Wednesday, 19 October 2011

European Court Rules Against (almost all) Patenting of Embryonic Stem Cells

Yesterday, the European Court publicized its ruling on the controversial case of the patentability of human emryonic stem cell lines (hESC) in European law. I have discussed this issue in two former posts: here and here. The complete ruling can be found here and is quite long, but the conclusions are clear:

On those grounds, the Court (Grand Chamber) hereby rules:
1.      Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:
–        any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;
–        it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
2.      The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.
3.      Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
In short, hESC lines can indeed be patented, but as part of a procedure for "for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it". In other words, patenting of hESC lines for the purpose of regenerative medical purposes or research is ruled out within the jurisdiction of European patent law.


  1. But the hESC lines are coming from human embryos... Aborted for example? And before being able to "treat" embryos are you not obliged to experiment on embryos? What am I missing here?

  2. No, the embryos are not "aborted". If you abort an embryo, there will be nothing left. The embryos in question are either created through IVF, or through so-called nuclear transfer.

    And, yes, conventional medical ethics would demand that appropriate research on treatments are undertaken before the treatment is used. If the treatment would be applied to embryos, experiments would thus have to be performed on embryos. But actually, the verdict of the court would seem to allow that such treatments are patented!

    This opens the issue how this room for allowed patents should be interpreted. Would it, for example, be OK to experiment on one embryo in order to be able to treat another? In all other areas of medical research, this would be acceptable (since subjects in medical research, due to the time factor, will seldom be around when the treatment is ready for use).

  3. Thank you for this answer.
    So my lack of optimism was justified. The dignity of the human life is NOT fully recognized and respected by this decision.
    It is cheaper and more "convenient" to "create" human beings and to arrest them at the stage of embryo in order to experiment on them and then to sell treatments, than to ask the permission/consent of already born human beings, eventually adults ones, then even to pay them for being experiment material. That is a complication!

  4. Well that depends on what sort of dignity you ascribe to it - your posts don't say that.

    However, the rest of what you say is a bit hard to get a grip on, since no experiments on born human beings would advance the knowledge sought in the research done on embryos or hESC. This is the same as research done on babies or children who are not yet competent decision makers. In those cases, besides regulation demanding extra promises of the research, the parents (or custodians) usually do the consent, as in the case of embryos.

    But perhaps what you are after is that the fact that regulation allows embryos to be destroyed in research means that it expresses a difference in moral protection compared to, e.g., born children? That is entirely correct when it comes to the EU research regulation (since it leaves it up to member states to decide those things).

  5. I might add that the embryos need not have been created merely for research purposes, many of them are left-overs from the clinical practice of IVF.

  6. Well, the intrinsic dignity of any human being. Because if we are taking in account the health as criterium for dignity and we are making a selection based on that then we are talking eugenics. For example. The fact that you or I have a certain IQ does not ad to our human dignity this being equal to that of any person with Down syndrome. Right? Or less dignity than that of the "left-overs" from IVF, meaning embryos which could have become BEAUTIFUL children. Now I hope I made clear the dignity I am mentioning. It is just A HUMAN DIGNITY. No gradations. As about the advance of knowledge helping some to prosper financially on behave of a LOT OF HUMAN suffering /I would not dear to call it "Advance". Rather: regression and barbarism. Hope I made clear this aspect as well.

  7. Anyhow: I am getting the point if you are really interested in Savulescu!

  8. Ok, you don't really explain this dignity business, but I think I can place your ideas on my map. You hold the view that a newly fertilised human ovum is as important as any of those people that could eventually be helped by stem cell therapies. To destroy such an entity is as morally grave as cold-blooded murder. I won't argue with you, since this topic is not really what the patenting issue is about. Embryo experimentation is legal according to European law (although restricted more or less in all countries, including my own). The decision regarding patentability doesn't change any of that.

    As to Julian Savulescu, I'm a bioethicist and hence interested in his opinions and arguments on bioethical issues, just as much as I am interested in those of anyone else in this area. When you are a researcher, this is how you work. You don't start with setting an opinion that decide never to change - that's the job of dogmatists and preachers.

    The rest of what you say is hard for me to grasp, but I can say that I agree (as I think most people do) that it would have been a nice world if we hadn't been dependent on the pharma industry for being able to develop medical therapies, drugs, etcetera that are cheap and accessible. Unfortunately, at the moment at least, this seems however to be the case.

  9. The whole problem is what does mean to be a human being. If the metaphysical transcendence id denied, the dignity will be given only by visible attributes. But if the universe and the man has a transcendent Source, the value / dignity of man belongs to that metaphysical basis.
    I know that Peter Singer, Săvulescu & company didn't accept such transcendence, so they will take the utilitarian way. I think, instead, maybe is better to be a little bit more humble and no to pretend that we are masters of everything.

  10. Well actually, transcedence doesn't really prove anything regarding the moral issues. You have to add the premise that the trascendent feature or quality ( having an immaterial soul or whatever it is) is of moral importance. No difference there, compared to if you do not believe in a transcendent quality of some sort except, perhaps, that making likely moral importance is probably easier for things that have a place in space-time.