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Biotechnology and law: biotechnology patents. Special considerations on the inventions with human material.

  • Simon, Jürgen
Published Article
Revista de derecho y genoma humano = Law and the human genome review / Cátedra de Derecho y Genoma Humano/Fundación BBV-Diputación Foral de Bizkaia
Publication Date
Jan 01, 2006
PMID: 17393801


The EC and the US differ considerably in their ruling on the patentability of biotechnological inventions apart from some exceptions. The most extreme positions in either direction with regard to the individual biotechnological inventions mark the margins of the scope which the WTO members may use for the ratification of Art. 27 TRIPS. Rulings which are not in accordance with Art. 27 TRIPS remain without consideration. In the most important point both WTO member agree: Human beings are not patentable. Other regulations could be considered, but one may assume that no member of the WTO intends to make use thereof. Thus the scope involving this option is only a theoretical one. The situation is different when it comes to the components of the human body. These may, provided they are produced artificially or are separated from the human body, be patented. According to the regulations in the US, this applies to all components with the exception of totipotent stem cells. They may be exempted from patenting entirely or their patenting is linked to far reaching conditions. As an example should be named here the regulation of the EPA for patenting gene sequences. The scope of this area is, thus, very great and allows for many options of applying the regulations of Art. 27 TRIPS. With regard to patenting procedures for cloning human beings, the scope is unlimited. These procedures may either be completely excluded from patenting as in the EC or may be considered patentable independent of their purpose as in the US. The same applies to procedures for gathering human stem cells in the US. Exempting procedures with regard to human genes or DNA sequences are, however, only possible in special cases, as for example in the EC with regard to procedures for altering the genetic identity of the germline of human beings. However, the interpretation of general patentability preconditions allows to influence the patenting of such procedures. This means, though, that the scope for interpretation is only a small one in this area.

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