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| http://dx.doi.org/10.1097/MS9.0000000000002047 | DOI Listing |
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Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.
JAMA Health Forum
November 2024
Arizona State University Consortium for Science Policy and Outcomes, Washington, DC.
Importance: In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.
Objectives: To determine the feasibility of using march-in rights to remove patent barriers to generic competition.
Design, Setting, And Participants: This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023.
Patenting: the Bayh-Dole Act and its transformative impact on science innovation and commercialization.
Ann Med Surg (Lond)
June 2024
Department of Biomedical Science, School of Medicine and Health Sciences, University of North Dakota, Grand Forks, ND.
Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more.
PLoS Negl Trop Dis
May 2024
Departments of Ophthalmology and Visual Science, The University of Chicago, Chicago, Illinois, United States of America.
Background: Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide.
Objectives: We asked whether high performance of an Immunochromatographic-test (ICT) could enable accurate, rapid diagnosis/treatment, establishing new, improved care-paradigms at point-of-care and clinical laboratory.
Methods: Data were obtained in 12 studies/analyses addressing: 1-feasibility/efficacy; 2-false-positives; 3-acceptability; 4-pink/black-line/all studies; 5-time/cost; 6-Quick-Information/Limit-of-detection; 7, 8-acute;-chronic; 9-epidemiology; 10-ADBio; 11,12-Commentary/Cases/Chronology.
Background: The finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations in outcome and in the effectiveness of atrial fibrillation (AF) ablation versus drug therapy in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. This paper describes these differences and investigates potential causes.
View Article and Find Full Text PDFNIH funding for patents that contribute to market exclusivity of drugs approved 2010-2019 and the public interest protections of Bayh-Dole.
PLoS One
July 2023
Center for Integration of Science and Industry, Bentley University, Waltham, Massachusetts, United States of America.
Previous studies have shown that National Institutes of Health (NIH) funding contributed >$187 billion for basic or applied research related to the 356 drugs approved 2010-2019. This analysis asks how much of this funding led to patents cited as providing market exclusivity, patents that would be subject to the provisions of the Bayh-Dole Act that promote and protect the public interest. The method involves identifying published research in PubMed related to the approved drugs (applied research) or their targets (basic research).
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