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12 September 2018Americas

Victory for Mylan and Teva as appeals court affirms invalidations

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.

In a 2-1 precedential opinion handed down on Monday, September 10, the Federal Circuit upheld a ruling by Judge Leonard Stark of the US District Court for the District of Delaware which had found that four patents covering Acorda’s multiple sclerosis drug Ampyra (dalfampridine) are obvious.

Mylan, Teva and Roxane have all submitted Abbreviated New Drug Applications seeking approval to market generic versions of Ampyra.

In July 2014, Acorda sued the companies, alleging infringement of US patent numbers 8,007,826; 8,663,685; 8,354,437; and 8,440,703 (the four patents that were later invalidated) and US patent 5,540,938.

Acorda holds an exclusive licence to the broader ‘938 patent, referred to as “the Elan patent” because it was originally assigned to Elan Corporation.

Stark held that the four patents were invalid for obviousness but upheld the claims of the Elan patent and enjoined the generic makers from infringing activity until the patent expired on July 30, 2018.

Acorda appealed against the invalidity ruling to the Federal Circuit.

The biotech company argued that the Delaware court erred in finding that a person of skill would have had a motivation to combine the prior art.

Acorda also claimed that the court had improperly applied a “categorical rule that a blocking patent (the Elan patent) negates any findings in favour of Acorda on the objective indicia of commercial success, failure of others, and long felt but unmet need”.

Circuit Judge Richard Taranto, on behalf of the court, rejected the challenges to the finding of obviousness and concluded that the evidence supported a finding that the Elan patent would have deterred other entities from investing in research.

In dissent, Circuit Judge Pauline Newman said that the district court had observed that objective indicia could change the result but had “discounted its weight” on the theory that Acorda had a “blocking” patent.

Newman added: “The consequences of this new legal theory are large, as the amici curiae advise. Had the court’s approach to the law of obviousness been in effect when Acorda took up the study of 4-aminopyridine after decades of failures by others, it is questionable whether this new treatment for multiple sclerosis would have been discovered and pursued. The loser is the afflicted public.”

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

Acorda is reviewing the decision and considering future options, including the possibility of a further appeal.

“Following the court’s original decision in 2017, we prepared a contingency plan that we could face generic competition, implementing a comprehensive corporate restructuring and bolstering our balance sheet,” added Cohen.

In August, Acorda revealed that it had entered into a settlement agreement with Mylan under which, subject to conditions, Mylan will be permitted to market its generic version of Ampyra in the US in 2025 or earlier.

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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
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.

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
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.