The U.S. Supreme Court gave a green light to generic versions of Ampyra this week, declining to hear Acorda Therapeutics‘ appeal of a lower court ruling that allowed generics of its treatment for walking or gait problems in multiple sclerosis.
That lower court ruling came from the U.S. District Court for the District of Delaware in March 2017, and was upheld in a decision by the U.S. Court of Appeals for the Federal Circuit, which specializes in patent issues, in September 2018.
In refusing to hear Acorda’s appeal, the Supreme Court essentially agreed on Oct. 7 with the lower court’s canceling of four of five patents the company held on Ampyra, its best-selling medicine. Those patents were invalidated because “they were obvious when compared to the fifth patent, which preceded them,” according to news reports of the decision. That fifth patent expired in July 2018.
Had Acorda succeeded in reviving its patents, it would have been able to block lower-cost, generic competition to Ampyra until at least 2025, Bloomberg reported.
Ampyra (dalfampridine) works to inhibit potassium channels on the surface of nerve cells, which is thought to strengthen signaling along nerve fibers whose myelin coating is damaged in MS. The treatment was approved to address walking problems in MS — a difficulty experienced by an estimated 90% of all patients — by the U.S. Food and Drug Administration (FDA) in 2010.
According to news reports, Acorda tried to argue that Ampyra — dalfampridine, discovered more than a century ago and used as a bird poison, in a form that would not cause seizures in people — reflected true innovation that would be deterred by invalidating its patents. Limiting invention in this way ultimately would hurt patients, the company argued.
But the Court of Appeals decided that keeping earlier patents alive indefinitely also would undercut any incentive for competition from other companies.
Acorda acquired a license for sustained-release oral dalfampridine to treat MS (known as fampridine-SR) from Elan, then an Irish biotech company, in 1998, the court noted. That license included a patent protecting the compound in this form, awarded to Elan a few years earlier but which that company was unable to develop into a medicine.
Research into testing dalfampridine as a potential treatment for neurological diseases traces back to the 1970s, Bloomberg noted.
Pharmaceutical companies in addition to Mylan have shown interest in developing generic versions of Ampyra. Teva Pharmaceuticals joined Mylan in voicing opinions against Acorda to the Supreme Court, and Roxane Labs, now part of Hikma Pharmaceuticals, was the chief opponent highlighted in the appeals court case carried to the Supreme Court, titled Acorda Therapeutics Inc. v. Roxane Laboratories Inc., 18-1280.
Ampyra was reported by Bloomberg to account for nearly all of Acorda’s $471 million in sales in 2018. The Ardsley, New York-based company also recently launched Inbrija, an FDA-approved treatment of “off periods” during levodopa use in people with Parkinson’s disease.