Phase 1 of our policies and practices component begins with an argument for why a new organizational solution is needed to help iGEM participants continue to develop their technology after the competition. A an original graphic depicting how our solution, the Student Research Collaborative, functions is then presented. Phase 2 presents our group's efforts to organize a collaboration with corporate entity, Anaerobe Systems. In addition to providing a summary of our experience, the case study contains a suite of legal forms future iGEM groups can use to organize their own corporate partnerships. Phase 3 is fulfills our collaboration requirement by presenting excerpts from three former iGEM participants that have used their experience in the competition to found their own technology startups. It also presents our survey results collected from members of current iGEM teams. Lastly, in addition to the interview and survey portions of our work, our team engaged in special collaborations with iGEM Bielefield and the University of Michigan Biosoft Team. With Bielefield, we assisted their efforts to draft a set of guidelines for minimizing the risk of a third party synthesizing date rape drugs from the disclosures made in their project. For University of Michigan Biosoft, we help them resolve copyright and trademark conflicts between their protocol database ProtoCat and a similar service offered by New England Bioscieces (protocols.io).
You can see the survey results here.
Entrepreneurship is not a novel concept. For centuries scientists, engineers, lawyers, and executives have combined their strengths to deliver new applications of technology to the marketplace. Many of these early entrepreneurs were seen as idealistic, arrogant, foolish, “in need of a real job”, or even a little bit crazy. Thanks to the rise of the billionaire tech entrepreneur demi-gods: Bill Gates, Larry Ellison, Steve Jobs, Jack Ma, and Mark Zuckerberg, the entrepreneurs of today have an improving reputation. Especially in some places like California's Silicon Valley where entrepreneurs are seen as visionary geniuses with the power to connect people and give them more information about their environment.
A youth movement is also occurring in entrepreneurship as more young people are given the opportunity to demonstrate their ability to create useful technology. Student entrepreneurs are being forged on late summer nights in empty lab facilities around the world. At these locations, you will find no demi-gods, no headlines describing million dollar investment deals, no flashy founders wearing Apple Watches or driving Teslas, no feng shui office space, and no sparkling mineral water. Instead, only the essence of entrepreneurship remains: an inventor and an idea.
As Conary Meyer, a junior bioengineering student at Santa Clara University, shuffles a batch of glassware into an autoclave it becomes clear why he's here every night toiling into the wee hours of the morning. He loves research, has a passion for the technical solutions it can create, and possesses an uncommon belief that his technology will one day have the power to make life better. Conary embodies the best of iGEM and its students like Conary that ensure iGEM remains a world leader in synthetic biology.
Keen to encourage the sense of purpose beyond the bench present in student entrepreneurs like Conary, iGEM introduced an entrepreneurship track to its global synthetic biology competition in 2012. That year thirty six teams of student entrepreneurs showcased their technology at the iGEM e competition. Since then, some, like MIT's Benchling, have come to fame for courting multimillion dollar investments from venture capital firms. Others driven by less academic prestige like, UC Davis's Ambercycle (which relies on a mixture of government, academic and corporate partnerships for support) are on progressing on a more deliberate track.
The majority of projects, however, were ahead of their time, passed over for better ideas, or simply shelved for no good reason. Many of the students who developed the technology behind the projects at iGEM e viewed continuing to work on their idea as impractical or too time consuming. Instead of the becoming entrepreneurs they opted to go to dental school, medical school, graduate school or took jobs in industry. In Europe, where student entrepreneurship is less established, even student ventures with award winning technology, like Morph Bio, struggle to break through with investors absent PH.D scientists, engineers with industry experience, or an executive with prior startup success. These ventures, however, can be just as valuable because of the personal growth, problem solving expertise, and technology development experience that accompanies iGEM participation. Talented individuals like Cindy Wu and David Brown exemplify the value working in a hands on research collaboration. Each has used the student driven collaborative research experience iGEM provides as a stepping stone to founding successful technology startups (Experiment and Mycodev respectively).
Despite the proclivity of iGEM projects to produce valuable technology and skilled research scientists the vast majority of syn bio projects are not supported after the iGEM competition. Sure, many schools have robust iGEM programs that provide students opportunities to do synthetic biology research every year (Heidelburg) and many of the most successful iGEM projects are continuations of previous years (SYSU Software 2014), but its still uncommon for groups of students to take on the technology they developed for the competition and focus its application to solving real world problems like unsustainable plastics recycling or waste intensive oil refining. Its as if most iGEM research happens in a vacuum. While iGEM has always been and will continue to be primarily a science education initiative designed in to engage more students in hands on synthetic biology research, the 2012 iGEM e class demonstrates that iGEM's student entrepreneurs and their technology are needed beyond the lab bench. Moreover, facilitating the transition from research project to entrepreneurial venture appears a natural extension of most university operations considering all the resources students need to continue their ideas are locally available on the same campus they frequent daily to attend class and study.
As academic corporate partnerships and the idea of applied research has come into vogue during the last twenty years, research focused universities have assembled all of the tools and infrastructure needed to become incubators for startups. They possess state of the art research facilities and equipment, esteemed faculty with experience in developing technology for industry, working relationships with corporate partners, networks of entrepreneurial alumni, technology transfer offices to provide guidance on intellectual property issues, and swaths of other students with the experience in ancillary business and legal arts needed to organize a startup venture.
Although seemingly immersed in an environment built for technology startup production, gifted science and engineering students still struggle to put all of these pieces together and lack the basic business and legal understanding needed to organize a technology startup. Of the seventeen students from eight programs we surveyed, no student indicated they had ever interacted with the school's technology transfer office despite the fact that most knew such an resource existed. Additionally, only one student indicated they had taken a course in entrepreneurship while we received no replies suggesting exposure to basic entrepreneurial skills was a required part of their science or engineering curriculum.
Being an entrepreneur is hard because it takes a tremendous amount of energy and involves working in a variety of different fields. As demonstrated by our survey, aside from a capstone senior design project or research thesis, few science and engineering curriculums provide opportunities for students to obtain the skill set required for organizing their research into a an ongoing commercializable project and pursing the relationships with technical advisors, financiers, and other entrepreneurs they need to succeed. As a result, many students with the time, passion, and technical capacity to develop technologies to improve man kind lack the ability to breathe credibility and legitimacy into their projects by writing a business plan and developing formal research milestones. This in turn impacts their ability to recruit fellow students to collaborate with in lab and find mentors and investors in the community. As a result, most student groups rely on the organizational framework of iGEM student groups to develop technology for the competition but struggle to develop infrastructure for continuing to develop their ideas after the competition. This is unacceptable because giving students opportunities to apply technology in ways that solve real world problems provides the best preparation for professional life and the industries and societies of the world have an acute need for technologies which make life cleaner, less resource intensive, and more sustainable.
Our project seeks to encourage student groups to continue developing the technology they created for iGEM by presenting the student research collaborative. This entity is an organizational solution for student groups that have an idea they would like to research, but have not developed it enough to invest in a full fledged startup operation.
Case study 1
Anaerobe Systems is a company that specializes in finding ways to maximize anaerobic culture techniques and is also the only company in the United States that produces the only true Pre-Reduced Anaerobically Sterilized (PRAS) plated and tubed culture media. After connecting with Mike Cox, the CEO of Anaerobe Systems, students from Santa Clara University’s iGEM team analyzed the fermentors utilized by Anaerobe Systems to degrade organic waste and realized there was room for improvement.
The primary issue that the Santa Clara University iGEM team identified was the constant acidification of the culture which compromises cell vitality. Anaerobe Systems adds a large amount of base to neutralize the acid but this process greatly damages the cells and slows the growth kinetics, while also adding extra costs.
Therefore, Santa Clara’s University’s iGEM team set out to create a system that will allow the cells to be able to survive in the increased acidity so that no or, at the very least, less base will need to be added. This new system could hypothetically lower operation costs while also decreasing culture run time. The team’s primary goal was to build a BioBrick that is capable of introducing Escherichia coli’s cyclopropane fatty acid defense system into other organisms in order to increase their survival under low pH conditions.
Case study 2
Research being conducted in universities across the globe has the potential to be the impetus for many of the private sector’s most innovative and successful technologies. Such research can help generate the building blocks for new commercial products, new products that can help the community at large and new patents that can be taken advantage of by the private sector. The relationship can begin when a private company simply provides funding for a new research product, or the relationship can begin when a university takes the current product or technology of a private company and provides modifications and improvements.
Arguably, the relationship has the opportunity to be so successful because of the different viewpoints, motivations and capabilities of the two sides - the private sector and the university. The private sector often has the means, typically in the form of capital or intellectual property assets, such as patents, to fund and begin specific research ventures and to provide the necessary equipment or technology. Universities, on the other hand, while not always having the means to conduct research on their own, possess the manpower, time, creativity and desire to conduct research and development that a company may simply not have the bandwidth or desire to direct its employees to conduct its own, all while bolstering their own prestige. Aside from the disparity in resources, generally, universities and the private sector also come to the table with different motivations. Specifically, the private sector is usually concerned with generating capital through the development of new products or intellectual property assets. Universities are often concerned with bolstering their standing in the creative community and their ability to attract new talent to build upon that standing.
The differences in motivation and resources may foster a creative relationship, but also presents a unique set of challenges for both of the players involved. Both companies and universities should take care to protect themselves before, during and after the relationship begins. Both sides often have intellectual property assets which they wish to protect. In order to begin a collaborative relationship, both sides often insist upon the a non-disclosure agreement - the mutual NDA. The agreement attached as Exhibit A represents a sample non-disclosure agreement with short explanations and suggestions that may hopefully provide a working understanding of the different facets of the agreement.
In addition to protecting information through the non-disclosure agreement, the two parties may want to both protect themselves and place concrete limits and boundaries on the relationship through an array of different agreements, including material transfer agreements and patent licensing agreements. Material transfer agreements can be beneficial in setting the specific terms and conditions by which either party may transfer their product or research materials/results while setting the boundaries on the rights of the receiving party. The agreement attached as Exhibit B represents a sample material transfer agreement with short explanations and suggestions that may hopefully provide a working understanding of such an agreement. A patent licensing agreement typically grants the right to one party to use the invention or method protected under a patent owned by the other party. Often times, the research conducted through these relationships is entirely dependent on material or methods that are owned exclusively by one party. Thus, the patent licensing agreement provides the core tool that enables such research. The agreement attached as Exhibit C represents a sample material transfer agreement with short explanations and suggestions that may hopefully provide a working understanding of such an agreement.
Case study 3
Currently, there does not exist a close relationship between Santa Clara University’s iGEM team and Anaerobe Systems and there has been very little recent contact between the students and the CEO, Mike Cox. The Santa Clara University iGEM team has been involved in pursuing an independent project in order to solve a problem that is encountered by many scientists and other companies. Therefore, the Santa Clara University iGEM team’s strategy has not been in danger of infringing upon any of Anaerobe System’s intellectual property rights due to the limited amount of interaction. Anaerobe System’s strategy of adding a large amount of base to neutralize acid is something that many biotech companies do and Santa Clara’s attempt to create a new system to find a solution to this problem does not constitute any kind of infringement.
Nevertheless, it is not uncommon for many student groups to be in a similar situation characterized by limited contact with a biotech company. Under these circumstances, the possibility always exists that the students may be infringing upon the intellectual property rights owned by the company.
Although the costs associated with patent litigation can be very high, the ramifications for an infringer can be severe. When an infringer loses a patent case, that party can sometimes become, in effect, a licensee and may be required to pay a reasonable royalty for any future sales derived from the patented product, method, or technology. Furthermore, a court may issue a post-trial injunction, which is an order for the infringer to stop infringing the patent currently and in the future. A patent holder can also request a preliminary injunction from the court, which is an order that prevents the alleged defendant infringer from using or selling the patent during the trial.
Therefore, it is important for a university or student group to learn how to avoid infringing on a patent or any intellectual property rights in order to not be forced to defend a costly and time-consuming patent infringement lawsuit in the future. The most important thing to do is to identify which patents, if any, there is a chance you may be infringing. The first step is to conduct an online patent search via the U.S. Patent Office. When conducting the search, it is important to search for patents that are in any way related to your technology. Using keywords that describe your technology and searching the assignee records for patents owned by other companies as well are good strategies. Many small companies may not assign a patent to their company, so it is imperative to also search using the names of any known inventor, typically the owner or CEO of the small company. In the case of larger companies, some do not own their patents directly. Instead, they may be associated with an intellectual property holding company that that owns their patents. Thus, you will have to research whether or not one of these holding companies is involved, find out their name, and conduct another search via that additional route.