Synthetic Biology: Generativity and the Limits of Intellectual Property

Lead Research Organisation: London School of Economics & Pol Sci
Department Name: Law

Abstract

Synthetic Biology: Generativity and the Limits of Intellectual PropertyGood science can make for good business, but only through the tortured road of property arrangements. Synthetic biologyis an emerging area of technology that brings engineering and biology together, creating unprecedented potential for the rational construction of living organisms with desirable qualities and characteristics. This project allows the principal investigator from the social sciences to discipline hop to synthetic biology. During this period she will explore property and licensing models in synthetic biology by studying the unique aspects of this technology as well as the limitations that are at the heart of intellectual property laws. The investigator will be hosted at Imperial college London, at the Centre for synthetic Biology and Innovation - itself a new joint initiative between Imperial and LSE. There are two main themes that will inform the year long project. The first is the need to anticipate the unique ways in which synthetic biology may challenge conventional principles of patentability. In synthetic biology, problematic aspects of software patents are compounded by unsettled patentability issues in biotechnology, with a consequent exacerbation of legal and policy uncertainty. Good legal policy in this area requires commentators who are skilled not just in the facts of the technology, but also well informed of the research heuristics in this field - skills that the principal investigator will learn during the period of immersion in synthetic biology.The second theme is the unprecedented 'generativity' of synthetic biology. 'Generativity' is a term coined and defined by Jonathan Zittrain in the context of the internet and in essence refers to the ever shrinking technological open spaces on the internet which can give rise to endless innovations due to open legal environments that are maintained through the selective application and non application of copyright, patenting or licensing regimes. It is in this respect that useful comparisons may be made between synthetic biology and the internet that makes end users, collaborators and contributors uniquely prominent.Synthetic biology currently appears to be imbued with an ethos of open science and a distaste for intellectual property. Various initiatives such as the BioBrick Foundation and the Bioconductor project seek to stall the creep of intellectual property, however proprietary technology is already here with synthetic biology patents, possible copyright protection for artificial DNA, privately owned central resources, licensing regimes and public domain resources. The property puzzle raised by intellectual property rights and by alternatives to intellectual property rights is a complex one - the mix of public, common and private property can result in either the stimulation or the dampening of innovation.The discipline hop (or discipline synthesis which may be a more accurate term for the project) will lead to two related goals:Aim 1 - To study the fundamentals of synthetic biology and isolate aspects of the technology that challenge core standards, general principles, and conventional methodology in patent law.Aim 2 - To unravel the property puzzle surroundiing synthetic biology as resource and as product, to examine the role of newly emerging institutions and actors; and to define parameters that are necessary to maintain and grow innovation.It is not uncommon for intellectual property law commentators to write about new developments in technologies, but for reasons central to the proposal, they often remain 'external' experts. In contrast this project provides a unique opportunity to embed a legal academic within synthetic biology for long term cross disciplinary benefit.

Planned Impact

There will be at least five key impacts of this project - creation of robust cross disciplinary links nationally and internationally, the generation of new ideas and concepts that may give content to legal and policy measures, the measurement and distribution of innovation in the UK and internationally, the formation of optimum intellectual property standards to increase technological and economic progress, and the ability to contribute to the process of setting priorities for international economic development through the appropriate application of intellectual property rights. Some specific pathways to impact resulting from this project are: 1) The conduct of two workshops with scientists at Imperial college and social science researchers at BIOS via the Centre for Synthetic Biology and Innovation. The final workshop in particular will provide legal imput to develop good governance mechanisms to manage the scientific output of research groups in the UK and internationally with respect to the ownership and dissemination of intellectual products. 2) The international links with scientists in the US will give a deeper understanding of the institutions and legal modes being used in order to maintain an open science ethos in synthetic biology. There is a specific opportunity to contribute to developing ideal licensing terms in templates such as the BioBrick Agreement which will benefit all end users, collaborators and contributors to synthetic biology. 3) Measuring levels of innovation in synthetic biology through patent counts and by reading relevant patent applications will be invaluable in analysing the impact and limitations of patent law. It will also provide insights into potential patentability challenges. At the end of the project, the possibility of a joint workshop with the UK Intellectual Property Office will be explored. As patent policy is often set in tandem with the US and Europe, forging international links with key scientists will faciliate participation in international fora such as the World Intellectual Property Organisation where international patent law priorities are often set. 4) Intellectual property has become a major point of global contention since its link to trade and my work will contribute to understanding the implications of property rights in synthetic biology for international economic development. Participation in forums where the Trade Related Intellectual Property Rights Agreement is discussed will be possible as a result of my collaboration with legal academics in India and other developing countries. 5) Due to the principal investigator's academic role as a teacher, many cohorts of undergraduate and post graduate students will benefit by knowledge that is transferred through taught and research courses on the legal implications of technology. For example there is an ongoing effort to forge a joint PhD programme between imperial and LSE on cross disciplinary aspects of synthetic biology and the social sciences. At the end of the project year, the principal investigator will be ideally placed to contribute academically to this programme. The contribution could come by way of supervision of specific students or by setting priorities and direction for the PhD programme.

Publications


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Siva Thambisetty (2016) Alice and Something More: The Drift Towards European Patent Jurisprudence in Journal of Law and Bioscience


 
Description The stated objectives of this project were primarily to study aspects of synthetic biology in a way that can be made relevant to patent law, and to work on theoretical and legal strategies for the management of the results and implication of synthetic biology. Both objectives of the project were actively pursued between 1/08/2011 - 1/08/2012, and continue to be fulfilled in various ways as summarised here.



The first objective - to study synthetic biology in a way that is easily translatable to patent law was undertaken at Imperial College, London. As visiting fellow the PI had online access to the full range of scientific journals and the physical library. The lectures and seminars attended as part of the MRes in Synthetic and Systems Biology formed the basis for a self-study of the technology. Five features characterising synthetic biology were identified and used to categorise the scientific information gained. These are - de-skilling, integrally multi-disciplinary, proprietary and non-proprietary information, shared innovation platforms and higher levels of scientific risk and unpredictability.



The second objective was to analyse how these aspects of the technology may impact on the intellectual property protection of inventions produced here. Using the knowledge of synthetic biology gathered the PI developed an alternate view of legal change and decision-making takes place in the patent system. In a 20,000 word paper I argue that patent law is subject to several institutional constraints that severely limit both courts' and patent offices' ability to make optimal decisions. This is largely due to 'learning needs' generated by the design of patent regimes, which are more acute in the context of an emerging technology like synthetic biology. I position the pre-characterised features of synthetic biology and how they exacerbate the learning needs in the patent system, and also the possible direction the law might take as a response to the learning needs going forward. The end result of this framework and case study is to show that patent law, if left to its own devices evolves mechanically towards certainty and as per an internal logic that rarely stands up to substantive or normative scrutiny. A key element of this paper is identifying the analytical significance of emergence of a technology for patent law.
Exploitation Route Potential informal collaboration with UK and European Patent Offices.

1. Publication of peer-reviewed publications in law journal and as a 'review' or 'general' piece in a scientific journal.

2. Conference and Workshop Participation to build up the theoretical ideas developed

3. Organisation of an inter-disciplinary workshop on 'Synthetic biology and the Patent System' Feb 8th, 2013 LSE.

4. Collaboration with international groups - Osgoode Hall, York University Canada, and BioSynergy University of Copenhagen

5. Supervision of PhD students in law
Sectors Creative Economy,Digital/Communication/Information Technologies (including Software),Manufacturing/ including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
 
Description The findings were included in an expert report submitted to the Nuffield Bioethics Council. The input was discussed and informed the findings of the Working Party that produced the report on "Emerging Biotechnologies: Technology, Choice and the Public Good'. My findings have also contributed directly to further engagement and a grant under Horizon 2020 to study the Nagoya Protocol, which is a regulatory measure of critical significance to all scientists working on plant and animal genetic resources, particularly synthetic biologists.
First Year Of Impact 2014
Sector Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Policy & public services
 
Description Horizon 2020
Amount € 165,000 (EUR)
Organisation European Commission (EC) 
Sector Public
Country European Union (EU)
Start 03/2014 
End 03/2019
 
Description Collaboration with BioSynergy, University of Copenhagen 
Organisation University of Copenhagen
Country Denmark, Kingdom of 
Sector Academic/University 
PI Contribution Collaboration with Timo Minssen, Centre for Information and Innovation Law, co-applicant this project.
 
Description Workshop on Synthetic Biology and Intellectual Property Law June 24-25th 2013 
Organisation University of Edinburgh
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Organised by ESRC Innogen Centre, University of Edinburgh
 
Description Joint Research Council Meeting on Gene Editing 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk on Gene Editing Technologies: Regulatory Competences of the European Patent System. The audience comprised of those in the networks of the international scientists under the umbrella of the International Genetic Engineering and Biotechnology Centre, Trieste.
Year(s) Of Engagement Activity 2016