COOPER, District Judge
This matter comes before the Court on the motion by GlaxoSmithKline Consumer Healthcare, L.P. ("GSKCH") pursuant to Federal Rule of Civil Procedure ("Rule") 65(a) for a preliminary injunction enjoining Pharmacia Corporation ("Pharmacia") from broadcasting a television commercial entitled "Trying to Quit." GSKCH contends that certain of the claims made by Pharmacia in "Trying to Quit" violate Section 43(a) of the Lanham Act, codified at 15 U.S.C. § 1125(a) ("the Lanham Act"). The Court will grant GSKCH's motion.
BACKGROUND
This case involves a dispute between distributors of over-the-counter ("OTC") products designed to help purchasers stop smoking cigarettes. Pharmacia and GSKCH market competing brands of nicotine replacement therapy ("NRT") products in the United States. (GSKCH Supp. Br. at 1.) Pharmacia sells a nicotine transdermal patch under the brand name Nicotrol ("Nicotrol"). (Id.) Nicotrol's directions state it is to be worn for 16 hours at a time. (4-16-03 Jaffe Dec., Ex. 1.) GSKCH markets a competing nicotine transdermal patch under the brand name NicoDerm CQ ("NicoDerm"). (GSKCH Supp. Br. at 1.) NicoDerm's instructions state that it may be worn for 16 or 24 hours. (2d Horvath Dec., Ex. 10.)
Pharmacia began airing "Trying to Quit" in February, 2003. (GSKCH Supp. Br. at 1.) The 15-second commercial shows a man tossing and turning in bed. (Videotape of "Trying to Quit"("ToQ").) A patch is barely visible on the man's right arm. (Id.) The man suddenly sits bolt upright. (Id.) An announcer then states: "Trying to beat cigarettes? Having trouble sleeping? You're probably using NicoDerm. Just read their label." (Id.) An image of NicoDerm's label appears, and the camera zooms in to focus on the part of the label reading: "If you have vivid dreams or other sleep disturbances, remove this patch at bedtime." (Id.) The words "sleep disturbances" are underlined in red. (Id.) The ad then shows the Nicotrol box, as the voice-over states: "The new step-down patch from Nicotrol was designed to let you sleep." (Id.) Superimposed text on the screen reads: "Nicotrol studies show low incidence of sleep disturbance vs. placebo." (Id.) The image then shifts to a shot of the same man sleeping peacefully, while the announcer says: "And with new Nicotrol, you're twice as likely to quit than with cold turkey." (Id.)
The term "cold turkey" denotes those smokers attempting to quit by themselves, that is, without using NRTs or other available therapies. (GSKCH Rep. Br. at 18-19.)
GSKCH alleges that two aspects of "Trying to Quit" make false claims in violation of the Lanham Act. First, GSKCH asserts that the statement "Nicotrol was designed to let you sleep" necessarily implies the false claim that Nicotrol has an advantage over NicoDerm in preventing sleep disturbances. Second, GSKCH contends that the statement "You're probably using NicoDerm" explicitly makes the false claim that any person who is (a) trying to quit smoking and (b) experiencing sleep disturbances is more likely than not using NicoDerm. The Court held an evidentiary hearing on July 11, 2003 and August 26, 2003 to determine whether a preliminary injunction should issue.
An issue arose during the August 26, 2003 proceeding as to whether certain declarations that had not been offered into evidence at the July 11, 2003 hearing should nevertheless be considered part of the record for the purposes of this motion. We do not decide that issue, as we have concluded after reviewing the declarations in question that their inclusion into evidence would make no difference in the outcome of this matter.
DISCUSSION
"[A]n injunction is an extraordinary remedy, which should be granted only in limited circumstances." Novartis Consumer Health, Inc. v. Johnson Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 586 (3d Cir. 2002) (quotations omitted). The Court will only issue a preliminary injunction if we are convinced that the following factors favor granting preliminary relief: (1) the likelihood that the moving party will succeed on the merits; (2) the extent to which the moving party will suffer irreparable harm without injunctive relief; (3) the extent to which the nonmoving party will suffer irreparable harm if the injunction is issued; and (4) the public interest. Id.; see also ATT v. Winback Conserve Program, Inc., 42 F.3d 1421, 1427 (3d Cir. 1994) ("The injunction should issue only if the plaintiff produces evidence sufficient to convince the district court that all four factors favor preliminary relief.").
I. Likelihood of Success on the Merits a. The Lanham Act
GSKCH must first show that at trial it is likely to succeed in proving that "Trying to Quit" violates the Lanham Act. The Lanham Act reads, in pertinent part, (1) Any person who . . . in connection with any goods or services . . . uses in commerce any word, term, name, symbol, or device, or any combination thereof, or . . . false or misleading description of fact, or false or misleading representation of fact, which —
(A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or
(B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damaged by such act.
15 U.S.C. § 1125(a). To prove a Lanham Act violation, the complainant must show: (1) the [alleged violator] made false or misleading statements about the [complainant's or his own] product; (2) there is actual deception or a tendency to deceive a substantial portion of the intended audience; (3) the deception is material in that it is likely to influence purchasing decisions; (4) the advertised goods traveled in interstate commerce; and (5) there is a likelihood of injury to the [complainant].
Highmark, Inc. v. UPMC Health Plan, Inc., 276 F.3d 160, 171 (3d Cir. 2001). Here, neither party contests the existence of the latter three elements: materiality, travel in interstate commerce, or likelihood of injury. Accordingly, we will focus our inquiry on the first two showings only: the false or misleading claim that deceives or has a tendency to deceive consumers.
The false or misleading claim may be proved in one of two ways. The movant must show that "the commercial message or statement is either (1) literally false or (2) literally true or ambiguous, but has the tendency to deceive consumers." Novartis, 290 F.3d at 586. If the complainant can show literal falsity, "the court may grant relief without reference to the advertisement's impact on the buying public." Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 943 (3d Cir. 1993).
In analyzing whether an advertisement or product name is literally false, a court must determine, first, the unambiguous claims made by the advertisement . . ., and second, whether those claims are false. A literally false message may be either explicit or conveyed by necessary implication when, considering the advertisement in its entirety, the audience would recognize the claim as readily as if it had been explicitly stated.
Novartis, 290 F.3d at 586-87 (quotations and citations omitted). However, "only an unambiguous message can be literally false"; if the message is susceptible of more than one meaning, the complainant cannot assert literal falsity. See id. at 587.
Where the movant is unable to demonstrate that the complained-of statement is literally false, a Lanham Act violation may still be established by proving that the commercial makes a false or misleading claim and that a substantial portion of consumers actually understand the ad to be making that claim. See Johnson Johnson-Merck Consumer Pharms. Co. v. Rhone-Poulenc Rorer Pharms., Inc., 19 F.3d 125, 129 (3d Cir. 1994) ("Rorer"); Dentsply Int'l, Inc. v. Great White, Inc., 132 F. Supp.2d 310, 324 (M.D. Pa. 2000). When the complainant chooses this evidentiary route because literal falsity cannot be shown, the complainant "must prove that [the statement] is deceptive or misleading, which depends on the message that is conveyed to consumers." Rorer, 19 F.3d at 129. Evidence that consumers are actually misled by the alleged violator's statements must therefore be produced; speculation as to how consumers could react is insufficient. See Highmark, 276 F.3d at 171.
b. "Nicotrol Was Designed to Help You Sleep"
GSKCH alleges that "Trying to Quit" makes the literally false claim that Nicotrol has an advantage over NicoDerm with regard to sleep disturbances. GSKCH asserts that Nicotrol's claim that "Nicotrol was designed to help you sleep," when viewed in the context of the entire commercial, either expressly claims or necessarily implies that Nicotrol is somehow superior to NicoDerm at allowing people to sleep better while trying to quit smoking. GSKCH further contends that this claim is false because there are no demonstrable differences between Nicotrol and NicoDerm with regard to sleep disturbances when both are used for 16 hours.
GSKCH makes two alternative claims as well. First, GSKCH asserts that "Trying to Quit" makes the false claim that NicoDerm is not designed to let you sleep. Second, GSKCH contends the ad is false because it omits material information, namely, that NicoDerm, like Nicotrol, is approved for 16 — as well as 24-hour use. Since we conclude, infra , that GSKCH's assertion that "Trying to Quit" falsely claims an advantage for Nicotrol in the context of sleep disturbances is correct, we need not address these alternative contentions.
The Court must determine "first, the unambiguous claims made by the advertisement . . ., and second, whether those claims are false."Novartis, 290 F.3d at 586. An unambiguous claim can be explicit, or can be necessarily implied by the advertisement. Id. at 586-87. If the statement in question does not make an unambiguous claim, there is no Lanham Act violation absent a showing of actual consumer deception. See id. at 587. The Court must look at the commercial as a whole when making its assessment. See, e.g., Rorer, 19 F.3d at 129 ("A determination of literal falsity rests on an analysis of the message in context.").
Pharmacia raises three arguments in response to GSKCH's interpretation of "Trying to Quit." First, Pharmacia contends the commercial does not claim Nicotrol has any design advantage over NicoDerm. We disagree. The commercial directly compares the two products, disparages NicoDerm because of its association with sleep disturbances, and then trumpets Nicotrol as being "designed" to avoid these same disturbances. We find that the ad makes a claim of some kind of superiority.
Pharmacia also urges us to view the statement in question not as part of the overall theme of comparing Nicotrol and NicoDerm, but merely as a reflection of the history of Nicotrol. Pharmacia introduced testimony explaining that from its inception as a product, the inventors of Nicotrol intended to design the patch to prevent sleep disturbances. (7-11-03 H'g Tr. at 159-77.) That is, Pharmacia urges that the statement "Nicotrol was designed to let you sleep" in the overall context of the commercial should not be understood to mean "Nicotrol will let you sleep better than NicoDerm" but rather "Nicotrol was designed with the intent to let you sleep, but from this statement you should take no guarantee that it actually does let you sleep any better than NicoDerm." We find there is no basis for this interpretation of the commercial. The ad lines up two products and compares them, with a special focus on their impact on a user's sleep. There is no mention of what Nicotrol's designers intended in the mid-1980s, when the product was developed. In the words of GSKCH's attorneys: "This interpretation is absurd. The `Trying to Quit' advertisement is a comparison of supposed product features, not a documentary about the making of the Nicotrol Patch." (GSKCH Rep. Br. at 14.)
Pharmacia contends finally that to the extent the commercial makes any claim, such claim is ambiguous, and therefore GSKCH can only show a Lanham Act violation by proving that consumers actually received the alleged claim of superiority. This objection we must reject as well. It is true that "Trying to Quit" does not expressly state "Nicotrol is better than NicoDerm when it comes to sleep disturbances." However, "when, considering the advertisement in its entirety, the audience would recognize the claim as readily as if it had been explicitly stated," a complainant may prove literal falsity. Novartis, 290 F.3d at 586-87 (quotations omitted). The commercial shows a man tossing and turning in his sleep. In succession, the ad asks if you are trying to quit smoking and if you cannot sleep, and then associates NicoDerm with sleep disturbance. It then tells the viewer that Nicotrol was designed to help you sleep. The next shot is of the man sleeping peacefully. Within this context, there is only one message consumers can take away from the statement "Nicotrol was designed to let you sleep": the unambiguous, necessarily implied claim that Nicotrol helps you sleep better than NicoDerm.
The next inquiry is whether this unambiguous claim is false. Normally, the movant has the burden to demonstrate that the alleged violator's advertising claim is false. Novartis, 290 F.3d at 590. However, the Third Circuit announced in Novartis that "a court may find that a completely unsubstantiated advertising claim by the [non-movant] is per se false without additional evidence from the [complainant] to that effect." Id. Pharmacia has no basis for its claim that Nicotrol is better than NicoDerm with regard to sleep disturbances, and therefore we hold that that claim is per se false.
Pharmacia asserts that its claim of superiority is true because Nicotrol has four distinct design elements that differentiate it from NicoDerm: the length of time the patch is worn (16 hours for Nicotrol versus 16 or 24 hours for NicoDerm); the amount of nicotine contained in the patch (25 milligrams versus 114 milligrams); the amount of nicotine absorbed by the user from the patch over 16 hours of use (6 to 7 milligrams versus 12 milligrams); and the residual amount of nicotine left in the patch after 16 hours of use (10 milligrams versus 102 milligrams). (7-11-03 H'g Tr. at 223-25.) Pharmacia claims that these differences provide a sufficient basis for an advertisement that Nicotrol has an advantage over NicoDerm with regard to sleep disturbances.
GSKCH rejoins, however, that there is no evidence that the latter three differences listed above (amount of nicotine in the patch, amount absorbed, and residual amount) have any bearing on sleep disturbances. In fact, GSKCH claims, all the evidence is to the contrary. Pharmacia's own two witnesses testified that they knew of no evidence that these three design elements give Nicotrol an advantage with respect to sleep disturbances. (Id.) at 185-86, 230-32.) Another Pharmacia witness testified in a deposition that the only advantage NicoDerm has with respect to sleep disturbance is that it is worn for 16 hours. (2d Horvath Dec., Ex. 1, at 22.) Thus, GSKCH claims, Pharmacia cannot claim Nicotrol's superiority with regard to sleep disturbances on the basis of these three features.
GSKCH readily admits that the first feature listed above, Nicotrol's 16-hour use, does lead to fewer sleep disturbances, but contends that this feature does not provide a basis for a claim that Nicotrol has an advantage over NicoDerm. First, it is undisputed that NicoDerm has this exact same design feature, and for the exact same reason: NicoDerm too may be worn for 16 hours, rather than 24, in order to reduce sleep disturbances. (GSKCH Supp. Br. at 2; Pharm. Opp. Br. at 10-11; 7-11-03 H'g Tr. at 83.) Second, GSKCH claims that there is no evidence that there is any difference in sleep disturbances between consumers using Nicotrol for 16 hours versus those using NicoDerm for 16 hours. If Pharmacia has no evidence that 16 hours of Nicotrol leads to better sleep than 16 hours of NicoDerm, GSKCH concludes, this claim may not be made in the commercial.
The Court finds that Pharmacia has no basis for its cla