Contrary to what is commonly believed, biotech patent law and biotech patent criminal law are not ethically neutral nor exclusively composed of domestic rules. On the contrary, this field is governed by European binding laws and affected by ethical dilemmas; therefore, we must take into account the principle of secularism: which imposes to guarantee the democratic debate among different word views and different moral codes, with the aim to determine a shared and common axiological nucleus; and forbids forcing the individual consciousness when there is no room for ethical compromises. In other words, when a conduct involves unresolvable ethical conflicts between moral strangers, a secular (patent, patent-criminal) law should reject duties and bans and only provide legal justifications. From a supranational perspective, this assertion means self restraint and national margin of appreciation: indeed, before relevant axiological-juridical asymmetries at the national level, an European law that pretends to be secular should not intervene in a penetrating manner. Taking the research and the patentability of human embryonic stem cells as an example of ethical and scientific uncertainty, the paper describes the patent–, criminal – and European law in this field, and focuses on two recent judgments of the ECJ. While the first judgment (Brüstle case), in the name of human dignity, embraced an omnivorous definition of human embryo; undermined the aim and the range of the patent system; forbidden the patenting of the human embryonic stem cells; and de facto limited the freedom of scientific research, the second judgment (International Stem Cell case) constitutes a significant back-step: according to the latter decision, a human parthenote cannot be considered as a human embryo due to the lack of the inherent capacity of developing into a human being. In the opinion of the ECJ, therefore, a biological entity, for being considered as an human embryo, must have in itself the capacity of developing into a human body-being, i.e. without additional genetic manipulation; and this ratio decidendi – to which our national order is bound to be consistent ex Art. 117 It. Const. – produces relevant effects on the patenting prohibitions ex Art. 81-quinquies IIPC as well as on the research prohibitions ex Art.13 l. nu. 40/2004.
Biodiritto penale delle invenzioni e laicità europea. Sull’eterno girotondo delle cellule staminali embrionali
Valentini, Vico
2015
Abstract
Contrary to what is commonly believed, biotech patent law and biotech patent criminal law are not ethically neutral nor exclusively composed of domestic rules. On the contrary, this field is governed by European binding laws and affected by ethical dilemmas; therefore, we must take into account the principle of secularism: which imposes to guarantee the democratic debate among different word views and different moral codes, with the aim to determine a shared and common axiological nucleus; and forbids forcing the individual consciousness when there is no room for ethical compromises. In other words, when a conduct involves unresolvable ethical conflicts between moral strangers, a secular (patent, patent-criminal) law should reject duties and bans and only provide legal justifications. From a supranational perspective, this assertion means self restraint and national margin of appreciation: indeed, before relevant axiological-juridical asymmetries at the national level, an European law that pretends to be secular should not intervene in a penetrating manner. Taking the research and the patentability of human embryonic stem cells as an example of ethical and scientific uncertainty, the paper describes the patent–, criminal – and European law in this field, and focuses on two recent judgments of the ECJ. While the first judgment (Brüstle case), in the name of human dignity, embraced an omnivorous definition of human embryo; undermined the aim and the range of the patent system; forbidden the patenting of the human embryonic stem cells; and de facto limited the freedom of scientific research, the second judgment (International Stem Cell case) constitutes a significant back-step: according to the latter decision, a human parthenote cannot be considered as a human embryo due to the lack of the inherent capacity of developing into a human being. In the opinion of the ECJ, therefore, a biological entity, for being considered as an human embryo, must have in itself the capacity of developing into a human body-being, i.e. without additional genetic manipulation; and this ratio decidendi – to which our national order is bound to be consistent ex Art. 117 It. Const. – produces relevant effects on the patenting prohibitions ex Art. 81-quinquies IIPC as well as on the research prohibitions ex Art.13 l. nu. 40/2004.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
