Amneal Pharmaceuticals LLC v. Almirall, LLC, No. 20-1106 (Fed. Cir. 2020)Annotate this Case
Almirall markets ACZONE®, a prescription medication used to treat acne. Almirall’s 926 and 219 patents are listed in the FDA Orange Book as claiming ACZONE. Before seeking approval to market a generic version of ACZONE, Amneal sought inter partes review (IPR), challenging claims of the patents. Amneal filed its Abbreviated New Drug Application with the FDA. Almirall sued, alleging infringement of only the 219 patent. Amneal counterclaimed that the 926 patent is invalid and is not infringed. Almirall offered to enter into a covenant-not-to-sue on the 926 patent upon the dismissal of the IPR. With the parties unable to reach a settlement, the underlying IPR on the 926 patent proceeded. The Patent Board found claims of the 926 patent not unpatentable. Amneal appealed but later moved to voluntarily dismiss its appeal.
Almirall agreed to the dismissal but argued that Amneal litigated in an unreasonable manner by continuing to pursue the IPR after the covenant-not-to-sue was offered, and Almirall sought removal of the patent from the Orange Book. Almirall sought (35 U.S.C. 285) fees and costs incurred from the date settlement negotiations ended to the date of the IPR trial. The Federal Circuit denied the request. Even if section 285 is not limited to district court proceedings, the plain meaning of its reference to “[t]he court” speaks only to awarding fees incurred during, in close relation to, or as a direct result of, judicial proceedings, not to fees incurred for work in Patent Office proceedings before the court asserted jurisdiction.