News & Analysis as of

Bayh-Dole Act

Tarter Krinsky & Drogin LLP

Technology Transfer Tips

Bayh-Dole Act Compliance: When Is an Invention a “Subject Invention”? Due to recent high-profile events at the national level involving universities, the Bayh-Dole Act is again at the top of everyone’s minds. One aspect...more

Foley Hoag LLP

Navigating Bayh-Dole Compliance in 2025: Risks and Risk Mitigation Strategies

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A significant number of inventions made at academic and research institutions, non-profit research organizations and businesses are developed using some amount of federal government funding (e.g., from NIH, NSF, DOD, and...more

Foley Hoag LLP

Bayh-Dole Compliance Requires Your Attention: Best Practices for Universities, Companies, Investors, Strategic Partners, and...

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A significant number of inventions made at academic and research institutions, non-profit research organizations and businesses are developed with federal government funding. The Bayh-Dole Act of 1980 provided a clear path...more

Kilpatrick

4 Key Takeaways | The Changing Framework of Intellectual Property Rights in Government Contracts and Grants

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Kilpatrick’s Jennifer Andrews and Matt Crookston recently presented on the topic of “The Changing Framework of Intellectual Property Rights in Government Contracts and Grants” at a Washington State Patent Law Association CLE....more

American Conference Institute (ACI)

[Event] 8th Annual Summit on Life Sciences IP Due Diligence - December 3rd - 4th, Boston, MA

Attend ACI's 8th Annual Summit on Life Sciences IP Due Diligence, and join IP counsel from across the life sciences industry to benchmark your diligence strategies, strengthen portfolio valuation approaches, and stay ahead of...more

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

Life Sciences IP Tool Kit 2025

Intellectual property (IP) strategy in the life sciences evolves as rapidly as the scientific breakthroughs driving the industry. Since the America Invents Act reshaped the U.S. patent system more than a decade ago, courts...more

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

Protecting Defense Technology Innovations

Defense contracting is entering an era characterized by more competition, a faster pace of innovation, and dual-use technology. Defense contractors that are succeeding in this new environment are pursuing patent protection...more

Baker Botts L.L.P.

Potential Impacts on Startups From the Federal Government Seeking Patent Royalties

Baker Botts L.L.P. on

The new suggestion from Commerce Secretary Howard Lutnick that the federal government may start seeking royalties on federal-funding patents owned by universities represents a potential major change in the landscape for...more

Goodwin

Would Exercising March-in Rights Lower Biologic Prices?

Goodwin on

The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

From Technology Transfer to Takings Clause: The Legal Stakes of March-In Rights

On August 8, 2025, U.S. Department of Commerce Secretary Howard Lutnick took an unprecedented step that could reshape the landscape of federally funded research and intellectual property law. He sent a letter informing...more

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

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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?

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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

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...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

PilieroMazza PLLC

The Rise of OTA in Defense Contracting, Part 3: Best Practices for OTA Negotiations

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In this Part 3 of PilieroMazza’s blog series, “The Rise of OTA in Defense Contracting,” we discuss tactics and best practices defense contractors should deploy when negotiating terms once selected for an OT award. This is...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

Seyfarth Shaw LLP

Six Essential Tips for Understanding Intellectual Property Rights Under Government Contracts

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In celebration of the release of the 6th Edition of the Government Contracts Compliance Handbook, we are sharing six essential tips for understanding intellectual property (IP) rights in government contracts. Contractors...more

Ropes & Gray LLP

Considerations When Contracting with Academic Spinouts

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Due in part to the Bayh-Dole Act of 1980, which incentivized universities to commercialize their technology, the number of academic spinouts has grown in recent years. This is particularly true in the life sciences space,...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Ropes & Gray LLP

Expected Changes to IP Policy under the Second Trump Administration

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Intellectual property (“IP”) policy does not weigh heavily on most voters’ minds, and so is not often addressed in presidential campaigns. This past campaign was no different – President-elect Donald Trump did not expressly...more

A&O Shearman

Election Results Are In—Here’s How IP Disputes Policy May Change.

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Intellectual property policy may not have driven many voters to the polls on November 7, but change was on the ballot. Below, we summarize changes in U.S. intellectual property law that you might see starting in January 2025....more

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

Historical Development of Substantial New Question contrasted with the new Section 325(d) Criteria

Ex parte reexamination proceedings have been available for over 40 years. The reexamination statutes, Public Law 96-517 of July 1, 1981 (also known as the Bayh-Dole Act), included 35 U.S.C. § 303, which codified, in part,...more

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