Abstract

The generic drug industry plays a critical role in ensuring that Americans can access necessary pharmaceuticals. Various laws, like the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch Waxman Act sought to simplify the complicated path to market for generic drug manufacturers. The Court of Appeals for the Federal Circuit’s recent decision in Glaxosmithkline LLC v. Teva Pharms. USA, Inc. (“GSK”), which concerns the use “skinny-labels” to avoid patent infringement, may prove to be an additional hurdle for the generic drugs market. The ruling in GSK weakens the intent and causation requirements of induced infringement that had been established by the Federal Circuit. This Note provides a historical analysis of how the Hatch-Waxman Act simplified generic entry into the pharmaceuticals market as well as the history of induced infringement with a focus on skinny-labels. Moreover, this Note examines the potential impact of the GSK ruling on the generic drug industry as well as possible legislative remedies to address “skinnylabel” induced infringement claims. Ultimately, this Author suggests several solutions for protecting the generic drug market in America such as legislative reform to the Patent act or agency-specific changes like a unified generic drugs approval process between the Food and Drug Administration and the Patent & Trademark Office.

Keywords

Patents, Generic Drugs, Teva, GSK, Patent, Federal Courts, Infringement, FDA