Judge denies Plavix injunction stay
PHILADELPHIA --A federal judge has denied Apotex Inc.'s request for a postponement of his order last week to halt the company's sales of a generic version of the heart drug Plavix.
Apotex, of Weston, Ontario, on Friday had asked U.S. Judge Sidney Stein to postpone the injunction he issued Thursday, pending the outcome of Apotex's appeal of the injunction to a higher court. Stein denied the request Friday; the denial was entered into the court docket Tuesday.
Apotex plans to appeal the injunction to the U.S. Court of Appeals for the Federal Circuit in Washington.
Apotex claims it raised "substantial questions" about the validity of a U.S. patent for Plavix held by Sanofi-Aventis of France. Sanofi and New York-based Bristol-Myers Squibb Co. co-market Plavix, a blockbuster blood-thinning drug.
Stein on Thursday granted an injunction halting Apotex's sales of a generic version of Plavix, which Apotex had been selling since Aug. 8. Stein essentially concluded that Apotex hadn't raised substantial questions about the validity of the Plavix patent, which expires in 2011.
Stein did, however, decline a request by Sanofi and Bristol to order a recall of generic Plavix already shipped. Apotex, Sanofi and Bristol are locked in patent litigation over Plavix, and a trial is set for January.
Now that Stein has rejected Apotex's request for a stay of the injunction, the company likely will file an emergency motion with the Court of Appeals for the Federal Circuit to stay the injunction pending the appeal. It would also file the actual appeal with the same appeals court.
On the New York Stock Exchange, Bristol-Myers shares fell 17 cents to close at $22.78 Tuesday, after the drug company lowered 2006 earnings forecast in the wake of the generic challenge to Plavix.
Although sales of generic Plavix were halted, enough copycat pills were shipped to distributors that they will put price pressure on branded Plavix for weeks or months to come.
Bristol late Friday lowered its 2006 earnings forecast to no less than 95 cents a share from a previous range of $1.15 to $1.25 a share.
Sanofi-Aventis similarly reduced its 2006 earnings growth forecast last week. The company's NYSE-traded American depositary shares fell 58 cents, or 1.3 percent, to close at $44.79 Tuesday.
