Abbott Laboratories v. Syntron Bioresearch, Inc.

• Decision Date: 10 July 2003
• Docket Number: No. 02-1203.,No. 02-1257.,02-1203.,02-1257.
• Citation: 334 F.3d 1343
• Parties: ABBOTT LABORATORIES, Plaintiff-Appellant, v. SYNTRON BIORESEARCH, INC., Defendant-Cross-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

334 F.3d 1343

ABBOTT LABORATORIES, Plaintiff-Appellant, v. SYNTRON BIORESEARCH, INC., Defendant-Cross-Appellant.

No. 02-1203.

No. 02-1257.

United States Court of Appeals, Federal Circuit.

July 10, 2003.

Rehearing Denied August 5, 2003.

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Lee Carl Bromberg, Bromberg & Sustein LLP, of Boston, MA, argued for plaintiff-appellant. With him on the brief were Joel R. Leeman and Eric Paul Belt. Of counsel on the brief were George C. Lombardi, Winston & Strawn, of Chicago, IL; and Regina M. Anderson, Office of the General Counsel, Abbott Laboratories, of Abbott Park, IL.

David C. Doyle, Morrison & Foerster LLP, of San Diego, CA, argued for defendant-cross appellant. With him on the brief were Jill D. Neiman and Steven E. Comer. Of counsel was Peng Chen.

Before MAYER, Chief Judge, MICHEL and DYK, Circuit Judges.

DYK, Circuit Judge.

Abbott Laboratories ("Abbott" or "appellant") appeals from the judgment of the United States District Court for the Southern District of California that Syntron Bioresearch, Inc. ("Syntron" or "appellee") did not infringe the asserted claims of United States Patent Nos. 5,073,484 ("the '484 patent") and 5,654,162 ("the '162 patent"). Abbott Labs. v. Syntron Bioresearch, Inc., No 98-CV-2359 (S.D.Cal. Oct. 12, 2001) ("Judgment"). Syntron cross-appeals from the judgment that the asserted claims are not invalid.

We affirm the judgment of noninfringement as to claim 26 of the '484 patent and claims 1, 22, 29, and 30 of the '162 patent. We reverse the judgment of non-infringement as to claims 22 and 23 of the '484 patent, and remand as to those claims. We affirm the judgment that the asserted claims are not invalid.

BACKGROUND

I

Abbott is the exclusive licensee of the '484 and '162 patents (collectively the patents-in-suit), respectively entitled "Quantitative Analysis Apparatus and Method" and "Chemical Analysis Apparatus and Method." The written descriptions of the '484 and '162 patents are substantially identical, being generally directed to devices and methods for performing chemical analysis. The Field of the Invention sections of both patents described the technical field disclosed in the patents as follows:

The invention is in the field of quantitative chemical analysis, and is particularly useful in the detection and analysis of small amounts of chemical substance in such biological fluids as milk, blood, urine, etc '484 patent, col. 1, ll. 10-13.¹

The technology at issue involves the reaction of three chemical constituents: a substance to be detected (called an analyte, ligand, or antigen), a substance that is complementary to and binds to the substance to be detected (called a reactant or antibody), and an indicator (called a detector), which also binds to the substance to be detected. The patents are particularly directed to chemical analysis related to the immune system and its reactions. Proteins produced by the immune system bind to particular foreign substances as a natural defense mechanism. The technology at issue here exploits the ability of the immune system to create proteins (antibodies or reactants) that bind with particularity to a substance to be detected (ligand or analyte). The indicator and the reactant bind to the analyte. The reactant immobilizes the analyte, and the indicator provides an indication of the presence of the analyte. The indication can be one of two types, a qualitative indication or a quantitative indication. Qualitative analysis provides an indication of the presence or absence of the analyte in the sample. A quantitative indication provides information about the quantity of the analyte present in the test sample. In the disclosed invention quantitative analysis is performed using a device that includes a number of analyte detection zones, wherein the number of zones in which analyte is detected is directly proportional to the amount of analyte in the sample.

An exemplary embodiment of a test device as shown in figure 5 of the '484 patent is reproduced below. The test device includes a test medium comprised of a filter paper strip (40) that permits a liquid test sample to flow downward therethrough. The test medium contains reaction zones (40.1), which include therein reactant, bound to the medium within the reaction zones. As the test solution flows through the reaction zone, the reactant bound therein reacts by binding with the analyte (if any) present within the test sample. An indicator also reacts with the analyte (e.g., by binding therewith), thus providing a "moiety derived from [the] analyte, and desirably ... a tagged or labeled form of the analyte" called an "analyte derivative" that functions as an indication of the presence of the analyte.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

In operation, the liquid sample is applied to the test strip and flows downward. The labeled or tagged analyte in the liquid sample is trapped by the reactant in the test zones. The label or tag associated with the analyte provides an indication of the analyte. The number of zones within which analyte is indicated provides a measurement of the concentration of the analyte within the liquid sample.

II

On December 30, 1998, Abbott filed a complaint for patent infringement against Syntron alleging infringement of both patents-in-suit and seeking damages and a permanent injunction. At trial the allegations of infringement were narrowed to claims 22, 23, and 26 of the '484 patent (of which claims 22 and 26 are independent) and claims 1, 22, 29, and 30 of the '162 patent (of which claims 1 and 22 are independent). Claim 22 of the '484 patent is exemplary of the asserted claims of that patent, and provides:

A method for the analysis of an analyte which is a member of a ligand-antiligand binding pair in a test solution comprising the steps of:

(a) providing a non-diffusively immobilized reactant in each of one or more reaction zones spaced successively along a flow path defined by a liquid permeable medium, wherein said reactant is the other member of said binding pair and is capable of binding with the analyte to form a predetermined product;

(b) flowing said solution along the medium and sequentially through the reaction zone(s); and

(c) detecting the presence of analyte, said reactant or said predetermined product in the reaction zone(s), wherein the number of zones in which detection occurs is related to the persence of analyte in the solution.

Claim 1 of the '162 patent is exemplary of the asserted claims of that patent, and provides:

A device generating a signal indicative of the presence of an analyte in a liquid solution suspected of containing said analyte, said device comprising:

(a) a liquid permeable solid medium comprising a solution contact portion and one or more spaced reactive zones separated from said contact portion;

(b) a solution suspected of containing said analyte and having traversed said medium, including said reactive zone(s);

(c) a reactant non-diffusively bound to said medium only at said reactive zone(s), said reactant being specific for and bound to said analyte or a reaction product comprising said analyte and a chemical moiety; and

(d) a labeled antibody specific for and bound to said analyte or said reaction product in said reactive zone(s); wherein said device provides a detectable signal in said reactive zone(s) as an indication of the presence or absence of said analyte in said solution.

On January 4, 2001, the district court issued an order resolving disputed issues of claim construction. Abbott Labs. v. Syntron Bioresearch Inc., No. 98-CV-2359, 2001 WL 34082553 (S.D.Cal. Jan. 5, 2001) ("Claim Construction Order"). On September 25, 2001, the district court issued an order adopting supplemental claim constructions. Abbott Labs. v. Syntron Bioresearch Inc., No. 98-CV-2359 (S.D.Cal. Sept. 25, 2001) ("Supplemental Claim Construction Order"). The constructions provided in the supplemental order were used as the basis for the jury instructions as to the claim terms "non-diffusively immobilized"; "non-diffusively bound"; "specific for"; "predetermined amount"; and "analyte."

On October 4, 2001, the jury returned a special verdict form finding the asserted claims of the patents-in-suit valid but not infringed. Abbott Labs. v. Syntron Bioresearch Inc., No. 98-CV-2359 (S.D.Cal. Oct. 4, 2001) ("Special Verdict"). The jury found with respect to all of the asserted claims that Abbott failed to prove that the accused products included a "non-diffusively immobilized" or "non-diffusively bound" reactant. Id. at 1-3. The jury found that Abbott failed to prove that the accused products included "a reactant bound [to the reaction zone] which is specific for ... the analyte" as recited claims 1, 22, 29, and 30 of the '162 patent. Id. at 3. With respect to claim 26 of the '484 patent and claims 22, 29, and 30 of the '162 patent, the jury found that Abbott failed to prove that the accused products included "a predetermined amount of reactant" in the reaction zone. Id. at 2-3. The jury also found with respect to claim 26 of the '484 patent that Abbott failed to prove that "detection occurs ... only if analyte is present in the test solution in a predetermined amount." Id. at 2. As to validity and enforceability, the jury returned verdicts that Syntron failed to prove by clear and convincing evidence that the claims were anticipated, obvious, invalid due to inventorship error, lacked enablement or written description support, or were unenforceable due to inequitable conduct. Id. at 4-7.

On October 12, 2001, the district court entered judgment in favor of Syntron as to infringement and in favor of Abbott as to validity and unenforceability in accordance with the special verdict. Abbott Labs. v. Syntron Bioresearch Inc., No. 98-CV-2359 (S.D.Cal. Oct. 12, 2001) ("Judgment"). Following judgment, Abbott and Syntron filed motions for JMOL and a new trial,...