APOTEX LAUNCH OF GENERIC PLAVIX MIRED IN LEGAL STRUGGLES
A Canadian court ruling that dismissed an appeal request by Apotex signals another defeat for the generic drugmaker in its efforts to market generic clopidogrel bisulfate.
Last week, the Canadian Federal Court of Appeals upheld a Federal Court of Canada ruling ordering the Health Ministry not to issue the company a notice of compliance with regard to selling generic Plavix.
In its appeal, the company had argued that it should be cleared to sell its generic version of the drug because the patent held by Bristol-Myers Squibb (BMS) and sanofi-aventis is not valid and not enforceable.
In the U.S., Apotex was hit with another legal defeat over generic clopidogrel bisulfate when the U.S. Court of Appeals for the Federal Circuit ruled in early December 2006 that the U.S. District Court for the Southern District of New York properly granted an injunction blocking ongoing sales of generic clopidogrel bisulfate. The appeals court ruled that the district court did not "abuse its discretion" in granting the injunction.
The appeals court in Washington upheld a ruling blocking sales until the trial, set to begin Jan. 22.
A proposed agreement between Apotex and BMS to ensure the generic version of Plavix would not be launched before the patent expires in 2011 collapsed in mid-2006, claiming the careers of two BMS executives. Apotex had launched a generic version of the drug Aug. 8, after a plan to delay competition had been rejected by state regulators.