Emily Iroz Rich


Beyond question, medical diagnostic tests, they save lives. The diagnostic tests also contribute to the overall health of the U.S. economy. However, the current state of subject-matter eligibility for patent protection does not incentivize the research and development of these life-saving tools. Previous legislative and judicial efforts to fix subject-matter eligibility have failed. This article proposes a diagnostic patent act to allow the protection of in vitro diagnostic tests. The proposed diagnostic patent act would include safeguards to allow adequate access to fundamental research while incentivizing the return of investment to the patent holder. Safeguards would include exceptions to patent infringement claims and compulsory licensing requirements under certain conditions. Exceptions, which limit infringement liability to third parties in specific situations, would be used for narrow experimental use and mandatory processes required to comply with federal regulations. Compulsory licensing, which requires patent holders to allow third parties to use a patent in certain circumstances in exchange for a determined fee, would be permitted when the patent holder acts in an anti-competitive way and for governmental or public health uses. The combination of these limitations on a patent holder’s exclusive monopoly will ensure that access to research is available while patent holders are adequately incentivized to develop innovative diagnostic tests.