BTG Int’l v. Amneal Pharms. LLC

The claims of the patent-in-suit were infringed, and though adequately described, they were found invalid as obvious.

October 25, 2018

GENERICally Speaking

Case Name: BTG Int’l v. Amneal Pharms. LLC, No. 15-cv-5909, 2018 U.S. Dist. LEXIS 183854 (D.N.J. Oct. 25, 2018) (McNulty, J.) 

Drug Product and Patent(s)-in-Suit: Zytiga® (abiraterone acetate / prednisone); U.S. Patent No. 8,822,438 (“the ’438 patent”)

Nature of Case and Issue(s) Presented: BTG owns the ’438 patent, which is directed to a method for the treatment of prostate cancer. Prior to trial, the PTAB found the ’438 patent claims invalid as obvious. At trial, the Defendants argued non-infringement and that the ’438 patent was invalid for lack of written description and obviousness. The court found the ’438 patent infringed but invalid.

Why Defendants Prevailed: Defendants argued that the allegedly infringing use would fall outside the scope of the FDA-approved use. Specifically, defendants argued that the claims of the ʼ438 patent required that each component (abiraterone and prednisone) have an anti-cancer effect, but that the prednisone component of the combination therapy was given only for its palliative effect (i.e., decreasing side-effects). The court explained, however, that if prednisone were approved solely to treat the side effects of abiraterone, such would not appear in the “Indications” section, but only in the label’s dosage and administration section, or the “Warnings and Precautions” section. Ultimately, the court was persuaded that FDA approved Zytiga based on a combination study of abiraterone and prednisone and that the indication language of the drug label mirrored claim 1 of the ’438 patent. As a result, defendants infringed.

Next, defendants argued that the ‘’438 patent specification did not adequately describe the invention because it failed to disclose test results showing that prednisone itself provided anti-cancer benefit. The court found, however, that the specification listed antibiotic agents as being anti-cancer agents and that prednisone was explicitly identified as an antibiotic agent. Thus, defendants’ written-description argument failed.

Finally, defendants argued that a POSA would have been motivated to combine abiraterone with prednisone for three reasons: (i) for its anti-cancer effects, (ii) to mitigate abiraterone’s side effects, or (iii) for prednisone’s palliative properties. The court noted that the claimed combination therapy was patented as a “treatment,” but explained that even if the requisite motivation to combine the two agents for their anti-cancer effects were not to exist, prednisone’s influence as a side-effect minimizer nevertheless would furnish a powerful motivation to combine with abiraterone. As a result, the court found the claimed combination therapy invalid as obvious.

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