The Jean Chretien Pledge to Africa act: Patent law and humanitarian aid

This article evaluates the implementation of the WTO General Council Decision in 2003, which resolved that developed nations could export patented pharmaceutical drugs to member states in order to address public health issues - such as HIV/AIDS, tuberculosis, malaria and other epidemics. The Jean Chretien Pledge to Africa Act 2004 (Canada) provides authorisation for the export of pharmaceutical drugs from Canada to developing countries to address public health epidemics. The European Union has issued draft regulations governing the export of pharmaceutical drugs. A number of European countries - including Norway, the Netherlands, France, and Switzerland - are seeking to pass domestic legislation to give force to the WTO General Council Decision. Australia has shown little initiative in seeking to implement such international agreements dealing with access to essential medicines. It is argued that Australia should implement humanitarian legislation to embody the WTO General Council Decision, emulating models in Canada, Norway, and the European Union. Ideally, there should be no right of first refusal; the list of pharmaceutical drugs should be open-ended; and the eligible importing countries should not be limited to members of the WTO.

Translating training in the NYU Caregiver Intervention in Australia: Maintaining fidelity and meeting graduate standards in an online continuing professional education setting

The aim of this study was to develop an Internet-based self-directed training program for Australian healthcare workers to facilitate learning and competence in delivery of a proven intervention for caregivers of people with dementia: The New York University Caregiver Intervention (NYUCI). The NYUCI is a nonpharmacological, multicomponent intervention for spousal caregivers. It is aimed at maintaining well-being by increasing social support and decreasing family discord, thereby delaying or avoiding nursing home placement of the person with dementia. Training in the NYUCI in the United States has, until now, been conducted in person to trainee practitioners. The Internet-based intervention was developed simultaneously for trainees in the U.S. and Australia. In Australia, due to population geography, community healthcare workers, who provide support to older adult caregivers of people with dementia, live and work in many regional and rural areas. Therefore, it was especially important to have online training available to make it possible to realize the health and economic benefits of using an existing evidence-based intervention. This study aimed to transfer knowledge of training in, and delivery of, the NYUCI for an Australian context and consumers. This article details the considerations given to contextual differences and to learners’ skillset differences in translating the NYUCI for Australia.

The alchemy of junk: patent law and non-coding DNA

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.

Environmental context for late Holocene human occupation of the South Wellesley Archipelago, Gulf of Carpentaria, northern Australia

A 2400 year record of environmental change is reported from a wetland on Bentinck Island in the southern Gulf of Carpentaria, northern Australia. Three phases of wetland development are identified, with a protected coastal setting from ca. 2400 to 500 years ago, transitioning into an estuarine mangrove forest from ca. 500 years ago to the 1940s, and finally to a freshwater swamp over the past +60 years. This sequence reflects the influence of falling sea-levels, development of a coastal dune barrier system, prograding shorelines, and an extreme storm (cyclone) event. In addition, there is clear evidence of the impacts that human abandonment and resettlement have on the island's fire regimes and vegetation. A dramatic increase in burning and vegetation thickening was observed after the cessation of traditional Indigenous Kaiadilt fire management practices in the 1940s, and was then reversed when people returned to the island in the 1980s. In terms of the longer context for human occupation of the South Wellesley Archipelago, it is apparent that the mangrove phase provided a stable and productive environment that was conducive for human settlement of this region over the past 1000 years.

Patent law and biological inventions

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.

Global rules on conflict-of-laws matters in international insolvency law cases: An Australian perspective

The 2012 Report “Transnational Insolvency: Global Principles for Co-operation in International Insolvency Cases” – commissioned by The American Law Institute in conjunction with The International Insolvency Institute – annexed 23 “Global Rules on Conflict-of-Laws Matters in International Insolvency Cases”. These proposed “Global Rules” are intended to “serve as legislative recommendations” to (inter alia) promote uniformity and greater certainty in the unpredictable area of conflict of laws. This article provides a brief commentary upon the 23 proposed Global Rules from an Australian perspective (comparing the effect and intent of each rule with the current Australian conflict-of-laws position) and offers some conclusions as to the merits of the “Global Rules” initiative.

Access to essential medicines: Public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980’s, there was much scientific, legal, and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus, and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute in Paris, published a paper in Science, detailing the discovery of a virus called lymphadenopathy (LAV). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

Moral rights and their application in Australia: a book review

In Moral Rights and Their Application in Australia, Maree Sainsbury offers a summary of the new moral rights regime established in Australia in 2000. It is a decent guide and handbook to moral rights for legal practitioners, the authors of copyright work, and the users of copyright material. As the author notes: "The Australian moral rights legislation impacts on the rights and obligations of many people in diverse circumstances, from the creator of a highly unique work of art to the designer of a web site incorporating factual information or graphics which someone else has created. Any person creating or dealing with copyright material should be aware of the moral rights implications. This book provides a detailed analysis of the moral rights legislation, while stressing the fundamental provisions. It also provides some useful practical guidance for those who are affected, both in general terms and with respect to the more specific situations outlined above." Maree Sainsbury provides an enjoyable account of the history and nature of moral rights. She charts the romantic, Continental origins of moral rights, and explains their translation to countries, such as Australia and the United States.

The Australia-Chile free trade agreement 2008: Intellectual property and development. A submission to the Joint Standing Committee on treaties

A submission to the Joint Standing Committee on treaties

A dangerous investment: Australia, New Zealand and the Trans-Pacific Partnership

This week, San Diego is hosting the latest round of talks over the Trans-Pacific Partnership. Australia and New Zealand are at loggerheads over this secretive new trade treaty spanning the Pacific Rim. The rift between the neighbours over the Trans-Pacific Partnership was revealed after the investment chapter of the agreement was leaked to the public.

IT pricing: Copyright law, consumer rights, and competition policy. A submission to the House of Representatives Standing Committee on Infrastructure and Communications Inquiry into IT Pricing

For a hundred years, since Federation, Australian consumers have suffered the indignity and the tragedy of price discrimination. From the time of imperial publishing networks, Australia has been suffered from cultural colonialism. In respect of pricing of copyright works, Australian consumers have been gouged; ripped-off; and exploited. Digital technologies have not necessarily brought an end to such price discrimination. Australian consumers have been locked out by technological protection measures; subject to surveillance, privacy intrusions and security breaches; locked into walled gardens by digital rights management systems; and geo-blocked.

The olive revolution: Australia's plain packaging leads the world

After much political debate, the Australian Parliament passed the Tobacco Plain Packaging Act 2011 (Cth). Australian legislators, such as Richard di Natale, provided moving accounts for the need for plain packaging of tobacco products.

The plain truth: Australia, tobacco control, and Southeast Asia

As of December 2012, Australia will be the first country in the world where tobacco products will be sold in olive plain packaging without branding. There has been much discussion as to whether this pioneering initiative will spark an ‘Olive Revolution’ around the world — with other countries adopting the plain packaging of tobacco products. Australia’s neighbours in Southeast Asia would particularly benefit from tobacco control measures such as the plain packaging.

A Submission to the Joint Standing Committee on Treaties on the Anti-Counterfeiting Trade Agreement 2011 (# ACTA)

“If Hollywood could order intellectual property laws for Christmas, what would they look like? This is pretty close.” David Fewer “While European and American IP maximalists have pushed for TRIPS-Plus provisions in FTAs and bilateral agreements, they are now pushing for TRIPS-Plus-Plus protections in these various forums.” Susan Sell “ACTA is a threat to the future of a free and open Internet.” Alexander Furnas “Implementing the agreement could open a Pandora's box of potential human rights violations.” Amnesty International. “I will not take part in this masquerade.” Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament Executive Summary As an independent scholar and expert in intellectual property, I am of the view that the Australian Parliament should reject the adoption of the Anti-Counterfeiting Trade Agreement 2011. I would take issue with the Department of Foreign Affairs and Trade’s rather partisan account of the negotiations, the consultations, and the outcomes associated with the Anti-Counterfeiting Trade Agreement 2011. In my view, the negotiations were secretive and biased; the local consultations were sometimes farcical because of the lack of information about the draft texts of the agreement; and the final text of the Anti-Counterfeiting Trade Agreement 2011 is not in the best interests of Australia, particularly given that it is a net importer of copyright works and trade mark goods and services. I would also express grave reservations about the quality of the rather pitiful National Interest Analysis – and the lack of any regulatory impact statement – associated with the Anti-Counterfeiting Trade Agreement 2011. The assertion that the Anti-Counterfeiting Trade Agreement 2011 does not require legislative measures is questionable – especially given the United States Trade Representative has called the agreement ‘the highest-standard plurilateral agreement ever achieved concerning the enforcement of intellectual property rights.’ It is worthwhile reiterating that there has been much criticism of the secretive and partisan nature of the negotiations surrounding the Anti-Counterfeiting Trade Agreement 2011. Sean Flynn summarizes these concerns: "The negotiation process for ACTA has been a case study in establishing the conditions for effective industry capture of a lawmaking process. Instead of using the relatively transparent and inclusive multilateral processes, ACTA was launched through a closed and secretive “‘club approach’ in which like-minded jurisdictions define enforcement ‘membership’ rules and then invite other countries to join, presumably via other trade agreements.” The most influential developing countries, including Brazil, India, China and Russia, were excluded. Likewise, a series of manoeuvres ensured that public knowledge about the specifics of the agreement and opportunities for input into the process were severely limited. Negotiations were held with mere hours notice to the public as to when and where they would be convened, often in countries half away around the world from where public interest groups are housed. Once there, all negotiation processes were closed to the public. Draft texts were not released before or after most negotiating rounds, and meetings with stakeholders took place only behind closed doors and off the record. A public release of draft text, in April 2010, was followed by no public or on-the-record meetings with negotiators." Moreover, it is disturbing that the Anti-Counterfeiting Trade Agreement 2011 has been driven by ideology and faith, rather than by any evidence-based policy making Professor Duncan Matthews has raised significant questions about the quality of empirical evidence used to support the proposal of Anti-Counterfeiting Trade Agreement 2011: ‘There are concerns that statements about levels of counterfeiting and piracy are based either on customs seizures, with the actual quantities of infringing goods in free circulation in any particular market largely unknown, or on estimated losses derived from industry surveys.’ It is particularly disturbing that, in spite of past criticism, the Department of Foreign Affairs and Trade has supported the Anti-Counterfeiting Trade Agreement 2011, without engaging the Productivity Commission or the Treasury to do a proper economic analysis of the proposed treaty. Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament, quit his position, and said of the process: "I want to denounce in the strongest possible manner the entire process that led to the signature of this agreement: no inclusion of civil society organisations, a lack of transparency from the start of the negotiations, repeated postponing of the signature of the text without an explanation being ever given, exclusion of the EU Parliament's demands that were expressed on several occasions in our assembly. As rapporteur of this text, I have faced never-before-seen manoeuvres from the right wing of this Parliament to impose a rushed calendar before public opinion could be alerted, thus depriving the Parliament of its right to expression and of the tools at its disposal to convey citizens' legitimate demands.” Everyone knows the ACTA agreement is problematic, whether it is its impact on civil liberties, the way it makes Internet access providers liable, its consequences on generic drugs manufacturing, or how little protection it gives to our geographical indications. This agreement might have major consequences on citizens' lives, and still, everything is being done to prevent the European Parliament from having its say in this matter. That is why today, as I release this report for which I was in charge, I want to send a strong signal and alert the public opinion about this unacceptable situation. I will not take part in this masquerade." There have been parallel concerns about the process and substance of the Anti-Counterfeiting Trade Agreement 2011 in the context of Australia. I have a number of concerns about the substance of the Anti-Counterfeiting Trade Agreement 2011. First, I am concerned that the Anti-Counterfeiting Trade Agreement 2011 fails to provide appropriate safeguards in respect of human rights, consumer protection, competition, and privacy laws. It is recommended that the new Joint Parliamentary Committee on Human Rights investigate this treaty. Second, I argue that there is a lack of balance to the copyright measures in the Anti-Counterfeiting Trade Agreement 2011 – the definition of piracy is overbroad; the suite of civil remedies, criminal offences, and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations, and remedies. Third, I discuss trade mark law, intermediary liability, and counterfeiting. I express my concerns, in this context, that the Anti-Counterfeiting Trade Agreement 2011 could have an adverse impact upon consumer interests, competition policy, and innovation in the digital economy. I also note, with concern, the lobbying by tobacco industries for the Anti-Counterfeiting Trade Agreement 2011 – and the lack of any recognition in the treaty for the capacity of countries to take measures of tobacco control under the World Health Organization Framework Convention on Tobacco Control. Fourth, I note that the Anti-Counterfeiting Trade Agreement 2011 provides no positive obligations to promote access to essential medicines. It is particularly lamentable that Australia and the United States of America have failed to implement the Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision 2003. Fifth, I express concerns about the border measures in the Anti-Counterfeiting Trade Agreement 2011. Such measures lack balance – and unduly favour the interests of intellectual property owners over consumers, importers, and exporters. Moreover, such measures will be costly, as they involve shifting the burden of intellectual property enforcement to customs and border authorities. Interdicting, seizing, and destroying goods may also raise significant trade issues. Finally, I express concern that the Anti-Counterfeiting Trade Agreement 2011 undermines the role of existing international organisations, such as the United Nations, the World Intellectual Property Organization and the World Trade Organization, and subverts international initiatives such as the WIPO Development Agenda 2007. I also question the raison d'être, independence, transparency, and accountability of the proposed new ‘ACTA Committee’. In this context, I am concerned by the shift in the position of the Labor Party in its approach to international treaty-making in relation to intellectual property. The Australian Parliament adopted the Australia-United States Free Trade Agreement 2004, which included a large Chapter on intellectual property. The treaty was a ‘TRIPs-Plus’ agreement, because the obligations were much more extensive and prescriptive than those required under the multilateral framework established by the TRIPS Agreement 1994. During the debate over the Australia-United States Free Trade Agreement 2004, the Labor Party expressed the view that it would seek to mitigate the effects of the TRIPS-Plus Agreement, when at such time it gained power. Far from seeking to ameliorate the effects of the Australia-United States Free Trade Agreement 2004, the Labor Government would seek to lock Australia into a TRIPS-Double Plus Agreement – the Anti-Counterfeiting Trade Agreement 2011. There has not been a clear political explanation for this change in approach to international intellectual property. For both reasons of process and substance, I conclude that the Australian Parliament and the Australian Government should reject the Anti-Counterfeiting Trade Agreement 2011. The Australian Government would do better to endorse the Washington Declaration on Intellectual Property and the Public Interest 2011, and implement its outstanding obligations in respect of access to knowledge, access to essential medicines, and the WIPO Development Agenda 2007. The case study of the Anti-Counterfeiting Trade Agreement 2011 highlights the need for further reforms to the process by which Australia engages in international treaty-making.

When the price is not right: Technology price gouging in Australia

Apple Inc. has often portrayed itself as the champion of consumers, with its advertising campaigns on “1984”, “Think Different”, and “Rip, Mix, Burn”. However, this reputation has been called into question after Apple refused to appear before the Parliament’s inquiry into IT Pricing in Australia and explain its pricing policies in Australia.