Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Bayh–Dole Act, signed into law in 1980, is U.S. legislation directed to inventions arising from research funded by the Federal government. (See 35 U.S.C. § 200–212, and 37 C.F.R. §§ 401 and 404.) The Act encourages...more
Organizations that receive federal funds or that license technology from third parties that receive Federal funds need to be aware of Federal funding obligations under the Bayh-Dole Act. Any invention conceived or reduced to...more
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
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
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
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
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