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Legal uncertainty in the area of genetic diagnostic testing

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.

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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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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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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).

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