The patentability of biotech and precision medicine inventionssubject matter eligibility of gene-related patents, biomarkers, diagnostics and algorithms for personalized medicine

Resumen

While there is clarity with regards to the patent eligibility of industrial age technology (e.g., machines, articles of manufacture, compositions of matter), there is currently a high degree of uncertainty with regards to the patentable subject matter eligibility of information age inventions. These include biotech and precision medicine inventions, information processing inventions, artificial intelligence (AI), machine learning inventions, smart systems that rely on programmed processors implementing data science and signal processing algorithms, and computer-implemented inventions where the inventive activity resides on the algorithms as opposed to the hardware. Given the complexity of the legal, policy, and economic issues involved, the patent offices and judicial bodies on both sides of the Atlantic have struggled to formulate a clear test for determining whether and under what circumstances such information age inventions should be patent-eligible subject matter or be excluded from patent protection. As an example of the complexity underlying this question, the same hardware (e.g., a microcontroller) can result in different and novel smart devices depending on how it is programmed. Consequently, this universal and generic computing machine can be transformed into other specialised machines by incorporating application-specific information process (data science) algorithms. The result is that the same underlying hardware can be transformed into diverse smart devices, for example, a medical device for personalized diagnosis and treatment that analyzes patient-specific physiologic data and uses mathematical relationships to improve precision diagnosis, a navigation system, or a controller for an industrial plant. The legal difficulty lies in that the underlying hardware is known and therefore not patentable, and all the novelty and inventive step lies on the mathematical methods (information processing, data science, algorithms) that when programmed on the non-novel hardware create a new special-purpose device. Similarly, the field of biotech is experiencing a great deal of uncertainty, especially with regards to the subject matter eligibility of gene-related patents. These patents often claim DNA molecules with nucleotide sequences that correspond directly to coding regions from the genomes of natural organism and are currently at the centre of controversy regarding subject matter eligibility and policy issues in both the US and Europe. Recent decisions such as Myriad, Mayo, and Alice could have substantial impact on 1) patent strategy and prosecution, 2) patent policy, jurisprudence and examination guidance in developed jurisdictions including US and Europe, 3) IP liquidity, and 4) investment in innovation. As an example, the recent highly controversial Alice Corp v CLS Bank (Alice) decision has increased the uncertainty regarding the patent subject matter eligibility of information age inventions that rely on algorithms and advanced mathematical methods. Similarly, the Association for Molecular Pathology v Myriad Genetics (Myriad) and Mayo v Prometheus (Mayo) decisions increased uncertainty for life science inventions and could significantly affect current and future R&D effort and investment in precision/personalized medicine and biotech in general. This high degree of uncertainty and lack of stability surrounding patent eligibility of information age inventions could discourage research, investment, commercialization, and may be suboptimal for the overall innovation ecosystem in key areas such as precision medicine. The future of precision medicine depends on the intellectual property frameworks that apply to its various forms. 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. The primary objective of this doctoral thesis/dissertation is to report the results of evidence-based studies aimed at analyzing the impact and effect of these seminal decisions and 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. A secondary objective is to illustrate how these empirical methodologies can be applied to conduct evidence-based legal IP research and study the impact of other legal decisions affecting the criteria for patentability for biomedical innovation or other emerging information age fields. 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).