New Delhi: Belgian biopharmaceutical company UCB on Wednesday lost its U.S. court appeal seeking to revive a patent covering its Parkinson’s disease drug Neupro, clearing an obstacle for Teva’s Actavis Laboratories UT Inc and Viatris‘ Mylan Technologies Inc to sell generic versions of the drug.
The U.S. Court of Appeals for the Federal Circuit agreed with a Delaware federal court that UCB’s patent on Neupro patches was invalid. A ruling for UCB could have delayed U.S. Food and Drug Administration approval of a Neupro generic until it expired in December 2030, the court said.
An earlier court order based on a separate patent had blocked Actavis’ proposed generic until 2021.
A Teva spokesperson said the company was pleased with the decision. Representatives for UCB and Viatris did not immediately respond to requests for comment.
The FDA first approved Neupro in 2007 to treat Parkinson’s disease, a neurodegenerative disorder. It was removed from the market in 2008 over dosing concerns and reapproved with a different formula in 2012.
UCB sold over 300 million Euros worth of the drug worldwide last year, according to a company report.
UCB and LTS Lohmann Therapie-Systeme AG sued Actavis and Mylan for patent infringement in 2019 over their planned Neupro generics. A Delaware court invalidated UCB and LTS’ patent in 2021 based on their earlier patents for the original version of Neupro that the court said covered the same invention.
The Federal Circuit affirmed Wednesday that the patent UCB accused Actavis and Mylan of infringing was obvious and unpatentable.
The case is UCB Inc v. Actavis Laboratories UT Inc, U.S. Court of Appeals for the Federal Circuit, No. 21-1924