• May 14 2019
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  • Category: CAFC Updates

BTG sued Amneal Pharmaceuticals, asserting that Amneal’s Abbreviated New Drug Applications (“ANDA”) for the generic version of BTG’s abiraterone product ZYTIGA® infringes U.S. Patent No. 8,822,438 relating to methods and compositions for treating cancer by administering a CYP17 inhibitor in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Subsequently, Amerigen, Mylan, and Wockhardt filed three separate inter partes review (“IPR”) petitions with the U.S. Patent Office alleging that the asserted claims would have been obvious under 35 U.S.C. § 103. In all three IPRs, the Patent Trial and Appeal Board (“PTAB”) issued claim construction orders adverse to BTG, as well as final written decisions finding the asserted claims obvious. Following a bench trial, the district court concluded that the asserted claims would have been obvious in light of its claim construction and the same combination of prior art relied on by the PTAB.  The CAFC finds that the PTAB correctly construed the asserted claims’ use of “treatment,” and that the PTAB correctly concluded that the asserted claims cover a therapy in which abiraterone has an anticancer effect, while prednisone either has its own anti-cancer effect or has a palliative/side-effect reduction effect. The CAFC further finds that substantial evidence supports the PTAB’s finding that a PHOSITA would have a reasonable expectation of success in combining the prior art to arrive at the invention of the asserted claims. Accordingly, the CAFC concludes that the asserted claims are unpatentable as obvious, and affirms the decision of the Board.

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