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.

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.

The right to humanitarian assistance in natural and human-made disasters: progress and challenges for an emerging international legal framework

Natural and human-made disasters cause on average 120,000 deaths and over US$140 billion in damage to property and infrastructure every year, with national, regional and international actors consistently responding to the humanitarian imperative to alleviate suffering wherever it may be found. Despite various attempts to codify international disaster laws since the 1920s, a right to humanitarian assistance remains contested, reflecting concerns regarding the relative importance of state sovereignty vis-à-vis individual rights under international law. However, the evolving acquis humanitaire of binding and non-binding normative standards for responses to humanitarian crises highlights the increasing focus on rights and responsibilities applicable in disasters; although the International Law Commission has also noted the difficulty of identifying lex lata and lex ferenda regarding the protection of persons in the event of disasters due to the “amorphous state of the law relating to international disaster response.” Therefore, using the conceptual framework of transnational legal process, this thesis analyses the evolving normative frameworks and standards for rights-holders and duty-bearers in disasters. Determining the process whereby rights are created and evolve, and their potential internalisation into domestic law and policy, provides a powerful analytical framework for examining the progress and challenges of developing accountable responses to major disasters.

Two Birds, One Stone: Combining Student Assessment and Socio-Legal Research

We describe here a method of assessment for students. A number of short-comings of traditional assessment methods, especially essays and examinations, are discussed and an alternative assessment method, the student project, is suggested. The method aims not just to overcome the short-comings of more traditional methods, but also to provide over-worked and under-resourced academics with viable primary data for socio-legal research work. Limitations to the method are discussed, with proposals for minimising the impact of these limitations. The whole �student project� approach is also discussed with reference to the Quality Assurance Agency benchmark standards for law degrees, standards which are expected of all institutions in the UK.

Rape Myths, Law, and Feminist Research: 'Myths About Myths?'

In an article recently published in the Oxford Journal of Legal Studies, the legal scholar Helen Reece argues that the prevalence and effects of rape myths have been overstated and the designation of certain beliefs and attitudes as myths is simply wrong. Feminist researchers, she argues, are engaged 'in a process of creating myths about myths' in a way that serves to close down and limit productive debate in this 'vexed' area. In this article we argue that Reece's analysis is methodologically flawed, crudely reductionist and rhetorically unyielding. We locate Reece's analysis within the wider theoretical field to show how her failure to engage with feminist literature on rape other than in the narrowest, most exclusionary terms, yields an approach which impedes rather than advances public understanding and panders to a kind of simplistic thinking which cannot begin to grapple with the complexity of the phenomenon that is rape. We conclude by emphasizing the continuing commitment of feminist researchers carefully to theorizing and (re)mapping the fraught field of progressive legal strategizing in order to identify and counter the kinds of risks and shortcomings of political activism with which Reece is rightly concerned.

Law and Society: Volume III: Legal Processes and Professional Groups within the Legal Field

The thriving and well-established field of Law and Society (also referred to as Socio-legal Studies) has diverse methodological influences; it draws on social-scientific and arts-based methods. The approach of scholars researching and teaching in the field often crosses disciplinary borders, but, broadly speaking, Law and Society scholarship goes behind formalism to investigate how and why law operates, or does not operate as intended, in society. By exploring law’s connections with broader social and political forces—both domestic and international—scholars gain valuable perspectives on ideology, culture, identity, and social life. Law and Society scholarship considers both the law in contexts, as well as contexts in law.
Law and Society flourishes today, perhaps as never before. Academic thinkers toil both on the mundane and the local, as well as the global, making major advances in the ways in which we think both about law and society. Especially over the last four decades, scholarly output has rapidly burgeoned, and this new title from Routledge’s acclaimed Critical Concepts in Law series answers the need for an authoritative reference collection to help users make sense of the daunting quantity of serious research and thinking.
Edited by the leading scholars in the field, Law and Society brings together in four volumes the vital classic and contemporary contributions. Volume I is dedicated to historical antecedents and precursors. The second volume covers methodologies and crucial themes. The third volume assembles key works on legal processes and professional groups, while the final volume of the collection focuses on substantive areas. Together, the volumes provide a one-stop ‘mini library’ enabling all interested researchers, teachers, and students to explore the origins of this thriving sub discipline, and to gain a thorough understanding of where it is today.

Cases, Materials and Text on National, Supranational and International Non-Discrimination Law

This casebook, the result of the collaborative efforts of a panel of experts from various EU Member States, is the latest in the Ius Commune Casebook series developed at the Universities of Maastricht and Leuven. The book provides a comprehensive and skilfully designed resource for students, practitioners, researchers, public officials, NGOs, consumer organisations and the judiciary. In common with earlier books in the series, this casebook presents cases and other materials (legislative materials, international and European materials, excerpts from books or articles). As non-discrimination law is a comparatively new subject, the chapters search for and develop the concepts of discrimination law on the basis of a wide variety of young and often still emerging case law and legislation. The result is a comprehensive textbook with materials from a wide variety of EU Member States. The book is entirely in English (i.e. materials are translated where not available in English). At the end of each chapter a comparative overview ties the material together, with emphasis, where appropriate, on existing or emerging general principles in the legal systems within Europe.
The book illustrates the distinct relationship between international, European and national legislation in the field of non-discrimination law. It covers the grounds of discrimination addressed in the Racial Equality and Employment Equality Directives, as well as non-discrimination law relating to gender. In so doing, it covers the law of a large number of EU Member States, alongside some international comparisons.
The Ius Commune Casebook on Non-Discrimination Law
- provides practitioners with ready access to primary and secondary legal material needed to assist them in crafting test case strategies.
- provides the judiciary with the tools needed to respond sensitively to such cases.
- provides material for teaching non-discrimination law to law and other students.
- provides a basis for ongoing research on non-discrimination law.
- provides an up-to-date overview of the implementation of the Directives and of the state of the law.
This Casebook is the result of a project which has been supported by a grant from the European Commission's Anti-Discrimination Programme.

The Olympics, transnational law and legal transplants: the International Olympic Committee, ambush marketing and ticket touting

This paper concerns the origination, development and emergence of what might be termed ‘Olympic law’. This has an impact across borders and with transnational effect. It examines the unique process of creation of these laws, laws created by a national legislature to satisfy the commercial demands of a private body, the International Olympic Committee (IOC). It begins by critically locating the IOC and Olympic law and examining Olympic law as a transnational force. Using two case studies, those of ambush marketing and ticket touting, it demonstrates how private entities can be the drivers of specific, self-interested legislation when operating as a transnational organisation from within the global administrative space and notes the potential dangers of such legal transplants.

The abuse of intellectual property rights and regulations in China: a law and economic analysis

From the institutional point of view, the legal system of IPR (intellectual property right, hereafter, IPR) is one of incentive institutions of innovation and it plays very important role in the development of economy. According to the law, the owner of the IPR enjoy a kind of exclusive right to use his IP(intellectual property, hereafter, IP), in other words, he enjoys a kind of legal monopoly position in the market. How to well protect the IPR and at the same time to regulate the abuse of IPR is very interested topic in this knowledge-orientated market and it is the basic research question in this dissertation. In this paper, by way of comparing study and by way of law and economic analyses, and based on the Austrian Economics School’s theories, the writer claims that there is no any contradiction between the IPR and competition law. However, in this new economy (high-technology industries), there is really probability of the owner of IPR to abuse his dominant position. And with the characteristics of the new economy, such as, the high rates of innovation, “instant scalability”, network externality and lock-in effects, the IPR “will vest the dominant undertakings with the power not just to monopolize the market but to shift such power from one market to another, to create strong barriers to enter and, in so doing, granting the perpetuation of such dominance for quite a long time.”1 Therefore, in order to keep the order of market, to vitalize the competition and innovation, and to benefit the customer, in EU and US, it is common ways to apply the competition law to regulate the IPR abuse. In Austrian Economic School perspective, especially the Schumpeterian theories, the innovation/competition/monopoly and entrepreneurship are inter-correlated, therefore, we should apply the dynamic antitrust model based on the AES theories to analysis the relationship between the IPR and competition law. China is still a developing country with relative not so high ability of innovation. Therefore, at present, to protect the IPR and to make good use of the incentive mechanism of IPR legal system is the first important task for Chinese government to do. However, according to the investigation reports,2 based on their IPR advantage and capital advantage, some multinational companies really obtained the dominant or monopoly market position in some aspects of some industries, and there are some IPR abuses conducted by such multinational companies. And then, the Chinese government should be paying close attention to regulate any IPR abuse. However, how to effectively regulate the IPR abuse by way of competition law in Chinese situation, from the law and economic theories’ perspective, from the legislation perspective, and from the judicial practice perspective, there is a long way for China to go!

The European Court of Justice and process-oriented review. Research Paper in Law, 01/2012

Structuralism is a theory of U.S. constitutional adjudication according to which courts should seek to improve the decision-making process of the political branches of government so as to render it more democratic.1 In words of John Hart Ely, courts should exercise their judicial-review powers as a ‘representation-reinforcing’ mechanism.2 Structuralism advocates that courts must eliminate the elements of the political decision-making process that are at odds with the structure set out by the authors of the U.S. Constitution. The advantage of this approach, U.S. scholars posit, lies in the fact that it does not require courts to second-guess the policy decisions adopted by the political branches of government. Instead, they limit themselves to enforcing the constitutional structure within which those decisions must be adopted. Of course, this theory of constitutional adjudication, like all theories, has its shortcomings. For example, detractors of structuralism argue that it is difficult, if not impossible, to draw the dividing line between ‘substantive’ and ‘structural’ matters.3 In particular, they claim that, when identifying the ‘structure’ set out by the authors of the U.S. Constitution, courts necessarily base their determinations not on purely structural principles, but on a set of substantive values, evaluating concepts such as democracy, liberty and equality. 4 Without claiming that structuralism should be embraced by the ECJ as the leading theory of judicial review, the purpose of my contribution is to explore how recent case-law reveals that the ECJ has also striven to develop guiding principles which aim to improve the way in which the political institutions of the EU adopt their decisions. In those cases, the ECJ decided not to second-guess the appropriateness of the policy choices made by the EU legislator. Instead, it preferred to examine whether, in reaching an outcome, the EU political institutions had followed the procedural steps mandated by the authors of the Treaties. Stated simply, I argue that judicial deference in relation to ‘substantive outcomes’ has been counterbalanced by a strict ‘process review’. To that effect, I would like to discuss three recent rulings of the ECJ, delivered after the entry into force of the Treaty of Lisbon, where an EU policy measure was challenged indirectly, i.e. via the preliminary reference procedure, namely Vodafone, Volker und Markus Schecke and Test-Achats.5 Whilst in the former case the ECJ ruled that the questions raised by the referring court disclosed no factor of such a kind as to affect the validity of the challenged act, in the latter cases the challenged provisions of an EU act were declared invalid.

Subsidiarity between Law and Economics. Research Papers in Law, 1/2005

From the Introduction. The present contribution is an attempt to raise awareness between the 'trenches' by juxtaposing the two approaches to subsidiarity. Subsequently, I shall set out why, in economics, subsidiarity is embraced as a key principle in the design and working of the Union and how a functional subsidiarity test can be derived from this thinking. Throughout the paper, a range of illustrations and examples is provided in an attempt to show the practical applicability of a subsidiarity test. This does not mean, of course, that the application of the test can automatically "solve" all debates on whether subsidiarity is (not) violated. What it does mean, however, is that a careful methodology can be a significant help to e.g. national parliaments and the Brussels circuit, in particular, to discourage careless politicisation as much as possible and to render assessments of subsidiarity comparable throughout the Union. The latter virtue should be of interest to national parliaments in cooperating, within just six weeks, about a common stance in the case of a suspected violation of the principle. The structure of the paper is as follows. Section 2 gives a flavour of very different approaches and appreciation of the subsidiarity principle in European law and in the economics of multi-tier government. Section 3 elaborates on the economics of multi-tier government as a special instance of cost / benefit analysis of (de)centralisation in the three public economic functions of any government system. This culminates in a five-steps subsidiarity test and a brief discussion about its proper and improper application. Section 4 applies the test in a non-technical fashion to a range of issues of the "efficiency function" (i.e. allocation and markets) of the EU. After showing that the functional logic of subsidiarity may require liberalisation to be accompanied by various degrees of centralisation, a number of fairly detailed illustrations of how to deal with subsidiarity in the EU is provided. One illustration is about how the subsidiarity logic is misused by protagonists (labour in the internal market). A slightly different but frequently encountered aspect consists in the refusal to recognize that the EU (that is, some form of centralisation) offers a better solution than 25 national ones. A third range of issues, where the functional logic of subsidiarity could be useful, emerges when the boundaries of national competences are shifting due to more intense cross-border flows and developments. Other subsections are devoted to Union public goods and to the question whether the subsidiarity test might trace instances of EU decentralisation: a partial or complete shift of a policy or regulation to Member States. The paper refrains from an analysis of the application of the subsidiarity test to the other two public functions, namely, equity and macro-economic stabilisation.2 Section 5 argues that the use of a well-developed methodology of a functional subsidiarity test would be most useful for the national parliaments and even more so for their cooperation in case of a suspected violation of subsidiarity. Section 6 concludes.

European Criminal Law and General Principles of Union Law. Research Papers in Law, 5/2005

From the Introduction. The European Court of Justice, partly followed in this by the European legislator, has regulated Community law and policy through a set of general principles of law. For the Community legal order in the first pillar, general legal principles have developed from functional policy areas such as the internal market, the customs union, the monetary union, the common agricultural policy, the European competition policy, etc., which are of great importance for the quality and legitimacy of Community law. The principles in question are not so much general legal principles of an institutional character, such as the priority of Community law, direct effect or Community loyalty, but rather principles of law which shape the fundamental rights and basic rights of the citizen. I refer to the principle of legality, of nulla poena, the inviolability of the home, the nemo tenetur principle, due process, the rights of the defence, etc. Many of these legal principles have been elevated to primary Community law status by the European Court of Justice, often as a result of preliminary questions. Nevertheless, a considerable number of them have also been elaborated in the context of contentious proceedings before the Court of Justice, such as in the framework of European competition law and European public servants law.

EU Law, International Law and Economic Sanctions against Terrorism: The Judiciary in Distress? Research Papers in Law, 3/2008

From the Introduction. This article seeks to examine the relationship between European Union law, international law, and the protection of fundamental rights in the light of recent case law of the European Court of Justice (ECJ) and the Court of First Instance (CFI) relating to economic sanctions against individuals. On 3 September 2008, the ECJ delivered its long-awaited judgment in Kadi and Al Barakaat on appeal from the CFI.3 In its judgment under appeal,4 the CFI had held that the European Community (EC) is competent to adopt regulations imposing economic sanctions against private organisations in pursuance of UN Security Council (UNSC) Resolutions seeking to combat terrorism; that although the EC is not bound directly by the UN Charter, it is bound pursuant to the EC Treaty to respect international law and give effect to UNSC; and that the CFI has jurisdiction to examine the compatibility of EC regulations implementing UNSC resolutions with fundamental rights not as protected by the EC but as protected by jus cogens. On appeal, following the Opinion of Maduro AG, the ECJ rejected the CFI’s approach. It held that UNSC resolutions are binding only in international law. It subjected the contested regulations to full review under EC human rights standards and found them in breach of the right to a hearing, the right to judicial protection and the right to property. Kadi and Al Barakaat is the most important judgment ever delivered by the ECJ on the relationship between EC and international law and one of its most important judgments on fundamental rights. It is imbued by constitutional confidence, commitment to the rule of law but also some scepticism towards international law. In the meantime, the CFI has delivered a number of other judgments on anti-terrorist sanctions assessing the limits of the “emergency constitution” at European level. The purpose of this paper is to examine the above case law and explore the dilemmas and tensions facing the EU judiciary in seeking to define and protect the EU’s distinct constitutional space. It is divided as follows. It first looks at the judgment in Kadi. After a short presentation of the factual and legal background, it explores the question whether the EU has competence to adopt smart sanctions. It then examines whether the EU is bound by resolutions of the Security Council, whether the ECJ has jurisdiction to review Community measures implementing such resolutions and the applicable standard of judicial scrutiny. It analyses the contrasting views of the CFI, the Advocate General, and the ECJ taking account also of the case law of the European Court of Human Rights (ECtHR). Further, it explores the consequences of annulling the contested regulation. It then turns to discussing CFI case law in relation to sanctions lists drawn up not by the UN Security Council but by the EC. The paper concludes by welcoming the judgment of the ECJ. Whilst its reasoning on the issue of Community competence is questionable, once such competence is established, it is difficult to support the abrogation of Community standards for the protection of fundamental rights. Such standards should ensure procedural due process whilst recognising the importance of public security.