Bristol Myers Squibb and sanofi aventis announce Apotex settlement
22 March 2006 00:00 in Pharmaceutical Company Product News
Bristol-Myers Squibb (BMS) and sanofi-aventis have announced that they have reached an agreement to settle with Apotex regarding the patent infringement case related to Plavix.
The lawsuit relates to validity of a composition of matter patent for clopidogrel bisulfate (the '265 patent), which is currently available in the US as Plavix, the BMS and sanofi-aventis product.
A settlement for the case entails sanofi-aventis granting a royalty-bearing licence to Apotex to manufacture and sell its FDA-approved product in the US from September 2011.
The exclusive agreement would mean that Apotex also agrees not to market its product in the United States until the licence becomes effective in five and a half years' time. The effective date may be brought forward under certain situations.
Payments to Apotex from BMS and sanofi-aventis included in the deal are provisional finalisation and termination payments.
The two companies have also said that if litigation is reinstated following failure to obtain antitrust clearance for the settlement, they will "vigorously pursue" enforcement of their Plavix patent rights.© Adfero Ltd
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