HOW INTELLECTUAL PROPERTY LAW CAN SOLVE LITIGATION SURROUNDING THE HATCH-WAXMAN ACT BROUGHT BY THE COURT’S DECISION IN BRAEBURN V. FOOD & DRUG ADMINISTRATION
JIPL Online
APRIL 22, 2021
By: Eddy Atallah. Introduction. This Blog aims to examine the Hatch-Waxman Act and one of the most significant incentives behind it, a three-year market exclusivity period for the “new clinical investigations.” Both the FDA and the courts have struggled with interpreting the exclusivity provision, among many other aspects of this inherently ambiguous regulation.
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