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...

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....

Pharmaceutical firms' use of secondary patents to extend periods of exclusivity generates concerns among policymakers worldwide. In response, some developing countries have introduced measures to curb the grant of these patents. While these measures have received considerable attention, there is...