With the function check, a user can determine immediately whether the NovoPen 1.5 is working properly and delivering the right amount of insulin. This feature is useful if a diabetes patient has dropped the NovoPen 1.5 or otherwise suspects that the NovoPen 1.5 might be damaged or malfunctioning.
To perform the function check, a user must attach a capped NovoFine needle to the NovoPen 1.5, set the dial-a-dose insulin indicator on the pen to twenty units, press the pen's push button, and dispense insulin into the needle's outer cap. The lower portion of the outer cap holds exactly twenty units of insulin so that if the NovoPen 1.5 is functioning properly the lower portion will fill precisely to the top.
With an Ultra-Fine needle, however, a user cannot perform the function check because the Ultra-Fine needle's outer cap does not measure twenty units. Becton concedes this point and, indeed, advertises on its Ultra-Fine packages that the "the Novo function check cannot be performed with this needle."
Whether or not this inability to perform the function check renders the Ultra-Fine needles incompatible turns on whether the function check is "an inherent quality or characteristic" of the NovoPen 1.5. See Weight Watchers Int'l, Inc. v. Stouffer Corp., 744 F. Supp. 1259, 1282 (S.D.N.Y. 1990).
In deciding this question for purposes of Becton's motion, the Court has considered the primary uses of the NovoPen 1.5, the nature of the diabetes market, the standards within the industry as defined by the ISO, and the definition of "compatibility" in other contexts. See Weight Watchers, 744 F. Supp. at 1278-80 (discussing compatibility in context of dieting plans); Princeton Graphics Operating, L.P. v. NEC Home Elecs. (U.S.A.), Inc., 732 F. Supp. 1258, 1260-62 (S.D.N.Y. 1990) (applying a rigid definition of compatibility in case of computer competition in part because of industry's emphasis on precision). An analysis of these factors cuts both ways, and therefore raises only serious questions as to Becton's claim.
Much of the evidence before the Court suggests that the function check is more of an extrinsic feature than an inherent one. That Becton received FDA approval to market its needles for use with the NovoPen 1.5 supports this position. Also supporting this position is the fact that the Ultra-Fine needles comply with standards promulgated by the ISO. Finally, certain statements made by Novo in the European litigation indicate that Novo itself has not always considered the function check to be an essential feature of the NovoPen 1.5.
At the same time, the Court recognizes that Novo has designed a "system" and that it should be entitled to promote components that enable every feature of that system to function. Needles that limit the capabilities of the system, even in a relatively minor respect, cannot be considered "fully" compatible in the strictest sense.
III. Balancing the Hardships
Having found that there are sufficiently serious questions going to the merits of Becton's claim and that there is a risk of irreparable harm, the Court now proceeds to balance the equities.
Although Becton has not presented evidence of the costs of its investment or of its market losses, the Court recognizes that Becton likely has invested time and effort in the development of the Ultra-Fine needles. A message of incompatibility, if misleading or false, constitutes irreparable harm to Becton's good will and reputation, in part, because it may raise concerns about safety and quality control. These concerns are especially harmful in the diabetes treatment market because health care consumers typically emphasize safety and efficacy. Moreover, with respect to the Ultra-Fine II, which is a relatively new entrant to the market, early losses in market share may be difficult to measure and recoup, since consumers in the diabetes treatment market may form early product loyalty and be adverse to switching to a competitor's product. Here, the Court notes that at the time of the preliminary injunction hearing Novo controlled as much as 95% of the United States market for pen injection systems.
At the same time, Becton's need for a preliminary injunction is mitigated by the fact that Becton delayed in bringing this action. Becton apparently knew of Novo's advertising by June 1996 and launched its own insulin pen and Ultra-Fine II needles in September 1996. Yet Becton did not file this cross-action against Novo until March 1997. Some of this delay may be attributable to settlement discussions with Novo that would have rendered Becton's current claims moot. Nevertheless, the length of Becton's delay--over six months--"undercuts the sense of urgency that ordinarily accompanies a motion for preliminary relief." See Citibank, N.A. v. Citytrust, 756 F.2d 273, 277 (2d Cir. 1985).
In addition, the broad injunction sought by Becton--which includes a requirement that Novo affirmatively notify patients and health care professionals of the compatibility of Becton's needles--would be inequitable in light of advertisements published by Becton to promote its own B-D Pen. Those advertisements employ similar directives to consumers to use Becton needles in the B-D Pen.
Turning to Novo, the Court finds that Novo should have been on notice that these advertisements had the potential to be misleading, particularly since the same advertisements had been enjoined in Europe. Of course, Novo is entitled to promote the NovoPen in such a way as to maximize profits, but it may not convey a message of incompatibility if that message is false. A simple change in Novo's language will clarify that message without imposing too great of a hardship. This factor weighs heavily in Becton's favor.
Lastly, in considering the public's interest in this matter, the Court notes that consumers have an interest in receiving precise and accurate information. Diabetes patients who own the NovoPen 1.5 should be informed of their options in a truthful and non-misleading manner, and should be able to benefit from compatible components when such components are available. Again, this factor weighs in Becton's favor.
Balancing these factors, the Court concludes that limited injunctive relief is warranted.
In determining Becton's remedy, the Court will fashion a narrow injunction to fit the specific legal violation alleged and to comport with the equities presented. See Waldman Publ'g Corp. v. Landoll, Inc., 43 F.3d 775, 785 (2d Cir. 1994) (citation omitted); Sterling Drug, Inc. v. Bayer AG, 14 F.3d 733, 747 (2d Cir. 1994).
Accordingly, Novo is enjoined from future dissemination or publication in packaging, product labels, advertisements, product literature or instruction manuals of the following statements:
. Use with NovoFine disposable needles only