A divided U.S. Court of Appeals for the Federal Circuit upheld a district court's finding of inequitable conduct against a patent owner, invalidating the drug maker's patents to its top-selling blood-thinner. Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., Case No. 07-1280 (Fed. Cir., May 14, 2008) (Prost, J.; Rader, J., dissenting).
The two patents-in-suit covered Lovenox®, which has generated billions in revenue for Aventis through more than 100 million prescriptions for the anti-blood-clotting drug. During prosecution of one of the patents, an Aventis scientist, Dr. Andre Uzan, advised the U.S Patent and Trademark Office (USPTO) that Lovenox® had a longer half-life than prior art drugs. Dr. Uzan failed to reveal, however, that the half-life studies used different doses than the prior art drugs. In fact, studies comparing the drugs with the same dose showed little difference.
Aventis argued that its scientist informed (or at least intended to inform) the USPTO regarding the different doses or, if the USPTO was not informed, then Dr. Uzan's failure to disclose the different doses was inadvertent. An earlier appeal had already affirmed the materiality of the omitted dose information. In this appeal, which addressed the issue of deceptive intent, Aventis failed to convince a majority of the Court that the district court committed clear error in finding that Dr. Uzan had intended to deceive the USPTO.
Judge Rader dissented. In his view, the Federal Circuit's teachings on inequitable conduct provide a more restrictive application of the doctrine. He focused on the Court's 1988 en banc decision in Kingsdown Medical Consultants Ltd. , which he read as "clearly convey[ing] that the inequitable conduct was not a remedy for every mistake, blunder or fault in the patent procurement process." Inequitable conduct, he wrote, is reserved for "only the most extreme cases of fraud and deception." According to Judge Rader, Amphastar had failed to meet its lofty burden of clear and convincing evidence.
Practice Note: In the wake of this decision, patent applicants will need to be particularly careful when comparing a claimed invention to the prior art based on experimental data, making sure than any experimental differences are clearly (and timely) stated. On the litigation front, the ruling may embolden defendants to assert inequitable conduct. Aventis was decided almost one year to the day after the Court's noteworthy ruling in McKesson, which affirmed an inequitable conduct finding based on an applicant's failure to disclose prior art that had been identified in similar co-pending applications. McKesson and Aventis appear to signal an increasingly expansive view of materiality and intent to deceive.
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