Novo, its motion for a preliminary must be denied. See Novo Nordisk, A/S, 108 F.3d at 1364.
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.
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.
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.
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.
Therefore, insofar as Claim 1 covers insulin suspensions, that claim is obvious in view of the Lytzen Article, if not anticipated by that article.
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).
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.
For the foregoing reasons, Novo's motion for a preliminary injunction is denied.
BARBARA S. JONES
UNITED STATES DISTRICT JUDGE
Dated: New York, New York
March 9, 1998