Abstract
Recent 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 owing 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. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.
Highlights
The patentability of genetic inventions and discoveries has been socially, legally and ethically controversial for decades
A pilot survey was tested by designated persons in the research team, and two independent persons respectively specialising in genetics policy for the UK civil service and a clinical genetics
The number of laboratories emailed in this study (~ 806) compared with the number emailed in the 2008 study (289) suggests that there has been a substantial growth in the European clinical genetic sector
Summary
The patentability of genetic inventions and discoveries has been socially, legally and ethically controversial for decades. The European Directive on the Protection of Biotechnological Inventions (98/44/EC) states that isolated DNA sequences shall be patentable in European Member States. The European Patent Convention is interpreted in the same way by the European Patent Office. The inherent patentability of isolated DNA sequences was confirmed in the European BRCA litigation [24]. Genetic diagnostic methods are patent eligible in Europe, even when the techniques implementing the methods are conventional. The European Patent Convention excludes methods of diagnosis on the human body, this exclusion has been interpreted narrowly and does not exclude in vitro diagnostic methods such as methods of genetic testing based on blood, cells or saliva samples [30, 31]
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