E. coli Nissle 1917 is one of the most studied probiotics in the world. It is commonly sold abroad under the brand name Mutaflor®, and it is used in the treatment of IBD. While we do not plan on making money off our invention, a superior probiotic strain has an obvious economic advantage. As a result, we considered a variety of theoretical entrepreneurial options. To determine the plausibility of our options, we met with Robert W. Emerson, J.D., Huber Hurst Professor of Business Law at the University of Florida.

Intellectual Property

To successfully file a patent, an invention has to meet three criteria. It must be:

Useful
Novel
Non-obvious

Because these requirements can be very specific, the iGEM Competition presents challenges where it comes to intellectual property that are rarely discussed. These obstacles include the BioBrick® Public Agreement that requires teams to give up intellectual property rights, and the simple fact that teams publish their work for the Jamboree. Both of these make claims that the invention is novel and non-obvious more difficult to prove. While the UFlorida team strongly believes in the open-source spirit of iGEM, our theoretical business plans require us to obtain intellectual property rights to our probiotic.

Since an intellectual property claim is essential to our entrepreneurial ambitions, our meeting with Professor Emerson was centered around securing a patent. Because attempts to upregulate butyrate production in E. Coli Nissle 1917 have been done before with little success, any successful bacterium would meet the non-obvious requirement by solving a standing problem. In addition to this, the U.S. provides a 12-month grace period in filing provisional patents. This means that presenting at the Jamboree will have no effect on our ownership claim. Lastly, our part in question was not submitted to Biobrick®; however, we wanted to mention that it would still be theoretically possible to obtain a patent if we did. We could continue to upregulate our probiotic strain by performing more gene deletions, or we could design a delivery system that allows dietary intake. Either of these options would merit a patent. Even though we plan to submit our part to Biobrick® soon and allow it to be used through open-source, we hope that discussing a theoretical exploit will encourage iGEM to take a stronger and more transparent stance on intellectual property.

After taking the necessary steps to ensure we have patentable subject matter, we have to consider competing stakes in our project. As per the University of Florida’s Intellectual Property Policy, we will disclose our invention to the Office of Technology Licensing (OTL) using the form provided. This has a dual effect of determining the university’s stake and provide us guidance in obtaining and implementing an effective patent. Once we obtain a patent, we can begin to implement one of our business plans.

Business Plans

We have identified three different entrepreneurial possibilities in regard to our product each with their own benefits and trade-offs:

Create a Start-up
License our product
Sell the invention

Start-Up Route

Creating a company from the ground up will allow us to maintain complete control of our probiotic. This is the most time-consuming route as it will require extensive planning. The first step is to create and maintain a brand for our probiotic, which we will call Gator-ate. As preliminary steps, we have prepared basic marketing models to gain a better understanding of what we have to accomplish to make this a reality.

SWOT Analysis

Marketing Mix (4P's):

1) Product

Gator-ate is a more potent strain of a widely studied probiotic that reduces inflammation in the gut. To meet client needs, the product must have a system that allows effective delivery to the gut. This will be in the form of a pill that is designed to protect the bacteria as it passes through the stomach. Customers will use an ideal dose until Gator-ate successfully colonizes the gut.

2) Price

Ideally, Gator-ate will be priced comparatively to standard strains of E. coli Nissle 1917 to help us gain shares in the niche medical probiotic market.

3) Place

Given the target demographic of adults with chronic conditions, Gator-ate will be most effectively distributed online and over the counter at pharmacies.

4) Promotion

Public relations will be the focus of our marketing campaign. The iGEM Jamboree allows us to share preliminary information. Additionally, we can reach out to well-respected experts in research on IBD to perform studies and utilize social media to spread word of mouth through the relatively homogenous target demographic.

Licensing Route

Licensing would allow us to maintain the rights to Gator-ate while allowing us to profit on royalties. Pursuing a narrow patent would be beneficial on this route as it will be easier to obtain and enforce our claim. This route would involve some marketing work and outreach. We would send ambassadors to conventions to meet with companies and tell them about our product. Additionally, it would be beneficial to get several research studies done on our project to spread by word of mouth.

Sell Route

Selling our patent would be the quickest and easiest route. It would allow us to collect money right away, but we would lose the rights to our invention. There are several notable companies we can approach including Mutaflor® to see if they would be willing to buy our rights. Marketing on this route will be very cheap. We would just send the Wiki link to companies that already have interests in the probiotic/IBD markets.

References

Emerson, Robert W. "Intellectual Property." In Law, Society and Business, 377-428. 2018.

"The BioBrick® Public Agreement (BPA)." BioBricks Foundation. Accessed October 15, 2018. https://biobricks.org/bpa/.

Team:UFlorida/Entrepreneurship

Entrepreneurship