On 18 October 2011, the European Court of Justice handed down a ruling in a case about German patents relating to isolated neural precursor cells, their production from embryonic stem cells, and their therapeutic use. The court’s judgment has received much discussion, a fair bit of it unfavourable. It raises important questions about bioethical principles, the regulation of biotechnology, and the role of the state in these controversial areas.
Let’s try to get the facts and the nature of the case reasonably clear, as these are obscured in much of the discussion that I’ve seen. The case was brought by Greenpeace in the German courts, seeking the annulment of a patent held by Mr Brüstle. The German courts referred certain questions of law to the European Court of Justice, and the answers to these are likely to determine the overall outcome: in the event, it appears that the patent cannot survive. In effect, the court has all but struck down the patent, though it seems that the formal determination of this will have to be made by the German courts. In any event, we can ignore the technicalities of court procedures for current purposes.
What was the European court asked to do? Basically, it answered three questions, which I’ll come to, relating to a rather complex body of legal instruments that regulate biotech patents in Europe. The immediate source of regulation in the case was Germany’s Patentgesetz (law on patents), which forbids patents on “inventions whose commercial exploitation would be contrary to ordre public or morality”; this is then elaborated at paragraph 2(2)(3) to include “uses of human embryos for industrial or commercial purposes”.
The Patentgesetz provisions are, in turn, supported by a Directive of the European Parliament relating to the legal protection of biotechnological inventions (i.e. to biotech intellectual property). The Directive excludes a wide range of innovations from being patentable and its preamble includes the words: “uses of human embryos for industrial or commercial purposes must also be excluded from patentability”. Article 6 expressly forbids patenting of “uses of human embryos for industrial or commercial purposes.” This elaborates on the statement in Article 6(1) that, “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality.”
In turn, a European convention relating to intellectual property requires that Eurppean patents not be given for “inventions the commercial exploitation of which would be contrary to ‘ordre
public’ or morality.”
I trust that the pattern is clear – at the respective levels of international conventions, a European Directive, and national (in this case German) law, we see an exclusion of patents whose use would supposedly be contrary to ordre public or morality. Where biotechnology is addressed more specifically, including in the Patentgesetz, it is made clear that such forbidden patents include those on “uses of human embryos for industrial or commercial purposes”.
The questions addressed by the court were basically as follows:
1. Were the early embryos to be used in the processes envisaged by the patent “human embryos” for the purpose of the Directive, and hence of the Patentgesetz? Answer, yes – though this would not necessarily apply to actual cells extracted from embryos (it would depend on whether they were capable of developing into fully formed human beings).
2. Were the scientific and therapeutic uses described in the patent application “uses of human embryos for industrial or commercial puposes”? Answer, (basically) yes.
3. Did the exclusion also apply to processes that did not directly employ human embryos, but relied on the previous destruction of human embryos? Answer, yes.
These answers render the patent untenable.
I suggest that the first two answers are actually quite plausible. The third is less so, as it does not conform to the literal wording of the relevant legal instruments. Still, it is at least arguable that this is a legitimate extension: the court appears to have believed it necessary to achieve the provision’s purpose, and specifically to avoid contrived evasions. Hence, I don’t wish to argue that the court was wrong as a matter of law. It seems to me that any problems are with the provisions themselves rather than with their interpretation by the European Court of Justice. To be clear, I do see problems.
Before getting to that, let me set aside another set of issues. There are arguments in the relevant literature that some kinds of biotech patents should not be granted for other reasons: for example, because they are economically inefficient (as is sometimes said of patents on DNA sequences) or because they are too much like patents on discoveries or mere products of nature, rather than on inventions or humanly-devised processes. However, no argument along these lines was employed in the case we’re considering.
The issues I see relate to the inclusion, at various levels of the law, of a requirement that patents not be given for inventions or processes whose use would be against “ordre public or morality” and the specific inclusion within that requirement of patents on uses for human embyros.
First, we might ask is all this really the proper role of the state. Should it be singling out as unpatentable certain inventions and processes that might be socially useful merely because their use would be contrary to some concept of morality? The notion of ordre public appears difficult to apply in this case, since it is difficult to see how the social structure or its functioning could be damaged by the use of the patented processes. This really seems to be a case where a particular, somewhat esoteric, and certainly contested, morality is being given legal effect. The destruction or commercial/industrial use of human embryos is being treated as immoral because it is repugnant to a particular conception of human dignity rather than, for example, because citizens’ civil interests in life and health are threatened, or because suffering is being inflicted on sentient creatures. Should the state really be getting into this?
Second, even if it should be … isn’t it more plausible that conducting embryonic stem-cell research or employing cells in new therapies is actually morally good? This kind of research and therapy appears to be in the public interest, and it is difficult to see how the state could decide otherwise unless it adopted some sort of reasoning based on otherworldly considerations, or at least on an esoteric morality whose official endorsement would be inconsistent with liberal ideas of social pluralism. Is that what we want the state to be doing when it enacts its laws?
We seem to have grounds to protest about the immediate case, even if the fault is with the legal instruments rather than the court’s interpretation of them. Beyond this, however, perhaps it’s time to revisit the widespread invocation of ordre public and morality in legal instruments, especially in international conventions. Though the word “morality” tends to be read somewhat narrowly by courts and other official bodies, since some moral code or another could be used to justify almost any law, there remains the prospect that esoteric, perhaps religously-based, moral ideas will be imposed by force of law. That should give us pause. Is it really something we want?
The role of Greenpeace in this case might also give us pause. In what way could the patent be considered damaging to the natural environment? It may be inconsistent with some systems of environmental ethics, but that’s not the same thing. How attractive is Greenpeace as an organisation deserving our support if it is going to seek judicial enforcement of a rather esoteric moral system that is not usually considered compulsory in modern liberal democracies?
At the least, there seem to be grounds here to consider whether the sweeping protection of human embyros in European patent law is really justified. Even if a case can be made out for discouraging certain uses of human embryos, the current provision in patent law appears far too unnuanced. There is a prospect that it will discourage valuable research and delay new therapies. This case merits all the scrutiny that it’s getting – time, I think, to change the law. At the very least, the law needs some fine-tuning to avoid such harsh outcomes. I suggest you make up your own mind about Greenpeace; in my case, this litigation doesn’t make me feel more friendly to it.