The CJEU paves the way for the patentability of embryonic stem cells
Research into embryonic stem cells, in view of their ability to differentiate into different types of specialized cells (they are “pluripotent” cells that can change into different types of cells), has grown exponentially over the last two decades, given their potential to treat diseases that up until now were considered difficult or impossible to cure.
However, to date Europe has been averse to protecting them through patents. Indeed, Directive 98/44/EC, on the legal protection of biotechnological inventions provides that inventions involving the use of human embryos for industrial or commercial purposes are not patentable. Article 5.1.c) of the Spanish Patents Law also establishes this prohibition.
The CJEU has recently ruled on the subject, in the judgment handed down in case C‑364/13 and now accepts, under certain conditions, patents for embryonic stem cells.
The case refers to two patent applications filed by International Stem Cell Corporation with the United Kingdom Intellectual Property Office claiming, respectively, methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and methods of producing corneal tissue, which involve the isolation of pluripotent stem cells from parthenogenetically-activated oocytes.
Parthenogenesis consists in the activation of an oocyte by a variety of chemical and electrical techniques. That oocyte (“parthenote”), is capable of dividing and further developing, but only to the blastocyst stage (after around five days).
Consequently, the debate focused on determining whether a parthenote can be classified as a “human embryo”, bearing in mind that the CJEU has until now defended a broad interpretation of the concept, as it did for example in the Brüstle decision (EU:C:2011:669). According to the CJEU’s ruling in this case, in order to classify a «human embryo» as such, it must necessarily have the inherent capacity of developing into a human being.
In its judgment last December 18, the CJEU declared that according to current scientific knowledge, human parthenotes that are not capable of commencing the process of development which leads to a human being cannot be classified as “human embryos”.
This has paved the way for protecting, via patents, inventions that protect stem cells obtained from parthenotes.
Garrigues Intellectual Property Department