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Ana Nordberg

The chapter considers the patentability of human enhancement, namely technologies that provide the means to intentionally develop, modify or introduce in the human body aesthetic features, physical or cognitive performance levels and abilities beyond the human species’ typical standards under the current evolutionary state, and resulting in induced permanent alterations. This mere possibility has led to ethical interrogations concerning the nature and boundaries of human nature and our relationship with science and technology. New technologies typically have a mixed nature, offering a wide range of uncontroversial benefits to humanity while simultaneously posing complex ethical challenges. The author concludes that the patent system is hardly the most appropriate legal tool to disincentivize specific commercial practices, business models or individual uses of technology. The author concludes that a broad, inclusive and interdisciplinary dialogue on science and technology is necessary.

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Ana Nordberg

This chapter focuses on legal interpretation, reflecting on policy options between pluralism and harmonisation in two separate levels: (1) the desirability of establishing, or not, further harmonisation of interpretative rules, criteria and praxis in IP law; (2) whether internal harmonisation or systemic coherence between different areas of law and regulation that affect the same object or legal fact is a desirable interpretative objective in IP law. The point of departure for the analysis is biomedical innovation and digitalisation, using as examples technologies such as synthetic biology, 3D printing, and gene editing that present a multitude of horizontal challenges and consequently an opportunity for debating policy choices between ‘functional pluralism’ or ‘systemic coherence’. It is argued that emerging technologies do not necessarily require legal coherence, but systemic coherence can play an important role in legal responses to global technology-induced business models and social phenomena.

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Ana Nordberg

This chapter discusses the morality exception from patentability, in Article 53(a) European Patent Convention (EPC). The analysis will look into the history of the provision and debate its rationale and interpretation. Bioscience innovation has always generated heated ethical debates in society. The patent system is not immune to such discussions. The EPC contains a morality and ordre public exception in Article 53(a), preventing patentability on grounds of lack of ethical compliance of the invention with prevailing standards. Many other jurisdictions have similar provisions or somehow impose restrictions on patentability based on similar ratio legis. The topic is further regulated in Article 6 of the Biotechnology Directive (which is also adopted in the EPC implementing rules). The ratio legis of this and the standards for its applicability and legitimacy to develop them are far from clear or consensual. Innovation in cutting-edge biosciences always implies a certain level of uncertainty concerning future technological possibilities. The same can be said in regard to any legislative attempt to regulate such technologies. The Biotechnology Directive was enacted in 1998 after a long legislative process. At the time, the academic and policy discussions were based on mere abstract scientific possibilities and imaginary dystopic eugenic futures. Today we are confronted with realistic possibilities for life-saving genetic health interventions that can be made possible provided there is enough incentive to innovation in genetic therapy. Science and technology has progressed considerably in the last 20 years. It will be argued that developments in scientific knowledge and technology are a factor to be taken into consideration in legal interpretation and de lege ferenda proposals.

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Ana Nordberg

This chapter examines the Trade Secrets Directive from a technologically informed legal perspective, looking at the possibilities and scope of protection that the Directive offers for knowledge-based activities and business models. Different types of informational resources have long been an important asset of businesses. Informational technologies, automated data retrieval and cross-referencing will produce large quantities of valuable data that can be used for research, development and marketing of all types of products and services. However, artificial intelligence and data mining tools pose a huge challenge to trade secrets as a legal concept.

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Ana Nordberg and Knud Wallberg

This chapter focuses on legal interpretation, reflecting on policy options between pluralism and harmonisation at two separate levels: (1) the desirability of establishing, or not, further harmonisation of interpretative rules, criteria and praxis in IP law; (2) whether internal harmonisation or systemic coherence between different areas of law and regulation that affect the same object or legal fact is a desirable interpretative objective in IP law. The point of departure for the analysis is biomedical innovation and digitalisation, using as examples technologies such as synthetic biology, 3D printing, and gene editing that present a multitude of horizontal challenges and consequently an opportunity for debating policy choices between ‘functional pluralism’ or ‘systemic coherence’. It is argued that emerging technologies do not necessarily require legal coherence, but systemic coherence can play an important role in legal responses to global technology-induced business models and social phenomena.

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Ana Nordberg and Bárbara Díaz Alaminos

As in the other EU countries (except for Sweden), the protection of trade secrets in Portugal and Spain has been derived from general legal principles (of civil law, penal law and unfair market law). This chapter considers the situation in Spain and Portugal.