Suchergebnisse

Intro -- Preface -- Acknowledgements -- Contents -- Abbreviations -- Chapter 1: Introduction -- References -- Part I: Setting the Scene -- Chapter 2: The Context and the Problem -- 2.1 Clinical Trials: General Aspects -- 2.1.1 Basic Definitions -- 2.1.2 The Social Value of Clinical Trials -- 2.1.3 Clinical Trials in the Regulatory Context -- 2.1.3.1 Clinical Trial Approval -- 2.1.3.2 Drug Marketing Authorisation -- 2.1.4 Clinical Trials as a Part of Industry RandD -- 2.2 The Debate Over Access to Clinical Trial Data -- 2.2.1 Concerns Related to Restricted Access to Clinical Trial Data -- 2.2.2 Transparency Issues -- 2.2.3 Levels of Transparency in Clinical Trials -- 2.2.3.1 Trial Registration -- 2.2.3.2 Reporting and Publication of Trial Results -- 2.2.3.3 Accessibility of Non-Summary Data -- 2.2.4 International Norm-Setting Initiatives Promoting Transparency in Clinical Research -- 2.2.5 Institutional Developments -- 2.2.5.1 Editorial Campaign -- 2.2.5.2 Funding Institutions -- 2.2.6 Access to Data as a Digital Resource in the Context of Data-Driven Innovation -- 2.2.6.1 The Promises of `Big Data´ -- 2.2.6.2 Legal and Policy Debate Concerning `Ownership´ of Sensor-Generated Data -- 2.2.6.3 `Big Data´ Analysis in Public Healthcare and Drug RandD -- 2.2.6.4 Data-Sharing Policies and Practices Adopted by the Pharmaceutical Industry -- 2.3 Diversity of Policy Approaches and Academic Views -- 2.3.1 The Controversy Over Disclosure of Non-Summary Clinical Trial Data in the EU -- 2.3.1.1 Investigations of the European Ombudsman -- 2.3.1.2 The EMA Transparency Policies -- 2.3.1.3 Evolving Case Law of the CJEU on Clinical Trial Data Disclosure -- 2.3.2 Policy Approaches in Other Jurisdictions -- 2.3.3 Academic Discourse -- 2.3.3.1 General Medical Literature -- 2.3.3.2 Legal Discourse on Access to Clinical Trial Data.

Abstract
The judgment of the German Federal Patent Court (Bundespatentgericht) in the Food container case1 holds a unique place in the worldwide series of DABUS2 cases. On the one hand, it confirmed that an artificial intelligence (AI) system cannot be regarded as an inventor under patent law, which has so far been a dominant trend in other jurisdictions concerned with the matter.3 On the other hand, it allowed the applicant Stephen Thaler, who insisted on not having invented the food container, to be designated as the inventor in the patent application, thus, opening up an opportunity for him to become the patent owner. While the case outcome may appear as a constructive compromise, one may question the internal consistency of the court's reasoning. This analysis shows that the judgment is paradoxical in that, by allowing Thaler to be deemed the inventor of the food container, it contradicts the very principle of human creativity underlying the inventor's (moral) right to be named – the principle that was relied upon by the adjudicating Board when denying the designation of DABUS as the inventor.

Abstract
This article attempts to clarify the notion of an 'AI-generated' invention, an issue which has triggered an intense debate on the future of patent law and policy. While there is a general consensus that such inventions are incompatible with the concept of human inventorship, it remains largely unclear to what extent concerns regarding 'non-human' ingenuity can be justified. Most uncertain is how AI 'autonomously generates' inventions, and in what way 'AI-generated' inventions differ from inventions developed with the aid of AI.
Drawing on the extensive literature review, this article depicts AI techniques as methods of computational problem solving. It emphasises that such methods should not be equated with a computer's 'cognitive autonomy'. Further, it clarifies that the types of AI that have been most debated in the patent law literature ‒ artificial neural networks and evolutionary algorithms ‒ essentially require detailed instructions that determine how the relation between inputs and outputs is derived through computation. Accordingly, it is argued that, as long as computers rely on instructions defined by a human as to how solve a problem, the separation between human and non-human (algorithmic) ingenuity is, in itself, artificial. Ultimately, the article calls for a broader technical inquiry that would elucidate the relevance of the currently debated normative concerns over 'non-human inventorship' against the background of the technological state of the art.