ACORDA THERAPEUTICS, INC. V. ROXANE LABORATORIES, INC.
- Sep 24 2018 |
- Category: CAFC Updates
Roxane and others submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Ampyra, a medication Acorda markets pursuant to FDA approval, containing the active ingredient 4-aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. In July 2014, Acorda and Alkermes sued those entities (“defendants”) in the District of Delaware, alleging infringement of several claims in Elan patents (licensed to Acorda) and Acorda patents. The defendants stipulated to infringement but challenged the validity of the asserted claims. The district court held that the asserted claims in the Acorda patents are invalid for obviousness, but upheld the asserted claims of the Elan patent against invalidity challenges and enjoined the defendants from activity infringing that patent until it expired on July 30, 2018. Acorda appealed the invalidity ruling regarding the Acorda patents. The defendants cross-appealed the validity ruling regarding the Elan patent and the resulting injunction. The CAFC affirms the judgment that the asserted Acorda patent claims are invalid and dismisses the cross-appeal as moot. Judge Newman dissents.