IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...more
The Supreme Court decided not to grant certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, which has come to be known as the “skinny label” case. That means the Federal Circuit’s August 2021 decision (which was a...more
This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...more
Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more