Galderma Laboratories sued Teva Pharmaceuticals under the Hatch-Waxman Act for infringement of three patents that all generally claim methods of treating rosacea through topical administration of a “pharmaceutical composition comprising about 1% by weight ivermectin.” The asserted claims also contained limitations for specific efficacy benchmarks that result from the treatment methods. Galderma listed the patents in the Orange Book for its Soolantra® product. At the district court, Teva challenged the validity of the asserted claims on multiple anticipation and obviousness grounds, as well as for lack of written description. Of note here, Teva argued that the asserted patents were anticipated by the “McDaniel” reference, which disclosed a “1%-5% ivermectin” general formulation. The parties stipulated that a second reference, Manetta, enabled McDaniel “as to the formulation” in the asserted claims. The parties also agreed that Manetta disclosed the formulation for Soolantra®.
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.
Galderma Labs., L.P. v. Teva Pharm. USA, Inc., C.A. No. 19-2396 (Fed. Cir. Jan. 29, 2020).