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BTG International Ltd. v. Amneal Pharmaceuticals LLC

Fed Cir Declines to Determine Whether IPR Estoppel Precludes District Court Validity Challenge

BTG International Ltd. v. Amneal Pharmaceuticals LLC, __ F.3d __, 2019 WL ___ (Fed. Cir. May 14, 2019) (Moore, WALLACH, Chen) (D.N.J.: McNulty / PTAB) (2 of 5 stars)

Fed Cir affirms IPR decision canceling claims as obvious, and dismisses as moot related appeals from the PTAB and district court. BTG’s patent related to methods for treating prostate cancer by application of abiraterone in combination with prednisone. The PTAB did not err in including within the broadest reasonable interpretation of “treatment” [as in, “treatment” of cancer] effects that were palliative or that reduced side effects without having an “anti-cancer effect.” The patent’s claims, description, and file history all referred to “treatment” as including palliation and reduction in side effects. The opinion rejects BTG’s argument that this expanded the claim to cover treatments having no anti-cancer effect, noting that the claims elsewhere required application of abiraterone “which was known to have an anti-cancer effect[.]” Op. at 19.

Substantial evidence supported the PTAB’s obviousness findings. The opinion discusses the evidence that a person of skill would have had a reasonable expectation of success in combining the cited references. It rejects BTG’s argument that the references themselves expressed uncertainty as to whether a “survival advantage” would be observed for the combination. The claims do not expressly require a survival advantage, and in any case, “[w]hile prednisone’s effect in combination may have been uncertain at the time, the law only requires a reasonable expectation of success.” Op. at 24 (citing Pfizer, 480 F.3d 1348 (Fed. Cir. 2007)). The opinion also approves the PTAB’s analysis of objective indicia relating to alleged nonobviousness. It rejects BTG’s arguments that the combination of drugs here (both of which were individually “well-known”) provided unexpected results. It notes that other prostate cancer treatments were available, deprecating BTG’s argument for long-felt need. It dismisses BTG’s evidence of failure of others as merely “lack of enthusiasm by a few.” Op. at 25. It also rejects BTG’s argument that evidence of commercial success strongly supported nonobviousness, noting that BTG had a blocking patent, and the evidence of record did not “remove the deterrent effect” of that patent on competitors in the space.

The Fed Cir declines to reach the question of whether IPR estoppel should have precluded the district court from considering appellees’ obviousness challenge (which had led to a judgment of invalidity over the same prior art). It dismisses appeals from district court and other IPRs as moot in view of the claims’ cancellation.

KEYWORDS: INTER PARTES REVIEW; OBVIOUSNESS (YES); SECONDARY CONSIDERATIONS