MS Drug Could Face Generic Competition

Acorda Therapeutics Inc. says it will appeal a federal judge’s ruling last week that invalidated four patents related to the multiple sclerosis drug dalfampridine (Ampyra). The move potentially opens up the drug to generic competition nearly a decade earlier than expected.

In his March 31 decision, US District Judge Leonard Stark threw out all but 1 of the 5 patents at issue in the case. The 4 invalidated patents would have protected the drug from competition through 2025 and 2027. The fifth patent -- pertaining to the 10 mg extended-release formulation of the drug -- was upheld, though it is already set to expire next year.

“We are disappointed by the court’s decision and are preparing our appeal,” said Ron Cohen, MD, (photo) president and CEO of the Ardsley, NY-based biotech firm, in a statement.

Last year, Acorda sued a handful of companies -- Apotex Inc., Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., and Teva Pharmaceuticals Inc. -- claiming the companies were infringing on its Ampyra patents. Those companies, and a half-dozen others, had announced plans to create generic competitors to Ampyra.

First approved in 2010, the drug is designed to improve walking and speed of walking in patients with MS. According to Reuters, the drug accounted for more than 90% of Acorda’s 2016 revenue, which totaled $519 million.

Stark, sitting in the US DIstrict Court for Delaware, considered the complex scientific arguments on both sides, and noted that the law is generally on the side of the patent-holder when issues of intellectual property are in dispute. However, in his 90-page ruling, he said the defendants ultimately succeeded in making the case that the four patents in question fail the so-called “obviousness standard.”

"The evidence as a whole establishes, clearly and convincingly, and objectively, that the asserted claims of the Acorda patents would have been obvious to a person of ordinary skill in the art at the priority date, notwithstanding the actual inventors' subjective experience,” Stark wrote.

That did not sit well with Cohen, who said the company’s findings weren’t obvious, but rather the result of hard work and ingenuity.

“Medical innovation depends on the recognition of valid intellectual property claims,” he said, “We believe that we demonstrated novel and unexpected findings in our Ampyra development program that led to the issuance of valid patents.”

The Acorda case was one of two MS-related patent disputes to be resolved last week. Shortly after the Acorda ruling in Delaware, the US Patent Trial and Appeal Board ruled in favor of Biogen Inc. in its dispute with the Danish firm Forward Pharma A/S. At issue was a patent for a key ingredient in Tecfidera, Biogen’s big-name MS treatment.

The patent board said Biogen’s use of the ingredient did not constitute patent infringement because the written description of Forward Pharma’s intellectual property claim was insufficient. The ruling freed Biogen from potentially having to pay a 10% royalty to Forward Pharma.

Forward Pharma CEO Claus Bo Svendsen, MD, PhD, said the company was disappointed by the patent board’s ruling and disagrees, “and therefore we intend to appeal the decision.”

Cohen's statements are in the Acorda press release.

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