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Research Involving Human Subjects and Human Biological Material from a European Patent Law Perspective. Autonomy, Commodification, Patentability

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Human Medical Research

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Abstract

Human medical research is often a part of a long and costly process of developing and marketing new kinds of medicines and medical products; this process cannot usually take place without private investments. One of the ways to encourage the private sector to invest in this area and to allow for a return on investments, is to allow investors to patent the outcomes of such research. This chapter analyses some crucial rules of European patent law which pertain to the ethical aspect of human medical research, i.e. in terms of their construction, practical applicability and efficiency. As it turns out, the said provisions leave much to be desired, despite the noble intentions of their introduction.

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Notes

  1. 1.

    See further Fiona McClenaghan’s Chap. 2 and also Rael Strous’s Chap. 3 in this volume.

  2. 2.

    See further Ilja Pavone’s Chap. 7 in this volume.

  3. 3.

    European Patent Office—an office whose main competence is granting patents according to the EPC.

  4. 4.

    The “fruits of the poisonous tree” approach towards patentability of certain inventions has recently been strengthened by the opinion of Attorney General Yves Bot, before the EU Court of Justice and the judgement of the Court in the case C-34/10. In the opinion, we read inter alia that “An invention must be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.” On the other hand, such approach has already been criticised by the doctrine as going too far (see, for example, Grund and Farmer 2011).

  5. 5.

    Such exclusion was recently mentioned also in an EU Tribunal judgment, in case C-34/10. This judgment could not be thoroughly commented in this paper due to the date, at which it was passed.

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Authors and Affiliations

  1. Institute for Law Studies, Polish Academy of Sciences, Warsaw, Poland

    Tomasz Zimny

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  1. Tomasz Zimny
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Correspondence to Tomasz Zimny .

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Editors and Affiliations

  1. Inst. Medizinische Ethik und, Geschichte der Medizin, Universität Bochum, Markstr. 258a, Bochum, 44799, Germany

    Jan Schildmann

  2. , Institute for Medical Ethics, Ruhr University Bochum, Markstr. 258a, Bochum, 44799, Germany

    Verena Sandow

  3. , Institute of Ethics, History and, Ludwig-Maximilians-University Munich, Lessingstr. 2, Munich, 80336, Nordrhein-Westfalen, Germany

    Oliver Rauprich

  4. Inst. Medizinische Ethik und, Geschichte der Medizin, Universität Bochum, Markstr. 258a, Bochum, 44799, Germany

    Jochen Vollmann

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Zimny, T. (2012). Research Involving Human Subjects and Human Biological Material from a European Patent Law Perspective. Autonomy, Commodification, Patentability. In: Schildmann, J., Sandow, V., Rauprich, O., Vollmann, J. (eds) Human Medical Research. Springer, Basel. https://doi.org/10.1007/978-3-0348-0390-8_8

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