Patents, Morality and Biomedical Innovation in Europe: Historical Overview, Current Debates on Stem Cells, Gene Editing and AI, and de lege ferenda Reflections
Forthcoming in Daniel Gervais (ed) Fairness, Morality and Ordre Public (Edward Elgar, 2020)
19 Pages Posted: 10 Mar 2020
Date Written: June 13, 2019
Bioscience innovation has always generated heated ethical debates in society. The patent system is not immune to such discussions. The European Patent convention contains a morality and ‘ordre public’ exception in Article 53 (a) EPC, preventing patentability on grounds of lack of ethical compliance of the invention with prevailing standards. Many other jurisdictions have similar provisions or somehow impose restrictions on patentability based on similar ratio legis. The topic is further regulated in Article 6 of the Biotechnology Directive (which is also adopted in the EPC implementing rules). The ratio legis of this norm, the standards for its applicability and legitimacy to develop them are far from clear or consensual.
This chapter discusses the existence and scope of the morality exception from patentability, in Article 53 (a) of the European Patent Convention. The analysis will focus on the historic origins of the morality-based provision (Section 2) and its recent development and expansion through the Biotechnology Directive and jurisprudence (Section 3). It will then debate its rationale and interpretation as a policy tool by reference to specific examples: stem cell therapy, gene editing, and AI and big data (Section 4) and conclude with three selected points for further reflection (Section 5).
Keywords: Patent Law, exceptions from patentability, stem cell patents, gene editing patents, AI patents
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