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

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: 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