Edited by Daniel J. Gervais
Chapter 11: Patents, morality and biomedical innovation in Europe: historical overview, current debates on stem cells, gene editing and AI, and de lege ferenda reflections
This chapter discusses the morality exception from patentability, in Article 53(a) European Patent Convention (EPC). The analysis will look into the history of the provision and debate its rationale and interpretation. Bioscience innovation has always generated heated ethical debates in society. The patent system is not immune to such discussions. The EPC contains a morality and ordre public exception in Article 53(a), 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 and the standards for its applicability and legitimacy to develop them are far from clear or consensual. Innovation in cutting-edge biosciences always implies a certain level of uncertainty concerning future technological possibilities. The same can be said in regard to any legislative attempt to regulate such technologies. The Biotechnology Directive was enacted in 1998 after a long legislative process. At the time, the academic and policy discussions were based on mere abstract scientific possibilities and imaginary dystopic eugenic futures. Today we are confronted with realistic possibilities for life-saving genetic health interventions that can be made possible provided there is enough incentive to innovation in genetic therapy. Science and technology has progressed considerably in the last 20 years. It will be argued that developments in scientific knowledge and technology are a factor to be taken into consideration in legal interpretation and de lege ferenda proposals.
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