Enabling open access to and re-use of publicly funded research data in Malaysian public universities : a legal and policy analysis

Numerous statements and declarations have been made over recent decades in support of open access to research data. The growing recognition of the importance of open access to research data has been accompanied by calls on public research funding agencies and universities to facilitate better access to publicly funded research data so that it can be re-used and redistributed as public goods. International and inter-governmental bodies such as the ICSU/CODATA, the OECD and the European Union are strong supporters of open access to and re-use of publicly funded research data. This thesis focuses on the research data created by university researchers in Malaysian public universities whose research activities are funded by the Federal Government of Malaysia. Malaysia, like many countries, has not yet formulated a policy on open access to and re-use of publicly funded research data. Therefore, the aim of this thesis is to develop a policy to support the objective of enabling open access to and re-use of publicly funded research data in Malaysian public universities. Policy development is very important if the objective of enabling open access to and re-use of publicly funded research data is to be successfully achieved. In developing the policy, this thesis identifies a myriad of legal impediments arising from intellectual property rights, confidentiality, privacy and national security laws, novelty requirements in patent law and lack of a legal duty to ensure data quality. Legal impediments such as these have the effect of restricting, obstructing, hindering or slowing down the objective of enabling open access to and re-use of publicly funded research data. A key focus in the formulation of the policy was the need to resolve the various legal impediments that have been identified. This thesis analyses the existing policies and guidelines of Malaysian public universities to ascertain to what extent the legal impediments have been resolved. An international perspective is adopted by making a comparative analysis of the policies of public research funding agencies and universities in the United Kingdom, the United States and Australia to understand how they have dealt with the identified legal impediments. These countries have led the way in introducing policies which support open access to and re-use of publicly funded research data. As well as proposing a policy supporting open access to and re-use of publicly funded research data in Malaysian public universities, this thesis provides procedures for the implementation of the policy and guidelines for addressing the legal impediments to open access and re-use.

Driver licensing experience of Korean Australians

Graduated licensing has been identified as the most promising approach to reducing the crash risk of novice drivers. However, research suggests that the effectiveness of graduated licensing appears to differ between urban and rural novice drivers and according to race or ethnicity. Extensive supervised driving practice as a learner driver is an important component of graduated licensing systems in Australia and many other countries. Earlier CARRS-Q research identified that falsification of logbooks was more common among particular demographic groups. The factors underlying this are not well understood. It is unclear whether this reflects a lack of understanding of the importance of supervised practice (given that it is not a licensing requirement in many countries of origin), or it reflects lack of access to vehicles and supervising drivers, or whether there is less respect for driver licensing requirements among some groups. It is possible that the importance of these factors may differ across ethnic groups, depending on socioeconomic factors and cultural attitudes to road safety. In an attempt to better understand these issues, this study presents some preliminary results of focus groups examining the experience of the Queensland Graduated Driver Licensing System by Korean-Australian novice drivers and their parents.

Implementing open licensing in government open data initiatives : a review of Australian government practice

As support grows for greater access to information and data held by governments, so does awareness of the need for appropriate policy, technical and legal frameworks to achieve the desired economic and societal outcomes. Since the late 2000s numerous international organizations, inter-governmental bodies and governments have issued open government data policies, which set out key principles underpinning access to, and the release and reuse of data. These policies reiterate the value of government data and establish the default position that it should be openly accessible to the public under transparent and non-discriminatory conditions, which are conducive to innovative reuse of the data. A key principle stated in open government data policies is that legal rights in government information must be exercised in a manner that is consistent with and supports the open accessibility and reusability of the data. In particular, where government information and data is protected by copyright, access should be provided under licensing terms which clearly permit its reuse and dissemination. This principle has been further developed in the policies issued by Australian Governments into a specific requirement that Government agencies are to apply the Creative Commons Attribution licence (CC BY) as the default licensing position when releasing government information and data. A wide-ranging survey of the practices of Australian Government agencies in managing their information and data, commissioned by the Office of the Australian Information Commissioner in 2012, provides valuable insights into progress towards the achievement of open government policy objectives and the adoption of open licensing practices. The survey results indicate that Australian Government agencies are embracing open access and a proactive disclosure culture and that open licensing under Creative Commons licences is increasingly prevalent. However, the finding that ‘[t]he default position of open access licensing is not clearly or robustly stated, nor properly reflected in the practice of Government agencies’ points to the need to further develop the policy framework and the principles governing information access and reuse, and to provide practical guidance tools on open licensing if the broadest range of government information and data is to be made available for innovative reuse.

Knowledge unlatched : encouraging innovation in academic publishing through collective action and Open Access licensing

This case study examines the way in which Knowledge Unlatched is combining collective action and open access licenses to encourage innovation in markets for specialist academic books. Knowledge Unlatched is a not for profit organisation that has been established to help a global community of libraries coordinate their book purchasing activities more effectively and, in so doing, to ensure that books librarians select for their own collections become available for free for anyone in the world to read. The Knowledge Unlatched model is an attempt to re-coordinate a market in order to facilitate a transition to digitally appropriate publishing models that include open access. It offers librarians an opportunity to facilitate the open access publication of books that their own readers would value access to. It provides publishers with a stable income stream on titles selected by libraries, as well as an ability to continue selling books to a wider market on their own terms. Knowledge Unlatched provides a rich case study for researchers and practitioners interested in understanding how innovations in procurement practices can be used to stimulate more effective, equitable markets for socially valuable products.

Repeatability or reproducibility in Australian Patent Law

This article considers the extent to which a claimed process must be repeatable or reproducible in order to be patentable according to Australian patent law. It asks whether a process must yield identical or near-identical results each time the process is invoked, or if not, what degree of repeatability is required. The question is relevant when considering, among other things, the patentability of some methods of medical treatment and diagnosis, biotechnology inventions and business methods.

Driver licensing experience of Korean Australian novice drivers

Graduated driver licensing has been shown to improve the safety of young drivers but relatively little is known about how well it works for drivers born in countries where the licensing system is less sophisticated. This research used Bronfenbrenner's ecological model to examine the driver licensing experience of Korean Australian young drivers using driver and parent focus groups and an online survey of drivers. Accumulating the required supervised driving was more difficult for international students than those living with parents and differences in road rules (particularly relating to seat belt use) between the countries exerted an important influence on behaviour.

Graduated driver licensing : an international review

Graduated driver licensing (GDL) aims to gradually increase the exposure of new drivers to more complex driving situations and typically consists of learner, provisional and open licence phases. The first phase, the learner licence, is designed to allow novice drivers to obtain practical driving experience in lower risk situations. The learner licence can delay licensure, encourage novice drivers to learn under supervision, mandate the number of hours of practice required to progress to the next phase and encourage parental involvement. The second phase, the provisional licence, establishes various driving restrictions and thereby reduces exposure to situations of higher risk, such as driving at night, with passengers or after drinking alcohol. Parental involvement with a GDL system appears essential in helping novices obtain sufficient practice and in enforcing compliance with restrictions once the new driver obtains a provisional licence. Given the significant number of young drivers involved in crashes within Oman, GDL is one countermeasure that may be beneficial in reducing crash risk and involvement for this group.

Moderation in higher education: Four discourses

Across the globe, higher education institutions are working in environments of increasing accountability with little sign of this trend abating. This heightened focus on accountability has placed greater demands on institutions to provide evidence of quality and the achievement of standards that assure that quality. Moderation is one quality assurance process that plays a central role in the teaching, learning and assessment cycle in higher education institutions. While there is a growing body of research globally on teaching, learning and , to a lesser degree, assessment in higher education, the process of moderation has received even less attention (Watty, Freeman, Howieson, Hancock, O'Connell, et al. 2013). Until recently, moderation processes in Australian universities have been typically located within individual institutions, with universities given the responsibility for developing their own specific policies and practices. However, in 2009 the Australian Government announced that an independent national quality and regulatory body for higher education institutions would be established. With the introduction of the Tertiary Education Quality Standards Authority (TEQSA), more formalised requirements for moderation of assessment are being mandated. In light of these reforms, the purpose of this qualitative study was to identify and investigate current moderation practices operating within one faculty, the Faculty of Education, in a large urban university in eastern Australia. The findings of this study revealed four discourses of moderation: equity, justification, community building and accountability. These discourses provide a starting point for academics to engage in substantive conversations around assessment and to further critique the processes of moderation.

Injecting Creative Commons Licensing into university policy and publishing

Australian universities are publishing previously unpublished works such as theses in institutional repositories or by publishing scholarly journals on their own presses. This re-invented role of publisher is due in part, to the availability of digital age technologies which scaffold the publishing process and facilitate inexpensive production of digital-only journals. The global push for Open Access to the outputs of publicly-funded research has also been a major driver. Research funder mandates and institutional Open Access policies apply only to publications for which the authors have no expectation of commercial gain. In all cases the primary motivation is to disseminate widely for maximum uptake with attribution to the author thereby increasing impact. This makes works published in institutional repositories and on university presses ideal candidates for Creative Commons licences.

Licensing system in Oman and literature review. Report to the Research Council of Oman, Muscat

This document reviews the existing literature in the area of novice driver behaviour and the impact of Graduated Driver Licencing (GDL) as a key response to young driver management. The document focuses on consolidating the available research evidence and identifying existing gaps in the current knowledge. The chapter reviews novice driver crash risk, the factors that influence novice driver behaviour, countermeasures used to address the problem, the learner phase, the provisional phase, The Australian example of GDL, compliance with the road laws and parental involvement in the GDL process...

Cosmo, Cosmolino: Patent law and nanotechnology

Patent law has a significant instrumental and symbolic role in regulating nanotechnology. A 2011 report of the United States Federal Trade Commission noted that ‘the patent system plays a critical role in promoting innovation across industries from biotechnology to nanotechnology, and by entities from large corporations to independent inventors’. This chapter considers the much contested legal, ethical and social issues involved with regulating the patenting of nanotechnology. Section I considers the efforts of patent offices to classify nanotechnology and the empirical evidence about patent filing rates. Section II examines whether there is a ‘tragedy of the anticommons’ emerging in respect of nanotechnology. It contemplates access mechanisms – such as the defence of experimental use, patent pools, open innovation models and technology transfer. Section III explores ethical and social concerns associated with nanotechnology – in particular, issues about the impact upon human health and the environment.

Patent-busting: The public patent foundation, gene patents and the Seed Wars

This chapter considers the Public Patent Foundation as a novel institution in the patent framework. It contends that such a model can play a productive role in challenging the validity of high-profile patents; working as an amicus curiae in significant court cases; and also promoting patent law reform. However, there are limits to the ‘patent-busting’ of the Foundation. The not-for-profit legal services organization has only had the time and resources to challenge a number of noteworthy patents. Other jurisdictions – such as Australia – lack such public-spirited "patent-busting" entities. This chapter considers a number of key disputes involving the Public Patent Foundation. Part I examines the role of the Public Patent Foundation in the landmark dispute over Myriad Genetics’ patents in respect of breast cancer and ovarian cancer. Part II considers the role of the Public Patent Foundation in litigation between organic farmers and Monsanto. Part III examines the role of the Public Patent Foundation in larger debates about patent law reform in the United States – particularly looking at the Leahy-Smith America Invents Act 2011 (US). The conclusion contends that the patent-busting model of the Public Patent Foundation should be emulated in respect of other technological fields, and other jurisdictions – such as Australia. The initiative could also be productively applied to other forms of intellectual property – such as trade mark law, designs law, plant breeders’ rights, plant breeders’ rights, and access to genetic resources.

A crowning glory: Patent law and public health

Australian patent law reforms are critical to ensuring Australians have access to vital health-care services and technologies and that people in developing countries have access to affordable, life-saving medicines...

The high price of drug patents: Australia, patent law, pharmaceutical drugs and the Trans-Pacific Partnership

This week, the secrecy surrounding an independent Australian report on patent law and pharmaceutical drugs has been lifted, and the work has been published to great acclaim...

The empire of cancer: Gene patents and cancer voices

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — "It is a chronicle of an ancient disease — once a clandestine, 'whispered-about' illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation." Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment. In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia. India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop evergreening. In the field of tobacco control, the Australian Government introduced plain packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic. This regime was successfully defended in the High Court of Australia. In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013. The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013. Such disputes have involved tensions between intellectual property rights, and public health. This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: "I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body." She observed: "For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me." The applicants made the following arguments: "Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention." The applicants also argued that "the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies". The applicants suggested that "the alleged invention is a mere discovery". Moreover, the applicants contended that "the alleged invention of each of claims 1-3 is not a patentable invention because they are claims for biological processes for the generation of human beings". The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows: "The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of 'gene patenting'. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been 'isolated'". In this context, the word "isolated" implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer.' The judge held in this particular case that Myriad Genetics’ patent claims were a "manner of manufacture" under s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth). The matter is currently under appeal in the Full Court of the Federal Court of Australia. This article interprets the dispute over Myriad Genetics in light of the scholarly work of Nobel Laureate Professor Joseph Stiglitz on inequality. Such work has significant explanatory power in the context of intellectual property and biotechnology. First, Stiglitz has contended that "societal inequality was a result not just of the laws of economics, but also of how we shape the economy — through politics, including through almost every aspect of our legal system". Stiglitz is concerned that "our intellectual property regime … contributes needlessly to the gravest form of inequality." He maintains: "The right to life should not be contingent on the ability to pay." Second, Stiglitz worries that "some of the most iniquitous aspects of inequality creation within our economic system are a result of 'rent-seeking': profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie". He observes that "the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom." Third, Stiglitz comments: "When the legal regime governing intellectual property rights is designed poorly, it facilitates rent-seeking" and "the result is that there is actually less innovation and more inequality." He is concerned that intellectual property regimes "create monopoly rents that impede access to health both create inequality and hamper growth more generally." Finally, Stiglitz has recommended: "Government-financed research, foundations, and the prize system … are alternatives, with major advantages, and without the inequality-increasing disadvantages of the current intellectual property rights system.’" This article provides a critical analysis of the Australian litigation and debate surrounding Myriad Genetics’ patents in respect of genetic testing for BRCA1. First, it considers the ruling of Nicholas J in the Federal Court of Australia that Myriad Genetics’ patent was a manner of manufacture as it related to an artificially created state of affairs, and not mere products of nature. Second, it examines the policy debate over gene patents in Australia, and its relevance to the litigation involving Myriad Genetics. Third, it examines comparative law, and contrasts the ruling by Nicholas J in the Federal Court of Australia with developments in the United States, Canada, and the European Union. Fourth, this piece considers the reaction to the decision of Nicholas at first instance in Australia. Fifth, the article assesses the prospects of an appeal to the Full Federal Court of Australia over the Myriad Genetics’ patents. Finally, this article observes that, whatever happens in respect of litigation against Myriad Genetics, there remains controversy over Genetic Technologies Limited. The Melbourne firm has been aggressively licensing and enforcing its related patents on non-coding DNA and genomic mapping.