Mylan sues FDA to overturn Teva Pharmaceutical’s exclusivity for Provigil

PITTSBURGH—MylanInc. announced that its subsidiary, Mylan PharmaceuticalsInc., has filed suit against the U.S. Food and Drug Administration (FDA) in theU.S. District Court for the District of Columbia seeking to overturn a decisionby FDA, which awarded Teva Pharmaceutical Industries Ltd. sole 180-day exclusivity for the generic version ofits affiliate Cephalon's Provigil.

The complaint alleges that Teva did not maintainvalid paragraph IV (PIV) certifications as a result of its acquisition ofCephalon. The complaint states that, once Teva became the owner of Cephalon,Teva could no longer infringe its own patents through a PIV certification andthat Teva therefore is not entitled to exclusivity based on patentcertifications. Mylan also alleges that FDA should have found that Mylan is thesole first filer on one of the Orange Book Patents for Provigil, that Tevaabandoned its abbreviated new drug application (ANDA), and that FDA should haveapproved Mylan's ANDA for this product. Mylan is seeking an immediate orderfrom 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 genericProvigil products, is unlawful. Mylan has indicated that it believes the Federal Trade Commission didnot contemplate the current outcome when it imposed its conditions on theTeva/Cephalon merger.

Mylan is seeking immediate equitable relief fromthe court requiring FDA to approve Mylan's ANDA.

According to IMS Health, Provigil had U.S. salesof approximately $1.1 billion for the 12 months ending Dec. 31, 2011.