On April 29, 2015, RMMS achieved a significant victory in the U.S. District Court for the District of Maryland, on behalf of its client Apotex Inc., by thwarting Otsuka’s second attempt to block generic versions of its blockbuster drug Abilify®. RMMS attorneys successfully intervened on behalf of FDA in Otsuka’s challenge under the Administrative Procedure Act seeking to block final approval of generic aripiprazole products until December 2021—when orphan drug exclusivity expires for Abilify®’s Tourette’s disorder indication.
In a 24-page opinion, U.S. District Judge George J. Hazel held that Otsuka failed to carry its burden on any of the requirements warranting a Temporary Restraining Order and/or Preliminary Injunction—specifically noting that “[f]or a long time now, Otsuka has been aware that it would eventually face generic competition for Abilify and, like any other sophisticated pharmaceutical company, has prepared itself for the day when its exclusivity expired.” Judge Hazel further observed, “far from sounding the death knell of Otsuka, the long-expected loss of Otsuka's exclusivity of Abilify has simply caused the company to launch other products.”
This victory follows RMMS’ success earlier this month opposing Otsuka’s Motion Temporary Restraining Order in an Abilify® patent action in the U.S. District Court for the District of New Jersey before Chief Judge Simandle. These wins demonstrate RMMS’ expertise and dedication to all matters pertaining to Hatch-Waxman and related pharmaceutical litigation matters.