Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament

March 2004

Issue: 59 Food and Drug Law Journal 155-168 (2004).

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 Food and Drug Administration approval for an unpatented drug with both patented and unpatented uses. This article 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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