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Former Bristol-Myers Exec Lied About Plavix Deal, Feds Say

A former Bristol-Myers Squibb Co. executive lied to government regulators about a secret part of his company's 2006 settlement of a patent infringement lawsuit against a rival drugmaker, according to a federal court indictment.

Andrew Bodnar is charged with violating federal law when he submitted documents to the Federal Trade Commission indicating that Bristol-Myers made no oral promises to Apotex Inc. as part of the deal, which involved the Bristol-Myers blood thinner Plavix.

But prosecutors say Bodnar did make such a promise to representatives of the Canadian generics manufacturer, according to the indictment, filed in the U.S. District Court for the District of Columbia.

Bodnar, once a senior vice president of Bristol-Myers, faces five years in jail and a $250,000 fine if convicted.

The company filed a patent infringement suit against Apotex in 2002 shortly after Apotex requested Food and Drug Administration approval to sell its own Plavix generic.

Prosecutors allege that Bodnar told Apotex officials during a 2006 settlement meeting that Bristol-Myers would not launch its own "authorized" generic version of Plavix to compete with Apotex's generic offering if Apotex stalled the release of its product until September 2011, two months before Bristol-Myers' Plavix patent expires.

At time of the settlement, Bristol-Myers was operating under a consent decree compelling it to provide the FTC with copies of any pending patent infringement settlements with generic-drug makers so the agency could look for any anticompetitive provisions.

In early 2006 Bodnar submitted certificates to the FTC on behalf of Bristol-Myers and Sanofi-Synthelabo Inc., which jointly holds the Plavix patent, according to the indictment.

The certificates said Bristol-Myers and Sanofi did not make any oral or private agreements outside the written language of the settlement contract.

At the same time, however, Apotex gave the FTC a copy of the agreement along with a letter that prosecutors say disclosed "certain oral agreements" reached between Apotex and Bristol-Myers regarding the deal.

According to the Justice Department, the Apotex letter said an oral accord was reached under which Bristol-Myers pledged not to market its own generic version of Plavix during a six-month period granted to Apotex for the exclusive sale of its generic.

The indictment says Bodnar knew his statements about private agreements were false when he submitted the certificates to the FTC.

In June 2007 Bristol-Myers agreed to plead guilty and pay a $1 million criminal fine, the maximum fine allowed, for misleading the FTC about the Plavix patent deal.

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