Continental Drift? Do European Clinical Genetic Testing Laboratories Have a Patent Problem?

European Journal of Human Genetics, 2019

University of Cambridge Faculty of Law Research Paper 32/2019

12 Pages Posted: 1 Apr 2019 Last revised: 31 Oct 2019

See all articles by John Liddicoat

John Liddicoat

University of Cambridge - Faculty of Law; University of Tasmania

Kathleen Liddell

University of Cambridge - Faculty of Law

Arlie McCarthy

Unversity of Cambidge

Stuart Hogarth

King’s College London, Dept of Social Science, Health & Medicine

Mateo Aboy

LML, University of Cambridge

Dianne Nicol

University of Tasmania

Simon Patton

European Molecular Genetics Quality Network

Michael M. Hopkins

University of Sussex

Date Written: March 7, 2019

Abstract

Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods thatapplied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have arelatively 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 surveythat collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportionof European laboratories that have refrained from providing associated testing services owing to patent protection hasincreased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly stronglyaffected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sectorlaboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchfulmonitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testinglaboratories.

Keywords: patents, genetic tests, Europe, patent law

JEL Classification: O30, O31, O32, O38, O33, O34, I1, I11, I10

Suggested Citation

Liddicoat, Johnathon and Liddell, Kathleen and McCarthy, Arlie and Hogarth, Stuart and Aboy, Mateo and Nicol, Dianne and Patton, Simon and Hopkins, Michael M., Continental Drift? Do European Clinical Genetic Testing Laboratories Have a Patent Problem? (March 7, 2019). European Journal of Human Genetics, 2019, University of Cambridge Faculty of Law Research Paper 32/2019, Available at SSRN: https://ssrn.com/abstract=3352410

Johnathon Liddicoat (Contact Author)

University of Cambridge - Faculty of Law ( email )

10 West Road
Cambridge, CB3 9DZ
United Kingdom

University of Tasmania ( email )

French Street
Sandy Bay
Hobart, Tasmania 7001
Australia

Kathleen Liddell

University of Cambridge - Faculty of Law ( email )

10 West Road
Cambridge, CB3 9DZ
United Kingdom

Arlie McCarthy

Unversity of Cambidge ( email )

Downing Street
Cambridge, CB2 3EJ
United Kingdom

Stuart Hogarth

King’s College London, Dept of Social Science, Health & Medicine ( email )

London, SE1 9NN
United Kingdom

Mateo Aboy

LML, University of Cambridge ( email )

Trinity Ln
Cambridge, CB2 1TN
United Kingdom

HOME PAGE: http://https://www.lml.law.cam.ac.uk/people/Research-Scholars-Associates/Prof-mateo-aboy

Dianne Nicol

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Simon Patton

European Molecular Genetics Quality Network ( email )

United Kingdom

Michael M. Hopkins

University of Sussex ( email )

Sussex House
Falmer
Brighton, Sussex BNI 9RH
United Kingdom

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