Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., No. 17-2078 (Fed. Cir. 2018)Annotate this Case
Acorda’s patents claim the administration of a medication containing the active ingredient 4- aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda holds an FDA-approved New Drug Application and markets, under the name “Ampyra®,” 10 milligram 4-AP sustained-release tablets for twice-daily oral administration and holds an exclusive license to the earlier, broader “Elan patent,” which is listed in the FDA Orange Book for Ampyra with the Acorda patents, and claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, including 4-AP. Defendants sought FDA approval to market generic versions of Ampyra. In Acorda's infringement suit, the district court held that the asserted claims in the Acorda patents are invalid for obviousness but upheld the Elan patent and enjoined infringement of that patent until it expired in July 2018. The Federal Circuit affirmed that the asserted Acorda patent claims are invalid, discounting the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need. The court noted the Elan patent issued in 1996 and was licensed exclusively to Acorda in 1997 for spinal cord injury and in 1998 for multiple sclerosis treatment, which blocked others from domestic marketing without risk of infringement and deterred other entities from investing in research whose reward depended on marketing a drug like Ampyra.