s41431-019-0368-7.pdf (626.45 kB)
Continental drift? Do European clinical genetic testing laboratories have a patent problem?
journal contribution
posted on 2023-06-09, 18:48 authored by Johnathon Liddicoat, Kathleen Liddell, Arlie H McCarthy, Stuart Hogarth, Mateo Aboy, Dianne Nicol, Simon Patton, Michael HopkinsMichael HopkinsOver 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.
History
Publication status
- Published
File Version
- Published version
Journal
European Journal of Human GeneticsISSN
1018-4813Publisher
Nature Publishing GroupExternal DOI
Issue
7Volume
27Page range
997-1007Department affiliated with
- SPRU - Science Policy Research Unit Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2019-08-30First Open Access (FOA) Date
2019-08-30First Compliant Deposit (FCD) Date
2019-08-30Usage metrics
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