Embryonic Stem Cell Patents: European Law and Ethics

Abstract

For many years, the question of whether or not to permit scientists to patent human embryonic stem cells (hESCs) has perplexed Europe as a whole and the individual countries therein. This one, seemingly straightforward intellectual property (IP) law question, causes such consternation, because it requires us to address much deeper and more fundamental issues: the basic purpose of patent protection; the moral status of the embryo; the point at which we are prepared to define a fertilised egg as an ‘embryo’; and the nature of science and the purpose of discovery. Although there is a fair amount of literature on the specific IP question of patenting hESCs, there is comparatively little that takes on both that narrow IP issue and the wider ethical and sociological considerations that spring from it, making this book a welcome addition. It is only just over eighteen months since the Enlarged Board of Appeals at the European Patent Office (EPO) handed down the most recent and emphatic judgment on this issue.1 The Wisconsin Alumni Research Foundation (WARF) was asking the EPO to look again at Article 6 of Directive 98/44/EC (the EC Directive on the Legal Protection of Biotechnological Inventions) and in particular at the exclusion in Article 6(2)(c) that excludes from patentability ‘uses of human embryos for industrial or commercial purposes’. The interpretation of this exclusion by the EPO has been heavily criticised for some time, even before the WARF case brought it back into the spotlight and this collection of essays largely condemns the interpretation once again, though for differing reasons. Plomer and Torremans essentially argue that the EPO is misguided in concluding that where the hESCs are obtained by a process that inevitably results in the destruction of the embryo, this equates with using human embryos for industrial or commercial purposes. They put forward the view, very convincingly in places, that this conclusion does not follow the spirit of the Directive and that it amounts to the EPO reading in wording that is simply not there. It does not, they argue, automatically follow that just because the embryo is destroyed, there must be some commercial purpose behind its creation in the first place.

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