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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

Please use this page to answer the safety questions posed on the safety page.

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 ==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.
+	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 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.
+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.
-	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.
+	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.
-	'''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 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 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 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.
-	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.'''
+	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
-	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.
+	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.
-	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.
 ==Safety==
 Please use this page to answer the safety questions posed on the [[Safety | safety page]].