The EU Court’s ban on embryonic stem cell patents and products derived therein continues to be the focus of attention and comments in scientific journals and newspapers, and will no doubt do so for a long time to come in the light of the unexpected and far-reaching scope of the ban. National patent offices in Europe and the European Patent Office have yet to analyze the implications of a judgment which requires the application of a uniform, judicially constructed definition of the human embryo across Europe, contrary to the existing diversity of legal definitions (see Asa Hellstadius, ‘A Comparative Analysis of the Implementation of the Directive’s Morality Clause’, in Plomer & Torremans, Embryonic Stem Cell Patents: European Law and Ethics, OUP, 2009) and the submissions of member States to the court.
Opponents of hESC research see the judgment as a ‘milestone’ and vindication of the rights of the embryo. But as legal definitions in this area have singularly been outstripped by the pace of scientific advance (see R v. SoS for Health ex parte Quintavalle), the Court’s ruling is likely to invite future challenges and fuel the chronic legal uncertainty which has attended the interpretation of the scope of moral exclusions in the Directive. It is also possible that the ban may have unintended consequences and catch the work of scientists who have re-directed their research efforts to adult stem cells (including induced pluripotent cells or iPS cells) in the face of the persistent and powerful opposition of religious lobbies (see recent advances published in Nature only last month).
Meanwhile, those who see the ban as a welcome freeing of the field through the invalidation of broad, foundational patents already granted, should reflect on the legal basis of the ruling and its reach. The justification for the ban is in no way to remove barriers to hESC research or commercialization posed by patents, something which would be wholly at odds with the aims of the Directive which is to enhance and strengthen patent protection in Europe. Instead, the ban is based on the Court’s view that research which requires destruction of human embryos violates respect for human dignity. Yet ‘human dignity’ is a notoriously indeterminate concept, and particularly so in its application to human embryos. Contrary to the Court’s view, a substantial number of countries in Europe permit research on ‘spare’ IVF embryos, in accordance with the consent of the donors. There is no industrial and commercial use or ‘farming’ of human embryos in Europe. The research is conducted under tight ethical and legal frameworks on registered lines. Thus, the effect of the ruling is to render unpatentable research which is not only considered morally permissible but is lawful in a substantial number of member States in Europe. This was never the intention. On the contrary, the drafting history of the Directive shows that it was specifically envisaged by the legislator that research which was lawful in member States should not be rendered unpatentable by the Directive (see G. Porter, The Drafting History of the European Biotechnology Directive, in Plomer & Torremans, supra). Moreover, the ban affects not only upstream hESC patents, but any downstream regenerative products which use the ‘morally tainted’ lines, irrespective of how removed the application may be from the original derivation. The practical implication is that none of the publicly (or privately) funded research on established hESC lines (including research funded under the EU FP7 program, or national policies such as the UK Stem Cell Initiative) can be commercialized in Europe. As research in the field is anticipated to yield important advances in regenerative therapies, the economic implications of turning Europe into an hESC patent free zone could be far reaching.