A federal court filing provided new details yesterday about accusations that a Bristol-Myers Squibb executive entered a secret side deal with a generic drug maker in hopes of preserving the lucrative monopoly over the anticlotting drug Plavix.
Those accusations are thought to be the focus of a Justice Department investigation of Bristol-Myers and the French company Sanofi-Aventis, its marketing partner for Plavix.
The filing, made in Federal District Court in Manhattan by lawyers for the Canadian generic drug maker Apotex, asserts that Bristol-Myers made the secret agreement as part of a proposed settlement with Apotex of a patent lawsuit. The secret deal, Apotex asserts, was an effort to evade the scrutiny of the federal and state regulators who were reviewing the settlement.
Although the Food and Drug Administration approved Apotex’s generic version of Plavix earlier this year, the settlement would have delayed the introduction of the generic drug until 2011, several months before the Plavix patent is scheduled to expire.
Apotex’s filing asserts that Dr. Andrew G. Bodnar, a top assistant to Bristol-Myers’s chief executive, Peter R. Dolan, negotiated the secret deal after regulators objected to an earlier version of the patent settlement because it would have restricted competition.
The side deal, the filing said, contained two provisions that had been in the original version of the settlement agreement but that were not included when the companies formally submitted their revised version.
One provision called for Bristol-Myers and Sanofi to give Apotex a six-month head start to introduce its generic version of Plavix in 2011 before the two big companies would introduce their own generic, according to today’s court filing.
Under the other provision, Bristol-Myers and Sanofi would secretly give Apotex a $60 million fee that had been part of the original settlement agreement.
After regulators rejected the revised settlement agreement late last month, Apotex began shipping its generic version of Plavix, known as clopidogrel bisulfate. The company has flooded the United States market with millions of pills priced 10 to 20 percent below the $4-a-day price of brand-name Plavix.
Plavix, used to prevent the recurrence of heart attack and stroke, had United States sales last year of $3.5 billion and is one of Bristol-Myers’s top products. Worldwide, the Plavix franchise is worth more than $6 billion.
Apotex has said that it negotiated the settlement on the assumption that regulators would reject it, but conducted the discussions to win concessions from Bristol-Myers and Sanofi that have made it easier to introduce its generic drug in defiance of the big companies’ patent claims. It is unclear whether Apotex is a subject of the Justice Department investigation.
Yesterday’s filing was made ahead of a hearing scheduled for today in Federal District Court in Manhattan. There, Judge Sidney H. Stein is to consider a request by Bristol-Myers and Sanofi to block further sales of the generic drug until after a patent trial, now expected to begin in January.
Tony Plohoros, a Bristol-Myers spokesman, said yesterday that an internal investigation by the company’s outside lawyers had found no evidence of unlawful conduct by Bristol-Myers employees. The results of that review are being shared with the Justice Department, Mr. Plohoros said.
Dr. Bodnar has declined several requests for an interview.
In a hearing before Judge Stein earlier this month, a lawyer for Bristol and Sanofi asserted that Apotex’s chief executive, Bernard C. Sherman, had lied to the federal government about the secret agreement to sabotage the settlement agreement and clear the way for his company’s sales of the product.
Mr. Sherman has denied that accusation.
Apotex began challenging the Plavix patent four years ago. A trial on the merits of that patent was set to begin in June, but Bristol and Sanofi sought to avoid that trial and settle the case, fearing they might lose exclusive rights to sell the product.
In March, the parties reached the initial tentative settlement that the regulators rejected. That agreement’s measures included permitting Apotex to begin selling its generic in September 2011, two months before the patent’s expiration.
The parties agreed to revised terms in late May and resubmitted the agreement to state and federal authorities.
