Kos Pharm Aceuticals, Inc. v. Andrx Corporation

PRECEDENTIAL
UNITED STATES COURT OF
APPEALS
FOR THE THIRD CIRCUIT
No. 03-3977
KOS PHARM ACEUTICALS, INC.,
Appellant
v.
ANDRX CORPORATION; ANDRX
LABORATORIES, INC.
On Appeal from the United States
District Court for the
District of New Jersey
(District Court No. 03-cv-03714)
District Court Judge: Honorable Dennis
M. Cavanaugh
Argued: March 9, 2004
Before: SLOVITER, NYGAARD,
Circuit Judges, and OBERDORFER,*
District Judge.
(Opinion Filed: May 24, 2004)
Richard W. Young (Argued)
Liisa M. Thomas
Nicole M. Murray
Gardner Carton & Douglas LLP
191 N. Wacker Drive, Suite 3700
Chicago, Illinois 60606
Mark S. Olinsky
James M . Hirschhorn
Sills Cummis Radin Tischman Epstein &
Gross, P.A.
One Riverfront Plaza
Newark, New Jersey 07102-5400
Attorneys for Appellant
Allyn Z. Lite (Argued)
Joseph J. DePalma
Michael E. Patunas
Lite DePalma Greenberg & Rivas, LLC
Two Gateway Center, 12th Floor
Newark, New Jersey 07102
James V. Costigan
Martin P. Endres
Kathleen A. Costigan
Hedman & Costigan, P.C.
1185 Avenue of the Americas
New York, New York 10036
Attorneys for the Appellees
OPINION OF THE COURT
OBERDORFER, Senior District Judge.
This is an appeal from the denial of
preliminary relief in a trademark
infringement action. Plaintiff-appellant
Kos Pharmaceuticals, Inc. (“Kos”) owns
* The Honorable Louis F. Oberdorfer,
Senior District Judge for the District of
Columbia, sitting by designation.

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2
the mark ADVICOR, which it uses in
connection with cholesterol-altering drugs
available by prescription. Kos sought a
preliminary injunction preventin g
defendants-appellees Andrx Corporation
and Andrx Laboratories, Inc. (collectively,
“Andrx”) from using the mark ALTOCOR
in connection with sales of Andrx’s own
cholesterol-altering prescription drugs.
The district court denied the requested
relief, and this appeal followed. Because
the denial of the preliminary injunction
was premised on legal errors, we reverse.
We remand the case to the district court
with directions to enter a preliminary
injunction on an expedited basis.
I. BACKGROUND
Unless otherwise noted, the
following facts are undisputed. On
October 3, 2000, Kos filed an application
with the United States Patent and
Trademark Office (the “PTO”) to register
ADVICOR as the mark for a new
medication designed to improve
cholesterol levels. This new drug
combines 20 milligrams of lovastatin
(which lowers LDL, or “bad” cholesterol)
with varying strengths (500, 750, or 1000
milligrams) of an extended-release
formulation of niacin (which increases
HDL, or “good” cholesterol). Kos has
been selling its proprietary extended-
release form of niacin under the trade
name Niaspan since 1997. In July 2001
Kos began advertising, and in December
2001 began selling, its new combination
drug, Advicor.1
Shortly after Kos began marketing
Advicor, it learned that Andrx planned to
use the mark ALTOCOR for its own new
anticholesterol medication, which would
contain only a single active ingredient, an
extended-release form of lovastatin, in
varying strengths (10, 20, 40 or 60
milligrams). Andrx announced on January
31, 2002 that it had received preliminary
marketing approval for Altocor from the
U n i t e d S t a t e s F o o d a n d D r u g
Administration (the “FDA”). On February
5, 2002, the PTO published for opposition
the ALTOCOR mark, which Andrx had
applied to register in December 2000.
Kos tried to dissuade or otherwise
prevent Andrx from using the ALTOCOR
mark several times, both before and after
Andrx began selling its new drug. On
April 1, 2002, Kos wrote to Andrx that, in
its view, the proposed use of the mark
ALTOCOR “would constitute trademark
infringement and unfair competition.” JA
at 273. It advised Andrx to “refrain from
using ALTOCOR or any other mark which
is likely to cause confusion with
A D V I C O R f o r p h a r m a c e u t i c a l
preparations.” Id. Kos described its prior
use of ADVICOR for its own cholesterol-
altering medication and stated further that:
If Andrx were to use the
1 To distinguish the marks from the
drugs they identify, we use all capital
letters to refer to the marks, but capitalize
only the first letter when referring to the
drugs.

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3
mark ALTOCOR for
[ t h e d e s c r i b e d ]
p h a r m a c e u t i c a l
p r e p a r a t i o n s ,
c o n s u m e r s a n d
m e d i c a l
professionals would
inevitably believe
that Andrx’s product
originates with or is
a u t h o r i z e d b y ,
sponsored by, or in
some way connected
with Kos and its
A D V I C O R
p h a r m a c e u t i c a l
products. . . . The
similarity between
the marks and the
goods may create
confusion among
h e a l t h c a r e
practitioners in terms
of both prescribing
a n d d i s p e n s i n g ,
r e s u l t i n g i n
d a n g e r o u s
medication errors.
Id. at 272-73. A similar letter followed on
April 15, 2002. Id. at 362. Andrx
responded to neither letter.2
Kos also expressed its concerns
about potential confusion to the FDA
division responsible for reviewing
proposed new drug names from a public
health perspective, the Office of Drug
Safety’s Division of Medication Errors and
Technical Support (the “Division of
Medication Errors”). The Division of
Medication Errors had preliminarily
approved the name Altocor in November
2001.3 At that time, the Division stated
that the “name Advicor looks and sounds
similar [to] Altocor,” but concluded that
the “difference in the written strengths” of
the drugs reduced the risk of “error . . .
between the two products.” Id. at 269.
After Kos learned of the preliminary
approval, it sent a letter to the FDA, dated
March 6, 2002, stating that it was
“concerned that the similarity in the
proprietary names of these two products
may create confusion among health care
practitioners in terms of both prescribing
and dispensing these medications.” Id. at
250.
In April 2002, the Division of
Medication Errors reiterated its opinion
that “the difference in the strengths
(combination vs. single) will help ensure
that medication errors do not occur
between the two products.” Id. at 261. At
the same time, however, it concluded that
“the name, Altocor, [is] no longer
2 At oral argument, counsel for
Andrx -- apparently and inexplicably
unaware of these letters -- incorrectly
stated that Kos did not inform Andrx
directly of its view that Andrx’s
proposed mark was confusingly similar
to its own before Altocor went to market.
3 The Division of Medication
Errors was then known as the Office of
Post-Marketing Drug Risk Assessment.
For ease of reference, we use the current
name.

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4
acceptable due to the potential for
confusion with” a third, unrelated drug.
Id. at 258. When Andrx objected to
changing the name of its product, the
Division of Medication Errors, while “not
recommend[ing] the use of the proposed
name, Altocor,” gave conditional approval
to using the name so long as Andrx
“commit[ed] to submitting all potential
and actual errors involving Altocor . . .
[and] to changing the proprietary name,
Altocor, if two or more reports of actual
errors occur.” Id. at 256.4
Kos next raised its concerns with
the PTO. In May 2002, Kos filed an
opposition to Andrx’s application to
register the mark ALTOCOR. Some
discovery has been conducted in that
proceeding, but no decision has been
issued. According to the PTO docket, the
opposition is susp ende d pen din g
disposition of this civil litigation.
In July 2002, Andrx began
marketing Altocor. Thereafter, Kos
“advised Andrx of the growing number of
instances of actual confusion” on multiple
occasions. Id. at 75. For example, on
January 10, 2003, Kos sent Andrx’s
counsel a chart “setting forth . . .
occurrences of actual consumer confusion”
reported to it. Id. at 368. On February 20,
2003, Kos sent an updated chart, entitled
“Summary of Confusion Involving
Advicor and Altocor,” that listed 39
discrete instances of purported confusion.
Id. at 304-08 (listing incidents between
September 2, 2002 and February 12,
2003).
In the meantime, on December 5,
2002, Andrx filed with the FDA a
“supplemental new drug application
propos[ing] three alternate proprietary
names” for Altocor. Id. at 380. On April
11, 2003, Andrx filed an application with
the PTO to register the mark ALTOPREV.
And Andrx’s 2002 Annual Report, issued
in the spring of 2003, stated:
Andrx’s application for a
registered trademark for
Altocor has been opposed
by Kos Pharmaceuticals,
who alleges that there is a
likelihood of confusion
between Kos’ trademark,
Advicor, and Altocor.
Andrx has requested FDA
guidance on other names,
and may seek to change the
name of Altocor.
4 The precise terms of the
conditional FDA approval are in some
dispute, but are only tangentially relevant
to issues raised here. Andrx claims it
needed to change its mark only if there
were four actual errors the first year
Altocor was sold, and then only if the
errors were between Altocor and the
unrelated drug about which the FDA
expressed concern. JA at 345 (citing a
letter Andrx sent the FDA shortly before
the April 2002 Division of Medication
Errors document was issued). In that
letter, however, Andrx agreed to “submit
all reports” of medication errors “related
to Altocor” that it receives, not just those
involving Altocor and one particular
drug. Id. at 348.

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5
Id. at 374. The FDA approved Andrx’s
supplemental application on August 20,
2003, stating that “the proprietary name,
Altoprev, is acceptable.” Id. at 380.5
By August 2003, Kos had spent
more than $ 40 million on promotion and
advertising, and Advicor had been
prescribed more than 350,000 times,
grossing approximately $ 70 million in
sales. Andrx had spent more than $ 21
million on promotion and advertising, and
Altocor had been prescribed more than
300,000 times, grossing more than $ 27
million.
On August 6, 2003, Kos filed a
verified complaint, claiming that Andrx’s
use of the mark ALTOCOR on its
anticholesterol drugs constituted trademark
infringement and unfair competition under
the federal Lanham Act, and under state
and common law equivalents. Kos
accompanied the complaint with the
application for a preliminary injunction at
issue here. Neither party requested an
opportunity to adduce oral testimony on
the application.
The documentary evidence before
the district court included the following:
Evidence Regarding Actual
Confusion
Kos submitted the Certification of
its Vice President of Marketing, Aaron
Berg, dated August 5, 2003 (“Berg
Certification”),6 which stated, inter alia,
that Andrx’s use of the mark ALTOCOR
has caused confusion. Berg further stated
that “over 60 instances of actual confusion
between the two drugs have been
documented and reported to [him] by [his]
staff,” including “six patients [who]
received the wrong medication, either
because they had been given a sample of
one drug instead of the other, or because a
pharmacist filled a prescription with the
wrong drug.” Id. at 69. Based on his
“personal knowledge or [his] review of the
business records of Kos,” Berg described
“representative . . . instances” of the
incidents reported to him. Id. at 68, 71.
These included, for example, doctors
complaining to Kos representatives about
the pricing or insurance coverage of
Advicor, when their complaints were in
fact about Altocor, as well as medical
professionals identifying Altocor samples
5 Andrx claims that it no longer has
FDA approval to use this name, but
submitted no evidence to support that
claim.
According to records available on
the PTO website, a Notice of Allowance
for the ALTOPREV mark was issued on
February 24, 2004. We may take judicial
notice of such public records. See, e.g.,
Hoganas AB v. Dresser Indus., Inc., 9
F.3d 948, 954 n.27 (Fed. Cir. 1993);
Standard Havens Prods., Inc. v. Gencor
Indus., Inc., 897 F.2d 511, 514 n.3 (Fed.
Cir. 1990).
6 Andrx challenged the
admissibility and probative value of the
Berg Certification. JA at 41-44. The
district court never ruled on Andrx’s
objection.

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a s A d v i c o r s a m p l e s , A l t o c o r
representatives as Advicor representatives,
A l t o c o r c o nfere nces as A dvic o r
conferences, and vice versa.
Andrx submitted excerpts from
Berg’s deposition testimony, taken on June
12, 2003 in the PTO opposition
proceeding. There, Berg said he had not
had “direct contact” with the medical
professionals involved in any of the
reported incidents of confusion, but had
learned of those incidents primarily
through voice-mail or e-mail. Id. at 291.
Andrx contrasted Berg’s characterization
of one incident -- where, Berg said, a
patient whose “condition was improving .
. . asked his cardiologist for more of the”
Advicor his doctor had prescribed, but the
“cardiologist refilled the prescription with
Altocor,” id. at 71 -- with the following
more detailed description of the same
incident, sent to Berg by e-mail:
[A doctor] said that he had a
patient that he had put on
Advicor and when he went
to his cardiologist, . . . he
was due for a refill on
Advicor. The patient
returned . . . and [the doctor]
notice[d] that the medicine
listed was not Advicor, but
Altocor! . . . [T]he patient
t o l d h i m t h a t [ t h e
cardiologist] renewed his
Rx. [The doctor] did not
question [the cardiologist]
directly . . . ‘not my place to
? a cardiologist’. Up to that
point, the patient had been
doing well on the Advicor .
. . no reason to change!
Id. at 340. Andrx also countered the Berg
Certification with the declaration of its
Vice President for Regulatory Affairs,
Nicholas Farina, whose job requires him to
report to the FDA “every incidence of
actual confusion” involving Andrx in
which “a product other than the one
prescribed by a physician is dispensed by
a pharmacist and the patient leaves the
pharmacy.” Id. at 345. Farina said no
such incidents relating to Altocor had been
reported to Andrx as of the date of his
declaration, August 26, 2003. Id. at 346.
Medical Evidence
The parties submitted competing
medical affidavits to support their
respective views as to the nature and
severity of potential consequences of mis-
filled prescriptions.7 Per Kos, niacin --
and thus Advicor, but not Altocor -- may
cause serious injury, or even death, to
patients with various conditions or
sensitivities to the drug. Other, less
serious, side effects of niacin may worry
patients who have not been warned of
those effects, and who may thus
discontinue needed treatment. Patients
who mistakenly receive Altocor rather
7 Kos initially relied on the Berg
Certification for these medical issues, but
supplemented this -- at the hearing --
with a physician’s certification. The
district court’s order, issued the day after
the hearing, mentions only the initial
certification.

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than Advicor are also at risk, says Kos,
since the conditions the niacin is meant to
address will remain untreated. Andrx, on
the other hand, claims that the “safety
profile of both products is similar” and that
there need not be “any unusual concern”
about “harm to the public if the Andrx
product is substituted for the KOS
product.” Id. at 226.
Evidence Regarding Adoption of
Marks
The Berg Certification also
addressed selection of the ADVICOR and
ALTOCOR marks. Berg stated that Kos
chose ADVICOR as “a fanciful, made-up
name” that would be “an unusual,
distinctive name to make the drug stand
out to doctors as unique.” Id. at 73. He
asserted that a former Kos product
manager, Charles Schneider, “who was
actively participating in [Kos’s] naming
initiative” left Kos for Andrx during the
“naming process.” Id. at 73-74. Kos
submitted an e-mail, sent to Schneider
before his departure, that listed 42 possible
names that it was considering, of which 12
-- including ADVICOR and AVICOR --
were “already picked” by it as possible
names, and asked Schneider and one other
Kos employee to select ten “back up
names.” Id. at 356-57. Berg said Andrx
then applied to register “two closely
similar trademarks: AVICOR and
ALTOCOR” “[a]lmost immediately after”
Schneider arrived there. Id. at 74. Andrx
submitted a declaration from Schneider
stating that he “was never involved with
nor aware of the selection of the name
AD VICO R,” and that the “name
ALTOCOR was one of many . . .
generated by” an outside firm. Id. at 342.

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8
Evidence Regarding Other
Proceedings
Andrx submitted letters Kos sent
the European Community Trademark
Office in support of its application to
register ADVICOR over the mark
ACTIVOR, which was being used, not on
prescription anticholesterol drugs, but
rather on over-the-counter “stimulants and
preparations used to build up vitality.” Id.
at 329, 333. Kos argued there, inter alia,
that (1) the “opening syllable[s]” of the
marks (AD v. AC) are “not identical,”
which is important “since attention to a
polysyllabic word is normally focused on
the beginning,” id. at 328; (2) neither the
middle (VI v. TI) nor final (COR v. VOR)
syllables are identical; (3) the “suffix COR
. . . is very common in the pharmaceutical
Class 5 category,” id. at 329; (4) the
“functions [of the products] do not
overlap,” id.; (5) “there is little chance that
any doctor would confuse a prescription
cholesterol altering medication with an
over the counter product,” or that a
“qualified pharmacist” would do so, id. at
333; and (6) “the channels of distribution,
method of purchase and the targeted
customer is different in relation to the two
products,” id.
On September 17, 2003, after
hearing argument, the district court denied
Kos’s application for a preliminary
injunction from the bench. The court
issued a supplemental memorandum the
following day that incorporated the
“reasons . . . stated on the record during
oral argument” and provided additional
reasons for its decision. Id. at 13. The
court held that Kos had not shown that it
was likely to succeed on the merits, and
found, based in large part on its negative
assessment of Kos’s likelihood of success,
that Kos did not satisfy the other
prerequisites for extraordinary relief. Kos
filed this interlocutory appeal, and we
granted Kos’s request for an expedited
appeal schedule.
II. LEGAL STANDARDS AND
JURISDICTION
The test for preliminary relief is a
familiar one. A party seeking a
preliminary injunction must show: (1) a
likelihood of success on the merits; (2) that
it will suffer irreparable harm if the
injunction is denied; (3) that granting
preliminary relief will not result in even
greater harm to the nonmoving party; and
(4) that the public interest favors such
relief. Allegheny Energy, Inc. v. DQE,
Inc., 171 F.3d 153, 158 (3d Cir. 1999).
Preliminary injunctive relief is “an
extraordinary remedy” and “should be
granted only in limited circumstances.”
American Tel. & Tel. Co. v. Winback &
Conserve Program, Inc., 42 F.3d 1421,
1427 (3d Cir. 1994) (quotation omitted).
“[O]ne of the goals of the preliminary
injunction analysis is to maintain the status
quo, defined as the last, peaceable,
noncontested status of the parties.”
Opticians Ass’n of Am. v. Indep.
Opticians of Am., 920 F.2d 187, 197 (3d
Cir. 1990) (citation and quotation
omitted); see also 5 J. Thomas McCarthy,
McCarthy on Trademarks and Unfair
Competition § 30:50 (4th ed. 2003) (“The
status quo to be preserved is not the

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situation of contested rights . . . . In a
trademark case, [it] is the situation prior to
the time the junior user began use of its
contested mark: the last peaceable, non-
contested status.”).
We review the denial of a
preliminary injunction for “an abuse of
discretion, an error of law, or a clear
mistake in the consideration of proof.”
Winback, 42 F.3d at 1427 (quotation
omitted). “[A]ny determination that is a
prerequisite to the issuance of an
injunction . . . is reviewed according to the
standard applicable to that particular
determination.” Id. (second alteration in
original, quotation omitted). “Thus, we
exercise plenary review over the district
court’s conclusions of law and its
application of law to the facts, but review
its findings of fact for clear error, which
occurs when we are left with a definite and
firm conviction that a mistake has been
committed.” Duraco Prods., Inc. v. Joy
Plastic Enters., Ltd., 40 F.3d 1431, 1438
(3d Cir. 1994) (citations and quotation
omitted). “Despite oft repeated statements
that the issuance of a preliminary
injunction rests in the discretion of the trial
judge[,] whose decisions will be reversed
only for ‘abuse,’ a court of appeals must
reverse if the district court has proceeded
on the basis of an erroneous view of the
applicable law.” Apple Computer, Inc. v.
Franklin Computer Corp., 714 F.2d 1240,
1242 (3d Cir. 1983) (quotation omitted).
The district court had original
jurisdiction pursuant to 15 U.S.C. §
1121(a) and 28 U.S.C. § 1338, and we
have jurisdiction over this interlocutory
appeal pursuant to 15 U.S.C. § 1121(a)
and 28 U.S.C. § 1292(a).
III. LIKELIHOOD OF SUCCESS ON
THE MERITS
To prevail on a claim for trademark
infringement or unfair competition under
the Lanham Act, the owner of a valid and
legally protectable mark, such as Kos,
must show that a defendant’s use of a
similar mark for its goods “causes a
likelihood of confusion.” A & H
Sportswear, Inc. v. Victoria’s Secret
Stores, Inc., 237 F.3d 198, 210 (3d Cir.
2000).8 This Court has adopted a non-
exhaustive list of factors to consider in
evaluating likelihood of confusion,
commonly referred to as the “Lapp
factors.” See Interpace Corp. v. Lapp,
Inc., 721 F.2d 460, 463 (3d Cir. 1983).
These factors were developed for cases
involving non-competing products. Id. at
8 See 15 U.S.C. § 1114(1)(a)
(defining infringement as the
unauthorized use of a “colorable
imitation of a registered mark in
connection with the sale, offering for
sale, distribution or advertising of any
goods or services on or in connection
with which such use is likely to cause
confusion, or to cause mistake, or to
deceive”); 15 U.S.C. § 1125(a)(1)
(creating cause of action for use “in
connection with any goods . . . [of] any
word, term [or] name . . . likely to cause
confusion, or to cause mistake, or to
deceive as to . . . the origin, sponsorship,
or approval of [those] goods . . . by
another person”).

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10
462. Although we have held that courts
“‘need rarely look beyond the mark itself’”
in cases involving competing goods, we
recently recognized that “consideration of
the Lapp factors . . . can be quite useful for
determining likelihood of confusion even
when the goods compete directly.” A &
H, 237 F.3d at 212 (quoting Lapp, 721
F.2d at 462). Because some of the initial
Lapp factors were “not apposite for
directly competing goods,” we “adapted
[them] to make them applicable whether
the products directly compete or not.” Id.
at 212-13. As adapted, the factors are:
(1) the degree of similarity
between the owner’s mark
and the alleged infringing
mark;
(2) the strength of the
owner’s mark;
(3) the price of the goods
and other factors indicative
of the care and attention
expected of consumers
when making a purchase;
(4) the length of time the
defendant has used the mark
without evidence of actual
confusion arising;
(5) the intent of the
defendant in adopting the
mark;
(6) the evidence of actual
confusion;
(7) whether the goods,
competing or not competing,
are marketed through the
same channels of trade and
advertised through the same
media;
(8) the extent to which the
targets of the parties’ sales
efforts are the same;
(9) the relationship of the
goods in the minds of
consumers, whether because
of the near-identity of the
products, the similarity of
function, or other factors;
(10) other facts suggesting
that the consuming public
might expect the prior
owner to manufacture both
products, or expect the prior
owner to manufacture a
product in the defendant’s
market, or expect that the
prior owner is likely to
expand into the defendant’s
market.
Id. at 215. “None of these factors is
determinative in the likelihood of
confusion analysis and each factor must be
weighed and balanced one against the
other.” Checkpoint Sys., Inc. v. Check
Point Software Techs., Inc., 269 F.3d 270,
280 (3d Cir. 2001). Each factor is
“weighed . . . separately,” which “is not to
say that all factors must be given equal
weight.” Fisons Horticulture, Inc. v.
Vigoro Indus., Inc., 30 F.3d 466, 476 &
n.11 (3d Cir. 1994). “[T]he different
factors may properly be accorded different
weights depending on the particular factual
setting. A district court should utilize the

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11
factors that seem appropriate to a given
situation.” A & H, 237 F.3d at 215. The
Lapp factors are best understood as “tools
to guide a qualitative decision.” Id. at 216.
Here, the district court held that two
of the factors -- strength of the owner’s
mark, and the extent to which the parties’
sales efforts are the same -- favored Kos,
but that “the remaining Lapp factors do
not.” JA at 10-11. The court found
“[s]uccess on these two Lapp factors . . .
insufficient to persuade [it] that confusion
is likely to occur.” Id. at 9. It further
found that Kos “failed to convince [it] that
the selective consumers in this case,
physicians and pharmacists, will suffer
from a likelihood of confusion.” Id. at 9.
The opinion analyzed only the two factors
the court found weighed in Kos’s favor.
As to the remaining factors, the court said
only that, “[a]fter carefully evaluating the
Lapp test in its entirety, [it] concludes that
there is no likelihood of confusion.” Id. at
11.
We recognize that district courts
must exercise their discretion on an
expedited basis in deciding whether to
grant preliminary relief. Although we
ordinarily defer to that discretion, we
cannot do so if it was exercised under a
mistaken view of the law. Here, two
fundamental errors of law taint the district
court opinion: (1) the court used an overly
narrow definition of confusion, in effect
evaluating the likelihood of misdispensing
rather than confusion; (2) the court did not
properly analyze or weigh the Lapp
factors.

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First, the hearing transcript betrays
a focus on whether prescriptions are likely
to be mis-filled, to the apparent exclusion
of all other types of confusion with which
the Lanham Act is concerned. For
example:
MR. YOUNG [Counsel for
Kos]: . . . The Lanham Act
d o e s n ’ t r e q u i r e
misdispensing. What we
have seen is, a lot of doctors
are saying --
THE COURT: Yes, but
misdispensing is the basis
for confusion.
MR. YOUNG: That’s
powerf ul evidence of
confusion. But what’s also
h a p p e n i n g i n t h e
marketplace is, doctors are
saying, Look, I’m not going
to prescribe either drug
because I can’t keep them
straight. . . .
. . .
THE COURT: Well, if that
were the case, then I guess
there’s no concern about
adverse health effects to the
patient, because they’re not
getting the wrong drug;
they’re getting another drug
that the doctor wants them
to have.
JA at 52 (emphasis added). Similarly:
MR. LITE [Counsel for
Andrx]: . . . A prudent
pharmacist cannot fill the
wrong prescription. It’s
impossible to fill the wrong
prescription.
THE COURT: That’s my
point: . . . that because of
the types of dosages, if they
have the wrong name, if
they have a name with the
w r o n g d o s a g e , t h e y
wouldn’t . . . be able to fill
that prescription.
MR. LITE: T h a t ’ s
absolutely correct, Your
Honor.
THE COURT: So there
can’t be confusion, you’re
saying.
MR. LITE: Well, I don’t
t h i n k t h e r e c a n b e
confusion. There can’t,
certainly, be confusion in
t h e p r e s c r i b i n g o r
dispensing of these drugs. .
. .
Id. at 39-40. Much of the balance of the
colloquy focused on the possibility, and
potential danger, of misdispensing.9 As
9 The court’s extensive focus on
misdispensing may reflect consideration
of Kos’s “public interest” argument (that
the chance of serious injury made
preliminary relief essential) as well as a
narrow view of the element of confusion.
See, e.g., JA at 20:20; id. at 21:3-22; id.
at 25:4-14, id. at 31:4-33:20; id. at 34:5-

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13
noted above, the district court opinion
incorporates the reasons articulated by the
court at oral argument. These statements
are thus a powerful indicator that the
court’s “likelihood of confusion” analysis
rested substantially, if not entirely, on
misdispensing as the confusion at issue.
This is not the law. It is clear error to treat
misdispensing as the only relevant Lanham
Act confusion.
The Lanham Act defines trademark
infringement as use of a mark so similar to
that of a prior user as to be “likely to cause
confusion, or to cause mistake, or to
deceive.” 15 U.S.C. § 1114(1).
Likelihood of confusion under the Lanham
Act is not limited to confusion of products,
as in misdispensing. Confusion as to
source is also actionable. See, e.g., Fisons,
30 F.3d at 472 (“[L]ikelihood of confusion
. . . exists when the consumers viewing the
mark would probably assume that the
product . . . it represents is associated with
the source of a different product . . .
identified by a similar mark.”) (quotation
omitted). We recently described how the
1962 amendments to the Lanham Act
broadened the scope of trademark
protection beyond the traditional source-
of-origin confusion. Checkpoint, 269 F.3d
at 295 (citing deletion of the phrase
“purchasers as to the source of origin of
such goods or services” from the end of
the former definition, which now reads
“likely to cause confusion, or to cause
mistake, or to deceive”).
The Act is now broad enough to
cover “the use of trademarks which are
likely to cause confusion, mistake, or
deception of any kind, not merely of
purchasers nor simply as to source of
origin.” Syntex Labs., Inc. v. Norwich
Pharmacal Co., 437 F.2d 566, 568 (2d Cir.
1971) (emphasis added); see, e.g.,
Checkpoint, 269 F.3d at 295 (overly
narrow view of confusion “would
undervalue the importance of a company’s
g o o d w i l l w i th it s c u st om e r s ” );
Morningside Group Ltd. v. Morningside
Capital Group, L.L.C., 182 F.3d 133, 141
(2d Cir. 1999) (reversing due to lower
court’s use of “inordinately narrow
definition of actual confusion” that
ignored “actual confusion regarding
affiliation or sponsorship”); Meridian
Mutual Ins. Co. v. Meridian Insurance
Group, Inc., 128 F.3d 1111, 1118 (7th Cir.
1997) (context of confusion “immaterial”
because any injury to goodwill or loss of
control over reputation is actionable);
Champions Golf Club, Inc. v. Champions
Golf Club, Inc., 78 F.3d 1111, 1119-20
(6th Cir. 1996) (relevant evidence of
confusion goes beyond purchaser
confusion and includes “confusion among
nonpurchasers” in order to “protect the
manufacturer’s reputation”); Fuji Photo
Film Co. v. Shinohara Shoji Kabushiki
Kaisha, 754 F.2d 591, 596 (5th Cir. 1985)
(actionable confusion includes any use
“likely to confuse purchasers with respect
to . . . [a product’s] endorsement by . . ., or
its connection with[,] the plaintiff”).
Second, the district court failed to
“employ all the relevant Lapp factors and
weigh each factor to determine whether in
13; id. at 35:4-36:20; id. at 37:19-40:15;
id. at 42:10-18; id. at 48:16-52:25.

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14
the totality of the circumstances
marketplace confu sio n is like ly.”
Checkpoint, 269 F.3d at 296 (emphasis
added). Despite recognizing that “‘each
factor must be weighed and balanced,’”
the court did not perform the requisite
weighing and balancing on the record. JA
at 8 (quoting Checkpoint, 269 F.3d at
280). The Lapp test is not a mechanistic
one. It need not be “followed precisely so
long as the relevant comparisons suggested
by the test are made.” A & H, 237 F.3d at
207. But if a district court finds “certain
of the Lapp factors are inapplicable or
unhelpful in a particular case,” that court
should “explain its choice not to employ
those factors.” Id. at 214 n.8. Here, the
court analyzed only two of the ten Lapp
factors -- both of which it found favored
Kos. The court’s conclusory statement
that “the remaining Lapp factors do not
[weigh in Petitioner’s favor],” JA at 10-11,
does not explain the basis for its holding as
to each factor, whether it viewed each as
neutral, irrelevant, or favorable to Andrx,
or how it weighed and balanced the
combined factors. The opinion thus does
not make the “relevant comparisons”
which the Lapp test identifies. Compare
Fisons, 30 F.3d at 481 (reversing because
“district court misapplied some [Lapp
factors] and did not consider others”) with
A& H, 237 F.3d at 215-16 (affirming since
“ostensibly missing Lapp factors appear to
be incorporated into the District Court’s
test,” which was “functionally similar to
the Lapp test”).10
When reviewing an order that does
not adequately support the resolution of a
motion for preliminary injunction, we may
vacate and remand for additional findings
or may “first look[] to see whether the
record provides a sufficient basis to
ascertain the legal and factual grounds for
the grant or denial of the injunction.”
Bradley v. Pittsburgh Bd. of Educ., 910
F.2d 1172, 1178 (3d Cir. 1990). Although
a district court’s application of an incorrect
legal standard “would normally result in a
remand, we need not remand” if
application of the correct standard could
10 The court’s failure to explain its
conclusions as to each Lapp factor also
runs afoul of Rule 52(a), which requires
courts to “set forth the findings of fact
and conclusions of law which constitute
the grounds” for “granting or refusing
interlocutory injunctions.” Fed. R. Civ.
P. 52(a). “[F]air compliance with Rule
52(a)” is “of the highest importance to a
proper review of the action of a court in
granting or refusing a preliminary
injunction.” Mayo v. Lakeland
Highlands Canning Co., 309 U.S. 310,
316 (1940). A district court’s factual
findings and legal conclusions must
“explain the basis for” and “permit
meaningful review of its ruling.” Elliott
v. Kiesewetter, 98 F.3d 47, 55 (3d Cir.
1996) (quotation omitted). “[T]he
conclusions of law must carefully
enunciate and explain the trial court’s
resolution of questions of law, so that the
appellate court is able to conduct a just
and orderly review of the rights of the
parties.” 9 James Wm. M oore et al.,
Moore’s Federal Practice § 52.15[3] (3d
ed. 2000).

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15
support only one conclusion. Duraco
Prods., Inc. v. Joy Plastic Enters., Ltd., 40
F.3d 1431, 1451 (3d Cir. 1994) (affirming
denial of preliminary injunction where
plaintiff could not demonstrate likelihood
of success even “with the evidence viewed
in the light most favorable to it”); see also
Opticians, 920 F.2d at 198; Lapp, 721 F.2d
at 460 (reversing and directing entry of
judgment). Our holding in Opticians is
instructive. There, we reversed due to
legal error and went on to assess the
likelihood of confusion, which the district
court had not addressed. Id. at 194-95
(“Likelihood of confusion is a fact
normally reviewable under the clearly
erroneous standard. Our review, however,
is plenary since there is no dispute as to
the facts relevant to this issue.”). Rather
than remanding for the district court to
exercise its discretion in the first instance,
we determined that plaintiff had made all
necessary showings on the undisputed
facts of record and directed entry of a
preliminary injunction. Id. at 196-98.
Here, we will review the findings
and conclusions of the district court and
the factual assertions and contentions of
the parties in light of the controlling legal
principles to see whether the facts and law
compel a particular result. If so, it would
be a waste of judicial resources to remand
for reweighing.
A. The Individual Lapp Factors
1. Degree of Similarity of the
Marks
“The single most important factor
in determining likelihood of confusion is
mark similarity.” A & H, 237 F.3d at 216;
see also id. at 214 (“[W]hen goods are
directly competing, both precedent and
common sense counsel that the similarity
of the marks takes on great prominence.”).
Marks “are confusingly similar if ordinary
consumers would likely conclude that [the
two products] share a common source,
affiliation, connection or sponsorship.”
Fisons, 30 F.3d at 477. The proper test is
“not side-by-side comparison” but
“whether the labels create the same overall
impression when viewed separately.” Id.
(quotation and citation omitted). Courts
should “compare the appearance, sound
and meaning of the marks” in assessing
their similarity. Checkpoint, 269 F.3d at
281 (quotation omitted). There is no
simple rule as to when marks are too
similar. “The degree of similarity . . .
needed to prove likely confusion will vary
with the difference in the goods . . . of the
parties. Where the goods . . . are directly
competitive, the degree of similarity
required to prove a likelihood of confusion
is less than in the case of dissimilar
products.” 3 McCarthy, supra, § 23:20.1.
The district court made no findings
as to the degree of similarity of the
ADVICOR and ALTOCOR marks; it
merely concluded that this factor does not
favor Kos.
The facts predicate to this analysis
are manifest and undisputed. The facial
similarity of the marks is apparent “on
their face.” Both are seven-letter, three-
syllable words that begin and end with the
same letters and the same sounds. The
marks are also similar in that both are

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16
“coined word[s], not found even in
approximation in the English or any other
familiar language.” Telechron, Inc. v.
Telicon Corp., 198 F.2d 903, 905 (3d Cir.
1952). “Fanciful marks are . . . given an
expansive scope of judicial protection . . .
as to more variations of format.” 2
McCarthy, supra, § 11:6. Two names that
look and sound similar will naturally seem
even more similar where there are no
differences in meaning to distinguish
them. Nor can the similarity of coined
marks be explained by, or ameliorated by
virtue of, any relationship between the
marks and the products identified. See,
e.g., Telechron, 198 F.2d at 909
(Defendant “cannot claim that he is
exercising the normal privilege of using
ordinary language . . . [in] a case of a first
coined word and a second coined word
resembling it.”); Lambert Pharmacal Co. v.
Bolton Chem. Corp., 219 F. 325, 326
(S.D.N.Y. 1915) (Hand, J.) (One who has
“adopt[ed a] . . . trade name, arbitrary in
character, . . . has the right to insist that
others in making up their arbitrary names
should so certainly keep away from his
customers as to raise no question.”).
Andrx would differentiate the
marks by distinguishing what it deems
unimportant features (namely, “the first
letter ‘A’ and the suffix ‘COR’”) from
those that are “salient” (the “first
syllables”). Appellees’ Br. at 19-20.
Andrx argues that the “first syllables (AD
compared to AL) . . . create a completely
different sight, sound and impression.” Id.
at 20 (emphasis added). But the proper
legal test is not whether there is some
confusing similarity between sub-parts of
the marks; the overarching question is
whether the marks, “viewed in their
entirety,” are confusingly similar. A & H,
237 F.3d at 216 (emphasis added). Cf.
Fisons, 30 F.3d at 478 (“[T]he district
court misapprehended the legal standard
when it undertook a detailed analysis of
the differences in the marks rather than
focusing on the overall impression created
by them.”).
Andrx attempts to, but cannot,
justify its approach by characterizing
statements Kos made in European
trademark proceedings as “admissions that
directly contradict its position before this
Court and the district court.” Appellees’
Br. at 10. The European proceeding
involved different marks (ADVICOR v.
ACTIVOR), different goods, and different
legal standards than those at issue here.
Kos’s statements in those proceedings
show that the material facts are not
equiv alent. For e x a m p l e , K os
distinguished Advicor from the over-the-
counter “stimulants and preparations to
build up vitality” at issue there by arguing,
inter alia, that “their functions do not
overlap,” and that they have different
“channels of distribution, method[s] of
purchase and . . . targeted customer[s].”
JA at 329, 333. More importantly, Kos’s
claims in those proceedings are all
premised on European Community law.
Trademark standards do not traverse
international borders. “The concept of
territoriality is basic to trademark law;
trademark rights exist in each country
solely according to that country’s statutory
scheme.” Fuji Photo, 754 F.2d at 599
(finding it “error to admit evidence of the

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17
parties’ foreign trademark practices”); see
also E. Remy Martin & Co. v. Shaw-Ross
Int’l Imports, Inc., 756 F.2d 1525, 1531
(11th Cir. 1985) (district court erred in
considering status of parties’ marks in
France; “Our concern must be the business
and goodwill attached to United States
trademarks, not French trademark rights
under French law.”) (quotation omitted);
Vanity Fair Mills v. T. Eaton Co., 234
F.2d 633, 639 (2d Cir. 1956) (“[W]hen
trade-mark rights within the United States
are being litigated in an American court,
the decisions of foreign courts concerning
the respective trade-mark rights of the
parties are irrelevant and inadmissible.”).
Andrx also claims that “[t]he FDA
and the USPTO have determined that the
marks are not confusingly similar.”
Appellees’ Br. at 19. But neither of those
proceedings can supplant the required
Lanham Act analysis. First, the FDA
applies a standard different from the
Lanham Act “likelihood of confusion” test
at issue here. The FDA reviews proposed
drug names “to predict potential confusion
that may arise in the actual prescription
process.” 3 McCarthy, supra, § 19:149
(emphasis added); see also id. at § 19:150
(FDA “likelihood of confusion test [is]
wholly distinct from the test employed by
the PTO”). As discussed above,
misdispensing is not the only type of
confusion actionable under the Lanham
Act. Indeed, to the extent that the FDA’s
proprietary name review is relevant here,
the reviewing division’s statement that the
“name Advicor looks and sounds similar
[to] Altocor” actually supports Kos’s
claim. See JA at 269.
Second, the PTO has not allowed
Andrx to register the ALTOCOR mark.
As stated above, Kos’s opposition remains
pending. Andrx’s claim about a favorable
PTO determination presumably rests on
the examining attorney’s decision
approving publication of the ALTOCOR
mark for opposition.11 The record contains
no information about the basis for the
publication decision or about what
information was before the examining
attorney at that time. Thus, the record
does not show that the PTO actually
considered the registrability of ALTOCOR
over ADVICOR, much less that it found
the marks not to be confusingly similar.
Cf. Marketing Displays, Inc. v. TrafFix
Devices, Inc., 200 F.3d 929, 934 (6th Cir.
1999) (rejecting claim that registration of
allegedly infringing mark creates inference
that “the trademark examining attorney at
the PTO actually examined the [earlier]
mark and found that the [registered] mark
11 We caution that Andrx’s apparent
shorthand characterization of this low-
level decision as a PTO determination
seems somewhat misleading, as do such
statements as, for example, “the USPTO
approved the mark.” Appellees’ Br. at
35. Publication of a mark is not
equivalent to its allowance or
registration; the PTO issues a Certificate
of Registration only if “all oppositions
filed” after publication are dismissed. 37
C.F.R. § 2.81. Reference to PTO action
is more naturally understood as
allowance (or denial) of an application
rather than publication of a mark,
especially where an opposition is filed.

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18
did not infringe it”), rev’d on other
grounds, 532 U.S. 23 (2001). Indeed, even
where the record shows that an examining
attorney has explicitly considered a prior
mark, we have held that an “initial PTO
determination . . . may be considered [but]
need not be given weight when the PTO
attorney did not review all the evidence
available to the District Court.” A & H,
237 F.3d at 221 (affirming decision that
gave “no weight” to “low-level
preliminary decision” even though
examiner assessed likelihood of confusion
with prior mark).
We hold that the district court
clearly erred in failing to recognize that
this factor weighs in Kos’s favor. It does.
2. Strength of the Owner’s
Mark
The record supports the district
court’s finding that this factor weighs in
favor of Kos. The court properly analyzed
both the conceptual and commercial
strength of the ADVICOR mark. Andrx
argues that this factor does not favor Kos
because ALTOCOR and ADVICOR are
similarly distinctive and have similar
strength in the marketplace. But the
relative strength of the Andrx’s mark is not
relevant here. The second Lapp factor
looks to “the strength of the owner’s
mark.” Lapp, 721 F.2d at 463 (emphasis
added). “Under the Lanham Act, stronger
marks receive greater protection” because
they “carry greater recognition, [so that] a
similar mark is more likely to cause
confusion.” A & H, 237 F.3d at 222. It
would not serve the purposes of the
Lanham Act for trademark owners to
receive less protection from strong
infringing marks than weak ones. Indeed,
it might be argued that a stronger junior
mark is more likely to cause confusion, at
least where, as here, both marks are being
used in the same market.
3. Factors Indicative of the
C a r e a n d A t t e n t i o n
Expected of Consumers
The third Lapp factor weighs
against finding a likelihood of confusion
“[w]hen consumers exercise heightened
care in evaluating the relevant products
before making purchasing decisions.”
Checkpoint, 269 F.3d at 284. The district
court held that Kos did not “convince [it]
that the selective consumers in this case,
physicians and pharmacists, will suffer
from a likelihood of confusion.” JA at 9.
The opinion provided no basis for this
conclusion, but did incorporate the
“reasons . . . stated on the record during
oral argument.” Id. at 13. There, the
judge stated that he thought the differences
in the dosage of each drug made errors in
filling prescriptions unlikely. E.g., id. at
49 (“[I]t seems to me because of the
dosage that has to be made part of the
prescription that the pharmacist would
have to ignore some aspect of such a
prescription to make a mistake.”). The
court did not analyze the likelihood of any
t yp e o f c o n f u s i o n o t h e r t h a n
misdispensing.
The district court and the parties
treated medical professionals, such as
doctors, nurses and pharmacists, as the

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19
relevant consumers.12 These trained
professionals may be expected to be
knowledgeable about, and to exercise care
in distinguishing between, medicines. We
have emphasized a countervailing concern
that weighs against allowing the expertise
of physicians and pharmacists to trump
other factors in assessing the likelihood of
confusion in drug cases. “Prevention of
confusion and mistakes in medicines is too
vital to be trifled with” since “[c]onfusion
in such products can have serious
c o n s e q u e n c es f o r t h e p a t i e n t . ”
Morgenstern Chem. Co. v. G.D. Searle &
Co., 253 F.2d 390, 393 (3d Cir. 1958)
(quotation omitted). “[P]hysicians are not
immune from confusion or mistake.” Id.
(quotation omitted); see also Syntex Labs.,
Inc. v. Norwich Pharmacal Co., 437 F.2d
566, 569 (2d Cir. 1971) (since confusion
of prescription drugs “could result in
physical harm to the consuming public,” a
“stricter standard in order to prevent
likelihood of confusion seems desirable”).
Other jurisdictions and a uthorities
similarly recognize that “greater care
should be taken to avoid confusion in
connection with medications which affect
the health of the patient.” 3A Louis
Altman, Callman on Unfair Competition,
Trademarks & Monopolies § 21:10 & nn.
121-132 (4th ed. 2003) (collecting cases
and authorities).
In assessing how customer
sophistication should be weighed “[w]ith
respect to pharmaceuticals,” the “expertise
of the physicians and pharmacists may be
outweighed by” this need for heightened
care. Id. at § 21:12 & n.24 (emphasis
added). Where both professionals and the
general public are relevant consumers,
“the standard of care to be exercised . . .
will be equal to that of the least
sophisticated consumer in the class.”
Checkpoint, 269 F.3d at 285. In
Morgenstern, we criticized the district
court for weighing the “high standards of
care” expected of “physicians and
pharmacists” more heavily than the
“obvious similarity in derivation,
suggestiveness, spelling, and sound in
careless pronunciation between [the
marks] as applied to pills to be taken by
12 We note that neither the parties
nor the court below addressed the
possible confusion of ultimate
consumers. While doctors and
pharmacists play a gate-keeping role
between patients and prescription drugs,
they are not the ultimate consumers.
Patients are. Courts have noted that
drugs are increasingly marketed directly
to potential patients through, for
example, “ask-your-doctor-about-Brand-
X” style advertising. See, e.g., Puritan-
Bennett Corp. v. Penox Techs. Inc., No.
IP 02-0762-C, 2004 WL 866618, at * 4
(S.D. Ind. Mar. 2, 2004) (admitting
evidence of patient confusion as to
medical devices available only by
prescription but advertised directly to
patients because patients “are a part of,
although not the entire, relevant
market”); Upjohn Co. v. American Home
Prods. Corp., No. 1:95CV237, 1996 WL
33322175, at *4 (W.D. Mich. Apr. 5,
1996) (patients are among relevant
consumers for prescription drugs whose
marketing targets them).

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20
mouth for therapeutic purposes.” 253 F.2d
at 392. Recognizing that doctors and
pharmacists “are carefully trained to detect
differences in the characteristics of
pharmaceutical products,” we held that
this “does not open the door to the
adoption by manufacturers of medicines of
trade-marks or names which would be
confusingly similar to anyone not
exercising such great care.” Id. at 393
(emphasis added).13 See also 3 McCarthy,
supra, § 23:32 (“[I]t is proper to require a
lesser quantum of proof of confusing
similarity for drugs and m edicinal
preparations. . . . [For] prescription drugs,
[this] rule . . . should control over the
supposed ‘sophistication’ of physicians
and pharmacists.”) (emphasis added).
Andrx argues that confusion is even
less likely here than in other cases
involving medical professionals since
prescriptions must reflect the different
chemical composition of the drugs, with
Advicor prescriptions specifying strengths
of two active ingredients, and Altocor only
one. Of course, this difference in
prescribing is not relevant to the common
practice of providing samples or to any
t y p e o f c o n f u s i o n o t h e r t h a n
misdispensing. There is no reason to
believe that medical expertise as to
products will obviate confusion as to
source or affiliation or other factors
affecting goodwill. “It is well settled that
expertise in the field of trademarks cannot
13 At oral argument, the question
was raised whether Morgenstern creates
a different standard for drug cases --
“possibility of confusion” rather than
“likelihood of confusion” -- and, if so,
whether it is good law. Compare
Morgenstern, 253 F.2d at 394 (“If there
is any possibility of . . . confusion in the
case of medicines public policy requires
that the use of the confusingly similar
name be enjoined.”) with A & H
Sportswear, Inc. v. Victoria’s Secret
Stores, Inc., 166 F.3d 197, 205 (3d Cir.
1999) (en banc) (“[T]he appropriate
standard for determining trademark
infringement under the Lanham Act is
the likelihood of confusion.”). But cf.
Morgenstern, 253 F.2d at 392 (test for
infringement is whether marks are so
similar “that ordinary purchasers, buying
with ordinary caution, are likely to be
misled”) (quotation omitted, emphasis
added).
We need not consider the
applicability of the discredited
“possibility of confusion” standard. Kos
conceded at oral argument that the proper
standard is “likelihood of confusion,”
relying on Morgenstern for the
proposition that “the potential harm from
a mistake warrants closer scrutiny” in
such cases. Audio Tape of Oral
Argument before Court of Appeals for
the Third Circuit (Mar. 9, 2004) (on file
with Court). Morgenstern’s holding --
that drug manufacturers cannot use
marks that would be confusingly similar
to non-experts -- may be best understood
as a warning that medical expertise is not
enough, in and of itself, to lessen the
likelihood of confusion in prescription
drug cases.

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21
be inferred from expertise in another area.”
Fuji Photo, 754 F.2d at 595 (collecting
cases); see also Altman, supra, § 21:10 &
n.139 (“[I]t has been held that the care
with which consumers select a product
does not impact the association they may
make regarding sponsorship of another
product or service; therefore even a high
degree of care would have little effect on
confusion of sponsorship.”); cf. Sterling
Drug Inc. v. Lincoln Labs., Inc., 322 F.2d
968, 971 (7th Cir. 1963) (that defendant’s
product requires prescription does not
“eliminat[e] the likelihood of confusion as
to source of origin” for medical products
“designed to remedy the same condition in
. . . [and] purchased and used by the same
classes of persons”); Champions, 78 F.3d
at 1121 (6th Cir. 1996) (sophistication of
consumers, who exercise great care in
joining golf club, does not preclude
confusion “about affiliation between the
two clubs”).
The district court did not err in
holding that this factor does not favor Kos.
We conclude, however, that no reasonable
factfinder could weigh it heavily for
Andrx.
4/6. Length of Time Defendant’s
Mark Has Been Used
W i t h o u t C o n f u s i o n /
E v i d e n c e o f A c t u a l
Confusion
Per the fourth Lapp factor, two
parties’ concurrent use of “similar marks
for a sufficient period of time without
evidence of consumer confusion about the
source of the products” allows “an
inference that future consumers will not be
confused either.” Fisons, 30 F.3d at 476.
The sixth Lapp factor looks at evidence of
actual confusion.
The district court recited Kos’s
claim that, in the thirteen months since
ALTOCOR was first sold,14 “at least six
patients have received the wrong
medication due to confusion between the
drugs’ names” and “over sixty instances of
actual confusion [have been] reported to
[Kos].” JA at 6. Yet the court
conspicuously failed to analyze either
Lapp factor concerned with actual
confusion or to explain why these factors
did not favor Kos in light of the incidents
Kos identified.
a. Admissibility of Berg
Certification
Before we reach the substantive
issue of actual confusion, we must
consider the evidentiary status of the Berg
Certification on which Kos’s claims about
such confusion rest. Andrx challenges the
admissibility and reliability of the Berg
Certification, which it deems “self-serving,
unreliable and uncorroborated hearsay”
that “is an insufficient basis for the
issuance of preliminary relief in a
14 Compare Scott Paper Co. v.
Scott’s Liquid Gold, Inc., 589 F.2d 1225,
1230 (3d Cir. 1978) (citing “over forty
years” of concurrent use “without any
evidence of actual confusion” in finding
no likelihood of confusion).

-- 21 of 39 --

22
trademark matter.” Appellees’ Br. at 25.15
We have considered the possibility
that the district court’s conclusory finding
as to these Lapp factors was based on its
acceptance of the objections Andrx raised
below to the Berg Certification. While it
is implicit in the district court’s holding
that it found the Berg Certification
insufficient to show actual confusion,
nothing in the record suggests that it
sustained Andrx’s objections to the
admissibility or credibility of the document
itself. See, e.g., JA at 41. Indeed, in its
opinion, the court twice took cognizance
of the Certification with no indication that
it viewed the document as inadmissible,
inherently unreliable, or otherwise
unworthy of consideration. Id. at 6, 12.
Nor do we agree with Andrx that
the Berg Certification is an inadequate
basis for preliminary relief because it
contains multiple levels of hearsay and is
not based solely on personal knowledge.
It is well established that “a preliminary
injunction is customarily granted on the
basis of procedures that are less formal and
evidence that is less complete than in a
trial on the merits.” University of Texas v.
Camenisch, 451 U.S. 390, 395 (1981). In
keeping with this principle, many of our
sister Circuits have recognized that
“[a]ffidavits and other hearsay materials
are often received in preliminary
injunction proceedings.” Asseo v. Pan
Am. Grain Co., 805 F.2d 23, 26 (1st Cir.
1986); see also Ty, Inc. v. GMA
Accessories, Inc., 132 F.3d 1167, 1171
(7th Cir. 1997) (citing Asseo); Levi
Strauss & Co. v. Sunrise Int’l Trading,
Inc., 51 F.3d 982, 985 (11th Cir. 1995)
(“At the preliminary injunction stage, a
district court may rely on affidavits and
hearsay materials which would not be
admissible evidence for a permanent
injunction . . . .”); Sierra Club, Lone Star
Chapter v. FDIC, 992 F.2d 545, 551 (5th
Cir. 1993) (courts at preliminary injunction
stage “may rely on otherwise inadmissible
evidence, including hearsay”); Flynt
Distrib. Co. v. Harvey, 734 F.2d 1389,
1394 (9th Cir. 1984) (“The urgency of
obtaining a preliminary injunction . . .
makes it difficult to obtain affidavits from
persons who would be competent to testify
at trial. The trial court may even give
inadmissible evidence some weight . . . .”);
cf. Heideman v. South Salt Lake City, 348
F.3d 1182, 1188 (10th Cir. 2003) (“The
Federal Rules of Evidence do not apply to
preliminary injunction hearings.”).
These cases are consistent with the
lack of any rule in the preliminary
injunction context akin to the strict rules
governing the form of affidavits that may
be considered in summary judgment
proceedings. Compare Fed. R. Civ. P.
56(e) (affidavits on summary judgment
15 Our holding in Versa Products.
Co. v. Biford Co., 50 F.3d 189 (3d Cir.
1995) does not support Andrx’s
argument that “[such] double hearsay is
an insufficient basis for . . . preliminary
relief in a trademark matter.” See
Appellees’ Br. at 25 (citing Versa Prods.,
50 F.3d at 212). Versa Products was an
appeal from a final judgment after a
bench trial; its holding is not relevant in
the preliminary injunction context.

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23
“shall be made on personal knowledge,
shall set forth such facts as would be
admissible in evidence, and shall show
affirmatively that the affiant is competent
to testify to the matters stated therein”)
with Fed. R. Civ. P. 65 (no similar
provision in rule governing preliminary
injunctions). See also 11A Charles Alan
Wright et al., Federal Practice &
Procedure § 2949 (2d ed. 1995) (“[A]
consideration of the different policies that
underlie Rules 56 and 65 indicates [that
the Rule 56(e) standard] should not be
imposed on applications under the latter
rule.”).
District courts must exercise their
discretion in “weighing all the attendant
factors, including the need for expedition,”
to assess whether, and to what extent,
affidavits or other hearsay materials are
“appropriate given the character and
objectives of the injunctive proceeding.”
Asseo, 805 F.2d at 26. The weight to
which such materials are entitled may of
course vary greatly depending on the facts
and circumstances of a given case.16
Under the circumstances here, we find that
the district court’s implicit admission of
the Berg Certification for use at this
preliminary stage was not clearly
erroneous.
Moreover, we note that some of the
evidence of actual confusion in the Berg
Certification would be admissible even if
compliance with the Federal Rules of
Evidence or the strictures governing Rule
56(e) affidavits were required. The first
level of hearsay analysis concerns the
underlying statements said to show
confusion. Such statements fall into two
categories -- those exhibiting confusion
and those proclaiming it. Statements of
the first type (Dr. A17 says “We have
plenty of Advicor” but points to Altocor
samples) are not hearsay because they are
16 We note that such assessments
must be made in light of the rule that it
may be improper to resolve a preliminary
injunction motion on a paper record
alone; where the motion turns on a
disputed factual issue, an evidentiary
hearing is ordinarily required. See, e.g.,
Sims v. Greene, 161 F.2d 87, 88 (3d Cir.
1947) (evidentiary hearing needed in
light of conflicting claims in pleadings
and affidavits). Neither party claims the
district court erred here by not holding a
hearing; indeed, neither party asked for a
hearing.
17 We note that one of Andrx’s
complaints is that the Berg Certification
does not identify the doctors involved in
each incident. This does not affect its
admissibility. See Callahan v. A.E.V.,
Inc., 182 F.3d 237, 252 n.11 (3d Cir.
1999) (“In a practical sense, the[]
identities [of the customers who made
the statements at issue] are not important.
The relevance of their statements
depends only on the fact that they were
the plaintiffs’ customers . . . .
Furthermore, we do not think that the
admissibility of their statements under
the Rule 803(3) hearsay exception
depends on their being identified.”).

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24
not submitted for their truth; indeed, it is
their falsity that shows the speaker’s
confusion. Statements of the second type
(Dr. B says “I find these names
c o n f u s i n g . ” ) a r e a d m i s si b l e as
“statement[s] of the declarant’s then
existing state of mind.” Fed. R. Civ. P.
803(3). To the extent such statements
address the speaker’s plans (Dr. C says
“Because these names are confusing, I will
not prescribe either drug.”), they create an
inference “that the declarant acted in
accord with that plan.” See, e.g., United
States v. Donley, 878 F.2d 735, 738 (3d
Cir. 1989). The second level is the report
of the marketing representative to Berg
(Employee D: “Dr. A told me . . . .”).
There is a factual dispute as to whether
some, all, or none of these reports satisfy
the “business records” exception to the
hearsay rule. Even if the reports are not
garden variety business records, however,
Berg could attest to having received more
than 60 reports of confusion in his official
capacity. Berg’s direct testimony that he
received numerous and varied reports of
alleged confusion is not hearsay but a
factual claim that, as discussed below, has
independent evidentiary significance
tending to show actual confusion.
b. Probative Value of Berg
Certification as to Actual
Confusion
As Vice President of Marketing,
Berg is responsible for Kos’s “overall
marketing strategy” and receives reports
from “district managers who oversee the
distribution of [Kos’s] drugs . . . about
significant issues occurring in the
marketplace.” JA at 68-69. He certified
that his staff has reported more than 60
incidents of actual confusion to him. He
describes a range of “representative . . .
i n s ta n c es,” i n c l u d i n g : m e d i c al
professionals providing patients the wrong
drug samples and, on one occasion,
improperly filling a prescription; doctors
complaining to Kos representatives about
“Advicor,” when their complaints really
con cerned Altocor; and medical
professionals confusing Altocor samples
w i t h A d v i c o r s a m p l e s, A l t o co r
r e p r e s e n t a t i v e s w i t h A d v i c o r
representatives, or Altocor-sponsored
events with Advicor-sponsored events. Id.
at 69-71.
It may be that the Berg Certification
is not competent proof or reliable evidence
of any particular incident that it describes.
However, as noted above, Berg is
competent to attest that he received over
60 reports of alleged confusion, and his
credibility as to this assertion has been
tested by deposition in the PTO opposition
proceedings. Moreover, the very number
of reports Berg says he received, and the
variety of sources and types of confusion
reported, bolster the reliability of the
reports as a whole. Courts are entitled to
view such diverse reports of confusion as
mutually reinforcing, particularly where,
as here, the names and products are so
similar as to make the reported confusion
plausible. Indeed, the reverse may be true
as well: here, for example, the 60 reported
instances of confusion tend to confirm our
determination that the names are
confusingly similar.

-- 24 of 39 --

25
Andrx argues that Kos cannot show
trademark confusion because the 60
alleged incidents of confusion comprise
too small a perc entag e of th e
a p p r o x i m a t e l y 3 5 0 , 0 0 0 A d v i c o r
prescriptions, or the approximately
650,000 combined prescriptions.18 We
have recognized, however, that evidence
of actual confusion “is difficult to find . .
. because many instances are unreported.”
Checkpoint, 269 F.3d at 291. W ithout
knowing how many, or what percent of,
incidents go unreported, anecdotal
evidence of confusion cannot usefully be
compared to the universe of potential
incidents of confusion. The rarity of such
evidence makes even a few incidents
“highly probative of the likelihood of
confusion.” Id. (Because “reliable
evidence of actual confusion is difficult to
obtain in trademark and unfair competition
cases, any such evidence is substantial
evidence of likelihood of confusion.”)
(quotation omitted, emphasis added); see
also Country Floors, Inc. v. Partnership of
Gepner & Ford, 930 F.2d 1056, 1064 (3d
Cir. 1991) (quoting cases holding that
“very little proof of actual confusion
would be necessary to prove likelihood of
confusion”) (emphasis added); cf. Sara
Lee Corp. v. Kayser-Roth Corp., 81 F.3d
455, 466 (4th Cir. 1996) (“[W]e can but
wonder how often the experiences related
by the trial witnesses have been repeated --
but not reported -- in stores across the
country.”).
The Berg Certification provides
more than enough evidence of actual
confusion to support weighing the fourth
and sixth Lapp factors in Kos’s favor.
Nonetheless, because there is room for
differing views as to the weight to which
the document is entitled, and because some
of the underlying facts are disputed,19 we
decline to hold that the record evidence
compels weighing these factors in Kos’s
favor as a matter of law. On the other
hand, it would be clear error to weigh
either factor against Kos on the present
record.
5. Defendant’s Intent in
Adopting the Mark
“[E]vidence of intentional, willful
and admitted adoption of a mark closely
similar to the existing mark[] weighs
strongly in favor of finding [a] likelihood
of confusion.” Checkpoint, 269 F.3d at
286 (quotation omitted). This inquiry
18 The district judge commented on
these figures, but did not analyze them or
otherwise indicate whether he saw them
as legally or factually significant. See,
e.g., JA at 19 (“So we’re talking about
something in the vicinity for both
prescriptions of 650,000 drugs, of which
you’re aware of approximately 60
instances of confusion.”).
19 For example, Andrx claims that
Berg’s characterization of one incident as
evincing confusion is belied by the e-
mail describing that incident, which,
Andrx claims, shows only that a
cardiologist overrode the prescription
choice made by a patient’s non-specialist
physician. See supra p. 6.

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26
extends beyond asking whether a
defendant purposely chose its mark to
“promot[e] confusion and appropriat[e] the
prior user’s good will.” Fisons, 30 F.3d at
479 (quotation omitted). The adequacy
and care with which a defendant
investigates and evaluates its proposed
mark, and its knowledge of similar marks
or allegations of potential confusion, are
highly relevant. See, e.g., id. at 480
(directing district court to consider
defend ant’s trademark search and
investigation of similar marks to determine
if it was “careless in its evaluation of the
likelihood of confusion”); Lapp, 721 F.2d
at 463 (relying on district court’s finding
that while defendant “may have acted
innocently, [it] was careless in not
conducting a thorough name search for
A m e r i c a n us e s o f th e n a m e ” );
Morgenstern, 253 F.2d at 394 (citing
finding that defendant “trod a very narrow
course when it adopted the name Mictine
with full knowledge of the prior use of the
name Micturin by the plaintiff”). A
defendant that “persisted in its plan” to
adopt a mark “after being warned of too
close resemblance between” its proposed
mark and plaintiff’s mark is not
“blameless[].” Telechron, Inc. v. Telicon
Corp., 198 F.2d 903, 908 (3d Cir. 1952).
The district court did not analyze
this factor on the record or make relevant
factual findings. Kos argues that Andrx’s
intent to trade on Kos’s goodwill may be
inferred from Andrx’s insistence on using
this particular made-up (and meaningless)
mark despite being warned of the
likelihood of confusion before beginning
to sell Altocor. Andrx responds that its
allegedly infringing mark “was specifically
considered by the USPTO, the FDA and a
district court and found not to be
confusingly similar.” Appellees’ Br. at 24.
As stated previously, Andrx is not
entitled to rely on the PTO or FDA actions
to justify its own. See supra pp. 16-17.
Andrx’s attempt to justify its conduct by
reference to the district court decision is
puzzling; that decision was obviously not
issued when Andrx adopted th e
ALTOCOR mark. Andrx chose to use this
mark with clear notice of Kos’s objections
and its successful prior use of the
ADVICOR mark for similar goods. There
was, in the words of Judge Learned Hand,
“no reason whatever why [defendant]
should have selected [an arbitrary, made-
up trade-name] which bore so much
resemblance to the plaintiff’s.” See
Lambert Pharmacal Co. v. Bolton Chem.
Corp., 219 F. 325, 326 (S.D.N.Y. 1915).
Andrx’s use of ALTOCOR for its anti-
cholesterol drug was at least reckless, at
worst a deliberate appropriation of the
goodwill Kos had generated for its anti-
cholesterol product, Advicor.
We therefore conclude that the
district court clearly erred in failing to
weigh this factor for Kos.20
20 In view of this conclusion, it is
unnecessary to address the factual
dispute between the parties as to whether
Andrx deliberately chose the ALTOCOR
mark knowing Kos would be using
ADVICOR for its own similar product in
order to trade on the goodwill it expected
Kos’s new product to generate.

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27
7. W h e t h e r G o o d s A re
Marketed Through the Same
Channels of Trade and Advertised
in the Same Media
“[T]he greater the similarity in
advertising and marketing campaigns, the
greater the likelihood of confusion.”
Checkpoint, 269 F.3d at 288-89 (quotation
omitted). This is a “fact intensive inquiry”
that requires a court to examine the “media
the parties use in marketing their products
as well as the manner in which the parties
use their sales forces to sell their products
to consumers.” Id. at 289. The district
court did not address this factor directly,
but implicitly found that it did not favor
Kos. Nonetheless, the court’s statement,
when analyzing the eighth Lapp factor,
that both parties’ “sales representatives
visit physicians with drug samples and
related information” is relevant here, and
supports weighing this factor in Kos’s
favor. JA at 10.
Andrx concedes that the “goods are
marketed through the same channels,” but
argues that confusion is not likely since the
“channels of trade and marketing efforts
are directed to a very educated and highly
sophisticated group.” Appellees’ Br. at 30.
Andrx also claims that this factor favors it
“because the products are not in direct
competition” since each should be
prescribed under somewhat different
circumstances. Id.
The problem with Andrx’s
approach is that neither customer
sophistication nor the relationship between
the goods is relevant to determining
whether the goods are “marketed through
the same channels and advertised through
the same media.” Lapp, 721 F.2d at 463.
There are other Lapp factors that take
those issues into account. “[W]e [do] not
discount the strength of plaintiff’s case in
one area because of weakness in another;
we weigh[] each factor separately.”
Fisons, 30 F.3d at 476 (holding district
court erred in “fail[ing] to count the
similarities in channels of trade and target
audience” for plaintiff due to district
court’s view that other Lapp factors
weighed against plaintiff).
We find that the district court
clearly erred in failing to recognize that
this factor favors Kos. It does.
8. Extent to Which Targets of
the Parties’ Sales Efforts Are
the Same
The record supports the district
court’s finding that this factor supports
Kos because the “‘parties target their sales
efforts to the same consumers,’” namely,
“physicians and pharmacists.” JA at 10
(quoting Checkpoint, 269 F.3d at 289).
Andrx again argues that “any potential
confusion” is “obviate[d]” because the
target audience is “a highly educated and
sophisticated group.” Appellees’ Br. at 30.
The district court properly rejected this
a r g u m e n t , r e c o g n i z i n g t h a t i t
impermissibly conflated different Lapp
factors. Cf. Fisons, 30 F.3d at 476.
9. Relationship of the Goods
“The closer the relationship
between the products, . . . the greater the
likelihood of confusion.” Lapp, 721 F.2d
at 462. The question is how similar, or

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28
closely related, the products are. Fisons,
30 F.3d at 481 (describing cases where
“the relationship of the products was close
enough to lead to the likelihood of
confusion” and “the goods were similar
enough that a consumer could assume they
were offered by the same source”). This
factor focuses on the nature of the
products themselves, asking whether it
would be reasonable for consumers to
associate them or see them as related. We
have recognized that “the near-identity of
the products” or their “similarity of
function” are key to assessing whether
consumers may see them as related. A &
H, 237 F.3d at 215.
The district court did not analyze
this factor. It did, however, make
potentially relevant findings about
similarities and differences in the usage
and composition of the drugs. JA at 6
(“While both drugs are used to treat
elevated cholesterol levels, their chemical
compositions differ in such a way that
there are different active ingredients,
dosages, and side effects.”). Andrx
maintains that doctors will necessarily
“distinguish the two products in their
minds” because they will need to decide
which to prescribe since Advicor, but not
Altocor, contains niacin. Appellees’ Br. at
30-31. Kos argues that the “differences in
active ingredients,” which make the drugs
appropriate “for treatment of different
types of patients with the same ailment[,]
. . . do not negate a likelihood of
confusion.” Appellant’s Br. at 25-26.
Goods need not be identical for this
factor to support finding a likelihood of
confusion. See, e.g., A & H, 237 F.3d at
224 (affirming holding that “product
similarity factor favored [plaintiff]” where
p r o d u c t s w e r e o n l y “ s o m e w ha t
interchangeable” due to “slightly different
functions”). The question is not whether it
is possible to distinguish between the
products but whether, and to what extent,
the products seem related, “whether
because of [their] near-identity, . . . or
similarity of function, or other factors.”
Id. at 215; see also Fisons, 30 F.3d at 481
(equating factor with Sixth Circuit test for
“Relatedness of the Goods”). Courts may
consider here “whether buyers and users of
each parties’ goods are likely to encounter
the goods of the other, creating an
assumption of com mon sourc e[,]
affiliation or sponsorship.” Checkpoint,
269 F.3d at 286.
Advicor and Altocor are both
prescription drugs used to improve
cholesterol levels. The products are of the
same type and serve the same function in
slightly different (but overlapping) ways
that may be appropriate for slightly
different (but overlapping) sets of patients.
That doctors will need to decide which
drug to prescribe does not mean they
won’t see the drugs as related or otherwise
associate them. Indeed, it could be argued
that the opposite is true, that is, that they
will associate the products because they
must consider both to decide which to
prescribe. See, e.g., Syntex Labs., Inc. v.
Norwich Pharmacal Co., 437 F.2d 566,
568-69 & n.1 (2d Cir. 1971) (affirming
finding that drugs for “treatment of closely
parallel and medically related conditions”

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29
-- which had different compositions such
that each was contraindicated for some
patients who could take the other drug --
“are likely to be closely associated in the
minds of those who prescribe and dispense
them”); Sterling Drug Inc. v. Lincoln
Labs., Inc., 322 F.2d 968, 971 (7th Cir.
1963) (confusion likely as to medicines
“designed to remedy the same condition in
[and] purchased and used by the same
class of persons,” even though products
had different active ingredients, and were
used and sold in different ways) (reversing
and directing entry of permanent
injunction); Ortho Pharm. Corp. v.
American Cyanamid Co., 361 F. Supp.
1032, 1040 (D.N.J. 1973) (medical
personnel likely to “mentally . . .
associate” products even though unlikely
to dispense one thinking it is the other).
Accordingly, we hold that the
district court clearly erred in holding that
this factor does not weigh in Kos’s favor.
It does.
10. Other Facts Suggesting the
Public Might Expect the
Prior Owner To Manufacture
Both Products
In assessing this factor, courts may
look at the nature of the products or the
relevant market, the practices of other
companies in the relevant fields, or any
other circumstances that bear on whether
consumers might reasonably expect both
products to have the same source. This
issue is highly context-dependent. See,
e.g., Checkpoint, 269 F.3d at 291
(affirming finding that consumers were
unlikely to expect plaintiff to “have the
expertise” to enter defendant’s field due to
“highly specialized and technical nature”
of defendant’s products); Fisons, 30 F.3d
at 480 (evidence that products “are closely
related and are used together” and that
“other companies market both products”
supports finding that public might expect
senior user to offer products of junior
user); Lapp, 721 F.2d at 464 (close
relationship between products that may be
used together supports finding that “even
sophisticated customers . . . would find it
natural or likely” that plaintiff might offer
product similar to defendant’s); McNeil
Labs., Inc. v. American Home Prods.
Corp., 416 F. Supp. 804, 806-07 (D.N.J.
1976) (consumer might reasonably think
T Y L E N O L m a n u f a c t u r e r u s e d
EXTRANOL mark for extra-strength
version of its drug); Ortho Pharm., 361 F.
Supp. at 1040 (while purchasing agents are
“likely to know that [drugs] are the
products of two separate companies” since
they typically order “face-to-face” with a
sales representative, medical professionals
will likely “associate with [defendant] the
goodwill and the high reputation which
[plaintiff] has acquired”).
The district court did not discuss
this factor, but held that it did not favor
Kos.
In light of the close relationship
between the drugs, customers could easily
expect the maker of one to make the other.
Cf. Checkpoint, 269 F.3d at 290
(“Evaluating this factor, courts look to
evidence that . . . the products at issue are
so closely related that the consuming
public might find it natural for one

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30
company to” sell both.). In addition, Kos
argues that medical professionals might
expect it to make a drug akin to Altocor in
light of how well such a drug would fit
into Kos’s product line. Kos sells “two
prescription drugs for the treatment of
chronic . . . cholesterol disorders” --
Niaspan, which contains only niacin, and
Advicor, which contains both lovastatin
and niacin. JA at 69. A lovastatin-only
anticholesterol drug could easily be a seen
as a natural brand extension.
Andrx responds that doctors choose
which drug to prescribe “based upon a
patient’s particular needs, not based upon
who manufactures the drug.” Appellees’
Br. at 31. This response is wholly
irrelevant to the question whether
customers might expect Kos to offer a
product like Altocor. Andrx’s argument
seems premised on the idea that goodwill
is virtually irrelevant for prescription
drugs. Andrx does not point to any
evidence in support of such a novel
position, which is counter to the purposes
and assumptions of the Lanham Act.
Because Andrx has done nothing to
rebut Kos’s showing that customers could
easily and naturally assume that Kos
manufactures both products, we find that
this factor favors Kos as a matter of law on
the present record. The district court
clearly erred in not weighing this factor for
Kos.
B. Weighing the Lapp Factors
The most important factor -- mark
similarity -- favors Kos. ADVICOR and
ALTOCOR are similar in sound and
appearance, and neither has any meaning
that could distinguish between them or
lead customers to associate them with
distinct products. The ADVICOR mark is
entitled to broad protection because it is a
coined term and because it is a strong
mark, both conceptually and commercially.
The products in question are closely
related and are marketed and sold to
practically identical audiences in
practically identical ways. These are
products customers could easily expect to
be manufactured by a single source. Also
in Kos’s favor is Andrx’s deliberate
decision to use a name dangerously close
to that of a competing drug, with no
apparent reason for choosing an arbitrary
mark so similar to its competitor’s and
despite being warned of the confusing
similarity. Accordingly, the first, second,
fifth, seventh, eighth, ninth, and tenth
Lapp factors unquestionably weigh in
favor of Kos as a matter of law.
There is a factual dispute as to how
Kos’s evidence of actual confusion affects
the analysis of the fourth and sixth Lapp
factors. We conclude that while the
evidence Kos submitted is undoubtedly
sufficient to support weighing these
factors in its favor, it is not so great as to
compel that result. But the best Andrx
could hope for on the present record is that
these factors be found in equipoise; no
reasonable factfinder could find that they
weigh against finding a likelihood of
confusion here. Only the third Lapp factor
arguably weighs against finding a
likelihood of confusion. It would,
however, be clear error to allow this one
factor to outweigh Kos’s strong showing

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31
on the key factor of mark similarity and on
the remaining factors, particularly in light
of our earlier discussion of the dangers of
relying too heavily on m edical
sophistication in prescription drug cases.
We have carefully considered
whether to direct the district court on
remand to weigh the Lapp factors anew in
light of the proper legal standards. On
reflection, however, we conclude that
doing so would serve no useful purpose.
The undisputed facts weigh heavily in
favor of Kos as a matter of law.
Regardless of how the factual disputes
might be resolved, any reasonable
factfinder weighing the Lapp factors in
accordance with the correct legal standards
would hold that Kos is likely to succeed on
the merits. Because the record could not
support a contrary holding, a remand for
reweighing would waste judicial resources
and unnecessarily delay the proceedings
further. Cf. Fisons, 30 F.3d at 482 (Garth,
J., concurring in part and dissenting in
part) (“I can see no purpose in remanding
for retrial of Fisons’ Lanham Act claims
when it is so evident that the marks at
issue here are confusingly similar.”).
Compare A & H, 237 F.3d at 238
(remanding where court could “not say as
a matter of law that a different weighing of
the factors could not have influenced the
District Court to make a different finding
of ultimate fact”) with Tanimura & Antle,
Inc. v. Packed Fresh Produce, Inc., 222
F.3d 132, 140 (3d Cir. 2000) (reversing
and directing entry of preliminary
injunction after finding “the four factors
required to grant a preliminary injunction
are apparent on the record before us”).
IV. IRREPARABLE HARM
The district court held that Kos had
not shown it would suffer irreparable harm
absent an injunction because Kos’s
product had been on the market “less than
two years.” JA at 11. The court
apparently deemed this an insufficient time
in which to establish the goodwill needed
to show such harm, as compared with the
“over sixteen years” during which the
goods were marketed in the case on which
Kos relied. Id. (comparing Merrell-
National Labs., Inc. v. Zenith Labs., Inc.,
194 U.S.P.Q. 157, 161 (D.N.J. 1977)).
“Grounds for irreparable injury
include loss of control of reputation, loss
of trade, and loss of good will.” Pappan
Enters., Inc. v. Hardee’s Food Sys., Inc.,
143 F.3d 800, 805 (3d Cir. 1998). Lack of
control over one’s mark “creates the
potential for damage to . . . reputation[,
which] constitutes irreparable injury for
the purpose of granting a preliminary
injunction in a trademark case.” Opticians
Ass’n of Am. v. Indep. Opticians of Am.,
920 F.2d 187, 196 (3d Cir. 1990). Thus,
“trademark infringement amounts to
irreparable injury as a matter of law.” S &
R Corp. v. Jiffy Lube Int’l, Inc., 968 F.2d
371, 378 (3d Cir. 1992); see also Times
Mirror Magazines, Inc. v. Las Vegas
Sports News, L.L.C., 212 F.3d 157, 169
(3d Cir. 2000) (“potential damage to . . .
reputation or goodwill or likely confusion
between parties’ marks” is irreparable
injury). “[O]nce the likelihood of
c o n f u s i o n c a u s e d b y tr a d e m a rk
infringement has been established, the
inescapable conclusion is that there was

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32
also irreparable injury.” Pappan, 143 F.3d
at 805.
The district court’s erroneous
holding that Kos had not proven that it was
likely to succeed on its trademark claims
deprived Kos of the benefit of this rule.
As we have already found that Kos has
shown a likelihood of success, we hold it
is entitled to a presumption that it will
suffer irreparable harm absent an
injunction.
We see nothing in the record that
could overcome this presumption.
Although we need not defer to the district
court’s holding since it was premised on
an error of law, we have considered
whether the length of time Advicor was
marketed weakens Kos’s showing of
irreparable harm. We conclude that it does
not. First, the district court’s view that the
relatively short time Advicor was on the
market shows that Kos had not generated
sufficient goodwill to suffer irreparable
harm seems inconsistent with its holding
that -- over the same time period -- Kos
developed a “high level of commercial
strength” based on sales grossing more
than $ 70 million on more than 350,000
prescriptions. JA at 9. Second, we do not
agree that a company’s goodwill is less
likely to be irreparably harmed if it has
used its mark for only a short time.
Indeed, it could be argued that irreparable
harm is more likely where a “young” mark,
rather than an old and well-established
mark, is infringed. Most importantly,
however, a company’s right to control its
own mark so it can avoid potential damage
to its goodwill or possible confusion does
not depend on the length of time it has
been using that mark.
Nor can we accept Andrx’s
argument that Kos’s delay -- filing suit
after Altocor had been on the market for
13 months -- shows that Kos is not being
irreparably harmed.21 The claim that this
delay bars preliminary relief is not
consistent with the law of this Circuit or
the facts of this case. The Third Circuit
case Andrx cites for the proposition that
“delay alone defeats Kos’ assertions of
irreparable harm” -- indeed, the only Third
Circuit case Andrx relies on for this
argument -- does not support its claim.
Appellees’ Br. at 32 (citing Times Mirror,
212 F.3d at 161). In that case, we
considered -- and rejected -- the argument
that a 15-month filing delay showed
plaintiff’s injury was “not immediate and
irreparable,” finding the argument
unpersuasive since the “delay was
21 Andrx’s other argument -- that
Kos will suffer no irreparable harm
because prescriptions will not be mis-
filled, and, even if they are, there will be
no “dire” medical consequences -- is
clearly disposed of by our earlier holding
that the Lanham Act covers likelihood of
confusion of all types, and not just the
likelihood that one product will be
mistakenly substituted for another.
Kos’s loss of control over its mark is
irreparable harm regardless of whether
resulting confusion might lead to further
injuries. Cf. Jiffy Lube, 968 F.2d at 378
(irrelevant whether “infringer is putting
the mark to better use”).

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33
attributable to negotiations between the
parties.” Times Mirror, 212 F.3d at 169.
While Times Mirror may imply that
inexcusable delay could defeat the
presumption of irreparable harm in an
appropriate case, it makes clear that the
present case is not an appropriate one.
Kos sought relief directly and through
administrative proceedings from the time
it learned of the proposed use of the
ALTOCOR mark through the time it filed
this suit. Andrx’s conduct -- submitting
alternate names to the FDA and the PTO,
and stating in its 2002 Annual Report that
Kos had opposed its application to register
ALTOCOR and, in the next sentence, that
it might “seek to change the name of
Altocor,” JA at 37422 -- could reasonably
be understood as a suggestion by Andrx
that the matter might be resolved absent a
lawsuit. Under these circumstances, no
reasonable factfinder could find that Kos
had waived its rights or conceded that it
was not irreparably harmed by filing when
it did.
Accordingly, we find that, given the
undisputed facts of record, this factor
weighs in favor of injunctive relief as a
matter of law.
V. BALANCE OF HARDSHIPS
The district court held that
“granting relief will result in greater harm
to” Andrx than Kos would suffer absent an
injunction. JA at 12. The court found that
an injunction would “significantly affect”
the “considerable time and expense”
Andrx had spent “developing the market
for [its] drug.” Id. The court rejected
Kos’s argument that the harm to Andrx
would be minimal since Andrx could
continue to market its successful product,
albeit under a different, non-infringing
name. This claim failed, according to the
district court, because “there is no
trademark infringement.” Id. We cannot
base our analysis on, or defer to, the
district court’s balancing of the equities
because that analysis is premised on
holdings we have already found clearly
erroneous, namely, that Kos has shown
neither trademark infringement nor
irreparable harm.
The question is whether, and to
what “extent[,] . . . the defendants will
suffer irreparable harm if the preliminary
injunction is issued.” Opticians, 920 F.2d
22 At argument, Andrx’s counsel
represented that Andrx applied for
alternate names “to be used only if” at
least four incidents of actual confusion
between Altocor and a third, unrelated
drug were reported the first year Altocor
was sold. Audio Tape of Oral Argument
before Court of Appeals for the Third
Circuit (Mar. 9, 2004) (on file with
Court) (emphasis added). Andrx points
to no record evidence that shows that
possible confusion with a drug other than
Advicor was its only concern in
considering a name change, and this
representation seems inconsistent with
the juxtaposition of the Kos Opposition
and the possible name change in the
same paragraph of the 2002 Annual
Report, with no mention of any other
basis for the name change.

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34
at 192. If temporary relief would
irreparably harm an alleged infringer
pending final disposition of the case, the
court should “balanc[e] the hardships” to
“ensure that the issuance of an injunction
would not harm the infringer more than a
denial would harm the mark’s owner.” Id.
at 197. “Irreparable harm must be of a
peculiar nature, so that compensation in
money alone cannot atone for it.” Pappan,
143 F.3d at 805 (quotation omitted).
District courts should consider financial
damages when establishing and setting the
bond for an injunction, not when deciding
whether to grant it. See Fed. R. Civ. P.
65(c) (“No . . . preliminary injunction shall
issue except upon the giving of security by
the applicant, in such sum as the court
deems proper, for the payment of such
costs and damages as may be incurred . . .
by any party who is found to have been
wrongfully enjoined.”).
Andrx states that “if required to
rename the product, [it will] incur
significant time and expense in obtaining
trademark clearance services, changing the
labeling and product inserts, product re-
l a u n c h a d v e rtising and the re -
establishment of goodwill,” and perhaps in
“destroying inventory or recalling the
products already distributed.” Appellees’
Br. at 35. Such costs, however, are
compensable by money damages and thus
do not constitute irreparable harm as a
matter of law. “Mere injuries, however
substantial, in terms of money, time and
energy necessarily expended in the
absence of a stay, are not enough.”
Sampson v. Murray, 415 U.S. 61, 90
(1974) (quoting Virginia Petroleum
Jobbers Ass’n v. FPC, 259 F.2d 921, 925
(D.C. Cir. 1958)). The costs in time and
money associated with adopting a new
mark are not “injuries . . . that could not be
remedied by money damages.” Pappan,
143 F.3d at 805-6 (“significant financial
injuries,” including costs of replacing
“several months worth of logoed product,”
do not constitute irreparable harm).
Andrx also argues that an injunction
would “destroy the market” it has
developed and would cause it to lose the
goodwill associated with the ALTOCOR
mark. Appellees’ Br. at 34. Kos responds
that this harm would be minimal since
Andrx already has an alternate mark
already in place. Appellant’s Br. at 34.
Although Andrx denies that it has an
approved alternate name available,23 its
vague, unsubstantiated representation that
the FDA approval is no longer valid
cannot create a factual dispute in the face
of record evidence that the FDA approved
its use of the ALTOPREV mark and the
judicially noticeable fact that the PTO has
23 Nor is it clear that the alleged
expiration of FDA approval would weigh
in Andrx’s favor. Even on Andrx’s
account, the lapse of approval is the
consequence of Andrx’s own actions in
that approval supposedly expired “when
we didn’t use the name.” See Audio
Tape of Oral Argument before Court of
Appeals for the Third Circuit (Mar. 9,
2004) (on file with Court). Moreover,
Andrx has never alleged that there would
be any barrier to its seeking reapproval
of the mark if it has indeed elapsed.

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35
issued a Notice of Allowance for this
mark.24
Injury to goodwill does constitute
irreparable harm. See, e.g., Opticians, 920
F.2d at 195. But, when the potential harm
to each party is weighed, a party “can
hardly claim to be harmed [where] it
brought any and all difficulties occasioned
by the issuance of an injunction upon
itself.” Id. at 197 (directing entry of
preliminary injunction). We have often
recognized that “the injury a defendant
might suffer if an injunction were imposed
may be discounted by the fact that the
defendant brought that injury upon itself.”
Novartis Consumer Health, Inc. v. Johnson
& Johnson-Merck Consumer Pharm. Co.,
290 F.3d 578, 596 (3d Cir. 2002). Indeed,
a different rule would allow “a knowing
infringer [that] construct[s] its business
around its infringement” to avoid an
injunction by claiming it would have a
“devastating effect” on that business, “a
result we cannot condone.” Apple
Computer, Inc. v. Franklin Computer
Corp., 714 F.2d 1240, 1255 (3d Cir. 1983).
Andrx knew before its drug was first sold
that Kos viewed ALTOCO R and
ADVICOR as confusingly similar when
used to identify competing prescription
drugs for patients with high cholesterol.
Andrx took a deliberate risk by proceeding
despite being warned that its mark was
dangerously close to that of a competing
product, and is thus “not in position to
urge its original blamelessness as a
consideration which should be persuasive
to a court of equity.” Telechron, 198 F.2d
at 908; see also Novartis, 290 F.3d at 596.
One other factor we have held
weighs in the balance of hardships analysis
is the “goal[] of the preliminary injunction
analysis [of] maintain[ing] the status quo,
defined as the last peaceable, noncontested
status of the parties.” Opticians, 920 F.2d
at 197 (directing entry of injunction where
such relief would restore status quo since
defendant could not use mark “[b]efore
this controversy began”) (citation and
quotation omitted). This factor favors Kos
since it objected to Andrx’s adoption of
the ALTOCOR mark before Andrx had
begun to use it in commerce.
We recently rejected an argument --
similar to one Andrx makes here -- that the
harm a defendant would suffer if enjoined
from selling its product under its current
name “outweigh[ed] the potential harm to
[its competitor] from losing market share
if the injunction were not issued.”
Novartis, 290 F.3d at 596 (affirming
preliminary injunction in false advertising
case). We emphasized that the injunction
did “not require [defendant] to abandon its
product name forever[, but] only [to] cease
shipping the [] product under that name
until the end of the litigation on the
merits.” Id. at 597. The same is true here.
We also stated that the defendant could
still “ship[] the product currently in
24 Our review of the record and the
parties’ arguments convinces us that the
facts relevant to balancing the hardships
are undisputed. Cf. Opticians, 920 F.2d
at 197 (conducting own assessment of
the balance of hardships where facts
were not in dispute).

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36
inventory under a different name [and]
label” or ship that product without any
such change if it were to prevail on the
merits. Id. Again, the same is true here.25
We note that Kos may be in an even
stronger position than was the plaintiff in
Novartis. The false advertising claim in
Novartis was not based on any confusing
similarity between the plaintiff’s and
defendant’s marks; thus, the plaintiff there
-- unlike Kos -- was not threatened with a
likelihood of confusion or with loss of
control over its own mark, which can lead
to loss of reputation, loss of trade, and loss
of goodwill. See Opticians, 920 F.2d at
195.
We have recognized that “[t]he
more likely the plaintiff is to win, the less
heavily need the balance of harms weigh
in his favor.” Novartis, 290 F.3d at 597.
In light of Kos’s strong showing of its
likelihood of success, and the fact that
Andrx accepted the risk of injury to its
goodwill when it ignored Kos’s claim of
infringement, we hold that no reasonable
factfinder could conclude that the
irreparable harm Andrx might suffer
pending resolution of this matter on the
merits outweighs the irreparable harm that
Kos would continue to suffer absent an
injunction. Cf. Tenafly Eruv Ass’n, Inc.
v. Borough of Tenafly, 309 F.3d 144, 178
(3d Cir. 2002) (assessing balance of
hardships based on own “review of the
record”) (reversing and directing entry of
injunction); Meridian Mutual Ins. Co. v.
Meridian Insurance Group, Inc., 128 F.3d
1111, 1121 (7th Cir. 1997) (“Our
examination of the record shows that . . .
the harm to the plaintiff if no injunction is
issued therefore outweighs any harm to the
defendants if one is entered.”) (reversing
and directing entry of injunction); Jiffy
Lube, 968 F.2d at 379 (balancing harms in
first instance and holding that “self-
inflicted harm” to alleged infringer “is far
outweighed by the immeasurable damage
done [plaintiff] by the infringement of its
trademark,” despite “sympathetic position”
of defendant who would have to change
name under which it was operating its
business) (reversing and directing entry of
injunction); Opticians, 920 F.2d at 197
(finding on undisputed facts that “grant of
an injunction would impose no greater
harm on [defendant] than would be
imposed upon the [plaintiff] by the denial
of an injunction”) (reversing and directing
entry of injunction).
Accordingly, we find that this
factor weighs in favor of injunctive relief
as a matter of law.
VI. PUBLIC INTEREST
The district court held that the
“public interest does not favor” injunctive
relief because Kos “failed to persuade [it]
. . . that the public is at a serious health
risk if this Court does not grant a
25 We note that the graphic Andrx
submitted of its product does not show
the ALTOCOR mark on the pills
themselves. See Appellees’ Br. at 28.
Cf. Opticians, 920 F.2d at 197 (noting
that defendant could continue to sell its
product since the challenged mark was
not placed on the “primary trade
product” but on “promotional material”).

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37
permanent [sic] injunction.” JA at 12.
Kos claims that the public interest
“demands entry of a preliminary
injunction” here because “[n]o public
interest is greater than the public interest to
preserve lives.” Appellant’s Br. at 35.
Andrx responds that Kos’s “self-serving,
inflammatory rhetoric” is belied by the
“neutral” conclusion of the FDA that it is
unlikely that a patient will receive the
wrong prescription. Appellees’ Br. at 37.
Andrx also argues that the public would be
harmed by an injunction because those
patients who depend on Altocor would be
“deprive[d] . . . of a drug product that has
been incorporated into their daily routine,”
and would suffer “unnecessary worry and
anxiety when their prescriptions cannot be
refilled and their doctors need to start them
on a new drug regimen.” Id. at 38.
These are not your usual Lanham
Act public interest arguments. Indeed,
neither the district court nor the parties
even mentions the most basic public
interest at stake in all Lanham Act cases:
the interest in prevention of confusion,
particularly as it affects the public interest
in truth and accuracy. We have often
recognized that “[p]ublic interest . . . in a
trademark case . . . is most often a
synonym for the right of the public not to
be deceived or confused.” Pappan, 143
F.3d at 807 (quoting Opticians, 920 F.2d at
197).
In light of our holding that “there is
a likelihood of consumer confusion created
by” the use of confusingly similar marks,
“it follows that if such use continues, the
public interest would be damaged.
C on ve rse ly, a p r o h i b it i o n u p o n
[defendant’s] use of [its] mark[] would
eliminate that confusion.” Opticians, 920
F.2d at 198. Ordinarily, this might be the
extent of the relevant analysis. Weighing
the public interest in preliminary relief is
often fairly routine. See American Tel. &
Tel. Co. v. Winback & Conserve Program,
Inc., 42 F.3d 1421, 1427 n.8 (3d Cir. 1994)
(“As a practical matter, if a plaintiff
demonstrates both a likelihood of success
on the merits and irreparable injury, it
almost always will be the case that the
public interest will favor the plaintiff.”).
Here, however, we must confront
the question whether the parties’ claims as
to specific harms to the public change the
usual calculus.
We first consider Kos’s claim that
the interest in “preserv[ing] lives” requires
injunctive relief. There is a factual dispute
as to this issue. The parties submitted
competing medical affidavits to support
their respective views as to the nature and
severity of the potential consequences of a
mis-filled prescription.26 Andrx also
26 We note that the affidavit Andrx
submitted focused on the potential harm
of substituting Altocor for Advicor,
while the more serious harms Kos
identified are those that may occur in the
reverse case, that is, when Advicor is
substituted for Altocor. See supra p. 6.
Although the Andrx affidavit cannot
create a factual dispute as to the type of
substitution it does not address, we
hesitate to draw conclusions from the
“undisputed” fact that serious harm may

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38
disputed Kos’s allegations as to the risks
of misdispensing by arguing it is extremely
unlikely that a pharmacist would
improperly fill a prescription. The district
court resolved this dispute in Andrx’s
favor, holding that Kos had not proven that
the public would face a serious health risk
absent an injunction. The colloquy at the
hearing shows that the court was
impressed by the FDA’s statement that the
“possibility of confusion was minimal,”
and was persuaded that “it would be
difficult to imagine a situation” where the
drugs would be confused “when a
pharmacist is filling a prescription.” JA at
25, 51. We note that, although the FDA’s
inquiry is not equivalent to the Lanham
Act “likelihood of confusion” test, its
review of proprietary drug names is
relevant in assessing the health risks of
mis-filled prescriptions. Indeed, the
purpose of FDA review is “to predict
potential confusion that may arise in the
actual prescription process.” 3 McCarthy,
supra, § 19:149 (4th ed. 2003). We defer
to the district court’s resolution of this
factual dispute because its finding is
supported by the record and is thus not
clearly erroneous.27
We must, however, distinguish
between the court’s finding that Kos did
not establish a “serious health risk” and its
conclusion that “[t]herefore, the public
interest does not favor” injunctive relief.
JA at 12 (emphasis added). While we
defer to the former, the court’s ultimate
assessment of the public interest is clearly
erroneous because it does not take into
account the “right of the public not to be
deceived or confused.” Opticians, 920
F.2d at 197. As stated above, that right is
implicated here.
The remaining question is whether
this public interest is outweighed by the
potential public harm of “depriv[ing]”
patients of Altocor. Appellees’ Br. at 38.
Andrx claims that an injunction would
mean that Altocor “prescriptions [could]
not be refilled and . . . doctors [would]
need to start [patients] on a new drug
regimen.” Id. The factual predicate for
this claim seems to be the Declaration of
Charles Schneider, which states that “[i]f
Andrx is forced to suspend sales of
ALTOCOR, [it] will suffer great economic
harm by losing sales of an existing product
and by a loss of good will with its
result from substituting Advicor for
Altocor. The most serious risks Kos
identifies were mentioned for the first
time in the affidavit Kos submitted at the
hearing. See JA at 28-29. Since the
district court ruled from the bench,
Andrx had no chance to respond to these
new claims and cannot be said to have
conceded them.
27 We do not suggest that the district
court or the FDA (or, for that matter, this
Court) is careless or insensitive to the
potentially serious health risks of mis-
filled prescriptions. Nonetheless, the
recognition that the stakes are high does
not mean that disputed claims about the
possibility for such harm must be
credited.

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39
customers due to an interruption in the
supply of an existing product.” JA at 343.
Andrx’s broad claims that it would
have to “suspend” sales and “deprive”
patients of Altocor ignore the fact that it is
only the ALTOCOR mark and not the drug
itself that an injunction should address.
Andrx has provided no evidence to show
that temporarily ceasing use of the
ALTOCOR mark would cause “an
interruption in the supply” of its extended-
release lovastatin product. The record is
bare of information as to how long it
would take Andrx to provide new labels or
label information for pharmacies to use
when dispensing the drugs, to replace
branded samples in physician’s offices, to
re-package its existing product as needed
for pharmacies, or to take other necessary
steps to suspend use of the mark
ALTOCOR. Andrx has thus introduced no
evidence from which a reasonable
factfinder could find that the public would
be harmed by the proposed injunction.
Accordingly, we find that this
factor weighs in favor of injunctive relief
as a matter of law.
VII.
In light of the foregoing analysis,
we conclude that the district court clearly
erred in denying Kos’s motion for a
preliminary injunction. We therefore
reverse and remand with instructions that
the district court fashion and enter, on an
expedited basis, an order preliminarily
enjoin ing Andrx from using the
ALTOCOR mark in connection with the
marketing and sale of its extended-release
lovastatin medication.28
28 We note that the district court will
be setting such bond as it determines to
be appropriate to secure payment to
Andrx of any compensable money
damages that it may incur prior to final
disposition of this matter should it be
determined that Andrx was erroneously
enjoined. In determining the amount of
such bond, the district court should, of
course, take into account Andrx’s ability
to minimize the potential for such
damages. See supra p. 61. To that end,
the court may wish to shape the
preliminary injunction, or set its effective
date, to allow Andrx to take reasonable,
expeditious steps to begin marketing its
product under another name.

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