Policy Perspective

The_Bayh-Dole_Act-__A_Guide_to_the_Law_and_Implementing_Regulations

The document, "The Bayh-Dole Act: A Guide to the Law and Implementing Regulations," authored by the Council on Governmental Relations (COGR), provides an in-depth overview of the Bayh-Dole Act of 1980 and its profound impact on technology transfer in the United States. The Act fundamentally altered the landscape for federally funded research, enabling universities and small businesses to elect ownership of inventions arising from federal support, with the express goal of encouraging commercialization and facilitating public benefit from government-sponsored research. Prior to the Act, federal agencies retained ownership of such inventions, leading to underutilization due to non-exclusive licensing and lack of commercial incentives. The passage of Bayh-Dole spurred the development of university technology transfer offices, increased university-industry collaboration, and established formal procedures for patenting, licensing, and compliance. The document details the compliance obligations of universities, including timely invention disclosure, patent filing, revenue sharing with inventors, and provisions favoring domestic manufacturing and small businesses.

The guide assesses the substantial benefits and challenges that have emerged since Bayh-Dole’s implementation, including an upsurge in academic patenting, a significant increase in the commercialization of research outcomes, and notable economic impact through job creation, new ventures, and the development of transformative products, particularly in the life sciences. It also acknowledges ongoing debates and regulatory complexities, such as safeguarding public interests, the exercise of "march-in rights," and the need for continued oversight and compliance. The document concludes that the Bayh-Dole Act has been instrumental in establishing a robust national infrastructure for technology transfer, promoting economic development, and fostering innovation by solidifying partnerships among government, academia, and industry. The guide emphasizes that clear title to inventions, combined with a uniform patent policy and the ability to grant exclusive licenses, remain key drivers of successful technology commercialization in the United States.

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