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ABBOTT LABS. v. DIAMEDIX CORP.

May 21, 1997

ABBOTT LABORATORIES, an Illinois corporation, Plaintiff,
v.
DIAMEDIX CORPORATION, a Florida corporation, Defendant.



The opinion of the court was delivered by: LEINENWEBER

 BACKGROUND

 On September 29, 1975, Seymour P. Halbert applied to the United States Patent and Trademark Office (the "PTO") for two patents which eventually became United States Patent Nos. 4,474,878 (the "'878 patent") and 4,642,285 (the "'285 patent"). These patents are currently owned by defendant Diamedix Corporation ("Diamedix") and are licenced exclusively to plaintiff Abbott Laboratories ("Abbott"). Abbott filed suit in this court seeking a declaration that the '878 and '285 patents are invalid and that the licensing agreement is void and unenforceable. Specifically, plaintiff points to Japanese Patent Application No. 46/16535 by S. Mukojima (the "Mukojima reference"), claiming that it anticipates both patents under 35 U.S.C. § 102(b), or in the alternative, that it renders the patents obvious under 35 U.S.C. § 103. Plaintiff now moves for summary judgment.

 The Invention

 The '878 and '285 patents (the "patents in question") relate to tests known as enzyme immunoassays ("EIAs") used to detect the presence of an antigen in a bodily fluid sample, such as a blood sample. By detecting the presence of antigens, which among other things can be viruses and other disease-causing agents, the tests can be used to test for diseases such as hepatitis. Immunoassays rely heavily on the fact that, when invaded by a foreign antigen, the immune system begins to produce antibodies that attach to the antigen and fight the disease. In adding a solution containing known antibodies to the bodily fluid sample, immunoassays detect whether the antibodies have attached to anything in the sample. If they have, then the sample contains the antigen to which the particular antibody naturally attaches, thus revealing that the subject has the suspected disease.

 (SOLID CARRIER)(ANTIBODY)(ANTIGEN)(ANTIBODY)(ENZYME)

 The solid carrier is then washed to remove any of the enzyme-linked antibodies that have not attached to antigen. Therefore, if no antigen is present in the sample, all of the enzyme-linked antibodies will be washed away; when the carrier is exposed to a substrate with which the enzyme reacts, no detectable reaction will occur. If antigen is present, however, "sandwiches" will be created, thus preventing the enzyme-linked antibodies from being washed away. This time, when the carrier is exposed to a substrate, a reaction will occur, such as a color change. The amount of antigen in the sample is directly proportional to the amount of detectable reaction product.

 The Mukojima Reference

 On March 24, 1971, S. Mukojima filed Japanese Patent Application No. 46/16535 for an improved method for blood serum reactions. Abb. Ex. 5. Though the application never became a patent, it did state the elements of an enzyme sandwich immunoassay. Specifically, the reference discusses an EIA in which an antibody specific to a sought antigen is bound to an insoluble support, which is incubated with the sample so that any antigen in the sample becomes bound to the antibody. Similar to the patents in question, another antibody, linked with an enzyme, is also incubated with the support. If the antigen is present in the sample, a sandwich, similar to the one in the patents in question, is created. A substrate is added to see if enzyme-linked antibodies have bound to antigens.

 SUMMARY JUDGMENT

 According to Rule 56(c), a court must grant summary judgment "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED. R. CIV. P. 56(c). A genuine issue of material fact exists where "there is sufficient evidence favoring the nonmoving party for a jury to return a verdict for that party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106 S. Ct. 2505, 2511, 91 L. Ed. 2d 202 (1986). If the nonmoving party could not prevail on its version of the facts, a trial is unnecessary and summary judgment should be granted. Seal-Flex, Inc. v. Athletic Track and Court Constr., 98 F.3d 1318, 1321 (Fed. Cir. 1996) (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S. Ct. 1348, 1356, 89 L. Ed. 2d 538 (1986)). However, the party moving for summary judgment bears the burden of proving the absence of a disputed material issue of fact and establishing its right to judgment as a matter of law. Id. Additionally, the court views the facts and the inferences to be drawn from the facts in the light most favorable to the non-moving party. Matsushita, 475 U.S. at 587, 106 S. Ct. at 1356.

 ANTICIPATION

 In the present motion, Abbott argues that the Mukojima reference anticipates the patents in question under 35 U.S.C. § 102(b). Specifically, Abbott argues that claims 1-3, 6-11 and 13 of the '878 patent and claims 1-13 and 15-18 of the '285 patent are anticipated by the Mukojima reference and that every other claim is rendered obvious under 35 U.S.C. § 103 by the Mukojima reference and other prior art. Diamedix agrees that the Mukojima reference "broadly states the elements of an enzyme sandwich immunoassay," Diamedix Mem. of Law in Opp. at 2, however, it believes that the reference was not identical in that it did not ...


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