Response to USPTO's Patent Eligibility Jurisprudence Study

On July 9, 2021, the USPTO published a Request for Information notice in the Federal Register seeking comments on the current state of U.S. patent eligibility jurisprudence (Docket No.: PTO–P–2021–0032)). These comments will be used to prepare a study on patent eligibility under 35 U.S.C. § 101, focusing on how the jurisprudence has impacted investment and innovation, particularly in technologies such as quantum computing, artificial intelligence, precision medicine, diagnostic methods, and pharmaceutical treatments.<br><br>Our research group at the Centre for Law, Medicine and Life Sciences (LML), Faculty of Law, University of Cambridge, UK has been conducting evidence-based (empirical) research to assess the impact of the US Supreme Court decisions in Myriad, Mayo and Alice on biotech, precision medicine, diagnostics, artificial intelligence, and other computer- related inventions affecting digital health. Our key findings directly address several of the questions raised on the Request for Information and have been published as Patent Articles in Nature Biotechnology (enclosed with this submission).<br><br>Since 2015 the LML patent research group has been 1) examining the impact of three seminal cases (Myriad, Mayo, Alice, and follow-on case law) by developing evidence-based (empirical) IP studies designed to understand the impact of these decisions, and 2) conducting a comparative legal analysis across the US and Europe on the patentability of information age inventions affecting precision medicine (biotech and computer-related inventions). <br><br>These evidence-based IP studies include empirical legal methodologies at three levels of analysis: 1) broad-level impact analysis (before & after patent landscape effects), 2) claim-level impact analysis (before & after claims, claim scope, claim strategies, claim formulations), and 3) prosecution-level analysis (before & after prosecution timelines, prosecutions strategies, effects on types of entity).<br><br>In this response to the USPTO Request for Information we report a selection of relevant results from our evidence-based studies which analyze the impact and effect of these seminal decisions. We offer empirical evidence to on-going legal debates about the significance of these cases on the changing patent landscape involving precision/personalized medicine inventions, including patents claiming 1) nucleic acids, 2) nature-based products, 3) biomarkers, 4) medical correlations and relationships, and 5) algorithms, AI and big data techniques.<br>