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Hatch-Waxman Safe Harbors Elan Pharmaceuticals

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

McDonnell Boehnen Hulbert & Berghoff LLP

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. ยง 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

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