Attorneys General from 29 States Sue Bristol-Myers Squibb Over Delays on Generic Competition

Attorneys general from 29 states yesterday filed suit against Bristol-Myers Squibb Co., alleging that the pharmaceutical company made "knowing, willful and fraudulent material misrepresentation" on patent applications for the cancer treatment Taxol to delay generic competition, the Wall Street Journal reports (Harris, Wall Street Journal, 6/5). According to the lawsuit, filed in Federal District Court in Washington, D.C., the government developed Taxol at a cost of more than $32 million and awarded Bristol-Myers exclusive marketing rights to the treatment for five years when the FDA approved the drug in December 1992. The lawsuit alleges that Bristol-Myers "illegally extended the five-year period by fraudulently obtaining two patents" on the delivery method of Taxol from the U.S. Patent and Trademark Office to prevent generic companies from "selling a lower-priced version" of the drug (Petersen/Walsh, New York Times, 6/5). Bristol-Myers filed for the patents, which delayed generic competition on Taxol until October 2000, based on a study that found the treatment "could be given during three-hour infusions instead of a more taxing 24-hour infusion," the Journal reports. However, according to the lawsuit, the three-hour infusion "had long been known," but Bristol-Myers did not "disclose to the patent office an earlier study proving three-hour infusions treatment worked" (Wall Street Journal, 6/5).

The lawsuit also alleges that Bristol-Myers colluded with American Bioscience Inc. to delay generic competition on Taxol. In September 2000, with the Taxol patents about to expire, American BioScience sued Bristol-Myers and demanded that the company file information about the patents with the FDA, a move that would "effectively bar any generic companies from selling their own versions of Taxol" for up to 30 months. However, according to the lawsuit, American BioScience's case against Bristol-Myers "was a 'sham' aimed only at delaying the sale" of generic versions of Taxol. The Federal Trade Commission has launched an investigation into the issue, the Times reports (New York Times, 6/5). According to the lawsuit, the moves allowed Bristol-Myers to extend the company's exclusivity period for Taxol by about three years, earning about $5 billion in additional sales (Ulferts, St. Petersburg Times, 6/5).

The lawsuit alleges that the delays in introducing generic competition for Taxol have forced hospitals, cancer patients and states to pay 30% more for the treatment (AP/Boston Globe, 6/5). The Times reports that Taxol can cost up to $10,000 for a course of treatment that may last several months. The lawsuit seeks to "recoup the extra money" that state governments spent on the treatment between December 1997, when Bristol-Myers' five-year exclusivity period from the government ended, and April 2001, when several companies began to market generic versions of the drug (New York Times, 6/5). The lawsuit accuses the company of antitrust violations, "meaning Bristol-Myers could be subject to triple actual damages" (Wall Street Journal, 6/5). New York Attorney General Eliot Spitzer (D) said, "We cannot tolerate anticompetitive and deceptive practices that allow drug companies to fatten their bottom lines illegally at the expense of people who depend on this drug." Bristol-Myers said that the company plans to fight the lawsuit (New York Times, 6/5). "We will continue to deal with the issues raised by this new suit as we have been doing with other litigation related to these matters," Bristol-Myers spokesperson Bob Laverty said (Wall Street Journal, 6/5).