Apotex Seeking Declaratory Judgment against GSK

Apotex has recently filed a complaint against GlaxoSmithKline in the U.S. District Court for the Eastern District of Virginia, Norfolk Division seeking declaratory judgment for non-infringement of Orange Book listed U.S. Patent # 5,068,249 (the ‘249 patent) covering oral syrup composition of ranitidine stabilized by adding effective amount of ethanol to the formulation. Apotex is seeking USFDA marketing approval for generic Zantac syrup and want the court to rule that its generic version won’t infringe the ‘249 patent that expires Mid-2009. Apotex in its complaint stated that it “faces potentially enormous infringement liability if it markets its generic product prior to the expiration” of the ‘249 patent and further added that “only a declaratory judgment from the court can alleviate this harm and allow Apotex to obtain approval of its product and compete in the lucrative ranitidine market free from infringement liability.” The case is Apotex Inc. v. Glaxo Group Ltd., 07cv40, U.S. District Court for the Eastern District of Virginia, Norfolk Division.