Sandoz Sued by Aventis over Fexofenadine Patent

On May 24, 2007 one of the leading global pharmaceutical major – Sanofi-Aventis has filed a patent infringement lawsuit in the US District Court for the District of New Jersey against Novartis generic arm – Sandoz alleging that Sandoz’s amended Abbreviated New Drug Application (ANDA) Nos. 76-707 and 77-999 for Allerga and Allerga-D respectively would be an act of infringement pursuant to 35 USC § 271 (e)(2), and would infringe Orange Book listed US Patent Nos. 6,399,632 (the ‘632 patent), 6,187,791 (the ‘791 patent), and 6,037,353 (the ‘353 patent). In its amended ANDAs submission, Sandoz changed its Para III certification for ‘632, ‘791 and ‘353 patents to Para IV certification. Earlier, in its original ANDAs submission, Sandoz made Para IV certification with respect to Orange Book US Patent Nos. 6,113,942 (the ‘942 patent), 5,855,912 (the ‘912 patent) and 5,932,247 (the ‘247 patent) and Para III certification for ‘632, ‘791 and ‘353 patents. In response to original ANDAs submission, Aventis filed a patent infringement complaint in same court on January 20, 2004, alleging infringement of ‘942, ‘912 and ‘247 patents and seeking declaratory judgment of infringement of the US Patent No. 5,738,872 (the ‘872 patent). Sandoz later amended and filed its amended ANDAs on April 11, 2007 extending Para IV certification to ‘632, ‘791 and ‘353 patents. In the meantime, the US District Court for the District of New Jersey denied Aventis motion for preliminary injunction on January 30, 2006 which Aventis subsequently appealed to the US Court of Appeals for the Federal Circuit which affirmed the district court judgment.