Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc.

• Decision Date: 31 August 2004
• Docket Number: No. 02-1532.,No. 02-1559.,02-1532.,02-1559.
• Citation: 381 F.3d 1371
• Parties: CARDIAC PACEMAKERS, INC., Guidant Sales Corporation, and Eli Lilly and Company, Plaintiffs-Appellants, and Anna Mirowski, Plaintiff-Appellant, v. ST. JUDE MEDICAL, INC., Pacesetter, Inc., and Ventritex, Inc., Defendants-Cross-Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

381 F.3d 1371

CARDIAC PACEMAKERS, INC., Guidant Sales Corporation, and Eli Lilly and Company, Plaintiffs-Appellants, and Anna Mirowski, Plaintiff-Appellant, v. ST. JUDE MEDICAL, INC., Pacesetter, Inc., and Ventritex, Inc., Defendants-Cross-Appellants.

No. 02-1532.

No. 02-1559.

United States Court of Appeals, Federal Circuit.

August 31, 2004.

Appeal from the United States District Court for the Southern District of Indiana, David F. Hamilton, J.

COPYRIGHT MATERIAL OMITTED

Arthur I. Neustadt, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., of Alexandria, VA, for plaintiff-appellant Anna Mirowski, argued for plaintiffs-appellants. With him on the brief was Jeffrey B. McIntyre. Of counsel on the brief was Richard R. McDowell, Hill, Fulwider, McDowell, Funk & Matthews, of Indianapolis, IN. Also on the brief were J. Michael Jakes and Kara F. Stoll, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, for plaintiffs-appellants Cardiac Pacemakers, Inc., et al.

Denis R. Salmon, Gibson, Dunn & Crutcher LLP, of Palo Alto, California, argued for defendants-cross appellants. With him on the brief was H. Mark Lyon. Also on the brief was Mark A. Perry, of Washington, DC. Of counsel on the brief were Jeffrey M. Olson, Sidley Austin Brown & Wood LLP, of Los Angeles, CA, and Michael I. Rackman, Gottlieb, Rackman & Reisman, P.C., of New York, NY.

Before NEWMAN, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and RADER, Circuit Judge.

PAULINE NEWMAN, Circuit Judge.

This patent infringement action was brought by Cardiac Pacemakers, Inc., Guidant Sales Corp., Eli Lilly and Company, and Anna Mirowski (collectively "CPI") against St. Jude Medical, Inc., Pacesetter, Inc., and Ventritex, Inc. (collectively "St. Jude"), in the United States District Court for the Southern District of Indiana.¹ The appeal relates to United States Patent No. 4,407,288, entitled "Implantable Heart Stimulator and Stimulation Method," inventors Alois A. Langer, Steve A. Kolenik, Marlin S. Heilman, Mieczyslaw Mirowski, and Morton M. Mower. We affirm in part and modify in part the district court's claim construction, reinstate the jury verdict of validity, and remand for a new trial of infringement and reassessment of damages. We affirm the district court's decision upholding the patent term extension.

THE PATENTED INVENTION

The pumping action of the human heart occurs by electrical stimulation of various parts of the heart muscle, a complex process flowing from the nervous and other bodily systems. Heart arrhythmias result from disturbances in this process, whereby the heart may beat too slowly (bradycardia), too rapidly (tachycardia), or in an erratic, disorganized, or quivering fashion (fibrillation). Arrhythmias may occur in varying degrees. In treating such heart abnormalities it is important to determine the form and degree of arrhythmia present, as well as to identify the section or sections of the heart in which the arrhythmia originates, such as the ventricles or the atria. The treatment must be appropriate to the specific abnormality.

The inventions subject of this lawsuit are implantable cardiac defibrillators (ICDs) that are permanently installed under the skin, and that determine abnormal cardiac activity and treat that activity by delivering electrical shocks to the heart muscle in appropriate strengths. The first successful ICDs were developed in about 1980 by a team led by the late Dr. Mieczyslaw Mirowski, an inventor of the patents in suit. In the district court two patents were in suit, for improved ICDs whereby the ICD evaluates the abnormal heart activity, determines the pattern of electrical stimulation needed to treat the type of arrhythmia exhibited by the heart, delivers the appropriate electrical pulses or shocks, and changes the pulses as necessary for optimum treatment. United States Patent No. 4,316,472 (the '472 patent) is for an improved ICD whereby the implanted device analyzes the arrhythmia, and the requisite energy levels for electrical shocks to the heart are calculated and externally programmed. Patent No. 4,407,288 (the '288 patent) is for a further improvement that continuously determines the nature of an arrhythmia as it occurs, and selectively performs multi-mode therapy. Multi-mode therapy includes administering relatively mild pacing shocks to correct mild arrhythmias, intense shocks to correct fibrillation, and shocks appropriate to correct cardioversion, which the district court defined as "the application of non-pacing electrical pulses designed to stimulate sufficient heart tissue to correct an arrhythmia, with energy levels generally below those used for defibrillation." The cardioversion capability is basic to this appeal.

CPI charged St. Jude with infringement of claims 1 and 18 of the '472 patent and claims 4 and 13 of the '288 patent. The jury found St. Jude liable for infringement of the '472 patent, but not the '288 patent. The jury found both patents valid, and rejected St. Jude's charge that the '288 patent is unenforceable for inequitable conduct during patent prosecution. The jury awarded damages of $140 million for infringement of the '472 patent.

On post-trial motions the district court granted JMOL in favor of St. Jude on most of the issues on which CPI had prevailed in the jury verdict. The court held that the claims of both the '472 patent and the '288 patent are invalid and not infringed, and granted a conditional new trial in the event of reversal on appeal. The court also granted St. Jude's motion for sanctions based on witness misconduct, and awarded partial attorney fees to St. Jude based on Cardiac Pacemakers' failure to comply with certain discovery obligations.

No appeal is taken as to the '472 patent. CPI appeals the judgment of invalidity and non-infringement of the '288 patent, and requests reinstatement of the jury verdict. St. Jude cross appeals the court's ruling, as a matter of law, that patent term extension was properly granted.

I

VALIDITY

At issue are claims 4 and 13 of the '288 patent. Claim 4, and claim 1 from which it depends, state:

1. A method of heart stimulation using an implantable heart stimulator capable of detecting a plurality of arrhythmias and capable of being programmed to undergo a single or multi-mode operation to treat a detected arrhythmia, corresponding to said mode of operation the method comprising the steps of:

(a) determining a condition of the heart from among a plurality of conditions of the heart;

(b) selecting at least one mode of operation of the implantable heart stimulator which operation includes a unique sequence of events corresponding to said determined condition; and

(c) executing said at least one mode of operation of said implantable heart stimulator thereby to treat said determined heart condition.

4. The method of claim 1, wherein at least one mode of operation of said implantable heart stimulator includes cardioversion.

Claim 13, and claim 10 from which it depends, state:

10. An implantable heart stimulator capable of monitoring and detecting a plurality of arrhythmias, and capable of being programmed to undergo a single or multi-mode of operation corresponding to a respective arrhythmia to treat automatically the detected arrhythmia, said stimulator comprising:

determining means for determining the occurrence of one of a plurality of conditions of the heart;

selecting means responsive to said determining means for selecting at least one mode of operation of said implantable heart stimulator corresponding to a respective one of said plurality of conditions for automatically treating said determined conditions; and

executing means for executing a sequence of events defined by said at least one mode of operation, whereby to treat said determined condition.

13. The stimulator of claim 10, wherein said at least one mode of operation includes cardioversion.

Granting judgment of invalidity as a matter of law, the district court ruled that Claims 4 and 13 are invalid on the ground of obviousness and for failure to disclose the best mode of making and using the invention.

Obviousness

In review of a jury verdict on the ground of obviousness, the underlying findings of fact, whether explicit or presumed as necessary to support the verdict, are reviewed for substantial evidentiary support; and the ultimate question of obviousness is reviewed for correctness in law, based on the factual premises. See Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1319 (Fed.Cir.2003); LNP Eng'g Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347, 1353 (Fed.Cir.2001). These standards are applied by the district court upon motion for judgment as a matter of law, and again by the appellate court upon grant or denial of that motion. Medtronic, Inc. v. Advanced Cardiovascular Systems, Inc., 248 F.3d 1303, 1309 (Fed.Cir.2001) ("This court reviews a district court's grant of JMOL de novo and reapplies the JMOL standard.") (citing Markman v. Westview Instruments, Inc., 52 F.3d 967, 975 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996)).

CPI argues that the jury verdict must be upheld because there was substantial evidence at trial whereby a reasonable jury could have sustained the validity of the patent on the ground of obviousness, pointing out that issued patents can only be proved invalid by clear and convincing evidence. See, e.g., Sun Studs, Inc. v. ATA Equip. Leasing, Inc., 872 F.2d 978, 988 (Fed.Cir.1989) (reviewing the verdict in light of the burden of proof).

At the trial each side explained what the cited references taught, as well as the general knowledge in this field of technology at the time the invention was made. The jury was instructed that:

The suggestion [to combine elements from separate references] can be expressly stated in a particular reference or it can be within the knowledge that was generally available to one of ordinary skill in the...