Team:uOttawa/Safety

From 2010.igem.org

Human practices, ownership

The biotechnology industry today is characterized by a thicket of overlapping gene patents arising from 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, and companies routinely try to patent short segments of DNA such as expressed sequence tags. Developing countries are even re-framing their native genomic biodiversity as a natural resource, and staking their claim to it. The problem with this over-patenting is that it places unbelievable restrictions and red tape on researchers, which impedes scientific progress. Specifically, 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 moving in opposition to this restrictive, ownership-based culture by attempting to make biotechnology accessible and easy. By providing a standard framework for the construction and manipulation of genetic parts, iGEM allows complicated research to be performed. This framework also lowers legal hurdles to genetic engineering. By providing an open source platform for researchers, it is hoped that innovation will come more quickly, and the public will reap the benefits. However, patents and licensing agreements still exist, preventing some genetic sequences from being BioBricked, and some biotechnology methods from being used by iGEM participants. In order to address current licensing and patent barriers a BioBrick Public Agreement (BPA) is currently in its draft stages. It is hoped that this document will serve as a link between iGEM participants, publicly funded researchers, and industry stakeholders. This document can also help to map out the legal no-man’s land in which iGEM often treads. By providing a mechanism for the limited use of materials and methods, it is hoped that the needs of the research community can be met without, undermining the interests of private industry.

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. This is a much more even incentive system than the one currently drafted in the BPA.

RTLA’s are an ideal legal instrument 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. However, at the same time RTLA’s also provide a strong incentive for industry: they outsource product development for a very small cost. This benefits small to medium sized enterprises the most. RTLA’s are generally regarded as an innovative application of contract law, and the few criticisms leveled at them can be easily dealt with, in our case. A common objection to RTLA’s is that they sap profits from smaller companies who are just starting up. We argue this is a fallacy. First, a small firm can leverage this sort of contract system to expand its capacity. If a firm wants to expand its research efforts in a direction that exceeds its financial resources, or expertise, it can in effect put the question up for auction. That is, by making the property in question available to a large community, and purchasing back ideas it likes. Furthermore, by making the property available to a large number of researchers, the likelihood of discovering unforeseen applications is greatly increased.

A second criticism is that with so many stakeholders at the table the likelihood of negotiated agreement regarding revenues is less likely to be reached. This argument is also easily dispensed. Firstly, disagreement arising from the presence of multiple stakeholders is not a problem unique to RTLA’s. All contractual agreements involve multiple parties coming to some agreement. In fact, this is one of the defining features of a contract, along with all parties having something to loose. But the key point about RTLA’s in this situation is that they shift any 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, allowing them to conduct research in a more free environment. If anyone wants to make a profit, they will have to endure these complications themselves.

We think that RTLA’s provide a straightforward, accessible legal instrument that could serve to both invigorate the iGEM community, and spur industry participation. Dynamic, small to medium sized firms are probably those most likely to benefit from this sort contract.

Our own experience with licensing agreements can serve to illustrate where RTLA’s could help the entire iGEM community. In the construction and design of our library of toggle switches, we purchased Blue Fluorescent Protein (BPF) from Evrogen, as a reporter. Initially, we were going to BioBrick this gene; however, it was not to be. The licensing agreement that came with the BFP stated that we were only permitted to use a specific Clonase (supplied by Invitrogen), in the manipulation of BFP. In practice, this meant that no pcr or sequence manipulation could be performed. Not wanting to get sued, we could not add BFP to the iGEM registry. This led us to research different licensing options and, ultimately RTLA’s

Our experience has spurred us to raise awareness about the current state of intellectual property law associated with iGEM, and biotechnology in general. We feel that the legal issues surrounding iGEM are often an under-appreciated aspect of the competition, in spite of their significance. It is difficult to overemphasized how different iGEM is from most other areas of biotechnology. The approach to modularity, its open-source principles, and the attempts to make legal issues transparent to the researchers are truly unique. We need to work to preserve this part of iGEM’s nature, by raising awareness about how fragile it is and also by implementing thoughtful legal principles such as RTLA’s. Finally, We have included a discussion of legal issues in our poster and presentation to try and inform other iGEM teams about this exciting and relevant topic.

Safety

1. Our project would not raise any serious concerns about researcher safety. We worked with standard strains of Escherichia coli and Saccharomyces cerevisiae, which are non-pathogenic. Lab coats, safety goggles, and biological grade gloves were used whenever manipulating biohazardous materials. There were no concerns about public safety, since the strains were safe, and since we constructed simple toggle switches which would not be able to do harm if they were taken up by a bacterium in the wild. There were no environmental concerns, as all used reagents were disposed of in accordance with our laboratory’s standard procedure.
2. No safety issues were raised by any of our parts and devices. We mostly submitted promoters and terminators for S. cerevisiae, which are not dangerous. The cassettes for drug resistance, however, could increase resistance in bacterial populations against antiobiotics if they were uptaken. We did not document this in the registry, as it seems to be a common issue. To deal with this safety concern, we were careful not to allow the resistance cassettes to be in a position where they could be taken up by bacteria in the wild.
3. We do not have a biosafety group at our university. The Government of Canada has issued a lengthy set of guidelines pertaining to biosafety (http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index-eng.php). Our lab falls under the first containment level, meaning that no special design and practice features are necessary as we are not working with organisms which are dangerous if ingested or airborne. The sections of the guide dealing with recombinant DNA and genetic manipulation state that most recombinant DNA work is safe, but containment level and pathogenicity should be considered. Containment level is addressed above, and none of the strains we worked with were pathogenic.
4. In the human practice section of our project last year, we documented some safety changes that we thought were necessary. Briefly, the self-regulated structure which currently exists should be replaced by a structure where a small team of experts looks at any hazards which could arise from each project. They would conduct this before the jamboree, raising questions about foreseeable and unforeseeable consequences. This would not be unduly time-consuming because most projects are straightforward biotechnology projects; it is only a few which raise real safety concerns (more precisely, the proposed application raises safety concerns). It is important to add a feature like this to the safety repertoire of iGEM. The full text of last year’s report can be found here: http://www.ipm-int.org/boxmode/pdf/Ethics.pdf