Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc.
United States Court of Appeals for the Federal Circuit
525 F.3d 1334 (2008)
Aventis (plaintiff) held patents covering a blood-thinning drug marketed as Lovenox. During prosecution, Aventis's expert submitted declarations comparing the drug's half-life to a prior-art compound, but omitted the prior-art compound's dosage, which later proved highly material to the comparison. After the patent issued, Aventis sued Amphastar (defendant) for infringement when Amphastar sought to sell a generic version. The district court initially found inequitable conduct and held the patent unenforceable; on appeal, the Federal Circuit sent the case back for a finding on intent to deceive. On remand, the district court found Aventis's expert intended to deceive the examiner, and Aventis appealed again.
Whether proving inequitable conduct before the U.S. Patent and Trademark Office requires evidence of both a material misrepresentation or omission and an intent to deceive.