The ethos of openness in synthetic biology

Patents and enabling technologies in an emerging innovation system, the case of CRISPR

Evaluation seminar for cand.jur. PhD student Jakob Wested

For the seminar we have invited Esther van Zimmeren from University of Antwerpen

I.                    Introduction

This section will introduce the general themes and macro-perspective on synthetic biology. This entails a presentation of the conceptual and technological lines of the development of synthetic biology. It also entails the presentation of selected trends that are important to place synthetic biology and the IP issues of the discipline in contemporary context. This macro perspective will particularly entail a presentation the concepts of knowledge society, responsible research and innovation (RRI) and innovation systems.  

II.                  Framework
The ambition to analyse patent issues of synthetic biology in a broader social context necessitates a broad and elaborated theoretical approach that may encompass the complex issues originating from the entanglement of the legal and the social perspective. This will be achieved through the combination of two theories that will integrate the legal, epistemic and innovation perspective. The theoretical framework for the legal analysis will be provided by critical legal positivism (CLP) and the concept of layers of law. This foundation in legal theory will then be enriched and tuned in on the issues of IP, Innovation and emerging technology by implementing system theory in the form of the quadruple helix model conceptualization of an innovation system.  The choice of method is inspired by the considerations presented within ELSA, RRI and STS scholarship that use multiple and diverse sources and place particular emphasis on case studies (Micro-analysis) leading to assumptions and theories about the constitution of meso- and macro levels of society.

III.                Synthetic biology
This section will start with a general presentation of the discipline of synthetic biology e.g. its subject matter, vision, practices, organisation followed by a presentation of the enablers of the discipline sorted by their relation to legal (IP) categories. From this general starting point we will move on to a presentation of the specific subject of the CRISPR technology, what it is, the observed present IP issues and feuds related to it. Finally a historical perspective on the issues of foundational technologies within the field of biotechnology will present some debated scenarios for the future of CRISPR.

IV.               The concept of openness in the layers of law
This section will seek to unfold and interpret the IP related disputes around the CRISPR technology in the context of the concept of openness and the applied theoretical framework. Particular emphasis will be on the relative difference and interplay between the concept and operationalization of openness in the different layers of law.

V.                 Discussion
On the basis of the above four issues (maybe more) that represents significant trends and challenges are discussed. Shifting or co-existing paradigms will address the issue whether this is a paradigm shift or an increase in varieties of paradigms, and the implications of this. Recognizing the under-determination of patent protection will discuss the possibilities of using flexibilities in patent law to navigate in innovation systems. Democratizing technology will discuss the implications of adding the fourth helix of civil society to the innovation system from a patent perspective. Finally, Privilege, right and resource will discuss the changing perspectives on patent rights, and compare present debates about the “essence” and draw comparisons to the observations made in legal-scholarship related to the shift from pre-modern to modern patent law.