Technology transfer, Bayh-Dole Act: Accelerating the Process in the U.S.

Technology transfer (Tech Transfer) in the biotechnology sector is essential for the transition of scientific innovations from the laboratory to the market. Therefore, through the implementation of licensing agreements, collaborations, and partnerships, it is possible to facilitate the flow of patented technologies and scientific knowledge among different entities. To better analyze this process, ITTBioMed by Edra and DLA Piper, with the support of Lendlease, MIND, and T-Factor, recently organized the event “Patents and Secrets: Technology Transfer in Life Sciences.” The main objective of the event is to promote fruitful exchange among biotech industry experts, aimed at consolidating its foundations in Italy and promoting the protection of industrial property and scientific know-how.

Building upon these premises, in her presentation, Lauren Murdza, Technology and Corporate Transactional Partner at DLA Piper, examined the Bayh-Dole Act, a U.S. federal law from the 1980s aimed at creating a uniform patent policy for federally funded research. “Before this law, there was no uniformity in terms of intellectual property ownership for government-funded research, which retained ownership of any resulting IP. The Bayh-Dole Act introduced significant changes, aiming to create uniformity and reliability in the management of intellectual property and federal research funding,” Murdza explained, emphasizing the “crucial role of this law in increasing university technology transfer, with a significant increase in federally funded patents from 1980 to 2020.”

The law, she added, “enabled universities to take an active role in licensing technology, accelerating the commercialization process of federally funded research. Thanks to Bayh-Dole, universities have become more agile and competent commercial partners compared to the federal government.”

Key provisions of the Bayh-Dole Act include “the retention by the university of ownership of any invention resulting from federal funding, an obligation of disclosure to the federal government, and a mandate of diligence in implementing the development and commercialization of inventions. The law also guarantees the federal government a non-exclusive license with sublicensing rights and emphasizes the priority of granting licenses to small businesses, although in practice this does not preclude agreements with large pharmaceutical companies.” Finally, Murdza addressed “controversies and implications of so-called ‘march-in rights,’ rights that have sparked debates, especially regarding drug prices and the Biden administration’s proposal to use these rights to influence prices.” The speaker then concluded the analysis by highlighting “the obligation of universities to allocate excess revenue from licenses to research and education and to share a portion of royalties with inventors.”