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Balancing Innovation, ‘Ordre Public’ and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law
European Journal of Health Law ( IF 0.6 ) Pub Date : 2022-04-08 , DOI: 10.1163/15718093-bja10073
Duncan Matthews 1 , Timo Minssen 2 , Ana Nordberg 3
Affiliation  

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.



中文翻译:

在人类种系编辑中平衡创新、“公共秩序”和道德:呼吁专利法采取更细致的方法

本文分析了“公共秩序”和道德例外在人类种系编辑领域的发明专利授予中可以发挥的作用以及该政策选择的后果。为了提供此类分析的背景,本文将首先概述相关基因组编辑技术的当前专利格局,提请人们注意最近的专利纠纷,其次,审查“公共秩序”和道德例外情况。国际、国家和地区法律中的专利法,以及对创新和获得新疗法的影响。文章认为,专利例外不应被用作生硬的政策工具,也不应以违背专利制度总体目标的方式进行解释。人类种系编辑背景下的“公共秩序”和基于道德的例外不应被解释和应用,从而导致与平衡创新与保护社会更高规范价值观的目标相悖的结果。相反,例外的适用应基于对基础科学以及更广泛的伦理、社会和法律影响的充分理解,从而能够根据具体情况做出决定,为专利权利要求修改和细致入微的分析提供基础。有目的的保护。因此,关于这种灵活性在基因组编辑技术背景下可以发挥的作用的进一步分析和辩论既必要又可取,并且可以通过本文所述的方式来促进。

更新日期:2022-04-08
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