Seattle - Attorney General Christine Gregoire today announced settlements -- one in principle -- with drug maker Bristol-Myers Squibb, which was accused of illegally trying to extend exclusive rights to two widely prescribed medications.
The two cases, which represent a combined value of $155 million, involve the company's attempts to keep less expensive, generic versions of the anti-anxiety drug BuSpar and the cancer medication Taxol off the market.
Nationally, the BuSpar settlement, which was finalized today, is worth $100 million. The tentative Taxol settlement is worth $55 million and should be finalized within a few weeks.
"This company tried to manipulate patent laws to keep a less expensive alternative drugs off the market," said Gregoire. "A license to manufacture prescription drugs is not a license to engage in unfair market manipulation - especially at the expense of people who depend on these products."
Under the BuSpar settlement, an estimated 10,000 Washington consumers will share about $800,000 in direct restitution and state agencies and programs will receive about $2 million. Those agencies and programs include Medicaid, the Uniform Medical Plan, the University of Washington and Harborview hospitals and various state mental facilities
In the Taxol case, Washington will receive approximately $1.1 million. Of that amount, about 3,000 consumers will share approximately $265,000. State agencies will get about $790,000. The remainder will go to administrative costs.
In the BuSpar case, the company was originally sued by 29 states for knowingly making false statements to the Food and Drug Administration (FDA) to obtain a new patent that granted the company an extension of its exclusive and lucrative hold on the market.
Washington joined that lawsuit last May.
Experts estimate that the wholesale price of BuSpar went from $62.48 per 100-tablet supply to $16.67 per 100-tablet supply after the generic entered the market.
Last June, Washington and 37 other states accused the company of making a fraudulent application to extend its patent on Taxol, which is used to treat ovarian, breast and a variety of other cancers.
The taxpayer-financed National Cancer Institute originally developed Taxol, but Bristol-Myers Squibb was given the rights to develop and market the drug.
Attorneys General claimed that the company illegally conspired with a smaller drug company to obtain an additional patent on the drug filed with the Federal Food and Drug Administration.
As a result, a lower-priced version of the cancer medicine was unavailable to patients and various state agencies from December 1997 to April 2001.
Aside from the monetary award in the settlement, Bristol-Myers Squibb also agreed to:
- Take no further actions relating to patents covering either drug;
- Not provide false or misleading information to U.S. patent officials or the FDA;
- Notify state and federal officials when it applies for a new patent or acquires an existing patent for other drugs from another party; and
- Not apply for certain other patents if they would unreasonably delay the entry of generic competitors onto the market.
In the Taxol settlement, the company is also required to provide the drug free of charge to certain indigent cancer patients.
The states will issue further information on how consumers can file claims for restitution in both cases within the next several months.
For more information on the BuSpar settlement, visit http://www.busparsettlement.com.