Resumen de tesis. The patentability of biotech and precision medicine inventions: subject matter eligibility of gene-related patents, biomarkers, diagnostics and algorithms for personalized medicine

Abstract

[EN]The overall goal of this doctoral thesis/dissertations (SJD) is 1) to examine the impact of three seminal international cases Myriad, Mayo, and Alice) by developing evidence-based (empirical) IP studies designed to understand the effect of these decisions at various levels of analysis, and 2) to conduct a comparative legal analysis across developed jurisdictions (US and Europe) on the patentability of information age inventions affecting precision medicine (biotech and computer-related inventions). These evidence-based IP studies include three levels of analysis: - Broad-level impact analysis (before & after patent landscape effects) - Claim-level impact analysis (before & after claims, claim scope, claim strategies, claim formulations) - Prosecution-level analysis (before & after prosecution timelines, prosecutions strategies, effects on different types of entities). The results of these three level of analysis are also the basis of "wide-impact studies'' designed to understand the side effects, ripple effects, and unexpected consequences of legal, regulatory, or examination guidance changes. In summary, the fundamental aim of this doctoral thesis/dissertation is to conduct an in-depth legal analysis of key US Supreme Court decisions affecting biotech (Myriad and Mayo) and computer implemented inventions (Alice), as well as the corresponding European patent law in order to: - better understand the legal impact of these decisions across both sides of the Atlantic; - report the results of evidence-based studies aimed at analyzing the impact and effect of these seminal decisions; - offer empirical evidence to on-going legal debates about the significance of these cases on the changing landscape of patents claiming 1) nucleic acids, 2) nature-based products, 3) biomarkers, 4) medical correlations and relationships, and 4) algorithms, AI and big data techniques; and - compare the patent law jurisprudence and examine the degree of convergence/divergence with regards to substantive patent law between US and EPC signatory jurisdictions for information age inventions affecting the emerging field of precision medicine (biotech and computer-related).