Bucerius Law School, Hamburg, Germany
October 11, 2013

Professor Dr. Timo Minssen (University of Copenhagen)
Standardization and Open Innovation in Synthetic Biology

Innovation finds itself embedded in an expanding milieu of openness these years, which is closely connected to the increase in knowledge flows across traditional boundaries of scientific disciplines, geography, languages, businesses, institutions, markets, professions and subjects. The general concept of openness assumes many forms and variations dependent on the context. The ethos of openness has also found its way to the emerging technological area of synthetic biology (SB).

SB applies the principles of engineering – abstraction, decoupling and standardization – to the study of biology. This approach, combined with advances in DNA synthesis, nanotechnology, automated strain engineering, and associated technical standards, is producing rapid increases in both the scale and complexity of genetically encoded functions used to create integrated biological systems. Spurred by the great promises of SB, both public and private investments in SB have increased dramatically. Meanwhile, the inherent dangers of this technology, as well as the numerous scientific, socio-economic, ethical and legal challenges posed by SB, remain a multifaceted enigma.

Some SB research communities and bio-hackers have embraced an ethos of "open biology" in the sense of "free sharing" and welcome it as an opportunity to challenge traditional IPR-based innovation models. Open innovation models in a business context are, however, often associated with the development of creative, user-generated approaches to protecting and licensing traditional IPRs instead of managing and defending them within the boundaries of one company. Some stakeholders regard the concept of openness as an unavoidable necessity to tackle innovation gaps, while others are mostly concerned by the threats that openness might pose to well-established innovation – and business models.

Irrespective of these different perceptions of openness, an effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering the recent developments within the software and ICT industries, it is fair to assume, that the process of standardization may also have significant impact on the development and adoption of SB. Within SB different standardization efforts have been made, but none has assumed a dominance or authority in the area. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns. Out of this notion arises i.a. the following question: How applicable are the approaches adopted by information and communication technology standards-setting organizations to biological standards?

These and further legal issues related to IP, regulation, standardization and competition law require a careful consideration of new models and solutions. This presentation will commence with a brief introduction to the field of SB. Part II will then present and explain standards, standards setting efforts and related institutions. This provides the basis for Part III, which discusses IP issues relevant to SB and standards setting in an open innovation context. Part IV summarizes the findings and conclusions.