Court Ruling Against 4 Patents Protecting Ampyra May Speed Arrival of Generics

A ruling by the  U.S. District Court for the District of Delaware invalidated four of five patents held by Acorda Therapeutics that pertained to Ampyra (dalfampridine), a treatment for walking difficulties in multiple sclerosis (MS) patients, raising the possibility of generic forms of the drug coming onto the market in a few years.

The March 31 ruling, however, upheld the company’s right to protection for the treatment’s extended-release formulation, but that patent is expected to expire in mid-2018. Acorda Therapeutics, based in Ardsley, New York, is planning to appeal.

“We are disappointed by the Court’s decision and are preparing our appeal,” Ron Cohen, Acorda’s president and CEO, said in a press release. “Medical innovation depends on the recognition of valid intellectual property claims. We believe that we demonstrated novel and unexpected findings in our Ampyra development program that led to the issuance of valid patents.”

Acorda, which focused on developing therapies that restore function to people with neurological disorders like MS and Parkinson’s, has also said that it had a contingency plan in place in the event of losing Ampyra exclusivity.

A patent challenge, originally filed as an inter partes review (IPR) petition by hedge-fund manager Kyle Bass, had lost an initial round with the U.S. Patent and Trademark Office. But the district court ruled otherwise in the lawsuit filed by Acorda and Alkermes Pharma against four companies — Apotex Corp.,  Mylan Pharmaceuticals, Roxane Laboratories, and Teva Pharmaceuticals — alleging patent infringement. The court ruled that Acorda’s claims of infringement were “invalid” for the four patents that relate to the use of 10 mg sustained-release formulations of dalfampridine.

The patent upheld is No. 5,540,938, and pertains to the formulation of extended-release Amprya.

Roxanne and Teva, among other companies, have expressed interest in marketing generic versions of Amprya, the first FDA-approved therapy specifically designed to improve walking performance in MS patients.

Last week, Acorda announced a ‘corporate restructuring’ to reduce costs, and said it will focus resources on maximizing patient access to Ampyra Extended Release Tablets through July 2018. The restructuring includes a 20 percent immediate reduction in personnel, which the company estimates will amount to an annual savings of $21.0 million starting in the second quarter of this year.

It is also focusing on advancing the development of two drug candidates for Parkinson’s disease, CVT-301 and tozadenant, and intends to apply for FDA approval of CVT-301 shortly.

“The cost reductions resulting from this restructuring will enable Acorda to continue to advance our two valuable late-stage programs for Parkinson’s disease, CVT-301 and tozadenant,” Cohen said in a press release. “Over the last several years, we have strategically diversified our portfolio, and we believe that CVT-301 and tozadenant can be a platform for significant future growth.”

Cohen, who founded Acorda in 1995, added: “The decision to reduce headcount is extremely difficult, but is necessary to ensure that Acorda can continue to bring important therapies to the market. We are grateful for the dedication and hard work of all of Acorda’s associates. Their commitment has enabled Acorda to deliver on our mission of developing therapies that restore function and improve the lives of people with neurological disorders.”