Judge Invalidates Ampyra Patents, Clearing Path for Generics a Decade Early

Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — less than a month after they were upheld by the PTO.

Judge Leonard Stark of the District Court for the District of Delaware ruled that the four patents covering Ampyra’s active ingredient, dalfampridine — relating to its use in MS patients and 10mg dosing structure — were obvious uses of the drug to trained members of the profession, and were therefore invalid.

Last month, the PTO’s Patent Trial and Appeal Board validated the same four Acorda patents — saying there was inadequate support to challenge them. Acorda had previously reached settlements with generic drugmakers Actavis, Aurobindo Pharma, Accord Healthcare, Par Pharmaceutical, Sun Pharmaceutical Industries and Alkem Laboratories over Ampyra infringements.

The latest of those four patents was set to expire in May 2027. The court’s decision now allows for generic development much earlier. A fifth Acorda patent, for a sustained-release formulation of dalfampridine, was upheld as valid by the court, but that patent is set to expire July 30, 2018.