Team:Manchester/HP/Silver

Beyond the bench, the world educates us on ethics, sustainability, social justice, safety, security, environmental impact and intellectual property rights, information which further shapes the direction of our research.

Exploring Human Practices 08/06/2017 & 20/06/2017

To start off with human practices, we talked with Dr. Robert Meckin and Dr. Andrew (Andy) Balmer to discuss and learn about Human Practices and the social implications of synthetic biology. From the start, we wanted to explore the possible areas where our project can be implemented. We thought of the water industry, specifically within water treatment plants where phosphate is removed. Another possible area is for bioremediation purposes within eutrophic lakes or water bodies.

Throughout our discussion, we agreed that we would need to approach companies in the water industry to establish the feasibility of our project. In addition, discussion with Robert brought up the idea of innovation in water treatment companies, in particular to answer the question: what drives water companies to adopt a new technology? The answer to this question would be important to determine whether these companies would be willing to adopt new technology such as synthetic biology to treat water. One interesting point that Andy brought up was to think about our project in a broader scale outside of iGEM and to think about product design. This challenges us to think about the project’s feasibility and how it will be implemented in a real world/business scenario.

Water Industry

To determine the feasibility of our project, we had a number of detailed discussions with the water industry to answer the question: how does innovation work in the water industry? The answer to this question would be important to determine whether water companies would be willing to adopt new technology such as synthetic biology to treat water. By talking to various experts, we were able to understand the background of the water industry in innovation and the requirements our synthetic biology device would need to meet in order to successfully sell it to water companies.

Interviewing Yorkshire Water - Professor Issy Caffoor 07/07/2017

To confirm what Dr. Thomas has said, we set out to contact several water companies. Dr. Andrew Balmer helped us to reach out to Professor Issy Caffoor, who is an Ex-Innovation Manager with decades of experience in Yorkshire Water. We contacted him via e-mail with questions relating to innovation and adoption of new technology in Yorkshire Water. The key points from our contact can be seen down below.

Three ways Yorkshire Water adopt new innovation/technology for water treatment:

1. Through its R&D activities where equipment may be codeveloped with universities or manufacturers and tested in water company operations before being commercialized by a manufacturer and sold to water companies

2. May be offered by a design and build company as a cost saver or performance enhancer as part of the whole treatment plant offering

3. May be offered within a framework agreement by a supplier if it provides significant benefits over other solutions

Actors that are involved in determining the kinds of innovations and treatment procedures that companies adopt:

1. The treatment type is never a mandatory regulatory requirement but the end of pipe limit is often set either by the Drinking Water Inspectorate (DWI) for drinking water and Environment Agency (EA) for wastewater

a. If the technology comes into contact with drinking water Drinking Water Inspectorate has to approve the materials used

b. Similarly if it involves contact and release into wastewater Environment Agency needs to approve

2. If it involves GMOs in any way, Health and Safety Executive (HSE) approval is required

3. If it is likely to offend the public (religion, custom and practice etc) then local groups and the Consumer Council for Water (CCW) should be consulted

Lastly, numerous solutions that are involved in phosphate management have been tried. Some involving biology and chemistry but none that involve synthetic biology

Skype call with an iGEM Alumni - Ben Reeves from CustoMem 17/07/2017

We wanted to know the steps required to develop our project into a real business so we reached out to CustoMem, a spin-out company from iGEM (Imperial 2014) that specializes in developing a membrane for water filtration. We talked to Ben Reeves, an ex-iGEM team member and supervisor that works within CustoMem.

He shared a lot of his experience with iGEM and CustoMem and we gained some useful feedbacks and comments in regards to our project and its implementation in real life. In addition, we also discussed about legislation issues surrounding iGEM and received some tips and advice about the competition.

Key point summary of our talk can be seen down below:

1. Municipal water treatment is very conservative about trying new technologies. It is difficult to get into municipal water treatment and selling our project idea to them if it were to be implemented into a business. Therefore, the market for water treatment would be around industrial water treatment. It is easier to get into the market for industrial water treatment because different industries have different waste. In this case, our customer will be companies from different industries that handles their own waste water.

2. Selling our idea: It will be great if we can provide a proof of concept to the water companies, specifically a lab proof of concept using wastewater from each specific water company. Water companies also like the technology to be tested on site. Perhaps we can use their wastewater to design some simple experiments. People will be interested in our project if we can prove that it is able to treat phosphate with minimum space and time efficiently than existing processes.

2. Legislation: CustoMem are using parts that are in the BioBrick registry but they do not patent the BioBrick. Everything that is in the wiki or presented in the Jamboree cannot be patented. If we were to patent our project, it will be on the specific process and application of the parts that are not disclosed through the competition. At this point, we should not be worried about any possible patent issues in our project.

3. Developing into a business: Business model often change through interactions with different stakeholders because from these interaction, CustoMem were more aware of the exact need that they are trying to address. It’s important to consider how to scale up the business from the lab into an industrial scale. For our project, we would have to think of the solutions to some questions: What concentration of phosphate comes out of the waste water? How quickly can our bacteria reduce this concentration of phosphate?

*Interview was conducted by Owen and Adam*

Interview with Jonathan Abra - Knowledge Transfer Network 19/07/2017

Dr. Andy Balmer helped us in contacting Jonathan Abra, the Knowledge Transfer Manager with responsibility for water and wastewater at Innovate UK, the UK government’s innovation agency. We wanted to confirm the things we learned from our interview with Dr. Duncan Thomas and throughout our discussion, we realized that there were indeed a lot of things that coincide with our previous findings. However, we also learned that there were new changes to existing methods that we have not known before. One of the important things that we learned is that the government is trying to push water companies to be more innovative and that there may be a role for synthetic biology to be adopted in the water industry.

Key points from our discussion can be seen below:

1. UK water regulation is regulated in a non-competitive environment. There are three regulators:

a. Drinking Water Inspectorate (DWI), which is responsible in overseeing drinking water

b. Environment Agency (EA), which is responsible in looking at water in the environment

c. Ofwat, which is responsible in determining the amount of money that water companies can charge their customers

2. Ofwat is the main regulator that water companies have to address to. Ofwat regulates the water industry through a periodic review process where every 5 years, water companies have to produce a business plan to cover the following 5 years. This business plan is now evaluated on 3 criterias: value for money, innovation and ambition.

3. Until now, it has been very difficult to get any novel new technology into the UK water industry and water companies have not been innovative in the past years. The target of success for water companies is to avoid getting punished by Ofwat and therefore, they are simply ‘ticking boxes’ and only doing what is necessary. This is no longer acceptable and there is now an incentive set by the government to push water companies to be more innovative (not only in technology but also in different ways of working i.e. different business models). If water companies do not demonstrate innovation, the government is going to punish them financially.

4. There is another new change which has been signalled about 5 years ago called the move to total expenditure (Totex) by Ofwat. Totex is about a switch from the previous situation whereby a company could spend lots of capital on building new treatment works and new assets. This increases the value of the company by improving the capacity but not the performance. With Totex, companies are now allowed to include the cost of operations expenditure (long term running cost) within their calculations in their business model. This means that by considering the cost of running a technology over 15-20 years, new technology that are more expensive in the short term (cost of setting up new equipment) can have its expenditure justified if water companies can demonstrate that the cost of running it is lower than existing technology.

5. It takes around 10-12 years for technology to come to the market in the water sector. The technology can be really attractive if it can replace an existing technology and save a lot of cost.

6. The government has no role in deciding the method to treat water; it is up to the individual companies as long as they can demonstrate that they can do it effectively and are not affecting public health.

7. Brexit is still a huge uncertainty although it is unlikely that they will change the existing Water Framework Directive (WFD). This is because it has been shown that the WFD have dramatically improved water quality across Europe.

8. Genetically modified organisms have not been used but it is not because they are being avoided.

*Interview was conducted by Owen and Adam*

Site Visit to Davyhulme Treatment Works - United Utilities 23/08/2017

*Owen, Maciek, Amber, and Alice came to the site visit*

Intellectual Property

As the paper that we based our project on cited a granted patent, we wanted to explore intellectual property situation in more detail to determine how this may influence our project. As none of our team members have any experience in intellectual property rights, we consulted experts in the field to seek guidance and answers. We contacted Dr. Rick Watson from the University of Manchester Intellectual Property office and Dr. Linda Kahl from the BioBrick Foundation. Through e-mail exchanges and a phone call discussion, the case of intellectual property became much clearer which directly impacted the development of our business plan and consequently shaped our experimental ideas.

E-mail Exchange with Dr. Rick Watson - University of Manchester Intellectual Property (UMIP)

We wanted to know whether our project would be viable for a patent. To understand this, we reached out to Dr. Watson from the University of Manchester Intellectual Property (UMIP). Through e-mail, Dr. Watson gave a very thorough explanation that helped us to understand the patent situation of our project.

We were told that a granted patent is different than a patent application because if the patent has not yet been examined, we do not know for certain which of the claims are approved as written by the applicant, or which of them may be modified or refused as part of the examination process. In addition, we learned that holding a patent in a certain territory will give a monopoly not only over that territory but it also stops products created outside from being imported into those territories.

If we were to commercialize and patent our project, we learned that we will have to consider all previous patents and all previous scientific literature known as the ‘prior art’. This is because to be patentable, our invention would have to pass four basic tests:

1. Is it novel? Has our idea been thought of before, and put into the public domain by either us, or someone before us? - if our idea is not novel then it fails this test and we cannot patent it

2. Our project will have to have an ‘inventive step’ that is different from other previous patents - and not just an obvious thing to do for someone who has the average level of understanding of our subject area

3. Is it industrially relevant? Will our idea be commercially useful?

4. Is it excluded? Some types of invention are not patentable due to the ethics involved, including many biotechnology related ‘inventions. Also, one cannot simply patent a pure scientific discovery

In addition to checking whether our invention can be patented, we will also have to balance out the commerciality of our project. If we were to patent this project, would it only cover a very narrow scope of protection? If so, could competitors easily ‘get around’ our patent without infringing us by producing a similar system with slightly altered components? Would the invention ultimately have a good chance of making us or our company more income to cover the cost of developing the idea and protecting it? If not, there would be no point in spending time and money on the patent in the first place.

Read more about our story with Intellectual Property.

Phone Call with Dr. Linda Kahl - BioBricks Foundation 29/07/2017

We wanted to confirm our understanding on the Intellectual Property side of our project in the context of the iGEM competition and the use of BioBricks. We then reached out to Dr. Linda Kahl, Senior Counsel & Director of Ownership, Sharing and Innovation for the BioBrick Foundation.

From our call, we gained some confirmation regarding the BioBrick Public Agreement and what it means for Users and Contributors. We learned that the User and Contributor agreement only protects users against the claims by the person who signs the Contributor agreement and it would not protect users from any third party claims. This means that if a User submitted a patented part into the iGEM Registry and the patent owner does not sign the Contributor agreement, the User would be liable for a patent infringement lawsuit. We realize that this may possibly have had happened in the past with previous iGEM teams that are unaware of IP issues. However, Dr. Kahl explains that it costs at least 3 million dollars to pursue a patent infringement lawsuit. Therefore, it is highly unlikely for anyone to file a lawsuit against iGEM or the BioBricks Foundation unless there is 3 million dollars or more worth of damages.

We then briefly discussed the Intellectual Property rights in the context of our business plan. Dr. Kahl advised us to consider the patent landscape to see who else is working in our field of interest. We were also advised to carefully examine the claims of the issued patents and see whether parts of our project are covered by the patent.

Lastly, we talked about iGEM and learned that the reason why anything we disclose in the Jamboree (wiki/presentation) cannot be patented is because patent laws generally say anything disclosed in public is already in the public domain and cannot be patented. There is, however, a one-year grace period after public disclosure where the inventor can still file a patent application, but this grace period is available only in the US and a few other countries.

Read more about our story with Intellectual Property.

*Phone call was conducted by Owen, Adam, and Theodore*

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