BTG Int’l Ltd. v. Amneal Pharms. LLC

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 just anti-cancer effects and should include the long-familiar steroid effects of palliation and the reduction of side effects.

Next, BTG did not contest that the prior art taught each limitation of the asserted claims or that a POSA would have been motivated to combine abiraterone and prednisone. Instead, BTG argued that a POSA would not have had a reasonable expectation of success. But BTG made no reasonable-expectation-of-success argument under the adopted claim construction.  Further, even under BTG’s proposed construction, the Federal Circuit explained that the record demonstrated that a POSA would have had a reasonable expectation of success in combining abiraterone and prednisone, as they were both together and individually considered promising prostate-cancer treatments.

The Federal Circuit also rejected BTG’s purported secondary considerations relating to unexpected results, skepticism, failure of other, long-felt need, and commercial success.  The use of abiraterone and prednisone to treat prostate cancer was well known and did not provide unexpectedly superior results. Further, given that other treatments for prostate cancer were available, the evidence did not establish that there was a specific unsolved, long-felt need. Moreover, BTG’s alleged lack of enthusiasm by a few was not equivalent to skepticism or failure of others such that the combination would not have been obvious. Finally, the existence of a blocking patent mitigated against a finding of commercial success.