Review of the Safe Harbor under 37 U.S.C. §271(e)(1) “Roche-Bolar” Exemption from Infringement in the United States
By Wan Chieh (Jenny) Lee and Joshua Goldberg There is currently no statutory basis in the United States for a broad “experimental use” exception to patent infringement. As outlined below, however, U.S. law provides for a more limited experimental use exception, sometimes referred to as the “Bolar exemption”, as supported by the relevant case law [...]