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Group Of State Attorneys General Reject Proposed Settlement From Bristol Myers Squibb Over Plavix Patent


State attorneys general on Friday rejected a settlement that Bristol-Myers Squibb and Sanofi-Aventis reached with Apotex to delay market entry of a generic version of the blood thinner Plavix, the Wall Street Journal reports (Carreyrou, Wall Street Journal, 7/29). FDA in January approved a generic version of Plavix manufactured by Apotex. In response, BMS, which markets Plavix in the U.S., and Sanofi, which markets the medication abroad, filed a lawsuit against Apotex to block market entry of the generic version of the treatment on the grounds that their patent does not expire until 2012. BMS and Sanofi earlier this year reached a settlement with Apotex under which they agreed to pay at least $40 million in exchange for a delay of the market entry of the generic version of Plavix until June 2011. The settlement would have protected at least $30 billion in revenue for BMS and Sanofi over the next five years. The settlement, which last week became the subject of a Department of Justice criminal antitrust investigation, required approval from the Federal Trade Commission and state attorneys general (Kaiser Daily Health Policy Report, 7/28). In a letter to BMS attorneys, the assistant Maryland attorney general wrote that a number of states "object to and will not approve" the settlement. FTC "is all but certain to follow the attorneys general and reject" the settlement, the Trenton Times reports (Jordan, Trenton Times, 7/29). BMS and Sanofi last week said that they would resume their lawsuit against Apotex in the event that the state attorneys general rejected the settlement. According to the Journal, the rejection of the settlement by state attorneys general marks an "increasing regulatory crackdown against such agreements," which "have proliferated in the past few years" (Wall Street Journal, 7/29).

Reaction

BMS and Sanofi in a statement said that they cannot "reasonably assess the outcome of the Plavix litigation, including the Apotex matter, or the timing of potential generic competition for Plavix." Tim Anderson, an analyst for Prudential Financial, said in a research note, "It is unclear whether ... the companies will even consider pursuing a new agreement given the negative PR they would likely have to endure." Anderson added, "It is possible that this ruling could have a chilling effect on other pending patent challenge settlements" (Trenton Times, 7/29).

Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.