title: European stem cell research in legal shackles.
abstract: Advances in stem cell biology have raised legal challenges to the patentability of stem cells and any derived technologies and processes. In 1999, Oliver Brüstle was granted a patent for the generation and therapeutic use of neural cells derived from human embryonic stem cells (hESCs). The patent was challenged and put before the European Court of Justice, which ruled that inventions involving the prior destruction of human embryos cannot be patented. The legal maneuvering around this case demonstrates that the future of stem cell-based patents in Europe remains unsettled. Furthermore, owing to the European Court's broad definition of hESC as 'any cell that is capable of commencing development into a human being,' novel technologies that could eliminate the need for hESCs, such as induced pluripotent stem cells (iPSCs), are at risk of being included under the same ruling. Advances in the in vitro development of germ cells from pluripotent stem cells may one day provide a direct developmental path from iPSC to oocyte and sperm, and, according to the European Court's reasoning, legally equate iPSCs with human embryos. In this review, we will briefly discuss the Brüstle v Greenpeace case and the implications of the European Court of Justice's ruling. We will identify potential risks for stem cell research and future therapeutics resulting from the broad legal definition of the human embryo. Finally, we will broach the current legal landscape, as this broad definition has also created great uncertainty about the status of human iPSCs.
authors.affiliation: Department of European Law, Utrecht University Law School, Utrecht, The Netherlands.
authors.forename: Myrthe G
authors.initials: MG
authors.lastname: Nielen
authors.forename: Sybe A
authors.initials: SA
authors.lastname: de Vries
authors.forename: Niels
authors.initials: N
authors.lastname: Geijsen
mesh_terms: D000818:Animals; D001208:Asia; D053595:Embryonic Stem Cells; D005060:Europe; D006801:Humans; D008297:Male; D009865:Oocytes; D010330:Patents as Topic; D039904:Pluripotent Stem Cells; D013094:Spermatozoa; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*; D014481:United States