In Biologics: The New Antitrust Frontier, Michael A. Carrier and Carl J. Minniti provide an overview of potential antitrust harms in the newly enacted biologic drug approval and litigation regime, the Biologics Price Competition and Innovation Act (“BPCIA”). Importantly, Carrier and Minniti suggest that the scientific complexity of biologic products has the potential to make some litigation conduct that is typically anticompetitive more or less so, given uncertainties surrounding regulatory approval and patent infringement. This response advances Carrier and Minniti’s thesis, suggesting the authors do not take it far enough for their assessments of reverse payment settlements, submarine patenting, and citizen petition abuse. It also makes use of two important court decisions, Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017)and Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) decided after Carrier and Minniti’s article went to press. Regardless of whether Carrier and Minniti’s predictions come to pass, their core insight—that scientific complexity can regulate antitrust harms—provides a key area of future exploration for practitioners, scholars, and policy makers alike.
Sherkow, Jacob S., "The Science of Substitution: A Response to Carrier and Minniti" (2018). Articles & Chapters. 1262.