In a non-binding ruling, Advocate General Cruz Villalón of the EU Court of Justice has determined that unfertilized human ova whose division and further development have been stimulated by parthenogenesis are not within the term “human embryos” in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions “as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity.” Int’l Stem Cell Corp. v. Comptroller Gen. of Patents, Case C-364/13 (E.C.J. Advocate Gen., decided July 17, 2014). The case had been referred from the High Court of Justice of England and Wales on an appeal from the U.K. Intellectual Property Office’s determination that the International Stem Cell Corp. could not patent methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes (referred to as parthenotes), as well as stem cell lines produced by these methods.
The advocate general reached his conclusion by finding that the judgment in Brüstle, C-34/10, EU:C:2011:669, did not require a contrary result. According to his ruling, the court believed in 2011 that fertilized ova, parthenotes and non-fertilized ova subjected to somatic-cell nuclear transfer were functionally equivalent, because the science at the time and the record before the court did not clarify that parthenotes cannot, without further manipulation, develop into human beings—they simply develop into the blastocyst phase from which pluripotent but not totipotent stem cells can be derived. The advocate general found the distinction significant and described how totipotent cells are capable of developing into all human cell types including extra-embryonic tissue and into a complete human being, but that pluripotent cells “can develop into all cells that make up the body, but not into extra-embryonic tissue and hence cannot develop into a human being.”
The opinion also considers how the Directive “opens up a space for ethical and moral considerations under the categories of ordre public and morality, a space that is particularly pronounced when it comes to biotechnology relating to the species homo sapiens.” In this regard, the advocate general states that each member state may determine which inventions are not patentable in light of considerations of ordre public and morality, but that the Directive “establishes a nucleus of non-patentability, a kind of ‘no-go zone’ that is common for all Member States as an expression of what has to be considered unpatentable in any case.” In this category are human embryos. By defining parthenotes not subject to further manipulation as not within the definition of “human embryos,” the advocate general removed them from this unpatentable baseline.
Several countries participated in the proceedings and advanced a similar position, although Poland argued that “in the interest of safeguarding human dignity the [Brüstle] Court correctly relies on the capacity of commencing the process of development of a human being.” Because parthenotes “initially undergo the same stages of development as a fertilised ovum, namely cell division and differentiation,” Poland argued that they thus “constitute human embryos.” The advocate general disagreed, saying “the mere possibility of a posterior genetic manipulation altering the fundamental characteristics of a parthenote does not change the parthenote’s character before the manipulation.”