This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry....

The U.S. Patent and Trademark Office (USPTO) has requested public comments on “the current state of patent eligibility jurisprudence in the United States, and how the current jurisprudence has impacted investment and innovation.”We write as academics who have conducted empirical studies of...

Recent policy attention has focused on proposals to reduce prices for drugs that have received public funding. From an implementation perspective, such policies rely on public disclosure of government support for research. In this paper, we highlight two conceptual problems with past attempts to...

This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it is more representative of the...

Recent policy attention has focused on proposals to reduce prices for drugs that have received public funding. From an implementation perspective, such policies rely on public disclosure of government support for research. In this paper, we highlight two conceptual problems with past attempts to...

In December 2023, the Biden-Harris Administration released a proposed framework for exercising government "march-in" rights on high-priced taxpayer-funded drugs. While both proponents and critics of the new rules view them as having broad scope, march-in rights can be exercised only on patents...