Sanofi-Aventis SA and Bristol-Myers Squibb filed for a preliminary injunction against Apotex Inc . to stop sales of a generic version of Plavix® (clopidogrel bisulfate). The companies are seeking an immediate halt on the sale of Apotex’ generic drug as well as a recall of drug already shipped. In the filing, the companies cited four reasons the injunction should be issued, including the likelihood that they will prevail in the patent case and that Apotex’s launch last week is causing them irreparable harm.

The motion, filed in the U.S. District Court for the Southern District of New York, is set for a hearing on the motion on August 18, 2006. This is the court hearing the patent infringement suit, Sanofi-Synthelabo v. Apotex Inc., 2:02-cv-02255. The companies had to wait five days before they could file the motion under the terms of their earlier agreement in which Apotex agreed not to sell its generic. This follows the announcement by Apotex that it had launched a generic version of clopidogrel bisulfate at risk. The drug companies also have begun discounting Plavix.

Earlier, Apotex agreed to delay selling its drug in return for a minimum of $40-million from Bristol and Sanofi. In return, Apotex would be allowed to introduce its version of Plavix before the patent expired sometime in 2011. The deal between the drug companies was rejected by state attorneys general, who must approve arrangements between Bristol-Myers and generic drug makers as a result of earlier litigation.

Now, the U.S. Federal Trade Commission has initiated a criminal investigation by the Department of Justice. FBI agents have already confiscated documents at Bristol-Myers’ New York headquarters, and both companies received grand jury subpoenas to determine if the agreement broke antitrust laws.

Aspects of the agreement still in place protect Apotex by stating that Bristol-Myers and Sanofi wouldn’t seek a court order to prevent Apotex from selling the drug and would give Apotex five days’ notice before they sought a court ruling to halt sales once they started. In addition, they also agreed to limit how much Apotex would have to pay if it began selling the generic drug and then lost the patent suit. Under the revised settlement agreement, Bristol and Sanofi could collect damages limited to 40-50% of Apotex’s net sales of the generic drug. In addition, the companies waived their right to seek triple damages under applicable patent laws if they were to prevail in the pending patent litigation.

There’s not a lot of love lost. At an Aug. 4 hearing, Bristol-Myers lawyers said Apotex had a clear strategy to “derail this settlement negotiation” claiming that Apotex told regulators the companies had reached a “secret side agreement” in which Bristol-Myers pledged not to introduce its own authorized generic of Plavix in competition with Apotex, even though it had removed such a promise from the agreement.

While Sanofi could win the suit against Plavix generic, the failure of the parties to agree doesn’t bode well. It’s also telling that Sanofi and Bristol made a lot of concessions to settle the patent litigation. Apotex must feel fairly secure to start selling the generic at risk. I doubt they’ll be getting any good deals from the brand name drug makers any time soon, though.

See earlier posts from the Patent Baristas:

Apotex To Launch Generic Plavix At Its Own Risk
FTC Rejects Patent Deal by Bristol-Myers and Sanofi
Does Sanofi-Aventis Patent Settlement With Apotex Reveal a Trend?

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