A federal judge has invalidated four patents held by Acorda Therapeutics Inc. for its multiple sclerosis drug Ampyra, which accounted for 95 percent of the Ardsley biotechnology company’s total revenues in 2016.
The ruling in U.S. District Court in Delaware opens the company’s product to competition from generic drug manufacturers.
Acorda founder and CEO Dr. Ron Cohen in a news release said the company is preparing to appeal the March 31 decision by Judge Leonard P. Stark.
Stark upheld one Acorda patent pertaining to the formulation of Ampyra extended release tablets, taken by multiple sclerosis patients to improve walking, but sided with two generic drug manufacturers, defendants in patent infringement lawsuits brought by Acorda, and found four other Acorda patents invalid due to obviousness.
The judge said that evidence produced by defendants Roxane Laboratories Inc. and Apotex Corp. “establishes, clearly and convincingly, and objectively, that the asserted claims of the Acorda patents would have been obvious to a person of ordinary skill in the art.”
Cohen said company officials are “disappointed” by the court’s decision and “believe that we demonstrated proven and unexpected findings in our Ampyra development program that led to the issuance of valid patents.”
Acorda officials said the company will announce contingency plans “to address its business needs and objectives in the event of a loss of Ampyra exclusivity.” Acorda’s net revenue from Ampyra sales amounted to $492.8 million in 2016, up 12.8 percent from 2015 and accounting for most of Acorda’s total revenues of $519.6 million last year.
Founded in 1998, Acorda is a subsidiary of Alkermes Pharma Ireland Ltd., a company headquartered in Ireland that specializes in drug treatments for central nervous system diseases.