Increasing the Efficiency of the U.S. Drug Market to Benefit Patients

The project team will identify areas ripe for patent reform by examining tertiary patents on devices used to administer drugs. The researchers will evaluate the externalities associated with extensions of patent terms, assess the criteria used to review patent applications, and analyze the effectiveness of the Patent Trial and Appeals Board at weeding out improperly granted patents. In addition, the team will identify ways to incentivize development of high-value drugs by examining the role various funding sources — public, nonprofit, and private — played in the development of drugs deemed innovative by international health technology assessment organizations. Lastly, the team will evaluate and quickly respond to proposed changes to the FDA regulatory process — including the accelerated approval pathway — that may be considered when the Prescription Drug User Fee Act comes up for renewal in fall 2022.