Bristol-Myers Squibb has pleaded guilty to two counts in a US court of making false statements over a botched agreement with Sanofi-Aventis and Apotex designed to protect sales of its blockbuster blood thinner Plavix® (clopidogrel), and has agreed to pay a criminal fine of $1m.
According to the two-count criminal charge filed yesterday in the US District Court in Washington DC, last year BMS and Apotex were embroiled in a lawsuit over the validity of Plavix’s patent and were negotiating a settlement. At the time BMS was subject to a separate US 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’s. However, the US Department of Justice said BMS not only entered into such an agreement anyway, but also failed to disclose it and then lied about its existence to the FTC.
The head of the department’s anti-trust division, assistant attorney-general Thomas Barnett, commented: “BMS is charged with both lying to the Federal government and with taking steps to conceal its false statement – both serious felonies. The seriousness of the offences is compounded by the fact that BMS’s 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.”
However, BMS spokesman Tony Plohoros fought back. According to media reports, he claimed the firm’s position had been “mischaracterised”. Filing of criminal charges was “the next procedural step in completing our previously announced agreement to resolve the Federal anti-trust investigation. There are no new facts or issues.”
A date for the plea hearing is yet to be set.