americanpharmaceuticalreviewSeptember 12, 2018
Tag: U.S. , Ampyra , District Court’s
Acorda Therapeutics announced that the United States Court of Appeals for the Federal Circuit, by a 2-1 vote, has upheld the United States District Court for the District of Delaware’s decision to invalidate four Ampyra patents. This decision affirms the District Court’s ruling on March 31, 2017 invalidating U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,007,826 (the ‘826 patent), 8,440,703 (the ‘703 patent), and 8,354,437 (the ‘437 patent) pertaining to Ampyra (dalfampridine) Extended Release Tablets, 10 mg. Acorda’s U.S. Patent No. 5,540,938 (the ‘938 patent), previously upheld by the District Court, expired on July 30, 2018.
"We are disappointed by the Court’s decision, as we continue to believe that our Ampyra patents reflected true invention and were valid. We are reviewing the decision and will consider future options, including the possibility of a further appeal," said Ron Cohen, M.D., Acorda's President and CEO. "Following the Court’s original decision in 2017, we prepared a contingency plan that we could face generic competition, implementing a comprehensive corporate restructuring and bolstering our balance sheet. As a result, we are well-capitalized and fully focused on the potential launch of Inbrija for Parkinson’s disease."
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