Abstract Biotechnology is a broad range of technologies that employ living organisms or parts of them to make diverse products. Biotechnology, within the American bioeconomy, is a growing topic of concern with recent investments to help address infectious diseases, food security, and energy security. From vaccine development to comprehensive DNA mapping, the medical biotechnological industry is rapidly expanding at the forefront of technological advancement. The evolution of biotechnology as it is known today began in the 1980s with the commercialization of biotech products. The future of biotechnology is bright with scientific breakthroughs, government incentive offerings, cost-effective research and development, and therapeutic advancements to cure medical conditions that currently have inadequate or no inaccessible therapies.
摘要 生物技术是利用生物或部分生物制造各种产品的广泛技术。在美国生物经济中，生物技术是一个日益受到关注的话题，最近的投资有助于解决传染病、食品安全和能源安全问题。从疫苗开发到全面的 DNA 图谱绘制，医疗生物技术产业正在技术进步的前沿迅速扩张。当今生物技术的发展始于 20 世纪 80 年代生物技术产品的商业化。随着科学的突破、政府激励措施的出台、具有成本效益的研发以及治疗手段的进步，生物技术的前景一片光明，可以治愈目前治疗手段不足或无法治愈的病症。
{"title":"The Push for the Free Transfer of IP Rights in Medical Biotechnology","authors":"Elijah Benzvi","doi":"10.1515/jbbbl-2023-0004","DOIUrl":"https://doi.org/10.1515/jbbbl-2023-0004","url":null,"abstract":"Abstract Biotechnology is a broad range of technologies that employ living organisms or parts of them to make diverse products. Biotechnology, within the American bioeconomy, is a growing topic of concern with recent investments to help address infectious diseases, food security, and energy security. From vaccine development to comprehensive DNA mapping, the medical biotechnological industry is rapidly expanding at the forefront of technological advancement. The evolution of biotechnology as it is known today began in the 1980s with the commercialization of biotech products. The future of biotechnology is bright with scientific breakthroughs, government incentive offerings, cost-effective research and development, and therapeutic advancements to cure medical conditions that currently have inadequate or no inaccessible therapies.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"50 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138955484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Introduction to Volume XIII","authors":"V. Sutton","doi":"10.1515/jbbbl-2022-2001","DOIUrl":"https://doi.org/10.1515/jbbbl-2022-2001","url":null,"abstract":"","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126889629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract This article analyzes various legal defenses and immunities against patent infringement liability during COVID-19 under the Public Readiness and Emergency Preparedness Act (“PREPA” or “Act”). Although initially enacted in response to the 2001 Anthrax attacks, PREPA was once again invoked in response to COVID-19 under the authority of the Secretary of Health and Human Services (the “Secretary”). Through declarations issued by the Secretary, the scope of the original Act inferably expanded in a pursuit to mitigate the public health emergency of COVID-19. The nature of this review primarily focuses on the uncertainties surrounding the extent and practical legal applications of this expansion.
{"title":"Attempting to Mitigate COVID-19: Does the Public Readiness and Emergency Preparedness Act Provide Patent Infringement Immunity?","authors":"Samuel E. Higgs","doi":"10.1515/jbbbl-2022-0003","DOIUrl":"https://doi.org/10.1515/jbbbl-2022-0003","url":null,"abstract":"Abstract This article analyzes various legal defenses and immunities against patent infringement liability during COVID-19 under the Public Readiness and Emergency Preparedness Act (“PREPA” or “Act”). Although initially enacted in response to the 2001 Anthrax attacks, PREPA was once again invoked in response to COVID-19 under the authority of the Secretary of Health and Human Services (the “Secretary”). Through declarations issued by the Secretary, the scope of the original Act inferably expanded in a pursuit to mitigate the public health emergency of COVID-19. The nature of this review primarily focuses on the uncertainties surrounding the extent and practical legal applications of this expansion.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"121 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128187517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Amid public health crises, contact tracing becomes an imperative mechanism in combatting the threat at hand. In today’s day and age, technology has exploded, leaving the legal world to determine technologies’ effect on the law. As the COVID-19 pandemic wreaks havoc upon the world, how is contact tracing affected by the advent of modern technology, and how does the use of technology such as geolocation, artificial intelligence (AI), and facial recognition technology (FRT) comport with the rights to privacy, association, free exercise of religion, and equal protection? This paper will examine the current constitutional precedents to provide insight as to how the use of digital contact tracing would influence the rights of everyday citizens. Constitutional implications of digital contact tracing using geolocation, AI, and FRT are considered against the First, Fourth, and Fourteenth Amendments (more specifically, against freedom of religion, freedom of association, the right to privacy, and the right to equal protection). Given the novel aspects of geolocation, AI, and FRT, digital contact tracing could result in potential constitutional violations under certain circumstances. This research shows that while digital contact tracing using novel technology could be done in a legal way, there are just as many concerns to be had about potential constitutional abuses that could affect each and everyone’s lives.
{"title":"Contact Tracing in the COVID-19 Pandemic: How Digital Contact Tracing Affects Our Individual Rights","authors":"Ryan Sherer","doi":"10.1515/jbbbl-2022-0005","DOIUrl":"https://doi.org/10.1515/jbbbl-2022-0005","url":null,"abstract":"Abstract Amid public health crises, contact tracing becomes an imperative mechanism in combatting the threat at hand. In today’s day and age, technology has exploded, leaving the legal world to determine technologies’ effect on the law. As the COVID-19 pandemic wreaks havoc upon the world, how is contact tracing affected by the advent of modern technology, and how does the use of technology such as geolocation, artificial intelligence (AI), and facial recognition technology (FRT) comport with the rights to privacy, association, free exercise of religion, and equal protection? This paper will examine the current constitutional precedents to provide insight as to how the use of digital contact tracing would influence the rights of everyday citizens. Constitutional implications of digital contact tracing using geolocation, AI, and FRT are considered against the First, Fourth, and Fourteenth Amendments (more specifically, against freedom of religion, freedom of association, the right to privacy, and the right to equal protection). Given the novel aspects of geolocation, AI, and FRT, digital contact tracing could result in potential constitutional violations under certain circumstances. This research shows that while digital contact tracing using novel technology could be done in a legal way, there are just as many concerns to be had about potential constitutional abuses that could affect each and everyone’s lives.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114743117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract COVID-19 is becoming an increasing concern since its emergence in late 2019. Texas in particular has seen an increasing number of cases along with overloaded hospitals. Texas has not dealt with a pandemic as severe as this for decades and the government is quickly implementing procedures to mitigate the effects of COVID-19. These COVID-19 procedures are spiking concern in many individuals, causing them to question the constitutionality of these ordinances and if the government is infringing on their rights. In this paper we will analyze these procedures and how they originated. We will explore the different roles of federal, state and local governments in public health law and the extent of their authority during a public health crisis. This analysis will provide the answers and show you why the government is likely not infringing on your constitutional rights.
{"title":"Dallas, Houston, and San Antonio Public Health Ordinance During COVID-19. Are They Constitutional?","authors":"Sana Achraf","doi":"10.1515/jbbbl-2022-0004","DOIUrl":"https://doi.org/10.1515/jbbbl-2022-0004","url":null,"abstract":"Abstract COVID-19 is becoming an increasing concern since its emergence in late 2019. Texas in particular has seen an increasing number of cases along with overloaded hospitals. Texas has not dealt with a pandemic as severe as this for decades and the government is quickly implementing procedures to mitigate the effects of COVID-19. These COVID-19 procedures are spiking concern in many individuals, causing them to question the constitutionality of these ordinances and if the government is infringing on their rights. In this paper we will analyze these procedures and how they originated. We will explore the different roles of federal, state and local governments in public health law and the extent of their authority during a public health crisis. This analysis will provide the answers and show you why the government is likely not infringing on your constitutional rights.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115066838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract The COVID-19 Pandemic created a need for a vaccine that would need to be rapidly created, tested and approved in order to reduce the pandemic’s tremendous impact on human life and the economy. This article discusses the vaccine development process as well as Operation Warp Speed, the United States plan for emergency vaccine development in a pandemic situation. Written before the approval of the currently available COVID-19 vaccines, this article also discusses the implications of a speedier vaccine development process as well as recommendations to the standard process.
{"title":"Operation Warp Speed: A Legal Analysis of the Vaccine Development Process and How We Got Here","authors":"Kenia Ascencio","doi":"10.1515/jbbbl-2022-0002","DOIUrl":"https://doi.org/10.1515/jbbbl-2022-0002","url":null,"abstract":"Abstract The COVID-19 Pandemic created a need for a vaccine that would need to be rapidly created, tested and approved in order to reduce the pandemic’s tremendous impact on human life and the economy. This article discusses the vaccine development process as well as Operation Warp Speed, the United States plan for emergency vaccine development in a pandemic situation. Written before the approval of the currently available COVID-19 vaccines, this article also discusses the implications of a speedier vaccine development process as well as recommendations to the standard process.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121972553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Introduction to Volume XII","authors":"V. Sutton, P. Horn","doi":"10.1515/jbbbl-2021-2011","DOIUrl":"https://doi.org/10.1515/jbbbl-2021-2011","url":null,"abstract":"","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"55 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132695851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Mitigating the proliferation of biological weapons remains uniquely challenging, even 48 years after the ratification of the Biological Weapons Convention (BWC). Suspected development of advanced biological weapons by the Democratic People’s Republic of Korea (North Korea), despite its status as a party to both the BWC and other nonproliferation agreements, has emphasized the need for international efforts to keep biological weapons out of the hands of rogue nations and terrorist networks. Among the numerous weaponized cultures believed to be in development by the North Korean military are anthrax, botulism, cholera, plague and smallpox. With a steady decrease in resources and attention devoted to preparedness for biological attacks or outbreaks since 2001, the United States and its allies remain vulnerable to biological weapons in development by North Korea. An ongoing example of this danger is demonstrated by the international community’s struggle to respond to the coronavirus disease 2019 (COVID-19) pandemic. With United Nations Security Council Resolution (UNSCR) 1540’s expiration in 2021, this paper aims to assess its effectiveness in preventing the proliferation of biological weapons by analyzing the legal requirements UNSCR 1540 imposes on UN member nations. Using North Korea’s biological weapons program as a case study, this paper will evaluate the successes and failures of UNSCR 1540’s legal mechanisms in controlling biological weapons development in North Korea in its penultimate year of validity. This paper will also examine the overlapping roles served by the World Health Organization (WHO), the Biological Weapons Convention (BWC), and UNSCR 1540, and how their administrative frameworks identify and respond to natural disease outbreaks and biological attacks. Finally, this paper will recommend actions the United Nations Security Council may take to more effectively pursue its mission of nonproliferation.
{"title":"The Hermit Kingdom’s Forgotten Threat: Evaluating UNSCR 1540’s Effectiveness in Controlling North Korea’s Biological Weapons Program","authors":"Jakob M Reynolds","doi":"10.1515/jbbbl-2021-2008","DOIUrl":"https://doi.org/10.1515/jbbbl-2021-2008","url":null,"abstract":"Abstract Mitigating the proliferation of biological weapons remains uniquely challenging, even 48 years after the ratification of the Biological Weapons Convention (BWC). Suspected development of advanced biological weapons by the Democratic People’s Republic of Korea (North Korea), despite its status as a party to both the BWC and other nonproliferation agreements, has emphasized the need for international efforts to keep biological weapons out of the hands of rogue nations and terrorist networks. Among the numerous weaponized cultures believed to be in development by the North Korean military are anthrax, botulism, cholera, plague and smallpox. With a steady decrease in resources and attention devoted to preparedness for biological attacks or outbreaks since 2001, the United States and its allies remain vulnerable to biological weapons in development by North Korea. An ongoing example of this danger is demonstrated by the international community’s struggle to respond to the coronavirus disease 2019 (COVID-19) pandemic. With United Nations Security Council Resolution (UNSCR) 1540’s expiration in 2021, this paper aims to assess its effectiveness in preventing the proliferation of biological weapons by analyzing the legal requirements UNSCR 1540 imposes on UN member nations. Using North Korea’s biological weapons program as a case study, this paper will evaluate the successes and failures of UNSCR 1540’s legal mechanisms in controlling biological weapons development in North Korea in its penultimate year of validity. This paper will also examine the overlapping roles served by the World Health Organization (WHO), the Biological Weapons Convention (BWC), and UNSCR 1540, and how their administrative frameworks identify and respond to natural disease outbreaks and biological attacks. Finally, this paper will recommend actions the United Nations Security Council may take to more effectively pursue its mission of nonproliferation.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"398 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124283196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract The United States Federal government faces significant difficulties when implementing federal quarantine. States have the jurisdiction to enforce quarantine within their states, and the federal government cannot infringe on this right. The issue therein lies in the places and modality in which the federal government may enforce quarantine. This Article aims to outline the places and methods by which quarantine is enforced by the federal government, the problems that arise from this limited jurisdiction, and solutions that ensure federal quarantine is meaningful.
{"title":"Federal Quarantine: The Issue with Limited CDC Presence at Ports of Entry","authors":"TA Walls","doi":"10.1515/jbbbl-2021-2009","DOIUrl":"https://doi.org/10.1515/jbbbl-2021-2009","url":null,"abstract":"Abstract The United States Federal government faces significant difficulties when implementing federal quarantine. States have the jurisdiction to enforce quarantine within their states, and the federal government cannot infringe on this right. The issue therein lies in the places and modality in which the federal government may enforce quarantine. This Article aims to outline the places and methods by which quarantine is enforced by the federal government, the problems that arise from this limited jurisdiction, and solutions that ensure federal quarantine is meaningful.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116059720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract The Judicial System is by and large a backward-looking, rather than a forward-looking system. The rapid advancement of technology is creating a greater strain on our legal framework. The current legal system considers whether the Technology is in common use to determine the expectation of privacy, however, this legal standard will, and arguably already does, lack the flexibility to make timely and efficient determinations on the constitutionality of using certain technology for governmental searches and seizures. The solution is a proactive approach through a combination of Legislative and Judicial action that will ensure individual privacy is protected in an ever-advancing technological world.
{"title":"Is the Expectation of Privacy a Dying Standard? The Government’s Access to Biological Data, Consumer Data and Bioinformatics – And the Limitations that Should be in Place","authors":"J. Gutiérrez","doi":"10.1515/jbbbl-2021-2004","DOIUrl":"https://doi.org/10.1515/jbbbl-2021-2004","url":null,"abstract":"Abstract The Judicial System is by and large a backward-looking, rather than a forward-looking system. The rapid advancement of technology is creating a greater strain on our legal framework. The current legal system considers whether the Technology is in common use to determine the expectation of privacy, however, this legal standard will, and arguably already does, lack the flexibility to make timely and efficient determinations on the constitutionality of using certain technology for governmental searches and seizures. The solution is a proactive approach through a combination of Legislative and Judicial action that will ensure individual privacy is protected in an ever-advancing technological world.","PeriodicalId":415930,"journal":{"name":"Journal of Biosecurity, Biosafety, and Biodefense Law","volume":"97 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127630467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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