Balancing innovation, ‘Ordre Public’ and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law
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Balancing innovation, ‘Ordre Public’ and Morality in Human Germline Editing : A Call for More Nuanced Approaches in Patent Law. / Matthews, Duncan; Minssen, Timo; Nordberg, Ana.
In: European Journal of Health Law, Vol. 29, No. 3-5, 2022, p. 562-588.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Balancing innovation, ‘Ordre Public’ and Morality in Human Germline Editing
T2 - A Call for More Nuanced Approaches in Patent Law
AU - Matthews, Duncan
AU - Minssen, Timo
AU - Nordberg, Ana
PY - 2022
Y1 - 2022
N2 - This article analyses the role that ‘ordre public’ and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to recent patent disputes and, second, examine ‘ordre public’ and morality exceptions under patent law in international, national and regional law, and the implications for innovation and access to novel treatments. The article argues that patent exceptions should not be used as a blunt policy instrument, nor interpreted in a way that is contrary to the patent system's overall objectives. The ‘ordre public’ and morality based exceptions in the context of human germline editing should not be interpreted and applied in a way which results in outcomes counterproductive to the goal of balancing innovation with the protection of societal higher normative values. Instead, the application of the exception should be based on a sound understanding of both the underlying science as well as the broader ethical, social and legal implications, thus enabling case-by-case decisions that provide the basis for patent claim amendments and nuanced purpose-bound protection. Further analysis and debate as to the role that such flexibilities can play in the context of genome editing technologies is therefore both necessary and desirable, and can be facilitated in the ways set out in this article.
AB - This article analyses the role that ‘ordre public’ and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to recent patent disputes and, second, examine ‘ordre public’ and morality exceptions under patent law in international, national and regional law, and the implications for innovation and access to novel treatments. The article argues that patent exceptions should not be used as a blunt policy instrument, nor interpreted in a way that is contrary to the patent system's overall objectives. The ‘ordre public’ and morality based exceptions in the context of human germline editing should not be interpreted and applied in a way which results in outcomes counterproductive to the goal of balancing innovation with the protection of societal higher normative values. Instead, the application of the exception should be based on a sound understanding of both the underlying science as well as the broader ethical, social and legal implications, thus enabling case-by-case decisions that provide the basis for patent claim amendments and nuanced purpose-bound protection. Further analysis and debate as to the role that such flexibilities can play in the context of genome editing technologies is therefore both necessary and desirable, and can be facilitated in the ways set out in this article.
U2 - 10.1163/15718093-bja10073
DO - 10.1163/15718093-bja10073
M3 - Journal article
C2 - 37582537
VL - 29
SP - 562
EP - 588
JO - European Journal of Health Law
JF - European Journal of Health Law
SN - 0929-0273
IS - 3-5
ER -
ID: 292063481