University of Sussex
Browse
s41431-019-0368-7.pdf (626.45 kB)

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

Download (626.45 kB)
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 Hopkins
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.

History

Publication status

  • Published

File Version

  • Published version

Journal

European Journal of Human Genetics

ISSN

1018-4813

Publisher

Nature Publishing Group

Issue

7

Volume

27

Page range

997-1007

Department affiliated with

  • SPRU - Science Policy Research Unit Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2019-08-30

First Open Access (FOA) Date

2019-08-30

First Compliant Deposit (FCD) Date

2019-08-30

Usage metrics

    University of Sussex (Publications)

    Categories

    No categories selected

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC