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Legal uncertainty in the area of genetic diagnostic testing

Nature Biotechnology volume 27, pages 903–909 (2009)Cite this article

A patent landscape analysis of 22 common genetic diagnostic tests shows substantially fewer claims on genes per se than initially suggested but raises questions of legal uncertainty as to the claims' scope.

Ever since genes were first patented, the legitimacy and economics of human gene patents have been at the forefront of intense debate1. Different stakeholders have expressed concerns about the effect of 'blocking patents' or 'patent thickets' on genetic technology, arguing that because such claims are difficult or impossible to circumvent, they would increase genetic testing prices and hinder innovation2,3. The debate has been directed towards the creation of possible solutions for the potential “tragedy of the anticommons” and several collaborative licensing models have been proposed4.

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Figure 1: Claim typology and impact.
Figure 2: Legal status and relative number of patent documents within the genetic diagnostic patent landscape.
Figure 3: Legal status and relative number of patent documents for the top 22 diseases.
Figure 4: Patent applicants according to their nationality, type of ownership (profit or nonprofit) and number of patent families (as shown by the area of the slices).

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Acknowledgements

This research was supported by grant number G.O120.04 of the Fund for Scientific Research (FWO, Belgium) and EuroGentest, an EU-FP6 supported Network of Excellence contract number 512148 and the Vancraesbeeck Fund (K.U.Leuven, Belgium). Special thanks go L.-A. Johnson, I. De Baere, E. van Zimmeren and B. Verbeure for interesting discussions and helpful comments on the manuscript.

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Authors and Affiliations

  1. Isabelle Huys, Nele Berthels and Geertrui Van Overwalle are at the Centre for Intellectual Property Rights, Faculty of Law, Catholic University of Leuven, Leuven, Belgium,

    Isabelle Huys, Nele Berthels & Gert Matthijs

  2. Gert Matthijs is at the Centre for Human Genetics, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium.,

    Geertrui Van Overwalle

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Correspondence to Gert Matthijs.

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Huys, I., Berthels, N., Matthijs, G. et al. Legal uncertainty in the area of genetic diagnostic testing. Nat Biotechnol 27, 903–909 (2009). https://doi.org/10.1038/nbt1009-903

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