Reported by Natalie Miazga, BBSRC-Funded CSaP Policy Intern (February 2015 - May 2015)
On 1 May the Centre for Science and Policy hosted a workshop in association with the Centre for Law, Medicine and Life Sciences at the University of Cambridge. The workshop brought together experts from the from the public and private sector in fields of genomic discovery, technology management, biobank development, intellectual property (IP) law and policy. The overall aim was to identify and discuss key issues with IP policies and strategies affecting the development of genomic medicine.
Many genetic biomarkers have been identified in the literature but very few have been sucessfully translated into the clinic. Large scale human data collection is required in order to better understand the complex relationships between genetics and disease. The 100K Genomes Project and the UK Biobank represent two prime examples of these large scale data collections. Careful consideration must be given to the IP strategies employed to fully exploit the data as public and private sector organisations seek to analyse these data collections.
The UK Biobank have adopted an access policy that states the UK Biobank will have no claim to any new inventions that are developed using the resource, unless these unreasonably restrict health related research or access to healthcare. In contrast, Genomics England have proposed a strategy that states Genomics England will own any IP generated but this will be licensed to third parties to commercialise opportunities on favorable terms.
How can IP best serve the realisation of genomic medicine?
Participants discussed the different access policies and deliberated alternative models of collaboration. The discussion also focussed on how different types of IP might benefit the realisation of genomic medicine. The use of IP may play a pivotal role in kick-starting the UK genomics industry but the mis-use of IP has the potential to hinder future developments. The balance of priorities needs to be addressed to develop the interests of companies and protect the public interest.
The impact of recent landmark US Supreme Court rulings on the genomics industry was also discussed. The rate of diagnostic patents filed has increased in the last decade, with a high proportion making a claim on a biomarker. However, recent US Supreme Court rulings have prohibited the patent protection of natural DNA sequences and invalidated patents that correlate biomarkers with disease. This presents huge challenges for the US genetic diagnostics market and has created legal uncertainty elsewhere.
Genomic medicine has the potential to revolutionise healthcare and kick-start the genomics industry but the success of biobanks requires public support. From the discussions it became clear that the issues are extremely complex, with no clear 'one size fits all' solution. One of the key emerging themes that arose was the importance maintaining the potential health benefits as the primary focus, from which the economic benefits should be built.
This workshop facilitated the collaborative input between attendees from a variety of backgrounds and fostered new connections, which hold scope for future collaborations. An event report will be published in due course.
(Thumbnail taken from http://commons.wikimedia.org/wiki/File:DNA_small.svg, banner image from Bill Dickinson via Flickr)
6 September 2016
This workshop will bring together academic and industry experts with relevant policy makers to discuss and analyse recent legal decisions in the US and Europe, and their implications for the future of precision medicine.