The Legal Vacuum Surrounding Access to Gene-based Research Materials and Data

Tangible research materials and data sets are integral to biomedical research and diagnostic genetic testing. Patents over genes and other research tools have been blamed for restricting access to these tools, potentially slowing the pace of biomedical research and reducing availability of diagnostic genetic testing options. Given that many of these patents are expiring or being invalidated by the courts, this article suggests that attention should now be focused on how the materials and data themselves might be used where access is blocked. Access is critical to the effective conduct of future biomedical research and clinical practice, yet the availability of legal causes of action to facilitate this has not previously been analysed. This article explores possible legal mechanisms and concludes that the outlook for compelling access in the absence of patents is pessimistic. Paradoxically, patents may actually provide a mechanism to gain access to these critical tools, rather than constituting a hindrance.