Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?

In a recent decision (AMP v. USPTO) from the US District Court, patent claims directed at DNA sequences corresponding to human genes and to diagnostic tests based on such genes have been found to be invalid, primarily on the basis that the DNA molecules claimed, which included cDNA, primers and probes, are 'products of nature' and are thus unpatentable. If upheld, this decision will have considerable impact on the ability of biotechnical companies and universities to patent the results of their research. In this article, we will explain the basis for this decision and discuss the appropriateness of patenting discoveries and their (obvious) uses in the light of this fascinating case. While our focus will primarily be on the product claims, diagnostic method claims were also revoked in AMP v. USPTO on the basis that they were for mental acts or did not involve any 'transformation of matter'. This will be discussed in the light of the recent US Supreme Court decision in Bilski v. Kappos, which focused on the patent-eligibility of process claims

The UK National Health Service’s 'innovation agenda': lessons on commercialization and trust

The UK National Health Service (the 'NHS'), encouraged by the 2011 report Innovation Health and Wealth, Accelerating Adoption and Diffusion in the NHS, and empowered by the Health and Social Care Act 2012, is in the process of adopting a new agenda for stimulating innovation in healthcare. For this, the bodies, body materials, and confidential health information of NHS patients may be co-opted. We explain why this brings the NHS into a moral conflict with its basic goal of providing a universal healthcare service. Putting NHS databases at the disposal of industry, without addressing ethical concerns regarding the privacy, autonomy, and moral integrity of patients and without requiring a 'kick-back' to enhance the service that the NHS provides, is inappropriate. As this article shows, with reference to the commercial arena of direct-to-consumer genetic testing, it is crucial that patient and public trust in the NHS is not eroded

Assessing the morality of the commercial exploitation of inventions concerning uses of human embryos and the relevance of moral complicity

In late 2008, the Enlarged Board of Appeal of the European Patent Office (EPO) reached a decision supporting the rejection of a patent application on human embryonic stem cells filed by the Wisconsin Alumni Research Foundation (WARF). This article comments on some of the shortcomings of the decision. The key legal provisions at issue in this case were Rule 28(c) EPC, which forbids the granting of patents in respect of biotechnological inventions which concern uses of human embryos for industrial or commercial purposes, and Article 53(a) EPC, the morality provision of the European Patent Convention. The Board rightly found the Rule to exclude WARF’s claims (but, we argue, left a “deposit loophole”). However, one of the issues the Board had to address was whether the Rule might not apply because it extended the scope of prohibited subject matter beyond that prohibited by the Article. We argue that, unless the Article had been found to exclude patentability, the applicability of the Rule could not be determined. Even though at the oral hearing before the Board, both WARF and the EPO President identified the question whether the Article (the morality provision) constituted a barrier to patentability as the core issue in this case, the Board astonishingly decided that this question did not need answering (even though the Board did hint at the basis for the answer). We argue that this is a major shortcoming of the decision. Finally, we comment on the relevance of moral complicity to the question of patentability

Everyday atrocities: does internal (domestic) sex trafficking of British children satisfy the expectations of opportunity theories of crime?

In this study we examine the internal (domestic) sex trafficking of British children using unique data from six major police investigations. This particular type of internal sex trafficking (sometimes known as ‘street grooming’) has been popularly conceptualised as a highly sophisticated, skilled and well-organised phenomenon. This study shows that this characterisation does not withstand empirical scrutiny. Instead, the routine activities and everyday associations of both offenders and victims are shown to play key roles in facilitating, sustaining and spreading the abuse. While the criminal acts associated with internal child sex trafficking can be atrocious, the people, places and processes involved are shown to be far from exceptional. In this respect, the results may be unsettling: they undermine explanations of an emotive crime that rest on reassuring but ultimately naïve errors of attribution. We argue that it is important, however, that preventative strategies are underpinned not by sensationalised narrative and untested assumptions but by sober and robust assessments of appropriate empirical data. The paper contributes to the theoretical and empirical literature on opportunity theories of crime, on human trafficking and on child sexual abuse/exploitation. While the sample size is not especially large (55 offenders and 43 victims), this study helps to expand a sorely limited knowledge base on a topical threat. It is also distinguished by its hard-to-access data and novel analytical approach. The work is likely to interest a broad and international audience of academics, practitioners and policy makers concerned with crime prevention and child protection

Introduction to the special edition ‘Child sexual abuse: analysis and intervention’

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Immaterial Boys? A Large-Scale Exploration of Gender-Based Differences in Child Sexual Exploitation Service Users.

Child sexual exploitation is increasingly recognized nationally and internationally as a pressing child protection, crime prevention, and public health issue. In the United Kingdom, for example, a recent series of high-profile cases has fueled pressure on policy makers and practitioners to improve responses. Yet, prevailing discourse, research, and interventions around child sexual exploitation have focused overwhelmingly on female victims. This study was designed to help redress fundamental knowledge gaps around boys affected by sexual exploitation. This was achieved through rigorous quantitative analysis of individual-level data for 9,042 users of child sexual exploitation services in the United Kingdom. One third of the sample were boys, and gender was associated with statistically significant differences on many variables. The results of this exploratory study highlight the need for further targeted research and more nuanced and inclusive counter-strategies

Children, gender and sexual exploitation: A quantitative analysis of adminstrative data

In this case study, we focus on our recent large-scale quantitative analysis of 9,042 children who accessed sexual exploitation support services provided by a major UK charity. In doing so, our aim is to discuss the practicalities of one important but often neglected source of data for research into child sexual exploitation: data that are routinely generated and collected by non-academic institutions in the course of their everyday business activities. There are considerable practical, logistical and ethical benefits to using such secondary data. Child sexual exploitation is a highly sensitive and largely hidden issue that is notoriously difficult to research. Consequently, we benefitted greatly from the unobtrusive approach, increased reach and cost-effectiveness, that our research design permitted. Nonetheless, there can also be substantial challenges associated with working with secondary data not generated for research purposes. Among the key barriers we encountered were lack of clarity around key terms and fundamental parameters, missing data and difficulties finding appropriate baselines against which to interpret our results. We will discuss approaches we took to mitigate these challenges and to ensure high-quality research outputs. Finally, we will reflect on some more general lessons both for the providers and the users of non-research oriented secondary data. Their application, we contend, could help ensure more effective research collaborations in future

From Conflict to Common Ground: Why anti-trafficking can be compatible with challenging the systemic drivers of everyday abuses

Response to the ATR debate proposition ‘It is worth undermining the anti-trafficking cause in order to more directly challenge the systems producing everyday abuses within the global economy.