Realising Genomic Medicine

Realising Genomic Medicine: Intellectual Property Issues

Genomic medicine is an emerging discipline that involves using genetic information about a patient as part of their clinical care. Since the sequencing of the human genome, a key goal has been to make genomic medicine an everyday reality. However, scientific research that recognises a correlation between genetic make-up and a future health outcome is not enough. Considerably more research is necessary to understand how genes, drugs and other environmental factors work together, and how they work in particular individuals. This research involves complex and high-powered data analysis, and resource-intensive translation into effective diagnostics and drug-diagnostic combinations. It is a multi-faceted challenge with scientific, regulatory, legal, ethical, and financial aspects, and thus requires interdisciplinary analysis. In this project we are investigating two topics of debate in genomic medicine in which intellectual property (IP) laws support, and hinder, the realisation of clinically-useful genetic developments.

The first topic concerns the operation of large-scale biobanks. Due to the complex interactions between genes and their environment, large amounts of human data are necessary to understand the causal relations in the genetics of complex and common diseases. The UK Biobank, and the more recent 100,000 Genomes Project, are primary examples of these collections. As they have advanced through the phases of creation and collection, ethicists and lawyers have commented on the governance arrangements with a view to protecting the participants in these novel research projects, and with a view to building and maintaining public trust to ensure their sustainability. This work has mainly focused on issues of consent. As these collections approach and reach the stage where public and private organisations can seek access to the amassed tissue and data, consideration is being given to the governance of IP rights, particularly in relation to publicly funded biobanks. Interest in these issues is growing but it is still at an early stage. It is markedly influenced by views about public benefit, but is less knowledgeable of the pressures faced by the diagnostic and medicine industries. To date there has been relatively little work that investigates the role that different types of IP and licensing practices may play in accessing and using these resources, but this is critical if they are to have real-world impact and become accessible tools for extensive and transformative research.

The second topic concerns the business models of genetic diagnostic companies and laboratories, and the way in which IP law interacts with those strategies. In contrast to pharmaceutical innovation, relatively little is known about diagnostic markets and diagnostic innovation despite the key role that it plays in genomic medicine. Even more contentious is the relative importance of IP, and its implications for downstream innovation. IP is just one of many factors companies need in order to obtain venture capital financing to take on the challenge of refining an initial discovery and securing clinical uptake, and to protect a reasonable return in the marketplace. On the other hand, there is continuing concern in applications of genomic medicine that IP may prevent the use of gene panels, aggregate tests and whole-genome sequencing.

This second topic is all the more complex because the diagnostic industry’s IP strategies are in a state of flux. Several years ago, diagnostic companies were using biomarker patents. In the last two years, however, following several landmark rulings by the US Supreme Court (for example, Association for Molecular Pathology vMyriad and Mayo Collaborative Services v Prometheus Laboratories Inc) this strategy is under unprecedented pressure in that jurisdiction. This legal reasoning was, to some extent, followed recently in Australia (in D’Arcy v Myriad Genetics Inc) and faces an uncertain future in Europe. But in fact, very little is known about how diagnostic innovators are responding to the legal changes, the differences emerging between the US and Europe, and how this is effecting diagnostic innovation.

In both topics, and to the extent that they overlap, the ultimate aim of this programme is to articulate legal strategies and/or legal policy changes that will assist the advancement of genomic medicine.

This project is led by Dr Kathy Liddell and John Liddicoat (Faculty of Law). Our collaborators include the University’s Department of Genetics at the School of Clinical Medicine (lead: Professor Eamonn Maher, Professor of Genomic Medicine) which is centrally involved with a new Genomic Medicine Centre and thoroughly immersed in the challenges of realising and implementing genomic medicine. The University’s Centre for Science and Policy is a second collaborator and will assist with impact and policy related aspects and engaging policy professionals. Our third collaborator is the Public Health Genomics Foundation (lead: Alison Hall)—which is a Cambridge University Health Partner and renowned for its expertise in genetic policy issues.