LATEST NEWS

China’s Anti-Monopoly enforcement agencies named July 21, 2008
Commission cracks down on collecting societies July 21, 2008
eBay not responsible for policing counterfeits, says US court July 21, 2008
European Commission’s IPR strategy focuses on SMEs July 21, 2008
Musicians welcome plan to extend copyright term in Europe July 21, 2008
Payless ordered to stop using American Eagle brand July 21, 2008
Reform dominates list of 50 most influential people July 21, 2008
Taiwan ends compulsory licensing dispute with Philips July 21, 2008

This article is FREE access as part of MIP Week, a weekly email newsletter written by the editors of Managing Intellectual Property magazine. Take a two week trial to MIP and find many more related articles.

Drugs maker guilty over reverse payment deal

Emma Barraclough, London

Bristol-Myers Squibb is to plead guilty to criminal charges relating to making false statements to a government agency as part of a deal with the US Department of Justice

Bristol-Myers Squibb is to plead guilty to criminal charges relating to making false statements to a government agency as part of a deal with the US Department of Justice.

The admission will resolve a criminal investigation launched by the Justice Department into a proposed settlement deal between Bristol-Myers Squibb, its product partner Sanofi-aventis, and Canadian generics drug maker Apotex over the blockbuster anti-blood clotting drug Plavix.

In January 2006 Apotex won approval from the US Food and Drug Administration (FDA) to produce a generic version of Plavix called Clopidogrel. At the time the company was involved in patent litigation with Sanofi over the validity of the drug, which is marketed in the US by Bristol-Myers Squibb.

Because Apotex was the first to file with the FDA, it was entitled to 180 days of generic market exclusivity. But the three companies then negotiated a deal in which Apotex would delay generic competition to Plavix in return for a financial settlement. The litigation would also be dropped.

But a modified version of that so-called reverse payment deal was subsequently struck down by the States' Attorneys General in July last year on the ground that it was anti-competitive.

Bristol-Myers Squibb later fired chief executive Peter Dolan and general counsel Richard Willard over the botched deal. Now the company faces a fine of $1 million after pleading guilty to violating Section 1001 of US Code Title 18.

The charges relate to representations made by a former Bristol-Myers Squibb senior executive during the renegotiation of the proposed settlement agreement in May 2006 that were not disclosed to the US Federal Trade Commission.

The May issue of MIP includes an analysis of reverse payment deals, which looks at a bill tabled in Congress in February this year to ban reverse payment deals and examines whether the US Supreme Court will decide to review a case – In re: Tamoxifen citrate antitrust litigation (aka Joblove et al v Barr Labs and AstraZeneca Pharmaceuticals – on reverse payments.