Prospect patents, data markets, and the commons in data-driven medicine : openness and the political economy of intellectual property rights

Scholars who point to political influences and the regulatory function of patent courts in the USA have long questioned the courts’ subjective interpretation of what ‘things’ can be claimed as inventions. The present article sheds light on a different but related facet: the role of the courts in regulating knowledge production. I argue that the recent cases decided by the US Supreme Court and the Federal Circuit, which made diagnostics and software very difficult to patent and which attracted criticism for a wealth of different reasons, are fine case studies of the current debate over the proper role of the state in regulating the marketplace and knowledge production in the emerging information economy. The article explains that these patents are prospect patents that may be used by a monopolist to collect data that everybody else needs in order to compete effectively. As such, they raise familiar concerns about failure of coordination emerging as a result of a monopolist controlling a resource such as datasets that others need and cannot replicate. In effect, the courts regulated the market, primarily focusing on ensuring the free flow of data in the emerging marketplace very much in the spirit of the ‘free the data’ language in various policy initiatives, yet at the same time with an eye to boost downstream innovation. In doing so, these decisions essentially endorse practices of personal information processing which constitute a new type of public domain: a source of raw materials which are there for the taking and which have become most important inputs to commercial activity. From this vantage point of view, the legal interpretation of the private and the shared legitimizes a model of data extraction from individuals, the raw material of information capitalism, that will fuel the next generation of data-intensive therapeutics in the field of data-driven medicine

The European Commission and the law-making process: compromise as a category of praxis?,

Article available on Cambridge Journals OnlineUnderstanding law-making requires coming to grips with cognitive schemas, practical wisdom of agents involved in the production of law, as agents may interpret or apply the law according to socially accepted mental schemas developed as a result of socialisation in families, schools, universities and other social settings or in the course of exchange in professional settings. A case study on the conduct of officials of the European Commission seeks to illustrate this point. This looks at tacit understandings regulating the conduct of officials of the European Commission, engaging in the production of a legal proposal or in the implementation of a legal measure. Such interaction may be successful, or less successful, depending on how contentious a legal file is, but is underlined by certain understandings, particular norms of conduct, as to how things are get done. In uncovering shared understandings, the article looks at modes of co-operation in working parties and shared files, promotion procedures, mobility, and how reputation is valued and acquired. The thesis advanced is of important cognitive schema, anthropological category of praxis, regulating the law-making process inside the European Commission is compromise

The European Commission and the construction of information society: Regulatory law from a processual perspective.

The focus of this thesis is on information society regulation in Europe and on the European Commission when forming legislative proposals and implementing laws by means of decentred and flexible regulation, respectful of difference, seeking to promote the engagement of diverse interested parties in the formation of laws affecting them. I seek to explain the above processes in a dynamic way, breaking away with a conceptualisation of regulation as (only) efficiently pursuing the public good and neutrally mediating among autonomous communities, and public administration as being (only) about reasoned choices and rational action. Bourdieu's theoretical tools are employed to argue that although it would be within agents' intention to design neutral rules and within regulatory law's original function to promote participation and deliberation, law encapsulates a vision that outruns its function and agents perceive the social world in a way that outruns perception. To illustrate this, I look at the following case studies: Architectural solutions introduced by the industry in DVDs to prevent copying, domain name dispute resolution by ICANN, Internet filters used to block harmful material on the net, and the proposal to introduce patent protection in computer-implemented inventions in the EU. In a nutshell, in the above instances the European Commission strives to reproduce or preserve its juridical, technocratic, social and symbolic capital, while one of the main strategies supported by its juridical capital is to sustain the belief in the neutrality and objectivity of regulatory law. However, the ways in which the administration perceives the potentialities inscribed in capital are subject to unspoken general cognitive schemas shaped by nationality and professional background, and by the subjective construction of notions such as recognition, reputation and communality, as formed in everyday interaction in the Commission. Yet, cognitive schemas and capital are not conceived as static, but as open to experience. In this way, although regulation is viewed as manifesting the freezing of power relations, dynamism is injected as all definitions in the field are potentially subject to re-definition, by virtue of struggles amongst the administration and interest groups, which, although they occupy different fields, strive to influence regulation. Redefinitions then result in re-orderings in the field, as for example, new forms of capital may enter it or cognitive schemas may be altered

From lab to mass production: a policy for enabling the licensing of mRNA vaccines

Using the South African vaccine technology transfer hub supported by the WHO as an example, we show that the know-how needed to move mRNA vaccines from prototype to mass-production acts as an invisible barrier to market entry of mRNA vaccines. Overcoming this barrier relies on scarce human capital. In view of this scarcity and in preparation for the next pandemic, we propose broadening the scope of an existing WHO program, the WHO Academy, so that it coordinates knowledge diffusion initiatives by forming a systematized repository of know-how and a register of experts. As we explain, this proposal has an advantage in overcoming barriers to entry over current approaches of know-how acquisition

Remote digital monitoring of medication intake : methodological, medical, ethical and legal reflections

In 2017, regulatory approval was given in the US for a 'digital pill', a pill for which actual ingestion could be remotely monitored. The pill, Abilify Mycite is marketed by Otsuka but the monitoring system derives from Proteus Digital Health. In this paper, we focus on this digital pill and another equivalent system from AiCure which relies on facial recognition. Both systems not only remind the patient to take a pill but also verify the actual intake. In this process, patient-related data beyond the fact that the pill has been taken are also collected and sent to a remote computer system of the system-providing company and possibly to third parties. Although marketed as 'innovative', the introduction of such systems raises questions as to the limitation of patient autonomy, secondary uses of patient data, impact on the physician's liability, and artificial inflation of drug prices. Whereas incorrect medication taking can be problematic, it can be questioned whether remote intake-monitoring systems are, from an ethical, legal and social perspective, the ideal way to address this. In this paper, we will reflect on this question from the position of the different potential stakeholders involved

Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies

This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required

University technology transfer and agricultural science entrepreneurial education: a view from inside

Summarization: Focusing on universities whose faculty has little understanding of technology transfer and the commercialization of academic research, we provide a case study of such a university and argue that even some elementary and indirect form of entrepreneurial training can positively affect faculty technology transfer. In light of the above, we seek to contribute to the literature exploring what makes technology transfer programs at Universities successful and our unique contribution lies on elucidating the link between university technology transfer and science and technology entrepreneurial education (STEE). To this effect, we discuss ways to develop integration processes among STEE and technology transfer offices.Παρουσιάστηκε στο: Journal of the Knowledge Econom