Behind the Paper

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?"

Published in Bioengineering & Biotechnology

Oct 06, 2019

Prof. Mateo Aboy, PhD, SJD, Fellow IAPP

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

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Summary
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 7^th, 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.

Funding
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

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

Prof. Mateo Aboy is Director of Research in Biomedical Innovation, AI & Law at the Faculty of Law, University of Cambridge, UK. He is a member of the Centre for Law, Medicine & Life Sciences (LML) and the Centre for IP & Information Law (CIPIL) at the University of Cambridge. His multidisciplinary background includes a combination of law, engineering, regulatory science, and management experience. He holds degrees in electrical & computer engineering (BS, BSEE, MSECE, MPhil/DEA, PhD ECE), law (LLB, SJD/PhD/LLD), and international management (MBA), as well as professional registrations as a Professional Chartered Engineer (CEng, EU/ES COIT), Certified Licensing Professional (CLP), Patent Practitioner with a Bar Admission/licensed to practice in patent cases before the United States Patent Office (USPTO), Fellow of Information Privacy (FIT, IAPP), Certified Privacy Information Professional (CIPP/E), Certified Privacy Manager (CIPM), 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), and Certified Data Protection Officer (C-DPO). His research investigates the intersection of digital innovation, IP policy and economics of healthcare by exploring the key tenets of innovation with a focus on the digital health, biotech, and pharmaceutical industries. This includes investigating the transformation of medical technology, drug development and healthcare delivery, as well as the associated legal, regulatory, policy and strategy questions raised by the growth of medical AI/ML/QC and biotech innovations for personalized medicine. Mateo’s research seeks to understand the drivers of technology-based innovation, IP incentives, and the determinants of how emergent medical technologies are protected, regulated, funded, developed, adopted and used in practice.

Mateo pursues research at the interface between technology, law, and innovation. His research ranges from biomedical signal processing (BSP) and R&D of novel medical devices to evidence-based IP studies of precision medicine and information age inventions (biomarkers, diagnostics, and algorithm/AI-based inventions), medical device regulation, information security, and data protection law.

He is the author of more than 150 scholarly articles published in leading scientific, engineering and legal journals, including Nature Biotechnology, IEEE Transactions of Biomedical Engineering, Medical and Biological Engineering & Computing, Medical Engineering & Physics, Journal of Law & the Biosciences, International Review of Intellectual Property and Competition Law (IIC), and Journal of Intellectual Property Law & Practice.. His professional experience includes work in various senior executive roles both in the private sector and in academia. As a Licensed Patent Practitioner, he has successfully prosecuted numerous cases before the USPTO, focusing primarily on medical device and computer-implemented inventions. He holds over 20 patents as an inventor.

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Biotechnology

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Nature Biotechnology

Nature Biotechnology

A monthly journal covering the science and business of biotechnology, with new concepts in technology/methodology of relevance to the biological, biomedical, agricultural and environmental sciences.

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European patent protection for medical uses of known products and drug repurposing

Behind the Paper

Mapping the European Patent Landscape for Medical Uses of Known Products

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