Teva Pharma. USA v. Sandoz, Inc., No. 12-1567 (Fed. Cir. 2015)
Annotate this CaseGeneric manufacturers submitted Abbreviated New Drug Applications seeking FDA approval to market generic versions of Copaxone®, to treat multiple sclerosis. Teva, which markets Copaxone®, sued for infringement under 35 U.S.C. 271(e)(2)(A). Its patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations entry for Copaxone® and include claims reciting a product called copolymer-1 and two methods of making copolymer-1. The district court found that various claims were infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The Supreme Court remanded, holding that the ultimate construction of a claim term is a question of law, subject to de novo review, and that underlying subsidiary fact findings are subject to clear error review. The Supreme Court also issued its opinion in Nautilus v. Biosig, addressing the standard for indefiniteness. Applying the standards set forth in those decisions, the Federal Circuit held that the Group I claims are invalid for indefiniteness. One statement contained a scientifically erroneous claim; given the specification and the prosecution history, the patentee failed to inform with reasonable certainty those skilled in the art about the scope of the invention.
This opinion or order relates to an opinion or order originally issued on July 26, 2013.
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