European Court Ruling on Embryonic Stem Cells: Ripple Effects

Abstract

production of cells that are to be used clinically will have to be provided when organizations seek regulatory approval. By contrast, patents provide transparency and thus facilitate competition and progress. The judgment refers only to ESCs, and a great deal of research is being carried out with other types of stem cells. A stated objective of Greenpeace UK is to bring pressure to increase research with alternatives to hESCs. There is no doubt that researchers do consider alternatives and that great interest is placed upon iPSCs. Patent applications made in the future can encompass both sources of pluripotent cells, but iPSCs are a relatively new invention, so early applications such as that made by Oliver Brü stle did not. It would be wasteful and it would delay treatment of patients if existing protocols for use of hESC derivatives are not taken to the clinic because the procedure cannot be patented. Finally, there is a real concern that Europe will be perceived as reactionary and resistant to progress in light of this regulation and that as a result, companies will choose to invest in other regions of the world. It is certainly to be hoped that this is not the case, because Europe has a fine record of research with both embryonic and tissue stem cells.

Human stem cells patents—Emerging issues and challenges in Europe, United States, China, and Japan

“…It occurs whatever the stage at which such destruction takes place and even if the claim does not refer to the use of human embryos. The Brüstle case has been widely commented both by scientists (Wilmut, ; Koch, Baum, & Trounson, ; Vrtovec & Scott, ) and lawyers (Bonadio, ; Davies & Denoon, ; Plomer, ). Third, on February 4, 2014 in the Technion Research and Development Foundation Case, the European Patent Office followed the Brüstle case excluding from patentability inventions using hESCs obtained by destruction of human embryos, whenever such destruction takes place.…”

The impact of European embryonic stem cell patent decisions on research strategies

“…10 However the opposite may also be true: American Biotechnologies societies may move to Europe to escape patents burden in the USA or in Asia 11 The exclusion from patentability may also delay medical applications as an impediment to the commercialization of cell therapies based on hESC 4,8 whereas it may also have no major impact 7 in this area. Furthermore such decisions may be seen as expressing that hESC research is considered immoral 11 whereas science regulation and intellectual property should not get mixed up. 7 Moreover, in such a context of legal clarification on patentability with stem cells, some argued they never thought it will be possible to obtain patent on hESC in case of embryo destruction.…”

“…7 Moreover, in such a context of legal clarification on patentability with stem cells, some argued they never thought it will be possible to obtain patent on hESC in case of embryo destruction. 11 It can also be considered these legal decisions have a limited impact in the lights of future technological developments: 12 it is still possible to obtain patents where hESC are obtained without embryo destruction 13 and IPS may provide new patent possibilities. While patents as such can be seen as necessary for investors, notably as they limit secrecy, patents' unavailability permits higher freedom of activities (no fear of patents' rights infringement, no royalties to pay for exploitative license) and other means to stimulate innovation can be used.…”