Developer of Cancer Drug Sues the FDA.

Santa Monica-based American BioScience Inc., owner of a patent on Bristol-Myers Squibb Co.'s cancer-treatment drug Taxol, has sued the U.S. Food and Drug Administration for the second time over its approval of Ivax Corp.'s generic version of the drug.

American BioScience is asking a judge to make the FDA accept Bristol-Myers' latest application to list an American BioScience patent on Taxol.

Listing the patent with the regulatory agency would effectively delay Ivax's introduction of a generic version of Taxol, which won FDA approval earlier this month.

American BioScience contends the FDA approval contradicts a decision last month by a federal judge in Los Angeles recommending that the FDA allow Bristol-Myers to list the patent again.

"Ignoring a federal judge's recommendation is unheard of," said Joseph Coyne Jr., American BioScience's attorney. "The FDA rejected his recommendation without a moment's thought."

The new lawsuit filed Oct. 16 brings the legal battle back where it al began several months ago: U.S. District Court in Los Angeles. Bristol-Myers, Ivax and American BioScience also are fighting in federal courts in New York and Washington and in a Florida state court, with the FDA named as a defendant in the Washington suit.

The stakes are high, as Taxol generates more than $1 billion in annual sales for Bristol-Myers. Competition could substantially erode Taxol sales, while boosting Ivax's fortunes.

By filing suit in California, Bristol-Myers seeks to block the impact of a preliminary court decision earlier this month in Washington, which gave Ivax a green light to begin marketing is generic version of Taxol. U.S. District Judge Colleen Kollar-Kotelly's ruling upheld the FDA's approval of the drug.

Listing the patent with the FDA would delay Ivax from marketing its generic drug, because the company would be required to prove to regulators that its product does not infringe on any patents filed with the agency. Once the U.S. Patent and Trademark Office issues a drug patent on the drug, the holder has 30 days to file it with the FDA.

U.S. District Judge William Matthew Byrne Jr. in Los Angeles last month reversed a previous decision, ordering that the patent be de-listed. At the same time, Byrne suggested that the FDA allow the patent to be listed again if Bristol-Myers filed a new application after his order was lifted, Coyne says.

Bristol-Myers sent the FDA a letter on Sept. 11 -- before Byrne's order took effect -- and the agency interpreted that letter as a new listing of the American BioScience patent. The FDA said the second listing did not come with the 30-day deadline. American BioScience is seeking a judge's order that the FDA consider the application as timely.

Ivax sued Oct. 2 in a Florida state court, alleging Bristol-Myers and American BioScience violated the state's antitrust and unfair trade practices laws and have committed fraud. The suit accuses Bristol-Myers and American BioScience of posing as adversaries while conspiring to block Ivax's generic Taxol from winning regulatory approval.