4-Aminopyridine: Acorda Win & Loss

May 3, 2017

Acorda won at the PTAB but lost in the US District Court.

Acorda Therapeutics, Inc. is fighting is to extend the life of their 4-aminopyridine formulations and methods.

160px-4-aminopyridine.svg

Acorda will retain market exclusivity to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg at least through July 2018.

The US District Court in Delaware ruled that Acorda’s four patents set to expire between 2025 and 2027 are invalid.  A few weeks earlier, the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld the four patents challenged via the inter partes review (IPR) process [U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent)]. These patents, if valid and enforceable, are calculated to expire in 2025, 2025, 2026 and 2027, respectively.

ACORDA THERAPEUTICS, INC., et al. v. ROXANE LABORATORIES, INC., et al.

Case #: 14-882
Judge: Chief Judge Leonard P. Stark

Next?: Acorda will appeal. Meanwhile Acorda announced restructuring and layoffs

http://www.4-traders.com/ACORDA-THERAPEUTICS-INC-8238/news/Acorda-Therapeutics-Implements-Corporate-Restructuring-to-Align-Cost-Structure-with-Focus-on-Promi-24209186/

http://cen.acs.org/articles/95/i15/Troubled-biotechs-cut-jobs.html

Fierce Pharma

http://www.fiercepharma.com/pharma/court-nixes-4-acorda-patents-teeing-up-amprya-generics-for-2018

Acorda press releases

03/31/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/US-District-Court-Issues-Decision-to-Invalidate-Four-AMPYRA-Patents-Company-Will-Appeal-Ruling/default.aspx

03/09/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/Patent-Trials-and-Appeal-Board-PTAB-Upholds-Four-AMPYRA-Patents/default.aspx