Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Generics Litigation

 News Release - March 22, 2006

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.--(HSMN NewsFeed)--March 22, 2006--Apotex Inc. and Apotex Corp. announced today that they have reached an agreement with sanofi-aventis and Bristol-Myers Squibb, subject to certain conditions, to settle the patent infringement lawsuit pending between the parties in the U.S. District Court for the Southern District of New York. The lawsuit relates to the validity of a patent for clopidogrel bisulfate (the '265 patent) sold in the United States as PLAVIX®. 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® 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 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 would be reinstated.

If the litigation were reinstated, Apotex intends to vigorously pursue its counterclaims for patent invalidity and unenforceability.

Plavix® 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 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.


Source: Apotex

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