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Innovation Pursuit in Synthetic Biology: an Analysis of the Relationship Between the Current Innovation Models and the Research Exemption in Synthetic Biology

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Innovation Pursuit in Synthetic Biology: an Analysis of the Relationship Between the Current Innovation Models and the Research Exemption in Synthetic Biology Innovation pursuit in synthetic biology: an analysis of the relationship between the current innovation models and the research exemption in synthetic biology Master Law & Technology Tilburg University, Tilburg Law School by M. van der Sluis (ANR 357164) to defend on June 12, 2019 in front of the exam committee composed of Assistant Professor M. Husovec and Mr. J.P. Waterson M van der Sluis – U1258779 Acknowledgements This thesis: “Innovation pursuit in synthetic biology: an analysis of the relationship between the current innovation models and the research exemption in synthetic biology”, is the final element of the curriculum of the Master Law & Technology at Tilburg University. During my time as a student at Tilburg Law School, I have obtain a tremendous amount of academic knowledge and the skills necessary to start my legal career. Through my two master programs, I have come to realize how incredibly interesting intellectual property rights are and I therefore aspire to continue working in this area of law in the future. With regard to this thesis, I would like to express my sincere gratitude towards several individuals. First, I would like to thank my supervisors M. Husovec and J.P. Waterson for their constructive comments, guidance and reassurance. Furthermore, my parents deserve full gratitude for their unconditional support, early morning wake-up calls and thorough review sessions. In addition, my brother Anton desires special credits for improving my English writing skills. Finally, I would like to thank all the friends I made during classes and consecutive days in the library as well as my partner for always being so supportive. 2 M van der Sluis – U1258779 TABLE OF CONTENT 1.Introduction ........................................................................................................................... 6 1.1 Background ....................................................................................................................... 6 1.1.2. Innovation ................................................................................................................. 7 1.1.3. Open source vs Closed proprietary ........................................................................... 8 1.1.4. Research exemption system ...................................................................................... 8 1.2. Research purpose and research question ......................................................................... 9 1.3. Societal and scientific relevance .................................................................................... 10 1.4. Methodology and overview ........................................................................................... 11 2. Synthetic biology framework ............................................................................................ 13 2.1. Introduction ................................................................................................................... 13 2.2. Development of synthetic biology ................................................................................. 13 2.3. Research areas and applications .................................................................................... 14 2.4. Application concerns ..................................................................................................... 17 2.5. Regulatory framework ................................................................................................... 20 2.5.1. Synthetic biology’s regulatory framework ............................................................. 20 2.6. Conclusion ..................................................................................................................... 22 3. Synthetic biology’s innovation models ............................................................................. 23 3.1. Introduction ................................................................................................................... 23 3.2. Closed proprietary model .............................................................................................. 23 3.2.1. Proprietary model .................................................................................................... 23 3.2.2. Closed proprietary model ........................................................................................ 25 3.2.3. Requirements for patentability ................................................................................ 26 3.2.4. Synthetic biology patenting .................................................................................... 27 3.2.5. Drawbacks of closed proprietary model ................................................................. 29 3.3. Open source model ........................................................................................................ 31 3.3.1. Open source software .............................................................................................. 31 3.3.2. Types of openness ................................................................................................... 32 3.3.3. Synthetic biology’s open source ............................................................................. 34 3.3.4. Drawbacks open source .......................................................................................... 37 3.4. Conclusion ..................................................................................................................... 40 4. Synthetic biology’s research exemption system ............................................................... 41 4.1. Introduction ................................................................................................................... 41 4.2. Research exemption ....................................................................................................... 41 4.2.1. Background ............................................................................................................. 41 3 M van der Sluis – U1258779 4.2.2. Research exemption system .................................................................................... 43 4.2.2. Relevance for synthetic biology .............................................................................. 44 4.3. Possible flaws of the existing research exemption system ............................................ 45 4.3.1. Suggestions for synthetic biology ........................................................................... 50 4.4. Analysis of the (improved) innovation model ............................................................... 54 4.4.1. Recap of the background......................................................................................... 54 4.4.2. Analysis of the innovation models in synthetic biology ......................................... 56 4.5. Conclusion ..................................................................................................................... 59 5. Concluding remarks ........................................................................................................... 61 Bibliography ........................................................................................................................... 65 4 M van der Sluis – U1258779 List of abbreviations BPA BioBrick® Public Agreement DIY Do-It-Yourself E.coli Escherichia coli ed/eds editor/editors EPC European Patent Convention et al. et alia (and others) EU European Union EUSynBioS European Association of Synthetic Biology Students and Postdocs GMMs Genetically Modified Microorganism GMOs Genetically Modified Organisms gTME global transcription machinery engineering tool ibid ibidem (in the same source) iGEM International Genetically Modified Machines IGSC International Gene Synthesis Consortium MIT Massachusetts Institute of Technology n (foot)note OJ Official Journal OpenMTA Open Material Transfer Agreement OSI Open Source Initiative R&D Research and development SBOL Synthetic Biology Open Language TRIPS Trade-Related Aspects of Intellectual Property Rights UPC Unified Patent Court US United States WTO World Trade Organization 5 M van der Sluis – U1258779 Introduction 1.1 Background Over the last few decades, synthetic biology emerged as a new field of technology, operating at the intersection between biotechnology, software and engineering.1 Although this new field of science has no generally accepted definition, it is characterized by the shift from creating new biological entities through the combining of naturally occurring organisms, to the manufacturing of these new biological entities from scratch.2 An increased focus on interdisciplinary research, improved technologies and the combination of several scientific research areas led to the emergence of synthetic biology.3 As this field of science has been said to: “supplant the world created by Darwinian evolution with one created by us”,4 expectations are quite high. However, scientists working in the area of synthetic biology are more modest than this and focus merely on reconstructing biological parts, genomes or cells performing new functions.5 An example of a product of synthetic biology is the previously too expensive medicine for malaria, which can now be produced on a large scale.6 Outside the medical sphere, the production of “green” synthetically created fuels in the form of cellulosic ethanol has likewise attracted attention.7 Furthermore, scientists have created a synthetic environmentally friendly version of the indigo paint used for dyeing blue
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