In the past several years, the Bayh-Dole Act – a 40+ year-old federal statute that governs the ownership of inventions conceived or first actually reduced to practice in the performance of work under a federal award – has been a focus of both the Trump and Biden Administrations, and the biotechnology sector has been tracking their moves closely. The Act preserves contractors' rights to federally funded "subject inventions," so long as the contractor meets certain specific disclosure, commercialization, and domestic manufacture criteria. Contractors are often U.S. universities that receive federal research funds. The Act also grants the government the extraordinary – and to date, never exercised – authority to "march in" and license inventions to third parties where required criteria have not been met.

The potential for march-in has been raised – and hotly debated – in recent years in the context of high-profile disputes over drug pricing and during the course of the COVID-19 pandemic. Responding to these and other concerns, in 2023, the Biden Administration issued a draft "framework" of guidelines encouraging agencies to consider march-in more closely. The framework went so far as to suggest that excessive pricing could factor into the statutory analysis. This prompted significant pushback from Republicans and other stakeholders concerned it would undermine Bayh-Dole's commercialization incentives. The framework ultimately did not move forward.

In 2025, focus turned again to Bayh-Dole, this time by the Trump Administration. While the Biden Administration had provided Federal agencies enhanced "tools" for march-in assessment, the current Administration turned its attention to the recipients of federal funds – specifically universities. In their thinking, Bayh-Dole could be used as a tool to scrutinize university activity. The Administration's stated concerns have included university compliance with requirements to "achieve practical application" of subject inventions and that products embodying subject inventions be "manufactured substantially" in the U.S. Indeed, the U.S. Secretary of Commerce, Howard Lutnick, has suggested that the Federal government take a substantial share of royalties on licensed university patents generated from federally supported research.

Viewed against more than forty years of non-enforcement, these recent developments are significant. Ultimately, whether the recent actions by the current Administration mark a durable shift in Bayh-Dole enforcement remains to be seen.