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September 12, 2018

Federal court invalidates Acorda’s patents covering MS drug Ampyra

The US Court of Appeals for the Federal Circuit has invalidated four patents held by biopharmaceutical company Acorda Therapeutics covering multiple sclerosis drug Ampyra (dalfampridine). 

The US Court of Appeals for the Federal Circuit has invalidated four patents held by biopharmaceutical company Acorda Therapeutics covering multiple sclerosis drug Ampyra (dalfampridine).

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The ruling upholds the District Court’s decision on 31 March 2017 regarding the patents of 10mg Ampyra extended-release tablets.

A separate patent that was previously upheld by the district court expired on 30 July.

Ampyra is a prescription therapy approved by the US Food and Drug Administration (FDA) to improve walking in adults suffering from multiple sclerosis.

The patent case started when Roxane Laboratories, Mylan Pharmaceuticals and Teva Pharmaceuticals USA submitted abbreviated new drug applications to the FDA seeking marketing approval for generic versions of Ampyra.

“We are disappointed by the court’s decision, as we continue to believe that our AMPYRA patents reflected true invention and were valid.”

Acorda filed the patent infringement complaint against these companies in July 2014 at the District of Delaware, which concluded that the claims in the Acorda patents are invalid for obviousness.

Acorda later appealed the invalidity of this ruling but the appeals court affirmed the judgement.

Acorda Therapeutics president and CEO Ron Cohen said: “We are disappointed by the court’s decision, as we continue to believe that our AMPYRA patents reflected true invention and were valid.

“We are reviewing the decision and will consider future options, including the possibility of a further appeal.”

The company added that a contingency plan has been prepared to address generic competition through corporate restructuring and strengthening its balance sheet.

In addition, Acorda is focusing on the potential launch of its Parkinson’s disease candidate Inbrija, a self-administered, orally inhaled levodopa (L-dopa) therapy.

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