Team:Uppsala/PolicyPractices MicrobialDesigns

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document.getElementById("tab1").innerHTML = '<br><p>In this overview section, we present our most important findings based upon developing of Microbial Designs. To view the subsections of our research, refer to the tabs above or follow the link that is presented at the short description of the subsections below.</p><h2>Business idea</h2><p>The goal of Microbial Designs is to develop genetically modified microorganisms that in different ways will be of benefit to humans all over the world. As experts in working and modifying microorganisms, we create value by developing strains with promising properties. These strains can then be further developed by companies with larger research budgets.<br><br>Initially, our main goal is to develop a Lactobacillus strain, with the ability to treat people with the disease caused by the pathogen Yersinia enterocolitica. The Lactobacillus strain will target the pathogen specifically, which will make it less likely that resistance to the produced antibiotic will develop. This strain will be sold to big medical companies as a promising technology for solving the problem with antibiotic resistance. These larger companies, that have larger budgets for the development of medicines, will then take responsibility for getting the medicine through further clinical studies. Our future goal is to establish a larger company, that develops strains of bacteria that specifically targets and neutralizes different pathogens, and in that way obviate the human need for antibiotics of today.</p><h2>Regulations: Intellectual Property Rights and Clinical Trials</h2><p>One of the areas of regulations that is especially important to Microbial Designs is the Intellectual Property Rights involved in getting a patent. The general criteria that must be met for a patent, novelty, industrial applicability and inventivity, seem to apply to the designer microorganisms. The open-source structure of the Registry of iGEM, however, makes successfully applying for a patent more challenging.<br><br>If you want to learn more about Intellectual Property Rights and how we can make them compatible with the Registry, see the <i>Intellectual Property Rights section</i>.<br><br>One area of regulations that is specific for the medical application of our designer microorganisms concerns clinical trials. To approve a product for clinical use, multiple stages of testing must be passed. As these clinical trials are expensive, take a long time and have a low success-rate, Microbial Designs will only focus on earlier stages or pre-clinical trials and will thereafter sell these products to larger companies.<br><br>Sweden is a country where its notoriously challenging to develop new pharmaceuticals. This is why our company would most likely aim to develop our products in the United States.<br><br>If you want to learn more about the different aspects of clinical trials, please see the <i>Clinical Trials and Regulations section</i>.</p><h2>The Market</h2><p>One of the core aspects of Microbial Designs Bactissile  is that it may be an alternative treatment for pathogens that are antibiotic-resistant. The disease caused by Y. enterocolitica is rare and not always life-threatening.  Developing the Bactissile might open ways to develop treatments for severe illnesses that are caused by antibiotic-resistant pathogens, however, and such technology could become very valuable in countries where antibiotics-resistance is wide-spread. The fact that antibiotics-resistance occurs relatively infrequently in Sweden makes for another reason to focus our activities on other parts of the world.<br><br>If you want to read more about our marketing strategy see the <i>Marketing section</i>.</p><h2>Budget & Financing</h2><p>In order to start Microbial Designs activities, we will need start-up capital. To estimate the amount of money that we will need to start developing our designer microorganisms, we have consulted a  professor who himself has been involved in starting a small biotechnology company. Based on our discussions with him, we estimate that our budget consist of approximately twelve million Swedish crowns (approximately two million dollars). The corresponding cost per treatment should then be ten thousand Swedish crowns.<br><br>If you want to learn more details about the budget of Microbial Designs, see the <i>Budget section</i>.<br><br>To access this start-up capital, we will need to reach out for funding. Sources of funds for newly established businesses are venture capitalists, business angels and government programs. Microbial Designs business plan is mostly compatible with a combination of funding through the American <i>Orphan Drug Act</i> and funding through venture capitalists.<br><br>If you want to learn more about the different sources of funding and why this specific combination suits us best, see the <i>Financing section</i>.</p><h2>Reflections</h2><p>Microbial Designs is sure to meet challenges during its development. We have reflected upon the different challenges that became apparent in the different sections and how to tackle them. We have bundled these considerations in the <i>Reflections section</i>.</p>';
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document.getElementById("tab1").innerHTML = '<br><p>In this overview section, we present our most important findings based upon developing of Microbial Designs. To view the subsections of our research, refer to the tabs above.</p><h2>Business idea</h2><p>The goal of Microbial Designs is to develop genetically modified microorganisms that in different ways will be of benefit to humans all over the world. As experts in working and modifying microorganisms, we create value by developing strains with promising properties. These strains can then be further developed by companies with larger research budgets.<br><br>Initially, our main goal is to develop a Lactobacillus strain, with the ability to treat people with the disease caused by the pathogen Yersinia enterocolitica. The Lactobacillus strain will target the pathogen specifically, which will make it less likely that resistance to the produced antibiotic will develop. This strain will be sold to big medical companies as a promising technology for solving the problem with antibiotic resistance. These larger companies, that have larger budgets for the development of medicines, will then take responsibility for getting the medicine through further clinical studies. Our future goal is to establish a larger company, that develops strains of bacteria that specifically targets and neutralizes different pathogens, and in that way obviate the human need for antibiotics of today.</p><h2>Regulations: Intellectual Property Rights and Clinical Trials</h2><p>One of the areas of regulations that is especially important to Microbial Designs is the Intellectual Property Rights involved in getting a patent. The general criteria that must be met for a patent, novelty, industrial applicability and inventivity, seem to apply to the designer microorganisms. The open-source structure of the Registry of iGEM, however, makes successfully applying for a patent more challenging.<br><br>If you want to learn more about Intellectual Property Rights and how we can make them compatible with the Registry, see the <i>Intellectual Property Rights section</i>.<br><br>One area of regulations that is specific for the medical application of our designer microorganisms concerns clinical trials. To approve a product for clinical use, multiple stages of testing must be passed. As these clinical trials are expensive, take a long time and have a low success-rate, Microbial Designs will only focus on earlier stages or pre-clinical trials and will thereafter sell these products to larger companies.<br><br>Sweden is a country where its notoriously challenging to develop new pharmaceuticals. This is why our company would most likely aim to develop our products in the United States.<br><br>If you want to learn more about the different aspects of clinical trials, please see the <i>Clinical Trials and Regulations section</i>.</p><h2>The Market</h2><p>One of the core aspects of Microbial Designs Bactissile  is that it may be an alternative treatment for pathogens that are antibiotic-resistant. The disease caused by Y. enterocolitica is rare and not always life-threatening.  Developing the Bactissile might open ways to develop treatments for severe illnesses that are caused by antibiotic-resistant pathogens, however, and such technology could become very valuable in countries where antibiotics-resistance is wide-spread. The fact that antibiotics-resistance occurs relatively infrequently in Sweden makes for another reason to focus our activities on other parts of the world.<br><br>If you want to read more about our marketing strategy see the <i>Marketing section</i>.</p><h2>Budget & Financing</h2><p>In order to start Microbial Designs activities, we will need start-up capital. To estimate the amount of money that we will need to start developing our designer microorganisms, we have consulted a  professor who himself has been involved in starting a small biotechnology company. Based on our discussions with him, we estimate that our budget consist of approximately twelve million Swedish crowns (approximately two million dollars). The corresponding cost per treatment should then be ten thousand Swedish crowns.<br><br>If you want to learn more details about the budget of Microbial Designs, see the <i>Budget section</i>.<br><br>To access this start-up capital, we will need to reach out for funding. Sources of funds for newly established businesses are venture capitalists, business angels and government programs. Microbial Designs business plan is mostly compatible with a combination of funding through the American <i>Orphan Drug Act</i> and funding through venture capitalists.<br><br>If you want to learn more about the different sources of funding and why this specific combination suits us best, see the <i>Financing section</i>.</p><h2>Reflections</h2><p>Microbial Designs is sure to meet challenges during its development. We have reflected upon the different challenges that became apparent in the different sections and how to tackle them. We have bundled these considerations in the <i>Reflections section</i>.</p>';
document.getElementById("tab2").innerHTML = '<br><p>A big aspect in finding venture capitalists and other investors is to have your product patented. A patent works like a security for the investor. It ensures that no other company will copy the product and make money on it as well as ensuring that they cannot outcompete your product in the market. Without patents it is very hard to find any investors since they want a security that the investment will be profitable. This results in the company having an empty budget, if the owners do not have a big amount of money to start with.</p><h2>The fundamentals of patenting</h2><p>To understand the fundamentals of  patenting we talked to Gerald Petterson,  a patent attorney at Uppsala University. Petterson explained that to be able to patent your invention it has to fulfill three main requirements. To begin with, the product needs to be industrially applicable. In other words, there has to be a market for the product. For instance, our medicine is an alternative to antibiotics that will treat patients infected with Yersinia enterocolitica. At present, 500-800 people in Sweden are infected with Yersinia enterocolitica every year [1]. Since the problem with antibiotic resistance is rising, there is a growing market and demand for our medicine.<br><br>The second requirement to patent an invention is novelty. It cannot be an existing product anywhere in the world. Furthermore, it cannot be known to a professional in the subject how to make the product. This is because you cannot patent anything that is widely known already even though it has not been patented. Our product, for example, is the only treatment against Yersinia enterocolitica that consists of gene modified Lactobacillus. In addition, if the combination of genes that we have used is not known to any professional already, it is fully possible to patent it.<br><br>Lastly, the product has to have a certain level of invention. It is not possible to take an already existing product, improve it slightly and then sell it in the same market as your own product and compete with the real inventors. However, if you find a whole new application for the invention by improving it, it is possible to patent it. For example, the company “upjohn” that worked with creating new heart medicines discovered that the medicine also worked for treating hair loss. Thereby they discovered a new, not obvious area of use for the product which made it possible for them to patent it as a medicine against loss of hair. [2]In our case, we have made a product that has a combination of genes that have not been assembled before to use as a medicine against Yersinia enterocolitica.<br><br>Furthermore, it is good to keep in mind when patenting your product, in what country you want to patent it. Because there are not many customers in Sweden, the most profitable for our company is to get a patent in the United States since the market is bigger there.</p><h2>Patent and iGEM</h2><p>Within iGEM, successfully acquiring  a patent becomes problematic, since the contest enforces  an open source policy. This policy means that someone that has contributed to the BioBricks foundation will not assert any existing or future intellectual property rights against anyone for using the contributed parts. This makes the parts hard to patent since the open source policy is the complete opposite of the policy of patent.<br><br>There exists a possibility, however, to patent only the combinations of the genes that builds up the medicine that our company is selling and still contribute only the different genes one by one. Thus, the team would still contribute to the foundation and be able to patent the product itself and the technology behind it. Furthermore, this would only benefit the BioBrick foundation, as sending in all different combination of genes would make the database overflow and make it hard to search for different parts. Likewise it would be hard to use and adapt the parts in other projects.  Therefore, only patenting the combination of genes with the parts assembled would be a good solution that would not interfere with the open source policy.<br><br>Another problem with getting a patent while participating in iGEM is that we will present all our results and research which interferes with the novelty requirement. This can be solved, however, by sending in a request for patent before presenting our research in the competition. Thereby our product will be protected.</p><h2>Summary</h2><p>When patenting your product there are three main criterias that the invention has to fulfill. Those criterias are: industrial application, novelty and level of invention. Our product fulfills these requirements and therefore we should be able to get a patent and thereby further evolve our company. Even though some of the iGEM policies of open source interfere with the principle of patent there are solutions that will satisfy both aspects. Only patenting the combination of genes and still sharing the basic parts to the BioBrick foundation is a solution to this issue.</p><ul class="reference"><li>[1]http://www.slv.se/upload/dokument/rapporter/bakterier_virus_mogel/2007_8_livsmedelsverket_riskprofil_yersinia.pdf</li><li>[2]http://www.belgraviacentre.com/blog/the-unusual-history-of-minoxidil/</li></ul>';
document.getElementById("tab2").innerHTML = '<br><p>A big aspect in finding venture capitalists and other investors is to have your product patented. A patent works like a security for the investor. It ensures that no other company will copy the product and make money on it as well as ensuring that they cannot outcompete your product in the market. Without patents it is very hard to find any investors since they want a security that the investment will be profitable. This results in the company having an empty budget, if the owners do not have a big amount of money to start with.</p><h2>The fundamentals of patenting</h2><p>To understand the fundamentals of  patenting we talked to Gerald Petterson,  a patent attorney at Uppsala University. Petterson explained that to be able to patent your invention it has to fulfill three main requirements. To begin with, the product needs to be industrially applicable. In other words, there has to be a market for the product. For instance, our medicine is an alternative to antibiotics that will treat patients infected with Yersinia enterocolitica. At present, 500-800 people in Sweden are infected with Yersinia enterocolitica every year [1]. Since the problem with antibiotic resistance is rising, there is a growing market and demand for our medicine.<br><br>The second requirement to patent an invention is novelty. It cannot be an existing product anywhere in the world. Furthermore, it cannot be known to a professional in the subject how to make the product. This is because you cannot patent anything that is widely known already even though it has not been patented. Our product, for example, is the only treatment against Yersinia enterocolitica that consists of gene modified Lactobacillus. In addition, if the combination of genes that we have used is not known to any professional already, it is fully possible to patent it.<br><br>Lastly, the product has to have a certain level of invention. It is not possible to take an already existing product, improve it slightly and then sell it in the same market as your own product and compete with the real inventors. However, if you find a whole new application for the invention by improving it, it is possible to patent it. For example, the company “upjohn” that worked with creating new heart medicines discovered that the medicine also worked for treating hair loss. Thereby they discovered a new, not obvious area of use for the product which made it possible for them to patent it as a medicine against loss of hair. [2]In our case, we have made a product that has a combination of genes that have not been assembled before to use as a medicine against Yersinia enterocolitica.<br><br>Furthermore, it is good to keep in mind when patenting your product, in what country you want to patent it. Because there are not many customers in Sweden, the most profitable for our company is to get a patent in the United States since the market is bigger there.</p><h2>Patent and iGEM</h2><p>Within iGEM, successfully acquiring  a patent becomes problematic, since the contest enforces  an open source policy. This policy means that someone that has contributed to the BioBricks foundation will not assert any existing or future intellectual property rights against anyone for using the contributed parts. This makes the parts hard to patent since the open source policy is the complete opposite of the policy of patent.<br><br>There exists a possibility, however, to patent only the combinations of the genes that builds up the medicine that our company is selling and still contribute only the different genes one by one. Thus, the team would still contribute to the foundation and be able to patent the product itself and the technology behind it. Furthermore, this would only benefit the BioBrick foundation, as sending in all different combination of genes would make the database overflow and make it hard to search for different parts. Likewise it would be hard to use and adapt the parts in other projects.  Therefore, only patenting the combination of genes with the parts assembled would be a good solution that would not interfere with the open source policy.<br><br>Another problem with getting a patent while participating in iGEM is that we will present all our results and research which interferes with the novelty requirement. This can be solved, however, by sending in a request for patent before presenting our research in the competition. Thereby our product will be protected.</p><h2>Summary</h2><p>When patenting your product there are three main criterias that the invention has to fulfill. Those criterias are: industrial application, novelty and level of invention. Our product fulfills these requirements and therefore we should be able to get a patent and thereby further evolve our company. Even though some of the iGEM policies of open source interfere with the principle of patent there are solutions that will satisfy both aspects. Only patenting the combination of genes and still sharing the basic parts to the BioBrick foundation is a solution to this issue.</p><ul class="reference"><li>[1]http://www.slv.se/upload/dokument/rapporter/bakterier_virus_mogel/2007_8_livsmedelsverket_riskprofil_yersinia.pdf</li><li>[2]http://www.belgraviacentre.com/blog/the-unusual-history-of-minoxidil/</li></ul>';

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