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.

From Kafka to KAFTA: Intellectual property, and the Korea-Australia free trade agreement

This paper provides a critical examination of the intellectual property sections of the Korea-Australia Free Trade Agreement 2014. Chapter 13 of the Korea-Australia Free Trade Agreement 2014 deals with the subject of intellectual property law. The Chapter covers such topics as the purposes and objectives of intellectual property law; copyright law; trade mark law; patent law; and intellectual property enforcement. The Joint Standing Committee on Treaties in the Australian Parliament highlighted the controversy surrounding this chapter of the agreement: The intellectual property rights chapter of KAFTA has drawn considerable attention from academics and stakeholders regarding the proposed need for changes to Australian intellectual property law and the inclusion of intellectual property in the definition of investment with regard to the investor-state dispute mechanism. Other concerns raised with the Committee include the prescriptive nature of the chapter, the lack of recognition of the broader public interests of intellectual property rights, and possible changes to fair use provisions. Article 13.1.1 of the Korea-Australia Free Trade Agreement 2014 provides that: ‘Each Party recognises the importance of adequate and effective protection of intellectual property rights, while ensuring that measures to enforce those rights do not themselves become barriers to legitimate trade.’ This is an unsatisfactory description of the objectives and purposes of intellectual property law in both Australia and Korea. There is a failure to properly consider the range of public purposes served by intellectual property law – such as providing for access to knowledge, promoting competition and innovation, protecting consumer rights, and allowing for the protection of public health, food security, and the environment. Such a statement of principles and objectives detracts from the declaration in the TRIPS Agreement 1994 of the public interest objectives to be served by intellectual property. Chapter 11 of the Korea-Australia Free Trade Agreement 2014 is an investment chapter, with an investor-state dispute settlement regime. This chapter is highly controversial – given the international debate over investor-state dispute settlement; the Australian context for the debate; and the text of the Korea-Australia Free Trade Agreement 2014. In April 2014, the United Nations Conference on Trade and Development (UNCTAD) released a report on Recent Developments in Investor-State Dispute Settlement. The overall figures are staggering. UNCTAD reports a significant growth in investment-state dispute settlement, across a wide array of different fields of public regulation. Given the broad definition of investment, intellectual property owners will be able to use the investor-state dispute settlement regime in the Korea-Australia Free Trade Agreement 2014. This will have significant implications for all the various disciplines of intellectual property – including copyright law, trade mark law, and patent law.

Entering the field as a sports coordinator: Negotiating the micropolitics of the profession

The work of French sociologist, anthropologist and philosopher Pierre Bourdieu has been influential across a set of cognate disciplines that can be classified as physical culture studies. Concepts such as field, capital, habitus and symbolic violence have been used as theoretical tools by scholars and students looking to understand the nature and purpose of sport, leisure, physical education and human movement within wider society. Pierre Bourdieu and Physical Culture is the first book to focus on the significance of Bourdieu’s work for, and in, physical culture. Bringing together the work of leading and emerging international researchers, it introduces the core concepts in Bourdieu’s thought and work, and presents a series of fascinating demonstrations of the application of his theory to physical culture studies. A concluding section discusses the inherent difficulties of choosing and using theory to understand the world around us. By providing an in-depth and multi-layered example of how theory can be used across the many and varied components of sport, leisure, physical education and human movement, this book should help all serious students and researchers in physical culture to better understand the importance of social theory in their work.

Breakfast at Tiffany's': eBay Inc., trade mark law, and counterfeiting

In an exploration of intellectual property and fashion, this article examines the question of the intermediary liability of online auction-houses for counterfeiting. In the United States, the illustrious jewellery store, Tiffany & Co, brought a legal action against eBay Inc, alleging direct trademark infringement, contributory trademark infringement, false advertising, unfair competition and trademark dilution. The luxury store depicted the online auction-house as a pirate bazaar, a flea-market and a haven for counterfeiting. During epic litigation, eBay Inc successfully defended itself against these allegations in a United States District Court and the United States Court of Appeals for the Second Circuit. Tiffany & Co made a desperate, unsuccessful effort to appeal the matter to the Supreme Court of the United States. The matter featured a number of interventions from amicus curiae — Tiffany was supported by Coty, the Fashion Designer's Guild, and the International Anticounterfeiting Coalition, while eBay was defended by publicly-spirited civil society groups such as Electronic Frontier Foundation, Public Citizen, and Public Knowledge as well as Yahoo!, Google Inc, Amazon.com, and associations representing telecommunications carriers and internet service providers. The litigation in the United States can be counterpointed with the fusillade of legal action against eBay in the European Union. In contrast to Tiffany & Co, Louis Vuitton triumphed over eBay in the French courts — claiming its victory as vindication of the need to protect the commercial interests and cultural heritage of France. However, eBay has fared somewhat better in a dispute with L’Oréal in Great Britain and the European Court of Justice. It is argued that, in a time of flux and uncertainty, Australia should follow the position of the United States courts in Tiffany & Co v eBay Inc. The final part examines the ramifications of this litigation over online auction-houses for trade mark law reform and consumer rights; parallel disputes over intermediary liability and safe harbours in the field of copyright law and the Anti-Counterfeiting Trade Agreement 2010. The conclusion calls for a revision of trade mark law, animated by a respect for consumers’ rights and interests in the electronic marketplace.

Intellectual property and biofuels: The energy crisis, food security, and climate change

In light of larger public policy debates over intellectual property and climate change, this article considers patent practice, law, and policy in respect of biofuels. This debate has significant implications for public policy discussions in respect of energy independence, food security, and climate change. The first section of the paper provides a network analysis of patents in respect of biofuels across the three generations. It provides empirical research in respect of patent subject matter, ownership, and strategy in respect of biofuels. The second section provides a case study of significant patent litigation over biofuels. There is an examination of the biofuels patent litigation between the Danish company Novozymes, and Danisco and DuPont. The third section examines flexibilities in respect of patent law and clean technologies in the context of the case study of biofuels. In particular, it explores the debate over substantive doctrinal matters in respect of biofuels – such as patentable subject matter, technology transfer, patent pools, compulsory licensing, and disclosure requirements. The conclusion explores the relevance of the debate over patent law and biofuels to the larger public policy discussions over energy independence, food security, and climate change.

Japonica rice: Intellectual property, scientific publishing and data-sharing

This article examines a series of controversies within the life sciences over data sharing. Part 1 focuses upon the agricultural biotechnology firm Syngenta publishing data on the rice genome in the journal Science, and considers proposals to reform scientific publishing and funding to encourage data sharing. Part 2 examines the relationship between intellectual property rights and scientific publishing, in particular copyright protection of databases, and evaluates the declaration of the Human Genome Organisation that genomic databases should be global public goods. Part 3 looks at varying opinions on the information function of patent law, and then considers the proposals of Patrinos and Drell to provide incentives for private corporations to release data into the public domain.

The grapes of wrath: The Coonawarra dispute, geographical indications and international trade

The famous wine region of Coonawarra in South Australia has been promoted as ’Australia's other Red Centre', emphasizing its terra rossa soil and its cabernet sauvignon. In his atlas of the wine regions of Australia, John Beeston comments upon the rich and contested history of the region: ’Coonawarra is certainly the most famous cabernet sauvignon region in Australia, and some would argue, the most renowned wine region in Australia per se'. A reporter, Penelope Debelle, captures a sense of the legal conflict over the parameters of the boundaries of Coonawarra: ’Behind the name Coonawarra, an inglorious contest is being waged that pits the romance of South Australia's terra rossa cool-climate wine region against the cold commercial reality of the label.'This Chapter tells the story behind the Coonawarra litigation, addressing the parties to the dispute; the legal and historical context of the case; and the immediate impact case, as well as its lingering significance. It considers the ’Coonawarra' case as, very literally, a landmark in Australian jurisprudence in respect of intellectual property. This chapter engages in the methodology of ’legal storytelling'. In the field of new historicism, the use of anecdotes - petite histoire - has been seen as a useful way of challenging grand historical narratives. Joel Fineman has observed that the anecdote is ’the literary form or genre that uniquely refers to the real.' This chapter has three parts. Part 1 outlines the European Community - Australia Wine Agreement 1994, and the operation of the Australian Wine and Brandy Corporation Act 1980 (Cth). Part 2 considers the various stages of the dispute over the Coonawarra region - moving from the decision of the Geographical Indications Committee, to the ruling of the Administrative Appeals Tribunal; and the conclusive decision of the Full Court of the Federal Court of Australia. Part 3 examines the implications of the Coonawarra litigation for other wine regions of Australia - most notably, the King Valley in Victoria; but also the Hunter Valley in the New South Wales; and the Margaret River in Western Australia. The conclusion considers the ramifications of the European Community-Australia Wine Agreement 2007, which has been initialed by both sides.

Relationship between Barthel index with physical tests in adults with intellectual disabilities

We usually find low levels of fitness condition affect other aspects of living for people with ID like dependency in carrying out activivities of daily living. Therefore we find high levels of dependency in activities of daily living due to poor fitness condition. The aim of the study is to explore the criterion validity of the Barthel index with a physical fitness test. An observational cross-sectional study was conducted. Data from the Barthel index and a physical fitness test were measured in 122 adults with intellectual disability. The data were analysed to find out the relationship between four categories of the physical fitness test and the Barthel index. It needs to be stressed that the correlations between the Barthel index and leg, abdominal and arm strength can confirm that these physical test are predictive of the Barthel index. The correlations between the balance variables as functional reach and single-leg stance with eyes open shown relationships with Barthel Index. We found important correlations between the physical fitness test and the Barthel index, so we can affirm that some physical fitness features are predictor variables of the Barthel index.

Improving adherence physical activity with a smartphone application based on adults with intellectual disabilities (APPCOID)

Background People with intellectual disabilities (ID) have lower levels of physical activity and quality of life and they have a lot of barriers to face when taking part in physical activity. Other problems are the poor adherence to physical activity such people have so this study is designed to improve adherence to physical activity for people with intellectual disabilities with the assistance of an application for smartphones. The aim of the study will be to improve physical activity and physical condition after multimodal intervention and to analyse the promotion of adherence to physical activity through a multimodal intervention and an app intervention (mHealth) in people with ID. Methods A two-stage study will be conducted. In stage 1 a multimodal intervention will take place will be done with physical activity and educational advice over eight weeks, two days a week. Data will be measured after and before the intervention. In stage 2 a randomized controlled trial will be conducted. In the intervention group we will install an application to a smartphone; this application will be a reminder to do a physical activity and they have to select whether they have or haven’t done a physical activity every day. This application will be installed for 18 weeks. Data will be measured after and before the application is installed in two groups. We will measure results 10 weeks later when the two groups don’t have the reminder. The principal outcome used to measure the adherence to physical activity will be the International Physical Activity Questionnaire; secondary outcomes will be a fun-fitness test and self-report survey about quality of life, self-efficacy and social support. Samples will be randomized by sealed envelope in two groups, with approximately 20 subjects in each group. It’s important to know that the therapist will be blinded and won’t know the subjects of each group. Discussion Offering people with ID a multimodal intervention and tool to increase the adherence to a physical activity may increase the levels of physical activity and quality of life. Such a scheme, if beneficial, could be implemented successfully within public health sense. Trial registration ClinicalTrials.gov Identifier: NCT01915381.

Gene network effects on brain microstructure and intellectual performance identified in 472 twins

A major challenge in neuroscience is finding which genes affect brain integrity, connectivity, and intellectual function. Discovering influential genes holds vast promise for neuroscience, but typical genome-wide searches assess approximately one million genetic variants one-by-one, leading to intractable false positive rates, even with vast samples of subjects. Even more intractable is the question of which genes interact and how they work together to affect brain connectivity. Here, we report a novel approach that discovers which genes contribute to brain wiring and fiber integrity at all pairs of points in a brain scan. We studied genetic correlations between thousands of points in human brain images from 472 twins and their nontwin siblings (mean age: 23.7 2.1 SD years; 193 male/279 female).Wecombined clustering with genome-wide scanning to find brain systems withcommongenetic determination.Wethen filtered the image in a new way to boost power to find causal genes. Using network analysis, we found a network of genes that affect brain wiring in healthy young adults. Our new strategy makes it computationally more tractable to discover genes that affect brain integrity. The gene network showed small-world and scale-free topologies, suggesting efficiency in genetic interactions and resilience to network disruption. Genetic variants at hubs of the network influence intellectual performance by modulating associations between performance intelligence quotient and the integrity of major white matter tracts, such as the callosal genu and splenium, cingulum, optic radiations, and the superior longitudinal fasciculus.

A stress and coping approach to organisational change: Evidence from three field studies

In this paper, a stress and coping perspective is used to outline the processes that determine employee adaptation to organisational change. A theoretical framework that simultaneously considers the effects of event characteristics, situational appraisals, coping strategies, and coping resources is reviewed. Three empirical investigations of organisational change that have tested various components of the model are then presented. In the first study, there was evidence linking event characteristics, situational appraisals, coping strategies and coping resources to levels of employee adjustment in a sample of pilots employed in a newly merged airline company. In a more focused test of the model with a sample of employees experiencing a restructuring process in their organisation it was found that the provision of change-related information enhanced levels of efficacy to deal with the change process which, in turn, predicted psychological wellbeing, client engagement, and job satisfaction. In a study of managers affected by a new remuneration scheme, there was evidence to suggest that managers who received change-specific information and opportunities to participate in the change process reported higher levels of change readiness. Managers who reported higher levels of readiness for change also reported higher levels of psychological wellbeing and job satisfaction. These studies highlight ways in which managers and change agents can help employees to cope during times of organisational change.

Eye-safe UV stand-off Raman spectroscopy for the ranged detection of explosives in the field

Increasing worldwide terrorist attacks involving explosives presents a growing need for a rapid and ranged explosive detection method that can safely be deployed in the field. Stand-off Raman spectroscopy shows great promise; however, the radiant exposures of lasers required for adequate signal generation are often much greater than what is safe for the eye or the skin, restricting use of the technique to un-populated areas. Here, by determining the safe exposure levels for lasers typically used in Raman spectroscopy, optimal parameter values are identified, which produce the largest possible detection range using power densities that do not exceed the eye-safe limit. It is shown that safe ultraviolet pulse energies can be more than three orders of magnitude greater than equivalent safe visible pulse energies. Coupling this to the 16-fold increase in Raman signal obtained in the ultraviolet at 266 nm over that at 532 nm results in a 131 times larger detection range for the eye-safe 266-nm system over an equivalent eye-safe 532-nm laser system. For the Raman system described here, this translates to a maximum range of 42 m for detecting Teflon with a 266-nm laser emitting a 100-mm diameter beam of 23.5-mJ nanosecond pulses.

Mathematical modelling of gas production and compositional shift of a CSG (coal seam gas) field: Local model development

In this work we discuss the development of a mathematical model to predict the shift in gas composition observed over time from a producing CSG (coal seam gas) well, and investigate the effect that physical properties of the coal seam have on gas production. A detailed (local) one-dimensional, two-scale mathematical model of a coal seam has been developed. The model describes the competitive adsorption and desorption of three gas species (CH4, CO2 and N2) within a microscopic, porous coal matrix structure. The (diffusive) flux of these gases between the coal matrices (microscale) and a cleat network (macroscale) is accounted for in the model. The cleat network is modelled as a one-dimensional, volume averaged, porous domain that extends radially from a central well. Diffusive and advective transport of the gases occurs within the cleat network, which also contains liquid water that can be advectively transported. The water and gas phases are assumed to be immiscible. The driving force for the advection in the gas and liquid phases is taken to be a pressure gradient with capillarity also accounted for. In addition, the relative permeabilities of the water and gas phases are considered as functions of the degree of water saturation.

Intellectual property and climate change: Inventing clean technologies

In the wake of the international summits in Copenhagen and Cancún, there is an urgent need to consider the role of intellectual property law in encouraging research, development, and diffusion of clean technologies to mitigate and adapt to the effects of climate change. This book charts the patent landscapes and legal conflicts emerging in a range of fields of innovation – including renewable forms of energy, such as solar power, wind power, and geothermal energy; as well as biofuels, green chemistry, green vehicles, energy efficiency, and smart grids. As well as reviewing key international treaties, this book provides a detailed analysis of current trends in patent policy and administration in key nation states, and offers clear recommendations for law reform. It considers such options as technology transfer, compulsory licensing, public sector licensing, and patent pools; and analyses the development of Climate Innovation Centres, the Eco-Patent Commons, and environmental prizes, such as the L-Prize, the H-Prize, and the X-Prizes. This book will have particular appeal to policy-makers given its focus upon recent legislative developments and reform proposals, as well as legal practitioners by developing a better understanding of recent legal, scientific, and business developments, and how they affect their practice. Innovators, scientists and researchers will also benefit from reading this book.

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.