Wednesday, November 13, 2013

Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc. case brief

Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc. case brief summary
525 F.3d 1334 (2008)


CASE SYNOPSIS
Appellant patentee sought review of a judgment of the United States District Court for the Central District of California, which found that it intended to deceive the United States Patent and Trademark Office in failing to disclose the dosage of a prior art composition used in half-life comparisons with a patented composition, held its patents unenforceable for inequitable conduct, and granted appellee generic manufacturers summary judgment.

CASE FACTS
The generic drug manufacturers were granted summary judgment on an action for the infringement of patents for a blood clotting drug comprising low molecular weight heparins.

HOLDING
  • The court held that the district court did not abuse its discretion in holding that the patentee engaged in inequitable conduct by failing to disclose that the half-life studies comparing the patent compound to the European patent compound were at different doses, which evidenced an intent to deceive. 
  • The court held that the district court did not clearly err in finding that the half-life comparisons were intended to show compositional differences to address the obviousness and anticipation rejections under 35 U.S.C.S. § 102 because the example did not suggest that the comparisons were designed to show only non-obviousness and not lack of identity, a chemist's declaration did not delineate evidence intended to address the anticipation and obviousness rejections, and the evidence directed to the European patent appeared without distinction between the 35 U.S.C.S. §§ 102 and 103 aspects of the rejection. 
  • The court held that the district court did not abuse its discretion in excluding industry practice evidence.

CONCLUSION
The court affirmed.

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