Acorda Therapeutics’ attempt to preserve its patent protection for multiple sclerosis drug Ampyra hit the proverbial wall Monday when the U.S. Supreme Court refused to hear the company’s appeal of a lower court ruling.
Acorda Therapeutics’ attempt to preserve its patent protection for multiple sclerosis drug Ampyra hit the proverbial wall Monday when the U.S. Supreme Court refused to hear the company’s appeal of a lower court ruling.
In September 2018, Acorda lost an appeal regarding four patents for Ampyra. Earlier that year, a judge in Delaware struck down key patents that covered Ampyra, which paves the way for the launch of generic versions developed by Mylan and Roxane Laboratories. Then, in July 2018, the U.S. Court of Appeals denied Acorda’s request for a restraining order against Teva Pharmaceuticals and Hikma Pharmaceuticals in an attempt to block those companies from selling generic versions while the appellate court reviewed the lower court’s decision regarding the patents.
As BioSpace reported at the time, Acorda argued that it “will suffer devastating and irreparable harm from a generic launch during the pendency of its appeal.”
Acorda sought to reinstate those patents as sales of Ampyra have been cut by the competing drugs. As Reuters reported late Monday, sales of Ampyra dropped 67% to $84.7 million for the first half of 2019. For the second quarter of 2019, Ampyra’s net revenue was $44.2 million compared to $150.3 million for the same quarter in 2018. With the increased competition, Acorda said it anticipates Ampyra’s revenue to continue declining. The company expects Ampyra net revenue for the full year 2019 to be greater than $140 million. In 2016, Ampyra generated $519 million in revenue and in 2018, generated about $450 million. According to Bloomberg, Ampyra was the primary driver of Acorda’s revenue stream of $471 million in 2018. Recently launched Parkinson’s disease drug Inbrija is Acorda’s other primary revenue source. Because it was recently launched, Acorda has not issued a 2019 revenue guidance for Inbrija.
As multiple publications reporting on the court case have noted, a central question raised by Acorda is whether or not a drug’s commercial success is enough to overcome legal challenges that attempt to invalidate a drug patent. It was that argument that the court of appeals rejected last year. Acorda said the patents for Ampyra reflected “true invention and were valid.” The company argued that invalidating its patents deters innovation by drug companies and also ultimately hurts patients who rely on the medication.
The court responded at the time that there was no incentive for other companies to develop competing products if patents block others from developing a competing product is an older patent remains in perpetuity. Many drugmakers have tweaked their products over the years in order to generate new patents that continue to protect their revenue stream.
Ampyra was approved in 2010 as a treatment to help multiple sclerosis patients walk without causing seizures. In clinical trials, patients who received Ampyra were able to increase their walking speed. The active ingredient in the drug is more than 100 years old. Dalfampridine, as Bloomberg reported, was first marketed as a bird poison and then in the 1970s researchers began testing it against neurological diseases.
