Otsuka Pharmaceuticals Abilify Litigations

Analysis Group client Otsuka Pharmaceutical Co. successfully defended at trial its patent on a blockbuster drug used to treat various conditions, including schizophrenia, bipolar mania disorder, and major depressive disorder. Managing Principal John Jarosz led a team on behalf of Otsuka in a consolidated set of patent disputes centered on generic versions of Otsuka's Abilify drug. Retained by Otsuka counsel Finnegan Henderson, the Analysis Group team provided expert analysis and trial testimony regarding the commercial success of Abilify, the product embodying the patent in the suit. Abilify, which Otsuka markets in partnership with Bristol-Myers Squibb, is the sixth-largest-selling pharmaceutical in the United States.

Judge Mary L. Cooper of the US District Court for the District of New Jersey ruled that Otsuka's patent covering Abilify is valid and enforceable and enjoined multiple defendants from marketing their generic versions of aripiprazole, the active ingredient in Abilify, before Otsuka's patent expired. Judge Cooper wrote: "Otsuka's witness, Mr. Jarosz, an expert in economics and intellectual property valuation, credibly testified at trial to the extraordinary commercial success of Abilify, the commercial embodiment of the compound and methods claimed in Claim 12, Claim 17, and Claim 23 of the '528 Patent, aripiprazole."

Defendants claimed that Otsuka's patent was invalid due to "obviousness" in relation to an earlier patent, and that the patent was not enforceable due to inequitable conduct by the patent holder. In her ruling, Judge Cooper rejected both claims and stated that Otsuka is entitled to a permanent injunction against infringement of its patent. The ruling was widely covered in the legal, industry, and business media.