TAXOL: Judge Refuses to Extend Patent Protection
In a "sharp setback" for drug giant Bristol-Myers Squibb, a federal district court judge issued a ruling yesterday that could pave the way for the introduction of a generic form of the pharmaceutical company's blockbuster antibreast cancer drug Taxol, the Wall Street Journal reports. The decision means that Miami-based generic manufacturer Ivax Corp. may market its version of paclitaxel, the chemical name for the drug (Hensley, 9/7). Litigation began last month when the small biotech firm American BioScience was issued a Taxol-related patent and reached an agreement with Bristol-Myers to list the patent with the FDA. The deal, which would have granted Bristol-Myers an additional 30 months of patent protection, was opposed by Ivax. In yesterday's ruling, the judge declined to "make permanent a temporary restraining order" that could have blocked the release of generic Taxol for 30 months, arguing that the court did not have jurisdiction in the matter ( AP/Ft. Worth Star-Telegram, 9/6). The Wall Street Journal reports that, in a separate development, the FTC has begun an investigation to examine possible "anticompetitive conduct" by Bristol-Myers and American BioScience concerning Taxol. A hearing is scheduled for today to determine whether to keep the patent listed pending an appeal (9/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.