HZNP Medicines LLC v. Actavis Laboratories UT, Inc., No. 17-2149 (Fed. Cir. 2019)Annotate this Case
Horizon’s patents generally relate to methods and compositions for treating osteoarthritis and share a substantially similar specification; there are method-of-use patents and formulation patents. Both groups of patents are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for Horizon’s PENNSAID® 2% product, a nonsteroidal anti-inflammatory drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees. Prior art, PENNSAID® 1.5%, also treats osteoarthritis knee pain but differs from PENNSAID® 2% both in the formulation and recommended dosage. Actavis sought to market a generic version of PENNSAID 2% and filed an Abbreviated New Drug Application (ANDA) with certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patents-at-issue were invalid or would not be infringed by Actavis’s generic product. Horizon filed an infringement suit under 35 U.S.C. 271(e)(2)(A). The Federal Circuit affirmed findings of invalidity and noninfringement, upholding claim construction that the terms “impurity A”; “degrades at less than 1% over 6 months”; and “consisting essentially of” are indefinite. Actavis’s ANDA label did not induce infringement of the method-of-use patent.