Judge Leonard P. Stark recently issued findings of fact and conclusions of law following a bench trial in an ANDA case relating to Avanir’s Nuedexta® product, which is used to treat a neurological condition known as pseudobulbar affect. Avanir Pharmaceuticals, Inc., et al. v. Actavis South Atlantic LLC, et al., Consol. C.A. No. 11-704-LPS (D. Del. Apr. 30, 2014). The Court found that the plaintiffs proved by a preponderance of the evidence that claims 1-9 of U.S. Patent No. 7,659,282, and claims 1-9, 12, 13, 15, and 17 of U.S. Patent No. 8,227,484 were infringed. The Court found further that the defendants failed to prove that the infringed claims were invalid as obvious or for lack of written description. With respect to U.S. Patent No. RE38,115, the Court found that the plaintiffs failed to prove infringement of claims 18-21, and that the defendants failed to prove that those claims are invalid.
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