Policy Perspective

The_Bayh-Dole_Act-__A_Guide_to_the_Law_and_Implementing_Regulations

This document, published by the Council on Governmental Relations (COGR), provides a detailed overview and guide to the Bayh-Dole Act of 1980, which fundamentally changed the landscape of technology transfer in the United States. The Bayh-Dole Act established a unified federal policy enabling universities, small businesses, and non-profit organizations to retain ownership of inventions developed with federal funding, rather than assigning rights to the government. Prior to the Act, fragmented policies and restrictive federal control resulted in limited commercialization of federally funded research—less than 5% of government-held patents were licensed for product development. The Bayh-Dole Act streamlined invention management and incentivized universities to actively pursue patenting and licensing, thus fostering collaboration with industry, encouraging investment, and ensuring that publicly funded research yielded tangible public benefits.

The guide outlines the evolution of university technology transfer since the Act's passage, the regulatory framework (notably codified in 37 CFR Part 401), and compliance requirements such as timely invention disclosure, preferential licensing to small U.S. businesses, and revenue sharing with inventors. It also discusses regulatory safeguards, “march-in rights” for the government, and related agency policies, particularly those of NIH. Since Bayh-Dole’s implementation, there has been a dramatic increase in university patenting, the formation of technology transfer offices, and commercialization activities—leading to the development of thousands of new products, startup companies, and significant economic impact. The Act’s success is attributed to the certainty of title, clear licensing authority, and a tripartite partnership model among government, academia, and industry, resulting in a robust national infrastructure for innovation and ongoing contributions to public health, economic growth, and scientific advancement.