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.

Trick or treaty?: The Australian debate over the Anti-Counterfeiting Trade Agreement

The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology. In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical. After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined. Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA. This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; 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. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

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.

A methodology for extracting legal norms from regulatory documents

We present a methodology to extract legal norms from regulatory documents for their formalisation and later compliance checking. The need for the methodology is motivated from the shortcomings of existing approaches where the rule type and process aspects relevant to the rules are largely overlook. The methodology incorporates the well–known IF. . . THEN structure extended with the process aspect and rule type, and guides how to properly extract the conditions and logical structure of the legal rules for reasoning and modelling of obligations for compliance checking.

Australian Consumer Law Commentary and Materials [5th Ed.]

"The Australian Consumer Law came into operation on 1 January 2011 as a single national law. It replaced 17 different pieces of Commonwealth, State and Territory legislation relating to consumer protection. Its introduction meant that for the first time, consumers throughout Australia had the same rights and remedies and correspondingly, businesses had the same obligations and responsibilities towards consumers without the barrier of confusing and expensive local variations in the law. Australian Consumer Law: Commentary and Materials contains up-to-date material on the Australian Consumer Law, and in particular the fifth edition incorporates: a revised treatment of unconscionability, taking account of the changes to Part 2-2 of the ACL that became effective in 2012; other State and Federal provisions relating to unfair terms and cases such as Kakavas v Crown Melbourne, ACCC v Lux Distributors, Director of Consumer Affairs v Scully and PT Ltd v Spuds Surf; a comprehensive treatment of the impact of Google v ACCC, Forrest v ASIC and ACCC v TPG – the trilogy of decisions that provide the most recent insights into the High Court’s thinking on aspects of the prohibitions of misleading conduct in the ACL and the Corporations Act 2001; numerous decisions of note; and the possible impact of the Harper Review."--publisher website

Will-making prevalence and patterns in Australia: Keeping it in the family

This article provides evidence of the prevalence of wills and the principles underpinning the intended distribution of estates in Australia. Intentions around wealth transfers and the social norms that underpin them occur in the context of predicted extensive intergenerational transfers from the ageing baby boomer generation, policies of self provision and user pays for care in old age, broader views on what constitutes ‘family’, the increased importance of the not-for-profit sector in the delivery of services, and the related need for philanthropy. A national telephone survey conducted in 2012 with 2,405 respondents aged 18 and over shows that wills are predominantly used to distribute assets to partners and/or equally to immediate descendants. There is little evidence that will makers are recognising a wider group of relationships, obligations and entitlements outside the traditional nuclear family, or that wills are being replaced by other mechanisms of wealth transfer. Only a minority consider bequests to charities as important. These findings reflect current social norms about entitlements to ‘family’ money, a narrow view of what and who constitutes ‘family’, limited obligation for testators to recompense individuals or organisations for care and support provided, and limited commitment to charitable organisations and civil society.

Rights and wrongs of Australian government asylum seeker policy

Worldwide, no fewer than 50 million people a year are now fleeing dangerous and often life threatening situations in their countries of origin (UNHCR, 2014c). As one part of this movement, thousands risk journeys through dangerous waters hoping to obtain asylum in Australia. However, Australian Government policies adopted since 2013 aim to ensure that no asylum seeker nor any of the 3,500 detainees held in offshore detention centres will ever be settled on the mainland. To this has now been added a declaration that none of the recent refugees or 6200 asylum seekers waiting in Indonesia in centres run by the United Nations High Commissioner for Refugees (UNHCR) will gain entry (Whyte, 2014a). These immigration policies differ dramatically from those adopted in earlier decades that produced the country’s decidedly multicultural identity. This article reviews these changing perspectives of Australian governments and communities within the context of international obligations and expectations; the experiences of those directly involved in border policing practices and in detention centres; and the attitudes of national media. Relations and conflicts among the interests of the different parties are discussed and the scope for less punitive responses to the plight of asylum seekers is examined. The authors then focus on alternative processes to better address the interests and objectives of legitimately interested parties by processes which successively examine, optimise and reconcile the concerns of each. In so doing, they aim to demonstrate that such methods of sequential problem solving can respond effectively to the multiple concerns of the many significant stakeholders involved in increasingly significant global issues, whereas recourse to such single-goal, top-down programs as are expressed in the government’s current determination to “Stop the boats” at all costs are unlikely to prove sustainable.

Prevalence and consequences of negative workplace cyber communications in the Australian public sector

This research studied the prevalence and impact of workplace cyberbullying as perceived by public servants working in government organisations across Australia. Using Social Information Processing theory, this research found employees reported task- and person-related cyberbullying that was associated with increased workplace stress, diminished job satisfaction and performance, and reduced confidence in their organisations' anti-bullying intervention and protection strategies. Furthermore, workplace cyberbullying can create a concealed, online work culture that undermines employee and organisational productivity. These results are significant for employers' duty-of-care obligations, and represent a cogent argument for improved workplace cultures in support to Australia's future organisational and economic performance.

Reinforcing stigma or delivering a fresh start: Bankruptcy and future engagement in the workforce

In Australia, bankruptcy retains a social stigma, as is often seen as a personal failing, and an indication that the individual cannot be trusted to meet their obligations. Official labelling and informal labelling reinforce this stigmatisation of bankruptcy in employment and business contexts. This occurs through legislation and policy that imposes restrictions on participation in some occupations on the grounds of bankruptcy, and imposes obligations on persons to disclose their bankruptcy to their employer. These restrictions and obligations that are varying in length and extent, both within industries and professions and across industries and professions, and appear to lack a coherent policy justification. Further, informal labelling is facilitated by the law providing for a permanent, publicly accessible record of bankruptcy, and failing to restrict the use of bankruptcy information in employment and business decision-making. This stigmatisation of bankruptcy inhibits the fresh start objective of bankruptcy, and is not supported by a strong correlation between bankruptcy and negative personal or other attributes. This article therefore argues that a review is needed to determine the circumstances in which there is a genuine policy justification for employment restrictions, and the appropriate length and scope of such restrictions. Reform of the Bankruptcy Act should also be considered. Possible areas for law reform including reducing the minimum period of bankruptcy; removing the permanency and/or public accessibility of the bankruptcy record; revising the language used in the Bankruptcy Act; and introducing a prohibition or restriction on the ability of employers to use bankruptcy status in employment decision making. Such changes would promote the fresh start objective of Australia’s bankruptcy system, and increase the likelihood that bankruptcy does not unfairly inhibit an individual’s ability to engage as an economic actor in Australian society and thereby improve their financial well-being.

Permissions in Deontic Event-Calculus

Permissions are special case of deontic effects and play important role compliance. Essentially they are used to determine the obligations or prohibitions to contrary. A formal language e.g., temporal logic, event-calculus et., not able to represent permissions is doomed to be unable to represent most of the real-life legal norms. In this paper we address this issue and extend deontic-event-calculus (DEC) with new predicates for modelling permissions enabling it to elegantly capture the intuition of real-life cases of permissions.

Submission to the draft Migration Assurance Policy - Improving the transition to the fixed-line national broadband network review

The rights of individuals to self-determination and participation in social, political and economic life are recognised and supported by Articles 1, 3 and 25 of the International Covenant on Civil and Political Rights 1966.4 Article 1 of the United Nations’ Human Rights Council’s Resolution on the Promotion and Protection of Human Rights on the Internet of July 2012 confirms individuals have the same rights online as offline. Access to the internet is essential and as such the UN: Calls upon all States to promote and facilitate access to the Internet and international cooperation aimed at the development of media and information and communications facilities in all countries (Article 3) Accordingly, access to the internet per se is a fundamental human right, which requires direct State recognition and support.5 The obligations of the State to ensure its citizens are able, and are enabled, to access the internet, are not matters that should be delegated to commercial parties. Quite simply – access to the internet, and high-speed broadband, by whatever means are “essential services” and therefore “should be treated as any other utility service”...

The Statutory Defence(s) of 'peer professional opinion'

In the wake of the GFC and with ever increasing consumer-protection-related laws, clients are more aware of their rights and your obligations as a professional valuer. They also are more likely to take legal action if, as a result of their reliance on a valuation, they suffer a financial loss. In some Australian jurisdictions, in response to a claim of negligence, the professional valuer may be able to raise a professional practice defence under civil liability legislation. This article considers the nature of this statutory defence, what is required to rely upon it and in which jurisdictions it applies.

Moments of flux in intermediary liability for copyright infringement

This chapter provides an overview of a recent shift in regulatory strategies to address copyright infringement toward enlisting the assistance of general purpose Internet Service Providers. In Australia, the High Court held in 2012 that iiNet, a general purpose ISP, had no legal duty to police what its subscribers did with their internet connections. We provide an overview of three recent developments in Australian copyright law since that decision that demonstrate an emerging shift in the way that obligations are imposed on ISPs to govern the actions of their users without relying on secondary liability. The first is a new privately negotiated industry code that introduces a 'graduated response' system that requires ISPs to pass on warnings to subscribers who receive allegations of infringement. The second involves a recent series of Federal Court cases where rightsholders made a partially successful application to require ISPs to hand over the identifying details of subscribers whose households are alleged to have infringed copyright. The third is a new legislative scheme that will require ISPs to block access to foreign websites that 'facilitate' infringement. We argue that these shifts represent a greater sophistication in approaches to enrolling general purpose intermediaries in the regulatory project. We also suggest that these shifts represent a potentially disturbing trend towards enforcement of copyright law in a way that does not provide strong safeguards for the legitimate constitutional due process interests of users. We conclude with a call for greater attention and research to better understand how intermediaries make decisions when governing the conduct of users, how those decisions may be influenced by both state and non-state actors, and how the rights of individuals to due process can be adequately protected.

Climate change and human rights: Intellectual property challenges and opportunities

Mitigating and adapting to the effects of climate change will require innovation and the development of new technologies. Intellectual property laws have a key part to play in the global transfer of climate technologies. However, failures to properly utilize flexibilities in intellectual property regimes or comply with technology transfer obligations under international climate change agreements calls for a human rights based analysis of climate technology transfer. Climate change is an unprecedented challenge and requires unprecedented strategies. Given the substantial impact of climate change on all of humanity and the ethical imperative to act, a complete rethink of traditional intellectual property approaches is warranted. This report proposes a series of intellectual property law policy options, through a human rights framework, aimed at promoting access to technologies to reduce the human suffering caused by climate change.

Neighbourliness and Australia’s contribution to regional migration strategies for climate displacement in the Pacific

The prospect of widespread displacement in the Pacific as a result of climate change is becoming increasingly likely and it is possible that many will eventually need to relocate to other countries. Regional migration strategies not only offer the potential to minimise the harms of relocation, while acknowledging existing relationships of friendship and regional cooperation. This article examines the use of the language of ‘neighbourliness’ in Australia’s regional climate change strategies and argues that, while it expresses friendship, such language can also be employed to avoid the creation of stronger obligations. The article considers the international doctrine of good neighbourliness and concludes that, while international legal obligations may not yet exist, Australia should nonetheless begin planning for regional migration within the Pacific to allow people to migrate with dignity.