In this patent infringement case spawned by an application to market a new generic drug, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s reliance on extrinsic evidence for claim construction. The Court also upheld its rejection of prosecution disclaimer based on arguments made in the prosecution of a corresponding European patent application. TAP Pharmaceutical Products, Inc., et al. v. OWL Pharmaceuticals, LLC, et al., Case Nos. 03-1634, 1635 (Fed. Cir. Aug. 18, 2005) (Bryson, J.).
TAP sued OWL, claiming OWL infringed five patents on the drug leuprolide. The district court granted summary judgment of infringement on the asserted claims of two patents.
OWL argued that, as the claim recited to "a copolymer . . . of lactic acid and . . .glycolic acid," it was limited to copolymers made from lactic acid and glycolic acid as starting materials and excluded the use of lactide and glycolide. OWL relied on examples of copolymer preparation in the prosecution history and on a statement made in prosecution of a corresponding European patent that lactide and glycolide are not part of the invention. The Federal Circuit rejected this argument, relying on treatises and expert testimony that lactic and glycolic acid were interchangeable terms with lactide and glycolide. Noting the statement made during prosecution of the European application was rejected by the European patent examiner and was not repeated in the prosecution of the U.S. patents, the Court accorded it little weight in claim construction.
The Court also affirmed consideration of expert testimony concerning construction of the non-technical word "containing" in the phrase "particles containing a water-soluble drug." The Court reasoned the term, while not technical, must be considered in context and from the perspective of one of ordinary skill in the art.
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