Vaccine Licensure in the Public Interest: Lessons from the Development of the U.S. Army Zika Vaccine

Authors

Ana Santos Rutschman, Saint Louis University School of Law

Document Type

Article

Publication Date

Winter 1-15-2018

Abstract

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding that exclusivity would serve the public interest with respect to the Zika vaccine. This proposed deal reflects the broader licensing opacity in the current regime, which undermines § 209’s safeguards. The Essay proposes changes to the Patent Act to increase transparency and accountability in the licensing process, which would ultimately result in more affordable vaccines for outbreak diseases like Zika.

Recommended Citation

Ana Santos Rutschman, Vaccine Licensure in the Public Interest: Lessons from the Development of the U.S. Army Zika Vaccine, 127 YALE L.J.F. 651 (2018), http://www.yalelawjournal.org/forum/vaccine-licensure-in-the -public-interest.