US District Court Invalidates 4 Patents for Multiple Sclerosis Drug Ampyra
Dalfampridine is the only FDA-approved drug to aid walking in patients with MS.
Four crucial patents that Acorda Therapeutics holds on the multiple sclerosis (MS) drug dalfampridine (Ampyra) have been struck down in federal court, according to Multiple Sclerosis News Today.
Dalfampridine 10 m extended release tablets is the only FDA-approved drug to help improve walking in adults with MS. Studies have shown that patients administered dalfampridine walk 20% faster compared with those not administered the drug, according to the Multiple Sclerosis News Today article.
If a patient is ineligible for copay assistance, out-of-pocket costs can cost approximately $500 per month, however, a March 31 court decision may change this high expense for patients, the article noted.
The 4 key patents on dalfampridine were regarding methods used to deliver the drug to the patient. The judge ruled that the company’s methods were not unique enough to warrant a patent.
Although the judge allowed a different patent covering the drug to hold up, the patent is due to expire in July 2018. The 4 other patents were not due to expire for another 8 to 10 years, according to Multiple Sclerosis News Today.
Currently, 10 rival drug manufacturers are seeking to sell generic versions of dalfampridine. Two of the companies have challenged the patents in court.
In a company press release, Acorda said it plans to appeal the ruling.
“We are disappointed by the court’s decision and are preparing our appeal,” said Ron Cohen, MD, president and CEO of Acorda. “Medical innovation depends on the recognition of valid intellectual property claims. We believe that we demonstrated novel and unexpected findings in our [dalfampridine] development program that led to the issuance of valid patents.”
Acorda has developed contingency plans to address the company’s business needs and objectives in the event of a loss of dalfampridine exclusivity, according to the release.