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

Liddicoat, Johnathon, Liddell, Kathleen, McCarthy, Arlie H, Hogarth, Stuart, Aboy, Mateo, Nicol, Dianne, Patton, Simon and Hopkins, Michael M (2019) Continental drift? Do European clinical genetic testing laboratories have a patent problem? European Journal of Human Genetics, 27 (7). pp. 997-1007. ISSN 1018-4813

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Over recent years, 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 due 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. Continued watchful monitoring is also recommended to ensure patents do not become a greater hindrance for clinical genetic testing laboratories.

Item Type: Article
Schools and Departments: University of Sussex Business School > SPRU - Science Policy Research Unit
Subjects: H Social Sciences
Depositing User: Joy Blake
Date Deposited: 30 Aug 2019 13:25
Last Modified: 30 Aug 2019 13:30

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