05/27/2015 After RMMS successfully defeated Otsuka’s motion for temporary restraining order, RMMS secured a second victory in the U.S. District Court for the District of Maryland, on behalf of its client Apotex Inc.The CourtgrantedFDA and Intervenor Defendant’s summary judgment (‘SJ’) motions and deniedOtsuka’s cross SJmotionwhich could have blocked final approval of generic aripiprazole products until December 2021—when orphan drug exclusivity expires for Abilify®’s Tourette’s disorder indication.
In a 28-page opinion, U.S. District Judge George J. Hazel held that Otsuka failed to cite to any evidence in support of its construction of a statutory provisionrelating to pediatric labeling information—specifically noting that ‘it would defy logic to believe that in enacting [a] measure to prevent three-year exclusivity from becoming a ‘fundamental abuse of the system’ that harmed consumers, Congress nontheless intended to permit the [abuse of the] seven-year exclusivity Otsuka seeks here. The Court concludes that it did not.’Judge Hazel concluded thatFDA’s decision to approve generic aripiprazole applicants ‘reasonable’ in light of the plain language of the Orphan Drug Act, Fourth Circuit case law interpreting the same, and FDA’s own regulations.
The RMMS team included William Rakoczy, Lara FitzSimmons, Trang Hoang Lin, and Chris Galligan.