343 resultados para Licensing Agreements
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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.
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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.
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This paper considers the ongoing litigation against the peer to peer network Kazaa. Record companies and Hollywood studios have faced jurisdictional and legal problems in suing this network for copyright infringement. As Wired Magazine observes: ’The servers are in Denmark. The software is in Estonia. The domain is registered Down Under, the corporation on a tiny island in the South Pacific. The users - 60 million of them - are everywhere around the world.' In frustration, copyright owners have launched copyright actions against intermediaries - like Internet Service Providers such as Verizon. They have also embarked on filing suits of individual users of file-sharing programs. In addition, copyright owners have called for domestic and international law reform in respect of digital copyright. The Senate Committee on Government Affairs in the United States Congress has reviewed the controversial use of subpoenas in suits against users of file-sharing peer to peer networks. The United States has encouraged other countries to adopt provisions of the Digital Millennium Copyright Act 1998 (US) in bilateral and regional free trade agreements.
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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.
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In the United States, there has been fierce debate over state, federal and international efforts to engage in genetically modified food labelling (GM food labelling). A grassroots coalition of consumers, environmentalists, organic farmers, and the food movement has pushed for law reform in respect of GM food labelling. The Just Label It campaign has encouraged United States consumers to send comments to the United States Food and Drug Administration to label genetically modified foods. This Chapter explores the various justifications made in respect of genetically modified food labelling. There has been a considerable effort to portray the issue of GM food labelling as one of consumer rights as part of ‘the right to know’. There has been a significant battle amongst farmers over GM food labelling – with organic farmers and biotechnology companies, fighting for precedence. There has also been a significant discussion about the use of GM food labelling as a form of environmental legislation. The prescriptions in GM food labelling regulations may serve to promote eco-labelling, and deter greenwashing. There has been a significant debate over whether GM food labelling may serve to regulate corporations – particularly from the food, agriculture, and biotechnology industries. There are significant issues about the interaction between intellectual property laws – particularly in respect of trade mark law and consumer protection – and regulatory proposals focused upon biotechnology. There has been a lack of international harmonization in respect of GM food labelling. As such, there has been a major use of comparative arguments about regulator models in respect of food labelling. There has also been a discussion about international law, particularly with the emergence of sweeping regional trade proposals, such as the Trans-Pacific Partnership, and the Trans-Atlantic Trade and Investment Partnership. This Chapter considers the United States debates over genetically modified food labelling – at state, federal, and international levels. The battles often involved the use of citizen-initiated referenda. The policy conflicts have been policy-centric disputes – pitting organic farmers, consumers, and environmentalists against the food industry and biotechnology industry. Such battles have raised questions about consumer rights, public health, freedom of speech, and corporate rights. The disputes highlighted larger issues about lobbying, fund-raising, and political influence. The role of money in United States has been a prominent concern of Lawrence Lessig in his recent academic and policy work with the group, Rootstrikers. Part 1 considers the debate in California over Proposition 37. Part 2 explores other key state initiatives in respect of GM food labelling. Part 3 examines the Federal debate in the United States over GM food labelling. Part 4 explores whether regional trade agreements – such as the Trans-Pacific Partnership (TPP) and the Trans-Atlantic Trade and Investment Partnership (TTIP) – will impact upon
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There has been much debate about the relationship between international trade, the environment, biodiversity protection, and climate change.The Obama Administration has pushed such issues into sharp relief, with its advocacy for sweeping international trade agreements, such as the Trans-Pacific Partnership and the Trans-Atlantic Trade and Investment Partnership. There has been much public concern about the impact of the mega-trade deals upon the protection of the environment. In particular, there has been a debate about whether the Trans-Pacific Partnership will promote dirty fracking. Will the Trans-Pacific Partnership transform the Pacific Rim into a Gasland?There has been a particular focus upon investor-state dispute settlement being used by unconventional mining companies. Investor-state dispute settlement is a mechanism which enables foreign investors to seek compensation from national governments at international arbitration tribunals. In her prescient 2009 book, The Expropriation of Environmental Governance, Kyla Tienhaara foresaw the rise of investor-state dispute resolution of environmental matters. She observed:'Over the last decade there has been an explosive increase of cases investment arbitration. This is significant in terms of not only the number of disputes that have arisen and the number of states that have been involved, but also the novel types of dispute that have emerged. Rather than solely involving straightforward incidences of nationalization or breach of contract, modern disputes often revolve around public policy measures and implicate sensitive issues such as access to drinking water, development on sacred indigenous sites and the protection of biodiversity.'In her study, Kyla Tienhaara observed that investment agreements, foreign investment contracts and investment arbitration had significant implications for the protection for the protection of the environment. She concluded that arbitrators have made it clear that they can, and will, award compensation to investors that claim to have been harmed by environmental regulation. She also found that some of the cases suggest that the mere threat of arbitration is sufficient to chill environmental policy development. Tienhaara was equally concerned by the possibility that a government may use the threat of arbitration as an excuse or cover for its failure to improve environmental regulation. In her view, it is evident that arbitrators have expropriated certain fundamental aspects of environmental governance from states. Tienhaara held: As a result, environmental regulation has become riskier, more expensive, and less democratic, especially in developing countries. This article provides a comparative analysis of the battles over fracking, investment, trade, and the environment in a number of key jurisdictions including the United States, Canada, Australia, and New Zealand. Part 1 focuses upon the United States. Part 2 examines the dispute between the Lone Pine Resources Inc. and the Government of Canada over a fracking moratorium in Quebec. Part 3 charts the rise of the Lock the Gate Alliance in Australia, and its demands for a moratorium in respect of coal seam gas and unconventional mining. Part 4 focuses upon parallel developments in New Zealand. This article concludes that Pacific Rim countries should withdraw from investor-state dispute settlement procedures, because of the threat posed to environmental regulation in respect of air, land, and water.
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TThis article considers the radical, sweeping changes to Australian copyright law wrought by the Australia–United States Free Trade Agreement 2004 (AUSFTA). It contends that the agreement will result in a “piracy of the public domain”. Under this new regime, copyright owners will be able to obtain greater monopoly profits at the expense of Australian consumers, libraries and research institutions, as well as intermediaries, such as Internet service providers. Part One observes that the copyright term extension in Australia to life of the author plus 70 years for works will have a negative economic and cultural impact — with Australia’s net royalty payments estimated to be up to $88 million higher per year. Part Two argues that the adoption of stronger protection of technological protection measures modelled upon the Digital Millennium Copyright Act 1998 (U.S.) will override domestic policy–making processes, such as the Phillips Fox Digital Agenda Review, and judicial pronouncements such as the Stevens v Sony litigation. Part Three questions whether the new safe harbours protection for Internet service providers will adversely affect the sale of Telstra. This article concludes that there is a need for judicial restraint in interpreting the AUSFTA. There is an urgent call for the Federal Government to pass ameliorating reforms — such as an open–ended defence of fair use and a mechanism for orphan works. There is a need for caution in negotiating future bilateral trade agreements — lest the multinational system for the protection of copyright law be undermined.
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This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called Edinburgh patent, and the inquiry of the European Group on Ethics in Science and New Technologies into The Ethical Aspects of Patenting Involving Human Stem Cells.
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This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): ’Human beings and the biological processes for their generation are not patentable inventions.' It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed.
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Efforts to reduce carbon emissions in the buildings sector have been focused on encouraging green design, construction and building operation; however, the business case is not very compelling if considering the energy cost savings alone. In recent years green building has been driven by a sense that it will improve the productivity of occupants,something with much greater economic returns than energy savings. Reducing energy demand in green commercial buildings in a way that encourages greater productivity is not yet well understood as it involves a set of complex and interdependent factors. This project investigates these factors and focuses on the performance of and interaction between: green design elements, internal environmental quality, occupant experience, tenant/leasing agreements, and building regulation and management. This paper suggests six areas of strategic research that are needed to understand how conditions can be created to support productivity in green buildings, and deliver significant energy consumption reductions.
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Service compositions enable users to realize their complex needs as a single request. Despite intensive research, especially in the area of business processes, web services and grids, an open and valid question is still how to manage service compositions in order to satisfy both functional and non-functional requirements as well as adapt to dynamic changes. In this paper we propose an (functional) architecture for adaptive management of QoS-aware service compositions. Comparing to the other existing architectures this one offers two major advantages. Firstly, this architecture supports various execution strategies based on dynamic selection and negotiation of services included in a service composition, contracting based on service level agreements, service enactment with flexible support for exception handling, monitoring of service level objectives, and profiling of execution data. Secondly, the architecture is built on the basis of well know existing standards to communicate and exchange data, which significantly reduces effort to integrate existing solutions and tools from different vendors. A first prototype of this architecture has been implemented within an EU-funded Adaptive Service Grid project. © 2006 Springer-Verlag.
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This article considers the recent international controversy over the patents held by a Melbourne firm, Genetic Technologies Limited (GTG), in respect of non-coding DNA and genomic mapping. It explores the ramifications of the GTG dispute in terms of licensing, litigation, and policy reform, and—as a result of this dispute—the perceived conflict between law and science. GTG has embarked upon an ambitious licensing program with twenty seven commercial licensees and five research licensees. Most significantly, GTG has obtained an exclusive licence from Myriad Genetics to use and exploit its medical diagnostics in Australia, New Zealand, and the Asia-Pacific region. In the US, GTG brought a legal action for patent infringement against the Applera Corporation and its subsidiaries. In response, Applera counterclaimed that the patents of GTG were invalid because they failed to comply with the requirements of US patent law, such as novelty, inventive step, and written specifications. In New Zealand, the Auckland District Health Board brought legal action in the High Court, seeking a declaration that the patents of GTG were invalid, and that, in any case, the Board has not infringed them. The New Zealand Ministry of Health and the Ministry of Economic Development have reported to Cabinet on the issues relating to the patenting of genetic material. Similarly, the Australian Law Reform Commission (ALRC) has also engaged in an inquiry into gene patents and human health; and the Advisory Council on Intellectual Property (ACIP) has considered whether there should be a new defence in respect of experimental use and research.
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Copyright estates have been unduly empowered by the extension of the term of copyright protection in Europe, the United States, Australia and elsewhere. The Estate of the Irish novelist, James Joyce, has been particularly aggressive in policing his revived copyrights. The "keepers of the flame" have relied upon threats of legal action to discourage the production of derivative works based upon the canonical texts of the novelist. The Estate has also jealously guarded the reputation of the author by vetoing the use of his work in various scholarly productions. Most radically of all, the grandson Stephen Joyce threatened to take legal action to prevent the staging of "Rejoyce Dublin 2004", a festival celebrating the centenary of Bloomsday. In response, the Irish Parliament rushed through emergency legislation, entitled the Copyright and Related Rights (Amendment) Act 2004 (Ireland) to safeguard the celebrations. The legislation clarified that a person could place literary and artistic works on public exhibition, without breaching the copyright vested in such cultural texts. Arguably, though, the ad hoc legislation passed by the Irish Parliament is inadequate. The Estate of James Joyce remains free to exercise its suite of economic and moral rights to control the use and adaptation of works of the Irish novelist. It is contended that copyright law needs to be revised to promote the interests of libraries and other cultural institutions. Most notably, the defence of fair dealing should be expanded to allow for the transformative use of copyright works, particularly in respect of adaptations and derived works. There should be greater scope for compulsory licensing and crown acquisition of revived copyrights.
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The increasing international political, public and scientific engagement in matters of environmental sustainability and development has produced a rapidly expanding body of environmental law and policy. The advent of international protocols, directives, and multilateral agreements has occurred concomitantly with the harmonisation of widespread environmental regimes of governance and enforcement within numerous domestic settings. This has created an unprecedented need for environmental legal apparatuses to manage, regulate and adjudicate legislation seeking to protect, sustain and develop global natural habitats. The evolving literature in green criminology continues to explore these developments within discourses of power, harm and justice. Such critiques have emphasised the role of dedicated environmental courts to address environmental crimes and injustices. In this article, we examine the important role of specialist courts in responding to environmental crime, with specific reference to the State of Queensland. We offer a critique of existing processes and practices for the adjudication of environmental crime and propose new jurisdictional and procedural approaches for enhancing justice. We conclude that specialist environmental courts endowed with broad civil and criminal jurisdiction are an integral part of an effective response to environmental crime.
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This thesis explored the impact of non-contractual agreements in economic decisions. These statements of intent serve as a commitment device in strategic decisions and have been found to be an effective alternative to strong regulations in promoting social behaviour. Three studies have been undertaken using conceptual and methodological approaches from Behavioral and Experimental Economics. The first study explored in a public good setting the effect of public statements about intended social behaviour. The second study tested whether promises can help to promote co-operation in environments with uncertain choice options. The third study investigated a possible application of statement of intent and tested the effect of payment promises in a tax setting.