Johnathon E Liddicoat

Are the gene-patent storm clouds dissipating? A global snapshot

In genetic diagnostics testing, what are the boundaries of the global patent problem, and is there a real risk that patents and licensing practices could impede access to tests?

Myriad's impact on gene patents

Three years later, the landmark Myriad decision on gene patents has led to some striking and unforeseen implications.

After Myriad, what makes a gene patent claim 'markedly different' from nature?

Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.

Do Patents Impede the Provision of Genetic Tests in Australia

OBJECTIVE Health policy and law reform agencies lack a sound evidence base of the impacts of patents on innovation and access to healthcare to assist them in their deliberations. This paper reports the results of a survey of managers of Australian genetic testing laboratories that asked a series of questions relating to the tests they perform, whether they pay to access patented inventions and whether they have received notifications from patent holders about patents associated with particular tests. RESULTS Some diagnostics facilities are exposed to patent costs, but they are all located in the private sector. No public hospitals reported paying licence fees or royalties beyond those included in the price of commercial test kits. Some respondents reported having received enforcement notices from patent holders, but almost all related to the widely known breast cancer-associated patents. Respondents were also asked for their views on the most effective mechanisms to protect their ability to provide genetic tests now and in the future. Going to the media, paying licence fees, ignoring patent rights and relying on the government to take action were widely seen as most effective. Litigation and applications for compulsory licences were seen as some of the least effective mechanisms. CONCLUSION These results provide an evidence base for development of health policy and law reform. What is known about the topic? The impact of patents on the delivery of genetic testing services remains unclear in Australia. What does this paper add? The survey reported in this paper suggests that, aside from well-known enforcement actions relating to the breast cancer associated patents, there is little evidence that providers of genetic testing services are being exposed to aggressive patent-enforcement practices. What are the implications for practitioners? Although patent-enforcement actions may increase in the future, a range of strategies are available to providers of testing services to protect them against adverse consequences of such actions. There are ongoing law reform activities aimed at improving these strategies.

Precision Medicine: Legal and Ethical Challenges

On 7 and 8 April 2016, the Centre for Medical Ethics & Law (University of Hong Kong) together with the Centre for Law, Medicine and Life Sciences (University of Cambridge) hosted a conference at the University of Hong Kong on the legal and ethical challenges facing the realisation of precision medicine. The aim of precision medicine is to revolutionise disease treatment and prevention by utilising personal variation in factors such as an individual’s genetic information, biochemistry, environment and lifestyle. Genomic data, for example, can be used to determine predispositions to particular diseases, predict the efficacy and safety of different treatment options, and help develop drugs that are targeted to the causes of diseases rather than their clinical manifestations. In these and other ways, scientific and technological advances have the potential to bring about an unprecedented tailoring of health care to the individual characteristics of patients. In order to realise the potential of precision medicine, however, we must rethink components of the legal and ethical foundation on which it will be built. The reason for this is that our current legal and ethical frameworks were built with a very different generation of medical products and practices in mind. At this conference, world experts convened to identify and explore the challenges that precision medicine brings to the fore. Part I of this report provides a summary of the presentations that were given at the conference. Section A of this part focuses on challenges in the implementation of precision medicine and is divided into two categories: implementation at the level of health care systems, and implementation at the level of clinical treatment. Section B addresses challenges in the development of precision medicine and is likewise divided into two categories: development at the level of foundational research, and development at the level of translational medicine. Part II categorises and summarises the key challenges that were explored in the roundtable discussions that followed the four categories of presentations, as well as some of the broader questions that emerged out of the conference.

Time to Get Serious About Privacy Policies: The Special Case of Genetic Privacy

Genetic information is widely recognised as being particularly sensitive personal information about an individual and his or her family. This article presents an analysis of the privacy policies of Australian companies that were offering direct-to-consumer genetic testing services in 2012–13. The results of this analysis indicate that many of these companies do not comply with the Privacy Act 1988 (Cth), and will need to significantly reassess their privacy policies now that significant new amendments to the Act have come into force. Whilst the Privacy Commissioner has increased powers under the new amendments, the extent to which these will mitigate the deficiencies of the current regime in relation to privacy practices of direct–to-consumer genetic testing companies remains unclear. Accordingly, it may be argued that a privacy code for the direct-to-consumer genetic testing industry would provide clearer standards. Alternatively it may be time to rethink whether a sui generis approach to protecting genetic information is warranted.