{"title":"Patent Pending: How the Current Patent Utility Requirement Hinders Biotechnological Innovation.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The legal system is always playing catch up to adapt to new legal landscapes, doctrines, and technology; however, patent law needs help to compete with biotechnological research in the race towards innovation. Biotechnological research in the realm of human health and medicine often involves the use of therapeutic drugs. The field of healthcare biotechnology takes biological systems and processes and generates novel, creative solutions to a number of human health conditions. However, the translation process for a new drug, therapy, or process is long and expensive which requires investors to help the researchers and scientists move their creations from inception to universal use. The United States Patent and Trademark Office has updated their criteria to accommodate the unique nature of biotechnological research, but the United States Court of Appeals for the Federal Circuit has not followed suit. The Court's stringent application of the utility requirement in patent law precludes numerous biotechnological processes and products from patent protection. Changing the Court's standard of interpretation will spur further innovation in the biotechnological field as researchers and scientists will receive necessary financial backing with the knowledge that patent protection is possible for their creations.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"39 2","pages":"131"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730853","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":"Roads to Regulation: A Discussion on Non-State Armed Groups' International Health Law Obligations.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Non-state actors can look and operate like governments, yet without formal statehood, they exist in a regulatory gray area. Non state actors play an increasingly influential role in international law, yet they remain largely unregulated. This paper examines non-state actors as a class, with particular attention to non-State armed groups (NSAGs), and analyzes the regulatory gap they occupy specifically within international health law. The paper first surveys the rise, diversity, authority, and legitimacy of non-state actors in relation to States, highlighting their growing involvement in governance functions traditionally reserved for States. This paper then introduces the World Health Organization (WHO) and the International Health Regulations (IHR) as the central framework governing global health emergencies, emphasizing that these legally binding obligations apply exclusively to WHO Member States. Lacking formal statehood, nonstate actors lack the legitimacy undergirding UN Member States' international obligations. Through an analysis of WHO's Framework for Engagement with Non-State Actors (FENSA) and its partnership with the International Federation of the Red Cross (IFRC), the paper demonstrates both the benefits and the limitations of existing engagement mechanisms, noting that WHO's narrow definition of non-state actors excludes NSAGs and leaves populations under their control beyond the reach of international health regulation.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"39 2","pages":"148"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730816","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":"FDA's New Approval Plan for COVID-19 Vaccines: An Inquiry of \"Benefit\" Rather than the Statutory Scope of \"Safety, Purity, and Potency\"?","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article analyzes the FDA's proposed policy plan issued in May 2025 regarding the approval of Covid-19 boosters for different groups of persons. It offers two constructive recommendations that will help prevent constitutionality challenge on impermissible intrusion of the freedom of health. The first is to avoid using the confusing term \"benefit\" but instead focus on the statutory parameters of \"safety, purity, and potency.\" The affected group can make a strong case that their free choice of vaccination should not be deprived, as long as the vaccine qualifies for the statutory thresholds of being safe, pure, and potent. They are free to choose what \"benefits\" them, not the FDA. Second, the FDA should also clarify for the public on the relevance (or irrelevance) of individualized factors that are currently not included in the proposed exhaustive list of risk factors, such as one's antibody level and varied exposure like workplace setting. The freedom of health guards against unconstitutional blanket policy that is deliberately indifferent to relevant individual medical circumstances.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"39 2","pages":"114"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730779","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":"Conversation in My Parlor About Climate Change and the Call to Thoughtful Service by Lawyers with Disabilities.","authors":"Gary Norman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pope John Paul II penned, \"So much of our world seems to be in fragments, in disjointed pieces.\" Experts admonish that an irreparable threshold of 1.5°C for global temperatures is not a theoretical remonstrance but an imminent imperative. Is this true? This article will explore if climate change exists. I will thoughtfully respond to this question in the affirmative, exploring center-based solutions. Specifically, this article will urge that these great United States require a new generation of leaders who can embody the energy of a Brother President Theodore Roosevelt, who possesses the eloquence of President John Kennedy, and who, like President Reagan, can maintain and show a bullish \"love\" of the country. The law is one of many tools and this new generation of leaders, who will use those tools, must better reflect the diversity of modern America. Specifically, I urge inclusion by lawyers with disabilities in leading center-based solutions to climate change.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"38 3","pages":"329-382"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144054493","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":"The Ultra (And Nearly Ultra) Locality Rules Persist! Why Continue to Ignore Modern Medicine and Contort the Standard of Care?","authors":"Marc D Ginsberg","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The use of the locality rule to define or modify the medical standard of care is inconsistent with modern medicine. Nevertheless, various states in the U.S. continue to adhere to a locality rule. This paper revisits this topic, about which I have previously written, by focusing on Idaho, Nebraska, Tennessee and Arkansas. The paper concludes by suggesting that locality rules should be eliminated in favor of a national standard of care.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"38 2","pages":"196-228"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671924","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":"Access to Healthcare for Irregular Migrants.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Access to Healthcare for Irregular Migrants is an assessment of the right to life, security of the person, and non-discrimination as viewed through the lens of Nell Toussaint's legal battle. It tells the compelling story of an irregular migrant's battle for access to health care. Highlighting a gap in the Canadian healthcare system, this piece raises valuable questions about why that gap exists. Toussaint's experiences with multiple levels of the legal system, both in Canada and internationally, are included. It tells the story from when Ms. Toussaint entered Canada to the present; wherein the matter remains before the court. This written work compels readers to consider the place of irregular migrants in Canadian society and challenges related stereotypes. It asks important questions about healthcare rights and ultimately, draws attention to Canada's international agreements and guides the reader to analyze the obligations they create. The Toussaint matter has drawn international attention, but this is the only piece of legal scholarship to tell the story this comprehensively, making it a crucial read for anyone interested in human rights and immigration issues.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"39 1","pages":"94"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730820","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":"An Essay on Trailblazing With Service Animals Langer, Pilot, Bowie, and Izzie: Preserving Non-partisan Public Health and the Law.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A direct correlation exists among humans, their animals, and human health and wellness. This article will focus concisely on law students with disabilities and lawyers with disabilities and how they can be empowered to be trailblazers while remaining healthy and well. Salutogenic Model should be optimized by lawyers with disabilities working at the intersection of animal law, disability law, and public health law. Service animals have positive and salubrious impacts upon their handlers in several ways, including psychosocial health and wellbeing. The Grand Architect (or in my Cherokee tradition, \"great spirit\") continuously partners me with complicated but magnificent dog partners who shape my emotional, physical, and spiritual health and wellness. (This is to mention but three of the seven dimensions of health and wellness.) As one article has indicated, public health advocacy is essential for promoting disability rights and shaping policies that address the unique needs of people with disabilities. Disability law and public health law, policy, and research, should be harmonized thereby designing and implementing interventions to empower trailblazers with disabilities to be healthy and well, in spite of social ignorance or insurmountable social prejudice. Arguably, service animals is a powerful public health intervention.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"39 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730818","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":"Splitting Equality: Access to Gender-Affirming Care in the Fourth Circuit.","authors":"Gilbert D Jones","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Note critically examines the evolving legal landscape surrounding transgender individuals' access to gender-affirming care in the United States, focusing on two pivotal cases before the Fourth Circuit: Kadel v. Folwell (North Carolina) and Fain v. Crouch (West Virginia). These cases present a constitutional and statutory challenge to the exclusion of medically necessary gender-affirming care from state health plans, under Title VII of the Civil Rights Act of 1964 and the Equal Protection Clause of the Fourteenth Amendment. The Note contextualizes these lawsuits within a broader historical trajectory of transgender rights, highlighting legal and cultural milestones that have shaped access to care and recognition. Drawing on precedent, including Grimm v. Gloucester County School Board and Bostock v. Clayton County, the analysis explores how gender identity is legally understood through the lens of sex discrimination. It further considers the persuasive value of medical consensus on the necessity of gender-affirming care, as endorsed by major health organizations. The paper identifies the legal inconsistencies and discriminatory rationales employed by states to deny this care and critiques the sociopolitical underpinnings of such exclusions. By comparing the different factual and legal circumstances of Kadel and Fain, the Note argues that the Fourth Circuit has an opportunity to affirm constitutional protections for transgender persons. It proposes a legally and politically viable middle ground: requiring states to provide coverage for non-surgical interventions such as medication and psychotherapy, thereby upholding basic standards of care while navigating judicial restraint. Ultimately, the Note underscores that the outcome of these joined en banc proceedings will significantly influence future litigation, legislative efforts, and the lived realities of transgender individuals. In doing so, it advocates for a legal framework rooted in equality, medical necessity, and the dignity of all persons under the law.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"38 3","pages":"402-421"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036223","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":"Cracking the Facade: Analyzing Ohio's \"Don't Say Gay\" Legislation as Disguised Discrimination Under the First and Fourteenth Amendments.","authors":"Sydni L Porter","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Ohio State Legislature is among the growing nationwide trend in attacking LGBTQ+ rights. Chief among these is Ohio House Bill 8, which claims to limit the types of content children encounter in schools. While the drafters cite this noble intent, the bill's actual impact further harms queer students and teachers, who already bear heavier mental health burdens due to such legislation and its societal implications. This type of legislation recently originated in Florida, where it was signed into law by Governor Ron DeSantis in 2022 and garnered national media attention. As Ohio Governor Mike DeWine signed a near-identical bill in January 2025, the outcomes observed in Florida inform the constitutional analyses for the Ohio constituency. As in Florida, Ohio's bill is left intentionally vague, banning \"gender ideology\" and \"sexual concepts\" in classrooms or constraining them to what is deemed age-appropriate without providing sufficient guidelines for what may be acceptable. The disparate impact of this legislation is rooted entirely in gender classifications, triggering intermediate scrutiny. The bill's ambiguity creates a chilling effect on students' First Amendment rights by restricting the ability to express gender non-conformity without the school disclosing such changes to their families, disregarding the child's safety, and limiting the type of instruction children may receive in the classroom. Consequently, this compels schools to treat LGBTQ+ students and age-appropriate content differently from their heteronormative counterparts, inherently relegating those with queer identities as second-class citizens under the Fourteenth Amendment's Equal Protection and Substantive Due Process clauses.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"38 2","pages":"267-303"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671908","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":"Rest in the Mourning: Navigating Assisted Suicide and Autonomy.","authors":"Jada Rhome","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Life, in all its diversity, has always been revered for its beauty, be it in the myriad opportunities it presents, the relationships we forge, or the cyclical changes that shape our journey. Yet, life's harsh winters, those prolonged periods of suffering, often push the boundaries of endurance, prompting the question: Should we insist on perseverance when the hope of relief seems distant? This paper aims to explore this very question in the context of assisted suicide. This paper delves into the intricate ethical landscape of assisted suicide, navigating the complex interplay between autonomy, dignity, and the sanctity of life. At the core of this discourse is the concept of \"rest in the mourning,\" where those grappling with the burdens of illness have already mourned the life they once knew. Their consideration of assisted suicide is not a mere desire to escape but a profound acknowledgment of life's impermanence and a quest for dignity in death. Utilizing the New Haven approach, this paper frames the debate over whether the right to die should be considered a fundamental liberty under the Fourteenth Amendment of the U.S. Constitution from various perspectives, including medical ethics, religious views, and constitutional considerations. The New Haven approach, a framework that aims to shape laws that foster human flourishing, raises an important question: Can the right to die, rooted in the principles of autonomy and dignity, be safeguarded without eroding the societal bonds that unite us? Do the laws governing assisted suicide truly serve people and promote human flourishing? This approach is crucial in understanding the implications of laws guiding assisted suicide and their impact on human flourishing.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":"38 2","pages":"229-266"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671913","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}