Office of Maryland Attorney General J. Joseph Curran, Jr.

December 13, 2001 Media Inquiries: Sean Caine 410-576-6357

Maryland Consumers, Agencies Forced to Pay More for BuSpar®

The Office of the Attorney General has filed an antitrust complaint against Bristol-Myers Squibb Co. regarding its popular brand-name prescription drug BuSpar®. Thirty attorneys general from across the country and the Commonwealth of Puerto Rico joined in the complaint, filed in the United States District Court for the Southern District of New York.

BuSpar® is prescribed to thousands of Maryland citizens, including the elderly and persons with HIV, to treat generalized anxiety disorder, a potentially debilitating condition. Last year, Bristol-Myers’s sales of BuSpar®, a drug known generically as buspirone hydrochloride, totaled more than $700 million worldwide.

Maryland’s lawsuit follows a multistate investigation focusing on whether Bristol-Myers deliberately made incorrect statements to the Food and Drug Administration about the scope of a new patent in order to keep generic buspirone products off the market and maintain its monopoly on brand-name BuSpar®. Bristol-Myers received the new patent from the Patent & Trademark Office on November 21, 2000, just a few hours before its previous patent on BuSpar® was set to expire. Bristol-Myers immediately sent the patent to the Food & Drug Administration along containing misinformation about the patent’s scope: it stated that the patent covered a new method of using BuSpar® for all approved indications, where in fact the patent only covered a new method of using a metabolite produced in the body after a person ingests a buspirone product.

As Bristol-Myers requested, the FDA listed the new patent in its official publication, the "Orange Book," as covering a new method of using the drug BuSpar® (by contrast, a patent claiming administration of a metabolite could not have been listed). The State’s Complaint alleges that Bristol-Myers knew that, by listing this patent using the incorrect information that Bristol-Myers furnished, the FDA effectively prohibited generic drug makers from coming to market with buspirone products. As a result, Bristol-Myers maintained its BuSpar® monopoly: generic drugs were kept off of the market for nearly four months, and consumers were forced to pay higher brand-name prices.

Maryland’s lawsuit seeks equitable relief, in addition to injunctive relief and damages from Bristol-Myers Squibb.