We have explored the <b>[[#The History of IP and Open Source in Zinc Finger Technology|history]]</b> and associated intellectual property (IP) issues that have surrounded zinc finger technology.
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Because teams are trying to solve real-world problems, the vast majority of iGEM projects intersect with the IP landscape. Aside from its immediate relevance to our project, we argue that the story of zinc finger discovery, development, and commercialization presents a useful and enlightening <b>[[#No_.22Finger.22_Pointing|case study]]</b> of how IP affects the synthetic biology community.
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Additionally, we wrote and sent a '''[https://2011.igem.org/Team:Harvard/Human_Practices/Letter letter]''' to multiple representatives regarding the conflict between IP and open source technology.
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Discovered in 1985, zinc finger proteins have rapidly become a staple of gene therapy innovation. A cascade of research has transformed our understanding of the zinc finger domain from a natural transcription factor to a tool for highly specific genome alteration. As the zinc finger motif was domesticated and fused to DNA cleaving domains, its practical application through targeted gene alteration rose to the forefront of gene therapy research.
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Seeking to harness zinc finger potential, researchers and entrepreneurs collaborated to form Sangamo Biosciences in 1995, which emerged as the sole commercial provider of the protein. Today, the Sangamo monopoly raises a variety difficult ethical and economic questions about intellectual property within the zinc finger field, and synthetic biology as a whole. As an open-source alternative to Sangamo’s proprietary system and commercial dominance, Keith Joung and others have published the OPEN system[[#References|[5]]] of zinc finger creation. However, while the OPEN system and subsequent improvements are promising for massive zinc finger production, the methods are difficult and time-consuming to implement, and gaps remain in the list of available DNA binding targets.
<div class="issuedate">Discovery of the zinc finger protein</div>
<div class="issuedate">Discovery of the zinc finger protein</div>
Revision as of 21:21, 12 October 2014
Intellectual Property
Intellectual Property is an increasingly important and controversial aspect of scientific advance, and synthetic biology is perhaps the paradigmatic area illustrating the effects of this growing legal influence. When thinking about how teams could turn their ideas from iGEM projects into viable real-world solutions, we realized that intellectual property is a crucial area to address.
Our team has produced a report exploring how teams can approach this task and how iGEM intellectual property policy can make the transition easier.
We begin with a brief overview of current intellectual property law (specifically relevant to the UK) before progressing to look at the challenges this poses for the iGEM competition. A number of different approaches which iGEM might choose to adopt towards intellectual property are discussed and the pros and cons of each are assessed. We then asked a range of interested groups, including iGEM students, professionals, and the public, for their views before concluding with recommendations for addressing intellectual property concerns in iGEM. We offer our conclusions in the form of advice to students, to the iGEM foundation, and briefly explore how a change in the law could have consequences for iGEM. This advice is purely based on our own views and our research which we hope will make interesting food for thought - it is not professional legal advice and should not be relied on as such!
Our policy research in relation to students, the iGEM foundation, and policy makers is summarized below, or download the full report to learn more about our work.
Team Policy
Dealing with intellectual property is not only necessary on a competition-wide level - each team must also make decisions as to how they wish to deal with the intellectual property they will acquire during the course of their project. Deciding whether to file a patent application can be a tricky decision - below are just some of the factors you might want to take into consideration…
Oxford iGEM 2014
Attitudes Survey
We conducted a survey of attitudes within iGEM teams to intellectual property. The results, illustrated below, are analysed in detail in our report. Broadly, we found a noticeable lack of understanding of IP issues (confirming the findings of University of British Columbia iGEM team 2013 - check out their great work on IP which we used as a starting point for our own research at https://2012.igem.org/Team:British_Columbia/Human_Practices/IP_FAQ), and a great deal of social mindedness in the responses.
Jonathon Miller, A. D. McLachlan, and Sir Aaron Klug first identify the repeated binding motif in Transcription Factor IIIA and are the first to use the term ‘zinc finger.'
First crystal structure of a zinc finger
Carl Pabo and Nikola Pavletich of Johns Hopkins University solve the crystal structure of zif268, now the most-commonly studied zinc finger. This paved the way for construction of binding models to describe how zinc fingers bind to DNA, setting the foundation for future custom engineering of zinc finger proteins.
CEO Edward Lanphier founds Sangamo Biosciences
Edward Lanphier leaves Somatix Therapy Corporation and makes a deal for exclusive rights to the work of Srinivan Chandrasegaran of Johns Hopkins University who combined the Fok I nuclease with zinc fingers.
Srinivasan Chandrasegaran publishes work on fusing the Fok I nuclease to zinc fingers
By attaching nuclease proteins to zinc fingers, a new genome editing tool was created. The DNA-binding specificity of zinc fingers combined with the DNA-cutting ability of nucleases opened up possibilities for future research in gene therapy by allowing researchers to directly modify the genome though use of zinc finger nucleases.
Sangamo enters the public sector
In April 2000, five years after its founding, Sangamo Biosciences goes public offering 3.5 million shares at a starting value of $15 per share.
Sangamo patents zinc finger nuclease technology
Sangamo's patent, titled "Nucleic acid binding proteins (zinc finger proteins design rules)", ensures that any use or production of zinc fingers with attached nucleases is the intellectual property of Sangamo.
Rapid open source production of zinc finger nucleases becomes available
Researcher Keith Joung of Harvard University and Mass. General Hospital develops a method for making zinc finger nuclease proteins that bind to custom target sequences, utilizing a bacterial two-hybrid screening system to identify specific zinc finger binders to a DNA sequence of interest.
Zinc finger nuclease enters clinical trials
Sangamo and University of Pennsylvania begin clinical trials with a zinc finger nuclease designed to target the CCR5 gene and inhibit HIV. Success of this therapeutic could prove a significant advance for gene therapy.
Keith Joung publishes tables of zinc finger binding sites that account for context-dependent effects and can be rearranged to form custom zinc finger proteins that bind to a variety of DNA sequences. This greatly increases the ease of engineering novel zinc fingers based on the structures of previously characterized zinc fingers.
Harvard iGEM develops a novel method to engineer custom zinc fingers
Using novel integration of existing technologies, we have developed a rapid, comparatively low-cost, open source method for making thousands of custom zinc fingers by integrating MAGE, lambda red, and chip-based synthesis technologies. Our work greatly increases the ease of access to zinc finger technology for researchers worldwide.
Young Synthetic Biologists Intellectual Property Workshop
In the process of putting together our report and our guidance for iGEM teams, our team, in collaboration with the event organisers Philipp and Bethan of UCL iGEM, ran an intellectual property workshop at the Young Synthetic Biologists Conference 2.0 for other iGEMmers interested in the issue. The event was a great success; teams attending said 'I hadn't really appreciated just how big an impact this area of law could have on scientific development and particularly on synthetic biology - it's given me a lot to think about!'. We had a great time and there were some really interesting and insightful debates and comments - thanks especially to iGEM Cambridge for their passion on this topic!
Another team member stated, 'I don't think our team had really put much thought into the IP ownership of our project - it's definitely something we should consider though, as we would want to be able to stop anyone using our project for potentially harmful research'. 'I always thought IP was kind of a binary question - you either patent something, or you give it away. But there are so many options in between. It's a very nuanced area of law, I think that's the main thing I hadn't really appreciated, there are lots of different ways you can share or protect your ideas'.
View and download the Oxford iGEM powerpoint presentation used as the basis for our workshop below!
Special thanks for the success of this event are owed to:
Bethan Wolfenden and Philipp Boeing for organising and iGEM UCL for hosting the YSB event
Andrew Russell, Glen Gowers, and Philipp Lorenz
Dundee, Cambridge, Edinburgh, and all the other teams which attended and had such enthusiasm for the debate!
iGEM policy
Given its ever increasing prominence in the field of synthetic biology and its unavoidable influence on the future of the field, iGEM must cannot remain neutral on the matter of intellectual property. In the words of iGEM start-up Morph Bioinformatics, “iGEM must position itself and not only define its role in the world of biotech - but also how it sees the role of synbio”.
iGEM’s approach to intellectual property will be intrinsically related to its overall position and self-definition in this exciting emerging field. “It is time now to rationalize this 'big picture' and find a business model by treating the public, academia, biotech, pharma etc. as different units to optimize and synergize their outputs. And as with all business and communities the major factor of success is to follow one ultimate vision - and that should remain increasing the quality of life”.
iGEM’s approach to intellectual property being critical for the future of the competition, its teams, and even the future of synthetic biology, our report analyses three alternative approaches to iGEM in dealing with this legal issue.
The benefits and disadvantages of each are summarised in the tables below.: maintaining the status quo; complete openness; confidentiality clauses; reach through licence agreements.
Oxford iGEM 2014
Government Policy
Legislators have the difficult task of balancing a number of diverse and often conflicting intellectual property consideration. On the one hand, the government must incentivize innotvation - IP is an essential means of achieving this, as demonstrated by studies showing how patents can positively influence innovation by a margin of 15-25%2 .
The flipside of this is the responsibility of the government to prevent the creation of monopoly and to ensure that ideas are shared so as to maximize productive research. Again, there is research indicating that intellectual property is crucial to maintaining this balance, as some studies have expressed concerns that patents on initial discoveries may 'delay, hamper, or deter' innovations building on the patented work. The transaction cost of working with patented material is unattractive to many researchers, particularly individuals and start-ups.3.
Based on our research and our experiences during iGEM and in the field of IP, we believe that one of the most important roles for the government is to lead a new, more imaginative line of thinking about intellectual property protection, and to move away from analyzing these issues within the traditional and deeply engrained innovation v access dichotomy.
Creating legal mechanisms to support this kind of innovative and flexible thinking about IP will be increasingly important to synthetic biology and to iGEM as the field grows increasingly complex and the dynamics between the many different interested parties continue to evolve. In order to successfully balance the demands of the public interest, investors, the environment, researchers, and inventors we will need to be more open minded when considering how to deal with IP in the future. It will not suffice to simply ask whether 'to patent or not to patent' and suppose that this is the extent of the available options.
A further issue which we believe needs addressing by a change in the law is the current incapacity of the law to provide protection for computer code and algorithms. This is an issue which extends far beyond iGEM. Counter-intuitively, the lack of protection for algorithms means that this information can justifiably be kept secret rather than being visible and accessible to the public and/or regulators. The danger of this situation was demonstrated only recently by Facebook's so called 'social experiment' during which the company controlled the newsfeed content of users in an attempt to manipulate their emotions. Jim Sheridan, a member of the Commons Media Select Committee, expressed his 'worries about the ability of Facebook and others to manipulate people's thoughts in politics or other areas', and stressed the need for legislation in this area.
Similarly, some form of protection for computer algorithms might allow models relevant to the iGEM competition (and to synthetic biology more broadly) to be shared in a similar way to BioBricks. Engineer Leroy Lim, responsible for some of the modeling aspect of the project commented that it would have been highly useful to have models from previous years available at the beginning of the project. 'People would be far more likely to share their code and collaborate on this if we thought we'd get credit for our work...with companies it's even worse, there's no option but to keep your code to yourself because there's nothing else stopping competitors from taking everything you've developed and taking away your business'.
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Intellectual Property is an increasingly important and controversial aspect of scientific advance, and synthetic biology is perhaps the paradigmatic area illustrating the effects of this growing legal influence. When thinking about how teams could turn their ideas from iGEM projects into viable real-world solutions, we realized that intellectual property is a crucial area to address.
In the process of putting together our report and our guidance for iGEM teams, our team, in collaboration with the event organisers Philipp and Bethan of UCL iGEM, ran an intellectual property workshop at the Young Synthetic Biologists Conference 2.0 for other iGEMmers interested in the issue. The event was a great success; teams attending said 'I hadn't really appreciated just how big an impact this area of law could have on scientific development and particularly on synthetic biology - it's given me a lot to think about!'. We had a great time and there were some really interesting and insightful debates and comments - thanks especially to iGEM Cambridge for their passion on this topic!
Oxford iGEM 2014
