Although the US and French drugmakers stressed from the moment they unveiled the agreement in March that their settlement with Apotex could be rejected by regulators, submission of a modified agreement that appears to be only slightly different from the original settlement raises questions about the future of the deal.
In the original deal, Apotex agreed to end the litigation in exchange for at least $40m, and was given a licence to sell a generic version of Plavix in September 2011, eight months earlier than the patent's maximum lifespan. Bristol also said it would inquire about other settlements with two other generic drugmakers.
The FTC has in the past challenged similar arrangements, arguing that they are anti-competitive and hurt consumers, and asked the Supreme Court to hear a case involving Schering-Plough in which a similar deal was struck. Although the high court this month declined to take on that case, the FTC has signalled that it will continue to strike down deals between big drug groups such as Bristol and generic rivals that involve so-called "reverse payments".
Bristol and Sanofi have said that, in response to concerns raised by the FTC and state officials also reviewing the deal, they had amended the original agreement.
Among other changes, Apotex could license and manufacture a generic version of Plavix in June 2011, which would be as much as a year before expiry.
[<-- from msnbc/ft.com]
Separately, recall that the Supreme Court denied certiorari in
the FTC/Schering case, and thereby left standing
the 11th Circuit's decision that a settlement of a patent infringement lawsuit between Schering-Plough and Upsher-Smith did not violate the antitrust laws. The patent infringement suit concerned Upsher's generic version of Schering's K-Dur 20 drug product, a treatment for high blood pressure and heart disease. The settlement agreement between Schering and Upsher included a cash payment from Schering to Upsher in exchange for Upsher's promise not to launch its generic version of K-Dur 20 for six more years—close to the end of Schering's patent term.
[IPBiz post 1730]