Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
By Dana A. Elfin
Jan. 22 — Acorda Therapeutics Inc. and Par Pharmaceutical Inc. have settled patent litigation over Par's application to make a generic of Acorda's multiple sclerosis treatment Ampyra (dalfampridine extended release tablets) before patents covering the drug expire.
Under a consent judgment entered in the U.S. District Court for the District of Delaware Jan. 21, Par agreed that the four Acorda patents at issue were valid and enforceable and that its proposed generic would infringe those patents.
The patents at issue, U.S. Patent Nos. 8,007,826 (the '826 patent), 8,354,437 (the '437 patent), 8,440,703 (the '703 patent), and 8,663,685 (the '685 patent), have expiration dates from Jan. 18, 2025, to May 26, 2027, according to the Food and Drug Administration's Orange Book.
Par agreed not to market generic versions of Ampyra until a license to the patents, provided in the parties's settlement agreement, becomes effective.
Ampyra is used to help people walk when they have multiple sclerosis, a disorder that attacks both the central nervous and immune systems. Acorda's patents cover a dosing regimen to make sure the drug works.
In 2015, Kyle Bass's Coalition for Affordable Drugs challenged two of Acorda Therapeutics's Amypra patents, the ‘685 patent and the ‘437 patent, at the Patent and Trademark Office. Bass argued that the Acorda patents simply cobbled together what scientists already knew about Ampyra's active ingredient and the optimal dosages. But the Patent Trial and Appeal Board ultimately rejected the petitions (13 PLIR 1253, 8/28/15).
Acorda is based in Ardsley, N.Y. Par is based in Chestnut Ridge, N.Y.
The firms of Kaye Scholer LLP in Washington and New York and Morris Nichols Arsht & Tunnell LLP in Wilmington, Del., represented Acorda.
The firms of Arent Fox LLP in Washington and Young Conaway Stargatt & Taylor LLP in Wilmington, Del., represented Par.
To contact the reporter on this story: Dana A. Elfin in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Brian Broderick at email@example.com
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