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From 2010.igem.org

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Human practices, ownership

The biotechnology industry, today, is characterized by a thicket of overlapping gene patents; this thicket has grown so dense as to become a barrier to innovation. An estimated 20% of the human genome has some sort of patent relating to its use. This approach to intellectual property management has led to a number of potentially obstructive business practices; such as, seeking patents for expressed sequence tags and single nucleotide polymorphisms. This veritable patent gold-rush had led entire countries to respond to the perceived threat of foreign interests. These countries are re-framing their native genomic biodiversity as a natural resource, and staking their claim to it. Together, these types of practices risk the creation of a “Tragedy of the Anticommons”, where the world’s genomic heritage is owned by so many different stakeholders that innovation grinds to a litigious halt. iGEM can be seen as moving in opposition to this restrictive, ownership-based culture by attempting to make biotechnology accessible. In addition to providing a standard framework for the construction and manipulation of genetic “parts”, iGEM 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. However, we are concerned that the conditions of the BPA do not provide enough incentive to its industry signatories to lure partners. We hope that by providing a more even incentive system, more industry side partnerships will be generated. We propose an amendment to the BPA in the form of a reach-through licensing agreement (RTLA). So as not to exclude participants that do not want to take part in this particular clause of the BPA, the RTLA would exist on an opt-in only basis. In an RTLA, the researcher pays little or nothing upfront for unlimited use of a sequence or technique under intellectual property protection. However, in the event that a marketable product or technique arises from this research, all stakeholders are entitled to a portion of the revenues. RTLA’s are an ideal legal instrument for iGEM. They preserve the open-source nature of the registry, thereby freeing researchers to explore new techniques and applications. RTLA’s also provide a strong incentive for industry as it effectively outsources product development. This can represents a significant increase in capacity, particularly for a small to medium sized enterprise. 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 that this is in fact a fallacy. As alluded to above, a small firm can leverage this sort of contract system to expand 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. Again, we propose that this too is a fallacy. 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. This argument is at best misinformed, and at worst disingenuous. So, it is our opinion that RTLA’s provide a straightforward, accessible legal instrument that could serve to both invigorate the iGEM community, and spur industry participation. Again, we feel that dynamic, small to medium sized firms are those most likely to benefit from this sort contract. Ultimately though, there is no legal instrument to deal with obstinance, and some contract negotiations will inevitably fail. 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, and we used lab coats and safety goggles. 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 lab’s standard procedure.
2. No safety issues were raised by most 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 are 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 are working with are 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