Court Opinion

ID: 2720877
Source: CourtListenerOpinion
Date Created: 2014-08-26 17:00:11.045764+00
Date Added: 2024-06-11T10:10:21.521960
License: Public Domain

PRECEDENTIAL

        UNITED STATES COURT OF APPEALS
             FOR THE THIRD CIRCUIT
                  _____________

                      No. 13-2290
                     _____________

         FERRING PHARMACEUTICALS, INC.,

                                             Appellant

                            v.

         WATSON PHARMACEUTICALS, INC.
                 _____________

      On Appeal from the United States District Court
                 for the District of New Jersey
               (No. 2-12-cv-05824-DMC-JAD)
      District Judge: Honorable Dennis M. Cavanaugh

                Argued: February 12, 2014

Before: CHAGARES, SHWARTZ, and ALDISERT, Circuit
                    Judges.

                 (Filed: August 26, 2014)

Arne M. Olson, Esq. (Argued)
Dennis H. Ma, Esq.
Brian R. Michalek, Esq.
Olson & Cepuritis
20 North Wacker Dr., 36th Floor
Chicago, IL 60606
             Counsel for Appellant

David W. Phillips, Esq. (Argued)
Karol C. Walker, Esq.
LeClairRyan
One Riverfront Plaza
1037 Raymond Boulevard, 16th Floor
Newark, NJ 07102
            Counsel for Appellee

David H. Bernstein, Esq.
Debevoise & Plimpton
919 Third Avenue
New York, NY 10022
            Counsel for International Trademark
            Association, Amicus Curiae

                       ____________

                         OPINION
                       ____________

CHAGARES, Circuit Judge.

       Appellant Ferring Pharmaceuticals, Inc. appeals from a
District Court order denying its motion for a preliminary
injunction against appellee Watson Pharmaceuticals, Inc.1
This appeal requires us to determine, inter alia, whether a
party seeking a preliminary injunction pursuant to a Lanham
Act claim is entitled to a presumption of irreparable harm.
We conclude that, in light of the Supreme Court’s decisions
in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006),
and Winter v. Natural Resources Defense Council, Inc., 555
U.S. 7 (2008), a party bringing a claim under the Lanham Act
is not entitled to a presumption of irreparable harm when
seeking a preliminary injunction and must demonstrate that
irreparable harm is likely. We also conclude that the District
Court did not err in finding that Ferring failed to demonstrate
irreparable harm. We will, therefore, affirm the District
Court’s order.

                              I.

                              A.

1
 Watson Pharmaceuticals, Inc. is now known as Actavis, Inc.
However, the parties refer to Watson in their briefs, and we
will do so as well for ease of reference.
                              2
       Ferring and Watson are pharmaceutical companies that
market competing prescription progesterone products.
Progesterone is a hormone that plays a key role in helping
women become pregnant and maintain their pregnancies,
specifically by preparing the uterine lining for the embryo and
maintaining the lining to support the embryo during the early
stages of pregnancy. Although women naturally produce
progesterone, women seeking to become pregnant through
assisted reproductive technology (“ART”) procedures, such
as in vitro fertilization, generally require progesterone
supplementation.       Historically, women have received
progesterone through intramuscular shots, which are not
approved by the Food and Drug Administration (“FDA”) and
which patients consider painful. Ferring and Watson each
manufacture a product that administers progesterone to
women through vaginal inserts rather than intramuscular
shots. Ferring’s product, Endometrin, is delivered in capsule
form and applied two or three times per day. Watson’s
product, Crinone, is a gel delivered via applicator and is
applied once daily. Endometrin and Crinone are currently the
only two vaginal progesterone inserts for ART approved by
the FDA.

       Ferring’s claims arise out of two presentations made
by Watson on September 11, 2012. On that date, Watson
hosted and invited doctors and healthcare professionals to
view two presentations about Crinone made by Dr. Kaylen M.
Silverberg, a paid consultant.      The presentations were
streamed online at 7:30 p.m. and 9:00 p.m. throughout the
United States and viewed by medical professionals in-person
and over the Internet with a password. The webcasts were
designed to encourage attendees to purchase Crinone and
consisted of a series of PowerPoint slides prepared by
Watson.

       During the presentations, Dr. Silverberg made three
statements with which Ferring takes issue: (1) he referenced
a “Black Box” warning on Endometrin’s package insert; (2)
he discussed a patient preference survey comparing Crinone
and Endometrin; and (3) he mischaracterized the results of
certain studies of Endometrin’s effectiveness in women over
the age of thirty-five.

                              3
                               1.

        First, during the 7:30 webcast, Dr. Silverberg stated
that “if you read the package insert, for Endometrin there is a
black box warning showing the efficacy has not been
demonstrated with . . . patients 35 years of age and older.”
Appendix (“App.”) 174-75. A Black Box warning is of
special note in the medical community, as it signifies that
medical studies indicate that the drug carries a significant risk
of serious or life-threatening effects. See 21 C.F.R. §
201.57(c)(1) (providing that “[c]ertain contraindications or
serious warnings, particularly those that may lead to death or
serious injury, may be required by the FDA to be presented in
a box”). The package insert does state that “[e]fficacy in
women 35 years of age and older has not been clearly
established.” App. 6. However, that statement is not
contained in a Black Box warning on the package insert.
Watson admits that Dr. Silverberg’s statement was, therefore,
made in error. Watson Br. 8.

        Dr. Silverberg was alerted to the inaccuracy of his
characterization of the statement as a Black Box warning after
the 7:30 webcast, and the 9:00 webcast did not contain such a
statement. Dr. Silverberg also certified to Ferring and to the
District Court that he would not repeat this statement in the
future.

                               2.

      During the two presentations, Dr. Silverberg also told
the audience that high percentages of women preferred
Crinone to Endometrin.        Specifically, during the 7:30
webcast, Dr. Silverberg stated:

       When you look at Crinone compared to
       Endometrin, similar findings. 94 percent of
       patients thought that Crinone was easier to
       incorporate into their daily lifestyle, probably
       because it’s given once a day compared to three
       times a day for Endometrin, 82 percent thought
       that it was more convenient, or I’m sorry, that
       may be 88 percent, 94 percent thought that it

                               4
       was more comfortable to use Crinone than the
       Endometrin.

App. 175. During the 9:00 webcast, Dr. Silverberg
stated:

       Now looking at Crinone compared to
       Endometrin, telephone survey, 94 percent of
       patients thought that Crinone was easier to
       incorporate into a daily lifestyle than the
       Endometrin given three times a day. 88 percent
       thought it was more convenient. 84 percent
       thought it was more comfortable to use.

App. 182-83.

        The slide used by Dr. Silverberg during the
presentations states that these percentages are based on a
survey of women who used Crinone or Endometrin. The
slide also states that the percentages are derived from a “tally
of yes/no questions about whether CRINONE was easy to
incorporate into a daily lifestyle, was convenient, and was
comfortable to use.” App. 376. Thus, the text of the slide
indicated that the survey was not actually a comparison of
Crinone and Endometrin. Watson has admitted that Dr.
Silverberg’s claims were false, because the figures cited were
not based on a survey comparing patient preferences for
Crinone and Endometrin.2 Watson Br. 9-10. Dr. Silverberg
certified to the District Court that he was aware of his mistake
in misreading the survey results and will not repeat it in the
future.

                               3.

        Dr. Silverberg also made several statements regarding
the efficacy of Crinone and Endometrin in women over thirty-
five years of age. Dr. Silverberg stated that “if you read the
package insert, for Endometrin there is a black box warning

2
  Watson asserts that other data from the survey did show that
“patients preferred Crinone over Endometrin by a two-to-one
margin” but acknowledges that “the figures were not identical
to the ones Dr. Silverberg recited.” Watson Br. 10; App. 312.
                               5
showing the efficacy has not been demonstrated with . . .
Endometrin for patients 35 years of age and older,” App. 174-
75 (emphasis added), but Endometrin’s package insert
actually states that “[e]fficacy in women 35 years of age and
older has not been clearly established,” App. 6 (emphasis
added).

       In addition, Dr. Silverberg discussed studies performed
by Schoolcraft WB, et al.,3 and Doody KJ, et al.,4 concerning
the use of Crinone and Endometrin in women over thirty-five
years of age. App. 191, 193-98. During the 7:30 webcast,
Dr. Silverberg stated:

      We know that efficacy has been established for
      Crinone in patients under the age of 35 as well
      as over the age of 35. Schoolcraft’s analysis of
      the Doody study and also our study found the
      exact same thing.

App. 176. During the 9:00 webcast, Dr. Silverberg stated:

      The efficacy of Crinone, unlike the other
      products, has been established in women
      throughout the entire reproductive spectrum
      from 22 to 47, including women age 35 years of
      age and older. Schoolcraft’s study found that,
      our study found that.

App. 184. He also stated, during the same webcast:

      Bill Schoolcraft has some published data
      showing that in fact that the efficacy of
      Endometrin given three times a day is not — it

3
  See Schoolcraft WB, et al., Efficacy of a novel form of
vaginal progesterone on continuing pregnancy rates in women
undergoing IVF with elevated BMI and advanced age, 87
Fertility & Sterility S24 (2007).
4
  See Doody KJ, et al., Endometrin for luteal phase support in
a randomized, controlled, open-label, prospective in-vitro
fertilization trial using a combination of Menopur and
Bravelle for controlled ovarian hyperstimulation, 91 Fertility
& Sterility 1012 (2009).
                              6
       was not found to be efficacious for women over
       the age of 35.

App. 183.

        The Schoolcraft study involved the administration of
Endometrin twice or three times a day or Crinone to
participants who were up to forty-two years old. The study
lists the results for the participants who took Crinone, but the
data analysis section and conclusion concern only
Endometrin. The study concludes that “Endometrin was well
tolerated and provided successful luteal support in poor-
prognosis patients” such as “those older than 35.” App. 191.
However, the study also includes a chart comparing the
results for the participants taking Endometrin with the
participants taking Crinone, and the chart indicates that
Crinone has higher pregnancy rates than Endometrin for
participants over the age of thirty-five.

       The Doody study, structured similarly to the
Schoolcraft study, directly compared Endometrin to Crinone
and concludes that “[n]o clinically meaningful differences
were observed across the three treatment groups in pregnancy
rates or live birth rates,” and that “Endometrin provides a
safe, well tolerated, and effective method for providing luteal
phase support in women undergoing IVF.” App. 197.

       Dr. Silverberg has certified that in future presentations
concerning Crinone, he will make only specified statements
as to the efficacy of Endometrin for women thirty-five years
old or older in accordance with the statement contained on the
product’s package insert.

                              B.

        On September 17, 2012, Ferring filed a complaint
pursuant to section 43(a) of the Lanham Act, 15 U.S.C. §
1125(a), the New Jersey Consumer Fraud Act, N.J. Stat. Ann.
§ 56:8-1 et seq., and New Jersey common law, alleging, inter
alia, that Watson’s statements at the presentations were false
and misleading. On November 9, 2012, Ferring moved for a
preliminary injunction to enjoin Watson from making further
false statements and for corrective advertising.

                               7
       The District Court denied Ferring’s motion on April 4,
2013. Of particular note, the District Court found that Ferring
was not entitled to a presumption of irreparable harm in
seeking a preliminary injunction. Without this presumption,
the District Court found that Ferring had failed to present
sufficient evidence to demonstrate a likelihood of irreparable
harm, and, accordingly, Ferring was not entitled to a
preliminary injunction. The District Court also briefly
addressed the likelihood of the success of Ferring’s claims on
the merits, noting that it was not clear, at the preliminary
injunction stage, that Watson’s allegedly false statements
were “completely unsubstantiated” because Watson
demonstrated that at least some support does exist to form the
basis of the challenged statements. App. 14. However, the
District Court stated that it did not need to make a
determination as to the likelihood of success of Ferring’s
claims in light of Ferring’s failure to demonstrate irreparable
harm.

       Ferring timely appealed.

                              II.

        The District Court had jurisdiction over this action
pursuant to 28 U.S.C. §§ 1331 and 1367, and this Court has
jurisdiction pursuant to 28 U.S.C. § 1292.

       We review the District Court’s decision to grant or
deny a preliminary injunction for abuse of discretion.
Highmark, Inc. v. UPMC Health Plan, Inc., 276 F.3d 160,
170 (3d Cir. 2001). The District Court’s findings of fact are
reviewed for clear error and its conclusions of law are subject
to plenary review. Id.5

5
  Ferring argues, citing E.T. Browne Drug Co. v. Cococare
Products, Inc., 538 F.3d 185, 196 (3d Cir. 2008), that where,
as here, the district court did not conduct an evidentiary
hearing in a Lanham Act case, the standard of review is
plenary. However, E.T. Browne does not stand for that
proposition. Rather, this Court in E.T. Browne observed that
it was required to apply a plenary standard of review to a
summary judgment ruling and distinguished this from a ruling
                              8
                              III.

       Preliminary injunctive relief is an “extraordinary
remedy, which should be granted only in limited
circumstances.” Novartis Consumer Health, Inc. v. Johnson
& Johnson-Merck Consumer Pharm. Co., 290 F.3d 578, 586
(3d Cir. 2002) (quotation marks omitted). “A plaintiff
seeking a preliminary injunction must establish that he is
likely to succeed on the merits, that he is likely to suffer
irreparable harm in the absence of preliminary relief, that the
balance of equities tips in his favor, and that an injunction is
in the public interest.” Winter, 555 U.S. at 20. The “failure
to establish any element . . . renders a preliminary injunction
inappropriate.” NutraSweet Co. v. Vit-Mar Enters., Inc., 176
F.3d 151, 153 (3d Cir. 1999). The movant bears the burden
of showing that these four factors weigh in favor of granting
the injunction. See Opticians Ass’n of Am. v. Indep.
Opticians of Am., 920 F.2d 187, 192 (3d Cir. 1990).

       Ferring takes issue with the District Court’s analysis of
the irreparable harm prong in deciding its motion for a
preliminary injunction. It argues that irreparable harm can
and should be presumed in Lanham Act comparative false
advertising cases, and that the District Court erred in
declining to afford Ferring that presumption and in denying it
a preliminary injunction. Watson responds that: (1) this
Court has never recognized such a presumption; (2) even if
such a presumption once existed, it no longer does in light of
the Supreme Court’s decisions in eBay, 547 U.S. 388, and
Winter, 555 U.S. 7; and (3) without that presumption, Ferring
failed to demonstrate a likelihood of irreparable harm. We
address these contentions below.

                              A.

       This Court has never held that a plaintiff seeking a
preliminary injunction pursuant to a Lanham Act false
advertising claim is entitled to a presumption of irreparable
harm. However, prior to eBay, several of our sister courts

on a motion for a preliminary injunction (which, in that case,
took place after a four-day evidentiary hearing), for which the
weighing of evidence is reviewed for clear error. Id.
                               9
had applied a presumption of irreparable harm upon a
showing of likelihood of success on the merits where a
plaintiff seeks a preliminary injunction in a comparative false
advertising case. See, e.g., Southland Sod Farms v. Stover
Seed Co., 108 F.3d 1134, 1146 (9th Cir. 1997) (noting that
for false comparative advertising claims, the Court of Appeals
for the Ninth Circuit has held that “[p]ublication of
deliberately false comparative claims gives rise to a
presumption of actual deception and reliance” (quotation
marks omitted)); Abbott Labs. v. Mead Johnson & Co., 971
F.2d 6, 16 (7th Cir. 1992) (referencing the “well-established
presumption that injuries arising from Lanham Act violations
are irreparable, even absent a showing of business loss”);
McNeilab, Inc. v. Am. Home Prods. Corp., 848 F.2d 34, 38
(2d Cir. 1988) (affirming the district court’s presumption of
irreparable harm from a finding of false or misleading
advertising).

       The Court of Appeals for the Second Circuit’s
reasoning for applying this presumption in McNeilab is
instructive. See 848 F.2d at 38. There, the court explained
that

      [a] misleading comparison to a specific
      competing product necessarily diminishes that
      product’s value in the minds of the consumer.
      By falsely implying that Advil is as safe as
      Tylenol in all respects, AHP deprived McNeil
      of a legitimate competitive advantage and
      reduced consumers’ incentive to select Tylenol
      rather than Advil. This is analogous to a
      Lanham Act trademark dispute. An infringing
      mark, by its nature, detracts from the value of
      the mark with which it is confused. In that
      context, we recently confirmed that irreparable
      harm will be presumed. Consequently, the
      district court did not err in presuming harm
      from a finding of false or misleading
      advertising.

Id. (citations omitted); see also Abbott Labs., 971 F.2d at 16
(“This presumption, it appears, is based upon the judgment
that it is virtually impossible to ascertain the precise

                              10
economic consequences of intangible harms, such as damage
to reputation and loss of goodwill, caused by such
violations.”). The justification for applying this presumption,
therefore, is twofold: (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,
similar to trademark infringement cases; and (2) the harm
necessarily caused to reputation and goodwill is irreparable
because it is virtually impossible to quantify in terms of
monetary damages.

        Although we have not applied a presumption of
irreparable harm to a false advertising case, we have
repeatedly held, prior to eBay and Winter, that a plaintiff
alleging a Lanham Act trademark infringement claim is
entitled to a presumption of harm when she demonstrates a
likelihood of success on the merits.6 See Kos Pharm., Inc. v.
Andrx Corp., 369 F.3d 700, 726 (3d Cir. 2004) (noting that
“trademark infringement amounts to irreparable injury as a
matter of law” (quotation marks omitted)); see also Opticians,
920 F.2d at 196. In Opticians, we concluded that trademark
infringement constitutes a per se injury because it inhibits the
owner’s “ability to control its own . . . marks, which in turn
creates the potential for damage to its reputation. Potential
damage to reputation constitutes irreparable injury for the
purpose of granting a preliminary injunction in a trademark
case.” 920 F.2d at 196; see also S & R Corp. v. Jiffy Lube
Int’l, Inc., 968 F.2d 371, 378 (3d Cir. 1992) (noting that
“[g]rounds for irreparable injury include loss of control of
reputation, loss of trade, and loss of goodwill” and
“trademark infringement amounts to irreparable injury as a
matter of law”). Accordingly, prior to eBay and Winter, we
applied a presumption of irreparable harm in Lanham Act
trademark infringement cases in which a plaintiff sought a

6
  Trademark infringement and false advertising claims both
arise under section 43(a)(1) of the Lanham Act, see 15 U.S.C.
§ 1125(a), and courts often rely on trademark infringement
precedent in deciding false advertising cases, as both types of
cases address irreparable injuries in the form of reputational
harm and loss of goodwill. See, e.g., McNeilab, 848 F.2d at
38 (analogizing false comparative advertising claims to
trademark disputes with regard to the type of harm caused).
                              11
preliminary injunction, and our reasoning for doing so has
been the basis for other courts’ decisions in comparative false
advertising cases: a false statement about a product in
comparison to another creates the potential for damage to the
product or brand’s reputation, which constitutes irreparable
injury that is difficult to quantify. See McNeilab, 848 F.2d at
38.

                               B.

       The Supreme Court revisited the analytical framework
governing injunctions in two significant cases from the last
decade: eBay and Winter. The ramifications of these
decisions have been considered by many of our sister Courts
of Appeals.

        eBay was a patent case in which MercExchange,
holder of a business method patent for an electronic market,
sued eBay and a subsidiary for patent infringement. See
eBay, 547 U.S. at 390. A jury found that MercExchange’s
patent was valid and had been infringed, and that an award of
damages was appropriate. Id. at 390-91. Following the
verdict, the district court denied MercExchange’s motion for
permanent injunctive relief, “adopt[ing] certain expansive
principles suggesting that injunctive relief could not issue in a
broad swath of cases” and specifically “conclud[ing] that a
‘plaintiff’s willingness to license its patents’ and ‘its lack of
commercial activity in practicing the patents’ would be
sufficient to establish that the patent holder would not suffer
irreparable harm if an injunction did not issue.” Id. at 393
(quoting MercExchange, L.L.C. v. eBay, Inc., 275 F. Supp.
2d 695, 712 (E.D. Va. 2003)). The Court of Appeals for the
Federal Circuit reversed, applying its “‘general rule that
courts will issue permanent injunctions against patent
infringement absent exceptional circumstances.’” Id. at 391
(quoting MercExchange, LLC v. eBay, Inc., 401 F.3d 1323,
1339 (Fed. Cir. 2005)). The Court of Appeals for the Federal
Circuit cited Richardson v. Suzuki Motor Co. for this
proposition, which arose out of the historical practice in the
Federal Circuit that “‘[i]n matters involving patent rights,
irreparable harm has been presumed when a clear showing
has been made of patent validity and infringement.’”
Richardson, 868 F.2d 1226, 1247 (Fed. Cir. 1989) (quoting

                               12
H.H. Robertson Co. v. United Steel Deck, Inc., 820 F.2d 384,
390 (Fed. Cir. 1987)).

         The Supreme Court vacated the decision and remanded
to the district court, holding that the Court of Appeals erred in
applying a categorical rule that injunctions should issue upon
a showing of valid patent infringement. eBay, 547 U.S. at
394. The Court held that a patent infringement plaintiff must
fulfill the traditional requirements for a permanent injunction.
Id. at 391. The Court observed that the Patent Act “expressly
provides that injunctions may issue in accordance with the
principles of equity,” and, accordingly, “a major departure
from the long tradition of equity practice should not be lightly
implied.” Id. at 391-92 (quotation marks omitted). The Court
also noted that in copyright cases, it had “consistently
rejected invitations to replace traditional equitable
considerations with a rule that an injunction automatically
follows a determination that a copyright has been infringed.”
Id. at 392-93 (citing cases).

        The Court held that neither the district court nor the
Court of Appeals “fairly applied these traditional equitable
principles in deciding respondent’s motion for a permanent
injunction,” because the district court applied a categorical
rule in denying relief, while the Court of Appeals applied a
categorical rule in granting injunctive relief. Id. at 393-94.
Accordingly, the Court remanded to the district court, holding
that “the decision whether to grant or deny injunctive relief
rests within the equitable discretion of the district courts, and
. . . such discretion must be exercised consistent with
traditional principles of equity, in patent disputes no less than
in other cases governed by such standards.” Id. at 394.7

7
  Although the Court rejected the application of categorical
rules that would eliminate the use of the traditional four-
factor test, two concurrences, written by Chief Justice Roberts
and Justice Kennedy, respectively, and separately joined by a
total of seven Justices, suggested that such rules might
survive as “lesson[s] of . . . historical practice” that might
inform the district courts’ equitable discretion “when the
circumstances of a case bear substantial parallels to litigation
the courts have confronted before.” Id. at 395-97, (Kennedy,
                               13
        Subsequently, in Winter, the Supreme Court addressed
the standard for demonstrating irreparable harm in the
preliminary injunction context. See 555 U.S. at 20-24.
There, several environmental organizations sought a
preliminary injunction against the Navy’s use of sonar in
training exercises, alleging that it would cause serious harm
to various species of marine mammals. Id. at 13-14. The
Court rejected the Court of Appeals for the Ninth Circuit’s
holding that “when a plaintiff demonstrates a strong
likelihood of prevailing on the merits, a preliminary
injunction may be entered based only on a ‘possibility’ of
irreparable harm.” Id. at 21. The Court “agree[d] with the
Navy that the Ninth Circuit’s ‘possibility’ standard is too
lenient. [The Court’s] frequently reiterated standard requires
plaintiffs seeking preliminary relief to demonstrate that
irreparable injury is likely in the absence of an injunction.”
Id. at 22. The Court also noted that “[i]ssuing a preliminary
injunction based only on a possibility of irreparable harm is
inconsistent with our characterization of injunctive relief as
an extraordinary remedy that may only be awarded upon a
clear showing that the plaintiff is entitled to such relief.” Id.

       Several of our sister courts, although not this Court,
have addressed the ramifications of these decisions for the
irreparable harm prong of the preliminary injunctive relief
analysis, uniformly holding that application of a presumption
of irreparable harm is no longer permissible, for instance, in
patent and copyright infringement cases.

       In 2011, the Court of Appeals for the Federal Circuit
held that, in patent cases, eBay “jettisoned the presumption of
irreparable harm as it applies to determining the
appropriateness of injunctive relief.” Robert Bosch LLC v.
Pylon Mfg. Corp., 659 F.3d 1142, 1149 (Fed. Cir. 2011). The
court acknowledged that eBay “did not expressly address the
presumption of irreparable harm.” Id. at 1148. However, the
court held that extension of the reasoning of eBay required
elimination of the presumption, observing that “[i]n eBay, the
Supreme Court made clear that ‘broad classifications’ and

J., concurring); see also id. at 394-95 (Roberts, C.J.,
concurring).

                               14
‘categorical rule[s]’ have no place in [the injunction]
inquiry,” but rather “courts are to exercise their discretion in
accordance with traditional principles of equity.” Id. (quoting
eBay, 547 U.S. at 393-94).

        The Courts of Appeals for the Second and Ninth
Circuits have extended the eBay analysis to copyright cases.
In Salinger v. Colting, a copyright case in which the plaintiff
sought a preliminary injunction, the Court of Appeals for the
Second Circuit held that eBay abrogated the presumption of
irreparable harm in copyright cases. See 607 F.3d 68, 76-78
(2d Cir. 2010). The court began by observing that it had
traditionally “presumed that a plaintiff likely to prevail on the
merits of a copyright claim is also likely to suffer irreparable
harm if an injunction does not issue.” Id. at 75. It then
discussed the ways it had historically interpreted and applied
the presumption: (1) as allowing a plaintiff likely to prevail
on the merits to make a less “detailed showing of irreparable
harm”; (2) “as though it applies automatically and is
irrebuttable”; and (3) as rebuttable “where the plaintiff
delayed in bringing the action seeking an injunction.” Id.
However, the court observed that “[u]nder any of these
articulations,” it had “nearly always issued injunctions in
copyright cases as a matter of course upon a finding of
likelihood of success on the merits.” Id. at 76.

        The Salinger court held that the Supreme Court’s
reasoning “applie[d] with equal force (a) to preliminary
injunctions (b) that are issued for alleged copyright
infringement.” Id. at 77. The court closely examined eBay,
noting that “nothing in the text or the logic of eBay suggests
that its rule is limited to patent cases. On the contrary, eBay
strongly indicates that the traditional principles of equity it
employed are the presumptive standard for injunctions in any
context.” Id. at 77-78. The also court noted that this holding
was consistent with the Supreme Court’s construction of the
preliminary injunction standard in Winter. See id. at 79.

      The Court of Appeals for the Ninth Circuit has also
explicitly interpreted eBay to mean that the Supreme Court
intended that the propriety of injunctive relief in copyright
cases “be evaluated on a case-by-case basis in accord with
traditional equitable principles and without the aid of

                               15
presumptions or a ‘thumb on the scale’ in favor of issuing
such relief.” Perfect 10, Inc. v. Google, Inc., 653 F.3d 976,
980-81 (9th Cir. 2011) (quoting Monsanto Co. v. Geertson
Seed Farms, 561 U.S. 139, 157 (2010)).

                              C.

       We now turn to the effect of eBay and Winter in
Lanham Act cases. We hold that although eBay in particular
arose in the patent context, its rationale is equally applicable
in other contexts, including cases arising under the Lanham
Act, for the reasons that follow.8

        The Lanham Act’s injunctive relief provision is
premised upon traditional principles of equity, like the Patent
Act’s. Compare 15 U.S.C. § 1116(a) (Lanham Act) (“The
several courts vested with jurisdiction of civil actions arising
under this chapter shall have power to grant injunctions,
according to the principles of equity and upon such terms as
the court may deem reasonable . . . .” (emphasis added)), with
35 U.S.C. § 283 (Patent Act) (“The several courts having
jurisdiction of cases under this title may grant injunctions in
accordance with the principles of equity to prevent the
violation of any right secured by patent, on such terms as the
court deems reasonable.” (emphasis added)). Accordingly,
we should interpret this nearly identical wording in the same
way. See N. Am. Med. Corp. v. Axiom Worldwide, Inc., 522
F.3d 1211, 1228 (11th Cir. 2008). Notably, the Court in eBay
suggested that a “major departure from the long tradition of
equity practice” should be permitted only to the extent that
“Congress intended such a departure,” and the language of
these two acts makes clear that Congress did not intend any
such departure in these contexts. 547 U.S. at 391-92
(quotation marks omitted).

       In addition, like the Court of Appeals for the Second
Circuit, we believe the logic of eBay is not limited to patent
cases but rather is widely applicable to various different types
of cases. See Salinger, 607 F.3d at 78 n.7 (“[W]e see no

8
  As will be discussed infra, Winter, by its terms, applies to
the instant case, as it addressed the standard for preliminary
injunctions generally. See 555 U.S. at 22.
                              16
reason that eBay would not apply with equal force to an
injunction in any type of case.”). Indeed, the Supreme Court
has applied the reasoning of eBay in a substantially distinct
context. In Monsanto Co v. Geertson Seed Farms, a case
involving violations of the National Environmental Policy
Act of 1969 (“NEPA”), the Court rejected the Court of
Appeals for the Ninth Circuit’s holding that “an injunction is
the proper remedy for a NEPA violation except in unusual
circumstances.” 561 U.S. at 157. Rather, the Court held that,
in light of eBay and Winter, an injunction should issue “only
if the traditional four-factor test is satisfied” and “[n]o . . .
thumb on the scales is warranted.” Id.

       Ferring argues that eBay does not apply to Lanham
Act cases because it was decided in the patent context, which
raises unique concerns not present in the Lanham Act
context.9 See Ferring Br. 31-33. Among other things,
Ferring notes that patents “‘have the attributes of personal
property,’” including “‘the right to exclude others from
making, using, offering for sale, or selling the invention.’”
eBay, 547 U.S. at 392 (quoting 35 U.S.C. §§ 261, 154(a)(1)).
By contrast, the Lanham Act creates no corresponding
property right, especially with regard to false advertising
claims. Lanham Act claims are also materially distinct from
patent or copyright claims because, while injury arising from
patent or copyright infringement can generally be measured
in monetary terms by examining the “appropriation of a
potential market for the patent invention or copyrighted
work,” see David H. Bernstein & Andrew Gilden, No Trolls
Barred: Trademark Injunctions After eBay, 99 Trademark
Rep. 1037, 1055 (2009), injury to goodwill and reputation “is

9
  In addition, although eBay addressed a permanent, rather
than preliminary, injunction, this distinction is not significant.
“The standard for a preliminary injunction is essentially the
same as for a permanent injunction with the exception that the
plaintiff must show a likelihood of success on the merits
rather than actual success.” Amoco Prod. Co. v. Vill. of
Gambell, Alaska, 480 U.S. 531, 546 n.12 (1987); see also
Flexible Lifeline Sys. v. Precision Lift, Inc., 654 F.3d 989,
996 (9th Cir. 2011) (concluding that “eBay applies with equal
force to preliminary injunction cases as it does to permanent
injunction cases”).
                               17
real but difficult to measure in dollars and cents,” 5 J. Thomas
McCarthy, McCarthy on Trademarks and Unfair Competition
§ 30:47 (4th ed. 1996). See also Abbott Labs, 971 F.2d at 16
(noting that “it is virtually impossible to ascertain the precise
economic consequences of intangible harms, such as damage
to reputation and loss of goodwill, caused by [Lanham Act]
violations”).

       We are not persuaded by this argument. The rationale
of the eBay decision was not that patent cases are somehow
unique, but rather, as stated supra, that “the decision whether
to grant or deny injunctive relief rests within the equitable
discretion of the district courts, and that such discretion must
be exercised consistent with traditional principles of equity, in
patent disputes no less than in other cases governed by such
standards.” eBay, 547 U.S. at 394. In addition, as noted
supra, the Court in eBay suggested that a “major departure
from the long tradition of equity practice” should be
permitted only to the extent that “Congress intended such a
departure.” 547 U.S. at 391-92. It follows that a court is not
free to depart from traditional principles of equity merely
because it believes such a departure would further a statute’s
policy goals, such as, in the case of Lanham Act claims,
compensating plaintiffs for harms that may be difficult to
quantify. Rather, the text of the Lanham Act clearly evinces
congressional intent to require courts to grant or deny
injunctions according to traditional principles of equity. See
15 U.S.C § 1116(a).

        Because a presumption of irreparable harm deviates
from the traditional principles of equity, which require a
movant to demonstrate irreparable harm, we hold that there is
no presumption of irreparable harm afforded to parties
seeking injunctive relief in Lanham Act cases. Consistent
with our holding, the Court of Appeals for the Ninth Circuit
recently extended the eBay analysis to a trademark
infringement claim, holding that the likelihood of irreparable
injury may no longer be presumed from a showing of
likelihood of success on the merits. See Herb Reed Enters.,
LLC v. Fla. Entm’t Mgmt., Inc., 736 F.3d 1239, 1242 (9th
Cir. 2013). The court noted that eBay and Winter “cast doubt
on the validity of this court’s previous rule that the likelihood
of ‘irreparable injury may be presumed from a showing of

                               18
likelihood of success on the merits of a trademark
infringement claim.’” Id. at 1248-49 (quoting Brookfield
Commc’ns, Inc. v. W. Coast Entm’t Corp., 174 F.3d 1036,
1066 (9th Cir. 1999)). After summarizing the holdings of
eBay and Winter, the court noted that following those cases,
it “held that likely irreparable harm must be demonstrated to
obtain a preliminary injunction in a copyright infringement
case and that actual irreparable harm must be demonstrated to
obtain a permanent injunction in a trademark infringement
action.” Id. at 1249 (citing Flexible Lifeline Sys. v. Precision
Lift, Inc., 654 F.3d 989, 998 (9th Cir. 2011) and Reno Air
Racing Ass’n, Inc. v. McCord, 452 F.3d 1126, 1137-38 (9th
Cir. 2006)). The court concluded that its “imposition of the
irreparable harm requirement for a permanent injunction in a
trademark case applies with equal force in the preliminary
injunction context” and held that “the eBay principle — that a
plaintiff must establish irreparable harm — applies to a
preliminary injunction in a trademark infringement case.” Id.
We agree with the holding and rationale of the Herb Reed
court.10

10
    Several other Courts of Appeals have held that the
reasoning of eBay applies to the Lanham Act context and
have acknowledged that eBay may call the use of a
presumption of irreparable harm into doubt, although they
have explicitly declined to decide the issue. See, e.g.,
Swarovski Aktiengesellschaft v. Bldg. No. 19, Inc., 704 F.3d
44, 53-55 (1st Cir. 2013) (noting that “we have so far
declined to address whether eBay’s bar on ‘general’ or
‘categorical’ rules includes the presumption of irreparable
harm in trademark disputes” and declining to decide the issue
because the plaintiff failed to demonstrate a likelihood of
success on the merits); Paulsson Geophysical Servs., Inc. v.
Sigmar, 529 F.3d 303, 313 (5th Cir. 2008) (acknowledging
that “whether a court may presume irreparable injury upon
finding a likelihood of confusion in a trademark case” was “a
difficult question considering the Supreme Court’s opinion in
eBay,” but declining to answer because the facts of the case
supported a finding of a substantial threat of irreparable injury
if an injunction was not issued); Axiom Worldwide, 522 F.3d
at 1226-28 (observing that “a strong case can be made that
eBay’s holding necessarily extends to the grant of preliminary
injunctions under the Lanham Act,” but “declin[ing] to
                               19
        The Court’s decision in Winter, requiring that a
plaintiff demonstrate a likelihood, rather than a possibility, of
irreparable harm, further supports our conclusion.11 As the
Court of Appeals for the Ninth Circuit has observed, if
requiring a plaintiff to “demonstrate at least a possibility of
irreparable harm[] is ‘too lenient,’ then surely a standard
which presumes irreparable harm without requiring any
showing at all is also ‘too lenient.’” Flexible Lifeline, 654
F.3d at 997. Rather, injunctive relief is an “extraordinary
remedy that may only be awarded upon a clear showing that
the plaintiff is entitled to such relief.” Winter, 555 U.S. at 22
(emphasis added). Presuming irreparable harm would relieve
the plaintiff of her burden to make such a showing.

address whether [a presumption of irreparable harm] is the
equivalent of the categorical rules rejected by the Court in
eBay”).
11
    We note that before Winter, we had not treated the
preliminary injunction irreparable harm requirement in a
uniform manner, at times requiring a showing of a
“possibility,” “probability,” or “potential” for irreparable
harm. See, e.g., Presbytery of N.J. of Orthodox Presbyterian
Church v. Florio, 40 F.3d 1454, 1458 (3d Cir. 1994) (holding
that the plaintiff “failed to demonstrate the possibility of
immediate and irreparable harm”); Furlong v. Gudknecht, 808
F.2d 233, 234 (3d Cir. 1986) (noting that the district court
considered, inter alia, the “potential for irreparable injury
absent temporary relief” in determining whether to grant a
preliminary injunction); United Tel. Workers, AFL-CIO v.
W. Union Corp., 771 F.2d 699, 703 (3d Cir. 1985) (“In
deciding whether to provide preliminary relief, the district
court must consider the probability of irreparable injury to the
moving party in the absence of such relief . . . .”); United
States v. Price, 688 F.2d 204, 211 (3d Cir. 1982) (noting that
the “factors which guide the exercise of the courts’ equitable
discretion” in granting or denying a request for preliminary
injunctive relief include “the probability of irreparable injury
to the moving party in the absence of relief”). However, in
light of Winter, parties seeking a preliminary injunction are
now required to demonstrate that “irreparable injury is likely
in the absence of an injunction.” Winter, 555 U.S. at 22.
                               20
       In addition, “Winter tells us that, at minimum, we must
consider whether irreparable injury is likely in the absence of
an injunction, we must balance the competing claims of
injury, and we must pay particular regard for the public
consequences in employing the extraordinary remedy of
injunction.” Salinger, 607 F.3d at 79 (quotation marks
omitted). A presumption of irreparable harm that functions as
an automatic or general grant of an injunction is inconsistent
with these principles of equity. See id.; see also Munaf v.
Green, 553 U.S. 674, 689-90 (2008) (noting that an injunction
is an “extraordinary and drastic remedy” that “is never
awarded as of right” (quotation marks omitted)).

       For these reasons, we hold that a party seeking a
preliminary injunction in a Lanham Act case is not entitled to
a presumption of irreparable harm but rather is required to
demonstrate that she is likely to suffer irreparable harm if an
injunction is not granted.

                              D.

       Although we agree with the District Court that Ferring
was not entitled to a presumption of irreparable harm, we
must also review the District Court’s finding that Ferring
failed to make a showing of likelihood of irreparable harm
without the presumption.

        In evaluating whether Ferring demonstrated that it
would suffer real, irreparable harm in the absence of an
injunction, the District Court noted that Dr. Silverberg agreed
he misstated the Black Box warning in the first webcast, but
removed the statement during the second webcast, and
certified to the District Court that he will never make that
statement in the future. App. 12, 237. The District Court also
found it significant that Dr. Silverberg certified that, at the
request of Watson, in future presentations concerning
Crinone, he will make only specified statements as to the
efficacy of Endometrin for women thirty-five years of age or
older, all in accordance with Endometrin’s package insert.
App. 12, 240. The District Court noted that there was no
showing that the allegedly false information contained in the
webcasts is still available online to be accessed by consumers.
App. 12. For these reasons, the District Court found that

                              21
Ferring did not produce evidence sufficient to prove that it
was harmed, or that the harm was irreparable and could only
be cured by a preliminary injunction. App. 12.

        Ferring disputes the District Court’s finding, arguing
that it did in fact present evidence of irreparable harm in the
form of a declaration by Dr. Angeline N. Beltsos (the
“Beltsos      Declaration”),     a     licensed     reproductive
endocrinologist. App. 144-48. The declaration stated, inter
alia, that: (1) Dr. Beltsos and other doctors would be less
likely to prescribe a drug if they believed it contained a Black
Box warning; (2) Dr. Beltsos and other doctors would be less
likely to prescribe a drug if patients in the marketplace
generally preferred another drug; and (3) Dr. Beltsos and
other doctors would be less likely to prescribe a drug if it was
not effective for a particular age group. App. 146-47.

       Ferring also argues that the District Court erred in
failing to analyze the specific harm caused by Watson’s
claims regarding the superiority of Crinone over Endometrin
in patient preference surveys. Ferring asserts that this is
particularly unjust because Watson is still making these
statements, as evidenced by the Declaration of Lynne Amato,
Watson’s Vice President of Global Brand Marketing,
submitted on December 3, 2012, stating that Watson’s slide
presentation now has a “correct slide stating that the survey
was of women who had used both Crinone and Endometrin.”
App. 303.12

       We hold that the District Court did not clearly err in
finding that Ferring failed to demonstrate irreparable harm.
We, like the District Court, find it significant that Dr.

12
   As evidence that Watson claims to have stopped making
these allegedly false statements but actually continues to do
so, Ferring states that one of Watson’s sales representatives
has already been caught making an allegedly false statement
regarding Endometrin’s efficacy in women over thirty-five
years old in a note. App. 140-43. However, the note at issue
was written on November 7, 2012, before Ferring even filed
for a preliminary injunction and almost a month before Dr.
Silverberg’s certification to the court. See App. 141.
Accordingly, this is not a persuasive argument.
                              22
Silverberg has certified to the court that he will not make the
Black Box statement in the future, and it was removed from
the 9:00 webcast. App. 12, 237. Dr. Silverberg also certified
that he will make age efficacy statements about Endometrin
only in accordance with the product’s package insert. App.
240. We see no evidence that the allegedly false statements
are still available to consumers. Although Ferring argues that
only Dr. Silverberg, and not Watson itself, has promised not
to make these offending statements in the future, Ferring has
adduced no evidence that there is any risk that any Watson
representative will make such statements, especially in light
of the fact that Watson has conceded that certain of these
statements were inaccurate, and that all of the statements at
issue here were made by Dr. Silverberg. See App. 6-8.

       We also hold that the Beltsos Declaration does not
sufficiently demonstrate irreparable harm such that the
District Court’s finding was clear error.13 The Beltsos
Declaration is speculative, containing statements by Dr.
Beltsos that the considerations of whether drugs are preferred
by certain patients or are considered effective for a particular
age group “may influence” her decision and the decisions of
other doctors as to which drugs they prescribe. App. 146-48.
Dr. Beltsos stated that she and other doctors “would be less
likely” to prescribe the non-effective and non-preferred drugs,
but this too is speculation, as she does not assert that she or

13
   Ferring argues that the District Court erred in failing to
consider the Beltsos Declaration in its irreparable harm
analysis. We acknowledge that it would have been preferable
for the District Court to have explicitly referenced the Beltsos
Declaration in its decision, especially with regard to Ferring’s
request for corrective advertising. But we observe that
Ferring did not raise, before this Court, any arguments
specifically referencing its request for corrective advertising.
In any event, “[a] party seeking a mandatory preliminary
injunction that will alter the status quo bears a particularly
heavy burden in demonstrating its necessity.” Acierno v.
New Castle Cnty., 40 F.3d 645, 653 (3d Cir. 1994). In light
of this heavy burden, and the fact that the harm described in
the Beltsos Declaration is purely speculative, we hold that the
District Court’s alleged failure to consider the Declaration
was, at most, harmless error.
                              23
any other doctors have prescribed Endometrin less frequently
in light of the allegedly false statements made by Dr.
Silverberg. App. 146-48.

       Ferring also argues that a Lanham Act defendant
cannot automatically moot a case simply by ending its
infringing conduct, but rather must irrefutably demonstrate
that the offending conduct has been totally reformed, and this
burden is a “heavy” one. Ferring Br. 38-39 (citing authority).
However, whether a case should be dismissed on mootness
grounds is a materially distinct inquiry from a determination
as to whether a plaintiff has demonstrated irreparable harm.
Whether a defendant’s conduct has ceased is certainly a
relevant consideration in making the latter determination, and
the District Court did not err in considering and crediting Dr.
Silverberg’s certifications that the allegedly false statements
would not be repeated.

       Accordingly, we hold that the District Court did not
clearly err in finding that Ferring failed to demonstrate that it
would likely suffer irreparable harm in the absence of
preliminary injunctive relief. Absent a showing of irreparable
harm, a plaintiff is not entitled to injunctive relief, even if the
other three elements are found. See NutraSweet, 176 F.3d at
153.

                               IV.

       For the foregoing reasons, we hold that the District
Court did not abuse its discretion in denying Ferring’s motion
for a preliminary injunction. We will, therefore, affirm the
District Court’s order.

                                24