The empire of cancer: Gene patents and cancer voices

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — "It is a chronicle of an ancient disease — once a clandestine, 'whispered-about' illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation." Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment. In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia. India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop evergreening. In the field of tobacco control, the Australian Government introduced plain packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic. This regime was successfully defended in the High Court of Australia. In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013. The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013. Such disputes have involved tensions between intellectual property rights, and public health. This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: "I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body." She observed: "For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me." The applicants made the following arguments: "Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention." The applicants also argued that "the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies". The applicants suggested that "the alleged invention is a mere discovery". Moreover, the applicants contended that "the alleged invention of each of claims 1-3 is not a patentable invention because they are claims for biological processes for the generation of human beings". The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows: "The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of 'gene patenting'. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been 'isolated'". In this context, the word "isolated" implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer.' The judge held in this particular case that Myriad Genetics’ patent claims were a "manner of manufacture" under s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth). The matter is currently under appeal in the Full Court of the Federal Court of Australia. This article interprets the dispute over Myriad Genetics in light of the scholarly work of Nobel Laureate Professor Joseph Stiglitz on inequality. Such work has significant explanatory power in the context of intellectual property and biotechnology. First, Stiglitz has contended that "societal inequality was a result not just of the laws of economics, but also of how we shape the economy — through politics, including through almost every aspect of our legal system". Stiglitz is concerned that "our intellectual property regime … contributes needlessly to the gravest form of inequality." He maintains: "The right to life should not be contingent on the ability to pay." Second, Stiglitz worries that "some of the most iniquitous aspects of inequality creation within our economic system are a result of 'rent-seeking': profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie". He observes that "the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom." Third, Stiglitz comments: "When the legal regime governing intellectual property rights is designed poorly, it facilitates rent-seeking" and "the result is that there is actually less innovation and more inequality." He is concerned that intellectual property regimes "create monopoly rents that impede access to health both create inequality and hamper growth more generally." Finally, Stiglitz has recommended: "Government-financed research, foundations, and the prize system … are alternatives, with major advantages, and without the inequality-increasing disadvantages of the current intellectual property rights system.’" This article provides a critical analysis of the Australian litigation and debate surrounding Myriad Genetics’ patents in respect of genetic testing for BRCA1. First, it considers the ruling of Nicholas J in the Federal Court of Australia that Myriad Genetics’ patent was a manner of manufacture as it related to an artificially created state of affairs, and not mere products of nature. Second, it examines the policy debate over gene patents in Australia, and its relevance to the litigation involving Myriad Genetics. Third, it examines comparative law, and contrasts the ruling by Nicholas J in the Federal Court of Australia with developments in the United States, Canada, and the European Union. Fourth, this piece considers the reaction to the decision of Nicholas at first instance in Australia. Fifth, the article assesses the prospects of an appeal to the Full Federal Court of Australia over the Myriad Genetics’ patents. Finally, this article observes that, whatever happens in respect of litigation against Myriad Genetics, there remains controversy over Genetic Technologies Limited. The Melbourne firm has been aggressively licensing and enforcing its related patents on non-coding DNA and genomic mapping.

Use of modal flexibility method to detect damage in suspended cables and the effects of cable parameters

Modal flexibility is a widely accepted technique to detect structural damage using vibration characteristics. Its application to detect damage in long span large diameter cables such as those used in suspension bridge main cables has not received much attention. This paper uses the modal flexibility method incorporating two damage indices (DIs) based on lateral and vertical modes to localize damage in such cables. The competency of those DIs in damage detection is tested by the numerically obtained vibration characteristics of a suspended cable in both intact and damaged states. Three single damage cases and one multiple damage case are considered. The impact of random measurement noise in the modal data on the damage localization capability of these two DIs is next examined. Long span large diameter cables are characterized by the two critical cable parameters named bending stiffness and sag-extensibility. The influence of these parameters in the damage localization capability of the two DIs is evaluated by a parametric study with two single damage cases. Results confirm that the damage index based on lateral vibration modes has the ability to successfully detect and locate damage in suspended cables with 5% noise in modal data for a range of cable parameters. This simple approach therefore can be extended for timely damage detection in cables of suspension bridges and thereby enhance their service during their life spans.

Reclaiming fair use: How to put balance back in copyright

This lively book, Reclaiming Fair Use: How to Put Balance Back in Copyright, is designed to liberate people from the "Mind Forg'd Manacles" of copyright law. The authors - film and media scholar Patricia Aufderheide and professor of law and stalwart defender of the public interest Peter Jaszi - hope to help readers "understand how to think about and use copyright, and especially your right to use copyrighted material without permission or payment when you make a work - whether a blog entry, a song, a mashup, a poem, a documentary, a magazine article, a lesson plan, a scholarly archive, a slide show, a technical manual, a scrapbook, a collage, or a brochure"...

An ethical approach to sharing school successes in times of high-stakes accountability

High-stakes testing has become an important element of the Australian educational landscape. As one part of the neo-liberal paradigm where beliefs in the individual and the free market are paramount, it is of concern how school leaders can respond to this phenomenon in an ethical manner. Ethics and ethical leadership have increased in prominence both in the educational administration literature and in the media (Cranston, Ehrich, & Kimber, 2006). In this paper we consider ethical theories on which school principals can draw, not only in the leadership of their own schools but in their relationships with other schools. We provide an example of a school leader sharing a successful intervention with other schools, illustrating that school leaders can create spaces for promoting the public good within the context of high-stakes testing.

Digital design interventions for creating new presentations of self in public urban places

During everyday urban life, people spend time in public urban places waiting for specific events to occur. During these times, people sometimes tend to engage with their information and communication technology (ICT) devices in a way that shuts off interactions with collocated people. These devices could also be used to better connect with the urban space and collocated people within. This chapter presents and discusses the impact of three design interventions on the urban user experience enabling collocated people to share lightweight, non-privacy-sensitive data in the urban space. We investigate and discuss the impact on the urban experience under the notions of people, place, and technology with an emphasis on how the sharing of non-privacy-sensitive data can positively transform anonymous public urban places in various ways through anonymous digital augmentations.

Design patterns for urban gardening

Urban agriculture is practiced in many forms within urban spaces, ranging from large organised community gardens to individuals with a backyard or balcony. We present the synthesis of findings from three studies exploring different types of urban agriculture: city farms, residential gardeners, and a grassroots group that supports local communities. Where the findings of individual studies are used to justify a design approach, there are often difficulties encountered because of different context of the original study. Through our understanding and synthesis of multiple studies, we propose a set of design patterns. The proposed patterns can be utilised concurrently depending on the scale and context of both the physical garden, and community. The relationships between the patterns and their concurrent use are discussed, and the resulting links provided the foundation for a pattern language. The eight initial patterns provide a foundation on which we would encourage other researchers to contribute, in order to develop a pattern language to holistically consider urban agriculture beyond the scope of our experiences in Brisbane, and to enrich the patterns with a variety of gardening practices.

Breaches of lease between exercise of option to renew and expiry of lease in Queensland

The decision of Greppo v Jam-Cal Bundaberg Pty Ltd [2015] QCA 131 illustrates a defect in s 128 of the Property Law Act 1974(Qld) which gives a right to a lessee to apply for relief against forfeiture against loss of a right to exercise an option to renew. The defect arises because the legislation does not adequately deal with breaches that occur after the exercise of the option but before the expiry of the lease. Most commercial leases of all kinds have a standard provisions, as the lease in this case, as a conditions of the exercise of the option to renew that the lessee will have given notice of exercise within the time specified to the lessor and will have up to the date of expiry of the lease paid all rent and observed all lessee’s covenants. The difficulties occur because invariably an option must be exercised before the expiry of the lease when a lessee may not be in breach of the lease but may later prior to the expiry of the lease fall into breach. As this decision indicates,at least in Queensland, that the lessee who desires to challenge the lessor’s right to enforce those conditions can neither seek relief under s 128 against forfeiture of the right to exercise the option ,or indeed, under s 124 of the Property Law Act 1974 to preserve the agreement for lease brought about by the otherwise regular exercise of the option to renew. The decision cries out for legislative reform along the lines of s 133E of the Conveyancing Act 1919(NSW) which was amended in 2001 to meet this contingency.

Use of phage display technology to investigate allergen-antibody interactions

Phage display is an advanced technology that can be used to characterize the interactions of antibody with antigen at the molecular level. It provides valuable data when applied to the investigation of IgE interaction with allergens. The aim of this rostrum article is to provide an explanation of the potential of phage display for increasing the understanding of allergen- IgE interaction, the discovery of diagnostic reagents, and the development of novel therapeutics for the treatment of allergic disease. The significance of initial studies that have applied phage display technology in allergy research will be highlighted. Phage display has been used to clone human IgE to timothy grass pollen allergen Phl p 5, to characterize the epitopes for murine and human antibodies to a birch pollen allergen Bet v 1, and to elucidate the epitopes of a murine mAb to the house dust mite allergen Der p 1. The technology has identified peptides that functionally mimic sites of human IgE constant domains and that were used to raise antiserum for blocking binding of IgE to the FcεRI on basophils and subsequent release of histamine. Phage display has also been used to characterize novel peanut and fungal allergens. The method has been used to increase our understanding of the molecular basis of allergen-IgE interactions and to develop clinically relevant reagents with the pharmacologic potential to block the effector phase of allergic reactions. Many advances from these early studies are likely as phage display technology evolves and allergists gain expertise in its research applications.

Robust principal component analysis in water quality index development

Some statistical procedures already available in literature are employed in developing the water quality index, WQI. The nature of complexity and interdependency that occur in physical and chemical processes of water could be easier explained if statistical approaches were applied to water quality indexing. The most popular statistical method used in developing WQI is the principal component analysis (PCA). In literature, the WQI development based on the classical PCA mostly used water quality data that have been transformed and normalized. Outliers may be considered in or eliminated from the analysis. However, the classical mean and sample covariance matrix used in classical PCA methodology is not reliable if the outliers exist in the data. Since the presence of outliers may affect the computation of the principal component, robust principal component analysis, RPCA should be used. Focusing in Langat River, the RPCA-WQI was introduced for the first time in this study to re-calculate the DOE-WQI. Results show that the RPCA-WQI is capable to capture similar distribution in the existing DOE-WQI.

The role of digital screens in urban life: New opportunities for placemaking

Large digital screens are becoming prevalent across today’s cities dispersing into everyday urban spaces such as public squares and cultural precincts. Examples, such as Federation Square, demonstrate the opportunities for using digital screens to create a sense of place and to add long-term social, cultural and economic value for citizens, who live and work in those precincts. However, the challenge of implementing digital screens in new urban developments is to ensure they respond appropriately to the physical and sociocultural environment in which they are placed. Considering the increasing rate at which digital screens are being embedded into public spaces, it is surprising that the programs running on these screens still seem to be stuck in the cinematic model. The availability of advanced networking and interaction technologies offers opportunities for information access that goes beyond free-to-air television and advertising. This chapter revisits the history and current state of digital screens in urban life and discusses a series of research studies that involve digital screens as interface between citizens and the city. Instead of focusing on technological concerns, the chapter presents a holistic analysis of these studies, with the aim to move towards a more comprehensive understanding of the sociocultural potential of this new media platform, and how the digital content is linked with the spatial quality of the physical space, as well as the place and role of digital screens within the smart city movement.

Disability Standards for Education

This chapter of Higher Education and the Law considers the scope of the obligation of Australian Universities to make reasonable adjustments to facilities, procedures and curriculum, for students with disability. It reflects upon relevant case law to inform analysis of problematic aspects of that scope including, for example, the accommodation of students with problem behaviour flowing from disability and adjustment to assessment for students with disability.

Author responsibilities in improving the quality of peer reviews: A rejoinder to Iivari (2016)

In this rejoinder to Iivari (2016), I discuss authors’ responsibilities in the process of ensuring quality reviews. I argue that one overlooked element in quality peer reviewing is authors’ unconstrained right to submit manuscripts in whatever form or quality they desire. As such, I suggest adding some constraints and offering more freedom to reviewers to maintain viability of the scholarly publication system. I offer three responses to Iivari’s suggestions and add two further suggestions for change.

Analysis and prevention of extreme vibration in high speed craft - A research framework

Extreme vibration has been reported for small, high speed craft in the maritime sector, with performance and health threatening effects on boat operators and crew. Musculoskeletal injuries are an enduring problem for high speed craft passengers. Spinal or joint injuries and neurological disorders may occur from repetitive pounding over rough water, continued vibration and single impact events. The risk from whole body vibration (WBV) induced through the small vessels mainly depends on time spent on the craft, which can’t be changed in a military scenario; as well as the number of shocks and jolts, and their magnitude and frequency. In the European Union for example, physical agents directives require all employers to control exposure to a number of physical agents including noise and vibration. The EC Vibration Directive 2002/44/EC then sets out regulations for the control of health and safety risks from the exposure of workers to hand arm vibration (HAV) and WBV in the workplace. Australia has exposure standards relating to WBV, AS 2670.1-2001 – Evaluation of human exposure to whole body vibration. This standard is identical to the ISO 2631-1:1997, Mechanical vibration and shock – Evaluation of human exposure to whole-body vibration. Currently, none of the jurisdictions in Australia have specific regulations for vibration exposures in workplaces. However vibration is mentioned to varying degrees in their general regulations, codes of practice and guidance material. WBV on high speed craft is normally caused by “continuous 'hammering' from short steep seas or wind against tide conditions. Shock on High Speed Craft is usually caused by random impacts. Military organisations need the knowledge to make informed decisions regarding their marine operations, compliance with legislation and potentially harmful health effects, and develop and implement appropriate counter-measures. Marine case studies in the UK such as published MAIB (Marine Accident Investigation Branch) reports show injuries that have occurred in operation, and subsequent MCA (Maritime Coastguard Agency) guidance is provided (MGN 436 (M+F), WHOLE-BODY VIBRATION: Guidance on Mitigating Against the Effects of Shocks and Impacts on Small Vessels. MCA, 2011). This paper proposes a research framework to study the origin, impact and pathways for prevention of WBV in small, high speed craft in a maritime environment.

Curious hybrids: Creating 'not-quite' beings to explore possible childhoods

Communications between adults and young children can expose different ideas and opinions. Adults and children have different capacities to speak, these discursive spaces can become filled with assumptions, stereotyping and conventional thinking about power and agency. If communication shifts away from the purely discursive, what might be exposed about the explorations, investigations and fantasies adults and children indulge in? Some time ago my young daughter obsessively drew hybrid beings. Created from mixtures of animal, object, human and creature forms, these beings, which are ‘not-quite’, are becoming, able to transform via myriad mutations. We agreed to collaborate and draw additional hybrid beings to experiment with becoming-other through complex entanglements of forms, to complicate, morph and (trans)form from our human selves to hybrid others. The ‘not- quite-ness’ of our monstrous hybrids subvert the conventions of ‘being’ and prompt contemplations about childhood subjectivities, identities, conventionalities and actively interrogate the assumptive knowledges and subjectifications that are held about young children in early childhood professional and academic systems.