Bristol-Myers Squibb Company has pleaded guilty to two counts of violating 18 U S C Sec. 1001 in US district court for the district of Columbia. This guilty plea resolved as to the company the previously disclosed investigation by the Antitrust Division of the US department of justice into the proposed settlement of the Plavix patent litigation with Apotex Inc., and Apotex Corp. (Apotex). As a result of the plea, the company will pay a fine of $1 million.
The company acknowledged that a former Bristol-Myers Squibb senior executive made oral representations to Apotex for the purpose of causing Apotex to conclude that the company would not launch an authorized generic in the event that the parties reached a final revised settlement agreement.
Those representations included the former senior executive's statement that he expected to oppose personally the launch of an authorized generic in the future, his statement that he expected to advocate against such a launch, and his implied suggestion that the company's former CEO shared his views. The failure to disclose this information to the Federal Trade Commission (FTC) in connection with the FTC's review of the revised settlement agreement operated as incomplete and therefore false statements to the FTC. The company acknowledged in court its responsibility for the conduct of the former senior officer.
The company continues to believe that there was no "side agreement" with Apotex not to launch an authorized generic version of Plavix. The impact of the plea on the previously disclosed investigations by the FTC and the New York State Attorney General into the proposed Plavix patent settlement cannot be predicted.