IVAX says generic Taxol closer as court spurns petition:
By Ransdell Pierson
NEW YORK, Sept 14 (Reuters) - IVAX Corp. (AMEX: IVX) said a federal appeals court in San Francisco has denied a petition from American BioScience Inc. (ABI) that threatened to delay IVAX's plans to sell a generic form of Taxol, the world's best-selling cancer drug.
Late on Wednesday IVAX hailed the refusal by the U.S. Ninth Circuit Court of Appeals to stay a favorable earlier decision by Los Angeles U.S. District Court Judge William Byrne, saying it put IVAX a step closer to launching its copycat version of Taxol in the United States.
Nevertheless, IVAX' patent dispute with ABI and New York drug giant Bristol-Myers Squibb Co. (NYSE: BMY) over Taxol remains alive because the tangled matter is also before a New York court.
"We feel the New York case is frivolous and we're going to seek to dismiss it," IVAX spokesman Jordan Siegel said in an interview on Thursday. He alleged that privately held ABI, of Santa Monica, Calif., and Bristol-Myers lost in the California courts and are now seeking to retry the case in a friendlier New York courthouse.
Neither American BioScience nor Bristol-Myers could be reached for comment.
Taxol is sold by Bristol-Myers for treatment of breast and ovarian cancer. Launched by the No. 3 U.S. drugmaker in 1993, it had annual global sales of $1.5 billion, including $1 billion in the United States.
IVAX last month received tentative approval from U.S. regulators to begin marketing a generic form of Taxol, but the FDA nod was contingent on Ivax resolving its ongoing patent battle with both Bristol-Myers and ABI.
Miami-based IVAX has been battling Bristol-Myers in the courts for several years to sell generic paclitaxel, the chemical name for Taxol. IVAX thought it was home free in March when a Newark federal judge invalidated key provisions of patents protecting Taxol.
But seemingly out of nowhere, tiny ABI entered the fray Aug. 11 by filing suit in U.S. District Court in Los Angeles alleging that Bristol-Myers had violated one of ABI's own patents related to dosing of Taxol.
ABI sued Bristol-Myers, even though a month earlier it had granted the drug giant an option to a nonexclusive license on ABI's patent.
Byrne then ordered Bristol-Myers to list the ABI patent in the so-called Orange Book kept by the U.S. Food and Drug Administration, which lists patents related to already marketed drugs.
Once a patent is listed there, the FDA is forbidden for 30 months to approve any generic drug which might interfere with the patent, a policy meant to give competing parties time to complete their court battles.
Although ABI sued Bristol-Myers, the Orange Book listing actually helped both companies because it forestalls IVAX and other companies from introducing generic paclitaxel.
Things swang back to IVAX' favor on Sept. 6, when Byrne ruled that he, in fact, had never had jurisdiction in the case and ordered Bristol-Myers to de-list the patent from the Orange Book.
But the judge stayed his decision until the close of business on Wednesday in order to give ABI and Bristol-Myers time to appeal his decision to the Ninth Circuit.
Late last night, IVAX said the federal appellate court indeed declined to undo Byrne's decision.
"The appellate court's decision means the federal court order requiring Bristol-Myers to use its best efforts to de-list the American BioScience patent from the Orange Book is now effective," Neil Flanzraich, president of IVAX, said in a statement.
Another hurdle remains for IVAX, however, namely an action filed by Bristol-Myers on Sept. 11 in the U.S. District Court for the Southern District which asks the Manhattan court to settle the patent wrangle.
"We don't know what the New York court will do, but the (Los Angeles) court order is in effect and the ABI patent must be de-listed. I don't think Bristol-Myers would ignore a federal judge's order," Siegel added.
Bristol-Myers earlier this week said it had actually filed the ABI patent a second time in the Orange Book to preserve its rights and those of ABI.
Shares of IVAX edged up 3/8 to $41-1/4 in afternoon trade on the American Stock Exchange. Bristol-Myers was up 15/16 to $53-3/16. |
