Intellectual Property Protection

The technology platform which is being commercially developed was originally produced from the Calgary iGEM team in 2012. This provides a unique IP situation, as this was completed by a large team composed of professors, students, and numerous funding sources. Additionally, all of the work which was completed was disclosed publicly through a variety of posters, presentations, and the 2012 iGEM Calgary Wiki. This has created numerous questions surrounding the protection of our invention, and the type of IP protection to take. The protection strategy that we have taken for our technology platform and business development is detailed below.

Figure 1. Overview of our intellectual property protection of which there are three major categories, regarding protection of our project, the right to operate within this intellectual space through our business development, and to assess the legal protection and ownership protection we require being a former iGEM project.

Patent Protection and Trade Secrets

The technology that we have developed, for the purpose of IP protection can be placed into two categories: 1) the Pseudomonas strain of bacteria genetically engineered to detect toxins in the environment; and 2) the electrochemical platform technology used to convert the sensory element used in the Pseudomonas into an electrical output. Both present unique challenges towards IP protection. The exact genomic region of the Pseudomonas bacteria that was modified was not disclosed at the iGEM 2012 competition, as the team did not have the time to identify where the transposon element was inserted. Because of this situation and the amount disclosed previously, the strain of bacteria will be held as a trade secret for IP protection. Patenting of strains can be useful, however, it fully discloses the nature and important components required for the system to work. Due to the increasing ease of genetic manipulation, it could be easy for competitive parties to copy and modify our system in the future. We can further protect our IP through genetic kill switch technology, and other genetic mechanisms of making it difficult to identify our organism. Each new product which is developed by the company will be treated in a unique circumstance.

The electrochemical sensing platform is the key component to our technology. It will allow for the development of this product, and could serve as a platform technology for future product lines. Therefore its protection is key to ensure the development and commercialization of our technology. Because of disclosures which began in September of 2012, patenting of this platform outside of the USA and Canada, is not possible. In order to protect the technology, our group has filed a provisional patent for protection in the US and Canada with the intent of filing a utility patent in one year. This has been completed with Harm Dekkers who is a consultant through HMG Consulting, and has a wide variety of experience with biotechnology related patents.

Our invention is novel and non-obvious and no other example of a multiplexed electrochemical output system exists in the literature nor in any previously published patent. Some examples of prior patent prior art we have looked into are as follows:

Table 1. Provisional Patent prior art patent samples demonstrating some of the prior art which was related to our project.

The electrochemical detection platform patent will provide protection for any in vitro or in vivo system using our enzyme/analyte combination or any related enzyme/analyte combination, allowing for our group to have the opportunity to diversify our technology if required, or further optimize the system all under protection of this utility patent.

During product development some engineering hardware/software based IP may be developed. While the present technology development plan aims to use open-source or generic materials, programs, and systems, it is possible that some intellectual property may be produced from the unique implementation of these systems. If that becomes the case, the system will be evaluated for their potential patentability.

Patents previously developed as a result of the 2012 iGEM group shall be held by the six iGEM students who are developing the technology. The patent will be freely licensed to FREDsense in order to ensure that the platform technology will be hampered in the event that the system can be used for other markets and applications.

Intellectual Property Relating to the iGEM Competition

An important aspect of our IP comes into play with those who were responsible for developing the original platform technology on the University of Calgary 2012 iGEM team. This team consisted of 4 professors at the University, ~25 undergraduate students from various faculties, and ~4 graduate students (MSc and PhD) from the faculties of Biological Sciences and Medicine. More information on team composition can be found at https://2012.igem.org/Team:Calgary/Team. Additional parties which hold a stake in our technology include the University of Calgary.

The IP for our project was developed exclusively from a subset of the undergraduate and graduate students who were a part of the team. Because of the rare situation with non-University employee’s developing IP using University of Calgary services we are presently negotiating with the University to determine their stake in our venture. Additionally, we have approached the University of Calgary tech transfer office known as Innovate Calgary. They provide support to new start-up ventures hoping to spin out of the University of Calgary. To collect the IP within the individuals moving the company forward, we have approached all members of the 2012 team and asked them to sign a release form for their contributions to the project. Additionally, we have negotiated with the professors of our group, who have signed release forms, and provided written consent that we have their permission to develop this technology independently. All of this information is available upon request.

In addition, many of the professors at the University have been given the opportunity to become involved in our company or to sit on our advisory board. Those who have not displayed interest in doing this have also been approached to sign a release.

Figure 2. IP strategy relating to previous iGEM members and professors.

In order to protect our intellectual property previously developed, we have chosen to hold the IP as a group of six members from the iGEM Entrepreneurial team and license this IP to any legal body which we are involved with and require that IP to grow.

IP that is developed in collaboration with our Academic and Industry groups will be held by all parties involved in the development of the technology. To ensure that this technology is not disclosed we have asked all parties involved with our technology development to sign non-disclosure agreements to ensure all information remains patentable.