United States: The Elevated Standard Of Proof In The Inequitable Conduct Context Remains Paramount

Judges: Michel (author), Schall, Dyk

[Appealed from D. Md., Senior Judge Garbis]

In Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 07-1448 (Fed. Cir. Aug. 25, 2008), the Federal Circuit reversed the district court's finding that U.S. Patent Nos. 6,202,649 ("the '649 patent") and 6,425,401 ("the '401 patent") are unenforceable due to inequitable conduct. The Court also reversed and remanded the district court's grant of SJ of invalidity with regard to all asserted claims of the '649 and '401 patents on the basis of indefiniteness.

Star Scientific, Inc. ("Star") is the owner of the '649 and '401 patents, directed to methods for curing tobacco in a way that reduces the amount of a carcinogen, tobacco specific nitrosamine ("TSNA"). During prosecution of the '649 patent, Star's attorneys became aware of a letter from one of Star's consultants regarding curing methods used in China that produced tobacco products containing very low TSNA levels ("the Burton letter"). The attorneys prosecuting the '649 patent also uncovered experimental data relating to reduced TSNA levels in cured tobacco ("the Curran data").

Shortly after filing the application that issued as the '649 patent, Star replaced its prosecution attorneys. After the '649 patent issued, Star initiated an infringement action against R.J. Reynolds Tobacco Company (N.C.) and R.J. Reynolds Tobacco Company (N.J.) (collectively "RJR"). During the litigation, the new prosecution attorneys became aware of the Burton letter and the Curran data by way of Star's trial counsel. Trial counsel advised that the Burton letter and the Curran data should be disclosed to the PTO, but the prosecuting attorneys concluded that neither was material and disclosed neither during prosecution of the '401 patent.

The district court granted RJR's motion for SJ that the asserted claims of both patents are invalid because the term "anaerobic condition" is indefinite and held both patents unenforceable due to Star's inequitable conduct.

On appeal, the Federal Circuit turned first to inequitable conduct. The Court concluded that the district court clearly erred in finding that RJR had proven that Star and the inventor intended to deceive the PTO. The Court rejected RJR's "quarantine theory" that Star and the inventor conspired to deliberately prevent the original prosecution attorneys from disclosing the Burton letter to the PTO by replacing them and purposely keeping the new firm ignorant of the letter. The Court held that the district court's finding of deceptive intent was clearly erroneous because it was not supported by clear and convincing evidence. Specifically, the Court found that RJR failed to elicit any testimony or submit any other evidence indicating that Star knew what the Burton letter stated before replacing the original firm, or that the letter was the reason for changing law firms. The Court also found that the inventor testified that he had never seen the Burton letter before his deposition in this litigation. Moreover, the Court found that the evidence did not support an inference that Star's failure to bring the Burton letter to the new prosecution firm's attention was motivated by a deceptive intent to keep it away from the examiner. In view of these gaps in the evidence, the Court had a "definite and firm conviction" that the finding of deceptive intent as to the '649 patent was clearly erroneous. Slip op. at 19.

With regard to the '401 patent, the Court found that the district court erred again in relying on RJR's "quarantine theory," but also concluded that the district court's finding of materiality was clearly erroneous. The Court found that in the course of the prosecution of the '401 patent, Star disclosed to the PTO other references that made the information contained in the Burton letter and Curran data cumulative. Because cumulative data are not material, the Federal Circuit held that the district court erred in finding the information material and reversed the judgment of unenforceability of both the '649 and '401 patents.

Turning to the question of indefiniteness, the Court concluded that the district court misapplied the standard for claim definiteness. The district court required that a potential infringer be able to determine if a process infringes before practicing the claimed process. The Court reiterated its rejection of this approach in Invitrogen Corp. v. Biocrest Manufacturing, L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005), and stated that the correct inquiry for definiteness is "whether the claim delineates to a skilled artisan the bounds of the invention." Slip op. at 25. The Court concluded that the term "anaerobic condition," as construed by the district court, delineates the bounds of claim scope and, thus, is not indefinite. Accordingly, the Court reversed the grant of SJ of invalidity due to indefiniteness.

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