Journal of Law and the Biosciences最新文献

Patents, genetic resources, and traditional knowledge: the WIPO treaty and the global access and benefit-sharing regime complex. 专利、遗传资源和传统知识：知识产权组织条约与全球获取和惠益分享制度的复杂性。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-05-06 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag015

Frédéric Perron-Welch

{"title":"Patents, genetic resources, and traditional knowledge: the WIPO treaty and the global access and benefit-sharing regime complex.","authors":"Frédéric Perron-Welch","doi":"10.1093/jlb/lsag015","DOIUrl":"https://doi.org/10.1093/jlb/lsag015","url":null,"abstract":"The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (GRATK Treaty) represents a significant doctrinal development in international intellectual property (IP) law. It introduces a mandatory disclosure requirement obliging patent applicants to indicate the origin or source of genetic resources and associated traditional knowledge on which claimed inventions are based. This article situates the GRATK Treaty within the global access and benefit-sharing (ABS) regime complex, examining its interaction with the Convention on Biological Diversity and Nagoya Protocol. It argues that the Treaty constitutes a path-dependent yet normatively consequential response to the problem of biopiracy, strengthening procedural transparency within the patent system while maintaining coherence with existing international legal regimes. By analyzing its disclosure, sanctions, mutual supportiveness, and institutional provisions, the article demonstrates that the GRATK Treaty consolidates the benefit appropriation sub-regime despite not creating any new IP rights. Although its effectiveness will depend on ratification and implementation by major patent jurisdictions, the Treaty marks an incremental but important step toward reconciling IP governance with core elements of the global ABS regime.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag015"},"PeriodicalIF":2.4,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Tear down the wall: why requiring the FDA and the PTO to share information will improve the decision-making of both agencies. 推倒墙：为什么要求FDA和PTO共享信息将改善这两个机构的决策。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-04-30 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag007

Robin Feldman, Gideon Schor

{"title":"Tear down the wall: why requiring the FDA and the PTO to share information will improve the decision-making of both agencies.","authors":"Robin Feldman, Gideon Schor","doi":"10.1093/jlb/lsag007","DOIUrl":"https://doi.org/10.1093/jlb/lsag007","url":null,"abstract":"An invisible wall separates the U.S. Food and Drug Administration (FDA) from the U.S. Patent and Trademark Office (PTO). This wall blocks inter-agency communication, depriving the PTO of information relevant to patent applications and depriving the FDA of information relevant to drug-approval applications. Consequently, it is too easy for a drug company to tell the PTO 'our drug is new' (in hopes of speeding a patent grant) while telling the FDA 'our drug is not new' (in hopes of speeding drug approval). Better communication between the FDA and PTO would increase agency accuracy by preventing inconsistent representations, and would increase agency efficiency by avoiding informational asymmetry and duplication of effort. Presidents Obama and Trump created enhanced mechanisms that allow the PTO to receive information from counterparts in foreign countries and from industry about what is truly innovative. It would also be helpful for the PTO to enjoy the expertise of its own sister agency, located down the road. Despite scholarly and governmental proposals to mandate cooperation between the FDA and the PTO, such coordination remains limited in practice. This article proposes to break through the invisible wall between the FDA and the PTO, and to open pathways for communication between the two agencies.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag007"},"PeriodicalIF":2.4,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13130058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147824005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Genetic testing fraud trends. 基因检测欺诈趋势。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-04-29 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag012

Jordan Paradise, Alyssa Valentine, Sara Cherny, Christina Ramesh

{"title":"Genetic testing fraud trends.","authors":"Jordan Paradise, Alyssa Valentine, Sara Cherny, Christina Ramesh","doi":"10.1093/jlb/lsag012","DOIUrl":"https://doi.org/10.1093/jlb/lsag012","url":null,"abstract":"Genetic testing fraud schemes are widespread, impacting patients, healthcare providers, and the US government. Fueled by rapid innovations in genetic testing capabilities and expansion of telehealth services following the pandemic, fraudsters are thriving. The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) enhanced scrutiny of such fraud schemes over a decade ago, and in September 2019, targeted enforcement began with the indictment of 35 individuals on allegations of genetic testing fraud activities totaling $2.1 billion (https://www.justice.gov/archives/opa/pr/federal-law-enforcement-action-involving-fraudulent-genetic-testing-results-charges-against). By the end of 2024, the DOJ and HHS had initiated hundreds of investigations, with litigation across multiple legal jurisdictions involving physicians, telemedicine companies, marketing companies, and genetic testing laboratories. This article investigates the nature and scope of genetic testing fraud and describes the concerted government activity to thwart the proliferation of these schemes. While the actual mechanisms to carry out genetic testing fraud, such as kickbacks and inappropriate coding, are not new, there are multiple characteristics that make this type of healthcare fraud distinctive. We describe three genetic testing features that make genetic testing fraud unique and heighten the potential for fraud on the government: widespread interest in test content; test complexity; and associated billing challenges. The article further contributes to the literature by assessing genetic testing fraud schemes and discussing implications for physicians and the healthcare system, including recommendations to prevent future genetic testing fraud.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag012"},"PeriodicalIF":2.4,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Biosecurity in the age of synthetic nucleic acids: modernizing the law to manage emerging threats. 合成核酸时代的生物安全：使法律现代化以管理新出现的威胁。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-04-28 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag005

Ayelet Berman

{"title":"Biosecurity in the age of synthetic nucleic acids: modernizing the law to manage emerging threats.","authors":"Ayelet Berman","doi":"10.1093/jlb/lsag005","DOIUrl":"https://doi.org/10.1093/jlb/lsag005","url":null,"abstract":"The rapid expansion of synthetic biology has transformed research and innovation but has also created profound biosecurity challenges. Synthetic nucleic acid (SNA) technologies, which allow genetic material to be synthetically created, enable scientific progress but also lower the barriers to constructing or enhancing dangerous pathogens. This article argues that the governance of SNA should be grounded in a transnational new governance approach that combines binding international obligations with harmonized technical standards. It assesses the fitness of current regimes-the International Health Regulations, the Biological Weapons Convention (BWC), UN Security Council Resolution (UNSCR) 1540, and national biosecurity laws-and finds that while these instruments already impose binding obligations to prevent misuse of biological agents, their terms remain outdated and their application fragmented. Most states lack explicit SNA order screening requirements, and voluntary private standards such as those of the International Gene Synthesis Consortium and ISO 20688-2 remain inadequate for managing this global risk. The article recommends modernizing international law by clarifying that existing treaties cover synthetic biology, developing harmonized global screening standards, and updating national legislation to mandate and incentivize SNA order screening. It further proposes leveraging market access and funding power to drive global practice. Ultimately, safeguarding innovation in the age of SNA requires aligning law to manage the risks of emerging biotechnologies.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag005"},"PeriodicalIF":2.4,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13122627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147790373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Alabama's LePage decision, the future of ex vivo embryos, and more. 阿拉巴马州LePage案的判决，体外胚胎的未来等等。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-04-20 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag013

Henry T Greely

{"title":"Alabama's LePage decision, the future of ex vivo embryos, and more.","authors":"Henry T Greely","doi":"10.1093/jlb/lsag013","DOIUrl":"https://doi.org/10.1093/jlb/lsag013","url":null,"abstract":"In February 2024 the Alabama Supreme Court held that the destruction of frozen embryos stored at an in vitro fertilization (IVF) center could be the basis of a wrongful death suit by the prospective parents under Alabama law. The opinion caused a bipartisan uproar that led to its effective overturning by the Alabama legislature and governor 19 days after it was issued. The Alabama Supreme Court's unexpected intervention in IVF shows the surprising ways a mishap in a clinic can trigger a collision of originalist jurisprudence, judicial rhetoric, political mobilization, and media amplification in our post-Dobbs world. A closer look reminds us of how variable court systems and laws are across the USA, as well as the complex motivations of patients and others involved in assisted reproduction. It also shows how state court decisions, perhaps through intentional provocations, can reverberate in the national debate, leading to overreactions, some far beyond their jurisdictions' borders. Plus, in context, beyond the online quips, the political soundbites, and the media articles, it is a fascinating tale and all of that from a case that could easily have been decided, in either direction, as a low-key interpretation of a unique Alabama statute, without broad consequences.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag013"},"PeriodicalIF":2.4,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13092730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147790428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Augmented inventorship: rethinking patent law in the age of generative AI. 增强发明：在生成式人工智能时代重新思考专利法。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-03-31 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag014

Haim V Levy

{"title":"Augmented inventorship: rethinking patent law in the age of generative AI.","authors":"Haim V Levy","doi":"10.1093/jlb/lsag014","DOIUrl":"https://doi.org/10.1093/jlb/lsag014","url":null,"abstract":"Generative artificial intelligence (AI) now participates in tasks constitutive of invention-problem framing, hypothesis generation, and design-yet patent doctrine remains anchored to a natural-person rule that offers limited guidance for AI-intensive workflows. This Article advances augmented inventorship, a conservative but operationally modern attribution doctrine that preserves human inventorship while making AI's generative role legible and auditable at the moment of conception. Drawing on an analogy to augmented immunology, the framework identifies two design criteria-directability (independent and substantive human intellectual judgment steering model behavior or selection) and traceability (a reviewable, claim-centered record linking human reasons to claim elements)-and translates them into a proportionate evidentiary practice: a Computational Traceability Report and a Human-Machine Contribution Statement. These instruments are content-rich but code-light. They support enablement and sufficiency, clarify claim drafting and construction, reduce prosecution and litigation error costs, and balance evidentiary transparency with trade-secret sensitivity through proportional disclosure. Situated within-and distinguished from-the growing literature on AI inventorship and disclosure, the doctrine aligns with existing law (US conception and significant-contribution standards; the UK's 'actual deviser'; EPC sufficiency) and is compatible with TRIPS disclosure norms. Rather than demanding 'more disclosure' in the abstract, augmented inventorship supplies an administrable grammar for human accountability in AI-assisted research.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag014"},"PeriodicalIF":2.4,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13037463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147596411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

In defense of diversity statements in medical education. 为医学教育中的多样性陈述辩护

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-03-26 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag010

Undaleeb Dairkee, Gregory Curfman, Carmel Shachar

引用次数: 0

Canadian copyright protections for neurodata: ethical and legal implications. 加拿大神经数据的版权保护：伦理和法律含义。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-03-14 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag008

Kyrstin Lavelle, Reina Magistro Nadler, Margot Gunning, Graham J Reynolds, Judy Illes

{"title":"Canadian copyright protections for neurodata: ethical and legal implications.","authors":"Kyrstin Lavelle, Reina Magistro Nadler, Margot Gunning, Graham J Reynolds, Judy Illes","doi":"10.1093/jlb/lsag008","DOIUrl":"10.1093/jlb/lsag008","url":null,"abstract":"This essay examines how Canadian copyright law treats neurodata generated for neuroprediction and further probes if copyright or similar protections would offer mechanisms to safeguard individuals who produce those data. Using a hypothetical fact pattern, we apply the conditions for subsistence of copyright to neurodata created by a research participant and processed by a researcher. The results of the analysis indicate that both parties can credibly argue that copyright subsists in the neurodata, although such an outcome is neither established nor guaranteed under current law. We then explore the policy significance of this legal analysis from a neuroethics perspective. Drawing together literatures on data justice, political economy, and neurotechnology governance, we argue that when people produce neurodata, legal systems should appropriately honor their contributions. This could be accomplished through protections of the integrity of neurodata from harmful misuse, akin to what moral rightsholders can accomplish under Canadian moral rights doctrine. We further highlight the need to protect individual autonomy over brain data, whether via copyright or another mechanism. We conclude that the Canadian approach to copyright law and moral rights offers a model for policy and governance as neurodata find their way into legally and socially consequential technologies.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag008"},"PeriodicalIF":2.4,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12988793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147464256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The law of open medical data: past application and future challenges. 开放医疗数据的规律：过去的应用和未来的挑战。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-02-27 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag006

Barbara J Evans

{"title":"The law of open medical data: past application and future challenges.","authors":"Barbara J Evans","doi":"10.1093/jlb/lsag006","DOIUrl":"https://doi.org/10.1093/jlb/lsag006","url":null,"abstract":"Since 2003, US federal funders' scientific data-sharing policies have encouraged open sharing of weakly de-identified medical and genomic data. This sharing fueled important scientific advances but, as this article explains, was of dubious legality, and recent regulations have removed any doubt: open access to medical data is a dying concept if not already dead. The future of medical data sharing lies with controlled access data repositories, which replicate many of the scientific benefits of data sharing but provide stronger privacy and data security protections. The drawback is that meaningful data protections cost money, forcing controlled access repositories to explore new private funding models to sustain data availability over the long haul after federal funding expires. Unless carefully crafted, transactions to finance controlled access repositories (such as charging user fees or receiving discounts on cloud storage from information technology service providers) can violate federal laws this article explores. Going forward, the law of medical privacy boils down to how much privacy those who share and use our data can realistically and lawfully finance. That is how much privacy we, the public, can expect.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag006"},"PeriodicalIF":2.4,"publicationDate":"2026-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12947787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147328228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Neurotechnological cognitive enhancement and human rights: a complex dynamic between empowerment and constraint. 神经技术认知增强与人权：赋权与约束之间的复杂动态关系。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-02-17 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag004

Timo Istace, Kristof Van Assche

{"title":"Neurotechnological cognitive enhancement and human rights: a complex dynamic between empowerment and constraint.","authors":"Timo Istace, Kristof Van Assche","doi":"10.1093/jlb/lsag004","DOIUrl":"https://doi.org/10.1093/jlb/lsag004","url":null,"abstract":"In recent decades, neurotechnological cognitive enhancers (NCEs), including neurofeedback systems and neurostimulation devices, have attracted increasing attention due to their potential to enhance human cognition. Developments in this field of technology raise significant ethical challenges that warrant careful reflection from a human rights perspective. Currently, human rights experts and international institutions are actively examining how neurotechnological interventions affecting mental states, capacities, and processes impact human rights and fundamental freedoms. Within these efforts, however, greater attention must be paid to the positive dimension of human rights, examining whether and to what extent human rights frameworks support individuals' freedom to use neurotechnologies to enhance their mental capacities. This article addresses that question by first outlining the concept of cognitive enhancement and assessing the current and anticipated development of NCEs. It then explores the tension between empowerment and constraint, analysing how human rights both support the use of NCEs and potentially justify limitations on that freedom. In doing so, it examines the existence and scope of a right to mental self-determination, the role of human dignity, and the conditions under which restrictions on NCE may be justified.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag004"},"PeriodicalIF":2.4,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12911505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0