May 14, 2019
Case Name: BTG Int’l Ltd. v. Amneal Pharms. LLC, 923 F.3d 1063, 2019 U.S. App. LEXIS 14241 (Fed. Cir. May 14, 2019) (Circuit Judges Moore, Wallach, and Chen presiding; Opinion by Wallach) (Appeal from D.N.J., McNulty, J.; Appeal from USPTO)
Drug Product and Patent(s)-in-Suit: Zytiga® (abiraterone acetate/prednisone); U.S. Pat. No. 8,822,438 (“the ’438 patent”)
Nature of Case and Issue(s) Presented: The ’438 patent recites a method for the treatment of prostate cancer comprising the administration of abiraterone and prednisone. Prior to trial, the PTAB found the ’438 patent invalid as obvious. After trial, the district court similarly concluded that the ’438 patent was invalid as obvious. BTG’s appeals of the PTAB and district court decisions were consolidated for purposes of appeal. The Federal Circuit adopted the PTAB’s claim construction and affirmed its obviousness decision.
Why Defendant Prevailed: BTG argued that the PTAB erred in its construction of “treatment.” In particular, BTG argued that “treatment” required an anti-cancer effect and should not be construed, as the PTAB found, to also include palliative effects and the reduction of side effects. The Federal Circuit explained, however, that the specification states that a “therapeutic agent” may be either “an anti-cancer agent or a steroid.” Further, because the specification explained that prednisone is an anti-cancer agent and a steroid, the Federal Circuit concluded that “treating” with prednisone must logically include more than...
