More at stake in stem-cell patents

Journal name:
Nature
Volume:
474,
Page:
579
Date published:
DOI:
doi:10.1038/474579d
Published online

Austin Smith and others argue in favour of patenting technologies derived from human embryonic stem cells (Nature 472, 418; 2011), a case still pending with the European Court of Justice. But there is more at stake than European commercial interests.

In 1998, agreement was reached in Europe under Directive 98/44 not to recognize patents involving the use of human embryos for commercial purposes (R. Hipp and P. Liese Nature 474, 36; 2011).

The court must decide whether the use of these cells 'necessitates the prior destruction of human embryos or their use as base material', as the advocate-general, Yves Bot, has argued (see http://go.nature.com/gsap8n). If so, such use would seem to fall beyond the scope of what is legally patentable.

Smith et al. warn that “European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen.” This begs the question of whether patents, which may also be held by non-European companies, may sometimes impede wider research cooperation (S. Rabin Nature Biotechnol. 23, 817819; 2005).

In any case there will often be some commercial risk whenever Europe defends a more rigorous ethical standard than is defended elsewhere. This risk is not itself an argument against upholding the standard prescribed by law.

Without prejudice to the final judgment in this case, the resolution of patent law is and ought to be more than a question of European commercial interest.

Author information

Affiliations

  1. Anscombe Bioethics Centre, Oxford, UK.

    • David Albert Jones
  2. On behalf of 25 co-signatories (see http://go.nature.com/2bkno7).

    • David Albert Jones

Corresponding author

Correspondence to:

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Comments

  1. Report this comment #24958

    Julian Hitchcock said:

    David Jones and his supporters repeat the error which they seek to criticise. Austin Smith and his supporters chastise the policy set out in the Opinion of Advocate General Yves Bot in the Greenpeace v Brüstle case. Jones reponds in support of the Advocate General's policy. But it is not the business of Advocates General to determine policy. It is their job to interpret the law for the benefit of the Court of Justice. Neither side appears to have considered this.

    I find this extraordinary, because if either side had read the Opinion, it would have noticed that the Opinion hinges upon a matter of scientific fact upon which it seems no scientist was consulted and about which there ought, in consequence, to be a great sense of injustice. To be specific, the question concerns the earliest stage in the formation of a (singular) human body. It is a question begged by Article 5 of the Directive that David Jones mentions and on which the Advocate General places all his emphasis. Until it is answered, there can be no meaningful discussion about "human embryos". That is the very reason that the case was brought. However, that scientific question, to which one might have heard words such as "Hox genes" and "primitive streak", was determined by M.Bot himself, in spectacularly sloppy style, without recourse to any scientific assistance. THAT is the thing to jump up and down about, not ethical issues that only arise once it is clear that the blastocyst is, in the legal sense provided under the Directive, a "human embryo".

    So the real question is not a matter of policy or of ethics but of procedure. Why was no scientific evidence taken as to the formation of the human body? All sides, pro and anti, should be concerned that the European Court should be denied the correct basis upon which to apply the law.

  2. Report this comment #24962

    David Jones said:

    Julian Hitchcock states that there can be no meaningful discussion about 'human embryos' without the involvement of scientists. However, within the United Kingdom there was a significant scientific consensus as well as public involvement in the formulating of the Human Fertilisation and Embryology Act 2008. According to this act, 'references to an embryo include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo' (HFE Act 1990 as amended, 1(1)(b)). This UK definition provides an admirable basis upon which to meaningfully discuss human embryos. It is no injustice to use an act constructed with so much involvement by scientists for a legal definition of the embryo. This is clearly preferable to redefining the embryo when it is commercailly advantageous to do so, or consulting those with a clear commercial interest on their prefered definition.

    The protection of the human embryo from commercial or industrial use was a pre-requisite for agreement on patentability of biotechnology in Europe. Without prejudice to the final decision in this particular case, it is reasonable for the attorney general, and indeed the European Court of Justice to take a restricive view of what was intended as a restricting law.

  3. Report this comment #25241

    Nicolas Jouve said:

    We the undersigned, agree with the Correspondence of David Albert Jones and co-signatories and support the opinion of the Advocate General of the Court of Justice of the European Union, Mr. Yves Bot, who considers that human embryo stem cells lines (hESC) should not be patented because they are derived by destruction of human embryos. Human life commences with fertilization and current scientific evidence shows that body plans starts being laid thereafter (H. Pearson. Nature 418, 14-15, 2002). The human zygote is the first corporal manifestation of a human being and any totipotent cell has the capacity to develop into a complete human being. The development of human life through the embryonic and fetal stages is considered a process in continuity. Therefore it is most questionable that cells extracted from a human living body at the expense of its destruction can give rise to a patentable invention.

    Granting patent rights on hESC lines could represent an incentive for the destruction of human lives at early stages. We are witnessing exciting advances in Regenerative Medicine namely the clinical use of adult stem cells and the development of iPS cells, that clearly overtake the possibilities of clinical applications of hESC. The Brustle case concerning the patentability of human embryonic stem cells (hESC) is pending at the European Court of Justice (ECJ). We consider that the opposition to patentability of hESC maintained by the General Advocate is based on sound ethical grounds.

    Nicolás Jouve. University of Alcala, Spain.
    ?Email?: nicolas.jouve@uah.es
    Pablo Gil Loyzaga, University Complutense Madrid, Spain.
    Obiglio Hugo, Academy of Ciencias Morales y Políticas, Argentina.
    Bernard Kerdelhué, Université René Descartes, Paris, France.
    Alejandro Leal, University of Costa Rica, San José, Costa Rica.
    Alain Lejeune, Conférence UCL, Villers-la-Ville, Belgium.
    Monica López Barahona, Biosciences Studies Centre, Madrid, Spain.
    Cesar Nombela, University Complutense Madrid, Spain,
    Rafael Luis Pineda, Universidad Austral, Buenos Aires, Argentina.
    Elena Postigo Solana, Universidad CEU San Pablo, Madrid, Spain.
    José Rueff, Univ. Nova Lisboa, Lisbon, Portugal.
    Miguel Angel Serra, University Pompeu Fabra, Barcelona, Spain.
    Jacques Simpore, Département de Biochimie Microbiologie, Ouagadougou, Burkina Faso.
    Antonio G. Spagnolo, _ Institute of Bioethics, School of Medicine "A. Gemelli", Rome_.
    Jacques Suaudeau, Pontifical Academy for Life, Cittá del Vaticano, Rome, Italy.

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