On 7 October 2015 the High Court of Australia unanimously allowed the appeal on D’Arcy v. Myriad Genetics Inc and ordered that claims 1, 2 and 3 of Australian Patent No 686004, entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”, be revoked.

The High Court's judgment overturned the decisions of Justice Nicholas of the Federal Court, at first instance, and the Full Federal Court. This case note provides an overview of the High Court's decision and discusses its meaning and implications for patenting isolated nucleic acids in Australia.

Twenty five years on from Chernobyl, the tragic events in Japan of March 2011 seem to reaffirm the ‘risk society’ perspective which the 1986 nuclear accident in the former Soviet Union did so much to popularise. It was amidst widespread predictions of mass harm – projected both across Europe and into the future – that German sociologist Ulrich Beck’s book of the same name found such a receptive audience. Beck wrote of a new era defined by the greater risk posed by ‘manufactured’, technological risk than natural, ‘external’ ones. The way in which the possible, nuclear threat from the damaged Fukushima nuclear plant looms larger than the devastation and the thousands actually killed by the ‘natural’ earthquake and tsunami reminds us of Beck's distinction.

At the meeting of the WTO Committee on Technical Barriers to Trade (hereinafter, TBT Committee) held on 13–14 June 2012, Argentina voiced its concerns over a measure adopted by Spain restricting imports of biodiesel products into its territory. These concerns were reiterated, jointly with Indonesia, at the meeting of the WTO Council for Trade in Goods of 22 June 2012. On 17 August 2012, Argentina fi led a request for WTO consultations with the European Union (hereinafter, the EU) and Spain, targeting Spain’s restrictions.

Nonhuman autonomous systems are not legal persons under current law. The history of organizational law, however, demonstrates that agreements can, with increasing degrees of autonomy, direct the actions of legal persons. Agreements are isomorphic with algorithms; that is, a legally enforceable agreement can give legal effect to the arbitrary discernible states of an algorithm or other process. As a result, autonomous systems may end up being able, at least, to emulate many of the private–law rights of legal persons. This essay demonstrates a technique by which this is possible by means of limited liability companies (LLCs), a very flexible modern type of business organization. The techniques that this essay describes are not just futuristic possibilities; as this essay argues, they are already possible under current law.

Case C-218/09 SGS Belgium NV v. Belgisch Interventieen Restitutiebureau and Others [2010] nyr

Article 5(3) of Commission Regulation (EEC) No 3665/87 of 27 November 1987 laying down common detailed rules for the application of the system of export refunds on agricultural products, as amended by Commission Regulation (EC) No 1384/95 of 19 June 1995, must be interpreted as meaning that damage to a consignment of beef in the conditions described by the national court does not constitute force majeure within the meaning of that provision (official headnote).

Professor Lofstedt presents a convincing illustration of the inconsistencies inherent in a European system of regulation where Member States choose whether to regulate based on assessments of risks or hazards depending on the product concerned. Particularly striking is the candid comment of a Swedish official who seems to marvel at the conflicting positions of his own government. The quote reminds this author of an official in the Swedish Ministry of Environment who in an interview stated that the application of regulation would be widely different if the precautionary principle as included in the Swedish Environmental Code or the precautionary principle as included in the Swedish Planning Code were to be employed.1 For a lawyer – or anyone else with an interest in the rule of law – such inconsistencies pose serious problems with regard to legal certainty. Unfortunately, those who could reasonably be expected to be most concerned with issues relating to the rule of law – national and European courts – have thus far proven reluctant to second-guess, or even criticise, decisions in the area of risk regulation.

The adoption by WTO Members of measures relating to the protection of health and life of animals, plants and humans is regulated by the WTO Sanitary and Phytosanitary (SPS)Agreement. A fundamental question in the application of this agreement concerns the distinction to be drawn between legitimate regulation and unlawful restriction of trade. This distinction can be difficult to discern, particularly since different communities have different levels of tolerance for risk, which leads to varying national regulatory decisions. This paper critically examines the approach taken to this question in rulings of the WTO dispute settlement panels and Appellate Body, highlighting and analysing three emergent issues:the role attributed to science, the two stage review process adopted and the application of the principle of mutual recognition. The importance of deliberative decision-making inthis context is emphasised, as is the need for recognition and acceptance of the regulatory diversity that this will bring.

In June 2013, the U.S. Supreme Court decided Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., holding that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”.

This case note gives an overview of the U.S. Supreme Court's decision, which is focused on the product of nature doctrine, and discusses its implications for the implementation of the criterion of isolation to DNA sequences and the United States Patent and Trademark Office's long-standing practice of granting patents on isolated DNA sequences (author's headnote).

Biotechnology is one of the great innovations of our time. While Genetically Modified Organisms (GMOs) present an advance in food safety and other fields, GMOs also pose risks to human health and biodiversity that are still subject to scientific uncertainty. Given the scientific uncertainty about the risks to people and the environment, the precautionary principle acquires a central role in the debate on these organisms. At the same time, the existence of an adequate regulatory framework that allows the management of those risks becomes critical.

EU consumers are becoming increasingly concerned about not only the characteristics and qualities of the food products that they are buying but also their origin. To address these concerns, the EU is considering – similarly to other countries – the introduction of mandatory country of origin labelling (COOL) for both unprocessed and processed food.

Reality is complex, and often does not lend itself to generalization or simplifying explanations. Yet at the same time, explaining reality often requires the shaping of notions and concepts of it through generalization and the reduction of complexity. This tension between complexity and particularity on the one hand and generalization and the search for abstracting explanatory patterns on the other is beautifully illustrated by two recently released publications on precaution and risk regulation in the United States and Europe, namely “The Politics of Precaution” by David Vogel1 and “The Reality of Precaution” edited by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand.

Both books together can be seen as the latest significant contribution to the ongoing debate on the role of the precautionary principle in risk regulation in a comparative EU-US perspective. Both contributions are significant in that they consolidate the trend towards an empirically informed analysis of the actual practice of the application of precaution in risk regulation.

The General Court reaffirms its traditional form-based approach to dominance (author's headnote).

Private law in Europe has undergone a significant transformation during the last two decades. From a branch of law that was scarcely affected by EU legislation, it has become the object of considerable harmonisation measures to facilitate free trade and protect European citizens. Simultaneously, there has been an increased attention for ‘better regulation’ in the EU. The efforts of the European Commission to improve regulatory quality and to reduce administrative burdens for industry have promoted a regulatory environment in which formal intervention is more limited and self–regulation and co–regulation have emerged as alternatives. The University of Maastricht organized a workshop on ‘Smart Regulation of European Private Law’ in January 2013 with the aim to assess how the Smart Regulation agenda has shaped/can shape European private law; investigate the contribution of different methodological approaches to achieve ‘smart regulation’; and explore opportunities and threats for European private law, in particular in respect with developments in self–regulation and co–regulation. This report shortly summarises the discussions.