GSK v. Teva: The End of Generic Skinny Labels?
This Note proceeds in three parts. Part I provides an overview of U.S Food and Drug Administration’s (“FDA”) pathway for generic drugs to enter the market and explores the legal background on issues of pharmaceutical patents and generic drug development. Part II asserts that the court’s holding in GSK v. Teva contradicts congressional intent in enacting the Hatch-Waxman Amendments and will make it difficult for generic developers to make informed decisions when marketing generics. Finally, Part III argues that courts should hold the specific intent element for inducing infringement to a higher threshold of finding that the evidence encourages, recommends, or promotes infringing use by requiring evidence of actual causation.