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States Sue Bristol-Myers

December 24, 2001

Bristol-Myers Squibb • FBI Raids Bristol Myers Squibb • FDA Approves Generic Version Of Pravachol • Drug Companies Reduce Discounts • BuSpar Checks Issued • States Sue Bristol Over BuSpar

New York and 25 other states are suing Bristol-Myers, charging that it illegally kept generic versions of its BuSpar anti-anxiety medication off the market.

New York Attorney General Eliot Spitzer said in a federal court complaint that the huge drug company violated both state and federal antitrust laws by obtaining a new patent that extends its market exclusivity on BuSpar, which generated more than $700 million in sales during the last year.

In a related development, 50 members of the Stop Patient Abuse Now (SPAN) coalition submitted a brief to a federal court of appeals to support the right of drug makers to continue marketing generic versions of BuSpar.

The states' complaint charges that Bristol-Myers made false statements to the Food and Drug Administration in an effort to keep generic drug makers from selling a cheaper version of BuSpar, Bristol-Myers' brand name for buspirone hydrochloride.

In November 2000, Bristol-Myers listed an additional patent on BuSpar, just hours before the existing patent was set to expire. Generic drug manufacturer Mylan Laboratories sued Bristol-Myers and in March a federal judge ordered the new patent withdrawn.

During the intervening time, Spitzer said, the company's attempts to extend its "patent monopoly" cost consumers millions of dollars. In New York alone, the state's Medicaid program paid more than $7 million in BuSpar prescriptions during the time the new patent was being contested, Spitzer said.

Earlier this year, attorneys general from 14 states filed suits accusing two pharmaceutical firms of blocking introduction of Cardizem CD, a blood pressure medication.

Besides New York, the states involved in the Bristol-Myers suit are Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Vermont, Wisconsin and West Virginia. Puerto Rico is also a party to the suit.

Meanwhile, the availability of generic forms of BuSpar remains in doubt.

An appeals court ruled in October that a lower court should not have ordered the de-listing of a patent Bristol-Myers Squibb used to prevent sales of generic BuSpar. The court ruled that, despite a lower court's finding that the patent was frivolous and unlawfully listed, a generic drug manufacturer that requested the de-listing did not have proper legal standing to initiate the court action. The new ruling may allow Bristol to demand that competitors stop selling the generic versions, which have been on the market since March.

"Consumers fought hard once already for the right to purchase generic BuSpar," said Tim Fuller, SPAN founder and Executive Director of the Gray Panthers. "We hope the final court decision won't force consumers to pay inflated prices again for this critical drug."

The amicus brief asks the court to reconsider its position because: 1) Bristol likely filed the patent to trigger an automatic 30-month delay in generic approvals; 2) The patent could not be legally listed by the FDA because it did not claim to cover approved versions of the drug, and; 3) Preventing generic drug companies from protesting unlawful patents will restrict patient access to more affordable medicine and allow brand drug companies to unfairly inflate prices.

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