Part I of this Note details the discovery of Truvada for PrEP [pre-exposure prophylaxis] and the ongoing patent infringement litigation brought by HHS [United States Department of Health and Human Services], discusses the patents currently held by CDC and Gilead, and examines the shortcomings of infringement litigation as a means to expand access to the drug. Part II analyzes the mechanism of march-in rights under the Bayh-Dole Act and discusses two previously attempted applications for the HIV-management drug ritonavir to demonstrate why march-in rights will always fail to expand access to life-saving medications or reduce costs to consumers. Part III discusses the unique legal right conferred to the government under § 1498 and demonstrates why § 1498 is the correct course of action to expand access to PrEP. PrEP is a life-saving and life-altering medication. Patient access is an issue to address proactively--and prophylactically--through established intellectual property regimes.
This abstract has been adapted from the author's introduction.