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Declaratory Judgments Win As Federal Circuit Tweaks Standards For ANDA Suits

Executive Summary

The parameters under which generic drug firms can seek declaratory judgments against patent holders have been expanded under a ruling by the U.S. Court of Appeals for the Federal Circuit

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Generic Firms’ Ability To Seek Declaratory Judgment Limited By Federal Circuit

The Federal Circuit U.S. Court of Appeals has provided further guidance as to when generic companies can seek a declaratory judgment that they do not infringe a patent

Generic Firms’ Ability To Seek Declaratory Judgment Limited By Federal Circuit

The Federal Circuit U.S. Court of Appeals has provided further guidance as to when generic companies can seek a declaratory judgment that they do not infringe a patent

Lexapro declaratory judgment

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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