The Hatch-Waxman Safe Harbor Provision
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This course is designed to inform patent practitioners on the bounds of the Hatch-Waxman Safe Harbor (35 U.S.C. § 271(e)(1)). This course will address the genesis of the statutory provision, key decisions relating to the breadth of the Safe Harbor, as well as activities that fall in and outside of the Safe Harbor defense. The course will also examine the possibility of an experimental use defense statute.
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