Mylan Sues FDA, Saying Agency Fumbled First-Filer Decision on Provigil ANDA

In the latest patent commotion over Provigil, Mylan Pharmaceuticals is suing the FDA over its recent decision to grant Teva sole first-filer status for a generic of the sleep disorder drug, saying the FDA overlooked an anti-competitive legal loophole. Mylan’s complaint, filed in the U.S. District Court for the District of Columbia, alleges Teva is not entitled to exclusivity because its recent acquisition of Cephalon — which bought Provigil (modafinil) from Lafon Laboratories in 2001 — means that Teva now lacks standing to challenge infringement of its own patent through a paragraph IV certification.
Drug Industry Daily