The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation.

TY - JOUR

T1 - The Evolution of the CJEU’s Case Law on Stem Cell Patents:

T2 - Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation.

AU - Minssen, Timo

AU - Nordberg, Ana

PY - 2015/11

Y1 - 2015/11

N2 - In its judgment in International Stem Cell Corporation v Comptroller General of Patents (ISCO) rendered on 18th December 2014, the CJEU qualified its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ovums stimulated by parthenogenesis. The Court held that in order to constitute 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”. In absence of further genetic manipulation this would typically exclude parthenotes, Hence the judgment establishes a significant limitation of the extremely broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo’ since they were considered to be “capable of commencing the process of development of a human being”. The ISCO decision is to be welcomed since it provides a reasonable and ethically justifiable leeway for patenting. This offers much needed support to the commercial viability of cell therapy research in Europe. Yet, ISCO only applies to certain hESC cells, and further clarifications would be helpful with regard to other non-totipotent hESCs.

AB - In its judgment in International Stem Cell Corporation v Comptroller General of Patents (ISCO) rendered on 18th December 2014, the CJEU qualified its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ovums stimulated by parthenogenesis. The Court held that in order to constitute 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”. In absence of further genetic manipulation this would typically exclude parthenotes, Hence the judgment establishes a significant limitation of the extremely broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo’ since they were considered to be “capable of commencing the process of development of a human being”. The ISCO decision is to be welcomed since it provides a reasonable and ethically justifiable leeway for patenting. This offers much needed support to the commercial viability of cell therapy research in Europe. Yet, ISCO only applies to certain hESC cells, and further clarifications would be helpful with regard to other non-totipotent hESCs.

KW - Faculty of Law

KW - patents, stem cells, biotech, innovation

M3 - Journal article

SN - 0027-6723

VL - 2015

SP - 493

EP - 503

JO - N I R

JF - N I R

IS - 5

ER -