Apotex Announces Agreement to Settle U.S. PLAVIX(R) Litigation; Apotex Announces Agreement to Settle U.S. Plavix(R) Litigation with Sanofi-aventis and Bristol-Myers Squibb Subject to Certain Conditions.WESTON, Fla. -- Apotex Inc. and Apotex Corp. announced today that they have reached an agreement with Sanofi-aventis and Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were , subject to certain conditions, to settle the patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. lawsuit pending between the parties in the U.S. District Court for the Southern District of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . The lawsuit relates to the validity of a patent for clopidogrel bisulfate clopidogrel bisulfate Plavix Pharmacologic class: Platelet aggregation inhibitor Therapeutic class: Antiplatelet drug Pregnancy risk category B Action(the '265 patent) sold in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. as PLAVIX(R). The trial scheduled to begin on June 12, 2006 has now been suspended pending the possible finalization of the proposed settlement.Under the terms of the agreement, Apotex would receive from Sanofi-aventis a royalty-bearing license under the '265 patent to manufacture and sell a generic clopidogrel bisulfate product in the United States. Apotex would agree not to sell a clopidogrel product in the United States until the effective date of the license. The license would be exclusive (except for Sanofi's PLAVIX(R) brand product) and would be effective on September 17, 2011, with the possibility of an effective date earlier in 2011 if Sanofi-aventis does not receive an extension of exclusivity for pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. use under the '265 patent. If another party obtains a final decision that the '265 patent is invalid or unenforceable, the license to Apotex may become effective earlier. The agreement includes other provisions, including payments by Sanofi-aventis and Bristol-Myers Squibb to Apotex, in the event of either finalization of the proposed settlement agreement or termination of the agreement. The proposed settlement is subject to certain conditions, including antitrust review and clearance by the Federal Trade Commission and state attorneys general. If the required antitrust clearance is not obtained, the proposed settlement would end and the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. would be reinstated. If the litigation were reinstated, Apotex intends to vigorously pursue its counterclaims for patent invalidity and unenforceability. Plavix(R) is a registered trademark of Sanofi-Synthelabo. Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida Weston is a city located in Broward County, Florida, USA. Established as a city in 1996, much of the community was developed by Arvida/JMB Partners and is located near the western developmental boundary of Broward County. As of 2006, the city had a total population of 65,793. and operations center in Indianapolis, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit http://www.apotexcorp.com. |
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