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17 August 2017Americas

BIO and PhRMA back Acorda in patent appeal

The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), two trade groups representing US pharmaceutical companies, have backed Acorda in an appeal to the US Court of Appeals for the Federal Circuit.

A Delaware district court had invalidated four patents owned by Acorda in March this year, after Acorda and Alkermes Pharma Ireland alleged that Apotex, Mylan, Roxane Laboratories and Teva infringed them.

The patents all cover treatments for multiple sclerosis (MS) and cover Acorda’s drug Ampyra (dalfampridine).

Each defendant had filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to bring generic versions of Ampyra to market.

“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,” said the district court in its ruling.

In May, Acorda appealed to the Federal Circuit, arguing that the court’s conclusion of obviousness “results from three significant, reversible errors”.

One of these errors, according to Acorda, was that instead of analysing whether a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, the district court construed the claims and “improperly conducted a mini-obviousness analysis on each”.

The following month, the defendants filed a cross-appeal.

On Monday, August 14, both BIO and PhRMA filed separate amicus briefs backing Acorda and urging the Federal Circuit to reverse the ruling.

“Despite making factual findings that Ampyra … was a commercial success, that it satisfied a long felt need for a treatment for one of the ‘most devastating symptoms’ of multiple sclerosis, and that Acorda established the requisite nexus for both, the trial court concluded that these objective indicia did not support a finding of non-obviousness,” said PhRMA.

BIO added that the district court had found that Acorda had presented “convincing evidence” of Ampyra’s commercial success.

“Relying on Merck v Teva (2005), the district court dismissed the probative value of this evidence because Acorda held dominating patent rights,” said BIO.

Both trade groups urged the Federal Circuit to find that the district court had erred in its decision.

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More on this story

Americas
3 April 2017   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.
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
3 April 2017   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.
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.