Generics May Seek Correction Of Overly Broad Use Codes

Generics May Seek Correction Of Overly Broad Use Codes

In Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (April 17, 2012) [enhanced version available to lexis.com subscribers], the Supreme Court unanimously held that a generic drug company may use a counterclaim provision of the Hatch-Waxman Act to seek correction of an overly broad use code submitted by a brand drug company in connection with patents listed in the FDA Orange Book. In this Analysis, Dianna Goldenson El Hioum addresses this issue and its implications.

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