AI (Re)Defining Pharmaceutical Exclusivities
Biotechnology Law Report
This article’s central thesis is twofold. First, the increased use of artificial intelligence (AI) technology, biomarkers, and new communications technologies have reduced both the time required (the time cost) and the associated monetary cost for conducting clinical trials, warranting a reduction in term of regulatory exclusivities, particularly for biologics. Second, the premise on which these exclusivities have been grated remain arguable and susceptible to misuse at a time when COVID-19 has exacerbated the need for policies that prioritize public health and access to health care. The article concludes that it is urgent to minimize the term of regulatory exclusivities.
Mary Ann Liebert, Inc.
Jonathan Kimball & Srividhya Ragavan,
AI (Re)Defining Pharmaceutical Exclusivities,
Biotechnology L. Rep.
Available at: https://scholarship.law.tamu.edu/facscholar/1532