Mylan seeks to overturn FDA decision on generic Provigil

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil®.

The Complaint alleges that Teva did not maintain valid paragraph IV (PIV) certifications as a result of its acquisition of Cephalon. The Complaint states that, once Teva became the owner of Cephalon, Teva could no longer infringe its own patents through a PIV certification and that Teva therefore is not entitled to exclusivity based on patent certifications. Mylan also alleges that FDA should have found that Mylan is the sole first filer on one of the Orange Book Patents for Provigil, that Teva abandoned its abbreviated new drug application (ANDA), and that FDA should have approved Mylan's ANDA for this product. Mylan is seeking an immediate order from the Court entitling it to exclusivity and immediate approval for its ANDA. 

The Complaint also alleges that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission did not contemplate the current outcome when it imposed its conditions on the Teva/Cephalon merger. As a result of FDA's decision, only one party—Teva/Cephalon—controlling 100% of the supply of product in the marketplace. This is despite the fact that Cephalon previously agreed to a Mylan launch of its generic product no later than April 6, 2012.