Will the Supreme Court Review Safe Harbor Provisions for Post-Approval Activity?
Momenta Pharmaceutica and Sandoz recently petitioned the Supreme Court to review the Federal Circuit’s interpretation of the 35 U.S.C. § 271(e)(1) safe harbor provisions. The petition was filed in response to a Federal Circuit decision, issued in August 2012, overturning a Preliminary Injunction that prevented Amphastar from selling its generic version of enoxaparin, a low…