Habit of Mistakes Does Not Establish Failure to Disclose Material Information Was Inadvertent

Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., [2007-1280] (May 14, 2008) [PROST, Rader, Moore] The Federal Circuit affirmed the district courts holding that the patents were unenforceable for inequitable conduct.
DISCUSSION: The court found a strong inference of intent to deceive because it could find no credible explanation for comparing half-lives at different doses and because comparisons at the same dose showed little difference in half-life, which was extensively argued for patentability. After weighing the evidence of materiality and intent, the court found weighty uncontroverted evidence establishing inequitable conduct.
Among other things, the patentee contended that Dr. Uzan’s failure to disclose the dosage information was purely due to inadvertence. Surprisingly, In support, the patentee relied on other evidence of inadvertent and benign mistakes made during prosecution of the ’618 patent application, suggesting that its omission of the dose of the EP ’144 compound was likewise inadvertent. “The Federal Circuit said that The fact that Aventis made other inadvertent errors during prosecution has no bearing on this material failure to disclose.” Therefore, the Federal Circuit could not agree that the district court clearly erred by not concluding that Dr. Uzan’s failure to disclose the dosage information was due to mere inadvertence.