Therasense, Inc. v. Becton, Dickinson and Co.

• Citation: 593 F.3d 1325
• Decision Date: 25 January 2010
• Docket Number: No. 2009-1034.,No. 2009-1008.,No. 2009-1035.,No. 2009-1037.,No. 2009-1009.,No. 2009-1010.,No. 2009-1036.,2009-1008.,2009-1009.,2009-1010.,2009-1034.,2009-1035.,2009-1036.,2009-1037.
• Parties: THERASENSE, INC. (now known as Abbott Diabetes Care, Inc.) and Abbott Laboratories, Plaintiffs-Appellants, v. BECTON, DICKINSON AND COMPANY, and Nova Biomedical Corporation, Defendants-Cross Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

593 F.3d 1325

THERASENSE, INC. (now known as Abbott Diabetes Care, Inc.) and Abbott Laboratories, Plaintiffs-Appellants, v. BECTON, DICKINSON AND COMPANY, and Nova Biomedical Corporation, Defendants-Cross Appellants.

No. 2009-1008.

No. 2009-1009.

No. 2009-1010.

No. 2009-1034.

No. 2009-1035.

No. 2009-1036.

No. 2009-1037.

United States Court of Appeals, Federal Circuit.

January 25, 2010.

Rohit K. Singla, Munger, Tolles & Olson, LLP, of San Francisco, CA, argued for plaintiffs-appellants. With him on the brief were Jason A. Rantanen; and Donald W. Ward, of Los Angeles, CA.

Bradford J. Badke, Ropes & Gray LLP, of New York, New York, argued for defendants-cross appellants. With him on the brief were Sona De and Gabrielle M. Ciuffreda.

Before LINN, FRIEDMAN, and DYK, Circuit Judges.

LINN, Circuit Judge.

Abbott Diabetes Care, Inc. and Abbott Laboratories (collectively "Abbott") appeal the final decision of the U.S. District Court for the Northern District of California, which entered judgment in accordance with a jury verdict that claims 11 and 12 of Abbott's U.S. Patent No. 5,628,890 ("the '890 patent") are infringed by Becton, Dickinson & Co. and Nova Biomedical Corp. (collectively "BD/Nova") but are invalid under 35 U.S.C. §§ 102, 103, and 112 ¶ 1, and denied Abbott's post-trial motions for judgment as a matter of law ("JMOL") and for new trial. Therasense, Inc. v. Becton, Dickinson & Co., No. 04-CV-2123 (N.D.Cal. Sept. 2, 2008). Although judgment was entered in favor of BD/Nova on all counts relating to the '890 patent, BD/Nova cross-appeals the jury's underlying finding that it infringes claims 11 and 12. Because we conclude that the district court did not err in denying Abbott's post-trial motions on invalidity, and because we lack jurisdiction over BD/Nova's cross-appeal, we dismiss the cross-appeal and affirm the judgment.

BACKGROUND

The '890 patent is directed to electrochemical sensors for measuring glucose levels in blood. A droplet of blood is placed on a disposable test strip that has two electrodes: a "working electrode" and a "counter electrode." The working electrode is coated with an enzyme and a mediator. The enzyme serves as a catalyst to facilitate a chemical reaction in which the glucose molecules in the blood sample lose some of their electrons, and the mediator then transfers those electrons to the working electrode. As the electrons flow through the working electrode, an electrical current is detected. The magnitude of the electrical current can then be correlated to the concentration of glucose molecules in the blood. The electrons are then brought back into the blood through the counter electrode. To complete this circuit, the blood must be in contact with both electrodes at the same time.

A problem occurs, however, if the blood only partially covers the working electrode. For example, if too little blood is supplied, or if the test strip is not held in a horizontal position, the blood may not fully cover the working electrode, resulting in the production of fewer free electrons. Because fewer electrons will flow between the two electrodes, the sensor will report an erroneously low glucose level. Based on this false reading, a patient may fail to take insulin when he should, or the patient may consume carbohydrates when he should not.

The inventors of the '890 patent sought to solve this problem, known in the art as the "short fill" problem, by placing the counter electrode on the downstream side of the working electrode. When the electrodes are arranged in this manner, the blood necessarily makes contact with the working electrode before it makes contact with the counter electrode. This arrangement helps to ensure that a circuit is not completed, and that no measurement is taken, until the working electrode is fully covered with blood.

Claim 11 of the '890 patent is directed to this "downstream" embodiment. It recites, with key term emphasized:

11. An electrode strip for use in an electrochemical sensor for measuring a compound in a sample, comprising:

an elongated electrode support defining a sample transfer path for directional flow of the sample from an application point along said electrode support;

a reference or counter electrode in said sample transfer path; and

a covering layer defining an enclosed space over the sample transfer path, the reference or counter electrode and said working electrode, said covering layer having an aperture for receiving sample into said enclosed space;

said aperture spaced away from and upstream of said electrodes in said sample transfer path and said reference or counter electrode spaced downstream of said working electrode in said sample transfer path.

Claim 12 depends from claim 11 and adds a requirement that the counter electrode is spaced downstream of "any portion" of the working electrode.

Abbott accused BD/Nova of infringing claims 11 and 12 of the '890 patent by making, using, and selling a product called BD™ Test Strips.¹ BD/Nova denied infringement and asserted that claims 11 and 12 are invalid under §§ 102, 103, and 112 ¶ 1. More specifically, under §§ 102 and 103, BD/Nova asserted that claims 11 and 12 are anticipated or rendered obvious in light of two prior art references: U.S. Patent No. 5,120,420 ("Nankai") and U.S. Patent No. 5,582,697 ("Ikeda").

Following briefing and a Markman hearing, the district court construed the contested terms in the asserted claims as follows: (1) "sample transfer path" means "the route along which the sample moves"; (2) "directional flow" means "the orientation and guidance in a particular direction"; (3) "defining a sample transfer path for directional flow" means "providing a channel for the sample to move in a particular direction from the application point to and including the electrodes"; and (4) "aperture" means "an opening." J.A. 5908-09.

A jury trial was held from July 15, 2008 to August 8, 2008. The jury, using a special verdict form, found that BD/Nova infringed claims 11 and 12 under the doctrine of equivalents, noting in particular that the "aperture" and "electrode support" limitations were present in BD™ Test Strips as equivalents. The jury also found that claims 11 and 12 were invalid. More specifically, the jury checked "Yes" in response to the question, "Have defendants proven by clear and convincing evidence that Claims 11 and 12 of the '890 patent are invalid by reason of anticipation or obviousness?" The jury also checked "Yes" in response to the question, "Have defendants proven by clear and convincing evidence that Claims 11 and 12 of the '890 patent are invalid by reason of inadequate written description?" In accordance with this verdict, the district court entered judgment in favor of BD/Nova and against Abbott on all counts relating to the '890 patent. On September 2, 2008, the district court denied Abbott's post-trial motions for JMOL and for new trial.

Abbott appeals the judgment that claims 11 and 12 are invalid. BD/Nova filed a cross-appeal with regard to the jury's finding that BD™ Test Strips infringe claims 11 and 12. BD/Nova subsequently moved this court to treat its argument in support of its cross-appeal as an alternative argument in support of affirmance. We have jurisdiction over Abbott's appeal under 28 U.S.C. § 1295(a)(1) (2006).

DISCUSSION

I. Abbott's Appeal

Abbott challenges the district court's denial of its motions for JMOL and for new trial. "This court reviews the denial of a motion for JMOL or a new trial under the law of the regional circuit where the district court sits. . . ." Voda v. Cordis Corp., 536 F.3d 1311, 1318 (Fed.Cir.2008). The Ninth Circuit reviews a district court's denial of a motion for JMOL de novo and the denial of a motion for new trial for abuse of discretion. In re First Alliance Mortg. Co., 471 F.3d 977, 991 (9th Cir. 2006). "JMOL should be granted only if the verdict is against the great weight of the evidence, or it is quite clear that the jury has reached a seriously erroneous result." Hangarter v. Provident Life & Acc. Ins. Co., 373 F.3d 998, 1005 (9th Cir.2004) (internal quotations omitted). "A new trial is proper only if the verdict is contrary to the clear weight of the evidence, or is based upon evidence which is false, or to prevent, in the sound discretion of the trial court, a miscarriage of justice." Id. (internal quotations omitted).

In contesting the district court's denial of its post-trial motions, Abbott seeks to overturn the jury's two verdicts of "anticipation or obviousness" and "inadequate written description."

A. "Anticipation or Obviousness"

The jury answered "Yes" to the question, "Have defendants proven by clear and convincing evidence that Claims 11 and 12 of the '890 patent are invalid by reason of anticipation or obviousness?" Abbott contends that this verdict is a general verdict encompassing separate legal theories of anticipation and obviousness, and that the verdict must be reversed, or a new trial granted, if any legal theory is legally flawed or is unsupported by substantial evidence. In particular, Abbott believes that the district court's jury instruction on the law of anticipation was erroneous, and that the jury could not have found the claims obvious under either of BD/Nova's two obviousness contentions.

"A jury verdict will be set aside, based on erroneous jury instructions, if the movant can establish that `those instructions were legally erroneous,' and that `the errors had prejudicial effect.'" Sulzer Textil A.G. v. Picanol N.V., 358 F.3d 1356, 1363 (Fed.Cir.2004) (quoting Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1281 (Fed.Cir.2000)).

1. Legal Error

"The question of whether a jury instruction on an issue of patent law is erroneous is a matter of Federal Circuit law and is reviewed de novo." Id. "In reviewing jury instructions, the full trial record and the jury instructions in their entirety must be examined because `instructions take on meaning...