Takeaways From Caraco V. Novo Nordisk

Law360, New York (May 3, 2012, 2:04 PM EDT) -- The United States Supreme Court has again reversed the Federal Circuit, ruling unanimously that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue.

In interpreting the text of 21 U.S.C. § 355(j)(5)(C)(ii)(I), the court in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, No. 10-844, 566 U.S. __ (2012), gave substantial weight to ensuring that the U.S. Food and Drug Administration fulfill its statutory duty to approve noninfringing generics...
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