APOTEX AGREES TO SETTLE PLAVIX SUIT

Pharmacy Times, Volume 0, 0

Apotex Inc and Apotex Corp announcedthat they have reached an agreement withsanofi-aventis and Bristol-Myers Squibb(BMS) to settle the patent infringementlawsuit between the parties in the USDistrict Court for the Southern District ofNew York, subject to certain conditions.The suit related to the validity of a patentfor clopidogrel bisulfate, sold under thebrand name Plavix. Under the terms of theagreement, Apotex would receive a royalty-bearing license from sanofi-aventis tomanufacture and sell a generic version ofthe blood thinner in the United States.Apotex agreed, however, not to sell thedrug in the United States until the licensebecomes effective, which could be as lateas September 17, 2011. This date could besooner if sanofi-aventis does not receivean extension of exclusivityfor pediatric use.

The agreement includesother provisions,including payments bysanofi-aventis and BMSto Apotex in the event ofeither termination orfinalization of the settlement agreement.The agreement is subject to certain conditions,including antitrust review and clearanceby the Federal Trade Commissionand state attorneys general. If the requiredclearance is not obtained, however, theproposed settlement would end and litigationwould continue. If that happens,Apotex has stated that it intends to pursueits counterclaims for patent invalidity andunenforceability.