Generic BuSpar clears last hurdle; BMS patent claims found 'baseless.'

Drug Store News, March 4, 2002 by James Frederick, Diane West

PITTSBURGH -- The end of the long legal tangle between Bristol-Myers Squibb and would-be generic makers of the anti-anxiety drug BuSpar (buspirone) came into sight after a U.S. District Court judge ruled in favor of one generic company seeking to sell the drug.

U.S. District Court Judge John Koeltl granted generic drug maker Mylan a summary judgement that essentially says its sale of buspirone does not infringe on BMS' BuSpar patent or any other lingering claims on the drug. In his Feb. 19 decision, the judge called BMS' claims and the subsequent patent infringement suit "objectively baseless."

Among BMS' contentions was a claim that BMS owned the right to a metabolite produced in the bodies of BuSpar users.

"We are pleased with this court decision, which we think should be viewed as a significant victory for the entire generic industry and for all consumers who rely on more affordable prescription drugs," Mylan chairman and chief executive officer Milan Puskar said. The court also denied Bristol-Myers Squibb's motion to dismiss Mylan's anti-trust counterclaims. Litigation of those claims, Mylan said, will proceed.

Even with uncertain availability of the generic version, BMS said BuSpar sales dipped 52 percent to $338 million in the fourth quarter. Mylan was the first generic drug approved to market 30 mg tablets of buspirone, in June 2001, but BMS court challenges prevented its consistent availability and distribution.