When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more
In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...more