The US Dept. of Justice (DOJ) Wednesday said that Bristol-Myers Squibb (BMS) has entered guilty pleas to two counts of making false statements to a government agency and will pay the maximum $1 million criminal fine for lying about its Plavix deal with Canadian generics drugmaker Apotex.
The pleas had been expected and bring to a close the DOJ’s investigation into the botched pact last year between the drug makers.
Apotex had sued to have Plavix’s patents declared invalid in order to release a generic version of the blockbuster blood-thinner. The case was heard in January, with a decision still pending.
According to the DOJ, BMS was required to have any patent-settlement agreements reviewed beforehand by the FTC, according to the terms of a previous settlement reached between the drugmaker and federal authorities in a separate investigation.
“The FTC warned BMS that it would not approve a settlement of the Plavix litigation if BMS agreed not to launch its own generic version of Plavix that would compete against Apotex for generic sales,” the DOJ said in a statement. “After nevertheless entering into such an agreement, BMS concealed it from and then lied about its existence to the FTC,” the DOJ added.
BMS markets Plavix, which had 2005 sales of $5.9 billion, with French drugmaker Sanofi-Aventis.
Last year, BMS CEO Peter Dolan was dismissed by the company’s board of directors after New York State and federal authorities questioned the company’s dealings with Apotex over Plavix. Board member James Cornelius, who formerly headed Guidant Corporation, was named CEO earlier this year.