The Hatch-Waxman Act revolutionized the prescription drug industry by streamlining the process for generics to gain FDA approval. The Act is credited as the primary source of infusing generics into the present day pharmaceutical landscape. However, overly broad use codes provided by the brand drug manufacturers for publication in the Orange Book may preclude generic manufacturers from a section viii statement, which may severely impede the healthcare consumer from access to affordable generic drugs. Although the FDA is responsible for publishing the Orange Book, it does not review its substantive information. As a result, generic companies were left without a mechanism to challenge an overly broad use code that may prevent or impede the launch of a generic drug. As a patch for this procedural hole, Congress introduced the counterclaim provision as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. However, to invoke the counterclaim provision, the generic company must engage in a cumbersome process as highlighted by Justice Sotomayor in Caraco Pharmaceuticals v. Novo Nordisk. This Note explores the road to the counterclaim provision, examines the Supreme Court’s construction of the counterclaim provision, and highlights Justice Sotomayor’s illuminative remarks. Finally, this Note argues for elevated FDA oversight and proposes requiring use codes to be identical to the FDA-approved use, provided that the approved method of use is within the scope of the patent claims.
Djung, Jane F., "Insufficient Mechanisms for Orange Book Corrections and the FDA's Ministerial Role: A Need for Reform Note" (2014). Connecticut Law Review. 268.