Apotex Inc and Apotex Corp announced that they have reached an agreement with sanofi-aventis and Bristol-Myers Squibb (BMS) to settle the patent infringement lawsuit between the parties in the US District Court for the Southern District of New York, subject to certain conditions. The suit related to the validity of a patent for clopidogrel bisulfate, sold under the brand name Plavix. Under the terms of the agreement, Apotex would receive a royalty- bearing license from sanofi-aventis to manufacture and sell a generic version of the blood thinner in the United States. Apotex agreed, however, not to sell the drug in the United States until the license becomes effective, which could be as late as September 17, 2011. This date could be sooner if sanofi-aventis does not receive an extension of exclusivity for pediatric use.
The agreement includes other provisions, including payments by sanofi-aventis and BMS to Apotex in the event of either termination or finalization of the settlement agreement. The agreement is subject to certain conditions, including antitrust review and clearance by the Federal Trade Commission and state attorneys general. If the required clearance is not obtained, however, the proposed settlement would end and litigation would continue. If that happens, Apotex has stated that it intends to pursue its counterclaims for patent invalidity and unenforceability.