Patent Law

Clotted

By Gary Odom and Jordan Kuhn

Aventis owns 5,389,618 / RE 38,743, claiming a blood clotting drug. Amphastar and Teva filed FDA ANDAs, prompting suit by Aventis. Amphastar shot back with an affirmative defense of inequitable conduct - Aventis failed to disclose that relied-upon studies, done by a non-inventor, Dr. Uzan, had used different dosages, thus muddying the results.

Aventis v. Amphastar Pharmaceuticals and Teva Pharmaceuticals (CAFC 2007-1280)

Specifically, Amphastar averred that Dr. Uzan engaged in inequitable conduct by failing to disclose that the half-life studies comparing the patented compound to the EP '144 compound were at different doses. Id. at 941, 944.

The district court determined that the representation by Aventis that the patented compound had an improved half-life as compared to the EP '144 compound was material to patentability because Aventis referred to the improved half-life at least four times during prosecution and the examiner ultimately allowed the '618 patent application after the final representation that the difference in mean half-life was statistically significant. Id. at 950-51. 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. Id. at 951-52. After weighing the evidence of materiality and intent, the court found weighty uncontroverted evidence establishing inequitable conduct. Id. at 952. It, therefore, granted summary judgment against Aventis and held the '618 patent unenforceable.

On first appeal, the CAFC found the withheld information "important to patentability and constituted a failure to disclose material information," but stopped at resolving intent to deceive, remanding for the district court to determine. Which it did.

Following remand, the district court held a bench trial limited to the issue of intent. Aventis Pharma S.A. v. Amphastar Pharms., Inc., 475 F. Supp. 2d 970, 975 (C.D. Cal. 2007) ("Aventis III").

Based on the totality of the facts and circumstances, the court determined that but for Dr. Uzan's intentional omissions, the probability was high that the '618 patent would not have issued. Id. at 994. Accordingly, the court held the '618 patent and the '743 patent unenforceable due to inequitable conduct. Id.

On second appeal, Aventis had dreamt up a new excuse, as well as polishing its previously presented turds of rationalization.

The CAFC warmed up the crowd for the down-for-the-count denouement by playing the case law anthem of "intent to deceive." The lyrics: "the more it has stink about it, the less you have to think about it."

"To satisfy the intent to deceive element of inequitable conduct, 'the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.'" Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1374-75 (Fed. Cir. 2006) (quoting Kingsdown, 863 F.2d at 876). Given that direct evidence is often unavailable, intent is generally inferred from surrounding facts and circumstances. Id. at 1375. The district court, upon finding materiality and intent, shall "balance the equities to determine whether the patentee has committed inequitable conduct that warrants holding the patent unenforceable." Id. (quoting Monsanto Co. v. Bayer Bioscience N.V., 363 F.3d 1235, 1239 (Fed. Cir. 2004)). "The more material the omission or misrepresentation, the less intent that must be shown to elicit a finding of inequitable conduct." Id.

The CAFC trawled through the details and affirmed the patents as unenforceable.

Full post as published by The Patent Prospector on May 15, 2008 (boomark / email).