Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
ARTIFICIAL INTELLIGENCE IN LIFE SCIENCES - Life sciences companies are forming AI-driven strategic collaborations with tech giants, creating synergy that promises to revolutionize the industry. Companies like NVIDIA,...more
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
In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the...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
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
On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...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 an attempt to rein in rising drug prices, the Biden administration unveiled a proposed framework of factors that federal agencies should consider when choosing whether to exercise so-called “march-in rights.” March-in...more
Under certain circumstances, federal agencies have statutory authority to force inventors of patented technology developed with federal funding to grant licenses allowing others to practice the invention. This authority is...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 following Q&A, in...more
On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...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
The Biden Administration’s recent publication of the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and its request for comments on the draft guidance will impact how march-in rights...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
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
The U.S. Patent and Trademark Office (USPTO) released a report on innovations in COVID-19-related diagnostics as a case study of how innovation and intellectual property operate during times of crisis. The study utilized...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