BTG INTERNATIONAL LIMITED v. AMNEAL PHARMACEUTICALS LLC
Before Wallach, Moore, and Chen. Consolidated appeals from the Patent Trial and Appeal Board and the U.S. District Court for the District of New Jersey.
Summary: The PTAB correctly construed the claim term “treatment,” based on the challenged patent’s specification, to include both anti-cancer effects and reduction in side effects.
BTG International and other plaintiffs (collectively, “BTG”) sued Amneal Pharmaceuticals and other defendants in the U.S. District Court for the District of New Jersey, asserting that the defendants’ filings of their Abbreviated New Drug Applications infringed all claims of U.S. Patent No. 8,822,438. Subsequently, three groups of defendants filed separate petitions seeking inter partes review. In all three IPRs, the PTAB issued claim construction rulings that were adverse to BTG and found all claims of the patent obvious over the asserted prior art. The district court found the claims obvious over the same prior art. BTG appealed from the decisions of both the district court and the PTAB.
The claims at issue were directed to a method for the “treatment of a prostate cancer in a human comprising administering” abiraterone (which is a well-known anti-cancer agent) and prednisone. BTG argued that the term “treatment” required abiraterone and prednisone to each have an anti-cancer effect. The Federal Circuit disagreed with BTG and affirmed the PTAB’s holding that “treatment” allowed for uses in which abiraterone has an anti-cancer effect and prednisone has some other benefit, such as reducing side effects. The Federal Circuit explained that the specification described prednisone as an anti-cancer agent and a steroid, thus suggesting that “treatment” includes effects of steroids other than anti-cancer effects.
Applying the PTAB’s construction, the Federal Circuit held that substantial evidence supported the obviousness determination in one of the IPRs. The Federal Circuit also observed that substantial evidence would have supported that determination even under BTG’s proposed construction. Based on this affirmance of the obviousness determination in one IPR, the Federal Circuit dismissed the remaining appeals as moot.
Editor: Paul Stewart
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