Stem-cell research patents – the case of Brüstle v. Greenpeace

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.

  1. Thanks for this Russell! A very astute analysis of what all of this is about – best I’ve seen so far, actually. One thing, though, re. the point that it shouldn’t be the role of the state to meddle in this particular matter. Since the patent system as such is in fact a privilege supplied to the commercial sector by the state, it may be argued that the state is free to make whatever requirements it wants to. I also think that the idea of the view on embryos that seems to lie behind the patent ban is not as esoteric in Europe as you assume. Many countries are distinctly catholic, and several of them (such as Poland and Ireland) apply total bans on embryo research, while many others restrict it severely. My own views are different, of course, but this is the political reality of the EU.

  2. Sorcha Ui Chonnachtaigh

    Notwithstanding the questionable legal basis for the ruling and the possibly suspect motivations of the parties in the case (re which I accept your critique), I wonder if the debate about patentability is being steam-rolled somewhat by private interests. The argument(s) in favour of patenting concern advancement of scientific progress in this area but the ability to profit from research is not the only thing that progresses it (in fact some argue that it hinders research). I am somewhat agnostic about patents (I do think there should be reward for financial and human investment in research but not sure that the current system is entirely just). If the aim of patent proponents is speedy and quality research, I want to see evidence that (i) patents achieve this end better than any other system, and (ii) an argument that it is the most just way of doing so. This ruling doesn’t prohibit ES cell research itself, only the generation of certain patents.

    One minor point (to Christian) regarding Irish law, it is largely the Constitution that has been guiding opinion on the legal permissibility of embryo research. Recent case law (Roche v Roche 2009) has established that the in vitro embryo does not have the same legal status and protections as that conferred on the in utero embryo by the Constitution. So a ‘complete ban’ can no longer be assumed.

  3. Christian Munthe

    Sorcha,

    that is intersting information. Thank you!

  4. To be honest, I’m finding it a bit of a stretch to see any philosophy in this. Reads a bit like a solicitor’s letter.

  5. The issue of whether and under what circumstances patents are justified is absolutely (partly) a philosophical question (especially if it concerns something such as BRCA1 and BRCA2).

    The point Russell is making is that it seems in this case that the decision has been made on the basis of spurious – and perhaps religiously motivated – moral notions.

    Plus, there are also wider issues about whether in cases such as these one wants the state to make judgements about the public moral good at all.

    Again that’s in part a philosophical question.

    So I’m not sure why you can’t see the philosophy in it. (Not that it would matter if there were no philosophy, since the bloggers here are not obliged to do philosophy in all their posts).

  6. Yes, there are very powerful arguments, I think, that the sort of morality apparently underpinning the law here is just wrong (or as “just wrong” as can ever be said of a moral position). Indeed, I’ve made some of those arguments elsewhere.

    But there’s also an issue of how far the state should be determining its policies on the basis of working out the true morality, if there’s such a thing, which could involve first having to work out the true religion or the true metaphysical system … since at least some moral systems seem to claim their justifications from religious teachings or metaphysical views. That seems like a potentially dangerous path for the state to go down, but of course there are questions about how should the state be making its decisions on what laws it enacts, etc., if not by first discovering the true moral system and applying it.

    I address this at some length in Freedom of Religion and the Secular State, but I don’t pretend to have an answer that’s going to convince everyone regardless of his or her starting point.

    The question of what counts as an esoteric morality is an interesting and tricky one. Perhaps it’s not answerable in a way that will convince everybody, and perhaps there’s no one criterion. Once again, though, how far should the state be applying a moral system – however popular it has become – that is justified by religious teachings or by a metaphysical system, or by some other body of thought that employs concepts which are not transparent to the general population, and into which we don’t expect everyone to be initiated? That’s rough and ready, admittedly, but there does seem to be a difference between a moral imperative not to initiate violence against the people around us, not to lie to them gratuitously, not to steal their property, and so on, based on fairly commensensical and widely-shared ideas, and a moral imperative not to destroy an early embryo, based perhaps on the idea that doing so violates a teleologically-conceived natural order, or is against the will of a god, or destroys something with a spiritual soul, or destroys something with a “dignity” or “worth” based on the fact that it is genetically human.

    There are going to be grey areas, alas, and although I have some fairly strong views on these things the post asks questions … and the questions aren’t entirely rhetorical.

  7. Russell,

    Thank you an interesting and important piece.

    Some EU member states have enacted laws that are “inconsistent with liberal ideas of social pluralism” as a result of the “otherworldly considerations” of large and vocal sections of their populace in order to prohibit or severly restrict (amongst other things) embryonic stem-cell research (and abortion). Within those jurisdcitons – it does seem to be the case that, on the basis of (largely) religous sentiment, there has been taken to be some “moral imperative not to destroy an early embryo”. But that seems usefully distintinguished from your specific concerns about the refusal of certain biotech patents on the grounds of ‘morality’ (I quite agree that ‘order public’ has nothing to do with this).

    The biotech Directives themselves do not, as I understand it, deny that “conducting embryonic stem-cell research or employing cells in new therapies is … morally good” or that “this kind of research and therapy” is “in the public interest.” Nor do they assert that “the use of such inventions or processes is contrary to some concept of morality” or that the destruction of human embryos is, of itself, “repugnant to a particular conception of human dignity.” There is no EU-wide ban on “conducting embryonic stem-cell research” using freely donated surplus IVF embroys already slated for desruction or “employing cells in new therapies” or on destroying said human embroys in that endeavour (and now, it seems, there is no financial disincentive from doing so). There is only a bar on the commercial use of such inventions – this being the necessary condition for the denial of patentability on grounds of ‘morality’. And European patent law itself enables no “protection of human embyros” – no embyros wil be ‘saved’ on account of it – except in so far as they will be ‘saved’ from commercial exploitation…

    I do not mean to imply that you think otherwise. But it seems important to distinguish between two, or rather, three things. Firstly, the (largely) religously-driven objections to the destruction of embryos (these slowly being eroded in terms of their legal influence). And secondly ‘esoteric’ concerns about the commerical use of embryos and the commercial exploitation of technologies derived from their destruction. The concerns about commercial use are, of course, shared by many religously-minded folk but it seems some – religious or not – can accept that a small cluster of embryonic cells have no particular moral significance but remain opposed to their commerical use on the basis of some ‘esoteric’ morality (as they might also object to the selling of sperm or blood). It seems we need to look at those moral intuitions about commercial use and not only focus only those who think the destruction of embryos is “against the will of a god” or that an embryo is something with a spiritual soul.

    Further, if we have objections to some biotech patent refusals and the bans on the commrical use of embryos, and seek changes to law, it seems we must try to understand the ‘esoteric’ objections on the part of ‘the Greens’ (and others) that relate to the issuing of patents to biotechnologies whatever species they are derived from or used upon. It seems those concerns could, in principle, be quite consistent with not caring a whit whether people sell their blood, sperm, ovums or embryos or whather small clusters of cells are destroyed in order to develop the therapies needed to help those suffering from horrendous conditions – and they may designate no particular moral significance to that which is part of the human species (indeed speciesism is part of what they object to). It is the Greens with those intutions who are fighting biotech patent applications generally. They too will want to have the law changed, but not in the you or I might like.

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