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Tuesday, February 27, 2018 11:14:43 AM
Recently, in a combined final written decision, the PTAB held that Kyle Bass’s Coalition for Affordable Drugs did not demonstrate by a preponderance of evidence that the challenged claims of four of Acorda Therapeutics’ patents are unpatentable. IPR2015-01850, Paper 72 at 4, 54-55 (PTAB Mar. 9, 2017). The challenged patents are directed to Acorda’s drug for treating multiple sclerosis (MS). Acorda produces the drug under the label Amprya®.
However, Acorda’s victory before the PTAB was short-lived. In Acorda Therapeutics, Inc. v. Roxane Labs., Inc., the U.S. District Court for the District of Delaware held that the defendants proved by clear and convincing evidence that the claims of Acorda’s patents were invalid as being obvious over the asserted prior art. 2017 WL 1199767 at *40 (D. Del. Mar. 31, 2017) (“While Defendants face a high burden in proving that the Acorda Patents are invalid as obvious, the Court finds … they have met this burden.”). Thus, even though the defendants in the Delaware litigation were faced with a higher burden of proof, the defendants were able to persuade the court to find that the claims which the PTAB previously held to be not invalid are invalid. In a footnote, the district court recognized the PTAB’s opposite conclusion, but indicated that “two of the three references the PTAB was considered are not part of the trial record here.” Id. at *41, n. 1. Thus, unlike Novartis, the court pointed out that the evidence it considered was different from the evidence considered by the PTAB.
In view of the Novartis and Acorda decisions, litigants should not expect the PTAB and the district courts to be bound by each other’s validity determinations.
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