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The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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