Hatch-Waxman Safe Harbor: Post-Approval Activity Update

Law360, New York (August 22, 2012, 3:50 PM EDT) -- The U.S. Supreme Court has twice addressed the scope of the safe harbor provision of the Hatch-Waxman Act (Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661 (1990) and Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005)), and has recently again expressed interest in this provision, requesting the solicitor general’s input in connection with a petition for a writ of certiorari from the Federal Circuit case, Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011).

The Classen decision implicates the...
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