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

381 F.3d 1371, 2004 WL 1925607
Court of Appeals for the Federal Circuit·Decided August 31, 2004·No. Nos. 02-1532, 02-1559·Published·Cited by 23 cases

Opinion

PAULINE NEWMAN, Circuit Judge.

This patent infringement action was brought by Cardiac Pacemakers, Inc., Gui-dant 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 [1374]*1374appeal 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 (bradycar-dia), 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. Miec-zyslaw 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 [1375]*1375the '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 car-dioversion.

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., [1376]*1376340 F.3d 1314, 1319 (Fed.Cir.2003);

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Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 381 F.3d 1371, 2004 WL 1925607 (Fed. Cir. 2004).

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