Inverness Medical v. Warner Lambert Co.

• Decision Date: 31 October 2002
• Docket Number: No. 01-1177.,No. 01-1147.,01-1147.,01-1177.
• Citation: 309 F.3d 1373
• Parties: INVERNESS MEDICAL SWITZERLAND GmbH and Unipath Diagnostics, Inc., Plaintiffs-Appellants, v. WARNER LAMBERT COMPANY, (now known as Pfizer Inc.), Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

309 F.3d 1373

INVERNESS MEDICAL SWITZERLAND GmbH and Unipath Diagnostics, Inc., Plaintiffs-Appellants, v.WARNER LAMBERT COMPANY, (now known as Pfizer Inc.), Defendant-Appellee.

No. 01-1147.

No. 01-1177.

United States Court of Appeals, Federal Circuit.

DECIDED: October 31, 2002.

J. Anthony Downs, Goodwin Procter, LLP, of Boston, Massachusetts, argued for plaintiffs-appellants.Of counsel were Ronald H. Schwillinski and Paul F. Ware, Jr.Also of counsel was Keith A. Zullow, Goodwin Procter LLP, of New York, New York; and Edwin F. Chociey, Jr., Riker, Danzig, Scherer, Hyland & Perretti LLP, of Morristown, New Jersey.

Charles P. Kennedy, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, argued for defendant-appellee.With him on the brief was Jonathan A. David.

Before RADER, BRYSON, and DYK, Circuit Judges.

DYK, Circuit Judge.

Inverness Medical Switzerland Gmbh and Unipath Diagnostics, Inc.(collectively "Unipath") appeal from the decision of the United States District Court for the District of New Jersey granting summary judgment of non-infringement of U.S. PatentNos. 5,622,871("the '871 patent"), 5,602,040 ("the '040 patent"), and 5,656,503 ("the '503 patent")(collectively "the patents-in-suit").Conopco, Inc. v. Warner Lambert Co.,No. 99-101(D.N.J.Nov. 22, 2000)("Opinion").In construing the claims of the patents-in-suit, we hold that the claim recitations "on" and "onto" encompass both surface and internal positioning and that the claim recitation "mobility... is facilitated" means the capacity to make movement easier at any stage.Under this claim construction, issues of material fact remain regarding infringement of the '871, '040, and '503 patents.Therefore, we vacate the grant of summary judgment for Warner Lambert Co.(now known as Pfizer, Inc.)("Pfizer") of non-infringement and remand for further proceedings.

BACKGROUND

Unipath is the assignee of the '871, '040, and '503 patents, respectively entitled "Capillary Immunoassay and Device Therefor Comprising Mobilizable Particulate Labelled Reagents,""Assays," and "Test Device for Detecting Analytes in Biological Samples."The patents all claim original priority back to U.S. PatentApp. No. 294,146("the '146 application").The disclosures of the three patents are substantially identical, being generally directed to the field of analytical testing devices.

A preferred embodiment of the disclosed invention is as a pregnancy-testing device.The urine of pregnant women includes human chorionic gonadotropin (hCG), a protein indicative of pregnancy.In the preferred embodiment a portion of the device is placed in contact with a test subject's urine.If the woman is pregnant a colored label binds with high specificity to the hCG protein.Two binding zones are located on the device.The first binding zone includes a reagent that binds solely to the protein, such that when the protein is present it (and its colored label) provide a visual indication of the presence of the protein.The second zone (a control zone) includes a reagent that binds to the colored label, so that whether or not the hCG protein is present a visual indication is provided in the control zone.Thus, the test subject is able to determine whether the device is operating properly.

A diagram of the operative portion of an assay device in accordance with the disclosed invention is shown in figure 10 of the patents (reproduced below), which depicts a cross-sectional view of the interior of the device.The device includes a porous member 506 in contact with a strip of porous material 510.Strip 510 contains three reagent zones disclosed as follows:

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

Test zone 517 incorporates [an] immobilised specific binding reagent, and control zone 518 contains a reagent to indicate that the sample has permeated a sufficient distance along the test strip.A portion of the test strip surface ... carries a glaze [of sugar] 519 on which is deposited a layer 520 of labelled specific binding reagent.

'871 patent, col. 13, ll.42-48.The labelled reagent is a direct-labelled antibody that binds with high-specificity to an analyte (e.g. human chorionic gonadotropin or hCG).Id. at col. 4, ll.21-22.The fixed specific binding reagent in zone 517 also binds with high-specificity to the same analyte, but is unlabelled.Id. at col. 11, ll.49-53.Finally, the reagent in zone 518 is an unlabelled fixed reagent that will bind to the labelled reagent without regard to the presence of the analyte in the sample.Id. at col. 11, ll.55-60.

In operation a liquid sample is brought into contact with porous member 506, which carries the liquid sample so as to permeate test strip 510.Id. at col. 12, ll.43-51.As the liquid sample moves through test strip 510 it releases the labelled reagent and dissolves the sugar, both of which are then carried along the strip to test and control zones.Id. at col. 13, ll.57-62.The sugar assists in the "mobility" of the reagent.If present in the sample, the analyte will bind to the labelled reagent and thereafter to the fixed unlabelled reagent in the test zone, thereby providing a visual indication (the label) of the analyte.Regardless of the presence of the analyte in the test sample, the labelled reagent will bind to the reagent in the control zone, thereby providing a visual indication in the control zone.Id. at col. 11, ll.45-60.

The disposition of the labelled specific binding reagent as a "surface layer" is disclosed as "assist[ing] the free mobility of the labelled reagent when the porous carrier is moistened with the sample, [and is therefore] preferable ... [to] being impregnated in the thickness of the carrier."Id. at col. 6, ll.59-62.The use of sugar as a glazing material between the labelled reagent and the test strip is disclosed as a "preferred embodiment."Id. at col. 6, ll.64-66.

Unipath initiated an action against Pfizer in the District of New Jersey on January 8, 1999, for infringement of the '871, '040, and '503 patents.Claim 1 of the '871 patent is representative and provides:

An analytical test device for detecting an analyte suspected of being present in a liquid biological sample, said device comprising:

a) a hollow casing having a liquid biological sample application aperture and means permitting observation of a test result;

b) a test strip comprising a dry porous carrier contained within said hollow casing, said carrier communicating directly or indirectly with the exterior of said hollow casing through said liquid biological sample application aperture to receive applied liquid biological sample, said carrier having a test result zone observable via said means permitting observation, said test strip, in the dry unused state, containing a labelled reagent capable of specifically binding with said analyte to form a first complex of said labelled reagent and said analyte, said label being a particulate direct label, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said applied liquid biological sample,

wherein mobility of said labelled reagent within said test strip is facilitated by at least one of 1) coating at least a portion of said test strip upstream from said test result zone with, or 2) drying said labelled reagent onto a portion of said test strip upstream from said test result zone in the presence of, a material comprising a sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;

said carrier containing in said test result zone a means for binding said first complex, said means for binding comprising specific binding means and being immobilized in said test result zone;

migration of said applied liquid biological sample through said dry porous carrier conveying by capillarity said first complex to said test result zone of said dry porous carrier whereat said binding means binds said first complex thereby to form a second complex;

said second complex being observable via said means permitting observation, thereby to indicate the presence of said analyte in said liquid biological sample.

(emphases added).

After answering, Pfizer filed a motion for summary judgment, requesting a construction for the asserted claims and summary judgment of non-infringement based on that construction.(Pfizer's Mot. for Summ. J.at 2-3.)The district court granted summary judgment of non-infringement both literally and under the doctrine of equivalents.Opinionat 1.In granting summary judgment the district court construed disputed claim language "on said test strip" and "onto a portion of said test strip" as requiring surface disposition and the phrase "mobility ... is facilitated" as requiring an improvement in the release of the labelled reagent from the test strip.Id. at 10.The district court construed the phrase "mobility ... is facilitated" to require the sugar to "help or improve the release."Id. at 10(citing the court's decision in the related case Conopco, Inc. v. Princeton Biomeditech Corp.,No. 97-6254(D.N.J.Sept. 28, 2000)("Motion Hearing")).The district court entered a final judgment of non-infringement on December 22, 2000, and dismissed without prejudice Pfizer's counterclaim for declaratory judgment of invalidity.

Unipath timely filed this appeal.

DISCUSSION

I.Jurisdiction and Standard of Review

We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1295(a)(1).We review a district court's grant of a motion for summary judgment without deference.Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,149 F.3d 1309, 1315, 47 USPQ2d 1272, 1275(Fed.Cir.1998).Claim construction is determined as a matter of law and is reviewed without deference.Cybor Corp. v. FAS Techs., Inc.,138 F.3d 1448, 1456, 46 USPQ2d 1169, 1174(Fed.Cir.1998)(en banc).

II.Claim Construction

Appellants raise two issues of claim...