Patentability of Human Enhancement: From Ethical Dilemmas to Legal (Un)Certainty
Book chapter, in Tana Pistorius (ed), Intellectual Property Perspectives on the Regulation of New Technologies, Edward Elgar Publishing, Incorporated (Forthcoming)
29 Pages Posted: 22 Apr 2016 Last revised: 23 Nov 2018
Date Written: October 21, 2014
Emerging technologies, such as nanotechnology, are paving the way for future revolutionary advances in science that may open the possibility to change the very anthropological definition of human being. This mere possibility has lead to ethical interrogations concerning the nature and boundaries of human nature and our relationship with science and technology. Meanwhile the Law has faced the challenge of reflecting on the legitimacy to legislate and whether the existing legal framework is appropriate to address the ethical concerns that emerging technologies bring fourth. It is a delicate balancing act between human dignity, autonomy, non-discrimination, equality, and justice. Anchored in this background, this work is a reflection on the role of European Patent Law in this debate.
The European Patent system contains rules designed to prevent the grant of patents concerning inventions that do not conform to the prevailing ethical standards – article 53 (a) European Patent Convention. Thus, in a sense European Patent Law was entrusted with a regulatory function. However, not only such construction is objectionable in abstract terms, as new technologies pose growing challenges to its effectiveness. Several issues require clarification. First, while the EPO Boards of appeal may have institutional legitimacy to determine if a certain technology or technological field conforms with the prevailing ethical principles in Europe, it is more difficult to accept that the European Patent Office Boards of Appeal may have been given the task to autonomously determine what is to be considered the common prevailing ethical standards of the signatory states to the European Patent Convention. Second, new technologies typically have a mixed nature, offering a wide range of uncontroversial benefits to humanity while simultaneously posing complex ethical challenges. Third, the patent system by its nature can only go as far as reducing economic incentive to innovation leading to non-ethical inventions. Thus, the debates concerning the patentability of human enhancement need to be closely linked to the function of patents and the ratio legis of the specific patent norm.
This article will begin by analyzing the concept of human enhancement and proposing for the current patent law analysis purposes its replacement with a more neutral term and narrow definition. The ethical questions surrounding these technological advances and prospects will be reviewed from a legal perspective, by framing such ethical considerations as human rights and general principles of law. Building upon the previous considerations the third part of this article will consider the patentability of technologies that provide the means to intentionally develop, modify or introduce in the human body aesthetic features, physical or cognitive performance levels and abilities beyond the human species typical standards under the current evolutionary state, and resulting in induced permanent alterations in light of the current rules of the European Patent Convention, corresponding implementing regulation rules (correspondents to the Biotechnology Directive) and EPO Boards of Appeal decisions.
Keywords: Patent eligibility, European Patent Law, Law & Ethics, Law & Emerging technologies, Human Enhancement
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