Human dignity as a bar to bio-patentability in European Patent Law: An exposé and a novel reform paradigm

Abstract

This research addresses a gap found in the literature which is that there is a lack of coherence about the standard of the fundamental, but under-defined, concept of human dignity in European patent law. This problem of uncertainty about the standard of human dignity is concerning because European patent legislation mandates that it must be safeguarded in the patenting of biotechnology. Notably, a substantial reason for this lack of coherence in adjudicating human dignity as a bar to bio-patentability is fragmentation. Multiple parallel court regimes on the continent of Europe have competency to decide cases that raise human dignity issues. Thus, this thesis tackles the pertinent but challenging issue of arbitrating human dignity in bio-patent cases within and across the fragmented European patent system. It seeks to find out whether a less fragmented decision-making structure can help to develop a more coherent standard of human dignity as a bar to bio-patentability in European patent law. It carries out a doctrinal study of the legislative instruments and case law at the European Patent Office and the Court of Justice of the EU to identify the problem. It employs interdisciplinary methods to critique past arbitration of human dignity in bio-patent cases. Also, it conducts an external inquiry of the concept of human dignity to study how it is treated in philosophy, in bioethics and in other courts. Ultimately, it makes a timely original contribution by proposing a reform paradigm that offers a less fragmented decision-making process that can improve coherence in the adjudication of human dignity in European patent law.