IVAX Court News:
VAX says court order could let it sell generic Taxol
NEW YORK, Sept 6 (Reuters) - IVAX Corp (AMEX: IVX) said a California federal judge issued a ruling on Wednesday
that could allow the Miami firm to soon begin selling a generic version of Bristol-Myers Squibb Co's (NYSE: BMY)
blockbuster cancer drug, Taxol.
IVAX last month received tentative approval from the U.S. Food and Drug Administration to begin marketing its copycat
version of Taxol, the world's biggest-selling cancer drug whose chemical name is paclitaxel.
The FDA go-ahead, however, was contingent on IVAX resolving a patent dispute between the company and two other
drugmakers -- privately held American BioScience Inc. (ABI), which had obtained a U.S. patent relating to dosage forms of
paclitaxel, and Bristol-Myers.
Los Angeles U.S. District Court Judge William Bryne last month ordered Bristol-Myers to register ABI's patent in the FDA's so-called Orange Book, which lists patents relating to already marketed medicines. With its patent registered in the Orange Book, ABI buttressed its jurisdiction to file a patent infringement suit against IVAX or any other companies intending to sell generic paclitaxel. Once a product lands in the Orange Book, the FDA typically refuses to approve generic rivals to that product for up to 30 months, in order to let patent disputes make their way through the courts.
Jordan Siegel, an IVAX spokesman, said Judge Bryne vacated his earlier order late Wednesday by ruling he did not in fact have jurisdiction over the matter, and ordered that the ABI patent be removed from the Orange Book. Consequently, barring an appeal, Siegel said IVAX planned to soon begin selling generic paclitaxel once the FDA gives it final marketing approval. |
