Federal Circuit Denies Apotex's Request to Stay Preliminary Injunction on Generic Plavix Sales, and Sets Expedited Schedule for Appeal

Sanofi-Aventis and Bristol-Myers Squibb announced in a press release today that the Court of Appeals for the Federal Circuit has refused Apotex's motion to stay the preliminary injunction against Apotex's sales of its generic version of Plavix.  Additionally, the CAFC established an expedited schedule for Apotex's appeal of the preliminary injunction order, with oral argument set for October 31, 2006.

Here's a brief history of the case:

• July 11, 1989:  Sanofi is awarded U.S. Patent No. 4,847,265 on clopidrogel bisulfate, the active ingredient of Plavix;
• November, 1997:  FDA approves Plavix for the prevention of heart attack and stroke;
• November, 2001:  Apotex files ANDA for clopidrogel bisulfate, ten years before the '265 patent will expire;
• March 21, 2002:  S-A and BMS (Sanofi's marketing partner for Plavix in the U.S.) file a patent infringement suit against Apotex; Apotex counters that the '265 patent is invalid as anticipated and obvious, as well as unenforceable;
• January, 2006:  the parties reach a preliminary settlement of the patent litigation;
• January 20, 2006:  FDA approves Apotex's ANDA;
• July 28, 2006:  state attorneys general reject the final settlement agreement;
• August 8, 2006:  Apotex launches its generic Plavix product;
• August 15, 2006:  S-A and BMS file motion for preliminary injunction;
• August 31, 2006:  In a 58-page opinion, S.D.N.Y grants motion for preliminary injunction;
• September 1, 2006:  S.D.N.Y. denies Apotex's motion to stay preliminary injunction;
• September, 2006:  Apotex appeals to CAFC and files motion to stay preliminary injunction;
• September 20, 2006:  CAFC denies Apotex's motion to stay; sets expedited appeal schedule.

Plavix, which is taken daily by 48 million Americans, had annual global sales of nearly $6 billion before Apotex launched its generic version last month.  According to published reports, Apotex had sold wholesalers over a year's supply of its generic Plavix before its sales were halted by the preliminary injunction.  The wholesalers are allowed to sell the generic Plavix they already have in stock while Apotex's appeal is pending.