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- 2019
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Tidskriftsartikel (refereegranskat)
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- 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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- 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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- 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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- 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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- 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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- Nordberg, Ana, et al.
(författare)
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EU Design Law and 3D Printing : Finding the Right Balance in a New E-Ecosystem
- 2017
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Ingår i: 3D Printing, Intellectual Property and Innovation. - 9789041183828 ; , s. 275-302
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Bokkapitel (refereegranskat)abstract
- The article considers the implications for EU design law of 3D-printing. It first describes the 3D-printing technology and the e-ecosystem which is evolving around the technology and involves a number of new stakeholders who in different ways are engaged in the making and sharing of CAD-files and/or printing. It is submitted that it is only a matter of time before 3D-printing equipment becomes ubiquitous. It is pointed out how the new technology and e-ecosystem at the same time represent threats and opportunities to design holders and to the societal interests in design and design law. EU design law is analysed and it is concluded that the current legal framework is not geared to deal with these challenges. In particular the scope of the private and non-commercial use exception and the liability of producers and providers of CAD-files are presently uncertain. It is finally argued that there is a dire need to address the challenges and to provide legal certainty. In so doing a balance should be struck which reflects both the legitimate interests of design holders and of users and which relies on a combination of responses found both in legislation and in systems based on self-governance.
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