A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US

Abstract

In Case C-364/13, International Stem Cell Corporation (ISCO) v. Comptroller General of Patents (18 December 2014), the Court of Justice of the European Union distinguished its earlier ruling in Brustle v. Greenpeace (Brustle) with regard to the patent eligibility of non-fertilised human ova stimulated by parthenogenesis. The Court found that in order to be considered a human embryo – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This permits the patenting of innovative pluripotent parthenotes and their applications. Yet the ISCO decision also leaves considerable discretion to national courts. Hence, the full impact of the decision still depends on national implementations. Moreover, ISCO only applies to very specific human embryonic stem cells (hESCs) and lacks further clarification concerning other non-totipotent hESCs, such as stem cells created through somatic cell nuclear transfer. Considering the significance of Brustle and ISCO for regenerative medicine and cellular therapy, the persistent legal uncertainty is unfortunate. Irrespective of these flaws, however, ISCO has opened patentability doors that were previously closed and thereby reinvigorated crucial debates. Thus, this might have the “inherent capacity” of developing into a reasonable doctrine on stem cell patenting. Paradoxically, the patentability of isolated hESCs is now less certain in the US, making a brief comparison inevitable.