On June 13th, Dr Liddicoat presented at the conference Intellectual Property, Ethics and the Market in the Era of Personalised Medicine, held at St Anne’s College, Oxford. His talk was titled ‘The Phantom Menace of Gene Patents Arises?’, and the abstract can be found below. Dr Liddicoat and colleagues are now in the midst of translating the talk into a peer-reviewed article, the publication of which will be announced as soon as it becomes publicly available.
Abstract:
The patentability of DNA-related discoveries has been socially, legally and ethically controversial for many years. The debates have recently re-ignited following some high-profile events on both sides of the Atlantic. In Association for Molecular Pathology v. Myriad Genetics, the US Supreme Court held that isolated gDNA is not patent eligible subject matter. In addition, the US Federal Circuit Court recently held invalid a patent for NIPT, directed to ‘a method for detecting inherited nucleic acid’, because it claimed a natural phenomenon. By contrast, a patent with claims to isolated forms of the FLT3 gene has been successfully enforced in Germany. Furthermore, the European version of the NIPT patent found invalid in the US is currently the subject of license fees and enforcement in the UK.
In the 2000s a number of studies examined whether patents were adversely affecting the provision of molecular genetic diagnostic tests in Europe. Broadly speaking, these studies found little enforcement activity and limited evidence that laboratories were paying licences or being prevented from supplying tests. As a result, the authors of one survey-based study concluded that the phantom menace of gene patents had not arisen — “yet”. In light of the events above, however, this situation may have changed. In early spring, we will deploy a survey that is designed to update and extend these studies. This presentation will present preliminary results.