BMS to Plead Guilty in Plavix Patent Case

May 14, 2007

Bristol-Myers Squibb (BMS) announced it would plead guilty to two criminal charges for making false statements to a U.S. government agency about the company’s patent settlement for the blood thinner Plavix.

The plea is part of an agreement to resolve a criminal investigation conducted by the Antitrust Division of the U.S. Department of Justice (DOJ) into BMS’ attempt to settle a patent dispute with Apotex. The maximum fine for the charges is $1 million, according to BMS.

A former BMS “senior executive” made certain statements in May 2006 during renegotiations of the Plavix patent agreement that were not disclosed to the FTC, the company said.

BMS has been under investigation for its plan with partner sanofi-aventis to pay Apotex not to launch its generic version of Plavix (clopidogrel bisulfate) before the U.S. patent expires in September 2011. State regulators rejected the reverse-payment settlement, and Apotex sold its generic version for a year until a federal judge stopped the sales. BMS’ Chief Executive Peter Dolan and Senior Vice President Richard Willard were fired after the deal fell apart.

BMS said it advised prosecutors in the U.S. Attorney’s Office for the District of New Jersey of its guilty plea agreement. The attorney’s office plans to terminate its supervision of the company under a deferred prosecution agreement June 15, the company added. BMS made the agreement to resolve fraud charges saying company executives improperly reported $1.5 billion in revenue to mislead investors.