Acorda Rebuffed by U.S. Supreme Court Over Ampyra Patents

(Bloomberg) -- The U.S. Supreme Court rebuffed Acorda Therapeutics Inc.’s bid to revive patents on its top-selling multiple sclerosis drug Ampyra.

Trade groups for the drug and biotechnology industries had urged the court to take up the case, saying an appeals court ruling that invalidated Acorda’s patents harms incentives to develop new medicines or explore new uses for older drugs.

The patents Acorda sought to revive would have barred competition to Ampyra from low-cost generic drugs until at least 2025. An earlier patent licensed by the company expired in 2018.

Ampyra accounted for nearly all of Ardsley, New York-based Acorda’s $471 million in sales last year.

At issue in the lawsuit was when a drug’s commercial success can be used to overcome legal challenges that claim its patents are invalid.

Patent challenges, particularly over pharmaceuticals, often rest on the idea that an invention was an obvious variation of known ideas. To illustrate that their patented inventions are unique, drugmakers point to the success of their medicines, failures by others, or evidence that the invention met a long-felt need.

No Incentive

Those arguments have less weight, the U.S. Court of Appeals for the Federal Circuit ruled, when earlier patents exist that blocked others from developing a competing product. There’s no incentive for competitors to conduct research, the court said, when they wouldn’t be able to sell a product because of the older patent.

The decision was hailed by those who say drugmakers tweak their medicines or develop new uses to get a second generation of patent exclusivity and block competition from generics. The practice, known as “evergreening,” has been the subject of congressional hearings aimed at limiting pharmaceutical patent abuses.

The active ingredient of Acorda’s Ampyra, dalfampridine, was first discovered more than a century ago and had been marketed as a bird poison. It initially wasn’t approved for human use because it may cause seizures, though researchers first began testing it for neurological diseases in the 1970s.

The Irish biotech company Elan Corporation Plc obtained a patent in the late 1990s for a sustained-release version of the drug to treat diseases including multiple sclerosis.

‘Unexpected Breakthrough’

After failing to develop a drug, Elan licensed the patent to Acorda, which conducted years of research before what it called an “unexpected breakthrough” that led to regulatory approval for Ampyra in 2010.

Acorda’s patents cover a dosing regimen that helps MS patients walk without causing seizures.

In a 2-1 ruling, Circuit Judge Richard Taranto said the dosing regimen would have been obvious to researchers before 2004, when Acorda sought its patents. The earlier patent it had licensed from Elan kept others from doing their own research, the judge said.

“Acorda’s exclusive license to Elan’s patent enabled Acorda to dominate research in that field in the ensuing years,” generic-drug makers Teva Pharmaceutical Industries Ltd., Mylan NV and Hikma Pharmaceuticals Plc’s Roxane Labs said in opposing Acorda’s Supreme Court petition.

The case is Acorda Therapeutics Inc. v. Roxane Laboratories Inc., 18-1280.

To contact the reporter on this story: Susan Decker in Washington at sdecker1@bloomberg.net

To contact the editors responsible for this story: Jon Morgan at jmorgan97@bloomberg.net, Laurie Asséo, Ros Krasny

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