How will today’s patent law affect tomorrow’s innovation in the areas of biomarkers; nature-based products; diagnostics; and algorithms, big data and AI?

Behind the paper "How does the emerging patent case law in the US and Europe affect precision medicine?"

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Precision medicine has stirred the excitement of patients, physicians, industry, entrepreneurs, and investors — it is already a market that is worth tens of billions of dollars with very rapid growth expected. But the future of precision medicine heavily depends on the intellectual property frameworks that apply to its various forms.  In order to chart this future, in this Nature Biotechnology paper we compare recent patent case law in the US and Europe in three areas of precision medicine: (1) biomarkers and nature-based products; (2) diagnostics; and (3) algorithms, big data, and AI. Our overarching goal is to explain how today’s law will affect tomorrow’s innovation. 

Behind the Article

The idea behind the paper originated at the 2018 CeBIL Annual Symposium that took place at Christ's College (University of Cambridge, UK) on September 7th, 2018 focused on Precision Medicine, Artificial Intelligence, and the Law (PMAIL). Following the presentation on the impacts of the Myriad, Mayo, and Alice decisions based on our previous evidence-based patent studies published in Nature Biotechnology, the co-authors started a discussion about the need for a paper that would incorporate: 1) the key US and European decisions affecting precision medicine over the last 6 years, 2) the results from  empirical studies analyzing the impact of these decisions, 3) the latest 2019 Examination Guidance of the USPTO and EPO, and 4) a comparative study of the US and European patent subject matter eligibility for precision medicine inventions. Additionally, the paper would address the three key tenets of precision medicine (biomarkers, diagnostics, and algorithms/AI). 

Prof. Mateo Aboy’s talk on Precision Medicine, AI and the Law at the 2018 CeBIL Symposium

The Team
The paper is co-authored by a multinational team of scholars from the University of Cambridge (LML), Harvard University (Petrie-Flom) and University of Copenhagen (CeBIL). The perspectives from the US, UK and Europe, as well as the multidisciplinary nature of the team were key to make the paper a reality. The co-authors are core partners of CeBIL.

Our Hope
Like all authors, we tried to write the go-to-paper in the field which answers cutting edge questions on IP and precision medicine in a single place. We hope it will be of significant interest to the readership of Nature, including scientists, physicians, legal scholars, patent practitioners, entrepreneurs, investors and corporate strategists. We know from experience that, inevitably, there will be further policy developments, possibly even substantial changes. Indeed the constancy of change was a theme in our paper. But we saw this horizon and hope that the paper will be consulted as a panoptic piece for many years to come.  

The research was supported, in part, by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (Grant No. NNF17SA027784).


Prof. Mateo Aboy, PhD, SJD, Fellow IAPP

Principal Research Associate in Biomedical Innovation, Precision Medicine, AI & Law (LML), University of Cambridge

Prof. Mateo Aboy joined the LML (University of Cambridge) in 2015. His research includes evidence-based IP studies of precision medicine and information age inventions (biomarkers, diagnostics, and algorithm-based inventions), medical device regulation (AI/ML SaMD), biomarker qualification, information security, and data privacy law. Mateo pursues research at the interface between engineering, law, and management sciences. He is currently researching the status of precision medicine inventions as patentable subject matter. A core component of this work is an in-depth quantitative analysis of trends in patenting activity and patent examination following key United States Supreme Court decisions affecting biomedical, biotech, and computer-implemented inventions (Myriad, Mayo, Alice), coupled with a comparative study of European patent law. This work sheds light on the implications of legal doctrine for prosecution strategies, licensing and innovation. Additionally, he pursues research on AI/ML SaMDs, medical device law, regulatory science, biomarker qualification, and data privacy law. This work has resulted in several Nature Biotechnology publications. Mateo’s multidisciplinary background includes a combination of intellectual property, engineering, regulatory science, and management experience. He holds degrees in engineering and data science (BS, MS, MPhil, PhD), law (LLB,SJD/PhD), international management (MBA), as well as professional registrations as a Professional Chartered Engineer (EU/ES COIT), Certified Licensing Professional (CLP), Patent Practitioner licensed to practice in patent cases before the United States Patent Office (USPTO), Lead Implementer of Information Security Management Systems-ISMS (ISO 27001), Lead Auditor of Medical Device Quality Management Systems (ISO 13485), Lead Implementer of Privacy Information Management Systems - PIMS (ISO 27701), Certified Information Privacy Profession (CIPP/E, IAPP), Certified Information Privacy Manager (CIPM, IAPP), and Fellow of Information Privacy (FIT, IAPP).