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Court Reinstates Jury Verdict of Validity, Modifies Claim Construction, and Remands for New Trial

02-1532
August 31, 2004

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Last Month at the Federal Circuit - September 2004

Judges: Newman (author), Friedman, and Rader

In Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., No. 02-1532 (Fed. Cir. Aug. 31, 2004), the Federal Circuit reinstated a jury verdict of no invalidity of U.S. Patent No. 4,407,288 (“the ‘288 patent”) and remanded for a new trial based on the Court’s partially modified claim construction.

At trial, Cardiac Pacemakers, Inc. (“CPI”) charged St. Jude Medical, Inc. (“St. Jude”) of infringing U.S. Patent No. 4,316,472 (“the ‘472 patent”) and the ‘288 patent, both of which relate to improved implantable cardiac defibrillators (“ICD”) for treating abnormal cardiac activity. The jury found both patents valid and found that St. Jude infringed the ‘472 patent, awarding damages of $140 million. On post-trial motions, the district court granted JMOL in favor of St. Jude, finding both the patents invalid and not infringed. CPI only appealed the district court’s judgment of invalidity and noninfringement as to the ‘288 patent.

The ‘288 patent relates to an improved multimode ICD that treats multiple types of abnormal cardiac activity by delivering electrical shocks to the heart muscle in appropriate strengths, including a treatment known as cardioversion. Despite the jury’s finding to the contrary, the district court found that the ‘288 patent was invalid based on obviousness and bestmode grounds.

In determining invalidity based on obviousness, the district court had found that cardioversion therapy was known, and that there was a known need to treat mixtures of arrhythmias. Thus, the court determined that it would have been obvious to combine known methods of separate treatment within a single ICD. The Federal Circuit disagreed, opining that the mere recognition of the problem of treating complex heart arrhythmias does not render obvious the eventual solution. Indeed, it was undisputed that the solution of this problem had not previously been
achieved.

The Federal Circuit explained that whether the prior art provides the suggestion or motivation to combine prior knowledge in a way to produce the invention at issue is a question of fact. And these issues were extensively explored at trial, including evidence of commercial success and licensing interest. The Court concluded that the trial record contained substantial evidence, whereby a reasonable jury could have reached the verdict that it would not have been obvious to provide an ICD that includes cardioversion therapy.

In determining invalidity based on best mode, the district court had found that the inventors requested a third party to develop an improved battery for use in CPI’s ICDs. Approximately four months before the ‘288 patent application was filed, the third party published an article describing the battery that it developed. The district court held that failure to include the thirdparty battery in the specification invalidated the patent on best-mode grounds, because it was the best battery then known to them.

The Federal Circuit disagreed for two reasons. First, the Court noted that the battery for use in battery-powered ICDs was not part of the claimed invention. Second, even if the battery was part of the claimed invention, a best-mode violation requires that the inventor knew of and concealed a better mode than was disclosed for making and using the claimed invention. The Federal Circuit held that there was no evidence of such concealment. Accordingly, there was substantial evidence, whereby a reasonable jury could have found that the best-mode requirement had not been violated.

The Federal Circuit also overturned the district court’s claim construction that “determining a condition of the heart from among a plurality of conditions of the heart” is in the step-plus-function form of 35 U.S.C. § 112, ¶ 6. Method claims, the Court explained, necessarily recite the steps of the method, and the preamble words, “the method comprises the steps of,” do not automatically convert each ensuing step into the form of § 112, ¶ 6. To the contrary, the absence of the signal “step for” creates a presumption that each ensuing step is not in step-plus-function form. The Court clarified, however, that removal of a clause from § 112, ¶ 6 does not automatically convert it into an open-ended step without limits. A claim limitation is always construed in light of the specification, regardless of the form of the claim. Accordingly, the Federal Circuit remanded the case in order to construe the “determining” step in light of the specification and the prosecution history.