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District Courts Warned to Provide Greater Scrutiny Over Inequitable Conduct Defenses

Client Alert | 1 min read | 08.27.08

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.

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Client Alert | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....

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