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3 April 2017Americas

Four of Acorda’s Ampyra patents invalidated

A Delaware district court has invalidated four patents owned by Acorda Therapeutics after the company and Alkermes Pharma Ireland alleged that Apotex, Mylan, Roxane Laboratories and Teva infringed them.

In the ruling, issued on Friday, March 31 at the US District Court for the District of Delaware, the court said that the defendants had proven “clearly and convincingly” that the Acorda patents are invalid because of obviousness.

The patents all cover treatments for multiple sclerosis (MS) and the decision followed a four-day bench trial held in September 2016.

In total there were five patents involved in the case, one which is referred to as the “Elan patent” as it belonged to former drug company Elan. It was acquired by Alkermes and Acorda has an exclusive licence to the patent.

This patent, which is listed in the Orange Book with respect to Ampyra, was upheld and is valid until next year.

The four patents which were invalidated cover Acorda’s drug called Ampyra (dalfampridine).

In the case, each defendant filed an Abbreviated New Drug Application with the FDA seeking approval to bring generic versions of Ampyra to market.

The defendants alleged that each of the patents-in-suit was invalid, unenforceable or not infringed by their generic versions.

The court said in its ruling: “While defendants face a high burden in proving that the Acorda patents are invalid as obvious, the court finds, after weighing all of the credible evidence, that they have met this burden.”

But the court added: “This is not to say that there is no significant evidence of non-obviousness.”


More on this story

Americas
17 August 2017   The Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America, two trade groups representing US pharmaceutical companies, have backed Acorda in an appeal to the US Court of Appeals for the Federal Circuit.
Americas
12 September 2018   Generic drug makers Mylan and Teva were afforded victory earlier this week when the US Court of Appeals for the Federal Circuit affirmed the invalidation of four patents owned by biotech company Acorda Therapeutics.

More on this story

Americas
17 August 2017   The Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America, two trade groups representing US pharmaceutical companies, have backed Acorda in an appeal to the US Court of Appeals for the Federal Circuit.
Americas
12 September 2018   Generic drug makers Mylan and Teva were afforded victory earlier this week when the US Court of Appeals for the Federal Circuit affirmed the invalidation of four patents owned by biotech company Acorda Therapeutics.