The Federal Circuit reversed a decision from the
Following a bench trial, the district court found that McDaniel anticipated the asserted claims. More specifically, the district court found McDaniel expressly disclosed the method of treatment and formulation limitations. The district court's finding that McDaniel disclosed the formulation rested largely on the parties' agreement that Manetta enabled McDaniel as to the formulation. The district court then reasoned that because Manetta enabled the formulation in McDaniel, one of ordinary skill in the art could practice the method of McDaniel with the formulation of Manetta without undue experimentation. And as a result, the district court found that McDaniel inherently disclosed the efficacy limitations. The district court declined to reach Teva's remaining defenses.
Galderma appealed the district court's decision, and shortly thereafter, Teva launched its generic drug product. Galderma then filed an emergency motion for a stay pending appeal, which the district court granted, thereby enjoining Teva from entering the market. That injunction was subsequently stayed by the Federal Circuit.
On appeal, Galderma argued the district court erred when it found the asserted claims anticipated in view of McDaniel and Manetta. The Federal Circuit agreed, and held that Manetta's enablement of McDaniel only meant that a person skilled in the art could practice the formulations in McDaniel. However, it did not mean, contrary to the district court's findings, that McDaniel disclosed the claimed method of treatment with the specific formulation that was disclosed in Manetta. And because McDaniel does not disclose the specific formulations necessary to achieve the efficacy limitations, it also fails to inherently disclose those limitations. Thus, the Federal Circuit reversed the decision of the district court, and remanded the case for further consideration of Teva's remaining invalidity defenses.
Practice tip: As the Federal Circuit explained, "[w]hether a prior art reference is enabled is a separate question from whether it discloses, expressly or inherently, the claimed limitations at issue." Anticipation may only be found based on the disclosures of a single reference. Therefore, it is important when presenting an anticipation defense that points to secondary references to clarify the specific purposes for which those references are cited.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Mr
44th Floor
TX 77002-5200
Tel: 310229 1000
Fax: 310229 1001
E-mail: Jlarivee@akingump.com; pazimi@akingump.com
URL: www.akingump.com
© Mondaq Ltd, 2020 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source