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NOVO NORDISK A/S v. BECTON DICKINSON & CO.

March 9, 1998

NOVO NORDISK A/S, NOVO NORDISK OF, NORTH AMERICA, INC. and NOVO NORDISK PHARMACEUTICALS INC., Plaintiffs, against BECTON DICKINSON AND COMPANY, Defendant. BECTON DICKINSON AND COMPANY, Cross-Claimant, - against - NOVO NORDISK A/S, NOVO NORDISK OF, NORTH AMERICA, INC. and NOVO NORDISK PHARMACEUTICALS INC., Cross-Defendants.


The opinion of the court was delivered by: JONES

 BARBARA S. JONES

 UNITED STATES DISTRICT JUDGE

 Cross-claimant Becton Dickinson and Company ("Becton") counterclaims against cross-defendants Novo Nordisk A/S, Novo Nordisk of North America, Inc. and Novo Nordisk Pharmaceuticals Inc. (collectively "Novo") alleging that certain promotional materials distributed by Novo constitute false advertising in violation of Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and Sections 349 and 350 of the New York General Business Law. *fn1"

 On June 30 and July 1, 1997, the Court conducted a hearing on Becton's motion for a preliminary injunction. Having analyzed the evidence presented at that hearing under the relevant standards, the Court denies the injunction requested by Becton, but grants limited injunctive relief.

 BACKGROUND

 Novo and Becton are pharmaceutical companies involved in the development, production and distribution of products related to the treatment of diabetes. At the heart of the current dispute is a pen delivery system manufactured by Novo, known as the NovoPen 1.5 ("NovoPen 1.5"), that offers diabetes patients a convenient means of self-administering insulin. The pen delivery system is a relatively new alternative to the traditional syringe and vial method of insulin injection that is used by over 90% of diabetes patients.

 The NovoPen 1.5 consists of three components: the actual pen, a disposable needle, and an insulin cartridge. The needle and cartridge are replaceable, and Novo sells both of these components, marketing the needle under the name "NovoFine 30."

 The primary advantage of the NovoPen 1.5 is that it allows patients to dial the appropriate insulin dose without having to measure insulin before each injection. The NovoPen 1.5 is also more discreet than the traditional syringe. As a result, when given the choice between the traditional syringe and the insulin pen, many diabetes patients will opt for the pen.

 After Novo introduced the NovoPen 1.5 in the United States *fn2" in June 1996, Becton developed its own pen system, known as the B-D Pen. Becton also began to market its disposable needles, known as the B-D Ultra-Fine and the B-D Ultra-Fine II *fn3" (collectively the "Ultra-Fine needles"), for use in the NovoPen 1.5, after receiving clearance from the Food and Drug Administration ("FDA").

 In marketing the NovoPen 1.5, Novo makes certain statements that Becton claims amount to false advertising. First, Novo advertises that the "NovoFine 30 disposable needle is the finest and shortest insulin needle available in the U.S." Second, in product packaging, instruction manuals, and brochures, Novo makes several statements to the effect that the NovoPen 1.5 is to be used only with NovoFine disposable needles. *fn4" Becton seeks a preliminary injunction to prevent Novo from making each of these statements.

 DISCUSSION

 In order to obtain a preliminary injunction, Becton must show (1) irreparable injury and (2) either (a) a likelihood of success on the merits or (b) sufficiently serious questions going to the merits to make them fair ground for litigation and a balance of hardships tipping decidedly in Becton's favor. See Castrol, Inc. v. Quaker State Corp., 977 F.2d 57, 62 (2d Cir. 1992); Jackson Dairy, Inc. v. H.P. Hood & Sons, Inc., 596 F.2d 70, 72 (2d Cir. 1979).

 I. Irreparable Injury

 Here, Becton has met its burden with regard to irreparable injury if its false advertising claims are meritorious. Becton and Novo are the major competitors in the insulin pen and needle markets, engaged in head-to-head competition. While this fact alone does not establish irreparable harm where there has been no direct reference to Becton in Novo's advertisements, see McNeilab, Inc. v. American Home Prods. Corp., 848 F.2d 34, 38 (2d Cir. 1988), Becton has submitted consumer survey evidence, as discussed below, that supplies "the causative link between the advertising and [Becton's] potential lost sales." See Coca-Cola Co. v. Tropicana Prods., Inc., 690 F.2d 312, 317 (2d Cir. 1982). Moreover, because Becton's claims relate to the Ultra-Fine II, which is a relatively new entrant in the needle market, Becton would have a particularly difficult time proving money damages if it were to succeed ultimately in its claims. *fn5"

 II. The Merits of Becton's Claims Under the Lanham Act

 Turning to the merits of Becton's claims, to succeed under § 43(a) of the Lanham Act, *fn6" Becton may proceed under either of two theories. First, Becton can attempt to show that the challenged advertisement is literally false, meaning that it is false on its face or "explicitly false." See Coca-Cola, 690 F.2d at 316-17; see also Johnson & Johnson * Merck Consumer Pharm. Co. v. Smithkline Beecham Corp., 960 F.2d 294, 297 (2d Cir. 1992); McNeil-P.C.C., Inc. v. Bristol-Myers Squibb Co., 938 F.2d 1544, 1549 (2d Cir. 1991). A claim based on this theory requires Becton to adduce evidence that affirmatively shows Novo's claim to be false. See Glaxo Warner-Lambert OTC G.P. v. Johnson & Johnson Merck Consumer Pharms. Co., 935 F. Supp. 327, 329 (S.D.N.Y. 1996) (citing Castrol, 977 F.2d at 62). *fn7"

 With these standards in mind, the Court now turns to Becton's claims.

 A. The "Finest and Shortest" Advertisement

 Becton's first claim is based on Novo's statement that the "NovoFine 30 disposable needle is the finest and shortest insulin needle available in the U.S." Becton claims that this statement is false because the B-D ...


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