ECJ stem cell ruling poses serious threat to medical research

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  • Ethical concerns outweigh the advice of 'patent experts'. What is the world coming to?!

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  • With great respect to David Martin, the fears expressed in his penultimate paragraph are unfounded and may tend to bring about the very problems he refers to. It is important to correct this impression.
    As reports in Nature, Nature Reviews Drug Discovery, SCRIP, The Lancet and elsewhere all confirm, the impact of this judgment, lamentable as it may be, is extremely limited. One obvious reason is that it affects all patentees, not just those in Europe. So the incentive remains the same WHEREVER you are in the world. Ironically, it gets a bit better in Europe for the very reason that most of these patents (clinical commercialisation being some way off) were aimed at research markets. So Greenpeace inadvertently freed up research in Europe. As David correctly states,- it does not affect use. Indeed, use is explicitly down to national laws (pursuant to other EU legislation). Further, rights in derivative lines may be protected by means of access rules. In effect this ensures market protection for much longer than the term of a patent. Add to that that regenerative medicine is about very very much more than stem cells,- poster boys though they be-, and the position of research is unaffected,- slightly improved, perhaps.
    The danger of talking about sentiment as a determinant of mood, is that the statements ARE the sentiments. While any ethically minded researcher will feel his or her blood boil at the Brüstle decision, they should take comfort that it really does not affect use. In the UK, the support of the MRC and Wellcome Trust has been wholly unaffected; nor am I aware of a single project or intended project being harmed in any way. The existing research rules under the Human Fertilisation & Embryology Act are unaffected. The government's commitment to regenerative medicines, through the Technology Strategy Board, remains solid (and it is, after all, intended to create wealth). As regards EU funding (F8 etc), then it is possible that there will be issues where the intended commercial output would be trimmed (if only in Europe), but I doubt it. A look at the recitals to the Advanced Therapies Medicinal Products Regulation and the EU Tissue & Cells Directive should make it very clear that the EU has nailed rather different colours to the legislative mast than the dodgy judicial ones in Brüstle.
    Finally, David's last paragraph. While he has not set out WHY this unpleasant ruling will impact upon research in Europe (as opposed to, say, that in Australia), I suspect that it will indeed exert an influence in other quarters, for reasons which I am very happy to discuss if required.

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  • Isn't much of the research publicly funded anyway.... ie "Professor Oliver Brüstle, a neuropathologist and expert in stem cell research from the University of Bonn"

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  • I largely agree with Julian Hitchcock, although it should be pointed out that in most (all?) European countries there is an exemption from patent infringement where work is carried out for the purposes of research, although the scope of such exemption is not always clear.
    What I find mad about the decision, and debates of this kind, is that the underlying work is regarded as entirely legal and ethical, but that the patenting of such work is deemed not to be ethical. If you understand what patents actually protect, and in particular what patents don't protect (i.e. anything that has been done before, anywhere in the world), you realise that phrases such as 'patenting life' are just nonsense.

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