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Otsuka Wins Appeal Ruling Upholding Abilify Drug Patent

Otsuka Holdings Co.’s pharmaceutical unit and partner Bristol-Myers Squibb Co. won an appeals court ruling that will help ward off generic-drug competition to their schizophrenia drug Abilify until April 2015.

The U.S. Court of Appeals for the Federal Circuit rejected today invalidity arguments by Teva Pharmaceutical Industries Ltd., the world’s biggest generic-drug company, and Apotex Corp. The decision upholding the Otsuka patent was posted on the court’s website.

Abilify, also known by its active ingredient aripiprazole, was first approved by U.S. regulators in 2002. New York-based Bristol-Myers reported its share of Abilify sales was $2.76 billion last year, or 13 percent of the company’s revenue.

The generic-drug makers conceded that their copycat versions would infringe the patent, so legal arguments centered on whether the patent was valid. Teva and Apotex contended that the drug was already covered by a patent that expired in 2005.

The Federal Circuit in Washington, which specializes in patent law, said researchers would have first looked to other compounds to find a new antipsychotic, and Teva and Apotex failed to prove that the compound aripiprazole would have been the obvious choice.

The appeals court called the argument by Petah Tikva, Israel-based Teva and Weston, Ontario-based Apotex “a poster child for impermissible hindsight reasoning.”

Patent Protection

Laura Hortas, a spokeswoman for Bristol-Myers, said the two drugmakers were pleased with the decision, which “maintains the patent protection for Abilify in the United States until April 2015.” Denise Bradley, a spokeswoman for Teva, said the company had no comment.

Otsuka, based in Tokyo, earlier today said that trials on the effectiveness of once-monthly intramuscular dosing of Abilify significantly delayed relapses throughout a 52-week study compared with a placebo. Otsuko and partner H Lundbeck A/S reported the results at the American Psychiatric Association.

The case is Otsuka Pharma Co. v. Sandoz Inc., 2011-1126 and 2011-1127, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Otsuka Pharmaceutical Co. v. Sandoz Inc., 07cv1000, U.S. District Court for the District of New Jersey (Trenton).

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