District Courts Warned to Provide Greater Scrutiny Over Inequitable Conduct Defenses

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. et al. (No. 2007-1448; August 25, 2008) involves two patents (U.S. Patent Nos. 6,202,649 and 6,425,401) directed to a process for substantially preventing the formation of certain carcinogens in tobacco during tobacco curing. There, in a decision by Chief Judge Michel, the Federal Circuit reverses an inequitable conduct determination as the district court's factual findings were deemed "clearly erroneous." The Court also reverses a summary judgment holding that the asserted claims of '649 and '401 patents were invalid due to indefiniteness.

In its decision the Federal Circuit warns that "courts must be vigilant in not permitting the [inequitable conduct] defense to be applied too lightly." In particular, the panel reiterates the "paramount" need to "strictly enforce the burden of proof and elevated standard of proof" for both elements of the defense, materiality and intent, as the penalty to the patentee for such a successful defense is so "severe" - the loss of an entire patent, "even where every claim clearly meets every requirement of patentability." Based on its analysis, the panel concludes that the defendant failed to prove deceptive intent with respect to the earlier '649 patent, and that the defendant failed to prove materiality of the non-disclosed information with respect to the later '401 patent, and accordingly reverses the inequitable conduct finding with respect to both patents.

The Federal Circuit also reverses the indefiniteness ruling. Below, the district court had construed the claim term "anaerobic condition," but later concluded that the term was indefinite. The panel clarifies the rule that, even for a construed claim, a definition "that does not provide sufficient particularity and clarity to inform skilled artisans of the bounds of the claim" is insolubly ambiguous and invalid for indefiniteness. The Federal Circuit, however, concludes that, on the facts, the patents clearly delineate the bounds of the claim scope and thus the disputed term is not indefinite.