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- 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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- 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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| 4. |
- Nordberg, Ana, et al.
(författare)
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Cutting Edges and Weaving Threads in the Gene Editing (Я)evolution : Reconciling scientific progress with Legal, Ethical, & Social concerns
- 2018
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Ingår i: Journal of Law and the Biosciences. - : Oxford University Press (OUP). - 2053-9711. ; 5:1, s. 35-83
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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.
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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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| 9. |
- Minssen, Timo
(författare)
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Meanwhile on the Other Side of the Pond: Why Biopharmaceutical Inventions that Were “Obvious to Try” Still Might Be Non-Obvious – Part I
- 2009
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Ingår i: Chicago-Kent Journal of Intellectual Property (forthcoming). - 1559-9493.
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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.
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- 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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