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Continental drift? Do European clinical genetic testing laboratories have a patent problem?


Liddicoat, JE and Liddell, K and McCarthy, AH and Hogarth, S and Aboy, M and Nicol, D and Patton, S and Hopkins, MM, Continental drift? Do European clinical genetic testing laboratories have a patent problem?, European Journal of Human Genetics, 27 pp. 997-1007. ISSN 1018-4813 (2019) [Refereed Article]


Copyright Statement

Copyright 2019 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0)

DOI: doi:10.1038/s41431-019-0368-7


Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods that applied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have a relatively low risk of infringing patents on naturally occurring DNA or methods for detecting genomic variants. In Europe, however, such claims remain patentable, and European laboratories risk infringing them. We report the results from a survey that collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportion of European laboratories that have refrained from providing associated testing services owing to patent protection has increased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly strongly affected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sector laboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.

Item Details

Item Type:Refereed Article
Keywords:gene, patent, diagnostic
Research Division:Law and Legal Studies
Research Group:Private law and civil obligations
Research Field:Intellectual property law
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Law reform
UTAS Author:Liddicoat, JE (Mr John Liddicoat)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:133263
Year Published:2019
Web of Science® Times Cited:4
Deposited By:Law
Deposited On:2019-06-20
Last Modified:2021-07-01
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