A new report from the UK Human Genetics Commission (see previous news) examines the impact of DNA patenting on innovation and development and calls for national action.
Intellectual Property and DNA Diagnostics is the product of a 2010 seminar focused on common concerns surrounding intellectual property (IP) issues related to DNA and biomarkers, notably that patents may impede research, development provision and quality of genetic tests for medical purposes. However, lack of financial incentives (in the form of IP protection) for commercial investment in developing DNA diagnostics was shown to be a barrier to innovation.
The report calls for a forum to be set up to gather independent evidence on the impact of biomarker IP on diagnostic innovation. It recommends that the UK government should establish ‘a biomarker IP monitoring function’ and support national implementation of ‘ways to manage biomarker IP issues’, and also suggests that the UK research councils should review their guidelines on licensing patents.
Comment: The report (which draws on a 2003 report on intellectual property rights and genetics from the PHG Foundation) notes that DNA and biomarker patents currently form a crucial element for both commercial and increasingly also academic researchers in securing financial investment in research and development. This perspective was mirrored in the latest legal ruling upholding the Myriad BRCA gene patents (see previous news), when Judge Kimberly Moore said that: “Disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation”
The question is how to create a regulatory environment that supports innovation in DNA diagnostics whilst maintaining fair access to high quality testing? Identifying ways to manage biomarker IP issues as suggested is no small ask, and would certainly require substantial political will, financial investment and cross-disciplinary collaboration to achieve it.