AI in Pharmaceutical Research and Development: A Tiered Proposal Realigning Regulatory Exclusivity Periods
This Note examines how artificial intelligence (“AI”) is fundamentally transforming pharmaceutical research and development (“R&D”), altering the cost, risk, and timelines that traditionally justify regulatory exclusivity protections. As AI-enabled technologies accelerate drug discovery and increase clinical success rates, the traditional assumptions supporting lengthy exclusivity periods are becoming less persuasive. This Note contends that Congress should implement a tiered regulatory exclusivity framework that calibrates market protections according to measurable efficiency gains attributable to AI. By aligning exclusivity periods with reduced R&D burdens, this approach maintains incentives for innovation while enabling earlier access to more affordable generic and biosimilar medications.
Ingrid Villarreal
J.D. Candidate, Georgetown University Law Center (2027); M.Sc. in Applied Digital Health, University of Oxford (2024); B.S.A in Biology, University of Texas (2023). My deepest gratitude to Professors Lawrence Gostin and Jeffery Crowley for their guidance throughout the development of this Note and for creating an exceptional course that allowed me to further explore my interests in biotechnology, life sciences, and artificial intelligence. I would also like to extend my gratitude to the incredibly talented editors at Georgetown Law Technology Review for making this publication possible. Thank you also to my friends, Hannah Shrader and Ryan Francis, for reading this paper and providing valuable feedback from their respective fields of study. Finally, to my parents and sister, Isabella, thank you for your endless encouragement, unwavering support, and confidence in me every step of the way.