Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc., et al.

Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc., et al.

Fed. Cir. (2012)

Federal Circuit Affirms Validity of Otsuka Pharmaceutical Co.’s Patent on Abilify®

The Court of Appeals for the Federal Circuit affirmed on May 7 the finding of validity of Otsuka Pharmaceutical Co. Ltd’s patent U.S. 5,006,528 for the compound aripiprazole. Aripiprazole is the active ingredient in the antipsychotic drug marketed by Otsuka and Bristol-Myers Squibb under the brand name Abilify®.

Defendants Apotex Inc., Apotex Corp., Teva Pharmaceuticals USA, Inc., Barr Laboratories, Inc., and Barr Pharmaceuticals, Inc. (collectively, “Defendants”) appealed the decision of New Jersey District Court Judge Mary L. Cooper finding that the ‘528 patent was not invalid for obviousness under 35 U.S.C. § 103 or under the doctrine of nonstatutory double patenting.

In addressing Defendants’ obviousness argument, the Federal Circuit held that the district court did not err in finding that Defendants failed to prove that the skilled artisan would have modified any one of three prior art “lead compounds” to arrive at aripiprazole. The Federal Circuit noted that the “district court’s careful analysis exposed the Defendants’ obviousness case for what it was—a poster child for impermissible hindsight reasoning.”

The Federal Circuit further rejected Defendants’ argument that the district court erred by relying in part on its § 103 obviousness analysis in its nonstatutory double patenting analysis. The Court held that the district court applied the correct test: for claimed chemical compounds, a nonstatutory double patenting analysis requires determining whether a skilled artisan would have reason or motivation to modify the earlier claimed compound to make the compound of the asserted claim, with a reasonable expectation of success. The Federal Circuit affirmed the finding of the district court that the prior art would not have given a person skilled in the art a reason to modify the prior art compound—one of the “lead” compounds analyzed in the § 103 analysis—to arrive at aripiprazole.

The Fitzpatrick team was led by partners John D. Murnane and Robert L. Baechtold and associates Kimberley Gavin and Gabrielle Markeson. Fitzpatrick’s co-counsel on the case was Finnegan, Henderson, Farabow, Garrett & Dunner.