PLAVIX PATENT SUIT AGAINST APOTEX WILL RESUME, SAYS SANOFI-AVENTIS
Patent litigation will recommence between sanofi-aventis, Bristol-Myers Squibb (BMS) and Apotex after state officials rejected a proposed patent settlement where Apotex would be paid to defer launching a generic version of the blockbuster blood thinner Plavix, sanofi-aventis said Aug. 2.
The settlement was proposed to resolve a patent lawsuit sanofi-aventis and BMS filed against Apotex in 2002 in the U.S. District Court for the Southern District of Ohio, after Apotex applied to market a generic version of the blood thinner Plavix (clopidogrel bisulfate). In March, the two companies offered to settle the litigation by paying Apotex at least $40 million to not launch its generic Plavix until the patent expired in mid-2011, an arrangement known as a reverse payment. Since Apotex was the first firm to successfully challenge the Plavix patent, no other company could sell a generic version before it does. BMS sells Plavix in the U.S. for French drugmaker sanofi-aventis.
Jean-Claude Leroy, executive vice president and CFO of sanofi-aventis, made the announcement during a conference call. The attorneys general of all 50 states rejected the proposal July 28, and the FTC continues to review the deal. Analysts said the companies were unlikely to revise the deal to make it more palatable to regulators, especially in light of the fact that they had already amended the agreement once after the FTC and state attorneys general turned down the original arrangement.
Leroy also refused to comment on the ongoing Department of Justice (DOJ) antitrust probe into the settlement. BMS announced July 26 that the DOJ was conducting a criminal investigation into the settlement. The following day, FBI agents searched BMS' headquarters in New York, seizing documents. Sanofi-aventis then revealed in a regulatory filing July 31 that it has received grand jury subpoenas in connection with the investigation.
Plavix had sales of $5.9 billion in 2005, according to IMS Health.