Publication: Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament
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2003
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Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament (2003 Third Year Paper)
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Abstract
In early 2003, two panels of the Federal Circuit clashed in a pair of cases (Warner-Lambert v. Apotex and Allergan v. Alcon) dealing with the question of whether an action for inducement of infringement could be leveled against a generic drug manufacturer seeking FDA approval for an unpatented drug with both patented and unpatented uses. This paper takes up this debate, analyzing the interpretive puzzles presented in the application of the intricate Hatch-Waxman Act to this set of facts, arguing that the correct interpretation weaves elements from both panels’ approaches. It finishes with an alternative solution borrowed from a lesson in copyright.
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Food and Drug Law, Hatch-Waxman
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