News & Analysis as of

March-In Rights Department of Health and Human Services (HHS) Bayh-Dole Act

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

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

McDermott Will & Schulte

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...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

Goodwin

NIH Again Refuses to Exercise March-In Rights to Control Drug Price

Goodwin on

In a letter dated March 21, 2023, the National Institutes of Health (“NIH”) again refused the request of petitioners to exercise march-in rights under the Bayh-Dole Act to control the price of a drug. Here, as before, the NIH...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

McDonnell Boehnen Hulbert & Berghoff LLP

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

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