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Lexapro declaratory judgment

Executive Summary

In an April 1 decision, U.S. Court of Appeals for the Federal Circuit upholds Caraco Pharmaceuticals' ability seek declaratory judgment against Forest Labs in a dispute involving a patent for Forest's Lexapro (escitalopram). The suit is aimed at forging a path to market for generic versions of the antidepressant, which holds patent protection until 2012. The ruling overturns a lower court decision dismissing Caraco's action on the basis that there is no threat of a lawsuit from Forest over Caraco's ANDA for a generic version of the drug. The appeals court ruling is consistent with a March 2007 decision by the same court in Teva v. Novartis that expanded the parameters under which generic firms can seek declaratory judgments for patent non-infringement (1"The Pink Sheet," April 9, 2007, p. 22). Ivax was the first to obtain approval for generic Lexapro. However, Forest has obtained a court judgment against Ivax upholding the validity of the patent covering the drug's active ingredient (2"The Pink Sheet," Sept. 10, 2007, In Brief)
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