Bristol-Myers accused of fraud in Taxol strategy
Bristol-Myers accused of fraud in Taxol strategy
The state attorneys general of 29 states have filed suit in federal district court, alleging that drug manufacturing giant Bristol-Myers Squibb and a small California drug company, American BioScience, illegally conspired to keep generic forms of the popular cancer drug, Taxol, off the market.
Taxol, known generically as paclitaxel, was developed by government scientists at the National Cancer Institute. The government later granted Bristol-Myers Squibb the exclusive right to sell the drug in the United States for five years, beginning in 1992 when the U.S. Food and Drug Administration approved it.
The states’ lawsuit contends Bristol-Myers illegally extended the five-year period by fraudulently obtaining two patents on the drug from the U.S. Patent and Trademark Office. Because it was developed with public funds, Taxol itself cannot be patented, but specific delivery methods can.
The lawsuit alleges that the company misused the patents to keep generic companies from selling cheaper versions of the drug.
When that strategy failed, the plaintiffs claim, the company colluded with American Bioscience, which had obtained its own patent on a generic version of the drug.
Company sued to file patent info with feds
In September 2000, American Bioscience sued Bristol-Myers to force the company to file information about its patent with federal regulators. In keeping with U.S. patent law, this litigation prevented any generic company from selling its own version of Taxol for up to 30 more months.
The states now contend the last lawsuit was a sham designed to protect Bristol-Myers’ exclusivity rights to market the medication. The Federal Trade Commission is currently investigating the relationship between Bristol-Myers and American BioScience to determine whether they were working together, the lawsuit claims.
This is not the first time that states have sued Bristol-Myers. A lawsuit currently is under way alleging that the company also acted illegally to extend its patent on the antianxiety drug BuSpar.
Consumer groups have long criticized pharmaceutical companies’ aggressive tactics in acting to extend the life of patents on drugs past their original expiration date.
"If they [the states] win, it will put up a big, strong, bright warning light to other companies that think it’s in their best interest — and in the best interest of their shareholders — to use any means necessary to extend their patents," Cynthia A. Pearson, executive director of the National Women’s Health Network, told The New York Times in reaction to suit. "This trend has escalated to the point where consumers are being gouged."
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