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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,
v.
BECTON DICKINSON AND COMPANY, Defendant.



The opinion of the court was delivered by: JONES

 BARBARA S. JONES

 UNITED STATES DISTRICT JUDGE

 This case involves a patent dispute between pharmaceutical companies competing for control of the diabetes treatment market in the United States. At issue, are patents held by plaintiffs Novo Nordisk A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals Inc. (collectively "Novo") for (1) a pentype insulin injection system and (2) a G30 *fn1" (or "thirty-gauge") disposable insulin pen needle.

 Novo alleges that defendant Becton Dickinson and Company ("Becton") directly and contributorily infringes, as well as induces infringement of, these two patents by marketing its own pen-type insulin injection device and a disposable G30 needle that fits both Novo's and Becton's insulin pens. Claiming a violation of Section 271 of the Patent Act, 35 U.S.C. ยง 271, Novo brings this motion seeking a preliminary injunction barring further infringement.

 In defense, Becton claims, among other things, that Novo's patents are invalid because Claim 1 in each patent is obvious in view of, if not anticipated by, prior art.

 On June 23 and June 25, 1997, the Court conducted a hearing. Having analyzed the evidence presented, the Court finds that Becton has raised a substantial question as to the validity of the patents and therefore denies Novo's motion for a preliminary injunction.

 BACKGROUND

 I. The Development of the Pen-Type Insulin Injection System

 Of the approximately 8 million Americans that have been diagnosed with diabetes, 3.5 million require daily insulin injections. The most commonly used insulin delivery system in the United States is the conventional syringe and vial, which currently is used by over 90% of insulin users. Recognizing the various limitations of the syringe and vial system, including dosage accuracy, convenience and privacy, and patient compliance, Novo began developing technology for the pen-type insulin injection system in 1980.

 In 1985, Novo produced the world's first pen-type insulin injection system, the NovoPen, which, like the system covered by the '535 patent, was comprised of a pen-type insulin injection device, a disposable needle, and an insulin cartridge. Because of its pen-like shape, this system was both easier to carry and could be used more discreetly than the syringe and vial system. In 1989, Novo introduced a more sophisticated version of the NovoPen, the NovolinPen, which had the same three components, but also included a "dial-a-dose" *fn4" mechanism. The NovoPen and NovolinPen employed G27, G28, or G29 disposable needles. *fn5"

 In June 1996, Novo launched its NovoPen 1.5 insulin delivery system nationwide in the United States. *fn6" The NovoPen 1.5 embodies the principles of the '535 and '323 patents and consists of three components: (1) the NovoPen 1.5 insulin pen device featuring a "dial-a-dose" mechanism, (2) the NovoFine 30 disposable needle--a G30 needle, and (3) the Novolin PenFill insulin cartridge.

 Beginning in or about September 1996, Becton began marketing in the United States its own pen-type insulin delivery device called the B-D Pen, and a G30 needle called the Ultra-Fine II that Becton markets for use with both the B-D Pen and the NovoPen 1.5. *fn7" Novo asserts that both the B-D Pen and Ultra-Fine II infringe Novo's '323 and '535 patents.

 To assemble the pen-type insulin delivery system, a patient loads an insulin cartridge into the pen and threads a needle onto the front end of the pen. After the insulin is injected, the needle is removed and discarded. The insulin cartridge, on the other hand, contains sufficient insulin for multiple doses, and thus may last several days before replacement is necessary. Currently, the NovoPen 1.5 and the B-D Pen account for more than 95% of the United States insulin pen market. Insulin in cartridges is manufactured only by Novo and Eli Lilly and Company ("Lilly"). *fn8" Novo's NovoFine 30 and Becton's Ultra-Fine II currently are the only thirty-gauge needles marketed for use with the Novo and Becton pen devices. *fn9"

 Insulin for use with pen-type insulin injection systems comes in two forms: insulin suspensions and insulin solutions. An insulin suspension is an insulin embodying crystalline particles. An insulin solution, in contrast, contains no particles.

 II. Novo's Infringement Claims and Becton's Defenses

 First, Novo claims that Becton's Ultra-Fine II thirty-gauge needle directly infringes Novo's '323 patent covering the G30 needle assembly in violation of Section 271(a) of the Patent Act. Specifically, Novo claims that Becton's Ultra-Fine II directly infringes the '323 patent because, like Novo's G30 needle, it is comprised of a needle hub and G30 needle.

 Second, Novo claims that Becton induces infringement of and contributorily infringes Novo's '535 patent on the pen-type insulin injection system, in violation of Sections 271(b) and 271(c) of the Patent Act, respectively. *fn10" Specifically, Novo argues that Becton's marketing of its Ultra-Fine II needle induces consumers to infringe Novo's '535 patent by encouraging them to combine the Becton G30 needle with a pen-type insulin delivery device manufactured by either Novo or Becton. Novo also argues that Becton's marketing of the B-D Pen induces consumers to infringe by encouraging them to combine the B-D Pen with an Ultra-Fine II needle and a Novo or Lilly insulin cartridge. *fn11"

 Regarding contributory infringement, Novo claims that Becton's Ultra-Fine II needle infringes a material part of the '535 patent because it is sold specifically for use in an infringing pen-type insulin delivery system. *fn12"

 A. Prior Art

 Before turning directly to the prior art, the Court notes that Novo admits that insulin injection pens, insulin cartridges, and G30 needles each were known prior to the issuance of the '323 and '535 patents. Novo further admits that before its inventions, G30 needles were marketed for use with nonpen-type insulin delivery systems employing insulin solutions. Prior to Novo's release of the NovoPen 1.5, however, the only needles available for use with pen-type insulin delivery systems, which accommodated both suspension and solution insulins, were G27, G28, and G29 needles.

 Novo claims that prior to the release of the NovoPen 1.5, G30 needles never were used in combination with pen-type insulin delivery systems because they were believed to be too small to be used safely with insulin suspensions. According to Novo, because insulin suspensions contain crystalline particles, they present a clogging or sieving *fn14" danger when used with certain needles. Novo claims that after "years of extensive research and development," it developed the NovoPen 1.5 insulin injection system, eliminating any danger of needle clogging. Memorandum of Law in Support of Plaintiffs' Motion for a Preliminary Injunction at 6. As Novo states in each patent, ...


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