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
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
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act.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
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
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
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
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
Patent Intellectual Property (collectively, “IP”) rights represent a significant element of many government contracts, including those for research and development, whether by commercial, non-profit or educational...more
On April 13, 2018, a final rule was published in the Federal Register adopting proposed rule changes from the National Institute of Standards and Technology (“NIST”)....more
The Bayh-Dole Act allocates rights for intellectual property developed with federal funds between contractors or grant recipients and the government. This infographic provides an overview of the Bayh-Dole Act, the steps that...more
Patenting - Patenting generally offers a superior means for legally protecting most inventions, particularly since: • copyright, when available, does not provide a broad scope of protection; and • the...more