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NOVO NORDISK A/S v. BECTON DICKINSON AND COMPANY

May 8, 2000

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, Judge

OPINION and ORDER

Defendant Becton Dickinson has moved for summary judgment on four issues arguing: (1) that the `535 patent, `323 patent, and the `906 patent are invalid as anticipated under 35 U.S.C. § 102(b) in view of a June 1991 issue of Novo Nordisk's informational brochure, Medview, containing an article by Lene Lytzen; (2) that all claims of the `323 patent and claims 11-14 of the `906 patent are invalid as anticipated under 35 U.S.C. § 102(b) in view of a May 1993 advertising brochure for Novo's NovoFine G30 pen needle product; (3) that Becton's G31. insulin pen syringe needle products do not infringe the `906 patent; and (4) that if Becton is found to have infringed on Novo's 906 patent, no damages have accrued due to Novo's failure to put Becton on notice of the infringement.*fn1

I.

A patent is presumed to be valid, see 35 U.S.C. § 282, and this presumption only can be overcome by clear and convincing evidence to the contrary. See, e.g., WMS Gaming Inc. v. International Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999). To be entitled to summary judgment, therefore, Becton has to establish that there are no material facts in dispute.

II.

A. Lytzen Article as Prior Art

Becton urges this Court to rule that Novo made a binding admission that the Lytzen article was a printed publication when it requested reexamination of the `535 patent. The Court rejects this conclusion as unfair to Novo and in any event, as without support.

It is recognized that positions are often taken during patent prosecutions out of convenience and expedience, and therefore such positions should not be given conclusive effect. See, e.g., Quad Envtl. Tech. v. Union Sanitary Dist., 946 F.2d 870, 873 (Fed. Cir. 1991) (refusing to treat the filing of a terminal disclaimer over a double patenting as an admission that the double patenting reference was invalidating).

Becton concedes that Novo submitted Lytzen to the Patent Office during the reexamination with the express proviso that "[t]he Patent Owner admits, for purposes of this reexamination proceeding only, that Lytzen is prior art under 35 U.S.C. § 102(b)." (emphasis added) The Patent Office conducted the reexamination on Nova's conditional representation that it was a publication for purposes of the reexamination proceeding and concluded that Lytzen was "not material to the patentability of the [`535 patent]" and created "no substantial new question of patentability."

Under the circumstances, Becton's various arguments regarding the reexamination proceeding are meritless. First, under the Manual of Patent Examining Procedure ("MPEP"), if the Patent Office had found Nova's conditional admission concerning the Lytzen article to be improper, it would have been obligated to inform Nova and return the citation papers and refuse to conduct the reexamination.

Second, since the Patent Office did not find the procedure improper, Becton's contention that conducting a reexamination proceeding based an a conditional admission constitutes an impermissible "advisory" opinion by the Patent Office and/or an impermissible expenditure of government funds is without merit.

Third, Becton's argument that citation of the Lytzen article during the prosecution of the `323 and `906 patents constitutes an admission that Lytzen is a prior art publication is incorrect. In Standard Manufacturing Company v. United States, 25 Cl. Ct. 1, 61 (1991), the United States Claims Court rejected such an argument holding:

The Patent & Trademark Office clearly recognize[s] that an applicant may choose to furnish material information in an Information Disclosure Statement which does not necessarily depict prior art. The Court, therefore, finds that Standard's disclosure of the document in question in the required disclosure statement should not be considered an acknowledgment, declaration, concession or any kind of recognition of the fact that the disclosed publication is prior art.

Id. at 61-62. Moreover, 37 C.F.R. § 1.97 (h) provides that "[t]he filing of an information disclosure statement shall not be construed to be an admission that the information cited in the statement is, or is considered to be, material to patentability. . . ."

Fourth, Becton argues that Nova should have attempted to "correct" the cover pages of the patents-in-suit to remove the reference to the Lytzen article. However, the Patent Examiner is required to list on the face of the patent or reexamination certificate all references considered during prosecution, regardless of whether those references are technically prior art. See MPEP § 130.12. Further, citation of a reference in an information disclosure statement — which requires the Patent Office to list the reference on the front cover of the patent — does not constitute an admission that the reference is prior art. Thus, the Lytzen article is properly cited on the cover pages of the patents-in-suits.

Accordingly, the Court declines to rule that the Lytzen article is prior art based upon Novo's conditional admission.

B. Lytzen and the Elements of the Patents-in-Suit

To anticipate a claim, a reference must: (1) disclose every element of the challenged claim; and (2) enable one skilled in the art to make the claimed subject matter. See PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1566 (Fed. Cir. 1996). It is not sufficient that each element be found somewhere in the reference, the elements must be "arranged as in the claim." Lindemannn Maschinenfabrik GmbH v. American Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed. Cir. 1984). Further, the reference must be sufficiently clear so as to prove the existence of each and every element in the reference. See Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1473 (Fed. Cir. 1997).

1. `535 Patent Claim

a. Claim 1

The elements of claim of the `535 patent are as follows:

(1) An insulin injection system compromising;

(2) a pen shape syringe system comprising;

(3) a cartridge with insulin; and

(4) an injection needle;

(5) wherein the injection needle is a G30 needle; and

(6) the cartridge contains an insulin type which may freely flow through the G30 needle.

Becton's argument for the proposition that the Lytzen article discloses the elements of claim 1 of the `535 patent is based on the deposition testimony of one of its experts:

It [Lytzen] describes the 30-gage needle, describes the needle, I guess the needle hub itself that's shown on the — actually shown on the cover, even though it only — it's only for a 27-gauge needle, but the concept is there and then the 30-gauge needle is described in the text portion.

Sharrott Decl. Exh. 37, Synderman Tr. 44:14-20. With respect to the insulin disclosed in Lytzen, Becton's expert also stated: "As far as the insulin that would flow freely through a 30-gauge needle, the only insulin that was available in cartridges is insulin that would flow through a 30-gauge needle." Id. at 45:9-13.

To rebut this, Novo's expert, see Fischell Declaration, opines that "[n]owhere in the Lytzen article does it disclose or teach that one should use a G30 needle with a pen syringe with a cartridge." 1999 Fischell Decl. ¶ 6. Moreover, "[n]o specific insulin is described in the Lytzen article that can be used with a pen shaped syringe and a cartridge and a G30 needle." Id. Finally, as Dr. Fischell stated, one cannot conclude, at this juncture, that "a person of skill in the art of medical devices could . . . utilize the Lytzen article to construct the system described in the `535 and `323 patents." Id. at ¶ 23.

In light of these contrary opinions, there are, at a minimum, genuine issues of material fact as to whether: (1) Lytzen teaches each and every element of claim 1 of the `535 patent; (2) Lytzen discloses the elements of claim 1 as arranged and disclosed in the `535 patent; and (3) Lytzen is enabling.

b. Dependent Claims 2-10 of the `535 Patent

Each of the dependent claims of the `535 patent contain all the elements of the independent claim 1 and the particular additional elements recited in each particular dependent claim. See 35 U.S.C. § 114, ¶ 4. Because there are genuine issues of material fact as to whether Lytzen discloses each element of claim 1 of the `535 patent, genuine issues of material fact exist as to each of claim 1's dependent claims. See Corning Glass Works v. Sumitomo Elec. USA. Inc., 868 F.2d 1251, 1256 n.4 (Fed. Cir. 1986). Moreover, ...


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