23andMe Inc.: Patent law and lifestyle genetics

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics Inc. There has been much debate and controversy over 23andMe Inc. filing patent applications – particularly in respect of its granted patent on ‘Polymorphisms associated with Parkinson’s Disease’. The direct-to-consumer marketing of genetic testing by 23andMe Inc. has also raised important questions of bioethics and human rights. It is queried whether the terms of service for 23andMe Inc. provide adequate recognition of the concepts of informed consent and benefit-sharing, especially in light of litigation in this area in the United States. Given the patent thickets surrounding genetic testing, the case study of 23andMe Inc. also highlights questions about patent infringement and patent exceptions. The future reform of patent law, policy, and practice needs to take into account new developments in lifestyle genetics and personalised medicine – as exemplified by 23andMe Inc.

A fair use project for Australia: Copyright law and creative freedom

This essay provides a critical assessment of the Fair Use Project based at the Stanford Center for Internet and Society. In evaluating the efficacy of the Fair Use Project, it is worthwhile considering the litigation that the group has been involved in, and evaluating its performance. Part 1 outlines the history of the Stanford Center for Internet and Society, and the aims and objectives of the Fair Use Project. Part 2 considers the litigation in Shloss v. Sweeney over a biography concerning Lucia Joyce, the daughter of the avant-garde literary great, James Joyce. Part 3 examines the dispute over the Harry Potter Lexicon. Part 4 looks at the controversy over the Shepard Fairey poster of President Barack Obama, and the resulting debate with Associated Press. Part 5 of the essay considers the intervention of the Fair Use Project as an amicus curiae in the ‘Column case’. Part 6 explores the participation of the Fair Use Project as an amicus curiae in the litigation over 60 Years Later, an unauthorised literary sequel to J.D. Salinger’s The Catcher in the Rye. Part 7 of the essay investigates the role of the Fair Use project in disputes over copyright law and musical works. Part 8 investigates the role of the Fair Use Project as an advocate in disputes over copyright law, fair use, documentary films, and internet videos. The conclusion has main three arguments. First, it contends that Australia should establish a Fair Use Project to support creative artists in litigation over copyright exceptions. Second, it maintains that Australia should adopt a flexible, open-ended defence of fair use, and draw upon the rich jurisprudence in the United States on the fair use doctrine. Finally, this paper argues that support should be given at an international level to the proposal for a Treaty on Access to Knowledge.

Bangarra Dance Theatre: Copyright law and Indigenous culture

This article considers the artistic and legal practices of Bangarra Dance Theatre in a case study of copyright law management in relation to Indigenous culture. It is grounded in the particular local experience, knowledge and understanding of copyright law displayed by the performing arts company. The first part considers the special relationship between Bangarra Dance Theatre and the Munyarrun Clan. It examines the contractual arrangements developed to recognise communal ownership. The next section examines the role of the artistic director and choreographer. It looks at the founder, Carole Johnson, and her successor, Stephen Page. The third part of the article focuses on the role of the composer, David Page. It examines his ambition to set up a Indigenous recording company, Nikinali. Part 4 focuses upon the role of the artistic designers. It looks at the contributions of artistic designers such as Fiona Foley. Part 5 deals with broadcasts of performances on television, film, and multi-media. Part 6 considers the collaborations of Bangarra Dance Theatre with the Australian Ballet, and the Sydney Organising Committee for the Olympic Games. The conclusion considers how Bangarra Dance Theatre has played a part ina general campaign to increase protection of Indigenous copyright law.

Canadian rhapsody: Copyright law and research libraries

This article considers the ground-breaking Supreme Court of Canada decision in The Law Society of Upper Canada v CCH Canadian Limited. The matter involved legal publishers bringing an action for copyright infringement against the Law Society of Upper Canada for operating a photocopy and custom copy service at the Great Library of Osgoode Hall. The Supreme Court of Canada decision laid down important precedents in relation to originality, authorisation, and the defence of fair dealing. The ruling has been hailed as ’one of the strongest pro-user rights decisions from any high court in the world, showing what it means to do more than pay mere lip service to balance in copyright'. This decision will have important implications for the regulation of new technologies. The approach has been applied in two decisions dealing copyright law and the Internet - the Canadian Federal Court case of BMG Canada v John Doe, and the Supreme Court of Canada ’Tariff 22' case. The Supreme Court of Canada decision in The Law Society of Upper Canada v CCH Canadian Limited provides an impetus to reconsider the judicial interpretation of user rights in Australian jurisprudence.

Genentech and the stolen gene: Patent law and pioneer inventions

This paper evaluates the litigation over the biotechnology patent dispute between the University of California and Genentech. First it outlines the scientific work behind the cloning of the human growth hormone, and looks at the patent office, and its treatment of biotechnological inventions. Second, it considers the court room dispute, and the legal case of the University of California and the biotechnology company in this dispute. Finally, it considers the implications of this dispute for policy reform in respect of patent law and biotechnology.

Robbery under arms: Copyright law and the Australia-United States free trade agreement

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.

Child protection training for professionals to improve reporting of child abuse and neglect (Protocol)

Child abuse and neglect results in significant costs for children and communities. As a core public health strategy, diverse professional groups are required by law and policy in many jurisdictions to report suspected cases. Numerous different training initiatives appear to have been developed and implemented for professionals but there is little evidence regarding the precise training components and mechanisms that improve reporting of child abuse and neglect both generally, for specific professions, and for distinct types of child abuse and neglect. To enhance reporting practice, designers of training programmes require detailed information about what programme features will offer greatest benefit. A systematic review which identifies the effectiveness of different training approaches will advance the evidence base and develop a clearer understanding of optimal training content and methods. In addition, it will provide policymakers with a means by which to assess whether current training interventions are congruent with what is demonstrated to be effective. It will also inform future research, public policy, and professional practice in this field.

Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

Gone with the wind: copyright law and fair use

The copyright defence of fair use has been tested in a recent United States case involving the classic Gone with the wind. [Suntrust Bank, as Trustee of the Stephens Mitchell trusts v Houghton Mifflin Company (2001) 136 F. Supp. 2d 1357; and Suntrust Bank, as Trustee of the Stephens Mitchell trusts v Houghton Mifflin Company (2001) US Appeal Lexis 21690.]

Precious images: Copyright law and television broadcasts

Over the last several years, Australian media magnate Kerry Packer has sought to maximise the value of the intellectual property assets of the television station Channel Nine. He has made a concerted effort to expand the scope of copyright protection over television broadcasts screened. The television station Channel Nine has taken a number of legal actions against its rivals and competitors - including the Australian Broadcasting Corporation and Network Ten. It has alleged that the broadcasters have used substantial parts of copyrighted television broadcasts without their permission.

The new conquistadors: Patent law and expressed sequence tags

It's akin to the old Spanish, English and Portuguese explorers. They would take their boats until they found some edge of land, then they would go up and plant the flag of their king or queen. They didn't know what they'd discovered; how big it is, where it goes to - but they would claim it anyway. David Korn of the Association of American Medical Colleges This article analyses recent litigation over patent law and expressed sequence tags (ESTs). In the case of In re Fisher, the United States Court of Appeals for the Federal Circuit engaged in judicial consideration of the revised utility guidelines of the United States Patent and Trademark Office (USPTO). In this matter, the agricultural biotechnology company Monsanto sought to patent ESTs in maize plants. A patent examiner and the Board of Patent Appeals and Interferences had doubted whether the patent application was useful. Monsanto appealed against the rulings of the USPTO. A number of amicus curiae intervened in the matter in support of the USPTO - including Genentech, Affymetrix, Dow AgroSciences, Eli Lilly, the National Academy of Sciences, and the Association of American Medical Colleges. The majority of the Court of Appeals for the Federal Circuit supported the position of the USPTO, and rejected the patent application on the grounds of utility. The split decision highlighted institutional tensions over the appropriate thresholds for patent criteria - such as novelty, non-obviousness, and utility. The litigation raised larger questions about the definition of research tools, the incremental nature of scientific progress, and the role of patent law in innovation policy. The decision of In re Fisher will have significant ramifications for gene patents, in the wake of the human genome project. Arguably, the USPTO utility guidelines need to be reinforced by a tougher application of the standards of novelty and non-obviousness in respect of gene patents.

Miami heat: Patent law, informed consent and benefit-sharing

This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California, a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital, the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’. In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

Four stories about copyright law and appropriation art

This article considers copyright law and the art of appropriation in an Australian context. It tells four stories about Australian artists - Imants Tillers, Gordon Bennett, Juan Davila and Tracey Moffatt. The stories examine the postmodern critique of copyright law, indigenous copyright and self-determination, the introduction of moral rights, and copyright, photography and film. The article concludes that the work of such contemporary artists has practical implications for the reform of copyright law.

Copyright, fair use and the Australian Constitution

There has been much debate over recent years about whether Australian copyright law should adopt a fair use doctrine. In this chapter we argue by pointing to the historical record that the incorporation of the term 'copyrights' in the Australian Constitution embeds a notion of balance and fair use in Australian law and that this should be taken into account when interpreting the Australian Copyright Act 1968. English case law in the 18th and 19th centuries developed a principle that copyright infringement did not occur where a person had made a fair use of a work. Fair use was generally established where the defendant had made a productive use that did more than alter the original work for the purpose of evading liability, and where the defendant had made an original contribution to the resulting work. Additionally, fairness was shown by a use that did not supersede or prejudice the market for the original work. At the time of including the copyright power in the Constitution, the UK Parliament’s understanding of “copyrights” included the notion of fair use as it had been developed in U.K. precedent. In this chapter we argue that the work “copyrights” in the Australia Constitution takes its definition from copyright in 1900 and as it has evolved since. Importantly, the word “copyrights” is infused with a particular meaning that incorporates the principle of copyright balance. The constitutional notion of copyright, therefore, is not that of an unlimited power to prevent all copying. Rather, copyright distinguishes between infringing copying and non-infringing copying and grants to the copyright owner only the power to control the former. Non-infringing copying includes well-accepted limitations on the copyright owner’s rights, including the copying of ideas, the copying of public domain works and the copying of insubstantial parts of copyrighted works. In this chapter we argue that non-infringing copying also includes copying to make a fair use of a work. The sections that distinguish infringing copying from non-infringing copying in the Copyright Act 1968 are sections 36(1) and 101(1), which define infringement as the doing, without licence, of an “act comprised in the copyright”. An infringing copy is an act comprised the copyright, whereas a non-infringing copy is not. We argue that space for fair uses of copyrighted works is built into the Copyright Act 1968 through these sections, because a fair use will not produce an infringing copy and so is not an act comprised in the copyright.

Doctors’ perspectives on law and life-sustaining treatment: Survey design and recruitment strategies for a challenging cohort

- Background Palliative medicine and other specialists play significant legal roles in decisions to withhold and withdraw life-sustaining treatment at the end of life. Yet little is known about their knowledge of or attitudes to the law, and the role they think it should play in medical practice. Consideration of doctors’ views is critical to optimizing patient outcomes at the end of life. However, doctors are difficult to engage as participants in empirical research, presenting challenges for researchers seeking to understand doctors’ experiences and perspectives. - Aims To determine how to engage doctors involved in end-of-life care in empirical research about knowledge of the law and the role it plays in medical practice at the end of life. - Methods Postal survey of all specialists in palliative medicine, emergency medicine, geriatric medicine, intensive care, medical oncology, renal medicine, and respiratory medicine in three Australian states: New South Wales, Victoria, and Queensland. The survey was sent in hard copy with two reminders and a follow up reminder letter was also sent to the directors of hospital emergency departments. Awareness was further promoted through engagement with the relevant medical colleges and publications in professional journals; various incentives to respond were also used. The key measure is the response rate of doctors to the survey. - Results Thirty-two percent of doctors in the main study completed their survey with response rate by specialty ranging from 52% (palliative care) to 24% (medical oncology). This overall response rate was twice that of the reweighted pilot study (16%). - Conclusions Doctors remain a difficult cohort to engage in survey research but strategic recruitment efforts can be effective in increasing response rate. Collaboration with doctors and their professional bodies in both the development of the survey instrument and recruitment of participants is essential.