Legal Uncertainty in the Area of Genetic Diagnostic Testing
27, Nature Biotechnology, October 2009, 903-909
Posted: 26 Dec 2015 Last revised: 4 Jan 2016
Date Written: 2009
Ever since genes were first patented, the legitimacy and economics of human gene patents have been at the forefront of intense debate. 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 innovation. 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 proposed. At present, a few studies provide empirical information on the granting or litigation of gene patents. Some of these studies primarily analyze anecdotal cases, whereas others examine the impact of gene patents more widely. Some further studies suggest that the patent thicket may emerge more manifestly in the diagnostic sector, resulting in an undersupply of diagnostic testing services or the development of suboptimal diagnostic tools. What has been lacking is a large-scale empirical study that defines the heart of the problem: which types of claims occur in disease-specific patents and to what extent are these claims essential for carrying out genetic diagnostic tests? The present study aims to unravel on a qualitative as well as quantitative basis what is claimed in US and European patents on the inherited diseases most frequently tested for in Europe. This research provides an in-depth analysis of patents, investigating the exact number, status, nature and scope of granted disease-specific patents that are in force. TOur 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. The results from this study will be valuable for future research regarding licensing models that facilitate access to blocking patents and patent thickets because, depending on the nature of the claimed subject matter, the appropriate licensing models differ.
Keywords: Gene patents, Tragedy of the anti-commons, Patent thickets, Diagnostics
JEL Classification: D23, D45, H 41, H51, I18, K11, L14, L 65, O31, O32, O34
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