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.

Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems

“…In the Brüstle versus Greenpeace case, a patent, filed by Prof. Oliver Brüstle on the production of neural progenitor cells from ESC and their use for cell-based therapy, was challenged in 2004 by Greenpeace. In 2011, the Court of Justice of the European Union (CJEU) ruled that patenting inventions based on human embryos, defined as "capable of commencing the development of a human being-derived products", is not appropriate (Nielen et al, 2013). In other parts of the world, in Asia and the USA, there is a more liberal approach to the patentability of ESC, although in the US public funding of hESC is more restricted.…”

Induced pluripotent stem cells in hematology: current and future applications

“…It has been estimated that the iPS cell market is projected to grow to US$ 1 billion by 2016. 83 Provided regulatory authorities will not pose limits to iPS cell research, 84 the growing engagement of all pharmaceutical companies appear today a crucial step for translating iPS cells from bench to bedside in the coming years.…”

Achievements, sensations and problemsof molecular prenatal diagnostics

“…Induced Pluripotent Stem Cells), ко-торые затем с помощью специфических индук-торов превращают в мужские и женские гаме-ты, способные к оплодотворению [23]. Однако юридические аспекты искусственного получе-ния гамет и эмбрионов из стволовых клеток, в том числе и индуцированных соматических клеток, пока не решены [24].…”