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

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

D.N.J. (2010)

Otsuka's Blockbuster Drug Abilify® Successfully Defended

On November 15, 2010, after facing a patent challenge by seven generic drug manufacturers in a Hatch-Waxman lawsuit, Otsuka Pharmaceutical Co.’s blockbuster antipsychotic drug Abilify® was successfully defended.


After a month-long trial, U.S. District Judge Mary L. Cooper in New Jersey ruled that generic drug makers Apotex, Teva, Barr, Sandoz, Sun, Synthon and Zydus infringed Otsuka’s patent on aripiprazole, and rejected the defenses that the patent was invalid and unenforceable. The Court entered a permanent injunction against all generic versions of aripiprazole until April 20, 2015, when the patent expires. U.S. net sales of aripiprazole have totaled more than $13 billion dollars from 2002 through 2009. In 2009, aripiprazole was the sixth highest selling drug in the United States.

The Fitzpatrick team was led by partners John D. Murnane and Robert L. Baechtold, with partners John Carlin and Joshua Rothman, and associates Alicia Russo, Kimberley Gavin, Kenneth Szeto, Gabrielle Markeson and Lauren Zuffante. Fitzpatrick’s co-counsel on the case were Finnegan, Henderson, Farabow, Garrett & Dunner, and Pepper Hamilton.