Plavix patent settlement rejected

An out-of-court settlement allowing Canadian generics firm, Apotex, to produce a version of sanofi-aventis' and Bristol-Myers Squibb's (BMS) blood-thinning blockbuster, Plavix, has failed to receive antitrust clearance from state attorneys general.

The decision came on Friday (July 28), the day after BMS disclosed that the antitrust division of the US Department of Justice began a criminal investigation into the deal. FBI agents seized document from the Manhattan office of BMS chief executive, Peter Dolan, as part of the investigation.

Sanofi confirmed it had received grand jury subpoenas related to the investigation and said in a filing to the Securities and Exchange Commission (SEC) that it intends to provide all required information to investigators.

Under the proposed revised settlement, Apotex had agreed not to begin selling the generic version of Plavix until June 2011, almost a year before the maximum patent lifespan ends in mid-2012, in return for undisclosed compensation from BMS and sanofi.

It is understood that the criminal probe is centred on potential discrepancies between the written agreement filed to the Federal Trade Commission (FTC) for review, and an alleged secret verbal agreement reached between interested parties.

A decision by the FTC is still pending, although it is expected to reject the Plavix deal too, on the grounds that it will impact negatively on consumers.

The rejection of the settlement has cast a cloud over BMS' and sanofi's future outlooks, with some analysts warning that it could feasibly pave the way for Apotex to not only revive its court challenge of Plavix's patent but also to launch its generic version immediately.

However, analysts said such a move would be very risky for Apotex; under federal law, if a firm launches a generic version that is later found to have infringed a patent, it can be forced to pay the original manufacturer up to three times its lost sales.

Sanofi and BMS are already suing three other generic manufacturers for infringement of the Plavix patent, although only Apotex has come close to launching the drug.

BMS announced the agreement to settle the patent dispute with Apotex in March. Plavix is the world's second biggest selling drug with potential 2006 sales of $7bn. Analysts have warned that any generic competition to Plavix could potentially bite into half its market share within weeks of introduction.

BMS was involved in a major accounting scandal in 2002, related to accusations that it offered excess inventory to customers in order to reflect higher sales numbers, which resulted in the firm having to significantly restate revenues for the period 1999-2001. BMS settled with the Justice Department and the SEC by agreeing to pay $150m.