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From 2010.igem.org

Human practices, ownership

Biotechnology today is characterized by a wasteland of overlapping gene patents, which is a product of commercialization and intellectual property management gone wrong. Approximately 20% of the human genome has some sort of patent on it or on tests surrounding it; companies routinely try to patent short segments of DNA such as expressed sequence tags; and developing countries are attempting to claim ownership over the genomes of the biologically diverse set of organisms inhabiting their corners of the world. This over-patenting can be seen as harmful, mostly due to the incredible restrictions and red tape it places on researchers. Researchers working with many types of genes or techniques must sift through layers and layers of intellectual property agreements, and risk paying large sums simply to have access to these tools and materials. iGEM can be seen as in opposition to this ownership-based culture. iGEM is an attempt first and foremost to make biotechnology easy, in the sense that it provides a standardized and unified collection of genetic parts, and has implemented ways of easily combining them. It tries to simplify legal and economic conditions for the benefit of the researcher, who can hopefully conduct groundbreaking research in this climate. Simply having a unified database of parts is a significant step in this direction. However, patents and licensing agreements still exist, preventing some genetic sequences from being BioBricked, or some biotechnology methods from being used by iGEM participants. What is being done to address this? A BioBrick Public Agreement (BPA) is currently in draft stages. This document is an interface between iGEM and companies or researchers providing genes. If signed by both parties, it allows iGEM to use a specific gene without infringing on a patent or paying any sort of fees, and in return gives companies exposure and credit.

We worry that the conditions of the BPA are not desirable enough for companies or researchers for them to sign on, which might lead to valuable genes being excluded from the registry. We propose an addition to the BPA called a reach-through licensing agreement (RTLA), which could be an optional component in the agreement. In an RTLA, the researcher pays little or nothing upfront for unlimited access to some gene or technology which was originally developed by somebody else. However, if the research conducted leads to a marketed product, the provider of the original gene or technology is entitled to a share of the profits. RTLA’s are the perfect agreement for iGEM. They preserve the open-source nature of the registry and allow researchers complete autonomy to do what they want. In practice this will likely lead to better science and bigger discoveries, since the scientists don’t have to worry about economics or intellectual property while they are doing the research. But at the same time, RTLA’s are an incredible incentive for companies or researchers who provide the gene. They know they are contributing to a climate of complete academic freedom, which will likely lead to groundbreaking research, and if that research leads to technology they have a bargaining position at the table. This all occurs for very little of their resources. RTLA’s are generally regarded as an innovative legal contract, and the few criticisms leveled at them can be dealt with easily in our case. A common objection to RTLA’s could be that they sap profits from smaller companies who are just starting up. Therefore we propose a graded system, like income tax, where companies making smaller profits pay less to the provider (0.5% of their profits, for example), while companies making larger profits pay more (say 2% of their profits). Another criticism of RTLA’s are that they are simply too complicated, with too many parties having a seat at the table when discussing profits when in reality they did not contribute much. First of all, this is missing the point that the initial parties played a large role by freely distributing their materials and allowing researchers freedom. However, if there are perceived complications, RTLA’s shift these complications from researchers onto companies who actually want to sell the product and make a profit. Thus it frees researchers from thinking of legal issues and profits almost completely. If anyone wants to make a profit, they will have to endure these complications themselves.

How did we get interested in discussing these pressing legal issues? We were working on building our library of toggle switches with varying dynamics, and we purchased Blue Fluorescent Protein (BPF) from Evrogen as a reporter for one half of the toggle switch. We were going to BioBrick this great gene, but we were shocked after reading the legal agreement they sent to us. We could only use one enzyme with BPF (a Clonase supplied by Invitrogen), meaning we could not use PCR on it. We also could not alter any of the restriction sites. Not wanting to get sued, we could not add BFP to the iGEM registry. That got us thinking about a number of issues which we discuss here. Due to our experience, we would like to raise awareness about the BPA and legal issues associated with iGEM in general, as it seems that this is an under-appreciated yet very important part of the competition. It can’t be emphasized how different iGEM is from most other areas of biotechnology, in that it is modular, open-source, and attempts to make legal issues transparent to the researchers so as to encourage better scientific progress. We need to work to preserve this part of iGEM’s nature, by raising awareness about how fragile it is and also by implementing smart legal policies such as the one suggested above. We have included a discussion of legal issues in our poster and presentation to try and inform other iGEM teams about this exciting and urgent area.

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