agreement that acknowledged “[f]or
the purpose of this Agreement only, . . . that absent [a patent
license], the SB17 Product would infringe on one or more” of
Janssen’s patents, App. 4, postponed SB17’s entry into the
marketplace until February 2025, and granted Samsung a
limited patent license. That limited license prohibited
Samsung from sublicensing its patent rights, with a few
exceptions, one of which was for sublicenses it could grant to
“commercialization partners to import, sell and offer to sell
SB17 Product on behalf of [Samsung].” App. 4.
Within the following year, Samsung invoked that
exception, entering into a “Commercialization Agreement”
and a “Sublicense Agreement” with Sandoz AG. According to
Sandoz’s press release, the Commercialization Agreement
granted Sandoz “exclusive rights to commercialize” SB17,
branded as “Pyzchiva.” App. 135-41 (emphasis added); App.
6. Pyzchiva’s FDA-approved packaging likewise indicated
that Samsung was manufacturing SB17 for Sandoz. So far so
good.
But Samsung also entered into two other agreements for the
manufacture and distribution of SB17—the ones giving rise to
this appeal. In November 2024, Samsung, along with Sandoz,
entered a Private Label Distributor (PLD) Agreement with an
entity called “Quallent Pharmaceuticals Health LLC.” App. 7,
121. Quallent is a subsidiary of the Cigna Group (Cigna), a
vertically integrated healthcare conglomerate that owns a
healthcare provider, an insurance company, a pharmacy

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benefits manager (PBM), and a network of specialty
pharmacies. That PLD Agreement designated Quallent “as a
commercialization partner” and provided that Samsung “shall
manufacture,” Sandoz “shall supply,” and Quallent “shall
distribute” SB17. App. 7. The same day they entered the PLD
Agreement, Samsung and Quallent executed a Sublicense
Agreement, under which Samsung granted that Cigna
subsidiary a “non-exclusive, non-transferable sublicense” to
sell SB17 “under Quallent’s own label,” subject to the terms of
Samsung’s own license with Janssen. App. 7-8. Meanwhile,
the healthcare provider in Cigna’s conglomerate announced
that it would begin to offer a Stelara biosimilar for $0 out-of-
pocket for eligible patients in early 2025.
B. Procedural History
Janssen then filed the underlying suit in this case, claiming
that Samsung’s sublicense to Quallent—unlike its sublicense
to Sandoz—breached the Settlement Agreement between
Janssen and Samsung because it did not fall within the
commercialization-partner (or any other) exception to the
settlement’s prohibition on downstream sublicensing by
Samsung. Specifically, Janssen asserted that Quallent would
not be selling SB17 “on behalf of” Samsung when it sells its
product under Quallent’s own private label. Janssen also
contended that it would be irreparably harmed by this breach
because the distribution of a private-label biosimilar by a Cigna
subsidiary would result in a potential loss of Janssen’s market
share, ability to compete, and negotiation leverage. On that
basis, Janssen filed a motion for a preliminary injunction to

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prevent Samsung from supplying Quallent or authorizing
Quallent to distribute SB17 during the pendency of the
litigation.2
In anticipation of the preliminary injunction hearing, the
parties submitted expert declarations from economists with
experience in the biologics market and focused on the issue of
irreparable harm. According to Janssen’s expert, Dr. Robert
Popovian, Quallent’s private labelling would represent “an
entirely different market dynamic than Janssen faces from
other biosimilars,” App. 85, because the “playbook” of
vertically integrated healthcare conglomerates, like Quallent’s
parent, Cigna, is to increase profits by steering their patients to
their own private-label biosimilars, rather than the lowest-cost
biosimilars, and then having the patients fill those private-label
prescriptions at their own specialty pharmacies, App. 92.
Because Cigna controls approximately 23% of the prescription
market in the United States, Dr. Popovian explained that the
entry of a private-label biosimilar by its subsidiary could
commandeer nearly a quarter of potential consumers
nationally.
2 Janssen also sought to require Samsung to comply with the
disclosure requirements in the Settlement Agreement, but does
not challenge on appeal the District Court’s determination that
there is no causal nexus between Samsung’s purported failure
to comply with the disclosure requirements and the alleged
irreparable harms to Janssen.

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To substantiate the likelihood of this harm, Dr. Popovian
pointed to the market effects of private-label biosimilars on
another brand-label biologic, Humira. As he described it,
when three large healthcare conglomerates prioritized their
private-label Humira biosimilars on their formularies, six of
Humira’s other biosimilars were effectively shut out of 80% of
the market, and Humira itself lost 31% of its market share—
the vast majority of which was steered to one conglomerate’s
private-label. From that, Dr. Popovian concluded, “[i]f
Quallent introduces its STELARA® biosimilar, the results will
be similar.” App. 113.
Not surprisingly, Samsung’s expert, Dr. DeForest McDuff,
took a different view. Dr. McDuff assessed Humira’s market
share loss after the launch of private-label biosimilars as, in
fact, “relatively modest, and at the very least . . . measurable.”
App. 398-99. In his opinion, any harms suffered by Janssen
would not be irreparable because “[b]iosimilar entry is
expected and has been authorized by Janssen”; any potential
harm caused by a private-label Stelara biosimilar would be
“measurable and quantifiable” and, in any event, “may not be
imminent”; and Janssen would not suffer operational or
reputational harm. App. 389-92, 403.
The District Court credited Dr. McDuff’s opinion over Dr.
Popovian’s, which it “[did] not find . . . persuasive.” App. 27.
In a thorough opinion issued after oral argument, the District
Court concluded that—even though Janssen was likely to
succeed on the merits of its breach-of-contract and implied

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covenant claims—it had not shown that it would suffer
irreparable harm or that its “damages would be incapable of
calculation,” App. 21, because: “there is no . . . bright-line
rule” that loss of market share equates to irreparable harm,
App. 24; Janssen did not argue “that Stelara users are brand
loyal” or that Quallent’s private-label biosimilar would cause
“reputational harm” or “price erosion,” App. 29, 31; and
Janssen’s asserted loss of negotiating power was, in the District
Court’s view, “too speculative,” App. 21 n.21. The District
Court therefore denied Janssen’s motion for a preliminary
injunction and this timely appeal followed.
II. JURISDICTION AND STANDARD OF REVIEW
The District Court had jurisdiction under 28 U.S.C. § 1332,
and we have jurisdiction under 28 U.S.C. § 1292(a)(1). We
review the District Court’s findings of fact for clear error, its
conclusions of law de novo, and its ultimate decision to deny a
preliminary injunction for abuse of discretion. See Spring
Creek Rehab. & Nursing Ctr. LLC v. Nat’l Lab. Rels. Bd., 160
F.4th 380, 383 (3d Cir. 2025).
III. DISCUSSION
Because a preliminary injunction “forces a party to act or
desist from acting” merely “because the law might require it,”
Del. State Sportsmen’s Ass’n v. Del. Dep’t of Safety &
Homeland Sec., 108 F.4th 194, 200 (3d Cir. 2024) (citation
modified), it is considered “an extraordinary remedy never
awarded as of right,” id. at 202 (quoting Winter v. Nat. Res.

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Def. Council, Inc., 555 U.S. 7, 24 (2008)). Instead, to obtain
a preliminary injunction, the moving party must convince the
district court that four factors favor granting preliminary relief:
“(1) the likelihood that the moving party will succeed on the
merits; (2) the extent to which the moving party will suffer
irreparable harm without injunctive relief; (3) the extent to
which the nonmoving party will suffer irreparable harm if the
injunction is issued; and (4) the public interest.” Siemens USA
Holdings Inc. v. Geisenberger, 17 F.4th 393, 407 (3d Cir.
2021) (citation modified).
The first two factors are the “most critical,” and only if the
moving party has made the requisite showing for both must the
district court reach the remainder. Del. State Sportsmen’s
Ass’n, 108 F.4th at 202. Because we use a sliding scale
approach, even where there is a significant likelihood of
success, there still must be some showing of irreparable harm.
See In re Revel AC, Inc., 802 F.3d 558, 568-71 (3d Cir. 2015);
S.S. Body Armor I, Inc. v. Carter Ledyard & Milburn LLP, 927
F.3d 763, 772 (3d Cir. 2019). In addition, irreparable harm is
not only harm that is not “speculative,” Boynes v. Limetree Bay
Ventures LLC, 110 F.4th 604, 610 (3d Cir. 2024), but also
“harm that cannot adequately be compensated after the fact by
monetary damages,” Adams v. Freedom Forge Corp., 204 F.3d
475, 484-85 (3d Cir. 2000). Therefore, the availability of
monetary damages “typically will preclude a finding of
irreparable harm,” Reilly v. City of Harrisburg, 858 F.3d 173,
179 n.4 (3d Cir. 2017), and thus “belie[] a claim of irreparable

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injury,” Frank’s GMC Truck Ctr., Inc. v. Gen. Motors Corp.,
847 F.2d 100, 102 (3d Cir. 1988).
With this background, we consider below Janssen’s four
arguments as to why the District Court erred in deciding that it
failed to sufficiently establish irreparable harm: (1) loss of
market share in a complex market, like that for biologics, is
categorically sufficient to demonstrate irreparable injury,
(2) the calculation of damages need only be difficult, not
“impossible,” (3) Janssen’s loss of negotiating leverage against
Cigna is not a speculative harm, and (4) the severity of
Janssen’s injury should not have factored into the District
Court’s analysis. None has traction.
A. Loss of Market Share as Per Se Irreparable
Harm
Janssen’s first argument is that the introduction of
Quallent’s private-label product into the complex
biopharmaceutical market will necessarily have a permanent
negative impact on Janssen’s sales, customer relationships, and
pricing, and that under Novartis Consumer Health, Inc. v.
Johnson & Johnson-Merck Consumer Pharmaceuticals Co.,
290 F.3d 578 (3d Cir. 2002), such “permanent” loss of market
share per se constitutes irreparable harm. For this purported
categorical rule, Janssen relies on our statement in Novartis
that “loss of market share constitutes irreparable harm,”
Opening Br. 18 (citing 290 F.3d at 596), but that case is
inapposite for three reasons.
First, in Novartis, the evidence supporting irreparable
injury from loss of market share was far stronger. The plaintiff

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there manufactured a brand-name medication for nighttime
heartburn, a type of heartburn that is particularly common and
often severe. Id. at 583-84, 588. When the defendant, a
competing biopharmaceutical company marketed its over-the-
counter biopharmaceutical as “made just for” nighttime
heartburn and “strong enough to get rid of even your toughest
nighttime heartburn,” id. at 584, the plaintiff sought and
obtained a preliminary injunction to prevent the defendant
from marketing its product to suggest that it was specially
formulated for nighttime heartburn, id. at 585. We upheld that
injunction on appeal because the plaintiff had established that
“the promotion and sale of [defendant’s product] had already
had a measurable effect on [plaintiff’s product’s] market
share,” and in “a competitive industry where consumers are
brand-loyal,” post-trial remedies would not suffice. Id. at 595-
96. It was “this loss of market share” that we concluded
“constitutes irreparable harm.” Id. at 596 (emphasis added).
Here, in contrast, the market consequences of Quallent’s
private-label entering the marketplace are not yet known, and
biologics patients, who are often steered to the label prescribed
by their doctors, are not “brand-loyal.”
Second, Novartis arose in the distinct context of the
Lanham Act during an era in which this Court and others
applied a presumption of irreparable harm upon a showing of
likelihood of success for trademark infringement claims.
Ferring Pharms., Inc. v. Watson Pharms., Inc., 765 F.3d 205,
211 (3d Cir. 2014) (citing Kos Pharms., Inc. v. Andrx Corp.,
369 F.3d 700, 726 (3d Cir. 2004)). In that era, some of our
sister circuits also applied the same presumption to false
advertising claims under the Lanham Act, see id. at 210-11
(collecting cases). That was the context in which we held that
“this loss of market share” constitutes irreparable harm,

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Novartis, 290 F.3d at 596, and for good reason, the
presumption of irreparable harm has not been extended beyond
that context. The twofold justification for the presumption was
specific to false advertising and trademark infringement
contexts: “(1) a misleading or false comparison to a specific
competing product necessarily causes that product harm by
diminishing its value in the mind of the consumer” and “(2) the
harm necessarily caused to reputation and goodwill is
irreparable because it is virtually impossible to quantify in
terms of monetary damages.” Ferring Pharms., Inc., 765 F.3d
at 211; see also Kos, 369 F.3d at 726. In contrast to the
presumption that historically applied in the Lanham Act
context, “damages are always the default remedy for breach of
contract.” United States v. Winstar Corp., 518 U.S. 839, 885
(1996) (plurality op.). Simply put, the contexts are different,
and the Novartis Court’s observation in a different context does
not control here.
Third, even if the presumption at play in Novartis had
applied more generally, we subsequently disavowed it.
Several years after Novartis, the Supreme Court decided eBay
Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), which
rejected a categorical presumption of irreparable harm upon a
showing of infringement in patent cases, and Winter v. Natural
Resources Defense Council, Inc., 555 U.S. 7 (2008), which
rejected the notion that a more lenient standard for showing
irreparable harm should apply in any category of cases.
Because we recognized that the logic of eBay and Winter “is
equally applicable in other contexts, including cases arising
under the Lanham Act,” we held in Ferring Pharmaceuticals,
Inc. v. Watson Pharmaceuticals, Inc., that “there is no
presumption of irreparable harm afforded to parties seeking
injunctive relief in Lanham Act cases,” 765 F.3d 205, 214, 216

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(3d Cir. 2014), even if that presumption “might survive as [a]
‘lesson[] of . . . historical practice’ that might inform the district
courts’ equitable discretion,” id. at 213 n.7 (quoting eBay, 547
U.S. at 396 (Kennedy, J., concurring)).
The handful of other cases on which Janssen relies are also
unavailing. Some are patent infringement cases from other
Courts of Appeals, which had historically applied a
presumption of irreparable harm,3 and the remainder are
antitrust cases, in which market share is tied to the elements of
the claim so a preliminary injunction may be necessary to
3 See TEK Glob., S.R.L. v. Sealant Sys. Int’l, Inc., 920 F.3d 777,
793 (Fed. Cir. 2019) (patent case); i4i Ltd. P’ship v. Microsoft
Corp., 598 F.3d 831, 862 (Fed. Cir. 2010), aff’d, 564 U.S. 91
(2011) (same); Abbott Lab’ys v. Sandoz, Inc., 544 F.3d 1341,
1362 (Fed. Cir. 2008) (same); Sanofi-Synthelabo v. Apotex,
Inc., 470 F.3d 1368, 1382 (Fed. Cir. 2006) (same)). The cited
cases from district courts within this Circuit similarly involve
claims in the contexts where a presumption of irreparable harm
previously applied. See Opening Br. 23 n.5 (citing LKRB
Indus., LLC v. xuzhouaiyaxundianzishangwuyouxiangongsi,
No. 2:24-cv-1601, 2025 WL 531845, at *14 (W.D. Pa. Feb. 18,
2025) (patent and false advertising case); Fresenius Kabi USA,
LLC v. Fera Pharms., LLC, No. 15-CV-3654, 2016 WL
5348866, at *13 (D.N.J. Sept. 23, 2016) (patent case); Allergan
Sales LLC v. Sandoz, Inc., No. 2:17-cv-10129, 2018 WL
3675235, at *9 (D.N.J. July 13, 2018), aff’d, 935 F.3d 1370
(Fed. Cir. 2019) (same); Indivior Inc. v. Dr. Reddy’s Lab’ys
S.A., No. 17-7111, 2018 WL 3496643, at *12 (D.N.J. July 20,
2018), vacated on other grounds, 752 F. App’x 1024 (Fed. Cir.
2018) (same)).

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preserve a district court’s ability to grant relief.4 See Del. State
Sportsmen’s Ass’n, 108 F.4th at 200-01 (explaining that the
“primary purpose” of preliminary injunctions is “to ensure that,
at the end of the case, the court can still grant an adequate
remedy”). Those two categories of cases share commonalities
inapposite to contract cases: just as patent infringement claims
seek to preserve a patent holder’s exclusivity in a competitive
market, antitrust claims seek to avoid monopolization of a
competitive market, and in both contexts, likelihood of success
on the merits would also support a finding of irreparable harm.
The same cannot be said of breach of contract claims where
“damages are always the default remedy.” Winstar Corp., 518
U.S. at 885.
Perhaps recognizing the dearth of authority for its position,
Janssen pivots in its Reply Brief, where it asserts that it is not
proposing that “loss of market share is categorically
irreparable,” but rather that “such losses are irreparable where
defendant’s unlawful conduct significantly changes the
relevant market in ways that are irreversible or otherwise make
damages difficult to quantify.” Reply Br. 12 (citation
modified). Although that narrows the scope of Janssen’s
proposed categorical rule, it is still contrary to the “case-by-
case” analysis required by this Court. Groupe SEB United
States, Inc. v. Euro-Pro Operating LLC, 774 F.3d 192, 205 (3d
Cir. 2014). And, as discussed below, mere difficulty
calculating damages from loss of market share is not the
standard, nor does mere complexity of an industry obviate the
4 See Boardman v. Pac. Seafood Grp., 822 F.3d 1011, 1023
(9th Cir. 2016) (antitrust case); Collins Inkjet Corp. v. Eastman
Kodak Co., 781 F.3d 264, 279 (6th Cir. 2015) (same).

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need for a case-by-case approach when assessing requests for
equitable relief.
B. The Standard for When Damages Are
Unavailable
Janssen next argues that the District Court erred as a matter
of law in requiring that the calculation of damages be
“impossible” or the damages be “incapable of calculation” to
obtain a preliminary injunction, Opening Br. 28, when it
should have been sufficient for Janssen to establish that the
calculation of damages was merely “difficult to calculate,” id.
at 29 (quoting BP Chems. Ltd. v. Formosa Chem. & Fibre
Corp., 229 F.3d 254, 263 (3d Cir. 2000)).5 Janssen, however,
takes the BP Chemicals language out of context. What we said
in that case was that “injuries to reputation are difficult to
calculate, and thus money damages are an inadequate remedy.”
BP Chems. Ltd., 229 F.3d at 263 (emphasis added). That
observation is consistent with our many cases recognizing that
damages may be inadequate when parties allege intangible
5 This is an odd argument, to say the least, given that Janssen
itself embraced “impossibility” as the proper standard below.
Of the five instances in which the District Court’s opinion used
the word “impossible,” two are direct quotes from Janssen’s
expert witness, Dr. Popovian, one is a direct quote from a
district court opinion on which Janssen relied, and the
remaining two reflect the District Court paraphrasing “their
position,” App. 28—per Dr. Popovian—that calculating
damages here would be impossible.

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harms, see, e.g., Novartis, 290 F.3d at 596 (customer
relationships); Groupe SEB USA, Inc., 774 F.3d at 204-05
(reputation and goodwill); Pappan Enters. v. Hardee’s Food
Sys., Inc., 143 F.3d 800, 805 (3d Cir. 1998) (same). Here,
however, Janssen does not allege intangible harms, but rather
lost sales and market share. See App. 22.6 And we are wary
when “a plaintiff in a breach of contract case” attempts to
“convert monetary harm into irreparable harm” by claiming
indirect “harm [to] the plaintiff’s reputation.” Bennington
Foods LLC v. St. Croix Renaissance Grp., LLP, 528 F.3d 176,
178-79 (3d Cir. 2008).
6 Although Janssen includes “[c]ustomer relationships” and
“negotiation status” in its list of purported injuries, those
phrases are used merely as labels for lost sales to the 23% of
patients nationwide who are in Cigna’s network due to
Stelara’s potential exclusion from its PBM’s formulary.
Opening Br. 22. Janssen’s alleged injury to customer
relationships does not implicate the loss of “brand-loyal”
consumers discussed in Novartis Consumer Health, Inc. v.
Johnson & Johnson-Merck Consumer Pharmaceuticals Co.,
where those customers’ purchasing decisions were influenced
by the defendant’s false statements. 290 F.3d 578, 594-96 (3d
Cir. 2002). Instead, Janssen’s patients can be steered to use the
medication prescribed by their doctors and covered by their
insurance. And since Janssen declined to allege injury via
price erosion, see App. 21 n.21, 31 & n.27, its asserted injury
to “negotiation status” translates to the possibility of lost sales
to Cigna’s network if its PBM chooses to purchase Quallent’s
private-label biosimilar instead.

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What Janssen calls the “impossibility” standard, Opening
Br. 18 (citation modified), on the other hand, comes directly
from our case law. In ECRI v. McGraw-Hill, Inc., we held that
when a claim for preliminary injunctive relief “is based on a
breach of contract, irreparable injury may be found in two
situations: (1) where the subject matter of the contract is of
such a special nature of peculiar value that damages would be
inadequate; or (2) where because of some special and practical
features of the contract, it is impossible to ascertain the legal
measure of loss so that money damages are impracticable.”
809 F.2d 223, 226 (3d Cir. 1987). Only the latter could
conceivably apply here because the Settlement Agreement
does not involve subject matter of a special nature or peculiar
value, like unique goods with sentimental worth or real estate.
See Restatement (Second) of Contracts § 360 cmts. c, e (A.L.I.
1981). The District Court was not requiring that calculation of
monetary damages be truly impossible, but rather, as described
in ECRI, that the calculation be “impracticable,” 809 F.2d at
226, meaning “practically impossible”7 or “incapable of being
performed or accomplished by the means employed or at
7 Impracticable, Oxford English Dictionary Online,
https://www.oed.com/dictionary/impracticable_adj?tab=mean
ing_and_use#888292 [https://perma.cc/J5ZP-9JXV] (last
visited Mar. 26, 2026) (emphasis added).

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command.”8 So even if the District Court had imposed an
“impossibility” standard by referencing Janssen’s failure to
show damages were “incapable of calculation,” App. 21, that
standard, as explicated in ECRI, would not have run afoul of
our case law, see 809 F.2d at 226.
C. Janssen’s Asserted Loss of Negotiating
Leverage
Janssen next argues that the District Court erred by
“essentially ignoring an entire category of irreparable harm,”
namely its loss of negotiating leverage against Cigna and other
industry participants if Quallent’s private-label biosimilar
entered the market. Opening Br. 36. But while a district
court’s complete disregard of evidence may constitute legal
error, see Inwood Lab’ys, Inc. v. Ives Lab’ys, Inc., 456 U.S.
844, 857 n.19 (1982), that is not what happened here. Instead,
the District Court did consider Janssen’s evidence of potential
loss of negotiation leverage and the cases to which it cited—
none of which found such harm “sufficient to support
preliminary injunctive relief”—and it determined as a factual
matter that Janssen’s claimed loss of negotiating leverage
against Cigna was “too speculative.” App. 21 n.21.
8 Impracticable, Merriam-Webster’s Unabridged Dictionary
Online, https://unabridged.merriam-
webster.com/unabridged/impracticable (last visited Mar. 26,
2026).

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We review that finding for clear error, see Novartis, 290
F.3d at 586, and see none. Because “[a]n inability to precisely
measure financial harm does not make that harm irreparable or
immeasurable,” our precedent requires “[m]ore than a risk of
irreparable harm.” Acierno v. New Castle Cnty., 40 F.3d 645,
655 (3d Cir. 1994) (citation modified). A movant “must
demonstrate an injury that is neither remote nor speculative,
but actual and imminent.” In re Revel AC, Inc., 802 F.3d at 571
(citation modified). The bald assertion of irreparable harm
from a loss of negotiating leverage and the “domino effect” that
loss allegedly would have on a movant’s business does not
clear that threshold. Acierno, 40 F.3d at 655.
Yet bald assertions of lost negotiating leverage are all that
Janssen has presented. Beyond asserting that it is “already in
ongoing, quarterly negotiations with” Cigna’s PBM, Reply Br.
9, and that it is Cigna’s “playbook” to feature its private-label
biosimilar and exclude brand-name biologics from its
formulary, Opening Br. 38-39, Janssen did not provide any
evidence to support the requisite “clear showing of immediate
irreparable injury” to those negotiations, ECRI, 809 F.2d at 226
(citation modified). If anything, its evidence—consisting of
Dr. Popovian’s case study of Humira—indicated the opposite.
Dr. Popovian described how the maker of Humira reached a
co-branding agreement whereby its healthcare-conglomerate
competitor “could reap a percentage of [its] profits in exchange
for” returning Humira to its formulary at a higher out-of-pocket
rate, App. 110, and how Janssen would likely make similar
concessions. But Dr. McDuff—whom the District Court found

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more persuasive—countered that the percentage of Humira
sales lost to biosimilar competitors was “relatively modest”
and, most importantly, quantifiable. App. 399. He also
pointed out that the need for preliminary relief was speculative
because, if Cigna waited many months after the entry of the
private-label biosimilar to change its formula in the case of
Quallent’s biosimilar, as Cigna had done in the case of its
Humira biosimilar, any alleged injury “may not be imminent.”
App. 403.
As for the cases on which Janssen relies, we—like the
District Court—do not find them persuasive. None held that
loss of negotiating power alone was sufficient to support a
preliminary injunction, and some did not address the
irreparable harm factor at all, see, e.g., Disney Enters., Inc. v.
VidAngel, Inc., 869 F.3d 848, 866 (9th Cir. 2017) (determining
that irreparable harm resulted from the combination of injuries
to the plaintiff’s “copyrighted works, their ‘windowing’
business model, and their goodwill and negotiating leverage”);
Brady v. Nat’l Football League, 640 F.3d 785, 793 (8th Cir.
2011) (analyzing harm to the non-movant under the third factor
of the preliminary injunction test—balance of the equities—
not the second, irreparable harm factor); United States v.
Colorado, 937 F.2d 505, 506, 508-09 (10th Cir. 1991)
(reviewing a denial of a motion to modify a consent decree, not
a motion for preliminary injunction, and applying the
corresponding tripartite test).

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Sanofi-Synthelabo v. Apotex, Inc., on which Janssen relies
most heavily, upheld a preliminary injunction not simply
because of lost negotiating power leading to concessions and
price erosion, but because the plaintiff’s losses included “loss
of good will, the potential reduction in work force, and the
discontinuation of clinical trials.” 470 F.3d 1368, 1382-83
(Fed. Cir. 2006). Janssen, on the other hand, did not argue
price erosion or other types of intangible losses, nor could it
“establish that [Quallent] was the ‘but for’ cause of [any]
claimed price erosion” given that at least four other biosimilars
were being offered on the market at a cheaper price than
Stelara. Nichia Corp. v. Everlight Ams., Inc., 855 F.3d 1328,
1343 (Fed. Cir. 2017) (citation modified); see also SmartSky
Networks, LLC v. Gogo Bus. Aviation, LLC, No. 2023-1058,
2024 WL 358136, at *5 (Fed. Cir. Jan. 31, 2024) (rejecting
claims for price erosion where, as here, there is not yet
“concrete evidence of reduced price”).
In short, neither the evidence nor the case law casts doubt
on the District Court’s rejection of lost negotiating power as
irreparable harm.
D. Consideration of the Severity of Janssen’s
Alleged Harms
Janssen next argues that the District Court erred as a matter
of law by subjecting Janssen’s loss of market share to a specific
“severity” threshold. Opening Br. 20 (emphasis omitted). We
do not share that reading of the Court’s opinion. When the
District Court stated that it was “not persuaded that Quallent’s

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introduction of its private label biosimilar will ‘crush the
market,’” App. 30, the Court was simply distinguishing Abbott
Laboratories v. Sandoz, Inc., an out-of-circuit district court
case where the plaintiff had alleged it would “face a 90%
decline in market share” if a generic drug entered the market.
500 F. Supp. 2d 807, 843 (N.D. Ill. 2007), aff’d, 544 F.3d 1341
(Fed. Cir. 2008).9 It was not adopting a particular percentage
threshold for lost market share. In any event, at the extremes,
the severity of harm does have a role to play in the irreparable
harm inquiry in breach of contract cases. We have considered,
for example, whether “despite the adequacy of money damages
there, nonetheless, is irreparable injury since [the movant] may
no longer be in existence to collect any money damages it is
awarded.” Instant Air Freight Co. v. C.F. Air Freight, Inc.,
882 F.2d 797, 802 (3d Cir. 1989). But Janssen has not
established that it is so reliant on Stelara sales that it would not
be able to “easily absorb any short-term harm before a trial on
the merits.” App. 404. The District Court thus correctly
determined that the severity of financial harm in this case did
not entitle Janssen to a preliminary injunction.
9 Before distinguishing Abbott Laboratories on the facts, the
District Court noted that the case “is not binding precedent in
this breach of contract case,” App. 30, so the District Court’s
comparison of the facts in Abbott Laboratories and the present
case was not essential to the District Court’s ruling, nor subject
to this Court’s review, see Drelles v. Metro. Life Ins. Co., 357
F.3d 344, 347-48 (3d Cir. 2003).

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IV. CONCLUSION
In sum, the District Court applied the correct legal
standards when assessing Janssen’s purported injuries absent a
preliminary injunction, considered all the parties’ evidence,
and reasonably concluded that Janssen was not likely to suffer
irreparable harm. Because Janssen failed to meet its burden to
satisfy that “gateway factor[],” Reilly, 858 F.3d at 179, we will
affirm the District Court’s denial of Janssen’s motion for
preliminary injunctive relief.
Counsel for Appellants
Lisa S. Glasser [ARGUED]
Michael D. Harbour
Jason G. Sheasby
IRELL & MANELLA
Jeffrey J. Greenbaum
Katherine M. Lieb
Peter C. Urmston
SILLS CUMMIS & GROSS
Counsel for Appellee
Bram M. Alden
John C. Hueston
Hagan Scotten [ARGUED]
Christine M. Woodin
HUESTON HENNIGAN

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Benjamin J. Dilorenzo
Diana C. Manning
BRESSLER AMERY & ROSS

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