In Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc., the key issues before the panel of the US Court of Appeals for the Federal Circuit were whether:

On August 24, 2010, the US District Court for the District of Arizona issued its final order in this long-standing patent infringement case, upholding a jury verdict finding that W.L. Gore & Associates (Gore) willfully infringed Bard Peripheral Vascular, Inc.'s (Bard's) patent through its sale of the vascular grafts.

On February 10, 2012, a panel of the Federal Circuit upheld and affirmed all of the trial court's conclusions. It found that Bard presented substantial evidence to satisfy both prongs of the Federal Circuit's standard for willful infringement. In its 2007 decision In re Seagate Technology, LLC (Seagate), the court held that to prove willful patent infringement and obtain enhanced damages, a patentee must show by clear and convincing evidence that:

In line with Federal Circuit precedent, the panel in its February 10, 2012 order held that the general standard of willfulness is to be treated as a question of fact. However, the panel did not specifically address the standard applicable to the objective prong of the Seagate test nor has the Federal Circuit addressed this standard previously.

W.L. Gore & Associates sought a rehearing en banc and, in particular, faulted the trial court's willfulness assessment. Amici curie filed separate briefs arguing that the objective first prong of the willfulness test was a matter of law to be considered first by the court and subject to de novo review.

The Federal Circuit granted the petition for rehearing en banc and returned the case to the panel for reconsideration, solely to address the issue of willfulness and the appropriate standard of review.

In its June 14, 2012 opinion, the Federal Circuit panel reaffirmed its February 10, 2012 opinion, but vacated the sections of the opinion related to willfulness.

The panel noted that the Federal Circuit had previously generalized that willfulness is a matter of fact. However, the panel found this approach should be refined, based on its review of Supreme Court and Federal Circuit precedent in similar contexts, for example objectively baseless claims. The panel concluded:

The Federal Circuit explained that while the ultimate question of willfulness may be a question of fact, there must always first be a threshold determination of objective recklessness. That determination requires an objective assessment of potential defenses based on the risk the patent presents. The court held that this objective determination of recklessness is best decided by the judge as a question of law subject to de novo review.

If the defense or noninfringement theory is based solely on a legal theory, such as claim construction, the prong may be evaluated solely by the judge. If the defense is a question of fact or a mixed question of law and fact, such as anticipation or obviousness, the judge may allow the jury to determine the underlying facts relevant to the defense. However, the ultimate legal question of whether a reasonable person would have considered there to be a high likelihood of patent infringement should be decided as a matter of law by the judge.

The Federal Circuit remanded the case to allow the lower court to apply the correct standard to the question of willfulness. The court explained that the remand would also allow the lower court to reconsider Gore's other defenses based on reasonableness, which included inventorship, inadequate written description, obviousness and anticipation. On remand, the Federal Circuit directed the lower court to determine, based on the record whether a reasonable litigant could realistically expect these defenses to succeed. If, in view of the facts, the defenses are found to be not reasonable, only then can the jury's subjective willfulness finding under the second prong be reviewed for substantial evidence.

Patent litigants should take note of how the first objective prong of the Seagate test will be applied in trying patent infringement cases.

Following this decision, the court will serve as a gatekeeper in any willful infringement analysis. The court's evaluation of the objective recklessness standard in the first instance will be dispositive in certain instances and will otherwise streamline proceedings where the court decides that certain factual matters are to be sent to a jury. Where, following a finding of objective recklessness, a jury must evaluate of the second prong, its evaluation may also be shaped by the court's initial evaluation of the matter.