After the gold rush: 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.

Commentary on the article by Swanenburg et al. ‘Validity and reliability of a German version of the Neck Disability Index (NDI-G)’

We commend Swanenburg et al. (2013) on translation, development, and clinimetric analysis of the NDI-G. However, the dual-factor structure with factor analysis and the high level of internal consistency (IC) highlighted in their discussion were not emphasized in the abstract or conclusion. These points may imply some inconsistencies with the final conclusions since determination of stable point estimates with the study's small sample are exceedingly difficult.

Electromyography and sonomyography analysis of the tibialis anterior: a cross sectional study

Background Foot dorsiflexion plays an essential role in both controlling balance and human gait. Electromyography (EMG) and sonomyography (SMG) can provide information on several aspects of muscle function. The aim was to establish the relationship between the EMG and SMG variables during isotonic contractions of foot dorsiflexors. Methods Twenty-seven healthy young adults performed the foot dorsiflexion test on a device designed ad hoc. EMG variables were maximum peak and area under the curve. Muscular architecture variables were muscle thickness and pennation angle. Descriptive statistical analysis, inferential analysis and a multivariate linear regression model were carried out. The confidence level was established with a statistically significant p-value of less than 0.05. Results The correlation between EMG variables and SMG variables was r = 0.462 (p < 0.05). The linear regression model to the dependent variable “peak normalized tibialis anterior (TA)” from the independent variables “pennation angle and thickness”, was significant (p = 0.002) with an explained variance of R2 = 0.693 and SEE = 0.16. Conclusions There is a significant relationship and degree of contribution between EMG and SMG variables during isotonic contractions of the TA muscle. Our results suggest that EMG and SMG can be feasible tools for monitoring and assessment of foot dorsiflexors. TA muscle parameterization and assessment is relevant in order to know that increased strength accelerates the recovery of lower limb injuries.

Bibliometric study of the reverse salient concept

In the development of technological systems the focus of system analysis is often on the sub-system that delivers insufficient performance – i.e. the reverse salient – which subsequently limits the performance of the system in its entirety. The reverse salient is therefore a useful concept in the study of technological systems and while the literature holds numerous accounts of its use, it is not known how often, in which streams of literature, and in what type of application the concept has been utilized by scholars since its introduction by Thomas Hughes in 1983. In this paper we employ bibliometric citation analysis between 1983 and 2008, inclusively, to study the impact of the reverse salient concept in the literature at large as well as study the dissemination of the concept into different fields of research. The study results show continuously growing number of concept citations in the literature over time as well as increasing concept diffusion into different research areas. The analysis of article contents additionally suggests the opportunity for scholars to engage in deeper conceptual application. Finally, the continuing increase in the number of citations highlights the importance of the reverse salient concept to scholars and practitioners.

Obesity gene NEGR1 associated with white matter integrity in healthy young adults

Obesity is a crucial public health issue in developed countries, with implications for cardiovascular and brain health as we age. A number of commonly-carried genetic variants are associated with obesity. Here we aim to see whether variants in obesity-associated genes - NEGR1, FTO, MTCH2, MC4R, LRRN6C, MAP2K5, FAIM2, SEC16B, ETV5, BDNF- AS, ATXN2L, ATP2A1, KCTD15, and TNN13K - are associated with white matter microstructural properties, assessed by high angular resolution diffusion imaging (HARDI) in young healthy adults between 20 and 30. years of age from the Queensland Twin Imaging study (QTIM). We began with a multi-locus approach testing how a number of common genetic risk factors for obesity at the single nucleotide polymorphism (SNP) level may jointly influence white matter integrity throughout the brain and found a wide spread genetic effect. Risk allele rs2815752 in NEGR1 was most associated with lower white matter integrity across a substantial portion of the brain. Across the area of significance in the bilateral posterior corona radiata, each additional copy of the risk allele was associated with a 2.2% lower average FA. This is the first study to find an association between an obesity risk gene and differences in white matter integrity. As our subjects were young and healthy, our results suggest that NEGR1 has effects on brain structure independent of its effect on obesity.

Intravascular device administration sets: Replacement after standard versus prolonged use in hospitalised patients--a study protocol for a randomised controlled trial (The RSVP Trial)

Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.

Food justice or food sovereignty? Understanding the rise of urban food movements in the USA

As world food and fuel prices threaten expanding urban populations, there is greater need for the urban poor to have access and claims over how and where food is produced and distributed. This is especially the case in marginalized urban settings where high proportions of the population are food insecure. The global movement for food sovereignty has been one attempt to reclaim rights and participation in the food system and challenge corporate food regimes. However, given its origins from the peasant farmers' movement, La Via Campesina, food sovereignty is often considered a rural issue when increasingly its demands for fair food systems are urban in nature. Through interviews with scholars, urban food activists, non-governmental and grassroots organizations in Oakland and New Orleans in the United States of America, we examine the extent to which food sovereignty has become embedded as a concept, strategy and practice. We consider food sovereignty alongside other dominant US social movements such as food justice, and find that while many organizations do not use the language of food sovereignty explicitly, the motives behind urban food activism are similar across movements as local actors draw on elements of each in practice. Overall, however, because of the different histories, geographic contexts, and relations to state and capital, food justice and food sovereignty differ as strategies and approaches. We conclude that the US urban food sovereignty movement is limited by neoliberal structural contexts that dampen its approach and radical framework. Similarly, we see restrictions on urban food justice movements that are also operating within a broader framework of market neoliberalism. However, we find that food justice was reported as an approach more aligned with the socio-historical context in both cities, due to its origins in broader class and race struggles.

Location and labor: Critical crossroads in global film and television

I approached the editorial prompt as an opportunity to work through some of the concerns driving my current research on creative labor in emergent or ‘peripheral’ media hubs, centers of production activity outside established media capitals that are nevertheless increasingly integrated into a global production apparatus. It builds from my research on the role that film, television and digital media production have played in the economic and cultural strategies of Glasgow, Scotland, and extends the focus on media work to other locations, including Prague and Budapest. I am particularly drawn to the spatial dynamics at play in these locations and how local producers, writers, directors and crew negotiate a sense of place and creative identity against the flows and counter-flows of capital and culture. This means not only asking questions about the growing ensemble of people, places, firms and policies that make international productions possible, but also studying the more quotidian relationships between media workers and the locations (both near and far) where they now find work. I do not see these tasks as unrelated. On the one hand, such queries underscore how international production depends on a growing constellation of interchangeable parts and is facilitated by various actors whose agendas may or may not converge. On the other hand, these questions also betray an even more complicated dynamic, a process that is shifting the spatial orientation of both location and labor around uneven and contested scales. As local industries reimagine themselves as global players, media practitioners are caught up in a new geography of creative labor: not only are personnel finding it increasingly necessary to hop from place to place to follow the work, but also place itself is changing, as locations morph into nebulous amalgamations of tax rebates, subsidized facilities, production services and (when it still matters) natural beauty.

Owning omega-3: Monsanto and the invention of meat

In August of 2010, Anna Salleh of the Science Unit of the Australian Broadcasting Corporation broke a story about Monsanto seeking to patent the enhancement of meat, including omega-3 fatty acids: ‘Enhanced port is sparking debate over the ethics of placing patents on food. Patent applications covering the enhancement of meat, including pork with omega-3 fatty acids, are stimulating debate over the ethics and legalities of claiming intellectual property over food. Monsanto has filed patents that cover the feeding of animals soybeans, which have been genetically modified by the company to contain stearidonic acid (SDA), a plant-derived omega-3 fatty acid... Omega-3s have been linked to improved cardiovascular health and there are many companies engineering them into foodstuffs. But the new patent applications have touched a raw nerve among those who see them as an attempt by the company to exert control over the food chain.’ This article providers a critical evaluation of the controversy of Monsanto’s patent applications, and the larger issues over patenting food. It first considers the patent portfolio of Monsanto; the nature of the patent claims; and the examination of the claims by patent examiners. Second, it examines the withdrawal and revision of the patent claims by Monsanto in the wake of criticism by patent authorities and the public disquiet over the controversial application. Third, this article considers the larger policy issues raised by Monsanto’s patent applications – including the patenting of plants, animals, and foodstuffs. There is also a consideration of the impact of patents upon the administration of health-care, competition, and research.

Developing pictorial conceptual metaphors as a means of understanding and changing the Australian health system for Indigenous people

This paper describes the development of Pictorial Conceptual Metaphors, created out of a literature review on gendered Indigenous health and wellbeing that depicts the inherited effects of the ‘system’ past, present and future. The Pictorial Conceptual Metaphors are pictures that were created to tell the story of colonisation and its inherited and ongoing impacts on Indigenous people’s health and wellbeing. Aboriginal historical experiences, past, present and future are briefly overviewed in order to unpack and communicate to readers the significance and impact of these experiences on Aboriginal health, and ultimately, to bring about understanding to initiate change within the Australian health system. Systemic racism, embedded in the Australian health system, excludes and discriminates against Indigenous peoples through a lack of cultural consideration resulting in a cumulative and ongoing negative effect on Indigenous people’s health (Dudgeon et al. 2014; Fredericks 2008; Marmot 2011; Queensland Government 2012). Systemic action research identifies actions and processes in large systems such as health and education in order to bring about systemic change. Our intention to highlight the systemic changes needed in the Australian health system to improve Indigenous people’s health and wellbeing require us to understand the processes involved in bringing about systemic change. For this to occur, we needed to ‘see the system’ in order to identify the system dynamics in operation. The Pictorial Conceptual Metaphors are the first step in ‘seeing the system’; they illustrate the past and the present, and identify the preferred future for Indigenous health and wellbeing outcomes

An Uber for apartments could solve some common housing problems

Speculative property developers, criticised for building dog boxes and the slums of tomorrow, are generally hated by urban planners and the public alike. But the doors of state governments are seemingly always open to developers and their lobbyists. Politicians find it hard to say no to the demands of the development industry for concessions because of the contribution housing construction makes to the economic bottom line and because there is a need for well located housing. New supply is also seen as a solution to declining housing affordability. Classical economic theory however is too simplistic for housing supply. Instead, an offshoot of Game Theory - Market Design – not only offers greater insight into apartment supply but also can simultaneously address price, design and quality issues. New research reveals the most significant risk in residential development is settlement risk – when buyers fail to proceed with their purchase despite there being a pre-sale contract. At the point of settlement, the developer has expended all the project funds only to see forecast revenue evaporate. While new buyers may be found, this process is likely to strip the profitability out of the project. As the global financial crisis exposed, buyers are inclined to walk if property values slide. This settlement problem reflects a poor legal mechanism (the pre-sale contract), and a lack of incentive for truthfulness. A second problem is the search costs of finding buyers. At around 10% of project costs, pre-sales are more expensive to developers than finance. This is where Market Design comes in.

Public Health Psychology: A Conceptual and Practical Framework

Introduction For many years concern for public health has transcended the boundaries of the medical sciences and epidemiology. For the last 50 years or so psychologists have been increasingly active in this field. Recently, psychologists have not only begun to see the need to take action to mould health promoting behaviours in individuals, but have also pointed out the need to join in an effort to develop appropriate social, political, economic and institutional conditions which would help to improve the state of public health. Psychologists have postulated the need to distinguish a new subdiscipline of psychology called public health psychology which, together with other disciplines, would further the realization of this goal. In the following article the historical and international context of health psychology and the changing nature of public health are put forward as having important implications for the establishment of a ‘public health psychology’. These implications are addressed in later sections of the article through the description of conceptual and practical framework of public health psychology in which theory, methods and practice are considered. Many aspects of the conceptual and practical framework of public health psychology have relevance to the health social sciences more generally and forming a basis for interdisciplinary work. The framework of public health psychology, together with the obstacles that need to be overcome, are critically examined within an overall approach that contends it is necessary to increase and improve the contribution of health psychology to public health.

Calcium phosphate flocs and the clarification of sugar cane juice from whole of crop harvesting

Sugar cane biomass is one of the most viable feedstocks for the production of renewable fuels and chemicals. Therefore, processing the whole of crop (WC) (i.e., stalk and trash, instead of stalk only) will increase the amount of available biomass for this purpose. However, effective clarification of juice expressed from WC for raw sugar manufacture is a major challenge because of the amounts and types of non-sucrose impurities (e.g., polysaccharides, inorganics, proteins, etc.) present. Calcium phosphate flocs are important during sugar cane juice clarification because they are responsible for the removal of impurities. Therefore, to gain a better understanding of the role of calcium phosphate flocs during the juice clarification process,the effects of impurities on the physicochemical properties of calcium phosphate flocs were examined using small-angle laser light scattering technique, attenuated total reflectance Fourier transformed infrared spectroscopy, and X-ray powder diffraction. Results on synthetic sugar juice solutions showed that the presence of SiO2 and Na+ ions affected floc size and floc structure. Starch and phosphate ions did not affect the floc structure; however, the former reduced the floc size, whereas the latter increased the floc size. The study revealed that high levels of Na+ ions would negatively affect the clarification process the most, as they would reduce the amount of suspended particles trapped by the flocs. A complementary study on prepared WC juice using cold and cold/intermediate liming techniques was conducted. The study demonstrated that, in comparison to the one-stage (i.e., conventional) clarification process, a two-stage clarification process using cold liming removed more polysaccharides (≤19%),proteins (≤82%), phosphorus (≤53%), and SiO2 (≤23%) in WC juice but increased Ca2+ (≤136%) and sulfur (≤200%)

Small gold nanoparticles as crystallization "catalysts": Effect of seed size and concentration on Au-ZnO hetero nanoparticles

This work reports the effect of seed nanoparticle size and concentration effects on heterogeneous crystal nucleation and growth in colloidal suspensions. We examined these effects in the Au nanoparticle-seeded growth of Au-ZnO hetero-nanocrystals under synthesis conditions that generate hexagonal, cone-shaped ZnO nanocrystals. It was observed that small (~ 4 nm) Au seed nanoparticles form one-to-one Au-ZnO hetero dimers and that Au nanoparticle seeds of this size can also act as crystallization ‘catalysts’ that readily promote the nucleation and growth of ZnO nanocrystals. Larger seed nanoparticles (~9 nm, ~ 11 nm) provided multiple, stable ZnO-nucleation sites, generating multi-crystalline hetero trimers, tetramers and oligomers.