Oregon Department of Justice

Attorney General Ellen F. Rosenblum

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Attorney General Sues Bristol-Myers Squibb for Unlawfully Keeping Generic Buspar Off Market

December 12, 2001

Attorney General Hardy Myers today joined 29 other states and Puerto Rico in suing Bristol-Myers Squibb Company (BMS) for allegedly making false statements to a federal agency concerning its new patent of a popular anti-anxiety drug BuSpar in order to prevent manufacturers of generic drugs from marketing it. The multi-state lawsuit was filed in the U.S. District Court for the Southern District of New York.

"The most vulnerable of Oregon's consumers and state agencies paid higher prices for a widely prescribed anti-anxiety drug due to the unlawful actions of Bristol-Myers Squibb," Myers said. "BMS made false representations to keep generic BuSpar off the market and the elderly and agencies that serve them were adversely affected."

Today's action against BMS alleges unlawful maintenance of a monopoly in the manufacturing and sale of buspirone-hydrochloride-based prescription drug products. Since 1986, BMS has manufactured and sold BuSpar as a medication for treating patients suffering generalized anxiety disorders. In 2000 alone, BMS had over $700 million in sales of BuSpar.

BMS had a monopoly on buspirone by virtue of a patent that was obtained in the 1980s and then listed in the Food and Drug Administration (FDA) "Orange Book" in 1986. That patent was scheduled to expire on November 21, 2000 at midnight. The states allege that BMS unlawfully maintained its monopoly by improperly submitting a separate patent (the '365 patent) for listing in the FDA's Orange Book and by making misrepresentations to the FDA about the scope of the '365 patent.

As a result of its misconduct, BMS succeeded in getting the '365 patent listed in the FDA Orange Book. This, in turn, caused the FDA to withhold final approval of applications by other drug manufacturers to market generic versions of buspirone. As a result, consumers and government agencies lost cost savings that generic sales would have produced.

The states' lawsuit seeks a permanent injunction preventing BMS from listing the '365 patent in the FDA's Orange Book and damages and penalties. In addition, Oregon's claim seeks an injunction and civil penalties under the Oregon Antitrust Act.

Consumers wanting information on the BMS action may call the Attorney General's consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5576 (Portland area only) or toll-free at 1-877-877-9392. The Department of Justice is online at www.doj.state.or.us.


Jan Margosian, (503) 947-4333 (media line only) jan.margosian@doj.state.or.us |
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