The School of Technolgy Law at NCTU

In order to understand the legal issues related to our project, we invited CHEN Chih-Hsiung, the School of Technolgy Law at National Chiao Tung University associate professor (specializing in FDA related laws), to help us.

We talked a lot and our team member learned the following:
1. The paper usually have copyright but no intellectual property rights, unless there is a special application.
2. If after the patent contents are published, the patent application is infeasible.
3. The patent application time:
(1) Before being published
(2) After modifying published patent content or to retain part of the technology can apply for part of the patent
4. The three patents for:
(1) Novelty: the published content in the application of new technologies must be present.
(2) Inventive Step (Non-Obviousness): Technical staffs cannot simply develop the same technology as patent content.
(3) Industrial Applicability (Utility): technology must be able to use.
5. The patent does not necessarily be achieved after the completion of the final test phase success.
For example: pharmaceutical industry can apply for a patent after the initial success on cell experiments without waiting for long-term clinical experiments
6. Clinical trial exemption is to protect medical equipment (we prefer this concept), and patent is to protect technology.
7. It is possible that FDA-approved drugs have patent so we have to go through verification to confirm whether our project violate the company.
8. When applying for a new patent, we must envisage extending concept for a wide range to consolidate core technology.

After the interview, we get a lot of information about patent application and we will be more clearly to deal with our project in the future. Thank CHEN Chih-Hsiung associate professor very much for this interview.

ApexBio

The iGEM organization has a strong history of promoting “bio-tools” to support industries in need. However, walking out of the labs and commercializing the products is something hard to achieve. During the process of developing products, we must address a lot of problems about mass production and quality control, etc. To have a strong connection with commercialization, we consulted APEX BIOTECHNOLOGY CORPORATION which is an international holistic development company. The ApexBio struggles on research, development, production, and sales relating biotechnology products, especially biosensors. It is the prime company which has deeply impact on bio-detection. Since our APOllO E.Cotector focus on the detection of prescribing therapy, we believe that this consultation would really lead us to a great breakthrough.

• ■Seek recommendation of developing our APOllO E.Cotector
• ■Seek advice for the revolution from research to development
• ■Seek answer about the position of our APOllO E.Cotector in the field of biodetection.

The thought-provoking lessons we learned

Transition of research to development:

At present, we put every effort for pursuing flawless and convinced experiments results to form our APOllO E.Cotector. However, after the conversation, we realized that experiments results are just the first step of commercialization. In order to further develop our APOllO E.Cotector into product, we must consider a lot of factors in reality. The BioApex has mentioned that the stability and specificity are two essential points that we must control in mass production. For example, the concentration (CFU), oxygen flux, and temperature of bacteria and the process of purification must be under control.

Expiration date of products:

In addition to meeting up the customer needs, the company must ensure that the products are safe. Moreover, the expiration date must be clearly indicated to remind customers. Thanks to ApexBio’s recommendation, we contemplate about the length of E.Cotector’s effective performance. Hence, we redesigned our experiment to achieve high standard of safety and get more closed to commercialization.

To get more details about our experiments, please see Safety page.

Product Packaging:

Without very impressive and attractive product packaging, our marvelous E.Cotector can’t exert its potential to contribute to the society. The ApexBio gave some advice about our presentation and some skills of product packaging, which made us more brainstorming.

After this trip to consult ApexBio company, we reassured the prominent value of our project and revised it to optimized. Our APOllO E.Cotector will have an impact beyond description and promote the iGEM organization spirit: create synthetic biology tools to contribute to the world.

Clinical: Visit Doctor and Interview with recovered patient

An oncologist visited our university, we grasped the opportunity and we talked to the doctor and elaborated our project. We were wondering how we will help patients with our project and if we really provide a better way to prediagnose. After a long discussion about the practical use of our project and the advantages. The doctors said he was pretty amazed by our intelligent idea that we just use E. coli to prediagnose. This simplified the procedure and improved the efficiency. We were so excited that our project could also be applied well in practical use. It could really help people!

One gorgeous day, three of us visited a teacher, who has recovered from breast cancer for 4 years. The purpose of this meetup was to recognize deeply how a cancer patient suffered from cancer. She surprised us with her open-minded, optimistic and brave personality. She discovered the tumor by herself and confronted with her misfortune straightly. Because of her characteristic, she overcame the cancer with only 4 chemotherapies. We really appreciate her sharing. During the conversation, we had a wonderful interaction with her, introducing our ideas and goals to her. Despite that the therapies she took was not relative to our project, we still received a lot of supportive response for our project from her. Last but not the least, we all realized some valuable experiences and feelings in the recesses of our mind from this meetup!