District court ruling maintains patent and regulatory protection of Otsuka’s Abilify®
The United States District Court in New Jersey ruled in favor of Finnegan client Otsuka Pharmaceutical Co. in its patent litigation against several companies seeking FDA approval to market generic copies of Abilify®, the sixth largest selling pharmaceutical in the United States. The court held that the asserted patent claims covering aripiprazole, the active ingredient in Abilify®, are both valid and enforceable. The ruling maintains patent and regulatory protection for Abilify® in the United States until at least April 20, 2015. The court also held that the proposed generics infringe the claims, and accordingly precluded the FDA from approving, and enjoined the respective companies from marketing, the generic products in the United States until at least April 20, 2015.