1,721,307 research outputs found
AI, MACHINE LEARNING & BIG DATA LAWS & REGULATIONS - Chapter on Denmark
No full textCountry report for Denmark by Minssen Timo; Anders Valentin; Patris Hajrizaj.
The Legal Dimensions of Big Data, Artificial Intelligence and Machine Learning in Pharmaceutical Innovation (original title in accepted version):Editorial to special issue of the European Pharmaceutical Law Review on "Big Data, AI & Machine Learning in Pharmaceutial Innovation"
Full text linkMultiple factors indicate that big data, artificial intelligence and machine learning will play a crucial role in the evolution of pharmaceutical innovation.The ongoing paradigm shift is fuelled by rapid technical advances that have greatly transformed and enhanced many facets of the pharmaceutical sector. Huge datasets are driving new drug discoveries and are making clinical trials more efficient, while sophisticated data models have enabled healthcare professionals to better predict and prevent illness using new technology ranging from precision medicine to AI assisted diagnostics as well as genetic engineering and sequencing. Big data and AI have also transformed international collaboration in the areas of drug discovery and development and in the future, the combination of pharmaceutical datasets with information technology based AI solutions will lead to new tools and improvements in pharmaceutical fields such as generative chemistry, image segmentation and analysis as well as optimization of cell and gene therapies. However, despite all the advantages of fostering pharmaceutical innovation and improving patient care, this paradigm shift has brought significant legal challenges in various areas of the law, both on a national and international level. While some of these technologies have not materialised yet and some areas are burdened with unrealistic hype and expectations, it cannot be denied that legal and regulatory challenges are already crystalizing
US COVID IP waiver U-turn will not fix the vaccines access crisis
No full textMatthews, Duncan and Minssen, Timo, US U-turn on Covid IP waiver alone will not solve vaccine crisis - Intellectual property is an important part of the debate, but greater transparency is required (May 1, 2021). A shortened and edited version of this opinion was published by The Financial Times on June 17th, 2021. The longer original version is available at SSRN: https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=388102
Perspectives on Limitations to Patentability- Report No. I of a Webinar Series on Reinterpreting TRIPS in the Life Sciences
No full textThis report is based on the material and input that was presented and discussed at the webinar with the title: “Perspectives on limitations to patentability”. The Webinar and the theme where introduced by Prof. Timo Minssen. Then Prof. Nari Lee gave a presentation introducing some of the context and considerations related to TRIPS art 27 and the concept of technological neutrality. This was followed by Dr. Mike Snodin presentation on some central points and arguments from his recent article considering the so-called “Correa Guidelines” and their compatibility with the obligations enshrined in TRIPS art 27. After the introduction and the two presentations, the open discussion turned to questions, comments and considerations of related issues such as the need for alternative incentives, purpose bound product protection, user driven solutions and post-grant instruments. Suggested citation: Wested, Jakob and Minssen, Timo, Trips and the Life Sciences - Perspectives on Limitations to Patentability (June 15, 2017). Available at SSRN: https://ssrn.com/abstract=2986751<br/
MUCH ADO ABOUT SOMETHING:LEGAL, ETHICAL AND SCIENTIFIC CHALLENGES IN INTERNATIONAL BIOBANKING AND TRANSLATIONAL EXPLOITATION
No full textIntroduction : The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing
No full textAIRR data under the EU Trade Secrets Directive:Aligning scientific practices with commercial realities
Full text linkWhether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike. One such technology—adaptive immune receptor repertoire sequencing, or AIRR-seq—raises difficult questions concerning what information is and should be protected under the new Directive, and how to best align scientific practices with commercial realities. The ‘raw’ form AIRR-seq data—massive genetic datasets of hundreds of millions of individuals’ immune cells—tends to be freely shared among academic researchers, thus typically destroying the protectability of the underlying information. But follow-on data—essentially, information interpreting that data—is nonetheless protectable under the Directive because it is both economically valuable and not readily available from an examination of the raw data itself. Protecting this follow-on information while encouraging the free sharing of AIRR-seq data best accords the purpose of the Trade Secrets Directive. Lessons from the case of AIRR-seq data also sheds light on other puzzles concerning the tensions between disclosure and intellectual property protections, such as the mutual exclusivity of patents and trade secrets, the sharing of clinical trial data, and protecting genetic diagnostics
An Appraisal of the EU Directive on Trade Secrets
No full textThe EU Trade Secrets Directive (‘the Directive’) has standardized the national laws in EU member states for the protection of trade secrets. For the first time, a harmonised definition of what constitutes a ‘trade secret’ is established as well as common measures aimed at preventing the misappropriating of trade secrets and rules for procedures and sanctions.The adoption of the Directive reflects the growing importance of trade secrecy protection internationally. Trade secrets offer protection even for knowhow and business information that cannot be protected by conventional Intellectual Property Rights (IPRs). This could, for instance, be an invention that does not fulfil the requirements to obtain patent protection, such as the eligibility, novelty or non-obviousness criteria or non-technical business information such as price or customer information. Another advantage of trade secrets is that the protection can in principle last in perpetuity, while conventional types of IPRs offer protection only for a limited period of time. Since it is not the information as such which is being protected the trade secret holder cannot, however, object to the fact that a third party independently develops identical products, processes, algorithms etc. Protection lapses as soon as the information protected as a trade secret becomes publicly available or loses its commercial value. As it is well-known from IPR, protecting information comes with strings attached. National experiences have shown that protecting trade secrets may give rise to special concerns about defining the protectable subject matter and the scope of the protection. One example includes the many instances where secrets are being developed or used as part of an employment contract. Here an overly broad conception of what constitutes a ‘secret’ e.g. to cover the normal skills of the particular trade or a broad scope of exclusivity may limit employee mobility. These concerns are going to magnify in the light of the EU objectives of furthering and securing the free movement of labor. In the same vein, concern has been raised that secrecy protection may impede on the ability of whistle blowers to document irregularities in companies (and for media to report on such events). Other contentious issues include public institutions. For such institutions (notably universities) protecting secrets and engaging in contracts with private companies (PPP) is going to give rise to problems not just regarding the practicalities but also on a more fundamental level as the very notion of keeping information ‘secret’ may be hard to incorporate into existing cultures based on openness and transparency. The Directive constitute the skeleton of the new EU protection system. The muscles arteries etc. that are going to create a body of EU trade secrets law will develop in the coming years at the intersections between the Directive, the national experiences and the diverse needs of users and society in general. It is for this reason that the contributions in this book cover a broad range of areas: Part I provides the general framework for the Directive and puts trade secrecy protection in context to other broader areas of law such as information law and international law. Part II turns to the implementation of the Directive in the Nordic countries, Germany, United Kingdom and Spain and Portugal. Next, Part III deals with more specific issues that emerge at the interface of trade with other areas of the law, such as the challenges and opportunities that can be expected with regard to employee mobility, choice of law or specific legal frameworks for enforcement of rights and data transfer. Finally, Part IV provides an overview of how specific sectors are affected by the TS regime, including a detailed and technical analysis of various areas of medical applications.[................
The Dynamic Context & Multiple Challenges of Data Sharing
No full textThis chapter outlines the dynamic context and multiple challenges of data sharing in the contemporary data ecosystem, specifically as it relates to healthcare. Here, we define ‘data sharing’ as the practice of sharing health-related data between a number of data controllers and processors. Data collected in this manner can come from the provision of health, clinical trials, observational studies, public health surveillance programs, and other health data collection methods. Several justifications for such sharing are introduced. Our main contention is that the regulatory environment today is an increasingly complex and rapidly evolving combination of norms and principles. To navigate it successfully requires careful analysis and judgment from all stakeholders across diverse fields of law and technology. The purpose of this volume, therefore, is to offer a series of case studies that integrate theoretical and practical perspectives and illustrate how to effectively navigate this rapidly evolving space
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