Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities

American Journal of Public Health (2022)

Posted: 11 Jul 2022

See all articles by Rebecca E. Wolitz

Rebecca E. Wolitz

Ohio State University (OSU) - Michael E. Moritz College of Law

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

Jonathan J. Darrow

affiliation not provided to SSRN

Date Written: June 16, 2022

Abstract

Adequate access to high-value patented medications is a longstanding and significant matter of public health importance. Patent protection, by design, facilitates high prices as a reward to inventors of novel products. A byproduct of these rewards, however, is that high prices sometimes prevent or hinder access to life-preserving medications, leading to worse health outcomes. To address this issue, some policymakers have advocated for reliance on a century-old law under which the government is liable for no more than “reasonable compensation” if it uses patented inventions without the permission of the patent holder, potentially leading to substantial savings compared to paying the prices set by drug companies for their medications. Yet, government patent use for pharmaceuticals faces numerous practical and legal hurdles. Among the most daunting are non-patent exclusivities, including those granted under the Hatch-Waxman Act for recently approved drugs such as COVID-19 therapies. This article analyzes four potential pathways that could allow for government patent use for brand-name drugs in the service of public health even before non-patent exclusivities expire. Yet, although each of these pathways is available to meet public health needs, each involves a largely reactive intervention and confronts challenges. For this reason, it would also be beneficial to have a greater emphasis on innovation policy levers through which the government could retain greater control over resulting products’ accessibility or preempt concerns about exclusivities altogether.

Paper available at: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2022.306888

Keywords: access to medications, patent law, FDA, non-patent exclusivities, Section 1498

Suggested Citation

Wolitz, Rebecca and Kesselheim, Aaron S. and Darrow, Jonathan J., Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities (June 16, 2022). American Journal of Public Health (2022), Available at SSRN: https://ssrn.com/abstract=4157807

Rebecca Wolitz (Contact Author)

Ohio State University (OSU) - Michael E. Moritz College of Law ( email )

55 West 12th Avenue
Columbus, OH 43210
United States

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.PORTALresearch.org

Jonathan J. Darrow

affiliation not provided to SSRN ( email )

No Address Available

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