Patent Eligibility and Precision Medicine: Emerging Technologies, Legal Flux and Empirical Methods
Patents and Emerging Technologies (edited collection)
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Sagar, a., Liddell, K., Liddicoat, J., & Aboy, M. Patent Eligibility and Precision Medicine: Emerging Technologies, Legal Flux and Empirical Methods. Patents and Emerging Technologies (edited collection) https://doi.org/10.17863/CAM.74388
To support emerging technologies the interests of the innovators of today must be carefully balanced with those of tomorrow. This constitutes one of the most fundamental challenges of the patent system. The patent system is designed to be applied to new forms of technology. Yet, the uncertainties, ambiguities, and transformative potential inherent to an emerging field like precision medicine present policymakers with difficulties finding the right balance, sometimes leading to unpredictable legal flux. Information-based innovations, particularly those in the life sciences, often lie close to the boundaries of patent ineligibility proposed for fundamental natural laws, abstract ideas, and other categories that could broadly pre-empt future innovation. In the emerging field of precision medicine, the challenges that arise from these boundaries have resulted in considerable change in the patent law of Europe (in the 1990s) and in the US (first in the 1980s and then in the 2010s). This chapter will offer evidence of this ‘legal churn’ and will invoke the Nuffield Council on Bioethics’ report on emerging biotechnology’s three characteristics of i) technological uncertainty, ii) ambiguity, and iii) transformative potential as an analytical lens through which to rationalise the flux. This chapter will also discuss the role of empirical studies in mitigating the problematic aspects of legal flux in the context of emerging biotechnology. In particular, it will show that empirical analysis is a useful tool for helping to steer the course through the confusion entailed by tumultuous legal change, and can help mitigate some of its more pernicious aspects.
This work was supported, in part, by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement number NNF17SA0027784).
Novo Nordisk Foundation (via University of Copenhagen) (NNF17SA0027784)
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This record's DOI: https://doi.org/10.17863/CAM.74388
This record's URL: https://www.repository.cam.ac.uk/handle/1810/326939
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