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Drug Maker Requests Taxol Case Intervention

Patents: Bristol-Myers could lose $2 billion in sales with release of generic version of cancer drug.


Bristol-Myers Squibb Co. opened a second front Monday in its effort to maintain a monopoly over sales of the cancer-fighting drug Taxol, asking a New York court to intervene in a case in which the giant pharmaceutical company faced an unfavorable ruling from the U.S. District Court in Los Angeles last week.

Bristol-Myers, which sells about $1 billion of Taxol annually in the U.S., asked the Southern District Court of New York to settle a dispute over whether a patent that American BioScience Inc. of Santa Monica claims covers certain dosages of Taxol should be listed in a federal registry of Taxol patents maintained by Bristol-Myers.

Bristol-Myers also said it had re-listed the American BioScience patent in the registry even though Judge William Matthew Byrne Jr. last week ordered Bristol-Myers to remove the patent.

Such a listing could block sales of a generic form of Taxol by Miami-based Ivax Corp. for up to 30 months while conflicting patent claims are litigated. The delay could give Bristol-Myers more than $2 billion of unhindered Taxol sales. Analysts expect the price of Taxol to drop rapidly after the Ivax version hits the market. It is used to treat breast and ovarian cancer.

Bristol-Myers said in a statement that its moves will "preserve the rights of the parties involved until the New York court determines Bristol-Myers Squibb's obligations in this matter."

The patent re-listing came as Federal Trade Commission investigators prepared subpoenas in a probe of whether Bristol-Myers and American BioScience have conspired to prop up the price of Taxol.

Also Monday, Ivax asked the Los Angeles court to hold American BioScience in contempt of court for ignoring the court order to remove its Taxol-related patent from the registry.

Instead of removing its patent, American BioScience sued Ivax for patent infringement. One target of the FTC probe is a proposed agreement between Bristol-Myers and American BioScience settling patent issues and establishing a licensing arrangement. Another focus of the investigation is the timing of the American BioScience patent, which came Aug. 1, just as Ivax was readying its drug for the market.

"Do these facts look suspicious enough to warrant an FTC investigation? The answer is yes," said Melvin Orlans, special litigation counsel with the FTC.

Ivax executives expressed continued frustration over the obstacles the company faces to produce a generic Taxol. The company already successfully defended a patent infringement lawsuit brought by Bristol-Myers but the litigation delayed Ivax sales by 30 months.

"The extent to which efforts have been undertaken to preserve Bristol-Myers' monopoly over Taxol, a drug discovered by the federal government with millions of taxpayer dollars, has reached a new level," said Neil Flanzraich, president of Ivax.

Flanzraich questioned why American BioScience did not file a patent infringement lawsuit against Bristol-Myers--which is actually selling the drug--rather than Ivax, which is still awaiting final federal approval to start marketing its version.

American BioScience attorney Joseph Coyne Jr. said the company will also sue Bristol-Myers if the two parties fail to reach a licensing pact.

Meanwhile, American BioScience appealed Byrne's ruling last week to the the U.S. 9th Circuit Court of Appeals.

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