News & Analysis as of

Federal Funding Bayh-Dole Act

Morrison & Foerster LLP - Government...

Trump Administration Imposes New Restrictions on Federal Grant Funding and Suggests Potential Use of “March-In” Rights to License...

In an effort to ameliorate perceived problems with the manner in which the federal government issues federal grant funding and the nature of the grants that it funds, President Trump recently announced a sweeping new grant...more

Wilson Sonsini Goodrich & Rosati

Department of Commerce Initiates Bayh-Dole Compliance Review and Asserts March-In Proceeding Targeting Harvard University Patents

On August 8, 2025, the U.S. Department of Commerce notified Harvard University (Harvard) that it has initiated a comprehensive review of Harvard’s federally funded research programs to assure compliance with the Bayh-Dole...more

Wolf, Greenfield & Sacks, P.C.

Bayh-Dole Compliance Under Scrutiny: HHS Adopts Aggressive Enforcement Stance

The Trump administration recently announced that it will begin investigating compliance with the Bayh-Dole Act, signaling it may invoke march-in rights or more dramatic request for title of patents relating to inventions...more

Kilpatrick

What Steps Educational Institutions Should Consider Taking to Protect Their Patent Portfolio

Kilpatrick on

In Fiscal Year 2023, colleges and universities spent approximately $109 billion on research and development expenditures of which $59.6 billion, or 55%, was federally funded. In Fiscal Year 2022, the Small Business Innovation...more

Quarles & Brady LLP

March-In Rights Revisited: A New Era of Enforcement?

Quarles & Brady LLP on

On August 8, 2025, the U.S. Department of Commerce sent a letter to Harvard University—also shared publicly on the social media platform X—alleging that the university failed to comply with several provisions of the Bayh-Dole...more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

Troutman Pepper Locke on

The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

Ballard Spahr LLP

Business Better Podcast Episode: Bridging Campuses: Legal Insights on Education Industry Consolidation - Intellectual Property

Ballard Spahr LLP on

This episode is part of our “Bridging Campuses: Legal Insights on Education Industry Consolidation” series, where we discuss trends in higher education consolidation and closures, and outline common characteristics of at-risk...more

Proskauer - Trade Secrets

Streamlining University IP Innovation: How the Improving Efficiency to Increase Competition Act Could Advance University...

University-driven innovation is a cornerstone of societal progress, as academic institutions play a pivotal role in advancing research and technology that fuel economic growth, enhance quality of life, and address global...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Weighs in on Temporal Rigidity of the Bayh-Dole Act’s Licensing Provisions

In University of South Florida Board of Trustees v. United States, the Federal Circuit rejected a strict temporal limitation on when the Government’s license rights in patents stemming from federally funded research is...more

Goodwin

Recent Bayh-Dole Act News: Comments on the Draft Framework; HHS Refuses to March-In on Xtandi; and Delayed Contracting Doesn’t...

Goodwin on

U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2024

Univ. of South Florida Bd. of Trustees v. United States, Appeal No. 2022-2248 (Fed. Cir. Feb. 9, 2024) In this week’s Case of the Week, the Federal Circuit examined the scope of a provision of the Bayh-Dole Act of 1980 (35...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Wilson Sonsini Goodrich & Rosati

Draft Guidance Puts March-In Authority Pursuant to Bayh-Dole in the News Once Again

On December 8, 2023, the National Institute of Standards and Technology (NIST) released the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (guidance) to the public for comment. The...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Quarles & Brady LLP

Recent Updates to Bayh-Dole Obligations May Require New License Terms and Reporting Procedures for Federally-Funded Inventions

Quarles & Brady LLP on

Effective October 1, 2023, certain aspects of reporting obligations under the Bayh-Dole Act changed, and further changes are potentially on the way. Frequent recipients of federal funding, such as universities and research...more

MoFo Tech

Top 10 Considerations In Licensing Cleantech Innovations

MoFo Tech on

Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas...more

Goodwin

Biden Executive Order Puts Focus on Domestic Manufacturing of Inventions Created Using Federal Funding

Goodwin on

President Biden recently signed Executive Order 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which places greater emphasis on manufacturing products in the United...more

Akin Gump Strauss Hauer & Feld LLP

Federally Funded Research & Development: New Executive Order Pushes Federal Agencies to Take Title to Subject Inventions and...

Key Points - On July 28, 2023, President Biden signed EO 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which aims to increase domestic manufacturing and...more

Morrison & Foerster LLP - Government...

Biden Executive Order Has Potential To Discourage U.S. Company Participation In Federal Research

A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Keeping Your Federally-Funded Inventions: Requirements to Comply with the Bayh-Dole Act

Federal funding is a huge boon for companies, universities, and research institutions conducting innovative research. However, it comes attached with requirements that can become a stumbling block, especially for emerging and...more

King & Spalding

Assessing the Value of Intellectual Property Rights in M&A Deals Involving Government Contractors

King & Spalding on

Intellectual property (“IP”) rights can be one of the most valuable assets of a government contractor. There are several factors potential buyers can use to properly evaluate a government contractor’s IP in mergers and...more

McCarter & English Blog: Government Contracts...

NIST On Track To Clarify Bayh-Dole To Ensure High Prices Cannot Be Used As Grounds For Exercising March-in Rights – Or Is It?

On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and...more

Goodwin

Changes To March-In Rights Under Bayh-Dole And More?

Goodwin on

Since its enactment in 1980, the Bayh-Dole Act has been credited with promoting the development of over 10,000 startup companies and at least 200 pharmaceutical drugs and vaccines, while contributing more than $500 billion...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Patenting Considerations for SBIR Awardees

Awardees of funding from the Small Business Innovative Research (“SBIR”) program face unique strategic questions as they plan their intellectual property development. Like all companies, SBIR awardees must decide whether to...more

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