Sanofi-Aventis, the world’s third largest pharmaceutical company jointly with Debiopharm has filed a patent infringement complaint in the US District Court for the District of New Jersey to keep generic drug maker Sandoz off from the US Eloxatin market till the expiration of Eloxatin Orange Book listed US Patent Nos. 5,338,874 (the ‘874 patent) and 5,716,988 (the ‘988 patent). In its complaint dated June 14, 2007, Sanofi alleged that Sandoz’s Abbreviated New Drug Application (ANDA) No. 78-817 will infringe one or more claims of the ‘874 and ‘988 patents and will constitute an act of an infringement pursuant to 35 USC § 271(e) (2). The The patents-in-suit are two of the four Orange Book listed patents for Eloxatin Injectable Solution exclusively licensed to Sanofi-Aventis from Debiopharm. The other two Orange Book listed patents are US 5,290,961 (the ‘961 patent) and US 5,420,319 (the ‘319 patent).The ‘961 patent particularly covers Oxaliplatin (the active ingredient of Eloxatin) as cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II). The ‘874 patent in particularly claims optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) whereas the ‘319 patent exemplifies optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) having optical purity of 99.94% or more and a melting point between 198.3 degree centigrade and 199.7 degree centigrade. The ‘988 patent covers pharmaceutically stable parenteral solution of oxaliplatin.
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