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1.	Bhaskar, Sonu, et al. (författare) At the Epicentre of COVID-19 - the Tragic Failure of the Global Supply Chain for Medical Supplies 2020 Ingår i: Frontiers in Public Health. - : Frontiers Media SA. - 2296-2565. Tidskriftsartikel (refereegranskat)abstract The tragic failure of the global supply chain in the face of the current coronavirus outbreak has caused acute shortages of essential frontline medical devices and personal protective equipment, crushing fear among frontline health workers and causing fundamental concerns about the sustainability of the health system. Much more coordination, integration, and management of global supply chains will be needed to mitigate the impact of the pandemics. This article describes the pressing need to revisit the governance and resilience of the supply chains that amplified the crisis at pandemic scale. We propose a model that profiles critical stockpiles and improves production efficiency through new technologies such as advanced analytics and blockchain. A new governance system that supports intervention by public-health authorities during critical emergencies is central to our recommendation, both in the face of the current crisis and to be better prepared for potential future crises. These reinforcements offer the potential to minimize the compromise of our healthcare workers and health systems due to infection exposure and build capacity toward preparedness and action for a future outbreak.
2.	Corrales Compagnucci, Marcelo, et al. (författare) Non-Fungible Tokens as a Framework for Sustainable Innovation in Pharmaceutical R&D: A Smart Contract-Based Platform for Data Sharing and Rightsholder Protection 2024 Ingår i: International Review of Law, Computers & Technology. - 1360-0869. ; 38:1, s. 66-85 Tidskriftsartikel (refereegranskat)abstract Research and Development (R&D) in the pharmaceutical sector traditionally occurred in closed, siloed institutional settings. This approach was a function of a rights-oriented model which framed access and reuse of data (data sharing) as a threat to rights-holders. However, a closed model of explorative collaboration is less suited to today’s more complex scientific ecosystem, where external engagement and dynamic partnering with multiple actors and diverse information sources has become essential. As such, devising alternative approaches is vital in ensuring that opportunities for scientific advances are not lost or innovation stifled.This article introduces a hybrid contractual framework that combines the benefits of the automated functionality of smart contracts and non-fungible tokens embedded in the blockchain with more traditional rights-based licensing schemes. The framework described is based on the outcome of an experimental pilot platform that enabled participants to store, find and reuse data following FAIR data principles. The platform documents real-world physical assets in the drug discovery of chemical molecules in an immutable digital ledger.More generally, smart contracts and non-fungible token’s point us towards an open and global collaborative platform for exploiting and advancing drug research assets. The resulting platform creates mechanisms for resolving issues regarding standardization, interoperability, and disclosure. As such, it overcomes many of the practical hurdles currently obstructing collaboration in pharmaceutical R&D, as well as providing a framework to address the central conflict in drug discovery, namely the demand for greater data sharing and the protection of rights-holder interests.
3.	de Miguel Beriain, Iñigo, et al. (författare) An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014 2020 Ingår i: European Public Law. - 1354-3725. ; 26:2, s. 307-330 Tidskriftsartikel (refereegranskat)
4.	Druedahl, Louise C., et al. (författare) A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways 2020 Ingår i: Nature Biotechnology. - : NATURE RESEARCH. - 1087-0156 .- 1546-1696. ; 38:11, s. 1253-1256 Tidskriftsartikel (refereegranskat)
5.	Druedahl, Louise C., et al. (författare) Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators 2021 Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361 Tidskriftsartikel (refereegranskat)abstract Background A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. Objective The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. Methods Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
6.	Druedahl, Louise C., et al. (författare) Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution 2022 Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:1 Tidskriftsartikel (refereegranskat)abstract Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
7.	Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives 2023 Samlingsverk (redaktörskap) (refereegranskat)abstract This book brings together several outstanding authors in the field and covers questions relating to the fundamental milestones in technology development and governance (Judit Sandor), an analysis of disability questions and empowerment of the community (Pin Lean Lau), right to health opportunities and challenges (Anne Kjersti Befring), the protection of the right to private life and life (Merel M. Spaander), and preconditions for the use of technology for heritable changes in the human genome (Noemi Conditi), and the intersection of genome editing and artificial intelligence (Anastasiya Kiseleva). It also examines the rules relating to the early access of gene therapy medicinal products (Vera Lucia Raposo) and the adequacy of the rules on safety and application of the technology in healthcare within the EU (Michal Koščík and Eliška Vladíková). Moreover, it looks into the availability and accessibility of the technology. The special issue examines the values behind the prohibitions of germline interventions in Europe and explores the feasibility of lifting these bans (Santa Slokenberga, gold OA); it looks at the social justice in the field and the need to ensure better access to biotechnological innovations (Oliver Feeney) as well as examines the morality clauses in patent legislation and their impact on the technology governance (Duncan Matthews, Timo Minssen and Ana Nordberg). At times, even the best technology governance tools fail in ensuring adequate access to the technology and the market actors risk behaving in a way that could undermine the right to health. Here, competition law perspectives come into play and offer tools for ensuring a minimum level of competition in the field (Vladimir Bastidas Venegas, gold OA). The book is an outcome of the Nordic Permed Law Symposium on Human Genome Editing, held online on November 3-4, 2021, and is expected to be published open access, latest September 2022.
8.	Groussot, Xavier, et al. (författare) Res judicata i EG –domstolens rättspraxis: en avvägning mellan rättssäkerhet och lagenlighet 2007 Ingår i: Europarättslig tidskrift. - 1403-8722. ; :3, s. 535-567 Tidskriftsartikel (refereegranskat)abstract Ny rättspraxis från EG-domstolen i fallen Köbler och Kühne & Heitz har visat att domstolen är beredd att etablera rättsprinciper som kommer göra det möjligt att på ett effektivt sätt hantera missbruket av acte clair-doktrinen. I det förstnämnda fallet, etablerade domstolen en möjlighet att utkräva skadeståndsansvar av medlemsstaten i det fall den nationella sista instansrätten (in casu den högsta förvaltningsdomstolen), med hjälp av acte clair-doktrinen, begår ett uppenbart brott mot gemenskapsrätten.2 I det senare fallet, konstaterade domstolen att ett förvaltningsorgan är förpliktigat, i enlighet med samarbetsprincipen i art. 10 EG, att ompröva ett beslut för att beakta den tolkning av en relevant gemenskapsrättslig bestämmelse som domstolen gjort under tiden. Det är slående att EG-domstolens domare i dessa två fall gett uttryck för samma logiska grund, nämligen strävan efter en jämvikt mellan rättsäkerhet och lagenlighet. Det är värt att notera att dessa viktiga EG-domstolsbeslut berört principen om res judicata både vad gäller statens skadeståndsansvar och omprövning av beslut. Det är emellertid fortfarande tvetydigt vilket omfång res judicata har, eftersom rättspraxis befinner sig i statu nacendi och således förefaller vara särskilt komplex. Det är allmänt känt att EG-domstolen förstärker och/eller tydliggör en nyetablerad princip genom efterföljande rättspraxis. De fall och förslag till avgöranden från 2006 och 2007, t.ex. TDM, EDF Man Sugar, Kapferer, i-21 och Arcor, Lucchini och Kempter som kan sprida ljus över de principe besluten från 2003 (Köbler) och 2004 (Kühne & Heitz), bör därför analyseras djupgående. Finns här något nytt under solen? Eller bekräftar dessa senare fall endast tidigare rättspraxis? Syftet med denna artikel är att fastställa omfånget av res judicata i ljuset av EG-domstolens senare rättspraxis. För detta ändamål kan två huvudlinjer av fall urskiljas, nämligen fall rörande medlemsstatens skadeståndsansvar och fall rörande ändring av slutgiltiga beslut. Denna rättspraxis är intrikat sammanvävd och måste därför läsas ihop. Vidare har Köbler-doktrinen ansetts vara underordnad den rättspraxis som går på Kühne & Heitz-linje. Om detta förhållande stämmer kan mycket av den kritik som framförts mot Köblerdoktrinen te sig mindre slagkraftig. Först och främst är det nödvändigt att ge en definition av res judicata (1). Vi kommer att undersöka detta koncept i relation till principen om rättssäkerhet (1.1) för att sedan analysera det i ljuset av gemenskapsrättslig lagenlighet (1.2). För det andra fokuserar artikeln på den rad av fall som rör res judicata och medlemstaternas skadeståndsansvar (2). Denna del kommer att titta på de fall som rör principens utveckling (2.1) och sedan dess bekräftande (2.2). För det tredje har vi utvärderat omfånget av res judicata i samband med den rättspraxis som har att göra med ändring av slutgiltiga beslut (3). För detta ändamål, kommer två områden att bli undersökta, å ena sidan, ändring av slutgiltiga förvaltningsbeslut (3.1), å andra sidan, ändring av slutgiltiga domstolsavgöranden (3.2).
9.	Groussot, Xavier, et al. (författare) Res judicata in the court of justice case-law: Balancing legal certainty with legality? 2007 Ingår i: European Constitutional Law Review. - 1744-5515. ; 3:3, s. 385-417 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Forms of res judicata - Unwritten principle of EU law - National procedural autonomy v. EC supremacy - Revision of decisions v. state liability - Finality of administrative decisions v. judicial decisions - Higher respect for judicial decisions than for administrative decisions - Res judicata not absolute - ECJ itself under demands of legal certainty - Analogy between res judicata rules and rules of direct and indirect effect.
10.	Kongsholm, Nana Cecilie Halmsted, et al. (författare) Challenges for the sustainability of university-run biobanks 2018 Ingår i: Biopreservation and Biobanking. - : Mary Ann Liebert Inc. - 1947-5535 .- 1947-5543. ; 16:4, s. 312-321 Tidskriftsartikel (refereegranskat)abstract Most university biobanks begin like other university research projects, i.e. with an idea conceived by an individual researcher in pursuit of his/her own research interests, publications, funding and career. Some biobanks, however, come to have scientific value that goes beyond the projects that were initially responsible for the collection of the samples and data they contain. Such value may derive from inter alia the uniqueness of the samples in terms of their sheer volume, the quality of the samples, the ability to link the samples with information retrieved in disease registries, or the fact that the samples represent very rare diseases. This paper focuses on biobanks of this kind, and the special obligations that publicly funded universities have to ensure the sustainability of biobanks with continued scientific value. We argue that universities should adopt policies to deal with the various, diverse issues which may arise during the lifecycle of a biobank. The policies should be flexible, accommodate the freedoms of individual researchers, and reflect the multifaceted nature of biobanks. Yet they should be specific enough to provide guidance and robust enough to safeguard legal norms and ethical values. The paper sets out concrete recommendations which universities should consider and act upon.
11.	M. Schwartz, Robert, et al. (författare) Life after Myriad: the uncertain future of patenting biomedical innovation and personalised medicine in an international context 2015 Ingår i: Intellectual Property Quarterly. - 1364-906X. ; 2015:3, s. 189-241 Tidskriftsartikel (refereegranskat)abstract On June 13, 2013, the U.S. Supreme Court decided the Myriad gene patent case. In a unanimous judgment the Court held that patent claims directed to isolated genomic DNA are identical to the naturally occurring sequence and thus unpatentable “products of nature”. This decision affects all isolated"products of nature", including genes, gene fragments, and other naturally occurring nucleotide sequences, as well as naturally occurring amino acid sequences, including peptides, ligands, and proteins. Consequently, Myriad has a severe impact on many patent portfolios. Although Myriad does not directly affect the patentability of cDNA or sufficiently modified compounds, and the most recent USPTO guidance provides hints on how the new eligibility standard can be met, it is still not entirely clear how much modification is required to render a molecule sufficiently distinct from naturally occurring counterparts. Moreover, when combined with the US Supreme Court decisions in Prometheus and Alice, Myriad may affect method claims which depend upon unmodified biological materials. The USPTO guidance, however, still leaves much uncertainty over the patentability of such methods and diagnostics. The substantial impact of these decisions on the biomedical sector and personalized medicine,as well the methodology used by the generalist Supreme Court in reversing a specialized CAFC judgment is particularly interesting from a comparative perspective. This paper analyses and discusses these U.S. developments, and compares them with the situation in Australia and in the EU. Keywords: biotechnology, comparative patent law, US, Europe, Australia, DNA, Myriad, patent-eligibility,personalized medicine, genetic diagnostics, USPTO 2014 Guidelines, methods,innovation, Unified Patent Court.
12.	Matthews, Duncan, et al. (författare) Balancing innovation, ‘ordre public’ and morality in human germline editing : A call for more nuanced approaches in patent law 2022 Ingår i: European Journal of Health Law. - : Brill. - 0929-0273 .- 1571-8093. ; 29:3-5, s. 562-588 Tidskriftsartikel (refereegranskat)abstract This article analyses the role that ‘ordre public’ and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to recent patent disputes and, second, examine ‘ordre public’ and morality exceptions under patent law in international, national and regional law, and the implications for innovation and access to novel treatments. The article argues that patent exceptions should not be used as a blunt policy instrument, nor interpreted in a way that is contrary to the patent system's overall objectives. The ‘ordre public’ and morality based exceptions in the context of human germline editing should not be interpreted and applied in a way which results in outcomes counterproductive to the goal of balancing innovation with the protection of societal higher normative values. Instead, the application of the exception should be based on a sound understanding of both the underlying science as well as the broader ethical, social, and legal implications, thus enabling case-by-case decisions that provide the basis for patent claim amendments and nuanced purpose-bound protection. Further analysis and debate as to the role that such flexibilities can play in the context of genome editing technologies is therefore both necessary and desirable, and can be facilitated in the ways set out in this article.
13.	Matthews, Duncan, et al. (författare) The Role of Patents and Licensing in the Governance of Human Genome Editing: A White Paper 2021. - 2021 Rapport (övrigt vetenskapligt/konstnärligt)abstract On 12 July 2021 the World Health Organization (WHO) Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing published a set of reports entitled Human Genome Editing: A Framework for Governance and Recommendations. These reports provide valuable advice and recommendations on appropriate institutional, national and global governance mechanisms for human genome editing. The Expert Advisory Committee’s A Framework for Governance highlights explicitly the role that patents and licences can play as a form of governance of human genome editing. The Recommendations state that the Committee ‘believes that governance measures based on patents or [other forms of] intellectual property, when used together with other tools, may help strengthen the governance and oversight of human genome editing’ [and that] ‘It will be important to avoid using patents in ways that potentially prevent others from delivering similar capabilities at a cheaper cost’. This paper responds to the recommendations of the Expert Advisory Committee and elaborates further on the role that patents and licensing can play in the governance of human genome editing. It concludes with our own recommendations on how the role of patents and licensing can be considered further in the light of the WHO Expert Advisory Committee’s reports.
14.	Minssen, Timo (författare) Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law - A comparative study with special emphasis on DNA- and protein-related inventions 2012 Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract “The implications and applications of biotechnology continue to be at the centre of public debate. In the light of rapid scientific advances and novel insights, the multi-faceted discussions are particularly fierce with regard to patents on DNA–related technology. In the often very emotionally-led debate basically two directly conflicting schools of thoughts can be identified. Some people believe for multiple reasons that DNA, and in particular human DNA, is much more than a mere chemical structure. They believe that any form of patenting DNA, or of the natural processes it is involved in, is utterly wrong, since any DNA and the information it contains is the embodiment of the code of life and should be regarded part of the common heritage of mankind. Some patent opponents go even further and argue for a prohibition of patents on proteins. Others, and in particular the life science industry, assert that DNA and proteins are simply chemical compounds, albeit complex ones. Thus they claim that it should be principally possible to grant various types of patents directed to isolated DNA sequences and proteins. In the past, U.S. and European patent authorities have basically followed this line of thinking. Thus, the grant of patents on DNA- and protein- related technology had become routine. While it almost seems impossible to reconcile these fundamentally diverging views, the purpose of this thesis is related to a third area of debate. It focuses on the fierce discussions among those who principally support patents on DNA -related technology over particular threshold-requirements for receiving such patents, the appropriate scope/form of its protection, and its exclusionary effects. This study scrutinizes one crucial aspect pertaining to the latter debate. More specifically, it investigates how the European and US patent systems interpret and apply the so called "inventive step" (Europe) or "non-obviousness" requirement (U.S.) vis-à-vis bio-pharmaceutical technology with a special emphasis on DNA-and protein related inventions. In addition to evaluating the de lata situation through analysis of recent case law and regulations, this study also discusses the impact of the inventive step/non-obviousness requirement on biomedical innovation. In that regard particular attention is given to the continuing debates over a variety of significant issues, such as the appropriated scope of protection to be conferred to patents, the "obvious to try" issue and hindsight problems, but also pharmaceutical life cycle strategies and the notion of a so called “innovation gap” in the pharmaceutical sector. Recognizing that the gravity of potential and actual problems associated with DNA- and protein related patents is often difficult to assess and depends on a variety of “pre-grant“ and “post-grant” factors that fall outside the scope of the analysis, this study highlights the importance of a properly balanced and stringent application of the inventive step/non-obviousness requirement in order to achieve well defined “high quality” patents that may either forestall problems or at least provide a sound basis for more comprehensive solution models.”
15.	Minssen, Timo, et al. (författare) Big Data and intellectual property rights in the health and life sciences 2018 Ingår i: Big Data, Health Law, and Bioethics. - : Cambridge University Press. - 9781108147972 - 9781107193659 ; , s. 311-323 Bokkapitel (refereegranskat)
16.	Minssen, Timo (författare) Book Review: Drexl, J., Lee, N. (2013). Pharmaceutical Innovation, Competition and Patent Law : A Trilateral Perspective. Edward Elgar Publishing 2014 Ingår i: European Competition Law Review. - 0144-3054. ; 35:4, s. 202-206 Recension (övrigt vetenskapligt/konstnärligt)abstract This is a review of the recent publication “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws? Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.Leaving aside these minor formalities I have studied this book with great pleasure and interest. Although I might personally not always fully agree with some of the findings and proposals presented in it, the overall theme of the book indeed reflects the most important aspects of “Pharmaceutical Innovation, Competition and Patent Law”. It provides valuable analyses of the fundamental challenges that the pharmaceutical sector encounters on both a global and regional level. The editors and authors have thus compiled an important publication that will provide stimulation and inspiration to many scholars and their students interested in pharmaceutical innovation. For the reason mention above, this book should also be of great interest to stakeholders, policy makers, judges and practitioners in intellectual property, competition law and life science regulation, as well as pharmaceutical companies and regulators. To cut it short: This is an enjoyable, readable and interesting book containing thorough studies of “hot” legal issues in the pharma sector converging in an decisive era for pharmaceutical innovation. It ought to be found in any library that has reserved space for pharma-, IP- or competition law-related literature.
17.	Minssen, Timo (författare) Es bleibet dabei: Eine schwedische Stellungnahme zur europäischen Debatte über den absoluten Erzeugnisschutz bei der DNA Patentierung 2008 Ingår i: Klinische Forschung und Recht. ; :3 & 4, s. 93-112 Tidskriftsartikel (refereegranskat)abstract Abstract in German Der Beitrag beschäftigt sich mit dem kürzlich publizierten Abschlussgutachten des schwedischen „Komitees zum Patentschutz für biotechnologische Erfindungen“ (SOU 2008:20). Insbesondere wird die von dem staatlich eingesetzten Expertengremium abgegebene Empfehlung zur Beibehaltung des absoluten Erzeugnisschutzes für Gensequenzen, vor dem Hintergrund der verschiedenen nationalen Umsetzungen der Richtlinie 98/44/EG und unter spezieller Berücksichtigung der neueren Praxis des Europäischen Patentamts (EPA) analysiert und diskutiert.
18.	Minssen, Timo, et al. (författare) Global Genes, Local Concerns: Legal, Ethical and Scientific Challenges in International Biobanking 2019 Bok (övrigt vetenskapligt/konstnärligt)abstract Publication Date: 2019 ISBN: 978 1 78811 618 3 Extent: 304 pp.Global Genes, Local ConcernsLegal, Ethical, and Scientific Challenges in International BiobankingEdited by Timo Minssen, Janne R Herrmann and Jens SchovsboWith interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
19.	Minssen, Timo (författare) Meanwhile on the Other Side of the Pond: Why Biopharmaceutical Inventions that Were “Obvious to Try” Still Might Be Non-Obvious – Part I 2009 Ingår i: Chicago-Kent Journal of Intellectual Property (forthcoming). - 1559-9493. Tidskriftsartikel (refereegranskat)abstract Following the seminal US Supreme Court decision in KSR v. Teleflex, the law of (non)-obviousness has once more become a major topic in US patent law. Of crucial importance to the biopharmaceutical industry is in particular the following question: Under what circumstances should an invention that was "obvious to try" be considered to be obvious in fact under current US patent law? In that regard, a comparative study of the present "inventive step" assessments in Europe is very interesting indeed, as several biotech- and pharma-related decisions of the Technical Board of Appeals at the European Patent Office, as well as recent high profile judgments of national courts, not only provided new general guidelines on the European determination of “inventive step” but also addressed specific questions similar to those raised in KSR and In re Kubin. Considering recent European case law, the main goal of this bi-partite article is not to provide yet another detailed analysis of the post-KSR developments in the US. Instead the focus is placed on an examination of recent EPO (part I) and UK case law (part II) in order to finally discuss the findings in the light of the CAFC’s decision in In re Kubin. More specifically, this article aims to scrutinize specific aspects that are crucial for the biopharmaceutical industry. Special emphasis is placed on DNA-related technology and the “obvious to try with a reasonable expectation of success” issue.
20.	Minssen, Timo, et al. (författare) Myriad reloaded and ready for the next round? The Association for Molecular Pathology v USPTO., 689 F.3d 1303 (Fed. Cir. 2012) 2013 Ingår i: Queen Mary Journal of Intellectual Property. - : Edward Elgar Publishing. - 2045-9807 .- 2045-9815. ; 3:1, s. 70-80 Tidskriftsartikel (refereegranskat)abstract In March 2011 the Supreme Court issued its Prometheus opinion and granted certiorari, and reversed and remanded Myriad I for consideration in light of Prometheus. In August 2012 the Myriad II decision was issued. The panel in Myriad II repeated most of their separate Myriad I opinions. Myriad deja vu looked much like Myriad I with panel members agreeing that Prometheus did not control the composition of matter claims. The opinions differed on whether composition claims were to be analysed from a chemical, structural or carrier of information standpoint with respect to laws of nature. The rationales used such rhetorical metaphors as cleaving, baseball bats, magic microscopes, extracted kidneys, slabs of marble or marble statues, the Sistine Chapel, and whether cells were `transformed' molecules or 'carriers of information'. The differing evaluations of patent-eligibility and the cursory manner in which they addressed the Supreme Court's GVR mandate may well guarantee a return appearance before the Supreme Court or, at a minimum, en banc review by the Circuit.
21.	Minssen, Timo (författare) När anses en bioteknologisk uppfinning vara komplett och praktiskt användbar?- Del I (When does US patent law regard a biotechnological invention as complete and useful?) 2008 Ingår i: NIR: Nordiskt immateriellt rättsskydd. ; 77:3, s. 201-260 Tidskriftsartikel (refereegranskat)abstract För att vara patenterbar, måste varje uppfinning uppvisa ”utility” (användbarhet), som det kallas i USA, eller ”industrial application” (industriell tillämpbarhet), som det heter i Europa. Utöver ”nyhet”, ”uppfinningshöjd”, och kravet på en ”tillräcklig beskrivning av uppfinningen” i patentansökan utgör denna förutsättning både i USA och i Europa ett av de fyra grundläggande patenterbarhetskriterierna. I jämförelse med de andra grundkraven har dock den substantiella tröskeln som etablerades för ”industriell tillämpbarhet” och ”användbarhet” varit ganska låg. Denna förutsättning tolkas traditionellt mycket brett och i de flesta fall anses den vara uppfylld om den påstådda uppfinningen helt enkelt är kapabel att bli på något sätt använd i sinnevärlden, eller, som det föreskrivs i Europa, kan tillgodogöras industriellt. Därför åberopas bristen på ”industriell tillämpbarhet” eller ”användbarhet” väldigt sällan som grund för en invändning eller ogiltighetstalan mot beviljade patent eller patentansökningar. De få tvister som uppstår berör för det mesta bioteknologiska och kemiska uppfinningar. Här har den europeiska och den US-amerikanska rättsutvecklingen lett till en något mer restriktiv standard för ”användbarhet”/”industriellt tillämpbarhet”. Detta kan anses bero på att den typiska uppfinnaren inom dessa snabbt utvecklande teknologiområden, till följd av den internationella patentkonkurrensen, har en viss benägenhet att söka patent på nya syntetiserade substanser i ett tidigt skede, d.v.s. innan man exakt vet vilka funktioner dessa substanser utför och hur de kan användas för att uppnå ett bestämt, praktiskt fungerande resultat. Inom den genrelaterade teknologin omfattar sådana substanser ofta isolerade DNA- och RNA-sekvenser, samt proteiner som dessa kodar för. Även ansökningar för isolerade partiella DNA-sekvenser, som motsvarar ett litet sekvensavsnitt av en naturlig förekommande gen, lämnas in. Oavsett de vetenskapliga framsteg som har förenklat identifikation och isolering av intressanta sekvenser, kan det dock fortfarande förefalla oklart i exakt vilka biologiska processer dessa (partiella) sekvenser är involverade eller vilken roll de spelar i sådana processer. Detta beror på att DNA/RNA-sekvenser och deras proteinprodukter, till skillnad från många andra substanser, ofta uppfyller flera funktioner vid helt olika tekniska positioner. En DNA-sekvens kan till exempel koda för en eller flera proteiner. Den kan dessutom interagera med andra DNA-sekvenser som kan vara funktionellt beroende av varandra. Det är därför föga förvånansvärt att forskare inte alltid har exakt kunskap om vilka funktioner och potentiella applikationer av RNA/DNA-sekvenser och deras fragment har vid tidpunkten för upptäckten. Emellertid kan dessa sekvenser på grund av deras (potentiella) funktioner visa sig vara mycket värdefulla som undersökningsobjekt och/eller forskningssubjekt (= forskningsverktyg). Följaktligen har många forskare från både den privata och offentliga sektorn försökt kommersialisera och patentera sådana sekvenser. Detta ledde, framförallt i samband med produktpatent och deras potentiell breda skyddsomfång, till intensiva patenträttsliga diskussioner. Samtidigt visar flera nypublicerade utredningar att patentansökningarna som omfattar produktkrav på DNA-sekvenser stadigt minskar och att forskningsinsatserna och patentansökningarna i allt större omfattning fokuserar på de (potentiella) användningarna av DNA-sekvenser och deras proteinprodukter. Mycket talar för att patentsystemet både stimulerar och reflekterar denna utveckling. Å ena sidan reflekterar patentreglerna den immanenta dynamiken av vetenskapliga framsteg och tar (dock i efterhand) ställning till alltmer sofistikerade (användnings )områden. Å andra sidan främjar och styr patenträtten just denna utveckling. Till exempel leder publikationen av DNA-sekvenser till att det blir allt svårare för DNA-relaterade uppfinningar, och det gäller i synnerhet breda produktkrav, att uppfylla nyhetskraven. Det har dessutom blivit betydligt svårare för många DNA- och proteinrelaterade uppfinningar att möta kravet på uppfinningshöjd, eftersom den europeiska granskningen, och numera (återigen) den US-amerikanska prövningen av ”nonobviousness”, tar särskild hänsyn till en ”reasonable expectation of success” i samband med etablerade isolations- och annotationsmetoder. Likaså verkar kraven på en ”tillräcklig beskrivning” och en ”industriell tillämpning” ha skärpts i båda patentsystemen. De etablerade trösklarna förefaller ha blivit alltmer väsentliga för patenterbarheten av bioteknologiska uppfinningar som sådan och för att bestämma när en uppfinning ska anses vara komplett. Den följande undersökningen kommer att belysa och diskutera den senare utvecklingen rörande tolkningen av ”industriell tillämpbarhet” och ”utility” för gen- och proteinrelaterade uppfinningar i USA (del I) och Europa (del II). Avsnitt 1 inleds med en beskrivning av den berörda teknologin. Det kommer dock att vara en starkt förenklad sammanfattning som begränsas till de teknologiska basfakta som har betydelse för den specifika juridiska diskussionen. I ljuset av denna grundläggande bakgrundsinformation ska avsnitt 2 sedan förtydliga de centrala patenträttsliga problemställningar som står i fokus för undersökningen. Därefter ska avsnitt 3 utförligt granska den långvariga utvecklingen av ”utility”- standarden i USA. För att kunna förstå den traditionella debatten och den senare utvecklingen kommer det att vara nödvändig att ge en historisk överblick som omfattar grundläggande ”utility”-avgöranden från 1800-talet och en grundläggande dom av Förenta Staternas högsta domstol (US Supreme Court) från 1960-talet. Fokus kommer dock att ligga på nyare kemiska och bioteknologiska rättsfall av den behöriga appellationsdomstolen (Court of Appeal of the Federal Circuit, CAFC), samt på senare beslut av den amerikanska patentmyndigheten (USPTO) enligt de gällande examinationsriktlinjerna. Den europeiska tolkningen av kravet på ”industriell tillämpning” kommer att diskuteras i avsnitt 4. Analysen kommer att koncentrera sig till relevanta föreskrifter i den Europeiska Patentkonventionen (EPC), granskningspraxis vid den Europeiska Patentmyndigheten (EPO), såväl som på nyare avgöranden av EPO’s tekniska besvärskammare (TBA). Dessutom behandlas tolkningen av några tillämpningsbestämmelser i EPC (Implementing Regulations), som till stor del motsvarar särskilda stipulationer i EG:s bioteknikdirektiv (98/44/EG). En utförlig diskussion av ytterligare frågor som uppstår i samband med de nationella genomförandena av bioteknikdirektivet, som till exempel den kända debatten kring användningsbegränsningen av produktskyddet för vissa (mänskliga) DNA-sekvenser, eller specifika nationella rättsfall rörande kravet på ”industriell tillämpning”, faller dock utanför ramarna av denna artikel och kommer endast att behandlas summariskt. Hela undersökningen kommer sedan att sammanfattas och jämföras i avsnitt 5 som kommer att bli utgångspunkten för mera generella, avslutande kommentarer i avsnitt 6.
22.	Minssen, Timo (författare) När anses en bioteknologisk uppfinning vara komplett och praktiskt användbar? - Del II (When does European patent law regard a biotechnological invention as complete and having an industrial application?) 2008 Ingår i: NIR: Nordiskt immateriellt rättsskydd. ; 77:4, s. 339-387 Tidskriftsartikel (refereegranskat)abstract Denna artikel utgör den andra delen av två uppsatser som behandlar det patenträttsliga kravet att en patentsökt teknologi måste vara praktiskt användbar. Fokus ligger på gen- och proteinrelaterade uppfinningar. En tredje uppsats kommer att undersöka kravet på en tillräcklig beskrivning av dessa teknologier. Medan den första delen analyserade den US-amerikanska tolkningen av det särskilda ”utility”-kriteriet, granskar del II senare praxis från den Europeiska Patentmyndigheten rörande kravet på den ”industriella användbarheten”. Eftersom del I och II är direkt förknippade med varandra, följer den kommande undersökningen samma fokusering och struktur som skildrades i de inledande avsnitten i del I. Således börjar denna artikel med avsnitt 4. Här ges först en redogörelse för det patenträttsliga regelverket som måste beaktas i samband med bedömningen av kravet på den industriella användbarheten. Därefter granskas senare avgöranden av EPO:s tekniska besvärskammare. Denna analys torde sedan göra det möjligt att sammanfatta principerna som kan härledas av EPO:s rättspraxis. Det kommer även att beskrivas hur dessa principer numera påverkar nationella avgöranden. Detta ska utgöra underlag för att kunna jämföra och diskutera den aktuella utvecklingen i USA och Europa i avsnitt 5. Undersökningen avslutas med generella synpunkter i avsnitt 6.
23.	Minssen, Timo, et al. (författare) Obesvarade frågor rörande patent på datorrelaterade uppfinningar och affärsmetoder? (Unanswered questions concerning patents on computer related inventions and business methods?) 2007 Ingår i: NIR: Nordiskt immateriellt rättsskydd. ; :3, s. 220-245 Tidskriftsartikel (refereegranskat)abstract Den 27 oktober 2006 meddelade den engelska appellationsdomstolen (UK Court of Appeal) ett vägledande avgörande i de s.k. Aerotel/Macrossan-avgörandena. Domen relaterade till två mål som berörde tolkningen av det patenterbara området enligt sektion 1 (2) i den engelska patentlagen (Patent Act 1977), vilken motsvarar art. 52 i den Europeiska Patentkonventionen (EPC). Det första målet gällde ett israeliskt företag, Aerotel, som ägde ett engelskt patent (Patent No. 2,171,877) på ett s.k. förbetalt telefonsystem och en metod för att använda systemet. Systemet bestod av olika fysiska komponenter som gjorde det möjligt för användaren att ringa från – t.ex. en offentlig telefon – till en växel som verifierade aktuella krediter. Medan alla komponenter som användes tillhörde känd teknik, var själva kombinationen i systemet i sin helhet ny. Aerotel stämde Telco och andra för patentintrång, eftersom de använde liknande system. Telco hävdade att användningen av systemet enbart utgjorde en affärsmetod och yrkade därför att patentet skulle ogiltigförklaras. I februari 2005 påbörjades målet först vid Patents County Court, men på grund av fallets komplexitet och de stora summor som var involverade, hänsköt domaren fallet snabbt till en högre domstol. Där (det var fortfarande första instans – fast i högre domstol) biföll sedan Mr. Justice Lewison (High Court) Telcos yrkande. Lewison J. påpekade att eftersom den tekniska utrustningen som användes i Aerotels system var tidigare känd, borde användningen av den tekniska utrustningen vara ny för att kunna vara patenterbar. Lewison J. ansåg dock att användningen av Aerotels system inte tillhörde det patenterbara området, eftersom utrustningen användes endast på ett sätt som utgjorde en affärsmetod. Aerotel överklagade beslutet till den engelska appellationsdomstolen (UK Court of Appeal). Det andra målet tog en annan väg. Neal William Macrossan ansökte om ett patent på ett datorbaserat system för att utforma formulär vid registrering av företag. Det engelska patentverket (UK Patent Office, nu: UK Intellectual Property Office) hade avslagit Mr. Macrossans ansökan under hänvisning till att uppfinningen grundades (1) på en metod för intellektuell verksamhet, (2) en affärsverksamhet och (3) ett datorprogram. Macrossanöverklagade beslutet till High Court, där beslutet bekräftades i väsentliga delar av Mr. Justice Mann. Även detta avgörande överklagades till UK Court of Appeal. I sina skäl inledde Lord Justice Jacob med en noggrann genomgång av förhållandet mellan sektion 1 (2) av Patent Acts 1977 och art. 52 EPC. Även om den engelska patentlagen innehåller små formuleringsskillnader i jämförelse med EPC, framhöll han att den skulle tjäna samma syfte. L. J. Jacob var tydligen angelägen om att basera domen på själva EPC och påpekade bl.a.: ”European patent judges ought, so far as they can, try to be consistent with one another, particularly in relation to the interpretation of national laws implementing provisions of the EPC.” Sedan fortsatte han med en grundlig analys av engelska, amerikanska och EPOavgöranden samt vissa franska och tyska rättsfall. Därutöver undersöktes även bestämmelser i TRIPS, EPO:s riktlinjer (Guidelines) och förarbeten till den Europeiska Patentkonventionen för att bestämma det patenterbara området. L. J. Jacob ansåg att den mer toleranta synen på datorrelaterade uppfinningar och affärsmetoder som har kommit till uttryck i amerikansk praxis inte var till mycken hjälp vid tolkningen av art. 52 EPC.8 Analysen ledde först och främst till frågor angående den korrekta tolkningen av EPO:s praxis. L. J. Jacob fann att de senaste EPO-avgörandena rörande mjukvarupatent inte stod i överensstämmelse med äldre praxis och att det fanns ett stort behov av att klargöra vilka principer som skall tillämpas vid en tolkning av art. 52 EPC.9 Han uttryckte sig dock försiktigt när han förklarade: ”It is formally no business of ours to define questions to be asked of an Enlarged Board of Appeal. What we say now is only put forward in case the President of the EPO finds it helpful. If he thinks it pointless or arrogant of us to go this far, he is of course entirely free to ignore all we say. Nonetheless in the hope that there is a spirit of co-operation between national courts and the EPO we ventured to ask the parties what questions might be posed by the President of an Enlarged Board pursuant to Art. 112. As we have said the British Comptroller of Patents has encouraged us in this course.” Till sist tog L. J. Jacob det ovanliga steget att identifiera tre frågeställningar i förhoppningen att EPO:s president skulle lägga fram dem till EPO:s stora besvärskammare enligt art. 112 EPC. Följande frågor föreslogs: ”(1) What is the correct approach to adopt in determining whether an invention relates to subject-matter that is excluded under Article 52? (2) How should those elements of a claim that relate to excluded subject-matter be treated when assessing whether an invention is novel and inventive under Articles 54 and 56? And (3) More specifically: (a) Is an operative computer program loaded on to a medium such as a chip or hard drive of a computer excluded by Article 52(2) unless it produces a “technical effect”? (b) What are the key characteristics of the method of doing business exclusion?” Innan dessa frågor blev besvarade, vägrade domstolen att följa senaste rättspraxis inom EPO och avgjorde fallet slutligen under hänvisning till principer som utvecklats i tidigare brittiska rättsfall. Svaret från EPO kom först den 22 februari 2007, när EPO:s president, Professor Alain Pompidou, i ett brev till L. J. Jacob meddelade att frågorna inte skulle hänskjutas till den stora besvärskammaren enligt art. 112 (1) (b).12 Beslutet har lett till stor besvikelse och diskussioner inte endast bland IP-tjänstemän och patentadvokater, utan även hos motståndare till patent på datorrelaterade uppfinningar. Avsnitt 1 av denna artikel avser att beskriva och kommentera den engelska appellationsdomstolens analys av EPO:s rättpraxis som ledde till ovan nämnda frågeställningar. Sedan skall i avsnitt 2 i all korthet redovisas hur appelationsdomstolen dömde i Aerotel/Macrossan- avgörandena i ljuset av tidigare nationell brittisk praxis och hur den slutligen nådde fram till beslutet genom att använda sig av ett nytt fyrstegstest. I avsnitt 3 skall Alain Pompidous brevsvar analyseras och kommenteras. Särskild uppmärksamhet kommer att riktas mot de rättsliga grunderna för beslutet, men vi skall även diskutera vilka skäl som kan tänkas ligga bakom beslutet och frågorna. Slutligen skall konsekvensfrågor och den tänkbara rättsliga utvecklingen behandlas.
24.	Minssen, Timo (författare) Patenting human DNA sequences in Europe and the US - A comparative analysis of patentability requirements for nucleic acid sequences with special emphasis on novelty and inventive step 2005 Licentiatavhandling (övrigt vetenskapligt/konstnärligt)abstract 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.
25.	Minssen, Timo (författare) “Restoring the balance: The patentability of DNA-related technology in the US and Europe” 2009 Ingår i: Nyheter/elektronisk nyhetsbrev. ; , s. 1-10 Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract Scholarship speech prepared for the AWAPATENT Foundation for the Promotion of Scientific Research in the Area of Intellectual Property Rights, Operaterassen Stockholm, Jan. 27th, 2009
26.	Minssen, Timo, et al. (författare) Rules and Tools in the Battle against Superbugs - A call for integrated strategies and enhanced international collaboration to promote antimicrobial drug development 2020 Ingår i: Infectious Diseases in the New Millennium: Legal and Ethical Challenges. - Cham : Springer International Publishing. - 9783030398187 - 9783030398194 ; , s. 111-136 Bokkapitel (refereegranskat)abstract The lack of treatments during the recent Ebola and Zika outbreaks dramatically exposed the vulnerability of the global health system and the dire consequences thereof. But even where therapies against infectious diseases had been available, an additional threat has gained world-wide attention: antimicrobial resistance (AMR). A growing number of microbial organisms are becoming resistant to available drugs with increasingly diverse risks for a rapid global spreading of infections. Unfortunately, the traditional IP based innovation system and regulatory frameworks do not provide sufficient incentives to invest in the development of new antimicrobials. Hence, there are few new treatments in the pipeline to replace a growing number of ineffective drugs or problematic drug combinations. Repairing these broken economic incentives, improving access to and sustaining the effectiveness of antimicrobials is among the most important challenges in the health and life sciences. In this paper we emphasize that this goal can only be achieved through integrated strategies and a better global coordination of interdisciplinary multi-sector responses.
27.	Minssen, Timo, et al. (författare) Separating sheep from goats : A European view on the patent eligibility of biomedical diagnostic methods 2016 Ingår i: Journal of Law and the Biosciences. - : Oxford University Press (OUP). - 2053-9711. ; 3:2, s. 365-372 Tidskriftsartikel (refereegranskat)
28.	Minssen, Timo, et al. (författare) Social, cultural and economic aspects of antimicrobial resistance 2020 Ingår i: Bulletin of the World Health Organization. - : WORLD HEALTH ORGANIZATION. - 0042-9686 .- 1564-0604. ; 98:12, s. 823-824 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
29.	Minssen, Timo, et al. (författare) Standing on shaky ground: US patent-eligibility of isolated DNA and genetic diagnostics after AMP v USPTO â€“ Part I 2011 Ingår i: Queen Mary Journal of Intellectual Property. - : Edward Elgar Publishing. - 2045-9815 .- 2045-9807. ; 1:3, s. 223-247 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
30.	Minssen, Timo, et al. (författare) Standing on shaky ground: US patent-eligibility of isolated DNA and genetic diagnostics after AMP v USPTO--Part I 2011 Ingår i: Queen Mary Journal of Intellectual Property. - 2045-9807. ; :3, s. 223-247 Tidskriftsartikel (refereegranskat)
31.	Minssen, Timo, et al. (författare) Standing on shaky ground: US patent-eligibility of isolated DNA and genetic diagnostics after AMP v USPTO--Part II1 2012 Ingår i: Queen Mary Journal of Intellectual Property. - 2045-9807. ; :2, s. 136-157 Tidskriftsartikel (refereegranskat)
32.	Minssen, Timo, et al. (författare) Standing on shaky ground: US patent-eligibility of isolated DNA and genetic diagnostics after AMP v USPTO - Part IV 2013 Ingår i: Queen Mary Journal of Intellectual Property. - : Edward Elgar Publishing. - 2045-9807 .- 2045-9815. ; 3:2, s. 118-144 Tidskriftsartikel (refereegranskat)abstract As discussed in the previous issues of QMJIP, the Federal Circuit's decisions in Myriad I-2 and II3 appear to provide considerable prospects for patentees, as clever claim drafting may still help to avoid most patent-eligibility traps set by the much debated US Supreme Court decision in Prometheus.(4) Yet, the split opinions also contain elusive reasoning by each of the three judges. The questions left open by Prometheus and the remaining split at the Federal Circuit with regard to inter alia DNA-related product claims provide excellent fodder for another US Supreme Court review with potentially broad implications for biotech patents. Acknowledging the criticism of excessively broad upstream patent claims and referring briefly to corresponding European debates, Part IV of this series finally discusses the recent developments from a broader innovation-policy perspective. Highlighting the mitigating effects of additional factors, such as higher thresholds for other patentability criteria, scientific advances, post-grant mechanisms and the dynamic qualities of biomedical innovation, the authors note that overly static eligibility doctrines entail considerable risks for technological progress. While it is essential that the Supreme Court further clarifies its principles, the authors urge it not to categorically close the 'patent-eligibility door' to important emerging technologies.
33.	Minssen, Timo, et al. (författare) The Evolution of the CJEU’s Case Law on Stem Cell Patents : Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation 2015 Ingår i: NIR: Nordiskt immateriellt rättsskydd. - 0027-6723. ; 2015:5, s. 493-503 Tidskriftsartikel (refereegranskat)abstract In its judgment in International Stem Cell Corporation v Comptroller General of Patents (ISCO) rendered on 18th December 2014, the CJEU qualified its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ovums stimulated by parthenogenesis. The Court held that in order to constitute a ‘human embryo’ and thus to be unpatentable under the EU Biotechnology Directive, the stimulated ovum must have the “inherent capacity to develop into a human being”. In absence of further genetic manipulation this would typically exclude parthenotes, Hence the judgment establishes a significant limitation of the extremely broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo’ since they were considered to be “capable of commencing the process of development of a human being”. The ISCO decision is to be welcomed since it provides a reasonable and ethically justifiable leeway for patenting. This offers much needed support to the commercial viability of cell therapy research in Europe. Yet, ISCO only applies to certain hESC cells, and further clarifications would be helpful with regard to other non-totipotent hESCs.
34.	Minssen, Timo, et al. (författare) The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology : The grand finale of a juicy patents tale? 2015 Ingår i: Biotechnology Law Report. - : Mary Ann Liebert Inc. - 0730-031X .- 1557-8704. ; 34:3, s. 81-98 Tidskriftsartikel (refereegranskat)abstract On 25 March 2015, the Enlarged Board of Appeal of the European Patent Office (EBA) finally delivered its’ much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”). The EBA affirmed that products, namely plants or parts thereof, obtained by essentially biological processes are – unlike individual plant varieties – principally patentable under the European Patent Convention (EPC). This decision leaves considerable leeway for patenting novel and inventive plants and products thereof, which have been produced by “conventional” methods including breeding steps. The EBA has also clarified that this applies irrespective of if such claims are formulated in a product-by-process format or as a per se product . Moreover, the combined effect of Broccoli & Tomato I & II opens new opportunities for patenting GMOs - provided that all other patent criteria are also met. This generally appears to be "good news" for innovative plant breeders and agrochemical companies. However, caveat needs to be added: Major industry players had challenged the relevant patent-claims and the EBA's decision(s) remain very controversial. It is, for example, very uncertain how the CJEU would decide if confronted with similar issues in the context of national implementations of the Biotech Directive, which have taken a very different view than the EBA. Moreover, the fierce European opposition against genetically modified organisms (GMOs) and Synthetic Biology remains a major challenge to the industry, research and innovation in an increasingly significant area of science and debate.Post scriptum (!) : After completion of this paper, the European Commission expressed that it did not share the opinion of the EPO’s Enlarged Board of Appeal (cf. the Interpretative Notice from November 2016). Like several EU member states, such as France, Germany, Italy and Netherlands, the Commission found that under the EU Biotech Directive products obtained by essentially biological processes should not receive patent protection. This intervention by the Commission, the divergences between the interpretation of the EPC and the Biotech Directive, and the need for legal certainty and harmonization, led the EPO to stay ex officio all the proceedings in which the decision depended entirely on the patentability of a plant or animal obtained by an essentially biological process. Then, on June 29, 2017, the Administrative Council of the EPO decided to amend Rules 27 and 28 of the Implementing Regulation. According to these amendments products (animals or plants) obtained exclusively from essentially biological process are now effectively excluded from patentability. Notwithstanding that this contradicts the earlier decisions by the Enlarged Board of Appeal, these amendments apply to European patent applications filed on or after July 1, 2017, as well as to European patent applications and European patents pending at that time.This paper has also been published as a working paper on SSRN, see: Minssen, Timo and Nordberg, A., The Impact of Broccoli II & Tomatoes II on European Patents in Conventional Breeding, GMO's and Synthetic Biology: The Grand Finale of a Juicy Patents Tale? (May 19, 2015). Univ. of Copenhagen Dept. of Economics Discussion. Available at SSRN: http://ssrn.com/abstract=2607865 or http://dx.doi.org/10.2139/ssrn.2607865
35.	Minssen, Timo, et al. (författare) The Industrial Application Requirement for Biotech Inventions in Light of Recent EPO and UK Case Law: A Plausible Approach or a Mere "Hunting Licence"? 2016 Ingår i: European Intellectual Property Law. - 978 1 78471 466 6 ; , s. 164-178 Bokkapitel (övrigt vetenskapligt/konstnärligt)
36.	Minssen, Timo, et al. (författare) The industrial application requirement for biotech inventions in light of recent EPO & UK case law:: A plausible "hunting license"?" 2012 Ingår i: European Intellectual Property Review. - 0142-0461. ; 34:10, s. 689-703 Tidskriftsartikel (refereegranskat)abstract In this study we illuminate and discuss the most recent developments in respect of the interpretation of the “industrial application” requirement with respect to gene and protein related inventions in Europe. The analysis will focus on the relevant provisions of the EPC and decisional practice from the European Patent Organisation (“EPO”), particularly decisions from the Technical Board of Appeal 3.3.08 (the “Board”). To get a glimpse of the national dimension, we will also look at the first patent judgment from the "new" UK Supreme Court, i.e. the groundbreaking decision in HGS v Eli Lilly, In the final discussion, we will elaborate on two issues in particular; (i) determine which types of qualities an invention should have in order to meet the industrial application requirement in the first place; and (ii) what type of evidence an applicant is expected to present in respect of (potential) applications at the date of filing to demonstrate a credible – or to use the terminology of the EPO – a plausible industrial application. In the final section of the article we shall also discuss various policy considerations relevant for the biotech industry and briefly refer to corresponding developments in the US. Before going into the decisional practice of the EPO, we start out by providing a brief overview of the applicable regulatory framework. Even though the industrial application requirement is relatively straightforward on the face of the EPC, we believe that it makes sense to provide a more in-depth background, and maybe repetition for some readers, as to why the industrial application requirement raises particular concerns and questions in respect of biotech inventions.
37.	Minssen, Timo, et al. (författare) The ”opt out” and “opt in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios 2014 Ingår i: NIR: Nordiskt immateriellt rättsskydd. - 0027-6723. ; 83:4, s. 340-357 Tidskriftsartikel (refereegranskat)abstract Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.
38.	Minssen, Timo (författare) The US Examination of Nonobviousness After KSR v. Teleflex with Special Emphasis on DNA-Related Inventions 2008 Ingår i: IIC - International Review of Industrial Property and Copyright Law. - 0018-9855. ; 39:8, s. 886-916 Tidskriftsartikel (refereegranskat)abstract The year 2007 was an extraordinary year for the U.S. patent system. In a response to far-reaching proposals for significant changes in substantive and procedural patent law, the House of Representatives adopted the 2007 Patent Reform Act in September, heating up the debate over crucial issues that are now being discussed in the U.S. Senate.(1) Moreover, the U.S. Supreme Court also turned its attention to patent issues, delivering three major patent judgments(2) and granting certiorari to hear another case.(3) Probably the most influential of the 2007 judgments was the decision in KSR v. Teleflex.(4) More than forty years after the landmark Supreme Court decision in Grabam v. Jobn Deere(5) developed the basic test for obviousness, the principles that were established in KSR will most likely remain the leading interpretation of the Graham standard for the following years. This article discusses the actual and potential impact of the KSR decision on the assessment of nonobviousness in the U.S. Special emphasis will be given to DNA-related inventions.
39.	Minssen, Timo, et al. (författare) US Patent Eligibility in the Wake of Bilski v Kappos: "Business as Usual" in an Age of New Technologies? 2011 Ingår i: Biotechnology Law Report. - : Mary Ann Liebert Inc. - 0730-031X .- 1557-8704. ; 30:1, s. 3-56 Tidskriftsartikel (refereegranskat)abstract THIS ARTICLE DISCUSSES the recent US Supreme Court decision in Bilski v Kappos. Although specifically applicable to the patentability of business methods, this seminal decision has consequences for determining patentable subject matter in various technologies. Focusing ultimately on Bilski's implications for the patentability of biopharmaceutical inventions, this paper first provides a broad chronological overview of the complex history of the judicial debate over patent eligibility under US law. It is followed by a brief discussion of the outcome and impact of the more restrictive Federal Circuit decision in In re Bilski, now abrogated by the Supreme Court. Here, a majority of the Federal Circuit judges misinterpreted Supreme Court precedent to hold that the "machine-or-transformation" (MOT) test was the universal and exclusive means for deciding patent eligibility for all process claims, implicitly including claims on biotechnological processes. Next, we carefully describe and analyze the Supreme Court decision rejecting this rigid application of the MOT test and allowing more flexibility in the eligibility assessment. The analysis includes general considerations, as well as a detailed discussion of the decision's potential implications for biotechnology inventions. In that context, we also refer to the most recent post-Bilski developments at the US Patent and Trademark Office (PTO) and in the US courts. Acknowledging the criticism concerning overly broad patent claims and referring briefly to parallel developments in Europe, this paper finally highlights the effects of heightened thresholds for other patentability requirements. Considering those developments and realizing that it appears impossible to achieve static legal certainty in high-technology patenting without risking technological progress, the authors generally welcome the Supreme Court decision. Yet it is also recognized that crucial questions remain unresolved and that lower courts are now tasked with articulating a reasonably coherent eligibility doctrine with identifiable and plausible principles.
40.	Minssen, Timo, et al. (författare) Zur Zulässigkeit von Feststellungsklagen im US Lizensrecht nach den Entscheidungen in MedImmune und SanDisk 2008 Ingår i: GRUR International (Gewerblicher Rechtsschutz und Urheberrecht). Tidskriftsartikel (refereegranskat)abstract Abstract in German Die bereits im Januar 2007 ergangene MedImmune-Entscheidung des U.S. Supreme Court (Supreme Court) und der im März 2007 vom Court of Appeals for the Federal Circuit (CAFC) entschiedene SanDisk-Fall haben in den USA für Aufregung gesorgt. In MedImmune hatte der Supreme Court entschieden, dass entgegen der bisher ständigen Rechtsprechung des CAFC auch aus einem intakten Lizenzvertragsverhältnis heraus Klage auf Feststellung der Nichtigkeit oder Undurchsetzbarkeit eines Patents erhoben werden kann. Die schon damit gesenkte Schwelle der Zulässigkeit von Feststellungsklagen wurde in der Folge vom CAFC in SanDisk noch weiter herabgesetzt. Der CAFC entschied dort, dass unter Umständen sogar schon im Vorfeld eines Lizenzvertrags die Erhebung einer Feststellungsklage zulässig sei. Die durch diese Rechtsentwicklung scheinbar drastisch gesenkte Zulässigkeitsschwelle für Feststellungsklagen wurde von Praktikern in ersten Stellungnahmen zumeist kritisch bewertet. Es wurden negative Auswirkungen auf das Patentlizenzsystem befürchtet und insbesondere eine Flut von Feststellungsklagen erwartet. Eine bedenkliche einseitige Besserstellung des Lizenznehmers ohne weiteren Schutz des Patentinhabers war zu befürchten. Inwiefern diese Sorgen vor dem Hintergrund der genannten Entscheidungen sowie der aktuelleren Rechtsprechung des CAFC gerechtfertigt sind, soll in diesem Artikel näher beleuchtet werden. Zum allgemeinen Verständnis werden zunächst die Rechtsgrundlage der Feststellungsklage und die bisherige Rechtsprechung des CAFC dazu dargestellt (I.). Sodann werden die Entscheidungen MedImmune (II.) und SanDisk (III.) aufbereitet. Vor dem Hintergrund der neuesten Rechtsprechung des CAFC soll sodann analysiert werden, inwieweit die dargestellten Befürchtungen und die Kritik an MedImmune und SanDisk begründet sind (IV.), bevor Lösungsansätze für tatsächlich bestehende Probleme aufgezeigt werden sollen (V.). Der Artikel endet mit einer zusammenfassenden Bewertung der Rechtsprechung und aktuellen Rechtslage (VI.).
41.	Nilsson, David, et al. (författare) What intent, whose intent and to what extent?: The Knowledge requirement in indirect patent infringement 2012 Ingår i: Journal of Intellectual Property Law & Practice. - : Oxford University Press (OUP). - 1747-1532 .- 1747-1540. ; 7:6, s. 437-448 Tidskriftsartikel (refereegranskat)abstract In Germany, the UK, the US and the Scandinavian countries there is a distinct difference between direct and indirect (also referred to as contributory) statutory patent infringement. The patent laws that regulate incursions on the exclusive rights of patent holders in these jurisdictions generally distinguish between direct patent infringement on the one hand, which is based on wholly objective criteria, and indirect patent infringement on the other, which in addition to objective criteria also requires the establishment of subjective conditions i.e. some form of intent on the part of the infringer. The latter is commonly referred to as the knowledge requirement. The basic idea behind indirect infringement is that the patentee can already start legal action before his patent is actually infringed. It is thus potentially a powerful tool for patentees. In respect of the UK, it has been said that the indirect infringement rules extend the patent proprietor’s monopoly to cover the supply of means, relating to an essential element, for putting the invention into effect. Similarly, in Germany the instrument of indirect patent infringement has been described as containing the expansion of the protection of process, use and combination patents such that even offering or supplying means that enable the person thus supplied to make unlawful use of the patented invention is prohibited. Moreover, in i.a. Germany and the UK someone can commit indirect patent infringement without there even being a direct infringement. Indirect patent infringement claims can also result in substantial damages awards. In a case against Microsoft, for instance, the software firm i4i Ltd managed to obtain a damages award of approximately USD 290 million with respect to an indirect patent infringement. It thus seems that indirect patent infringement is a potent tool at the disposal of patentees, which can be used to to stop a problem before it becomes a problem. At the same time, there are many reasons why an indirect infringement claim may fail. A prominent commentator in the field of patent law in Germany submits that indirect patent infringement under German law is not easy to understand and its application causes problems in practice. One of the reasons why an indirect patent infringement could fail is because the knowledge requirement in an indirect patent infringement claim is not fulfilled. Why this is so, and also under which circumstances the requirement is fulfilled, shall be the focus of this article. In short, we will look at how the knowledge requirement in indirect patent infringement is construed in the US, the UK, Germany and the Scandinavian countries. The impetus for the article came from two fairly recent judgments rendered by the US Supreme Court and the England and Wales Court of Appeals addressing indirect patent infringement and the knowledge requirement in particular. We will use these cases as a backdrop to analyse the knowledge requirement in these jurisdictions. We will then briefly look at the decisional practice of the German Federal Supreme Court, by virtue of the pioneering role of this Court in respect of adjudicating indirect patent infringement cases in the EU. The choice of focusing on the Scandinavian countries is mainly due to the authors being domiciled in Sweden and Denmark. Also, we shall establish that the state of case law in Scandinavia on the topic of indirect patent infringement is fairly nascent, and argue that this provides for an ample opportunity for cross-fertilization in European cross-border jurisprudence. Each jurisdictional section will be concluded by a comment. In the end, we shall attempt at concluding the article with some comparative remarks.
42.	Nordberg, Ana, et al. (författare) A “ray of hope” for European stem cell patents or “out of the smog into the fog”? 2016 Ingår i: IIC - International Review of Intellectual Property and Competition Law. - : Springer Science and Business Media LLC. - 0018-9855 .- 2195-0237. ; 47:2, s. 138-177 Tidskriftsartikel (refereegranskat)abstract In Case C-364/13 International Stem Cell Corporation (ISCC) v. Comptroller General of Patents (December 18th, 2014), the Court of Justice of the European Union (CJEU) distinguished its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilized human ova stimulated by parthenogenesis. The Court found that in order to be considered a ‘human embryo’- and thus to be unpatentable under the EU Biotechnology Directive - the stimulated ovum must have the “inherent capacity to develop into a human being”. This permits the patentability of innovative pluripotent parthenotes and their applications. Yet, ISCC also leaves considerable discretion to national courts and the full impact of the decision still depends on national implementations. Moreover, ISCC only applies to very specific human embryonic stem cells (hESCs) and lacks further clarifications concerning other non-totipotent hESCs, such as stem cells created through somatic cell nuclear transfer. Considering the significance of Brüstle and ISCC for regenerative medicine and cellular therapy, the persisting legal uncertainty is unfortunate. Irrespective of these flaws, however, ISCC opened at least doors that were thought to be closed and thereby reinvigorated crucial debates. Thus, it might have the “inherent capacity” of developing into a reasonable doctrine on stem cell patenting. Paradoxically, the patentability of isolated embryonic stem cells is now less certain in the US.
43.	Nordberg, Ana, et al. (författare) A “ray of hope” for European stem cell patents or “out of the smog into the fog”?: The CJEU decision in C-364/13 and how it compares to recent US developments.(under review) 2015 Ingår i: Biotechnology Law Report. - 0730-031X. Tidskriftsartikel (refereegranskat)
44.	Nordberg, Ana, et al. (författare) Cutting Edges and Weaving Threads in the Gene Editing (Я)evolution : Reconciling scientific progress with Legal, Ethical, & Social concerns 2018 Ingår i: Journal of Law and the Biosciences. - : Oxford University Press (OUP). - 2053-9711. ; 5:1, s. 35-83 Tidskriftsartikel (refereegranskat)abstract Gene editing technologies, such as CRISPR/Cas9, hold great promises for the advancement of science and technology. These foundational technologies enable to modify the genetic structure of living organisms with unprecedented precision. Potential applications include both plant, animal and human genetic interventions. In plant biology, gene editing introduces more precise, target- and time-efficient tools to engineer plants for multipurpose uses such as crops, medicines or biofuel. In humans, the technologies offers hope in the fight against severe genetic diseases and many other illnesses. Yet, before society can harness such potential it is imperative to not only consider the enormous benefits of these technologies, but also their problematic aspects from a broader societal and value-based perspective. In this paper an interdisciplinary group of lawyers, biologists, philosophers, social scientists, and physicists analyses and discusses the most problematic legal, ethical and societal implications of gene editing.
45.	Nordberg, Ana, et al. (författare) Implementation of the Trade Secrets Directive into National Law: Portugal and Spain 2020 Ingår i: The Harmonization and Protection of Trade Secrets in the EU : An Appraisal of the EU Directive - An Appraisal of the EU Directive. - : Edward Elgar Publishing. - 978 1 78897 333 5 ; , s. 125-150 Bokkapitel (refereegranskat)abstract The protection of trade secrets in Portugal and Spain has been derived from general legal principles (of Civil Law, Penal Law and Unfair Marketing Law). This chapter on implementation of the Trade Secrets Directive (TS Directive) in Portugal and Spain presents the traditional views and positions and the implementation of the TS Directive into the respective national legal orders.In Portugal, implementation of the TS Directive was part of a broader intellectual property (IP) legislative reform package. This reform entailed the approval of a new Industrial Property Code transposing both the TS Directive and the new Trade Mark Directive; and that also modified procedural norms relating to the competence of the IP court and new rules on IP arbitration. In Spain, implementation has been made by specific TS legislation – The Law on Trade Secrets, approved in December 2019. The chapter contains an introduction (section 1), and overview of the pre-directive frameworks (Section 2), the post-directive national TS legislation (section 3), expected post-implementation legal developments (section 4); and the main conclusions of our analysis.
46.	Nordberg, Ana, et al. (författare) Regulating Germline Editing in Assisted Reproductive Technology : An EU Cross-disciplinary Perspective 2019 Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 34:1, s. 16-32 Tidskriftsartikel (refereegranskat)abstract Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has a EU starting point and is meant as a contribute to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions which will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global-scale responsibility and governance should be fostered by promoting cross-disciplinary thinking and multi-level stakeholder involvement in legal and regulatory processes.
47.	Nordberg, Ana, et al. (författare) Response to Nuffield Council on Bioethics’ Genome editing and human reproduction: open call for evidence 2018 Annan publikation (övrigt vetenskapligt/konstnärligt)abstract During a meeting held in Trento, Italy in March 2017, and organised by the COST Action CHIP ME (IS1303) to discuss about ELSI of genome-editing, many different positions emerged on the possibility to intervene on reproduction and especially on the human embryo. At the time, the Nuffield Council on Bioethics had commissioned a background paper on genome editing, and the corresponding Working Group had launched an open call for evidence. This short paper is the response to this call, summarizing the main ideas discussed by a group of scholars from diverse disciplines.
48.	Nordberg, Ana, et al. (författare) Trade Secrets, Big data and Artificial Intelligence Innovation: a Legal Oxymoron? 2020 Ingår i: The Harmonization and Protection of Trade Secrets in the EU : An Appraisal of the EU Directive - An Appraisal of the EU Directive. - 978 1 78897 333 5 ; , s. 194-220 Bokkapitel (refereegranskat)abstract This chapter will analyse the Trade secret Directive from a technological informed legal perspective, looking at the possibilities and scope of protection that it offers for knowledge based activities and business models. It opens by restating the basic yet important fact that “Information is power”. Asymmetries in information are a fundamental transaction cost and in this sense informational quality and quantity translates into economic competitive advantage. Different types of informational resources have for long been an important asset of businesses. Informational technologies, automated data retrieval and cross reference will produce large quantities of valuable data that can be used for research, development and marketing of all types of products and services. Big data is not static data, is real time data, searchable and able to produce new data. Such data will constitute an important immaterial asset and trade secrets an important form of legal protection. However, and as a reverse side of the coin, Artificial Intelligence and data mining tools pose a considerable challenge to trade secrets as a legal concept.
49.	Radziwon, Agnieszka, et al. (författare) Ecosystem effectuation : creating new value through open innovation during a pandemic 2022 Ingår i: R and D Management. - : Wiley. - 0033-6807 .- 1467-9310. ; 52:2, s. 376-390 Tidskriftsartikel (refereegranskat)abstract The severity of the COVID-19 pandemic confronts us with a global grand challenge representing an unprecedented crisis for health, economies, and societies. While digital champions are thriving, a large number of businesses and industries have been facing radical uncertainty, pushing some to the edge of collapse. This emergency calls for new ways to look at organizational ambidexterity and business model innovation. In this paper, we present and discuss a unique case study of a low-cost airline, AirAsia. With their fleet of aircraft grounded, and unable to pursue any incremental innovation opportunities, AirAsia decided to follow a radical ambidexterity path – focusing on exploration by building an innovation ecosystem. This case not only offers insights on a novel way to create value through open innovation but also extends the body of knowledge on entrepreneurial effectuation by introducing the concept of an ecosystem effectuation. AirAsia’s case shows that, in financially distressed times, business model reconfiguration may not be enough, and instead of selecting means to attain goals, the goals may be created upon available means.
50.	Slokenberga, Santa, et al. (författare) Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives 2022 Ingår i: European Journal of Health Law. - : Brill Nijhoff. - 0929-0273 .- 1571-8093. ; 29:3-5, s. 327-340 Tidskriftsartikel (refereegranskat)

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