Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founding Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL), see: https://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631. His research, supervision, teaching
On 7 March 1953 two young scientists, James Watson and Francis Crick, announced to fellow patrons... more On 7 March 1953 two young scientists, James Watson and Francis Crick, announced to fellow patrons of the Eagle pub in Cambridge that they had found “the secret of life”. Then, on 25 April 1953, they published an article in the famous Nature magazine and announced: “We wish to suggest a structure for the salt of deoxyribose nucleic acid (D.N.A). This structure has novel features which are of considerable biological interest.” What Watson and Crick suggested in their short article - a model of clarity, precision and British understatement - was the winding double helix structure of DNA which immediately suggested how DNA would replicate itself. Less than 900 words later they concluded on the same page with the simple sentence: “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” Their proposed model had great beauty and simplicity, and fitted the experimental data available, so it was soon accepted as correct. While this paper can be regarded as the first step into a new era of genetics, DNA is presently at the centre of a storm. On the one hand, the breathtaking development of DNA related sciences during the last decades led to a technological and medical revolution. Due to the far reaching possibilities connected to this technology, it is the focus of many people’s interest and one source of the hope that one day we will find cures for terrible illnesses. Unsurprisingly, DNA related biotechnological science has at the same time become a very important economic factor in global business. On the other hand, the public has been made much more concerned about the level of knowledge about the human blueprint and how it is applied and commercialized. These debates are highly emotional. This is particularly so with regard to the question of whether it should be possible to patent human DNA. In the often heated debate on the subject there are, by and large, two schools of thoughts. The first is convinced that DNA is simply a chemical compound, albeit a complex one, and takes the view that it must be possible to grant patents on DNA, as on any other chemical compound. The approach taken by the US and European patent authorities basically follows this line of thinking and consequently the grant of (human) DNA related patents has become routine. The second school of thought sees DNA as much more than a pure chemical structure. They argue that DNA is the embodiment and incarnation of the code of life and is part of the common heritage of mankind. They believe that any form of appropriation or patents on DNA is absolutely wrong. Both points of view are bogged down in their own logic and it seems to be extremely difficult to find a compromise. Moreover there is a continuing debate among those who support patents on DNA sequences over the threshold-requirements for receiving such a patent, the appropriate extent of its entitlements and its preclusive effects. Especially the specific issue of patents on partial sequences (ESTs and SNPs) and DNA sequences whose functions and applications have not fully been specified is heavily discussed, since they may have a chilling effect on beneficial research. The purpose of my PhD is to scrutinize this latter debate. I want to investigate different possibilities for patenting (and perhaps even licensing) human DNA technology in the US and Europe. The main goal of my research is to balance the arguments of the parties involved in the debate over specific human DNA related patents, in order to outline a reasonable legal approach that would lead to an acceptable compromise on how to combine economic interests with the necessary freedom of research and an effective product development in the field of healthcare. Naturally this will involve a thorough examination of the scope of protection that is given to various human DNA related inventions by the respective the patent offices. This licentiate thesis represents the first sections of my doctoral project and deals with basic patentability requirements that have a more indirect effect on the scope of genetic patents, namely patentable subject matter novelty and inventive step.
On 7 March 1953 two young scientists, James Watson and Francis Crick, announced to fellow patrons... more On 7 March 1953 two young scientists, James Watson and Francis Crick, announced to fellow patrons of the Eagle pub in Cambridge that they had found “the secret of life”. Then, on 25 April 1953, they published an article in the famous Nature magazine and announced: “We wish to suggest a structure for the salt of deoxyribose nucleic acid (D.N.A). This structure has novel features which are of considerable biological interest.” What Watson and Crick suggested in their short article - a model of clarity, precision and British understatement - was the winding double helix structure of DNA which immediately suggested how DNA would replicate itself. Less than 900 words later they concluded on the same page with the simple sentence: “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” Their proposed model had great beauty and simplicity, and fitted the experimental data available, so it was soon accepted as correct. While this paper can be regarded as the first step into a new era of genetics, DNA is presently at the centre of a storm. On the one hand, the breathtaking development of DNA related sciences during the last decades led to a technological and medical revolution. Due to the far reaching possibilities connected to this technology, it is the focus of many people’s interest and one source of the hope that one day we will find cures for terrible illnesses. Unsurprisingly, DNA related biotechnological science has at the same time become a very important economic factor in global business. On the other hand, the public has been made much more concerned about the level of knowledge about the human blueprint and how it is applied and commercialized. These debates are highly emotional. This is particularly so with regard to the question of whether it should be possible to patent human DNA. In the often heated debate on the subject there are, by and large, two schools of thoughts. The first is convinced that DNA is simply a chemical compound, albeit a complex one, and takes the view that it must be possible to grant patents on DNA, as on any other chemical compound. The approach taken by the US and European patent authorities basically follows this line of thinking and consequently the grant of (human) DNA related patents has become routine. The second school of thought sees DNA as much more than a pure chemical structure. They argue that DNA is the embodiment and incarnation of the code of life and is part of the common heritage of mankind. They believe that any form of appropriation or patents on DNA is absolutely wrong. Both points of view are bogged down in their own logic and it seems to be extremely difficult to find a compromise. Moreover there is a continuing debate among those who support patents on DNA sequences over the threshold-requirements for receiving such a patent, the appropriate extent of its entitlements and its preclusive effects. Especially the specific issue of patents on partial sequences (ESTs and SNPs) and DNA sequences whose functions and applications have not fully been specified is heavily discussed, since they may have a chilling effect on beneficial research. The purpose of my PhD is to scrutinize this latter debate. I want to investigate different possibilities for patenting (and perhaps even licensing) human DNA technology in the US and Europe. The main goal of my research is to balance the arguments of the parties involved in the debate over specific human DNA related patents, in order to outline a reasonable legal approach that would lead to an acceptable compromise on how to combine economic interests with the necessary freedom of research and an effective product development in the field of healthcare. Naturally this will involve a thorough examination of the scope of protection that is given to various human DNA related inventions by the respective the patent offices. This licentiate thesis represents the first sections of my doctoral project and deals with basic patentability requirements that have a more indirect effect on the scope of genetic patents, namely patentable subject matter novelty and inventive step.
AI in eHealth : Human Autonomy, Data Governance & Privacy in Healthcare, 2021
The use of digital technologies in healthcare is changing how medical treatments are developed by... more The use of digital technologies in healthcare is changing how medical treatments are developed by researchers, applied/practiced by medical professionals and experienced by patients. This article argues that a defining feature of this disruption is the emergence of new medical "apps" that leverage algorithm-based AI systems. As the use of such apps and AI wearables goes mainstream and new players-notably "Super Platforms" with digital rather than a medical expertise-enter the healthcare sector, the traditional means of providing medical services will be further transformed. These developments pose several challenges for regulators and other policymakers, most obviously, in the context of privacy and data protection. Here, we examine how the emerging field of Legal Design can provide a more transparent infrastructure that embeds relevant legal protections in the user interfaces of healthcare products and services. Such a user interface (UI) focused Privacy-by-Design approach offers a number of advantages, most obviously greater transparency, accountability and (consequently) human choice. The article offers several realworld examples of design patterns that illustrate the value of UI focused Privacy-by-Design in protecting individuals' sensitive information, enabling people to make choices and retain control of their personal data. The article concludes with some examples and reflects on the challenges specific to implementing Legal Design in an eHealth context.
This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in h... more This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be followed in Section 3 by a discussion of four primary ethical challenges, namely (1) informed consent to use, (2) safety and transparency, (3) algorithmic fairness and biases, and (4) data privacy. Section 4 will then analyze five legal challenges in the U.S. and Europe: (1) safety and effectiveness, (2) liability, (3) data protection and privacy, (4) cybersecurity, and (5) intellectual property law. Finally, Section 5 will summarize the major conclusions and especially emphasize the importance of building an AI-driven health care system that is successful and promotes trust and the motto “Health AIs for All of Us”.
The EU Trade Secrets Directive (‘the Directive’) has standardized the national laws in EU member ... more The 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. [................]
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Papers by Timo Minssen
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.
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