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.

Beyond blue gene: Intellectual property and bioinformatics

This article considers the challenges posed to intellectual property law by the emerging field of bioinformatics. It examines the intellectual property strategies of established biotechnology companies, such as Celera Genomics, and information technology firms entering into the marketplace, such as IBM. First this paper argues that copyright law is not irrelevant to biotechnology, as some commentators would suggest. It claims that the use of copyright law and contract law is fundamental to the protection of biomedical and genomic databases. Second this article questions whether biotechnology companies are exclusively interested in patenting genes and genetics sequences. Recent evidence suggests that biotechnology companies and IT firms are patenting bioinformatics software and Internet business methods, as well as underlying instrumentation such as microarrays and genechips. Finally, this paper evaluates what impact the privatisation of bioinformatics will have on public research and scientific communication. It raises important questions about integration, interoperability, and the risks of monopoly. It finally considers whether open source software such as the Ensembl Project and peer to peer technology like DSAS will be able to counter this trend of privatisation.

Brain network efficiency and topology depend on the fiber tracking method: 11 tractography algorithms compared in 536 subjects

As connectivity analyses become more popular, claims are often made about how the brain's anatomical networks depend on age, sex, or disease. It is unclear how results depend on tractography methods used to compute fiber networks. We applied 11 tractography methods to high angular resolution diffusion images of the brain (4-Tesla 105-gradient HARDI) from 536 healthy young adults. We parcellated 70 cortical regions, yielding 70×70 connectivity matrices, encoding fiber density. We computed popular graph theory metrics, including network efficiency, and characteristic path lengths. Both metrics were robust to the number of spherical harmonics used to model diffusion (4th-8th order). Age effects were detected only for networks computed with the probabilistic Hough transform method, which excludes smaller fibers. Sex and total brain volume affected networks measured with deterministic, tensor-based fiber tracking but not with the Hough method. Each tractography method includes different fibers, which affects inferences made about the reconstructed networks.

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.

Copyright and creativity: An ongoing debate in the creative industries

This paper critically analyzes the divergent perspectives on how copyright and intellectual property laws impact creativity, innovation, and the creative industries. One perspective defines the creative industries based on copyright as the means by which revenues are generated from innovation and the dissemination of new ideas. At the same time, it has been argued that copyright and intellectual property regimes fetter creativity and innovation, and that this has become even more marked in the context of digital media convergence and the networked global creative economy. These issues have resonated in debates around the creative industries, particularly since the initial DCMS mapping study in the UK in 1998 defined creative industries as combining individual creativity and exploitable forms of intellectual property. The issue of competing claims for the relationship between copyright and the creative industries has also arisen in Australia, with a report by the Australian Law Reform Commission entitled Copyright and the Digital Economy. This paper will consider the competing claims surrounding copyright and the creative industries, and the implications for policy-makers internationally.

The logics of good teaching in an audit culture: A Deleuzian analysis

This article examines the attempted reform of education within an emerging audit culture in Australia that has led to the implementation of a high-stakes testing regime known as NAPLAN. NAPLAN represents a machine of auditing, which creates and accounts for data that are used to measure, amongst other things, good teaching. In particular, we address the logics of a policy intervention that aims to improve the quality of education through returning ‘good teaching’. Using Deleuze’s concepts of series, events, copies and simulacra, we suggest that an attempt to return past commonsense logics of ‘good teaching’ as a result of NAPLAN is not possible. In an audit culture as exemplified by NAPLAN, ‘good teaching’ is being reconceptualized through those practices and becomes unrecognizable. Whilst policy claims to improved equity and quality are admirable, this article suggests that the simulacral change to logics of good teaching may actualize something very different.

Performance pay for Australian teachers: A critical policy historiography

In May 2011, the Australian Federal Education Minister announced there would be a unique, innovative and new policy of performance pay for teachers, Rewards for Great Teachers (Garrett, 2011a). In response, this paper uses critical policy historiography to argue that the unintended consequences of performance pay for teachers makes it unlikely it will deliver improved quality or efficiency in Australian schools. What is new, in the Australian context, is that performance pay is one of a raft of education policies being driven by the federal government within a system that constitutionally and historically has placed the responsibility for schooling with the states and territories. Since 2008, a key platform of the Australian federal Labor government has been a commitment to an Education Revolution that would promote quality, equity and accountability in Australian schools. This commitment has resulted in new national initiatives impacting on Australian schools including a high-stakes testing regime 14 National Assessment Program 13 Literacy and Numeracy (NAPLAN) 14a mandated national curriculum (the Australian Curriculum), professional standards for teachers and teacher accreditation 14Australian Institute for Teaching and School Leadership (AITSL) 14and the idea of rewarding excellent teachers through performance pay (Garrett, 2011b). These reforms demonstrate the increased influence of the federal government in education policy processes and the growth of a 1Ccoercive federalism 1D that pits the state and federal governments against each other (Harris-Hart, 2010). Central to these initiatives is the measuring, or auditing, of educational practices and relationships. While this shift in education policy hegemony from state to federal governments has been occurring in Australia at least since the 1970s, it has escalated and been transformed in more recent times with a greater emphasis on national human capital agendas which link education and training to Australia 19s international economic competitiveness (Lingard & Sellar, in press). This paper uses historically informed critical analysis to critique claims about the effects of such policies. We argue that performance pay has a detailed and complex historical trajectory both internationally and within Australian states. Using Gale 19s (2001) critical policy historiography, we illuminate some of the effects that performance pay policies have had on education internationally and in particular within Australia. This critical historical lens also provides opportunities to highlight how teachers have, in the past, tactically engaged with such policies.

The Value of Financial Planning Advice: Process and Outcome Effects on Consumer Well-being [Time 1 and 2 Survey Summary Results]

While anecdotal evidence indicates financial advice affects consumers’ financial well-being, this research project is motivated by the absence of empirically-grounded research relating to the extent to which, and, importantly, how, financial planning advice contributes to broader client well-being. Accordingly, the aim of this project is to establish how the quality of financial planning advice can be optimised to add value, not only to clients’ financial situation, but also to broader aspects of their well-being. This broader construct of well-being captures a range of process and outcome factors that map to concepts of security, control, choice, mastery, and life satisfaction (Irving, 2012; Gallery, Gallery, Irving & Newton, 2011; Irving, Gallery, and Gallery, 2009). Financial planning is commonly purported to confer not only tangible benefits, but also intangible benefits, such as increased security and peace of mind that are considered as important, if not more important, than material outcomes. Such claims are intuitively appealing; however, little empirical evidence exists for the notion that engaging with a financial planner or adviser promotes peace of mind, feelings of security, and expands choices and possibilities. Nor is there evidence signalling what mechanisms might underpin such client benefits. In addressing this issue, we examine the financial planning advice (including financial product advice) provided to retail clients, and consider the short- and longer-term impacts on clients’ financial satisfaction and broader well-being. To this end, we examine both process (e.g., how financial planning advice is given) and outcome (e.g., financial situation) effects.

Mid-Holocene Aboriginal occupation of offshore islands in northern Australia? A reassessment of Wurdukanhan, Mornington Island, southern Gulf of Carpentaria, Australia

Claims for mid-Holocene Aboriginal occupation at the shell matrix site of Wurdukanhan, Mornington Island, Gulf of Carpentaria, Australia, are reassessed through an analysis of the excavated assemblage coupled with new surveys and an extensive dating program. Memmott et al. (2006, pp. 38, 39) reported basal ages of c.5000–5500 years from Wurdukanhan as 'the oldest date yet obtained for any archaeological site on the coast of the southern Gulf of Carpentaria' and used these dates to argue for 'a relatively lengthy occupation since at least the mid-Holocene'. If substantiated, with the exception of western Torres Strait, these claims make Mornington Island the only offshore island used across northern Australia in the mid-Holocene where it is conventionally thought that Aboriginal people only (re)colonised islands after sea-level maximum was achieved after the mid-Holocene. Our analysis of Wurdukanhan demonstrates high shellfish taxa diversity, high rates of natural shell predation and high densities of foraminifera throughout the deposit demonstrating a natural origin for the assemblage. Results are considered in the context of other dated shell matrix sites in the area and a geomorphological model for landscape development of the Sandalwood River catchment.

The Pirate Bazaar: The Social Life of Copyright Law

This thesis provides a cultural history of Australian copyright law and related artistic controversies. It examines a number of disputes over authorship, collaboration, and appropriation across a variety of cultural fields. It considers legal controversies over the plagiarism of texts, the defacing of paintings, the sampling of musical works, the ownership of plays, the co-operation between film-makers, the sharing of MP3 files on the Internet, and the appropriation of Indigenous culture. Such narratives and stories relate to a broad range of works and subject matter that are protected by copyright law. This study offers an archive of oral histories and narratives of artistic creators about copyright law. It is founded upon interviews with creative artists and activists who have been involved in copyright litigation and policy disputes. This dialogical research provides an insight into the material and social effects of copyright law. This thesis concludes that copyright law is not just a ‘creature of statute’, but it is also a social and imaginative construct. In the lived experience of the law, questions of aesthetics and ethics are extremely important. Industry agreements are quite influential. Contracts play an important part in the operation of copyright law. The media profile of personalities involved in litigation and policy debates is pertinent. This thesis claims that copyright law can be explained by a mix of social factors such as ethical standards, legal regulations, market forces, and computer code. It can also be understood in terms of the personal stories and narratives that people tell about litigation and copyright law reform. Table of Contents Prologue 1 Introduction A Creature of Statute: Copyright Law and Legal Formalism 6 Chapter One The Demidenko Affair: Copyright Law and Literary Works 33 Chapter Two Daubism: Copyright Law and Artistic Works 67 Chapter Three The ABCs of Anarchism: Copyright Law and Musical Works 105 Chapter Four Heretic: Copyright Law and Dramatic Works 146 Chapter Five Shine: Copyright Law and Film 186 Chapter Six Napster: Infinite Digital Jukebox or Pirate Bazaar? Copyright Law and Digital Works 232 Chapter Seven Bangarra Dance Theatre: Copyright Law and Indigenous Culture 275 Chapter Eight The Cathedral and the Bazaar: The Future of Copyright Law 319

Atmospheres : Aesthetics of emotional spaces[Review]

More problematic than his avoidance of recent geographic scholarship is his treatment of indigenous, ethnographic and postcolonial perspectives on island life. Not only is much of this scholarship absent, the bits that are there are mostly derided. He slams Kamau Braithwaite and his concept of ‘tidalectics’ as ‘unpackable’ (p. 20) and also claims that Greg Dening’s approach to islands as having ‘permeable cultural boundaries’ has ‘intellectual costs’ (p. 23). In a section of the book on ‘Naming and Sovereignty’, instead of an in-depth examination of the processes of decoding and recoding that goes on in indigenous island landscapes under colonialism (as could be discussed at length if Shell chose to examine Aotearoa, Hawaii, or hundreds of other places) we are instead presented a vignette about his childhood street fights with other kids over the naming of a hometown island in Canada, as well as ruminations about what Herman Melville and Ellen Semple thought of islands in the nineteenth century. In short, if you want to know what dead Caucasians like Shakespeare, Melville, Kant, Mackinder, More, and ancient Athenians thought about islands, then this book is a good resource. If, however, you are looking for information about what islands are like today – and what they mean to the people who live on and interact with them – then you will have to look elsewhere.

The race to patent the SARS virus: The TRIPS agreement and access to essential medicines

This article considers the race to sequence the Severe Acute Respiratory Syndrome virus ('the SARS virus') in light of the debate over patent law and access to essential medicines. Part II evaluates the claims of public research institutions in Canada, the United States, and Hong Kong, and commercial companies, to patent rights in respect of the SARS virus. It highlights the dilemma of ’defensive patenting' - the tension between securing private patent rights and facilitating public disclosure of information and research. Part III considers the race to patent the SARS virus in light of wider policy debates over gene patents. It examines the application of such patent criteria as novelty, inventive step, utility, and secret use. It contends that there is a need to reform the patent system to accommodate the global nature of scientific inquiry, the unique nature of genetics, and the pace of technological change. Part IV examines the role played by the World Trade Organization and the World Health Organization in dealing with patent law and access to essential medicines. The article contends that there is a need to ensure that the patent system is sufficiently flexible and adaptable to accommodate international research efforts on infectious diseases.

Vanquishing the'Patent Trolls'

Patent law provides exclusive rights to exploit scientific inventions, which are novel, inventive, and useful. The regime is intended to promote innovation, investment in research and development, and access to scientific information. In recent times, there have been concerns that the patent system has been abused by opportunistic companies known by the phrase “patent trolls”. It has been alleged that such entities have stunted innovation and spurred unnecessary patent litigation. Adam Jaffe and Josh Lerner discuss such pathologies of patent law in their book, Innovation and Its Discontents: How our Broken Patent System is Endangering Innovation and Progress, and What To Do About It. James Bessen and Michael Meurer have addressed such concerns in their recent text, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk. There have been particular fears about the rise of “patent trolls” in the field of information technology. Peter Dekin, an assistant general counsel at Intel, used the phrase “patent troll” to describe firms, which acquired patents only to extract settlements from companies on dubious infringement claims.

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.

Can the Gates Foundation be convinced to dump fossil fuels?

This week, The Guardian newspaper has campaigned for the Bill and Melinda Gates Foundation to divest its fossil fuel investments – which the newspaper claims are worth US$1.4 billion. The foundation can and should address the climate crisis, particularly given the threat it poses to food security, public health, human rights, and the development agenda.