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- 2019
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Tidskriftsartikel (refereegranskat)
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| 4. |
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Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives
- 2023
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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.
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| 5. |
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| 6. |
- Huang, Fang, et al.
(författare)
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Cultivation of the gut bacterium Prevotella copri DSM 18205T using glucose and xylose as carbon sources
- 2021
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Ingår i: MicrobiologyOpen. - : Wiley. - 2045-8827. ; 10:3
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Tidskriftsartikel (refereegranskat)abstract
- Prevotella copri DSM18205T is a human gut bacterium, suggested as a next-generation probiotic. To utilize it as such, it is, however, necessary to grow the species in a reproducible manner. Prevotella copri has previously been reported to be highly sensitive to oxygen, and hence difficult to isolate and cultivate. This study presents successful batch cultivation strategies for viable strain inoculations and growth in both serum bottles and a stirred tank bioreactor (STR), without the use of an anaerobic chamber, as long as the cells were kept in the exponential growth phase. A low headspace volume in the STR was important to reach high cell density. P. copri utilized xylose cultivated in Peptone Yeast Xylose medium (PYX medium), resulting in a comparable growth rate and metabolite production as in Peptone Yeast Glucose medium (PYG medium) in batch cultivations at pH 7.2.Up to 5 g/L of the carbon source was consumed, leading to the production of succinic acid, acetic acid, and formic acid, and cell densities (OD620 nm ) in the range 6-7.5. The highest yield of produced succinic acid was 0.63 ± 0.05 g/g glucose in PYG medium cultivations and 0.88 ± 0.06 g/g xylose in PYX medium cultivations.
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| 7. |
- Matthews, Duncan, et al.
(författare)
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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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Ingår i: European Journal of Health Law. - : Brill. - 0929-0273 .- 1571-8093. ; 29:3-5, s. 562-588
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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.
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| 8. |
- Matthews, Duncan, et al.
(författare)
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The Role of Patents and Licensing in the Governance of Human Genome Editing: A White Paper
- 2021. - 2021
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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.
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| 9. |
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| 10. |
- Mattsson, Titti, et al.
(författare)
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Sweden: Legal Response to Covid-19
- 2021
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Ingår i: The Oxford Compendium of National Legal Responses to Covid-19. - : Oxford University Press.
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Bokkapitel (refereegranskat)
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| 13. |
- Minssen, Timo, et al.
(författare)
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Rules and Tools in the Battle against Superbugs - A call for integrated strategies and enhanced international collaboration to promote antimicrobial drug development
- 2020
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Ingår i: Infectious Diseases in the New Millennium: Legal and Ethical Challenges. - Cham : Springer International Publishing. - 9783030398187 - 9783030398194 ; , s. 111-136
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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.
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| 14. |
- Minssen, Timo, et al.
(författare)
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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
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Ingår i: NIR: Nordiskt immateriellt rättsskydd. - 0027-6723. ; 2015:5, s. 493-503
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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.
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| 15. |
- Minssen, Timo, et al.
(författare)
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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
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Ingår i: Biotechnology Law Report. - : Mary Ann Liebert Inc. - 0730-031X .- 1557-8704. ; 34:3, s. 81-98
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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
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| 16. |
- Moenaert, Antoine, et al.
(författare)
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Evaluation of Laminaria Digitata Hydrolysate for the Production of Bioethanol and Butanol by Fermentation
- 2023
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Ingår i: Fermentation. - : MDPI AG. - 2311-5637. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Seaweeds (macroalgae) are gaining attention as potential sustainable feedstock for the production of fuels and chemicals. This comparative study focuses on the characterization of the microbial production of alcohols from fermentable carbohydrates in the hydrolysate of the macroalgae Laminaria digitata as raw material. The potential of a hydrolysate as a carbon source for the production of selected alcohols was tested, using three physiologically different fermentative microbes, in two main types of processes. For the production of ethanol, Saccharomyces cerevisiae was used as a benchmark microorganism and compared with the strictly anaerobic thermophile Thermoanaerobacterium strain AK17. For mixed production of acetone/isopropanol, butanol, and ethanol (A/IBE), three strictly anaerobic Clostridium strains were compared. All strains grew well on the hydrolysate, and toxicity constraints were not observed, but fermentation performance and product profiles were shown to be both condition- and strain-specific. S. cerevisiae utilized only glucose for ethanol formation, while strain AK17 utilized glucose, mannitol, and parts of the glucan oligosaccharides. The clostridia strains tested showed different nutrient requirements, and were able to utilize glucan, mannitol, and organic acids in the hydrolysate. The novelty of this study embodies the application of different inoculates for fermenting a common brown seaweed found in the northern Atlantic Ocean. It provides important information on the fermentation properties of different microorganisms and pinpoints the value of carbon source utilization when selecting microbes for efficient bioconversion into biofuel and chemical products of interest.
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| 18. |
- Nordberg, Ana, et al.
(författare)
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A “ray of hope” for European stem cell patents or “out of the smog into the fog”?
- 2016
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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
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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.
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| 19. |
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| 20. |
- Nordberg, Ana, et al.
(författare)
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AI, Big Data, e-Health and the Right to be Forgotten
- 2020
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Ingår i: Kunstig intelligens og big data i helsesektoren : Rettslige perspektiver - Rettslige perspektiver. - 9788205531963 - 9788205531963 ; , s. 275-275
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Bokkapitel (refereegranskat)abstract
- This paper examines the rights of users of health, fitness and wellness e-services concerning the use, re-use and conservation of their health and health related data. In particular, it will analyse the scope and limits of the ‘right to be forgotten’ recently codified under Article 17 in the General Data Protection Regulation. It will address generally patience records and clinical trial data, and focus on health and health related data provided outside a traditional health care and medical research setting. Big data, machine learning and artificial intelligence promise to enable great advances in personalised medicine, public health and generally in bio-medical research. Already we start to see a proliferation of e-health, e-fitness and e-wellness services. These are emerging inserted in strategies to optimise and personalize public health services, in particular in the areas of general health information and pre-clinical advice, emergency services triage, pre-screening, long-term monitoring of patients, elderly care, etc. Some types of e-health services start to be offered by or subcontracted to private entities, such as insurance companies, private clinics, long term care facilities and e-health care providers. Also in the market, we can already observe emerging a long list of other e-services with health relevance, offered by a variety of heterogeneous commercial enterprises with different goals and business models, but which include inter alia genetic testing, biometric data monitoring, sample analyses and health, wellness and fitness questionnaires. Mostly data flows multidirectional, using a combination of testing devises, ‘apps’ and machine learning tools. Physiologic and psychologic health indicators can also be retrieved from social networks, using e.g. language, speech pattern and biometrics analysis. Digitalization of medical journals, biobanks, clinical trials and medical research, also offers possibilities for personalised and precision medicine, public health decision making and bio-pharmaceutical innovation. Since most non-communicable diseases are caused, aggravated or mitigated by social-economic conditions, life-style, cultural factors and socialization habits, comprehensive health data will likely tend to include highly private information. In theory, in the near future it will be possible to predict, detect and prevent or treat at an early stage an increase number of health conditions. It will also be possible to more accurately tailor treatments and health interventions to specific individual needs. As recently stressed by the EU Parliament in the resolution on the fundamental rights implications of big data, public health interest in creation and access to health big data will necessarily interface and need to be balanced with the protection of other fundamental rights. Such will be particularly pertinent to consider in cases where the supply and/or creation of such data involves commercial entities and other actors operating outside the scope of the traditional confidentiality protected relationship between a patient and a health care professional or medical researcher.
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| 21. |
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| 22. |
- Nordberg, Ana
(författare)
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Artificial Intelligence and automated decision-making in healthcare
- 2019
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Ingår i: ; , s. 92-92
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- AI is expected to be a driver for improved standards of health, reduced costs, decentralized care and facilitated access to healthcare. Its successful implementation depends on technology factors and industrial investments in AI innovation, but also conditional to trust and acceptance by patients, medical staff and healthcare authorities. AI will inevitably change the nature of health care innovation impacting all areas of healthcare and allowing the development of precision or personalized medicine (PM). Data quality is crucial for AI predictive tools in PM, and reliable and comprehensive data require patient trust and willingness to cooperate. All of which depends in large measure on the existence of clear legal frameworks for AI capable of reflecting fundamental legal norms and prevailing social values. Development and application of AI, as well as their application triggers privacy and data protection challenges in the context of research and clinical application, including issues of algorithmic discrimination and the right not to be subject to automated decision making.Simultaneously, technological limitations (the black box issue) and legal entitlements (intellectual property rights and trade secrets) exacerbate practical limitations and difficulties to the exercise of patient rights. This presentation concerns the rights of individual’s concerning algorithmic decision-making in the context of healthcare in the EU. It will examine both general data protection issues, intellectual property and patient rights.
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| 23. |
- Nordberg, Ana, et al.
(författare)
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Big Science, Big Data, Big Innovation? : ERIC Policies on IP, Data and Technology Transfer
- 2021
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Ingår i: Big Science and the Law. - 9788742000366 ; , s. 65-106
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Bokkapitel (refereegranskat)abstract
- Science originates knowledge and downstream innovation. “Big” science is likely to, along the line, give rise to “big” innovation. Large research infrastructures are characterized by containing a large number of partners involved in complex networks of internal and external collaborations. This chapter explores how large research infrastructures (broadly defined) manage internally and externally the innovation they produce. It is the result of a comparative analysis of Statutes and policies documents publicly available of the current twenty-one large research infrastructures granted the legal status of European Research Infrastructure Consortium (ERIC). It uses ERICs as an example, to explore how large research infrastructures manage internally and externally the innovation they produce. In particular, it analyses knowledge transfer and technology transfer policies covering issues such as patent ownership, registration, licensing and enforcement, and data related issues.
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| 24. |
- Nordberg, Ana, et al.
(författare)
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Biobank and Biomedical Research: Responsibilities of Controllers and Processors under the EU General Data Protection Regulation
- 2021
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Ingår i: GDPR and biobanking : Individual rights, public interest and research regulation across Europe - Individual rights, public interest and research regulation across Europe. - Cham : Springer International Publishing. - 9783030493875 - 9783030493882 ; , s. 61-89
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Bokkapitel (refereegranskat)abstract
- Biobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk for privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonization, resulting in a framework defining specific duties and obligations of entities processing personal data – controllers and processors. Biobanks, in the exercise of their functions assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules, in light of Article 89 GDPR, which creates safeguards and derrogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when should a biobank be considered controller and processor; what are the main duties of biobanks as data controllers and processors and options for compliance.
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| 25. |
- Nordberg, Ana, et al.
(författare)
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COVID-19 Pandemic in Sweden : Measures, Policy approach and Legal and Ethical debates
- 2020
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Ingår i: BioLaw Journal - Rivista di BioDiritto. - 2284-4503. ; :1/2020, s. 731-739
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- In this article we analyse the legal approach and measures implemented as a response to the COVID-19 pandemic implemented by Sweden’s public authorities and their legal background. Further, we discuss general legal and ethical questions related to measures to contain public health threats such as the current COVID-19 pandemic. It is outside of the scope of this paper to compare and critically analyse the effectiveness of Sweden’s public health strategy.
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