John Liddicoat is the Philomathia Research Associate in Law at the University of Cambridge. He is currently working on a research project analysing intellectual property issues that interface with the realisation of genomic medicine. His research is funded by the Wellcome Trust, Cambridge University and the Philomathia Foundation. John adopts a variety of research methodologies including doctrinal legal research and established empirical methods, as well as developing new, science-inspired quantitative methods.
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 non-invasive prenatal testing (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 this year we deployed a survey that is designed to update and extend these studies. The results from the survey will be presented for the first time during this talk.