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

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK


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

OPINION & ORDER

 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's pen-type insulin injection system, issued as United States Patent No. 5,462,535 ("'535 patent") on October 31, 1995, *fn2" consists of three components: (1) a pen-type insulin delivery device, (2) a G30 needle, and (3) a cartridge "containing only insulin types that may flow freely through a G30 needle." '535 Patent, Becton Ex. 1. Novo's G30 needle patent, issued United States Patent No. 5,599,323 ("'323 patent") on February 4, 1997, consists of a G30 needle positioned on a hub and fitted for use with a pen-type insulin delivery system. *fn3"

 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. § 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"

 In response to Novo's claims, Becton argues that Novo's patents are invalid. *fn13" Specifically, Becton contends that Claim 1 in the '323 and '535 patents is anticipated by or obvious in view of prior art, including three insulin injection devices and a Novo publication.

 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, the "invention is based on the surprising recognition that needles thinner than G29 may be used for injecting insulin." '535 Patent, Col 2., Lns. 6-8; '323 Patent, Col. 2, Lns. 9-11.

 In support of its contention that insulin suspensions cause needle clogging, Novo relies on, and cited in its patents, a 1976 article in Diabetes Forecast entitled "How to Avoid Clogging of Insulin Syringes." That article concluded that "with poor injection techniques all insulin suspensions produced" clogging in G25, G26, and G27 needles. *fn15" Becton Ex. 19. The article also noted, however, that needle clogging did not occur when insulin solutions were injected through these needles.

 Turning to the prior art, Becton argues that Claim 1 in both the '323 and '535 patents--the only independent claim in each of the patents--describes inventions that "accept" ('323 patent) or "contain" ('535 patent) cartridges containing either insulin solutions or insulin suspensions which may flow freely through a G30 needle. Accordingly, because, as Novo admits, insulin solutions have always been known to flow freely through G30 needles, Becton argues that Claim 1 in each patent is obvious, rendering both patents invalid. *fn16"

 Second, Becton argues that even without Novo's admission that insulin solutions always have been known to flow freely through a G30 needle, the prior art demonstrates this fact, and therefore Claim 1 in each patent is obvious. Becton contends that the invention covered by Novo's '323 patent is invalid because it is obvious in view of U.S. Patent No. 4,552,561 ("Eckenhoff" or the "Eckenhoff patent"), issued on November 12, 1985, which teaches the use of an insulin pump that injects insulin solution through a G30 needle. Becton argues that it would have been obvious to one skilled in the insulin syringe art to combine the teachings of the Eckenhoff patent with other prior art, including the G27, G28, and G29 pen needles referred to in the '323 patent, to produce the claimed G30 pen needle.

 As for the pen-type insulin injection system covered by Novo's '535 patent, Becton claims that it is invalid because it is obvious in view of U.S. Patent No. 4,973,318 ("Holm" or the "Holm patent"), issued on November 27, 1990, and assigned to Novo. The Holm patent discloses all of the claimed elements of the '323 and '535 patents, that is, a pen-type insulin injection device, an insulin cartridge, and a disposable pen needle, except that it does not identify the gauge of the pen needle. When Holm is viewed together with Eckenhoff, Becton argues that Novo's pen-type insulin injection system, insofar as insulin solutions are concerned, is obvious. *fn17"

 Third, even insofar as insulin suspensions are concerned, Becton claims that Novo's patents are invalid because the inventions they cover are obvious in view of a G29 syringe-type insulin needle manufactured by Terumo ("Terumo needle"), *fn18" which was on the market in 1989 and accommodated not only insulin solutions, but also insulin suspensions. *fn19" An internal Novo report discloses that in 1989, Novo purchased Terumo needles to test whether insulin suspensions caused clogging or sieving when injected through them. The "results of the test with the [Terumo needles] surprisingly showed no sieving effect." Kimer Decl. P 8.

 Significantly, this report also indicates that the internal diameters of the Terumo needles tested with insulin suspensions ranged from 0.13 to 0.15 mm. See Kimer Decl. Ex. C. Thus, although labeled a G29 needle, the Terumo needle's internal diameter was in fact the same size as, if not smaller than, the internal diameter of Novo's G30 needle, which measures 0.15 mm. Accordingly, Becton argues that because Terumo needles were available for purchase in 1989 they constitute prior art, and because insulin suspensions passed through the Terumo needle without causing clogging, it was obvious that insulin suspensions would also pass through Novo's G30 needle without causing clogging.

 Finally, Becton claims that the inventions covered by Novo's patents are invalid because they are obvious in view of, if not anticipated by, a June 1991 article written by Novo research associate Lene Lytzen (the "Lytzen Article" or "MedView Article"), entitled "Hypodermic, Disposable Needles: Mechanical Properties and Pain Perception as a Function of Needle Diameter." The Lytzen Article, published in Novo's company magazine, MedView, and disseminated to affiliates, acknowledged that "inhouse laboratory tests have shown that reduction of the diameter of the needles to 0.30 mm (G30) does not cause alterations of insulin concentration, precipitation or needle clogging." Lytzen Article at 13, Becton Ex. 4. Since these G30 needles were tested in combination with pen-type insulin injection systems, Becton contends that Claim 1 in each of the patents is obvious in view of, if not anticipated by, the Lytzen Article, and therefore invalid.

 DISCUSSION

 Because substantive matters unique to patent law are involved in this case, the law of the Federal Circuit controls. See Hybritech, Inc. v. Abbott Lab., 849 F.2d 1446, 1451 n.12 (Fed. Cir. 1988). Under the law of the Federal Circuit, in order to obtain a preliminary injunction, Novo must establish a right thereto in light of four factors: (1) reasonable likelihood of success on the merits, (2) irreparable harm, (3) the balance of the hardships tipping in its favor, and (4) the impact of the injunction on the public interest. See id. Irrespective of how the Court resolves the third and fourth factors, the Court may deny the motion based upon Novo's failure to establish either of the first two factors. See Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1556 (Fed. Cir. 1994).

 At the preliminary injunction stage, a patentee must establish a likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement. See Nutrition 21 v. United States, 930 F.2d 867, 869 (Fed. Cir. 1991). Patent infringement analysis involves two steps: first, the Court must construe the meaning of the patent's claims as a matter of law, and second, the Court must determine whether the accused product infringes the asserted claim as properly construed. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370, 134 L. Ed. 2d 577, 116 S. Ct. 1384 (1996). At the preliminary injunction stage, although the Court may in exercising its discretion decide to interpret the patent claims conclusively, it is under no obligation to do so. See Sofamor Danek Group, Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1221 (Fed. Cir. 1996). Here, the Court declines to construe the claims finally.

 I. Claim Construction Under Markman

 A. General Principles

 To ascertain the meaning of a patent's claims, the Court examines the claims themselves, the specification, and the prosecution history. See Markman, 52 F.3d at 979. First, the Court looks to the words of the claim, both asserted and nonasserted, to define the scope of the patented invention. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). "The terms of a claim will be given their ordinary meaning, unless it appears that the inventor used them differently." ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1579 (Fed. Cir. 1988); see also Hoganas AB v. Dresser Indus., 9 F.3d 948, 950 (Fed. Cir. 1993).

 Second, the Court reviews the patent specification "to determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning." Id. "The specification acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication." Id. "Thus, the specification is always highly relevant to the claim construction analysis," and usually "is the single best guide to the meaning of a disputed term." Id.

 Third, if a patent's prosecution history is in evidence, the Court may consider that history when construing the meaning of the patent's claims. See id. "This history contains the complete record of all the proceedings before the Patent and Trademark Office, including any express representations made by the applicant regarding the scope of the claims." Id.

 B. Claim 1 of the '323 and '535 Patents

 Here, Becton and Novo disagree as to the proper construction of Claim 1 of the '323 and '535 patents. *fn20" Claim 1 of the '323 patent states:

 

A needle assembly comprising:

 

(a) a needle hub having a base and a standard insulin needle fitting for removably mounting said needle assembly on a pen-type insulin syringe having a standard mounting and which accepts cartridges containing only insulin types that may flow freely through a G30 needle; and

 

(b) a G30 needle secured in said base and having first and second needle portions extending from said base in opposite directions.

 '323 Patent, Becton Ex. 7.

 Claim 1 of the '535 patent provides:

 

An insulin injection system comprising a pen shaped syringe comprising a cartridge with insulin and an injection needle, wherein the needle is a G30 needle and the cartridge contains an insulin type which may freely flow through the G30 needle.

 '535 Patent, Becton Ex. 1.

 At issue here is the meaning of the language "insulin types that may flow freely through a G30 needle" contained in the '323 patent, and the similar language "an insulin type which may freely flow through the G30 needle," contained in the '535 patent. Novo argues that this language applies to both insulin solutions and insulin suspensions. Becton counters that this language must be interpreted as applying only to insulin suspensions.

 C. Construing the Patents

 Having reviewed the specifications and prosecution histories of the patents, the Court agrees with Novo's reading of the claims. That is, for the limited purpose of ruling on Novo's motion for a preliminary injunction, the Court construes the language of Claim 1 of the '323 and '535 patents to apply to both insulin suspensions and solutions.

 Column 3, Line 10 of the '323 patent, and Column 3, Line 7 of the '535 patent explicitly refer to both insulin solutions and suspensions. Likewise, the Abstracts *fn21" of both the '323 and '535 patents state in relevant part: "The needle is a G30 needle and the insulin is a type which may freely flow through a G30 needle. When the insulin is the type comprising suspended crystals the maximum dimension of any crystal is 15 [mu] m." *fn22" '323 and '535 Patent Abstracts, Becton Exs. 1, 7 (emphasis added). The clear implication from these Abstracts is that insulin that may flow freely through a G30 needle can be insulin solutions or suspensions.

 Moreover, the prosecution histories of both patents indicate that the patents apply to both insulin suspensions and solutions. See Declaration of Benjamin S. Lee, Ex. D at 3; '535 Patent Reexamination Request, Becton Ex. 14.

 Accordingly, the Court concludes that the words "insulin types" and "insulin type" as used in Claim 1 of the '323 and '535 patents apply to both insulin solutions and insulin suspensions.

 Having interpreted Claim 1 of Novo's patents, the Court now turns to whether the patents, as interpreted, are valid.

 II. Validity of the Patents

 At the preliminary injunction stage, Novo as the patentee, carries the burden of showing likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement. *fn23" Nutrition 21, 930 F.2d at 869; see also Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 n.2 (Fed. Cir.), cert. denied, 139 L. Ed. 2d 310, 118 S. Ct. 397 (1997); Bio-Technology Gen. Corp. v. Genentech, Inc., 80 F.3d 1553, 1558 (Fed. Cir.), cert. denied, 136 L. Ed. 2d 197, 117 S. Ct. 274 (1996); Novo Nordisk of N. Am., Inc. v. Genentech, Inc., 77 F.3d 1364, 1367 (Fed. Cir. 1996). Therefore, if Becton raises a "substantial question" concerning validity, enforceability, or infringement, Novo, in order to succeed on its preliminary injunction motion, must demonstrate that Becton's defense lacks "substantial merit." See New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882-83 (Fed. Cir. 1992); see also Novo Nordisk, A/S, 108 F.3d at 1364; Boehringer Ingelheim Animal Health v. Schering-Plough Corp., 984 F. Supp. 239, 1997 WL 663079, at *15 (D.N.J. 1997). Absent such a showing by Novo, its motion for a preliminary must be denied. See Novo Nordisk, A/S, 108 F.3d at 1364.

 A. Obviousness

 Here, Becton claims that it has raised a substantial question concerning the validity of Novo's patents. Specifically, Becton argues that Novo's patents are invalid because the inventions they describe are obvious in view of prior art, pursuant to Sections 103(a) of the Patent Act. *fn24"

 Whether a patent is obvious under Section 103 is a question of law requiring the examination of four factors: (1) the level of ordinary skill in the pertinent art; (2) the scope and content of the prior art; (3) the differences between the claims at issue and the prior art; and (4) secondary considerations, if any, of nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17-18, 15 L. Ed. 2d 545, 86 S. Ct. 684 (1966); B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996).

 1. Level of Ordinary Skill in the Pertinent Art

 Based upon the qualifications of various witnesses relied upon by the parties, the Court concludes that the pertinent art is medical supply manufacturing, and the level of ordinary skill is a bachelor's degree in pharmacy medicine, engineering, and possibly biology, with several years of experience.

 2. The Scope and Content of the Prior Art25

 "The scope of the prior art has been defined as that reasonably pertinent to the particular problem with which the inventor was involved." Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1535 (Fed. Cir. 1983) (internal quotations and citation omitted). The problem allegedly facing Novo was preventing needle clogging when insulin suspensions were used in pen-type insulin injection systems employing G30 needles. The prior art includes the 1976 Diabetes Forecast article, the Holm and Eckenhoff patents, and the Terumo needle -- none of which were disclosed in the '323 and '535 patent applications --and the Lytzen Article, disclosed for the first time in connection with Novo's '535 patent Reexamination Request. Each of these items pertains to insulin injections.

 Specifically, the 1976 Diabetes Forecast article addressed needle clogging caused by insulin suspensions when poor injection techniques were employed. Holm disclosed a pen-type insulin injection system and Eckenhoff taught the injection of insulin solutions through a G30 needle used with an insulin pump. Novo's own measurement of the Terumo needle in 1989 indicated that its internal diameter was the same size if not smaller than Novo's G30 needle, and Novo's own tests demonstrated that the Terumo needle safely accommodated insulin suspensions. Finally, the Lytzen Article disclosed that clogging did not occur when insulin suspensions were injected through a G30 needle.

 3. The Differences Between the Claimed Invention and the Prior Art

 As Novo admits, the pen-type insulin injection device, insulin cartridge, and G30 needle each were known prior to the filing of the '323 and '535 patent applications; only the employment of a G30 needle in a pen-type insulin injection system, instead of G29 or other larger diameter needle, was supposedly unknown. See, e.g., Preliminary Injunction Hearing Transcript at 15. Taken alone, the fact that each of these individual components was known does not render Novo's patents invalid. See Environmental Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 698 (Fed. Cir. 1983) ("Virtually all inventions are combinations and virtually all are combinations of old elements."), cert. denied, 464 U.S. 1043, 79 L. Ed. 2d 173, 104 S. Ct. 709 (1984). Nevertheless, Becton has raised a substantial question as to the validity of the patents when the inventions they describe are considered as a whole in light of prior art. See Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1462 (Fed. Cir. 1984) ("The claimed invention must be considered as a whole, and the question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination."); see also Gillette Co. v. S.C. Johnson & Son, Inc., 919 F.2d 720, 724 (Fed. Cir. 1990); Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1448 (Fed. Cir. 1984); Stratoflex, 713 F.2d at 1540.

 First, Novo admits that insulin solutions always have been known to flow freely through a G30 needle without any potential for clogging or sieving. Nevertheless, Novo failed to limit Claim 1 in either patent to insulin suspensions. Accordingly, because Claim 1 in each patent covers insulin solutions, and because insulin solutions always have been known to flow freely through G30 needles, the Court finds substantial merit in Becton's argument that Claim 1 in each patent is obvious. *fn26" See, Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed Cir. 1983) (where patent claim was so broad as to read on prior art, claim was obvious and therefore invalid); Philip v. Mayer, Rothkopf Indus., Inc., 635 F.2d 1056, 1060 (2d Cir. 1980) ("a patent is invalid, no matter how useful and original the invention it protects, if the applicant for the patent claims the invention so broadly that it encompasses already established prior art"); Maclaren v. B-I-W Group Inc., 535 F.2d 1367, 1372-73 (2d Cir.) (same), cert. denied, 429 U.S. 1001, 50 L. Ed. 2d 612, 97 S. Ct. 531 (1976); see also 35 U.S.C. § 251 (patent reissue statute) (stating that where patent holder's patent is deemed invalid because patentee claimed more than he had a right to claim, patentee may apply for reissuance of patent).

 Second, even without Novo's admission that insulin solutions have always been known to flow freely through a G30 needle, the Court finds that Becton has raised a substantial question as to the validity of Claim 1 of the '323 and '535 patents in light of the Holm and Eckenhoff patents. The Holm patent is directed to a pen-type insulin injection system; the Eckenhoff patent teaches that insulin solutions flow freely through a G30 needle. As discussed above, Claim 1 of the '323 and '535 patents is not limited to insulin suspensions, but rather covers both insulin suspensions and insulin solutions. Therefore, taken together, the Holm and Eckenhoff patents clearly teach the combination of a pen-type insulin injection system with a G30 needle that will allow insulin solutions to flow freely.

 Third, even insofar as insulin suspensions are concerned, Becton has raised a substantial question as to the validity of the patents in light of the G29 Terumo needle. Novo's purchase and testing of Terumo needles, a photocopy of packaging for the Terumo needle, see Becton Ex. 23, and the Nielsen report, see Becton Ex. 25, all demonstrate that Terumo needles were on the market in 1989 and constitute prior art. As indicated on the packaging for the Terumo needle, the needles were syringe-type needles for use with U-100 insulin, an insulin suspension. Likewise, Novo itself conducted a study in 1989 that indicated that no clogging problem existed when insulin suspensions were injected through these needles. Moreover, Novo's measurements of the Terumo needles indicated that the internal diameter of those needles ranged from 0.13 to 0.15 mm, which is as small, if not smaller than, Novo's then-future G30 needle. Therefore, the Court finds substantial merit in Becton's argument that the Terumo needle renders Claim 1 in each of Novo's patents obvious, even as to insulin suspensions.

  Finally, Becton has raised a substantial question as to the validity of Claim 1 in each patent based on the Lytzen Article. *fn27" After all, Novo contends that its inventions were issued patents because they solved a clogging problem that could occur when insulin suspensions were used in combination with pen-type insulin injection systems. Yet, the Lytzen Article--an article printed over two years before the filing of the '535 patent and over three years before the filing of the '323 patent--acknowledged that "in-house laboratory tests have shown that reduction of the diameter of the needles to 0.30 mm (G30) does not cause alterations of insulin concentration, precipitation or needle clogging." Lytzen Article at 13, Becton Ex. 4. Furthermore, it is clear to the Court, despite Novo's assertions to the contrary, that the G30 needles discussed in the Lytzen Article were tested in combination with a pen-type insulin injection system. *fn28" Therefore, insofar as Claim 1 covers insulin suspensions, that claim is obvious in view of the Lytzen Article, if not anticipated by that article. *fn29"

 4. Secondary Considerations

 Finally, the Court notes that Novo has not presented any evidence of secondary considerations. Accordingly, the Court cannot engage in a secondary considerations analysis. See, Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1555 (Fed. Cir. 1995) (courts must only consider evidence of secondary considerations such as commercial success, long-felt need, failure of others to find a solution to the problem at hand, and copying, when such evidence is presented by patent holder); Stratoflex, 713 F.2d at 1538 (same).

 5. Summary

 At this preliminary injunction stage, the Court "does not resolve the validity question but rather must . . . make an assessment of the persuasiveness of the challenger's evidence, recognizing that it is doing so without all evidence that may come out at trial." New England Braiding, 970 F.2d at 882-83. The Court may deny a preliminary injunction "where the evidence presented in support of invalidity raises a substantial question, although the defense may not be entirely fleshed out." Id. at 883. Here, based on the fact that insulin solutions always have been known to flow freely through a G30 needle, as well as upon the Holm, Eckenhoff, Terumo needle, and Lytzen prior art, it is clear that Becton has raised a substantial question about the validity of Claim 1 of the '323 and '535 patents. Because Novo has failed to carry its burden on the likelihood of success by failing to demonstrate that Becton's defenses lack substantial merit, the Court denies Novo's motion for a preliminary injunction. See Reebok, 32 F.3d at 1556. *fn30"

 CONCLUSION

 For the foregoing reasons, Novo's motion for a preliminary injunction is denied.

 SO ORDERED:

 BARBARA S. JONES

 UNITED STATES DISTRICT JUDGE

 Dated: New York, New York

 March 9, 1998


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