WASHINGTON (AP) - The Food and Drug Administration was wrong to approve a generic version of the breast cancer drug Taxol, a federal appeals court said Tuesday, ordering that the generic drug be pulled from the market.
The order had not yet trickled down to the FDA, and the generic drug maker plans an appeal, so it is unclear if or when cancer patients would lose access to the cheaper version.
Taxol is one of the most widely used treatments for breast and ovarian cancer and earns manufacturer Bristol-Myers Squibb Co. more than $1 billion in U.S. sales each year.
Ivax Corp. of Miami has been selling its generic version of Taxol, called paclitaxel, for just over a year.
It was approved by the FDA despite objections from a third company, American Bioscience Inc., which claims it holds a patent that covers the methods by which the drug is administered. If ABI's patent is valid, then Ivax could be forced to negotiate with ABI for the right to manufacture the drug.
Under federal law, the FDA cannot approve generic drugs if there are valid patent claims. Bristol-Myers Squibb's patent has expired, but ABI says it has a claim on the drug, too, and says that claim is still in force.
The FDA argued that ABI's patent claim was not filed on time and therefore is not valid. But after analyzing the complex regulatory law, the judges disagreed and said the FDA was wrong to ignore the claim.
"We are convinced that the FDA's order, in this case, was arbitrary and capricious and must be vacated," wrote Judge Laurence Silberman for a three-judge panel of the U.S. Court of Appeals.
Specifically, the order instructs the district court to order the FDA to rescind its approval, but that hasn't happened yet.
Ivax said it would ask the full appeals court to reconsider Tuesday's ruling.
Separately, in a California court, Ivax is arguing that on its scientific merits, ABI's patent claim itself is not valid. That question was not before the appeals courts in Washington.
In the last year, the FDA has approved two other generic forms of Taxol. While the court's action does not directly affect them, the FDA used the same reasoning in approving those applications.
Ivax President Neil Flanzraich would not say how much his company charges for its version of the drug but said it was 30 to 40 percent less than Taxol, which can cost $5,000 to $7,000 per person. He said the court's action would hurt consumers.
"There are thousands and thousands of women suffering from breast and ovarian cancer who need this product and can't afford the monopoly prices the brand company charges," Flanzraich said. "We feel we are fighting this battle in the public interest."
ABI attorney Arthur Tsien countered by noting that the law governing approval of generic drugs tries to balance the interests of consumers who want cheaper drugs with those of drug companies, which will not invest the money to create new drugs if they cannot sell them at a profit.
"Without intellectual property rights there wouldn't be the kind of innovation that leads to products like Taxol and without that there would be nothing for them to copy," Tsien said.
Taxol was discovered by the taxpayer-funded National Cancer Institute, which licensed the drug to Bristol-Myers. First approved in 1992 as second-line therapy for advanced ovarian or breast cancer, Taxol today is used against AIDS-related Kaposi's sarcoma and lung cancer as well.
Shares of Bristol-Myers Squibb closed Tuesday at $55.76, up $2.49 or 4.7 percent on the New York Stock Exchange. Ivax shares closed at $17, down $2.15 or 11 percent.