Bayer AG v. Elan Pharmaceutical Research Corp.
United States Court of Appeals for the Federal Circuit
212 F.3d 1241 (2000)
- Written by Mary Phelan D'Isa, JD
Facts
Bayer AG (plaintiff), the manufacturer of a patented high-blood-pressure medication—Adalat CC—brought an infringement claim against Elan Pharmaceutical Research Corp. (Elan) (defendant), the manufacturer of a generic version of Bayer’s Adalat CC. Elan had filed an abbreviated new drug application (ANDA) under the Hatch-Waxman Act to get the Food and Drug Administration’s approval to produce and market its generic drug. The district court granted summary judgment for Elan, and Bayer appealed, arguing that the filing of the ANDA constituted a literal infringement of its patent or alternatively an infringement under the doctrine of equivalents. Elan argued that because the proposed specific surface area (SSA) for its drug was greater than 5m2/g and the SSA for Bayer’s Adalat CC was under 4.7m2/g, there was no evidence that Elan’s proposed generic would meet the specifications in its ANDA, and thus there was no evidence that there would be an infringement of Bayer’s patent.
Rule of Law
Issue
Holding and Reasoning (Schall, J.)
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