CLG Professors Nicol and Otlowski Welcomed as AAL Fellows

On the evening of 2IMG_02047 April in Hobart, the President of the Australian Academy of Law Kevin Lindgren welcomed six new Tasmanian fellows to the Academy. The University of Tasmania, Faculty of Law was well represented with Professor Gino Dal Pont along with both the director and co-deputy director of the CLG, Professor Di IMG_0207IMG_0220Nicol and Professor Margaret Otlowski, all elected as fellows. They join Professor Don Chalmers as CLG members who have been granted the honour. In recognition of the occasion, the Patron of the Academy, the Honourable Robert French Chief Justice of the High Court of Australia presented an address on “Rationality and Reasonableness” to an audience of judges, magistrates, members of the legal profession, academics and law students. 

We congratulate the professors on their election in recognition of their continual commitment to high quality research and contributions to the legal field.




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Recent Milestones: ICGC 1000th Access 

Professor Chalmers recently reported that in March The International Cancer Genome Consortium (ICGC) celebrated an important milestone, having provided it’s 1000th authorised user with access to the resource. The ICGC provides access for authorised researchers to over 2,400 genomes for cancer research. The datasets are freely available to the scientific community and facilitate cancer research aimed at better diagnosis and treatment. Donors are protected by, and those wishing to access the resource are subject to robust ethical frameworks and protections which in turn ensure that best practice procedures and practices are in place. The consortium is also focussed on providing high quality, and consistent data to support research and the follow on outputs.  Professor Chalmers is chair of the ICGC International Data Access Committee (IDAC) that oversees the Data Access Compliance Office (DACO).

Prototype of women

Prototype of women


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Awareness: A Big Week of Big Days

World Immunisation Week 

In relation to medical developments generally, the 24-30th of April signifies World Immunisation Week promoting protection of disease. Immunisation is one of the most significant medical research inventions of the last two centuries that has stopped the contraction and spread of a range of serious health conditions for example polio, small pox and more recently the human papillomavirus and chickenpox.

Millions of children in low and middle income countries die from preventable diseases; immunisation ‘considered essential for improving infant and drug survival.‘ (Arevshatian et al, 2007). In Australia, although there are good rates of immunisation, it is not only those in poor areas that do not immunise their children, as reported by the Age earlier this year despite it being critical to the health of the community.

National DNA Day (US)

The 25th of April in the US is National DNA Day ‘Celebrating Genomics Through Awareness’ and of course, is the same day in 1953 when scientists first published on the double helix structure of DNA. More recently, on that day in 2003, the Human Genome Project completion was announced. These two important discoveries are key foundations to our knowledge of genetics and the human genome. Although our understanding has greatly increased since the 1950s, there is still so much about the human genome that we don’t know, and that may help or even answer important questions about life.

Still thinking about DNA? Consider a PhD in genetics at the Menzies, University of Tasmania or in social, legal and ethical implications of genetic research with the CLG…

World Intellectual Property Day 

For people like the CLG Director, Dianne Nicol, it would be difficult to choose between DNA and intellectual property (IP), but luckily there’s a day for both. The 26th of April is World Intellectual Property Day to learn about the role that intellectual property rights play in encouraging innovation and creativity. In 2016, the theme is the future of culture in the digital age. The CLG’s intellectual property project on 3d Printing, aligns with many of the focus of this year – to consider how a balanced system can support the creative sector, in the modern digital world. The issues that arise with 3d printing are a key interest of CLG researcher Jane Nielsen as well as the director.

IP Australia provides resources for understanding IP and the different IP rights that exist, and also provides links where you can search the public databases of Australian Patents if there is something particular that you are looking for.








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Ethics Review for International Data-Intensive Research – Published in Science

The authors of a recent article in Science (DOI: 10.1126/science.aad5269), consider Research Ethics Committees (RECs) processes for approving projects that involve international data sharing. They note that

growth in international data-sharing collaborations adds stress to the system already under fire for subjecting multisite research to replicate ethics reviews, which can inhibit research without improving the quality of human subject’s protections.[citations omitted]’  

In the article the authors look at models – of reciprocity, delegation and federation -that could provide basis for a ‘bottom-up’ solution, so that these large scale linkage projects might occur more readily. They suggest that ‘ad-hoc’ solutions should be supported in an effort to improve a system which currently is ‘not working well.’  They substantiate this proposition by clarifying that these solutions should be subject to ‘metrics to evaluate the quality and efficiency of ethics review in the current system and in the proposed models.’

The authors, members of the Ethics Review Equivalency (ERE) Task Team of the Global Alliance for Genomics and Health (GA4GH) Regulatory and Ethics Working Group, (including CLG Director, Dianne Nicol) will also participate in a Symposium to be held in Montreal, Canada in May this year to discuss this further.


Image from Thinkstock

RECs need new approaches in order to support international collaborative research using large data sets. [Image:Thinkstock]

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Nicol Presentation- Gene Patents Forum

Last week, Professor Dianne Nicol presented at the Gene Patents Forum hosted by QUT’s Intellectual Property and Innovation Law Research Program in Brisbane. The forum, organised by Professor Matthew Rimmer, was attended by a number of experts and HDR students in the field. Speakers discussed key cases and recent developments in the area; Intellectual property law is a particularly dynamic area of the law but even so, has been subject to particular change over the last few years. A key component of this change was the frequently debated question about whether genes are patentable subject matter. The legal implications of the Myriad Genetics BRCA cases, noted a number of times on this blog, brought this debate into the public arena and culminated with the Australian High Court Ruling. Nicol’s Presentation ‘Patentable subject matter: be careful what you wish for’, outlined the Myriad development, ruling and her view on the narrow implications of the case and then looked at the differences in jurisdictions concluding with whether the whole process has been worthwhile. Other genetic tests that have received some attention include those relating to Long QT Syndrome, Pre-Natal genetic testing. The implications of these and other cases are were discussed at length as they may have far reaching effects on innovation and technological advancement as well as healthcare and patients rights today and into the future.

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Chalmers Presentation – Legal and Ethical Challenges of Precision Medicine in Hong Kong

Last week, Professor Donald Chalmers presented at the Conference on the Legal & Ethical Challenges of Precision Medicine at The University of Hong Kong. The Conference was held on the 7 – 8 April 2016, jointly hosted by the University of Cambridge Centre for law, Medicine and the Life Science and The University of Hong Kong Centre for Medical Ethics and Law. The conference was an impressive launch of the collaboration between both centres and the promise of academic and professional bridges across continents in the global challenges of achieving the promises of precision medicine.

Professor Chalmers presented on recent work of the CLG in connection with other collaborators in a session entitled ‘Has the Biobank Bubble Burst, A Translational Challenge?’. This question was first posed by Professors Chalmers, Nicol and Kaye at a conference in 2015 at Oxford, and this second presentation illustrated the investigation we have undertaken since that time, comparing the differences in pressures and responses relating to biobanks in a number of countries.


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New PhD Student – Suzana Nashkova

As noted in the CLG Annual Report 2015-2016, the centre has recently welcomed a new student who has relocated from Macedonia to undertake a PhD in the field of intellectual property law. Suzana Nashkova will conduct her research under supervision from Professor Dianne Nicol and Dr Jane Nielsen. The investigation primarily concerns the interface between intellectual property and competition law in the specific area of ‘know-how’. This is a topical area of research that was highlighted in a recent debate between The Honourable Michael Kirby AC, CMG and University of Tasmania Vice-Chancellor Professor Peter Rathjen and facilitated by CLG director, Professor Nicol. The debate concerned the appropriate balance that is required between access to pharmaceuticals and other health benefits and protection for those health-related inventions granted by virtue of intellectual property laws.

 You can view Suzana’s past publications from her profile. More detailed information about her investigation will be available as her research progresses.

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CLG Annual Report 2015-2016

The CLG has released its first annual report outlining news and our the major achievements from the last year. It includes highlights from our PhDs, Projects and International Collaborations.



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High Court Decision in d’Arcy v Myriad Genetics Inc – Appeal Allowed

We have been waiting almost 30 years for a decision of this nature, on the issue of whether isolated DNA sequences are patentable subject matter. This case considered a patent claiming rights to isolated DNA sequences relating to the BRCA 1 gene, which is linked to increased susceptibility to breast and ovarian cancer in some women. Incidentally, that patent expired in August this year, so the decision itself will have no effect on the availability of BRCA 1 testing in Australia. Rather, what is important is its effect on the availability of patents in new areas of technology more generally. In three separate judgments, the court unanimously held that patent claims of this nature are invalid. My focus here is on the decision of the majority – Chief Justice French and Justices Kiefel, Bell and Keane. Their Honours’ judgment focused primarily on the informational nature of the isolated gene, in much the same way that the US Supreme Court judgment did in the equivalent case in that country. The Full Court of the Federal Court had earlier decided that it was the chemical nature of DNA that was important, and the act of isolation created sufficient chemical differences for there to be an ‘artificially created state of affairs’. Chief Justice French and his colleagues begged to differ, noting that ‘it is the existence of that information [the information stored in the DNA sequence coding for the gene] which is an essential element of the invention as claimed’. The majority provided further guidance on the application of the Australian subject matter requirement to new areas of technology. Essentially, their Honours said that in areas that open up new fields of patent protection, the patentable subject matter requirement involves more than simple application of the two factors that traditionally have been applied in Australia (whether there is an artificially created state of affairs and whether the invention has economic utility). Rather, it is necessary to consider a range of other factors such as the effect on innovation of opening up a new field to monopoly rights and the coherence of national and international patent law. This is perhaps the most exciting part of the judgment as it signals that the courts and the patent office need to look at broad public policy considerations when considering the appropriate bounds of patents. Time will tell how they rise to this challenge. (Posted by Dianne Nicol). 

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Released: USPTO Report to Congress on Confirmatory Genetic Diagnostic Test Activity 

IMG_3929The US Patent and Trademarks Office (the USPTO) have publicly released their long-awaited Report to Congress on Confirmatory Genetic Diagnostic Test Activity. The USPTO was required to study a number of issues relating to confirmatory (or second opinion) genetic diagnostic testing pursuant to section 27 of the Leahy Smith America Invents Act, which was signed into law in 2011. Since then, two significant US Supreme Court decisions, Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc., 132 S.Ct. 1794 (2012), have changed the patent landscape relating to genetic diagnostic testing. This led the USPTO to conclude that ‘unless and until the legal environment shifts again, it is difficult to conceive of a gene-based diagnostic correlation that could be exclusively protected by a patented means of determining the correlation owned by a single provider’. Thus, these Supreme Court decisions have superseded whatever findings that the USPTO would have been able to make to Congress based on the limited evidence that was available to them. Looking to the future, the main restriction on consumer choice is likely be whether there is sufficient demand to support multiple providers in the diagnostic testing market. The USPTO urged Congress to continue to monitor this space, with particular focus on data sharing and the availability of insurance cover for gene-related diagnostic tests. (Posted by Dianne Nicol).

Read the full report.

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