Hacking or Hatching the Skinny Label: How the Federal Circuit’s Decision in GSK v. Teva Threatens Generics and Induced Infringement

Abstract

This Note focuses on the recent precedential decision handed down by the Federal Circuit in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which impacts “one of the greatest public health inventions of the 21st century”: generic drugs. An invention that rose to prominence when former President Ronald Reagan signed into law the Hatch-Waxman Act (“the Act”), formally known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Act aimed to increase competition between brand-name and generic manufacturers while balancing two seemingly opposing interests: (1) encourage and reward innovation by pioneer drug companies and (2) increase access to low-cost alternatives. This in-depth analysis will evaluate how the Federal Circuit’s decision has jeopardized the Act’s purpose and conflicts with present U.S. policy under the Biden administration. Additionally, it will offer a critical analysis of Katherine Eban’s book, Bottle of Lies, which chronicles the generic drug boom that transpired after the Act’s passage. Eban’s often one-sided account fails to provide depth and context to an industry vital to public health.