Otsuka Pharmaceutical Co., Ltd. and Otsuka Holdings, Co.,
Ltd., the parent company of Otsuka Pharmaceutical Co., Ltd., announced today
that the U.S. District Court for the District of New Jersey issued its judgment
dated November 15, 2010 in favor of Otsuka Pharmaceutical Co., Ltd. in its
patent litigation against several companies seeking FDA approval to market generic
copies of Abilify(R).
The District Court held that the asserted claims of U.S.
Patent No. 5,006,528 covering aripiprazole, the active ingredient in
Abilify(R), are both valid and enforceable, thus maintaining patent and
regulatory protection for Abilify(R) in the United States until at least April 20,
The District Court also held that the proposed generic
products infringe these patent claims, and accordingly precluded the FDA from approving,
and enjoined the respective companies from marketing, these products in the United States
until at least April 20, 2015.