News & Analysis as of

Inventions Bayh-Dole Act Patents

Wolf, Greenfield & Sacks, P.C.

Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance

Rob Sahr is a shareholder in Wolf Greenfield’s Biotechnology Practice. He develops strategies for life science companies to maximize exclusivity for therapeutic and diagnostic products. Rob has also assisted federal grant...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

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

Fitch, Even, Tabin & Flannery LLP

Government’s Royalty-Free Licensing Rights Affirmed Over USF Patent

On February 9, in University of South Florida Board of Trustees v. United States, the Federal Circuit upheld royalty-free license rights of the U.S. government over a University of South Florida (USF) patent directed to...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

McDermott Will & Emery

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

McDermott Will & Emery on

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

Morgan Lewis

Proposed Framework Would Expand US Government’s Discretion to ‘March-In’ on Patent Rights

Morgan Lewis on

In the Biden administration’s pursuit of increasing affordability of healthcare and prescription drugs, the National Institute of Standards and Technology (NIST) released in December 2023 its draft framework on the US...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

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

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

Jones Day on

The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for...

Goodwin on

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...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

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

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

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

Pillsbury - Internet & Social Media Law Blog

Keep an Eye on the Bayh-Dole Act in Regard to COVID-19-Relevant Patents

While companies in every industry are working hard to figure out the best response to this global pandemic, those in the pharmaceutical and medical device industries have been faced with some unique challenges related to the...more

McCarter & English Blog: Government Contracts...

iEdison’s 2020 New Year’s Resolution – Improvement! Time To Submit Your Comments

The Interagency Edison (“iEdison”) system is the principal mechanism for preserving rights to title in Government-funded inventions. Its use is now mandatory per 37 CFR 401.16, and we expect FAR 52.227-11, Patent Rights –...more

Fenwick & West LLP

Intellectual Property Bulletin - Summer 2019

Fenwick & West LLP on

In This Issue - A Looming AI War: Transparency v. IP Rights - As artificial intelligence systems become more prevalent in daily life, efforts to create a unifying set of AI principles have intensified. In the past few...more

Fenwick & West LLP

Avoiding Loss of Title to Inventions Made Under Federal Funding as New Bayh-Dole Requirements Affect Patent Rights

Fenwick & West LLP on

Federal grants are an important source of funding for many businesses and research institutions. The Bayh-Dole framework provides contractors the ability to retain title to an invention developed using federal funding, but...more

Sunstein LLP

August 2018 IP Update - Revisions to Bayh-Dole Act Regulations Governing Rights to Federally Funded Inventions

Sunstein LLP on

Rules affecting recipients of federal research and development funding have recently been revised, adding new deadlines and obligations. Changes to the regulations implementing the Bayh-Dole Act went into effect on May 14,...more

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

Updated Bayh-Dole Regulations Increase Certain Risks of Losing Title to Federally Funded Inventions

Businesses and nonprofits that receive funding under a federal government agreement (e.g., contract, cooperative agreement, or grant) executed after May 14, 2018, are subject to the updated regulatory provisions that...more

McCarter & English Blog: Government Contracts...

Contractors And Grantees Beware! Safe Harbors Removed In Preserving Patent Ownership Rights Under Bayh-Dole

Buried in a grab bag of seemingly innocuous course-correcting changes to the Bayh-Dole Act regulations (effective May 14 of this year) is the removal by regulators of the sixty-day window between the federal agency’s notice...more

Knobbe Martens

Bayh-Dole Act Revisions

Knobbe Martens on

On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published...more

Foley & Lardner LLP

Patent Related Changes To Bayh-Dole Act Regulations

Foley & Lardner LLP on

Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more

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