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news.Sanofi-Aventis has resolved the US patent infringement suits related to Barr Pharmaceuticals and Teva Pharmaceuticals's generic version of Allegra, as well as the US patent infringement suits related to Barr's proposed generic versions of Allegra D-12 Hour and Nasacort AQ. In each case, the settlement agreement is subject to review by the Federal Trade Commission and US state attorneys general.
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Under the terms of the agreements, in exchange for payment of royalties, Sanofi-Aventis US has agreed to grant Barr and Teva a license to certain patent rights to permit Barr and Teva to sell generic versions of Allegra 30mg, 60mg, and 180mg tablets in the US, and to grant Barr a license to certain patent rights to sell generic versions of Allegra D-12 and Nasacort AQ in the US at a future date.
In each case, the license is to be non-exclusive, will allow generic entry prior to the expiration of Sanofi-Aventis US’s patents, and will not preclude Sanofi Aventis US’s own marketing of a generic version of these products. No license is granted with respect to any other Allegra product.
With respect to Allegra, for which Barr and Teva already market a US generic, royalties are to be retroactively applied to past sales. Royalty rates under the Allegra D-12 and the Nasacort AQ licenses will take into account the number of AB-rated generics of these products on the US market.
The license related to Nasacort AQ authorizes production and marketing of a generic of this product for the US market no earlier than June 2011 and at the latest December 2013.
The license related to Allegra D-12 authorizes production and marketing of a generic of this product for the US market no earlier than November 2009. For either product, these dates may be accelerated under certain conditions, notably in the event an AB-rated generic of Nasacort AQ or an authorized AB-rated generic of Allegra D-12 were to be launched in the US or in the event a final US court of appeals decision were to hold the related patents invalid, unenforceable or not infringed.
Under the agreements related to Allegra D-12 and Nasacort AQ, Barr will have an option to purchase the finished pharmaceutical product on a non-exclusive basis from Sanofi-Aventis US. Under the settlement agreements, Sanofi-Aventis US will dismiss without prejudice its US patent suits, including any damage claims, against Barr and Teva related to Sanofi-Aventis US’s US Allegra patents and the US patent suits against Barr related to its US Allegra D-12 and Nasacort AQ patents.