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- Corrales Compagnucci, Marcelo, et al.
(author)
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- 2024
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In: International review of law computers & technology. - 1360-0869 .- 1364-6885. ; 8:1, s. 66-85
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Journal article (peer-reviewed)abstract
- Research and development (R&D) in the pharmaceutical sector traditionally operated with in closed, siloed institutional settings, driven by intellectual property rights concerns that viewed data sharing as a threat. However, the evolving scientific landscape demands a more collaborative approach involving external engagement and dynamic partnerships. To address this, a hybrid contractual framework combining smart contracts, non-fungible tokens (NFTs), and traditional licensing schemes is introduced. This framework was developed through an experimental pilot platform that adhered to FAIR data principles, allowing participants to store, find, and reuse data related to drug discovery. The platform utilizes blockchain technology to document real-world assets in an immutable digital ledger. Smart contracts and NFTs offer an open and global collaborative platform for advancing drug research assets, overcoming hurdles related to standardization, interoperability, and disclosure. This framework aims to reconcile the conflict between the demand for greater data sharing and the protection of rightsholder interests in pharmaceutical R&D. By providing mechanisms for resolving practical challenges, it facilitates further cooperation and innovation in the field.
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- Corrales Compagnucci, Marcelo, et al.
(author)
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Non-Fungible Tokens as a Framework for Sustainable Innovation in Pharmaceutical R&D: A Smart Contract-Based Platform for Data Sharing and Rightsholder Protection
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In: International Review of Law, Computers & Technology. - 1360-0869.
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Journal article (peer-reviewed)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.
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Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives
- 2023
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Editorial collection (peer-reviewed)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.
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- Groussot, Xavier, et al.
(author)
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Res judicata i EG –domstolens rättspraxis: en avvägning mellan rättssäkerhet och lagenlighet
- 2007
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In: Europarättslig tidskrift. - 1403-8722. ; :3, s. 535-567
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Journal article (peer-reviewed)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).
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- Kongsholm, Nana Cecilie Halmsted, et al.
(author)
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Challenges for the sustainability of university-run biobanks
- 2018
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In: Biopreservation and Biobanking. - : Mary Ann Liebert Inc. - 1947-5535 .- 1947-5543. ; 16:4, s. 312-321
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Journal article (peer-reviewed)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.
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- M. Schwartz, Robert, et al.
(author)
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Life after Myriad: the uncertain future of patenting biomedical innovation and personalised medicine in an international context
- 2015
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In: Intellectual Property Quarterly. - 1364-906X. ; 2015:3, s. 189-241
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Journal article (peer-reviewed)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.
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| 10. |
- Matthews, Duncan, et al.
(author)
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Balancing innovation, ‘ordre public’ and morality in human germline editing : A call for more nuanced approaches in patent law
- 2022
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In: European Journal of Health Law. - : Brill. - 0929-0273 .- 1571-8093. ; 29:3-5, s. 562-588
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Journal article (peer-reviewed)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.
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