Bristol-Myers Squibb has held up it hands and pleaded guilty to two counts of making false statements over a botched agreement with Sanofi-Aventis and Apotex designed to protect sales of its blockbuster blood thinner Plavix, and has agreed to pay a criminal fine of $1 million.

According to the two-count criminal charge filed yesterday in the US District Court in Washington, last year, BMS and Apotex were embroiled in a lawsuit over the validity of Plavix’ (clopidogrel) patent, and were negotiating a settlement. At the time, BMS was subject to a separate Federal Trade Commission investigation that required the group to submit any proposed patent settlements for review. The FTC warned BMS that it would not allow a settlement of the Plavix litigation if, as part of it, the company agreed to hold back an authorised generic that would rival Apotex’. But after entering into such an agreement anyway, BMS then not only failed to disclose it but also lied about its existence to the FTC, the US Department of Justice said.

’Serious’ offences

“BMS is charged with both lying to the federal government and with taking steps to conceal its false statement – both serious felonies," said Thomas Barnett, Assistant Attorney General in charge of the Department's Antitrust Division. "The seriousness of the offences is compounded by the fact that BMS' obstructive conduct occurred in connection with the FTC's review of a proposed patent settlement affecting the cost of a lifesaving drug sold to tens of millions of Americans," he added.

“Our position on this has been mischaracterised,” commented B-MS spokesman Tony Plohoros. The filing of criminal charges is “the next procedural step in completing our previously announced agreement to resolve the federal antitrust investigation. There are no new facts or issues,” he said, according to media reports.

A date for the plea hearing is yet to be set.