Team:BHSF ND/Human Practices

Safety

Index
1. Background
2. Overview
3. Factory
4. Government
See More About
Collaborations
Public Engagement

Human Practices

Background

With the rapid development of the bioindustry, substrates such as microorganisms are widely used in production, fermentation, and etc. Although we enjoy the dividends brought by the bioindustry, there are hidden problems indeed.

First, problem exists in deliberate core bacterial theft. The core bacteria in some technology companies or food production companies that determine their new products and technologies at their cutting edge may be stolen by other competitors.

The second problem is that some companies' biosafety system development are not comprehensive enough, causing some bacteria in the company being inadvertently leaked. These inadvertent leaked bacteria may have a great impact and damage on the ecological environment, so we need to take some measures to reduce these.

In the first case, this deliberate bacterial stealing behavior can be called an intellectual property dispute.

What is intellectual property?

Intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. One of the most highly scrutinized aspects of companies is its intellectual property. As part of most legal transactions, whether involving a financing, an acquisition, asserting IP against a third party, or even a collaboration with another company, confirmation that no third parties can step in and claim ownership of the company’s core assets is crucial.

Why intellectual properties are important?

Intellectual properties can provide incentive to the individual for new creations and recognition to the creators and inventors. It can also ensure the material reward for intellectual property and the availability of the original product. In technology and industrial company, intellectual property protection is significant for it closely related to the economic growth (GDP) and advancement in technology sector. They are benefited for the growth of the business in the field of technology.

In the history of intellectual property theft is a very common problem. Theft of intellectual property is spread across all fields. The government and relevant agencies have been trying to solve this problem. In recent years, instruments enforcing intellectual property rights (IPRs), such as patents and trade secrets, have received much attention than before. However, there are still problems dealing with Intellectual property.

Figure S5 shows the PTAB decisions for all IPRs instituted for the period from 2012 to 2016. The data above shows that although there are more and more people applying for and successfully granted intellectual property rights in China, there are still many problems.

China has a large intellectual property dispute in the entertainment industry. Trademarks of Chinese companies are regularly counterfeited, and locally produced music and movies are veraciously pirated in both digital and physical form. Countering Chow’s premature example of China’s successful efforts to protect Beijing Olympics merchandise, these commentators often point to the seemingly ubiquitous presence of counterfeit merchandise both prior to and after the Olympic Games in 2008 as evidence of the central government’s inability to control the problem. In this regard, Yu states: “If one could draw any lesson from the protection of Olympic symbols in China, it is how serious and entrenched the piracy and counterfeiting problems are in the country... Due to the country’s rapid decentralization, the central government does not have the ability to fully protect the Olympic symbols throughout the country.”

As another example, biotechnology companies use patents to protect their intellectual property rights to drug delivery devices. AstraZeneca owns the intellectual property rights to the Symbicort Turbuhaler, which is the drug budesonide/formoterol in a dry powder inhaler for the maintenance treatment of asthma and COPD. Other health care companies use patents to protect their intellectual property rights to devices such as splints, prostheses, vision testing machines and the computer systems used in health care management.

In the second case, inadvertent bacterial leakage can damage the environment. Bacteria produced by some companies may react with some substances in the environment, causing necrosis of some plant organisms, and may even threaten human health and life.

For instance, leakage of Campylobacter Jejuni may cause diseases of people. Drinking water contaminated with Campylobacter Jejuni can cause infections with symptoms of cramping, diarrhea, fever, and pain. Symptoms of infection appear between two and ten days after exposure.

To deal with two kinds of problems listed above: intellectual properties theft problems and bacteria leakage, we developed our project, bistable system, to prevent the bacteria leakage and deliberate bacteria theft.

Reference:

https://www.investopedia.com/terms/i/intellectual-property-rights-biotechnology.asp

https://www.nap.edu/read/2054/chapter/32

https://www.ukessays.com/essays/property/importance-of-intellectual-property-rights.php

http://www.biologydiscussion.com/biotechnology/intellectual-property-rights/intellectual-property-rights-and-biotechnology-an-overview/11921

Overview

To us, human practice is a chance to realize the relationship between our project and realistic problems thus improving our project to solve realistic problems better. It is also a chance to engage in public and help them to know about synthetic biology and its application.

In order to know whether stealing patented microbes among factories is a problem with ineffective solutions, we interviewed a manager in Yanjing Brewery and enterprise patent right consultant Mrs. Chen Yingjuan. Based on the interview and research on patent right, we came up with proposals that may help improving the methods and exectution of patent right protection.

In order to know about the present methods of protecting patented microbe strains from spreading out of labs and factories, we interviewed Ph.D. Candidate Mr. Wang Xuan and forensic microbiologist Dr. Yuan Meiqing.

At the meantime, we also received useful suggestions on optimizing our project from the manager in Yanjing Brewery, Mr. Wang Xuan, Dr. Yuan Meiqing and Mrs. Chen Yingjuan.

For public engagement, firstly, we went to high schools and gave them lecture and games on basic ideas of synthetic biology that expand their scope of knowledge. Secondly, we went to nursing homes and gave lectures to them on the application of synthetic biology.

Factory

We mainly interviewed and in-depth surveyed two microbiology companies, Yanjing Beer and Bluepha Microbiology. After working with them and discussing, our projects, experimental operations, and hardware design have been significantly improved. At the same time, our projects and actions have had a positive impact on the development of their company.

Yanjing Brewery

Many factories use patented microbes to produce their products, and their patented microbes may be stolen by their competitors. In order to know in factories whether there are effective solutions to the problem, how our project can help and how we can make our project more applicable on solving the problem, in July, we visited Yanjing Brewery in Shunyi, Beijing.

Figure 1: inside the Yanjing Brewery

We interviewed one manager, and he indicated that their yeast strain was once stolen by one of their competitors. They solved the problem by negotiation, without having a prosecution, since prosecution is time and money consuming, and finding effective proof is difficult. However, he thought their factory need to protect their patent right. His feedback confirmed that stealing patented microbes among factories is a problem with ineffective solutions.

To help them to solve this problem, then, we introduced our project design and asked whether it can be useful in solving their problems. The response was promising. The staff said the project was creative, and it had a strong potential application prospect. Based on their discussions, they appreciate the ability of our projects to prevent leaks, while at the same time, they provide more plant-related improvements to our project design. In the line design, they emphasized the cost of the bacteria needed for industrialization. To solve this problem, we changed the original multiple bistables to two bistables. At the same time, we designed our hardware according to their needs.

They think that our project has a big promotion. They gave us an in-depth introduction to the process of industrial production and related considerations. Also, they suggest that we should expand its adaptability so that it works in different microbe strains, reduce the cost of customizing different plasmids, and popularize it among different factories.

At the same time, we help their government-related departments teach the importance of patent protection for their company's interests and development. We helped them to clarify the latest patent application process and related laws, and the importance of patent protection with their researchers.

Figure 2: our visit to Yanjing Brewery

Bluepha- the first synthetic biology company of China.

In August, we were fortunate to meet Li Teng, CEO of Bluepha Bio Ltd. The purpose of this interview is to understand more about how synthetic biotech companies can protect their strains in industrial production while achieving efficient mass production.

Figure 3: Li Teng

After our interview, we found that Bluepha has a special government public relations department. They will always keep in touch with the government and assist the patent office in completing the patent protection of their company's bacteria. We were fortunate enough to visit their R&D staff. They are developing degradable plastic. We are confused about the two concepts of biodegradation and leakage. After discussions with R&D personnel, we have a deep understanding of the safety issues of synthetic biology. The R&D staff gave us some advice on the toxin. They emphasized the efficiency and relative safety of toxins.

They showed us their lab. The visit to their experimental equipment and the cleanliness of the experimental environment gave us a good example. Together with them, we have standardized our protocol and our experimental operations related to our project. Inspired by them, we cleaned our lab and improved our experimental operations. These changes have greatly improved the efficiency of our experiments.

Future

In the future we will increase our cooperation with other bio companies. We hope that more companies can focus on the use and protection of intellectual property, using synthetic biology and more cutting-edge technology to protect their products. In the future, we also intend to commercialize our products and hardware into the factory to truly promote the development of the entire field.

Government

In order to solve the problem of intellectual property in the microbiology field, we discussed with many experts how to improve patent protection issues and related policies. After summarizing the interviews and inquiring about the information, we provided the government with a proposal that succumbed to changes in policy and management.

Interview with an anonymous government official

(Because the official also appointed the Central Committee of the Republic to appoint the government's patent office, it is not convenient to directly disclose the name and related information.)

We first asked the questions we were most interested in: how patent offices and related laws protect intellectual property in microbiology and synthetic biology. After our interview, we learned that the patent law has no relevant effective rights records and success stories for the newly developed synthetic biology and related products. However, we have discussed that there are many microbiology companies, such as breweries, yogurt factories, and pharmaceutical companies, which have related intellectual property disputes. Most of the acts of stealing and illegally earning trade secrets are privately resolved between companies. We are aware that in the context of the rapid development of microbial and synthetic biotechnology, there is still much room for improvement in related intellectual property protection and related protection measures similar to our projects.

In addition, she also introduced us to the difficulties and solutions that our iGEM project will encounter when registering patents and applications with relevant government agencies. While affirming the results of our project, she also proposed some relevant government recommendations on biosafety requirements to our toxin section.

Interview with Patent Right Consultant

We interviewed biology Ph.D. Candidate Mr. Wang and forensic microbiologist Dr. Yuan to find out the answer.

“What problems can be caused by GMO microbes leaking into the environment? What are the present methods of protecting patented microbe strains from spreading out of labs and factories and their weaknesses? How can our project provide a better solution to this problem? ”

Figure 4: meeting Dr. Yuan

We asked about the outcome of GMO microbes to leak into the environment. They suggest that if GMO microbes leak outside the lab or factory, they can exchange their GMO plasmids with the bacteria in natural environment, thus causing gene pollution which may reduce biodiversity since the gene pool of the microbes is changed.

We wanted to know what methods we now use to prevent gene pollution. They suggest that current methods include adding NaOH or H2O2 solution in the GMO microbes or putting the liquids containing GMO microbes in a High-Pressure Steam Sterilization Pot to kill the microbes then pour it down the sewer. This can be done in lab conditions, but for a factory, it is too costly and slow, and the risk of letting out GMO microbes is high.

While understanding the relevant measures, let's explore some solutions together. We analyzed the strengths and weaknesses of the current approach, and we discussed how to work with the government to solve and promote related areas. We believe that the government plays a powerful role in regulation. We explore how to write relevant proposals to the government and what are the appropriate ways to send our proposals to the government.

Interviewing Consultant and first author of an academic paper

To learn more about why people tend to solve disputes on patented microbes stolen by their competitors by negotiation rather than prosecution, we interviewed enterprise patent right consultant Mrs. Chen Yingjuan.

According to Mrs. Chen, the evidence that proves the microbe is stolen is difficult to find since microbes often leak to places outs. The patented microbes can easily spread outside of the lab or factory by air, contact or water due to improper disinfection of the factory.

Therefore, it is difficult to judge whether the defendant has stolen the bacteria since the microbes.

In order to improve our experiment, we communicated with the author of our major reference paper on e-mail. He provided inspiration and strong support for our project design. Besides getting a lot of help on doing our experiment, we also knew about how Europe protects microbial patents. He showed me how European countries and European patent offices protect their microbial products. We introduced each other's advantages and disadvantages in patent protection in China and Europe. We realized that we have a lot to learn and improve.

From the interviews, we realized that our project is important and promising since it can fundamentally avoid disputes related to patented microbes between competing companies.

Proposal

As mentioned before, we found patent protection a huge factor influencing the current scientific research environment in China. In our last part of human practice, we focused on the improvement of patent right relating to microbes and biology.

To start with, Yuxuan did some background research around the topic. According to the 2015 Economic Survey Report of the American Intellectual Property Law Association, in the United States, the average cost of litigation from the prosecution to the end of investigation and evidence collection is $950,000 for various patent cases with a target amount of $1 million to $10 million. Compared with the millions of dollars in litigation expenses in the United States, the patentee’s cost of defending rights in China is relatively low with the cost of less than 10,000 yuan per case.

Specifically, we want to promote Intellectual Properties in the field of synthetic biology and microbiology. Jianing contacted a law expert in order to hear some professional advice. She found out that the current strain deposit process is well-established. There are legal terms regarding to all process under the regulation of China General Microbiological Culture Collection Center (CGMCC). Yet in practice, we found that current law cannot provide new strains under all circumstances. According to Chinese Patent Regulation(2010), due to the natural method of screening specific microorganisms largely depend on natural condition of the specific location from where the new train is isolated, it impossible to reproduce the same species in the 20-year patent validity period. Therefore, it can not be patented. However, strains from natural environment may play a huge role in future science research. Thus it is important to provide protection for those strain.

Our project might be a great approach to this problem. Scientists can integrate bi-stable system to the strain to protect them. Our system can provide protection to microbe under special circumstances that current law terms does not provide patent.

Given all the background information and research results, we came up with several potential improvements:

1.Full search should be done before scientific research patent database in order to fully recognize the problems in the prior articles and then designing the solution.

2.New regulations and protections (other than patent) should be provided for strains and microbes isolated under natural methods.

3. Biomaterials that are not available to the public are required to submit a deposit certificate.

4. There should be enough experimental data to make the results novel and creative.

5. In the writing of the application documents, review opinions and the follow-up review, should be given sufficient attention to create a positive scientific atmosphere.

Future

In the future, we will strengthen cooperation with the government to help the government improve its patent protection and related fields in policy and management. At the same time, we will work with more relevant academic and professional institutions to improve this series of issues through our experience in working with the government.