In case you missed it, the European Court of Justice grabbed headlines last year with its decision in Brüstle v. Greenpeace, a long-running case concerning the patentability of embryonic stem-cell research in Europe.
In essence, the ECJ ruled that research procedures which use embryonic stem-cells cannot be patented within the European Union.
The case began in 1997 when Dr Oliver Brüstle, a neurology professor at Bonn University, sought to patent a process for extracting neural precursor cells from human embryonic stem-cells. The patent was successfully filed in Germany, but was subsequently contested in the German courts by Greenpeace.
The dispute ultimately relied on an EU biotechnology directive which states: “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to [public order] or morality.… [I]n particular, uses of human embryos for industrial or commercial purposes … shall be considered unpatentable.”
In EU law, such directives are binding on EU member-states.
A German federal patent court initially invalidated the patent, prompting Professor Brüstle to appeal to Germany’s Federal Court of Justice, and it was this court which sought a ruling from the European Court of Justice — the highest court in the EU — on how the biotechnology directive should be applied.
The key elements of the ECJ’s ruling are worth noting.
First, the court defined the term “human embryo” in broad terms, affirming that it includes not only any fertilised human ovum, right from the moment of fertilisation, but also any non-fertilised human ovum which has had the nucleus from another human cell placed within it (i.e., a cloned human embryo) or whose development has been stimulated by parthenogenesis (i.e., without any paternal genetic material from either spermatozoa or from another cell’s nucleus).
The court even left open the possibility that, where a stem-cell is derived from a human embryo, the extracted stem-cell might itself constitute a human embryo for the purposes of the biotechnology directive.
In light of its definition of the human embryo, the court held that a stem-cell line obtained from any such embryo, even at the early blastocyst stage, cannot be patented under EU law; neither can any process or invention which depends on the use of human embryos at any stage be patented, even if the specific process or invention for which the patent is being sought does not itself refer to the use or destruction of human embryos.
The decision was met with muted joy by opponents of embryonic stem-cell research — including churches and pro-life organisations — and with muted outrage by researchers in the field, a reaction which reflects the somewhat muted significance of the decision itself.
On the one hand, it is a relief to see a court of any kind, let alone the highest court in Europe, acknowledging that the human embryo does in fact have a degree of inherent dignity worth protecting.
On the other hand, the ruling only confirms that the patenting of embryonic stem-cell research is prohibited; it does not prohibit the research itself. The court’s decision is thus laden with a sort of twisted irony, confirming that while EU law protects human embryos from the indignity of being commercialised, it does nothing to defend them against the indignity of being destroyed.
European researchers whose work revolves around embryonic stem-cells were predictably angered by the decision. Professor Brüstle noted that while “fundamental research can take place in Europe … developments that follow from that cannot be implemented in Europe”.
Professor Brüstle’s reaction echoes an earlier warning from the International Society for Stem Cell Research that “excluding products or technologies based on embryonic stem-cell research from intellectual property protection will preclude investment in potentially life-saving treatments”.
Certainly, commercialising embryonic stem-cell research in Europe has been made more difficult by the ECJ’s ruling, and opponents of embryonic stem-cell research could be forgiven for hoping for a slowdown of research of this nature on the Continent.
However, a statement from the London Regenerative Medicine Network reveals that the warnings of Professor Brüstle and the ISSCR may have overstated the real impact of the ECJ’s decision.
Rather, in the view of the LRMN, the decision was “not as destructive to progress in this field as has been widely suggested.… Even if the decision does prohibit some patents regarding embryonic stem-cells, there are a variety of technical and regulatory reasons why this would not actually affect any development of the UK cell therapy industry.”
Suffice it to say that the embryonic stem-cell train is likely to keep chugging along for now, despite its ethical failings, manifest lack of therapeutic results, and this new (albeit minor) dent in the likelihood of developing profitable therapies through European-based research.
Nevertheless, it cannot be denied that the ECJ decision offers some affirmation, however small, of the inherent dignity of human life at its earliest stages. And that is reason, however small, for hope.
Tim Cannon is a spokesman for the Australian Family Association.