News & Analysis as of

Bayh-Dole Act Research and Development

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...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

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

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

Seyfarth Shaw LLP on

On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...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

Akin Gump Strauss Hauer & Feld LLP

Biden Administration Research and Development Executive Order May Impact University, Academic Medical Center, and Independent...

On July 28, 2023, the Biden administration issued “Executive Order on Federal Research and Development in Support of Domestic Manufacturing and United States Jobs” (the “Executive Order”). How federal agencies implement...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

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

Dual-Use Ventures & Intellectual Property: SBIR Data Rights, Patents, and Deals

Dual-use ventures—startups that intend to sell both commercially and to the Department of Defense (DoD)—enjoy many advantages. You have a strong opportunity to secure millions of dollars of non-dilutive R&D funding through...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

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

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

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

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