"Adiós Sui Géneris" : a study of the legal feasibility of the sui generis right in the context of research biobanks.

Peer reviewedPublisher PD

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

Influence of geometrical ratios in forgeability of complex shapes during hot forging of Ti-6Al-4V titanium alloy

AbstractTitanium alloys are considered desirable materials when both mechanical properties and weight reduction are requested at the same time. This class of materials is widely used in application fields, like aeronautical, in which common steels and light-weight materials, like aluminum alloys, are not able to satisfy all operative service conditions. Most of manufacturing processes of titanium alloy components are based on machining operations, which allow obtaining very accurate final shapes but, at the same time, are affected by several disadvantage like material waste and general production costs. During the last decade, the forging processes for titanium alloys have attracted greater attention from both industrial and scientific/academic researchers because of their potential in providing a net shaped part with minimal need for machining. In this paper, a numerical analysis of the forging process design for an Ti-6Al-4V titanium alloy aerospace component is presented that focuses on the role of material evolution during thermomechanical processing. This component geometry is characterized by thin webs and ribs, and sharp corner and fillet radii. The numerical model was tested and validated by means of comparison with real experimental forgings in order to verify the quality in the prediction of material flow and microstructure evolution. Moreover, the analysis of forgeability of the same component with more critical geometrical ratios is considered in order to test the capability of code to support the forging sequence design in the case of a complex shape component

Dual phase titanium alloy hot forging process design: experiments and numerical modeling

Titanium alloys are considered desirable materials when both good mechanical properties and weight reduction are required at the same time. This class of materials is widely used in those fields (aeronautics, aerospace) in which common steels and light-weight materials, e.g., aluminum alloys, are not able to satisfy all operative service conditions. During the last decade, forging of titanium alloys has attracted greater attention from both industrial and scientific/academic researchers because of their potential in providing a near net shaped part with minimal need for machining. In this paper, a numerical model of the forging sequences for a Ti-6Al-4V titanium alloy aerospace component is presented. The model was tested and validated against experimental forgings. The model is then applied to predict loads final microstructure and defects of an aeronautical component. In addition to metal flow and die stresses, microstructural transformations (α and β phases) are considered for the determination of proper process parameters. It is found that transformation from α/β to β phase during forging and reverse transformations in post-forge cooling needs to be considered in the computational model for reasonable prediction of forging loads and product properties

Remote Teaching During the Emergency and Beyond: Four Open Privacy and Data Protection Issues of ‘Platformised’ Education

4sireservedDue to the spread of Covid-19 in the first months of 2020, almost all Universities across Europe had to close their buildings and migrate online. This rapid shift towards the provision of education online has been characterized by the externalization to and use of third-party service providers, raises several concerns, especially from a privacy and data protection perspective. The aim of this paper is to map the possible data protection risks emerging from the platformisation of education by focusing on the most pressing points of friction with the European data privacy regime: 1) allocation of roles and responsibilities of the actors involved; 2) transparency of the processing and possibility to effectively exercise data subjects’ rights; 3) extra-EU data transfers after Schrems II; 4) challenges of e-proctoring systems. The paper argues that the implementation of the right to privacy and data protection in remote teaching is not merely an issue of compliance, but a substantial measure that Universities shall ensure to guarantee the fundamental rights of our students and colleagues. The paper concludes with recommendations for ensuring a safer and fairer remote teaching experience, also discussing long-term strategies beyond the emergency and beyond the mere compliance with the General Data Protection Regulation. such as Zoom, for ensuring the continuity of learning. The ‘platformisation’ of education, however,mixedChiara Angiolini; Rossana Ducato; Alexandra Giannopoulou; Giulia SchneiderAngiolini, CHIARA SILVIA; Ducato, Rossana; Giannopoulou, Alexandra; Schneider, Giuli