Intellectual Property and Biotechnology: Biological Inventions

This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive – particularly in respect of Myriad Genetics’ BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies – such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.

Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

Intellectual property and emerging technologies: The new biology

This unique and comprehensive collection investigates the challenges posed to intellectual property by recent paradigm shifts in biology. It explores the legal ramifications of emerging technologies, such as genomics, synthetic biology, stem cell research, nanotechnology, and biodiscovery. Extensive contributions examine recent controversial court decisions in patent law – such as Bilski v. Kappos, and the litigation over Myriad’s patents in respect of BRCA1 and BRCA2 – while other papers explore sui generis fields, such as access to genetic resources, plant breeders' rights, and traditional knowledge. The collection considers the potential and the risks of the new biology for global challenges – such as access to health-care, the protection of the environment and biodiversity, climate change, and food security. It also considers Big Science projects – such as biobanks, the 1000 Genomes Project, and the Doomsday Vault. The inter-disciplinary research brings together the work of scholars from Australia, Canada, Europe, the UK and the US and involves not only legal analysis of case law and policy developments, but also historical, comparative, sociological, and ethical methodologies. Intellectual Property and Emerging Technologies will appeal to policy-makers, legal practitioners, business managers, inventors, scientists and researchers.

Patent law and biological inventions

In response to scientific breakthroughs in biotechnology, the development of new technologies, and the demands of a hungry capitalist marketplace, patent law has expanded to accommodate a range of biological inventions. There has been much academic and public debate as to whether gene patents have a positive impact upon research and development, health-care, and the protection of the environment. In a satire of prevailing patenting practices, the English poet and part-time casino waitress, Donna MacLean, sought a patent application - GB0000180.0 - in respect of herself. She explained that she had satisfied the usual patent criteria - in that she was novel, inventive, and useful: It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new: I have led a private existence and I have not made the invention of myself public. I am not obvious (2000: 18). MacLean said she had many industrial applications. 'For example, my genes can be used in medical research to extremely profitable ends - I therefore wish to have sole control of my own genetic material' (2000: 18). She observed in an interview: 'There's a kind of unpleasant, grasping, greedy atmosphere at the moment around the mapping of the human genome ... I wanted to see if a human being could protect their own genes in law' (Meek, 2000). This special issue of Law in Context charts a new era in the long-standing debate over biological inventions. In the wake of the expansion of patentable subject matter, there has been great strain placed upon patent criteria - such as 'novelty', 'inventive step', and 'utility'. Furthermore, there has been a new focus upon legal doctrines which facilitate access to patented inventions - like the defence of experimental use, the 'Bolar' exception, patent pooling, and compulsory licensing. There has been a concerted effort to renew patent law with an infusion of ethical principles dealing with informed consent and benefit sharing. There has also been a backlash against the commercialisation of biological inventions, and a call by some activists for the abolition of patents on genetic inventions. This collection considers a wide range of biological inventions - ranging from micro-organisms, plants and flowers and transgenic animals to genes, express sequence tags, and research tools, as well as genetic diagnostic tests and pharmaceutical drugs. It is thus an important corrective to much policy work, which has been limited in its purview to merely gene patents and biomedical research. This collection compares and contrasts the various approaches of a number of jurisdictions to the legal problems in respect of biological inventions. In particular, it looks at the complexities of the 1998 European Union Directive on the Legal Protection of Biotechnological Inventions, as well as decisions of member states, such as the Netherlands, and peripheral states, like Iceland. The edition considers US jurisprudence on patent law and policy, as well as recent developments in Canada. It also focuses upon recent developments in Australia - especially in the wake of parallel policy inquiries into gene patents and access to genetic resources.

The persistence of predictors of wellbeing among refugee youth eight years after resettlement in Melbourne, Australia

This short report assesses the predictors of subjective health and happiness among a cohort of refugee youth over their first eight years in Australia. Five waves of data collection were conducted between 2004 (n=120) and 2012–13 (n=51) using mixed methods. Previous schooling,self-esteem, moving house in the previous year, a supportive social environment, stronger ethnic identity and perceived discrimination were significant predictors of wellbeing after adjusting for demographic and pre-migration factors. When compared with a previous analysis of this cohort over their first three years of settlement, experiences of social exclusion still have a significant impact on wellbeing eight years after arriving in Australia. This study contributes to mounting evidence in support of policies that discourage discrimination and promote social inclusion and cultural diversity and which underpin the wellbeing of resettled refugee youth.

Through their eyes: Seeing experiences of Settlement in photographs taken by refugee background youth in Melbourne, Australia

Although “refugees” are frequently represented in visual media, it is predominantly as the central subject matter and rarely are they positioned as the photographers of their own journeys. In this article we present photographic images that have been taken by refugee background youth portraying their experiences of the first years of settlement in Australia. We consider how, in our longitudinal research conducted with 120 refugee background youth, visual materials can provide equally important yet different insights in comparison to written or spoken narratives on the experiences of refugee settlement. Through an examination of over 1,000 photos taken by these youth, we explore the ways in which they portrayed their early experiences of external suburban settlement environments and their depictions of interior spaces and home-making practices. We discuss how these visual insights capture an alternative way of seeing the experiences of becoming at home as the youth become emplaced post-resettlement in Australia. We argue that the photographs taken by these refugee background youth illustrate how visual methods and materials can provide equally important but often overlooked insights into early settlement experiences. Importantly, the photographic images offer a way of portraying the people, places and sentiments that are central to the everyday lives of refugee background youths in ways that oral and written narratives can not.

Burden attributable to child maltreatment in Australia

Child maltreatment is a complex phenomenon, with four main types (childhood sexual abuse, physical abuse, emotional abuse, and neglect) highly interrelated. All types of maltreatment have been linked to adverse health consequences and exposure to multiple forms of maltreatment increases risk. In Australia to date, only burden attributable to childhood sexual abuse has been estimated. This study synthesized the national evidence and quantified the burden attributable to the four main types of child maltreatment. Meta-analyses, based on quality-effects models, generated pooled prevalence estimates for each maltreatment type. Exposure to child maltreatment was examined as a risk factor for depressive disorders, anxiety disorders and intentional self-harm using counterfactual estimation and comparative risk assessment methods. Adjustments were made for co-occurrence of multiple forms of child maltreatment. Overall, an estimated 23.5% of self-harm, 20.9% of anxiety disorders and 15.7% of depressive disorders burden in males; and 33.0% of self-harm, 30.6% of anxiety disorders and 22.8% of depressive disorders burden in females was attributable to child maltreatment. Child maltreatment was estimated to cause 1.4% (95% uncertainty interval 0.4–2.3%) of all disability-adjusted life years (DALYs) in males, and 2.4% (0.7–4.1%) of all DALYs in females in Australia in 2010. Child maltreatment contributes to a substantial proportion of burden from depressive and anxiety disorders and intentional self-harm in Australia. This study demonstrates the importance of including all forms of child maltreatment as risk factors in future burden of disease studies.

Ad hoc communities on the road: Serendipitous social encounters to enhance tourist experiences

Driving can be a lonely activity. While there has been a lot of research and technical inventions concerning car-to-car communication and passenger entertainment, there is still little work concerning connecting drivers. Whereas tourism is very much a social activity, drive tourists and road trippers have few options to communicate with fellow travelers. Our study is placed at the intersection of tourism and driving. It aims to enhance the trip experience during driving through social interaction. This paper explores how a mobile application that allows instant messaging between travelers sharing similar context can establish a temporary, ad hoc community and enhance the road trip experience. A prototype was developed and evaluated in various user and field studies. The study’s outcomes are relevant for the design of future mobile tourist guides that benefit from community design, social encounters and recommendations.

TrainYarn: Probing perceptions of social space in urban commuter trains

We studied the ways that urban commuter train passengers experience their journeys. We present the design process and in-situ evaluation of TrainYarn, a mobile app prototype designed to facilitate social interaction between co-located urban train passengers. Through the deployment of the prototype, we sought to probe perceptions of social space with a view to positively impact the assessment of public transport. Our results support that our target users saw value in the use of TrainYarn, perceiving it as emancipatory, in alignment with their communicative needs, and having the ability to transform their perceptions of social space. To further inform future research and practice, we put forward a series of design recommendations.

Perceptions of the prevalence of self-organising amongst Australian road safety stakeholders: A comparative perspective

The Australian road traffic fatality rate is slowing down at a much lower rate than that of comparable high income countries. This slow rate of reduction may be attributable to a wide range of causes such as deficits in coordination and low community engagement. However, it may also be due to the absence of understanding of systems thinking in road safety in Australia. This exploratory study aimed to investigate the perceptions of Australian stakeholders about the prevalence of a principle of the Dynamic Systems Theory, namely: self-organising. The results pointed to a need to decentralize the road traffic injury prevention efforts in Australia through a range of self-organising principles and the adoption of emergent rather than deliberate strategies.

Older adults and driving reduction: Is the gender gap narrowing?

This study investigated driving reduction in a diverse sample of 229 male and female older drivers aged 70 years and above in Queensland, Australia. The study sought to determine whether differences existed between male and female older drivers in regard to driving patterns, and to identify factors that were predictive of driving reduction in female versus male older drivers. Participants provided information on their health, self-reported driving patterns, driving perceptions, alternative transport options, and feedback. Overall, females were more likely to avoid challenging situations but less likely to reduce their driving when compared to males. Self-rated health and driving confidence were significant predictors for driving reduction among females. For males, driving importance was the only significant predictor for driving reduction in this sample. This study indicates the need for longitudinal research on the process of driving reduction and whether the planning process for driving cessation differ between females and males.

Improving the outcomes of foot and ankle surgery. Professional impact of the Australasian College of Podiatric Surgeons' audit tool

Background Surgery is an example of expanded practice scope that enhances podiatry and incorporates inter-professional collaboration. By 2050 demand for foot and ankle procedures is predicted to rise nationally by 61.9%. Performance management of this increase motivated the development of an online audit tool. Developed in collaboration with the Australasian College of Podiatric Surgeons (ACPS), the ACPS audit tool provides real-time data capture and reporting. It is the first audit tool designed in Australia to support and improve the outcomes of foot and ankle surgery. Methods Audit activity in general, orthopaedic, plastic and podiatric surgery was examined using a case study design. Audit participation enablers and barriers were explored. Case study results guided a Delphi survey of international experts experienced or associated with foot and ankle surgery. Delphi survey-derived consensus informed modification of a generic data set from the Royal Australasian College of Surgeons (RACS). Based on the Delphi survey findings the ACPS online audit tool was developed and piloted. Reliability and validity of data entry and usability of this new tool was then assessed with an online survey. Results The case study found surgeon attitudes and behaviours positively impacted audit participation, and also indicated that audit data should be: (1) available in real time, (2) identify practice change, (3) applicable for safety and quality management, and; (4) useful for peer review discussion. The Delphi process established consensus on audit variables to be captured, including the modified RACS generic data set. 382 cases of foot and ankle surgery were captured across 3 months using the new tool. Data entry was found to be valid and reliable. Real-time outcome reporting and practice change identification impacted positively on safety and quality management and assisted peer review discussion. An online survey showed high levels of usability. Conclusions Surgeon contribution to audit tool development resulted in 100% audit participation. The data from the ACPS audit tool supported the ACPS submission to the Medical Services Advisory Committee to list podiatric surgery under Medicare, an outcome noted by the Federal Minister of Health.

Indoor Air Quality in Naturally Ventilated Italian Classrooms

Characterization of indoor air quality in school classrooms is crucial to children’s health and performance. The present study was undertaken to characterize the indoor air quality in six naturally ventilated classrooms of three schools in Cassino (Italy). Indoor particle number, mass, black carbon, CO2 and radon concentrations, as well as outdoor particle number were measured within school hours during the winter and spring season. The study found the concentrations of indoor particle number were influenced by the concentrations in the outdoors; highest BC values were detected in classrooms during peak traffic time. The effect of different seasons’ airing mode on the indoor air quality was also detected. The ratio between indoor and outdoor particles was of 0.85 ± 0.10 in winter, under airing conditions of short opening window periods, and 1.00 ± 0.15 in spring when the windows were opened for longer periods. This was associated to a higher degree of penetration of outdoor particles due to longer period of window opening. Lower CO2 levels were found in classrooms in spring (908 ppm) than in winter (2206 ppm). Additionally, a greater reduction in radon concentrations was found in spring. In addition, high PM10 levels were found in classrooms during break time due to re-suspension of coarse particles. Keywords: classroom; Ni/Nout ratio; airing by opening windows; particle number

An interactive method for engaging the public health workforce with evidence

Introduction Systematic review authors are increasingly directing their attention to not only ensuring the robust processes and methods of their syntheses, but also to facilitating the use of their reviews by public health decision-makers and practitioners. This latter activity is known by several terms including knowledge translation, for which one definition is a ‘dynamic and iterative process that includes synthesis, exchange and ethically sound application of knowledge’.1 Unfortunately—and despite good intentions—the successful translation of knowledge has at times been inhibited by the failure of reviews to meet the needs of decision-makers, and the limitations of the traditional avenues by which reviews are disseminated.2 Encouraging the utilization of reviews by the public health workforce is a complex challenge. An unsupportive culture within the workforce, a lack of experience in assessing evidence, the use of traditional academic language in communication and the lack of actionable messages can all act as barriers to successful knowledge translation.3 Improving communication through developing strategies that include summaries, podcasts, webinars and translational tools which target key decision-makers such as HealthEvidence.org should be considered by authors as promising actions to support the uptake of reviews into practice.4,5 Earlier work has also suggested that to better meet the research evidence needs of public health professionals, authors should aim to produce syntheses that are actionable, relevant and timely.2 Further, review authors must interact more with those who will, or could use their reviews; particularly when determining the scope and questions to which a review will be directed.2 Unfortunately, individual engagement, ideal for examining complex issues and addressing particular concerns, is often difficult, particularly when attempting to reach large groups where for efficiency purposes, the strategy tends to be didactic, ‘lecturing’ and therefore less likely to change attitudes or encourage higher order thinking.6 …

Podcast: Community wide interventions for increasing physical activity

If the amount of physical activity in a society increased, it should improve public health; but uncertainties remain about how to achieve this. Professor Philip Baker from the Queensland University of Technology in Australia describes the findings from the January 2015 update of the Cochrane review of the evidence on community-wide interventions.