Today the European Court of Justice (CJEU) ruled that human embryonic stem cell patents could be allowed if organisms can't develop into human being. The decision overturns a 2011 European Union ruling that outlawed patents on hESC research, affirming that pluripotent human stem cells derived from parthoenogenetically activated oocytes can be patented in Europe.
Parthenogenesis refers to the initiation of embryogenesis without fertilization by oocyte activation in the absence of sperm though a variety of chemical and electrical techniques. The activated oocyte contains a single or double set of maternally derived chromosomes but does not contain paternal DNA.
While patents on hESC have been upheld in the United States, the European Patent Office (EPO) has refused to grant many of the same patents on ethical grounds if the commercial exploitation of those patents goes against public order or morality. Combined with a principle of noncommercialization of the human embryo, human body, and its products led Europe to deny the patentability of hESC.
Today’s judgment was precipitated though an appeal brought by International Stem Cell Corporation (ISC), a California-based biotechnology company developing novel stem cell based therapies and biomedical products seeking European patent protection. The company had initially applied to the U.K. Intellectual Property Office for two national patents covering production of stem cell lines and corneal tissue from parthenogenetically activated oocytes.
The Office rejected both applications on the grounds that the inventions in question entail use and/or the destruction of human embryos. They are therefore not patentable under the Court of Justice’s Brüstle v. Greenpeace ruling, in which the Court stated that any nonfertilized human ovum whose development has been stimulated by parthenogenesis and which is capable of commencing the process of development of a human being constitutes a “human embryo”.
Scientists have argued that the 2011 decision was based on a misinterpretation of scientific fact and should not extend to parthenotes, which the judgment said required the same protections of personhood, and lumped parthenotes made with and without nuclear transfer together. This classification was made on the grounds that these eggs are “capable of commencing the process of development of a human being just as an embryo created by fertilization of an ovum can.”
But scientists argue that mammalian parthenogenetic embryos neither develop the same way as normal embryos nor are they developmentally viable if made without nuclear transplant. They are, a commentary in Nature said, “Far down the sliding scale of developmental potential shared by all cells (including cells in the adult human body). “It is therefore misguided for the ruling to put all parthenote-derived cells, which have technical potential, at the same end of the scale as cells that can fully differentiate (totipotent cells)”.
According to Advocate General Pedro Cruz Villalón’s reading of the ruling in Brüstle, the key criterion for determining whether an unfertilized ovum is a human embryo is whether the ovum possesses the inherent capacity to develop into a human being. Parthenotes, in the Advocate General's view, don’t have this inherent capacity given current scientific knowledge and should not be considered “human beings” within the meaning of the European Parliament’s Biotechnology Directive. Advocate General Cruz Villalón, one of the Advocates General at the European Court of Justice, further noted that the situation could change in the future if parthenotes can, in fact, be genetically altered so as to develop into human beings.
Today’s ruling states that “The mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a 'human embryo',” the court ruled.
On November 4, 2014, ISC announced that the U. S. Food and Drug Administration (FDA) has cleared its human parthenogenetic stem cells line for investigational clinical use. Today’s decision marks a victory for ISC, clearing the path for European patents.