Enterpreneurship
Competitor Analysis
Introduction
Our competitors in the biofungicide space are focused on replacing chemical fungicides with more sustainable options, with new players even looking at targeted fungicide development. However, none are addressing the issue of timeliness of application - i.e. to ensure that fungicide effectiveness is increased by applying in the early phase, immediately following detection.
Our project uniquely addresses diagnosis and treatment in a single step, via the application of a technology as of yet unexplored in the synthetic biology industry landscape, as determined through literature surveys. Namely, the engineering of spores as Biosensing agents with germination being the response. Thus, we innovate not only in the approach of our solution breaking the paradigm of diagnosis and treatment as separate steps, but also by engineering biology in a novel way.
Core Competitiveness & Inventivity
1. Shelf Life
One of the main concerns with biofungicides in the market today is the short shelf life period within which the farmers need to use the product. Sporadicate eliminates this concern by adopting Bacterial Spore Technology, thus enabling the B.subtilis in our biofungicide to remain as spores - dormant, tough non-reproductive structures which can be stored for much longer as compared to regular biofungicides. The bacteria are much more likely to survive for a long period when they are in the form of spores rather than as free-living bacteria.
Not only do spores help with the longevity of the product, but their technology also makes it easier to produce formulations for crop protection. Bacterial spores represent dormant cellular forms of gram-positive bacteria possessing a high potential of stability and the capability to endure extreme conditions of their habitat. Thanks to these properties, bacterial spores are recognized as the most stable systems on the planet.
2. Timely Application
We have devised a one step-solution, consisting of a B. subtilis bacterial spore system that eliminates the time lag between diagnosis and treatment. Natural strains of this bacteria are present in the soil microbiome and have been found to act as excellent biocontrol agents, whilst being completely nonpathogenic or toxigenic to humans, animals, or plants.
Our B. subtilis spores will be modified to exclusively display a mutant germinant receptor, engineered to be capable of binding to chitin monomers. Upon binding, a cascade is triggered, enabling germination of B. subtilis into its bacterial form. Within four minutes post-detection, the growing colony of B. subtilis cells begin to produce lipopeptides effective at eliminating fungal pathogens. Thus, with a single spray of B. subtilis spores, we can target fungal pathogens over space and time, achieving both early detection and treatment.
3. Lower Applications
Owing to the lack of a clear, indicative system for diagnosis and treatment in chemical fungicides, wheat farmers typically must respray their crop up to 8 times per season, which can dramatically increase the cost of treatment, and leave their crop at risk to epidemic level outbreaks regardless.
However, due to the ‘Sense and Respond’ technology that Sporadicate offers, our product effectively deals with fungal infections as soon as recognised and supports early stage detection of disease (even when the farmers may not necessarily be aware of the attack), therefore requiring fewer applications.
4. Economic Benefits
Economically, the primary consequence of our product would be a reduction in costs over time for farmers in terms of fewer yield losses. This is most likely only going to soften the impact of rising costs of fertilizers, fuels and seeds, thus improbable to result in lower wheat prices. Thus, we would expect the product to aid farmers and farming cooperatives in maintaining or increasing the amount of wheat planted each year. Through the innate durability of spores and the cost-effectiveness of a ‘Sense and Respond System’, our product has been designed with accessibility in mind. This means we can effectively address the threat of fungal diseases in the regions of the world most at risk, with a tool that can be easily adopted by subsistence and smallholder farmers who carry the majority of the burden of wheat production there.
We envision our solution becoming a low-cost, low-labour treatment option for wheat farmers. The spore-based nature of the solution has a strong potential for industrial scale up and mass production, which would make our product a disruptive, affordable and sustainable alternative within the fungicide market. Furthermore, the spores’ natural stability allows not only longer lasting crop protection, but also cheaper storage methods, facilitating product delivery and implementation even to more infrastructurally deprived areas, further consolidating the unique value proposition of our product and its global outreach.
5. Environmental Benefits
The current chemical fungicides in the market have been shown to leach into soil and groundwater, thereby disturbing a wide range of organisms and aquatic biota.
Today, for both preventative and curative treatment against stem rust, unselective and frequent application of chemical fungicides must be relied upon. These not only damage the environment but pose a health-risk to those exposed to them, with studies showing maternal exposure to crops that were sprayed with fungicides were associated with adverse and gender-specific effects on infant neurodevelopment.
Our product does not have such toxic effects on the environment and will require fewer applications. B. subtilis is already naturally occurring in the soil microbiome of wheat crops and is known to confer several advantages being classified as a plant growth promoting rhizobacteria (PGPR). By reducing yield loss, our product ensures that more environmental resources like land, water and nutrients will not go to waste on dead crops. Our solution not only addresses the main challenges, it also confers several advantages as B. subtilis is known to boost plant immunity and growth.
6. Social Benefits
The climatic conditions greatly favour the spread of pathogenic fungi leading to above average regional yield losses, reaching up to 100% in severe cases such as with wheat stripe rust [2]. Such regional losses not only affect the livelihood of the farming community but severely damage the food security of the area leading to an increase in hunger and extreme poverty. As is well-studied, the consequences of hunger do not only severely affect one's quality of life, but also stunts one's development towards a more promising future. Our project can mitigate the impact of pathogenic fungi by being non-race specific and applicable to different wheat varieties, with no reduction in efficacy.
7. Sustainability
Today, the main goal in the Natural Plant Protection space is the development of biofungicides that are stable against harsh weather conditions. Biofungicides have typically not been used on cereal crops because they are very unstable against severe weather conditions, such that more frequent applications would be required. Stable biofungicides would solve this problem. Bacterial spores as used in our product, represent dormant cellular forms of gram-positive bacteria possessing a high potential of stability and the capability to endure extreme conditions of their habitat. Owing to these properties, bacterial spores are recognized as the most stable systems on the planet. (Andryukov, Karpenko and Lyapun, 2021)
Competitor Profile
Market Analysis
The global fungicide market was valued at $13.4 billion in 2019, and is projected to reach $19.5 billion by 2027, growing at a CAGR of 4.7% from 2020 to 2027.
According to the estimated market values, biofungicides take up approximately 10% of the whole fungicide market value. Three main factors boost the demand for fungicides in emerging countries like China and India.
Firstly, affordable fresh fruits and vegetables are needed by the market. However, due to the short shelf life of vegetables and fruits, more expensive transport e.g. air transport, is needed most of the time. The fragile nature of vegetables and fruits makes shipment by sea almost impossible: the high humidity, high salinity, and limited ventilation during the 15-23 day journeys inevitably favor the growth of microorganisms. Current solutions, chemical fungicides, are not preferred by farmers and exporters as they leave chemical residuals, and exceeding the maximum limit of residuality is prohibited. Luckily, with the help of less toxic and more durable biofungicides, long-distance and more affordable shipments become available.
Secondly, more frequent extreme weather typically favors the outbreak of plant-pathogenic fungi, like yellow rust. In the past three decades, El Niño can be seen in 1991-1992, 1993, 1994, 1997-1998 and 2015-2016. La Niña occurred in 1995, 1998, 2007 and 2011. (US Department of Commerce, no date) In 2001, when extreme weather hit China, sales of propiconazole and similar products boosted by more than 5% this year. Both El Niño and La Niña are causing abnormal precipitations, more intense rainy seasons, that escalates the severity of fungal diseases during pre-harvest stages between flowering and harvest in mango orchards in Mexico for example. (Galindo et al., 2013) Both traditional fungicides and biofungicides are falling short; more sprays are needed in rainy seasons because most fungicides are soluble and easy to be washed off from the surface. Putting the cost of the extra fungicides aside, more significantly, farmers are facing commercial relationships because both quantity and quality are below the optimal threshold and lack of trust: a sharp fall-off of yield and lack of satisfied appearance caused by fungal diseases cannot meet the requirement. It takes more than 1 or 2 years for farmers and exporters to recover reputations and regain the trust of consumers and their clients. Frequent La Niña and El Niño occur in a two or three years cycle, resulting in farmers experiencing tensions with retailers regularly. As a result, more stable and water-resistant fungicides and/or large quantities of cheap fungicides are desperately needed by the market.
Third, environmental regulations in agricultural nations, Brazil, China, and the EU, have been greatly tightened up and the number of customers who are choosing organic food has increased over recent years. (Donley, 2021) Therefore, in the foreseen future, the demand for low-toxicity fungicides is set to increase. In 2016, 1.2 billion pounds of pesticides were used in USA agriculture, about 26% were of dangerous pesticides banned in the EU, 3.3% were of pesticides banned in China, and 2.1% were pesticides banned in Brazil. Experts in the US suggest more dangerous pesticides should be banned following the other main agricultural countries’ footsteps. According to the definition of organic farming, the use of synthetic pesticides, fertilizers, genetically engineered organisms and growth enhancers to stimulate soil and crops are all prohibited. To satisfy the soaring organic food market, farmers are more open to biofungicides as alternatives to traditional chemical fungicides. Keeping this in mind, the phase-out of toxic fungicides creates many hard-won opportunities for non-toxic effective fungicides.
Last but not least, people are seeking more effective fungicides to deal with resistant pathogens. For example, in the rice disease control market in China, Jinggangmycin, a cheap, low-toxicity, effective fungicide, has been preferred by most rice farmers since the 1970s. Over 200 million mu, a Chinese area unit, of rice fields benefited from Jinggangmycin. However, over 50 years of usage results in resistant pathogens emerging, gradually pushing Jinggangmycin out of the market; now it is only used in 1.5 million mu of rice fields. Because of resistant pathogen strains, the price advantage of Jianggangmycin has been cancelled: its control effect is short, only about 7 days. On the other hand, a competitor, hexaconazole, offers prevention effective up to 25 days. During the whole period of sheath blight control, Jinggangmycin needs to be applied 7-8 times, while hexaconazole only needs 2-3 times. Jinggangmycin has poor control effects on other diseases, especially on the fast-growing greenhouse fruits, vegetables and other economic crops. New products should be able to overcome these shortages.
Manufacturing Analysis
To commercialise our product and get financial support from investors, cost and manufacturing analysis is one of the most important aspects of the launch of our product. We are aware that to attract strong investment, we must carefully list what we need and the costs of items as a spin-off company.
Introduction
Under extreme conditions, such as high/low temperature, low humidity, or nutrient limitation, B.subtilis undergo a differentiation process, from rod-shaped cells into spores. To maximise the efficiency and lower the cost, high cell density reaction and high efficiency of sporulation are required to reach an industrial standard. (Monteiro et al., 2005) As a result, a fed-batch process was developed: before the completion of depleting the nutrients, in the middle of the exponential growth phase of B. subtilis, bacteria should be fed. Using this method, the maximum spore concentration reached 7.4 × 109 spores mL-1, 20 times higher than traditional batch cultivation. Two main standards should be achieved by using this method: during the vegetative growth phase, nutrients limitation should be avoided, as it starts sporulation; keep nutrients concentration below a certain level (e.g. glucose concentration should be lower than 3.5 g/L ), since a higher concentration inhibits sporulation. In doing so, 91.25% less glucose is required than what is typically used for Escherichia coli cultivation. Moreover, the concentration of B.subtilis reaches 7.4 × 106 spores L-1.
Liquid Media Price Litre
Media price per litre : $1.23.
The price goes down to $0.6 or even less if we choose a wholesale supplier.
Packaging and Delivering Cost
Several crucial factors should be considered for packaging: fragility, volume, complexity, and marketing strategy.
Given that B. subtilis is compatible with a wide range of both chemical and physical conditions, no extra is needed during the shipment. Also, spores can be easily converted from liquid to powder form, which reduces the volume of our product by about 90%, assuming 10g powder can be made out of 1L liquid solution ($0.06 per gram). The purpose of labelling and packaging is to beautify a product and appeal to new customers.
We will also be able to save on labelling and packaging costs.Since we are targeting mainly farmers, usually large quantities of fungicides are purchased at once and the brands are preselected. Therefore, special labelling is not an effective or required strategy to attract new customers.
Farmers typically select fungicides from pre-approved lists from larger corporations like El Rodeo Farm. Thus, we aim to gain the trust of these approving organisations which can then recommend our product to farmers. This can pave the way to farmers adopting long-term use of our product.
With most commercial products, retailers and producers spend 10-40% of the product price on packaging and labelling[13]. Since our product has a long shelf life, high durability, and a unique targeting mechanism, we may only spend 5% to 10% of the retail price on it. Thus, the cost of labelling and packaging should be around $0.003 to $0.006 per gram.
Shipping costs depend on distance. Assuming 200 grams of biofungicide powder takes up 20*20*20 cm^3 of space. For the extra large option provided by UPS, from London to France, $23 would be charged( 23/12.5*200= $0.0092 per gram). For the largest shipping size unit to the US, $99.5 will be charged by UPS (99.5/12.5*200 = $0.0398 per gram).[14]
In summary, depending on different marketing approaches and shipping distances, the cost of our product is around$0.06+$0.003+$0.0398=$0.102 per gram without considering labour costs and renting, which could add another 35% on top of the cost of raw materials[15]. The total cost should be around $0.137 per gram. Considering a 30% gross margin, the marketing price should be higher than $0.1781 per gram. In other words, the cost per application should be less than $8.9(50 grams).
Variable Costs:
Several crucial factors should be considered for packaging: fragility, volume, complexity, and marketing strategy.
Given that B. subtilis is compatible with a wide range of both chemical and physical conditions, no extra is needed during the shipment. Also, spores can be easily converted from liquid to powder form, which reduces the volume of our product by about 90%, assuming 10g powder can be made out of 1L liquid solution ($0.06 per gram). The purpose of labelling and packaging is to beautify a product and appeal to new customers.
We will also be able to save on labelling and packaging costs.Since we are targeting mainly farmers, usually large quantities of fungicides are purchased at once and the brands are preselected. Therefore, special labelling is not an effective or required strategy to attract new customers.
Farmers typically select fungicides from pre-approved lists from larger corporations like El Rodeo Farm. Thus, we aim to gain the trust of these approving organisations which can then recommend our product to farmers. This can pave the way to farmers adopting long-term use of our product.
With most commercial products, retailers and producers spend 10-40% of the product price on packaging and labelling(Cost of Packaging | Packaging Pricing Models, 2021). Since our product has a long shelf life, high durability, and a unique targeting mechanism, we may only spend 5% to 10% of the retail price on it. Thus, the cost of labelling and packaging should be around $0.003 to $0.006 per gram.
Shipping costs depend on distance. Assuming 200 grams of biofungicide powder takes up 20*20*20 cm^3 of space. For the extra large option provided by UPS, from London to France, $23 would be charged( 23/12.5*200= $0.0092 per gram). For the largest shipping size unit to the US, $99.5 will be charged by UPS (99.5/12.5*200 = $0.0398 per gram).(Send a parcel | Ship to UK and Internationally | UPS - United Kingdom, no date)
In summary, depending on different marketing approaches and shipping distances, the cost of our product is around$0.06+$0.003+$0.0398=$0.102 per gram without considering labour costs and renting, which could add another 35% on top of the cost of raw materials(Bhimani, 2019). The total cost should be around $0.137 per gram. Considering a 30% gross margin, the marketing price should be higher than $0.1781 per gram. In other words, the cost per application should be less than $8.9(50 grams).
$6720 should be raised in future to support further research.
An Alternative Method Provided by Beihai Qunlin Bioengineering Co., Ltd. (Guangxi, China) (Zhao et al., 2008).The estimated cost should be around 234 USD. Therefore, the calculated cost per application(50g/hectares) should be around 0.014625 USD per application. Compared to other competitors, the estimated cost of our product is much lower than their whole sale price.
Business Canvas
Idea Canvas
We completed an ‘Idea Canvas’ formatted by Imperial’s Enterprise Lab in preparation for meeting with them.
Competitions & Grants
Sponsorship €3,000
January
eureKARE is a European investment company that focuses on synthetic biology and microbiome research. We pitched our initial idea to them, and received advice on future steps for the project.
Winners £5,000
March
Catalyse is an entrepreneurship program run by SynBioUK, involving a 5-week workshop series culminating in a pitch competition. Our team attended throughout the program, and prepared an extensive pitch that included market analysis, a 5-year plan and stakeholder feedback. At this stage, our idea was not yet general purpose. We focused on wheat stem rust, proposing to engineer receptors in B. subtilis to respond to ribitol, which is thought to be a specific biomarker of the disease. We won the competition, and were awarded £5,000 in funding as well as bespoke legal advice from IP firm Potter Clarkson. It was also a wonderful opportunity to network; it was at the Awards ceremony that we connected with many experts that helped us further down the line, such as spore researcher Dr John Heap and IP attorney Dr Sarah Holland.
Second Runners Up €500
March
ERA CoBioTech is a biotechnology institution that focuses on representing the field in Europe. It hosts an annual video competition where students are tasked with creating a video explaining biotechnology to public audiences. Our team decided to film a video about how biotechnology influences our food, as we had already narrowed down to focus on food insecurity. To feature diverse perspectives, we engaged with fellow students, asking what biotechnology they thought might be found in a burger. We also featured a researcher sharing his thoughts on the future of biotechnology. We came third in the competition according to the judging criteria, which encompassed public reception of the video. The video also gave us a platform to share about synthetic biology, and draw more interest to our project.
Second Runners Up £5,000
May
The Ideas To Impact Challenge is an entrepreneurship competition that celebrates impactful, innovative ideas addressing global issues. We applied to this challenge with our Catalyse pitch. The pitch was improved based on feedback from the first pitch; for instance, we expanded further upon self-digesting plasmid technology and how it is technically defined in the EU as non-GMO, as we received many questions regarding this at Catalyse.
Finalists £10,400
May
FoNS-MAD is a research startup competition run by Imperial College London, supporting the development of low-cost technology to solve global issues. It has three stages; two initial proposals, which culminate in a pitch competition. We placed as finalists, one of three teams selected to develop our proof of concept in the lab over the summer. This means we were granted four full bursaries in funding, lab space, consumables, and supervision from Dr Geoff Baldwin. The final stage of this competition comes in late October, where we will submit a final presentation and report on our summer progress. The winners at this stage will be awarded a further £7,000.
Plate reader lease
August
We reached out to BMG Labtech for funding, and while they were not able to provide us with capital due to company policy, they offered support in the form of a plate reader. A member of their team also came in to give us in-person support using the machine.
Grant Runners up £50,000
September
SynbiCITE is the UK's National Centre for the Acceleration and Commercialisation of Synthetic Biology/Engineering Biology. It is hosted at Imperial College London and led by Prof. Richard Kitney and Prof. Paul Freemont, the Centre's Co-Directors, with the goal of creating a new industry based on Synthetic Biology. SynbiCITE ran a Proof-of-Concept grant Round this June. We submitted a business proposal, featuring market analysis, responsible innovation and social, economic and environmental benefits. We were selected by the committee to receive £50,000, as they saw us as a project with commercial viability. This money is intended go towards bringing our product to real-world markets.
Runners up $2500
May
We applied for and received the iGEM Impact Grant, which we used to fund our baseline conference fees.
Value Proposition
Manufacturing Viability
Shandong Sukahan Bio-Technology Co., Ltd.
Sukahan Bio-Technology Co., Ltd. focuses on the manufacturing of various industrial and commercial enzyme products, spores, and other related product lines. With a total investment of $2,200,000 and a registered capital of $2,200,000, Sukahan covers an area of 20,000m² and state-of-art research facilities, manufacturing installations and experimental fields.
As an expert in his field, the manager of Sukahan, Wang shared his insights towards GMOs and related bio-products. First of all, he pointed out the lack of domestic regulations on GMOs. There are no direct specific regulations regarding GMOs, and GMO-related research institutions should carry on the responsibility of discovering side effects of GMOs. Then, to show possible drawbacks of GMOs, he pointed out that after the harvest of genetically modified soybeans, no other crops can be grown in the same field for a relatively long time.
Regarding regulations of exportation, same as we know, he explicitly told us exportation of live bacterial strains is strictly forbidden by Chinese domestic law. However, because of the vagueness of the law, he claimed that they can export our product in the name of biological enzymes. To make it easier for shipment, he suggested we convert liquid-state spores into dry powder; also, the common practice of packaging is to seal spores in wooden barrels.
Aside from related regulations, other factors are equally important to consider. They have a group of experts to conduct field trials before the industrial scale production and the timeframe of field trials depends on what kind of crops we choose; for example, if we choose wheat, at least 8 months should be arranged for efficacy testing. Wang also suggested we should consider how to apply our product to crops. Currently, there are two ways to apply fungicides to crops: spraying and root irritation. Sukahan can help us determine which way is the best. Because we have not revealed any specific details to the manager, he cannot give us a general cost of the manufacturing process, but he pointed out that, in general, for biofungicides, one application per mu (Chinese area unit, 1mu = 666.667m²) costs about 100 Yuan (13.89 USD). We need to be either more effective or much cheaper than our competitors, as suggested by Wang.
GMO Regulation in China
Translated Regulations
Recipient organisms meeting any of the following conditions shall be determined to be at Safety Level I:(a) They have never adversely impacted human health and the environment. (b) The possibility of their evolution into pests is minimal. (c) They are short-lived recipient organisms used for special studies, and are less likely to survive in the natural environment after the end of the experiment. The impacts of genetic manipulation on the safety levels of recipient organisms are classified into three types: enhancing the safety of recipient organisms; not impacting the safety of recipient organisms, and reducing the safety of recipient organisms.
Type 1: Genetic manipulation enhancing the safety of recipient organisms
Including the genetic manipulation of removing a gene (some genes) that is (are) known to be dangerous or inhibiting the gene expression of a gene (some genes) that is (are) known to be dangerous.
Type 2: Genetic manipulation not impacting the safety of recipient organisms
Including: (1) genetic manipulation that changes the phenotype or genotype of recipient organisms without impacting human health or the environment; and (2) genetic manipulation that changes the phenotype or genotype of recipient organisms but whose impact on human health cannot be determined.
Determining of the safety levels of agricultural GMOs
The safety levels of GMOs shall be determined according to the safety levels of recipient organisms and the types and degrees of impacts of genetic manipulation on their safety levels. (a) The safety level of a GMO obtained from Type-1 or Type-2 genetic manipulation of a Safety Level I recipient organism is still Safety Level I. (b) The safety level of a GMO obtained from Type-3 genetic manipulation of a Safety Level I recipient organism is still Safety Level I, if the reduction of safety is minimal and no safety control measure is required; is Safety Level II, if safety is reduced in a certain degree but the potential dangers may be completely avoided by taking appropriate safety control measures; is Safety Level III, if safety is seriously reduced but the potential dangers may be avoided by taking rigorous safety control measures; and is Safety Level IV, if safety is seriously reduced and its dangers cannot be completely avoided by taking safety control measures.(农业转基因生物安全评价管理办法（2022年1月21日修订版）, 2022)
How should we classify our product?
Because of the organism we chose and the carefully designed bio-containment, our product satisfies the Safety Level I criteria. No special supervision is needed for the production of spores and no separate isolated buildings are required according to the regulations, which significantly lower the standard of the manufacturing process and special extra costs.
The Labelling Regulations
First of all, labelling is mandatory and both manufacturers and distributors should be responsible for labelling. There’s no existing labelling regulation regarding the biofungicides produced by using biological engineering methods. However, as one clause states, even though no genetically modified ingridients could be detected in final products, products made by genetically modified organisms or products that used genetically modified organisms ingridients during the manufacturing process should be labelled as this product used GMO ingridients during the manufacturing process, but no GMO ingridients in the final product.
Can foreign capital investment in agricultural GMOs in China?
Like other industries, the industry access to foreign investment in China is subject to the Special Administrative Measures for Foreign Investment Access (Negative List). According to the 2019 version of the Negative List of Foreign Investment, foreign investment in the selection and breeding of genetically modified varieties of crops, breeding livestock and the production of genetically modified seeds is expressly prohibited. (Mallesons, 2020)
According to the negative list, other GM business activities (such as the research and experimentation, production and processing of GM crops in China) other than the projects listed in the negative list should be consistent with domestic and foreign investment in terms of market access. Therefore, unless this article specifically states that different laws apply to foreign investment, relevant laws and regulations shall apply equally to domestic and foreign investment. Chinese regulations on the export management of genetically modified products are relatively loose. After accepting the export application, customs will conduct sampling tests for genetic modification according to the information released by the competent department on the approval of the application of genetically modified technology to commercial production. If it is confirmed to be a genetically modified product and meets the entry requirements of the importing country or region, relevant inspection documents shall be issued; if it is confirmed to be a non-genetically modified product, a non-genetically modified product certificate shall be issued.
According to the Regulations on Administration of Agriculture Genetically Modified Organisms Safety, agricultural genetically modified organisms are classified into Classes I, II, III and IV according to the extent of their risks to human beings, animals, plants, microorganisms and the ecological environment.
Intellectual Property
We realized that in setting ourselves up as a startup, protecting our Intellectual Property is key. We joined online workshops on IP offered by Imperial, and spoke with Prof Holland and other members of Potter Clarkson, a legal firm, to educate ourselves on the next steps to take.
What is Intellectual Property?
Intellectual Property or IP is a type of intangible property generated by people’s intelligence. Novelty, originality, and creativity are always the essence of IPs and differ inventions from existing ones. Common Intellectual Property Rights include trademarks, copyrights, patents, industrial designs and other disclosed information. Jurisdictions grant inventors the right to prevent others from using their designs, ideas, and inventions without consensus; and also grant inventors the right to use their inventions for profits. In turn, preceding inventors benefit society and inspire other inventors by revealing their inventions and providing funding to support further inventions.
Patent Terminology
Novelty
Novelty means a product or a new process should be new and confidential to the public before applying for patents. Published works, like journals, papers, and books, and existing patents cannot be patented again; however, if they are disclosed in scientific conferences or exclusive exhibitions and no public can access them, then such inventions could not be considered as novel.
Inventive step/non-obviousness
Based on the definition, “a supposed invention is usually obvious if someone of ordinary skill in a relevant field could easily make the invention based on prior art.” For example, one cannot change variables of a formula and claim predictable results as inventions.
Industrial use
Patents should be able to solve existing problems or be more effective than the current solutions, and such invention should be used on an industrial scale to help society.
The Non-Inventions Recognized Globally
Discoveries and scientific theories cannot be patented.
Innovation is Sequential and Complementary
Sequential in the sense that most successful innovations are built from the preceding ones. And, by complementary, it means that individual researchers may take different research lines and boost or inspire others' research efficiency. For example, genetically modified mice promote the development of GFPs; and, in turn, GFPs boost consequential discoveries of metabolic pathways, etc. Therefore, we need a good balance to provide open-source technology to inspire others and take appropriate steps to make our IPs profitable. This led us to contact Prof Sarah Holland, a patent attorney at Potter Clarkson, who specializes in synthetic biology and biotechnology.
Provisional Patent Application and Non-Provisional Patent Application
A provisional patent application is filed when research is still in progress and normally such an application will not be examined or published. Technically speaking, there are no so-called "provisional patents" in the UK, as stated by Prof Holland. But other jurisdictions, like the US, offer provisional patents to establish an early filing date. In the UK, the common practice is to file a non-provisional patent: such a non-provisional patent needs to be filed within 12 months and the application usually comprises detailed disclosed information. In other words, the first application should still include enough information and data to support a relevant professional to put the invention into effect. No matter whether we apply for US provisional patents or UK non-provisional patents, we need to provide precise information first and future patents must match the first patent. Because of the timely nature of the non-provisional patent application, we must run all feasible tests within 12 months, and if we don't have any breakthroughs, we should stop carrying on the first application and file another one.
Patent Applying Strategy
Moreover, Prof Holland suggested that instead of applying the whole project as a singular patent, it's better to file multiple, narrow-scope patents for different bio-parts. To be more specific, we can file an application for the linker that we developed. Although we have not done much wet lab experimentation on the engineered receptors yet, the patent examiner may still recognise the computational work we have done so far.
Regarding public disclosure, we were informed that everything revealed on the Wiki is no longer patentable. Nevertheless, conveying more general ideas is still good for the promotion of scientific acknowledgement and our product.
IP Ownership
Last but not least, Prof Holland suggested we should check Imperial College's IP policies. In most situations, universities always ask for a chunk of ownership of IPs. We need to be prepared to talk to relevant departments within the Imperial College. We consulted some professors for technical help; they may also have the right to claim shares of the ownership unless they made no technical input. Regarding our funding, most of them are non-diluted, but, still, we need to double check clauses carefully in the end.
References
About SOLATENOLTM (no date) Syngenta. Available at: https://www.syngenta.com/en/protecting-crops/products-list/about-solatenoltm (Accessed: 21 September 2022).
Adepidyn | Syngenta (no date). Available at: https://www.syngenta.com/en/protecting-crops/products-list/adepidyn (Accessed: 21 September 2022).
AgroPages-Bayer launches its first biofungicide Serenade to Chinese market-Agricultural news (no date). Available at: https://news.agropages.com/News/NewsDetail---34380.htm (Accessed: 5 October 2022).
Andryukov, B.G., Karpenko, A.A. and Lyapun, I.N. (2021) ‘Learning from Nature: Bacterial Spores as a Target for Current Technologies in Medicine (Review)’, Sovremennye Tekhnologii V Meditsine, 12(3), pp. 105–122. Available at: https://doi.org/10.17691/stm2020.12.3.13.
BASF (no date) ‘Serifel’. BASF. Available at: https://drive.google.com/file/d/1ePW5_Bpt_5Iq4IJLV_3vKR2M0j4QheQp/view?usp=sharing&usp=embed_facebook (Accessed: 5 October 2022).
Bayer Launches Its First Biofungicide, Serenade (no date). Available at: https://krishijagran.com/industry-news/bayer-launches-its-first-biofungicide-serenade/ (Accessed: 5 October 2022).
Bio Fungicides (no date). Available at: https://agriculture.basf.com/global/en/business-areas/crop-protection-and-seeds/use-areas/BioSolutions/BioFungicides.html (Accessed: 5 October 2022).
Hopkins, M. (2022) ‘Biotalys’ First Biocontrol Evoca Wins World BioProtection Award 2022 for Best Biofungicide Product’, AgriBusiness Global, 31 May. Available at: https://www.agribusinessglobal.com/biologicals/biotalys-first-biocontrol-evoca-wins-world-bioprotection-award-2022-for-best-biofungicide-product/ (Accessed: 21 September 2022).
NV, B. (2022) Biotalys and Novozymes Enter into Partnership to Expand Opportunities for EvocaTM, GlobeNewswire News Room. Available at: https://www.globenewswire.com/en/news-release/2022/06/21/2465705/0/en/Biotalys-and-Novozymes-Enter-into-Partnership-to-Expand-Opportunities-for-Evoca.html (Accessed: 21 September 2022).
Serenade ASO Fungicide | Crop Science US (no date). Available at: https://www.cropscience.bayer.us/products/fungicides/serenade-aso (Accessed: 5 October 2022).
Serifel® BioFungicide (no date). Available at: https://agriculture.basf.us/content/basf/cxm/agriculture/us/en/agriculture/crop-protection/products/fungicides/serifel.html (Accessed: 5 October 2022).
Taegro® for Europe (no date) Novozymes. Available at: https://biosolutions.novozymes.com/en/products/biocontrol-europe/taegror-europe (Accessed: 5 October 2022).
Taegro: the broad-spectrum biofungicide (no date). Available at: https://fargro.co.uk/news/product-news/taegro-the-broad-spectrum-biofungicide (Accessed: 5 October 2022).
Unparalleled Standards In Innovation For Fungicides (no date). Available at: https://agriculture.basf.com/global/en/innovations-for-agriculture/innovation-for-fungicides.html (Accessed: 5 October 2022).
Donley, A. (2021) From the editor: India’s agriculture conundrum, World Grain. Available at: https://www.world-grain.com/articles/15421-from-the-editor-indias-agriculture-conundrum (Accessed: 6 June 2022).
Galindo, E. et al. (2013) ‘The challenges of introducing a new biofungicide to the market: A case study’, Electronic Journal of Biotechnology, 16(3), pp. 5–5. Available at: https://doi.org/10.2225/vol16-issue3-fulltext-6.
US Department of Commerce, N.O. and A.A. (no date) What are El Nino and La Nina? Available at: https://oceanservice.noaa.gov/facts/ninonina.html (Accessed: 12 October 2022).
Bhimani, S. (2019) What is Labor Cost Percentage? Definition, Formula & Applicability, ExcelDataPro. Available at: https://exceldatapro.com/labor-cost-percent/ (Accessed: 12 October 2022).
Bioreactor Industrial 50l Bioreactor Price Fermenter Bioreactor - Buy 50l Bioreactor Price,Fermenter Bioreactor,Bioreactor Industrial Product on Alibaba.com (no date). Available at: https://www.alibaba.com/product-detail/Bioreactor-industrial-50l-bioreactor-price-fermenter_62345942751.html?spm=a2700.pc_countrysearch.main07.10.e60526096FA0Ih (Accessed: 12 October 2022).
Cost of Packaging | Packaging Pricing Models (2021) PackMojo. Available at: https://packmojo.com/blog/understanding-packaging-pricing-economies-of-scale/ (Accessed: 12 October 2022).
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Fomenkov, A. et al. (2018) ‘Complete Genome Sequence and Methylome Analysis of Bacillus caldolyticus NEB414’, Genome Announcements, 6(6), pp. e01605-17. Available at: https://doi.org/10.1128/genomeA.01605-17.
High Quality Pure Powder Achieve Chem-tech (since 2008) Cas 9014-63-5 Xylan Price Xylan - Buy Xylan,Xylan Price,9014-63-5 Product on Alibaba.com (no date). Available at: https://www.alibaba.com/product-detail/High-quality-pure-powder-Achieve-Chem_1600382877677.html?spm=a2700.7724857.0.0.35354ed1edlj3m (Accessed: 12 October 2022)
Joint Statement: The Heads of the World Bank Group, IMF, WFP, and WTO Call for Urgent Coordinated Action on Food Security (no date) World Bank. Available at: https://www.worldbank.org/en/news/statement/2022/04/13/joint-statement-the-heads-of-the-world-bank-group-imf-wfp-and-wto-call-for-urgent-coordinated-action-on-food-security (Accessed: 6 June 2022).
Monteiro, S.M. et al. (2005) ‘A procedure for high-yield spore production by Bacillus subtilis’, Biotechnology Progress, 21(4), pp. 1026–1031. Available at: https://doi.org/10.1021/bp050062z.
Potassium Hydroxide 10% Solution | APC Pure (no date). Available at: https://apcpure.com/product/potassium-hydroxide-10-solution/?attribute_pack-size=100ml&gclid=Cj0KCQjwmouZBhDSARIsALYcourbaUBDut_05D-73fmnlRmnauFJHP-c8iPCekprc6NnDHH0P4xWS24aAvhvEALw_wcB (Accessed: 12 October 2022).
Prabu, S.L. et al. (2022) Intellectual Property. Available at: https://doi.org/10.5772/intechopen.94621.
Send a parcel | Ship to UK and Internationally | UPS - United Kingdom (no date). Available at: https://www.ups.com/smallbusiness/ship/quote/delivery-speed?loc=en_GB&tx=2565564876047456 (Accessed: 12 October 2022).
Zhao, S. et al. (2008) ‘Cost-effective production of Bacillus licheniformis using simple netting bag solid bioreactor’, World J Microbiol Biotechnol, 24, pp. 2859–2863. Available at: https://doi.org/10.1007/s11274-008-9820-5.
枯草芽胞杆菌_CICC 20968_菌种产品_中国工业微生物菌种保藏管理中心（CICC）_国家菌种资源库 (no date). Available at: http://m.china-cicc.org/cicc/detail2/?sid=3156 (Accessed: 12 October 2022).
Mallesons, K.& W. (2020) 一文读懂中国转基因生物监管政策, China Law Insight. Available at: https://www.chinalawinsight.com/2020/02/articles/uncategorized/一文读懂中国转基因生物监管政策/ (Accessed: 12 October 2022).
农业转基因生物安全评价管理办法（2022年1月21日修订版） (2022). Available at: http://www.moa.gov.cn/ztzl/zjyqwgz/zcfg/202206/t20220607_6401864.htm (Accessed: 12 October 2022).
Prabu, S.L. et al. (2022) Intellectual Property. Available at: https://doi.org/10.5772/intechopen.94621.