|December 12, 2001
Media Contact: Jenn Meale
Phone: (850) 245-0150
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TALLAHASSEE -- Attorney General Bob Butterworth today charged Bristol-Myers Squibb Co. with violating antitrust laws in delaying the availability of a cheaper, generic version of BuSpar, an anti-anxiety drug which last year accounted for about $700 million in sales for the company.
Along with his counterparts in 28 other states and Puerto Rico, Butterworth filed a civil complaint in New York federal court charging Bristol-Myers Squibb with misleading the Food and Drug Administration (FDA) about the scope of its new BuSpar patent.
"As a result, generic BuSpar was blocked from the marketplace for about four months, forcing individual patients and government health agencies to pay unduly higher prices for the drug," Butterworth said.
Bristol-Myers Squibb has manufactured and sold BuSpar, the company's brand name for buspirone hydrochloride, since 1986. The company's original patent for the drug was scheduled to expire on November 21, 2000, and two drug companies were prepared to begin selling generic buspirone on November 22. However, the same day that the original BuSpar patent was set to expire, Bristol-Myers Squibb successfully obtained another patent, which the company claimed covered a new method for anxiety treatment using a metabolite of BuSpar. A metabolite is a substance created by the interaction of a particular drug and the body's own chemistry.
Immediately after obtaining the new patent, Bristol-Myers Squibb notified the FDA that BuSpar should be listed in the agency's Orange Book, effectively preventing FDA approval for the manufacture and marketing of generic buspirone. However, the law does not allow a patent claiming only a metabolite to be listed in the Orange Book. To overcome this hurdle, Bristol-Myers Squibb claimed that its new patent covered a method of using BuSpar itself, a claim the company had earlier abandoned in order to obtain the patent.
The two drug makers prevented from coming to market with a generic version of BuSpar later sued for the right to manufacture their products, alleging fraud by Bristol-Myers Squibb. A federal court ruling in favor of the two companies led to a generic version coming to market in March of last year. However, that ruling was reversed this past October on technical grounds and the status of generic BuSpar and the ability of consumers to continue purchasing a less expensive version of the drug remain in doubt.
The complaint was handled for Florida by Antitrust Chief Trish Conners and Assistant Attorneys General Craig Farringer and Peter Fritsche.