Summary of a Series of Court Decisions relating to Antibody Drug Patents

he Intellectual Properties (IP) High Court of Japan handed down decisions on December 27, 2018, in lawsuits against trial decisions by the Japan Patent Office (JPO), to accept the validity of Company A (Amgen)’s patents relating to anti-PCSK9 monoclonal antibodies and cholesterol-lowering antibody drugs (Case Nos. 2017 (H29) (Gyo-ke) 10225 & 10226). Subsequently, the Tokyo District Court handed down a decision on January 17, 2019, to grant an injunction to suspend Company B (Sanofi)’s acts of infringing Company A’s patents (Case No. 2017 (H29) (Wa) 16468). These court decisions will have a huge impact, since they will provide guidelines for judging the validity and construction of functionally-defined antibody claims. This article summarizes these court judgments.