Sanofi-Aventis and Bristol-Myers Squibb said yesterday that a US federal court had denied a motion by rival Apotex to set aside the August 31 injunction ordering it to halt sales of a generic version of blood thinner Plavix.
The US Court of Appeals for the Federal Circuit has now scheduled oral arguments for the appeal of the preliminary injunction for October 31, and in the meantime B-MS is free to sell Plavix without competition from its generic rival.
Apotex launched its generic version of Plavix on August 8, after US lawmakers invalidated a sweetheart deal, signed with B-MS, which sought to keep the copycat version off the market until 2011.
B-MS and partner Sanofi-Aventis promptly sued for patent infringement and secured an injunction against sales of the generic, but not before Apotex had flooded the US market with its clopidogrel product, claiming that the terms of its deal with B-MS actually protected itself from a large measure of the potential liability it faces should it eventually lose the lawsuit.
Both Sanofi and B-MS have had to scale down their financial forecasts for 2006 as a result, and the debacle led to the sacking of B-MS chief executive Peter Dolan and general counsel Richard Willard.
Apotex’ appeal questions the validity of a US patent for Plavix owned Sanofi. The Canadian firm has scored one victory, in that it moved forward the hearing on the injunction by several weeks.
Now, if it wins out in the October 31 hearing, Apotex could re-launch its products ahead of the patent infringement trial, which is due to start in January 2007.