Intellectual Property, Open Science and Research Biobanks

In biomedical research and translational medicine, the ancient war between exclusivity (private control over information) and access to information is proposing again on a new battlefield: research biobanks. The latter are becoming increasingly important (one of the ten ideas changing the world, according to Time magazine) since they allow to collect, store and distribute in a secure and professional way a critical mass of human biological samples for research purposes. Tissues and related data are fundamental for the development of the biomedical research and the emerging field of translational medicine: they represent the “raw material” for every kind of biomedical study. For this reason, it is crucial to understand the boundaries of Intellectual Property (IP) in this prickly context. In fact, both data sharing and collaborative research have become an imperative in contemporary open science, whose development depends inextricably on: the opportunities to access and use data, the possibility of sharing practices between communities, the cross-checking of information and results and, chiefly, interactions with experts in different fields of knowledge. Data sharing allows both to spread the costs of analytical results that researchers cannot achieve working individually and, if properly managed, to avoid the duplication of research. These advantages are crucial: access to a common pool of pre-competitive data and the possibility to endorse follow-on research projects are fundamental for the progress of biomedicine. This is why the "open movement" is also spreading in the biobank's field. After an overview of the complex interactions among the different stakeholders involved in the process of information and data production, as well as of the main obstacles to the promotion of data sharing (i.e., the appropriability of biological samples and information, the privacy of participants, the lack of interoperability), we will firstly clarify some blurring in language, in particular concerning concepts often mixed up, such as “open source” and “open access”. The aim is to understand whether and to what extent we can apply these concepts to the biomedical field. Afterwards, adopting a comparative perspective, we will analyze the main features of the open models – in particular, the Open Research Data model – which have been proposed in literature for the promotion of data sharing in the field of research biobanks. After such an analysis, we will suggest some recommendations in order to rebalance the clash between exclusivity - the paradigm characterizing the evolution of intellectual property over the last three centuries - and the actual needs for access to knowledge. We argue that the key factor in this balance may come from the right interaction between IP, social norms and contracts. In particular, we need to combine the incentives and the reward mechanisms characterizing scientific communities with data sharing imperative

Free Expression and Internet Intermediaries: The Changing Geometry of European Regulation

This chapter explores ongoing shifts in the geometrical patterns of speech regulation in Europe. It first sets out the regulatory framework, which comprises an array of intertwined legally binding and political standards adopted by the Council of Europe and the European Union. It then explains how this framework has given rise to, and indeed encouraged, particular geometrical patterns in European lawmaking and policymaking. Those patterns have been shaped by an awareness that the mass media have been powerful actors in public debate, and that their freedom must be safeguarded—within certain agreed limits. They also demonstrate a concern that regulation should not curb the development of new information and communications technologies and services and new markets for such technologies and services. The chapter's next focus is the recent and ongoing shift in existing regulatory patterns, which entails a significant move towards foisting greater liability and responsibility on internet intermediaries for illegal third party content hosted by them or distributed via their services or networks. There is an emergent preference for self-regulatory codes of conduct as a regulatory technique. However, as this chapter will argue, the relevant European codes of conduct are less voluntary than they may ostensibly seem as recent codes of conduct seem to have a coercive undertone.</p

Method and device for monitoring the risks for sudden infant death syndrom and for positional plagiocephaly

A portable monitoring device (101) performs the monitoring of the short term, mid term and long term risks of Sudden Infant Death Syndrome (SIDS). It is also used to estimate the risk of onset of positional plagiocephaly. The monitoring device (101) is capable to acquire one or more signals associated to the typical breath and positioning patterns of an infant through a tri-axial accelerometer, and to register the data in electronic format. Statistical analysis of the signal and pattern recognition are performed in real time by a processing unit of the monitoring device. The monitoring device (101) can be used for monitoring the breath activity of an infant in various conditions, alerting a caregiver when a potentially dangerous situation is detected, with respect to a SIDS event or to the onset of plagiocephaly.; Thanks to its simplicity of use, small encumbrance and low power consumption, it can be turned on and attached to the clothes of the infant for as long as one day (or more), without the need of further supervision. Registered data can be transferred on a computer through a standard USB port, which can also be used for recharging a battery of the monitoring device (101). Statistical analysis of the registered data can be performed by a computer for quantifying the long term SIDS risk, the risk of plagiocephaly and for optimizing the functional parameters of the monitoring device (101). To get a more accurate estimation of the risk of plagiocephaly, the monitoring device (101) can be attached to the head of an infant

Method And Device For Monitoring The Risks For Sudden Infant Death Syndrom And For Positional Plagiocephaly

A portable monitoring device (101) performs the monitoring of the short term, mid term and long term risks of Sudden Infant Death Syndrome (SIDS). It is also used to estimate the risk of onset of positional plagiocephaly. The monitoring device (101) is capable to acquire one or more signals associated to the typical breath and positioning patterns of an infant through a tri-axial accelerometer, and to register the data in electronic format. Statistical analysis of the signal and pattern recognition are performed in real time by a processing unit of the monitoring device. The monitoring device (101) can be used for monitoring the breath activity of an infant in various conditions, alerting a caregiver when a potentially dangerous situation is detected, with respect to a SIDS event or to the onset of plagiocephaly.; Thanks to its simplicity of use, small encumbrance and low power consumption, it can be turned on and attached to the clothes of the infant for as long as one day (or more), without the need of further supervision. Registered data can be transferred on a computer through a standard USB port, which can also be used for recharging a battery of the monitoring device (101). Statistical analysis of the registered data can be performed by a computer for quantifying the long term SIDS risk, the risk of plagiocephaly and for optimizing the functional parameters of the monitoring device (101). To get a more accurate estimation of the risk of plagiocephaly, the monitoring device (101) can be attached to the head of an infant

Intermediary Liability and Trade Mark Infringement: Proliferation of Filter Obligations in Civil Law Jurisdictions?

This chapter discusses intermediary liability and trade mark infringement from a civil law perspective, while highlighting differences and commonalities of trade mark and copyright enforcement online. The chapter considers first how the infringement test in EU trade mark law is more context-specific than the infringement analysis in copyright law and how limitations of trade mark rights provide room for unauthorized use that serves (commercial) freedom of expression and freedom of competition. In this context, this chapter looks into the use of filtering mechanisms and how they might wash away these important nuances of the scope of trade mark protection. Again, the chapter makes a distinction between legitimate comparative advertising and infringing consumer confusion, legitimate brand criticism and infringing defamation, legitimate offers of second-hand goods and infringing sales of replicas in order to consider the threshold when trade mark owners obtain overbroad protection. Further, this chapter reviews leading case law of the Court of Justice of the European Union on the question of intermediary liability and filter obligations that points towards a cautious approach in trade mark cases—an approach that does not undermine the inherent limits and statutory limitations of trade mark rights. However, examples of court decisions in civil law jurisdictions, such as Germany, show a tendency of developing national doctrines that allow the imposition of more extensive filtering duties. Against this background, the chapter concludes by considering whether a balanced approach based on the principle of proportionality should prevail in trade mark cases