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Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law 制药、专利和反垄断法交叉领域的最新进展
IF 0.2 4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-12-01 DOI: 10.1089/blr.2023.29331.cmh
Christopher M. Holman
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引用次数: 0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act? HIPAA、HIPPA 或 HIPPO:什么是《医疗保险可携性与责任法案》?
IF 0.2 4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-11-23 DOI: 10.1089/blr.2023.29329.aso
Ashtyn Oakley
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引用次数: 0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law 在生物银行中导航跨境挑战:分析欧盟立法,欧洲法院判例法和国际私法的作用
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-17 DOI: 10.1089/blr.2023.29328.xs
Laura Çami, Ilda MuÇmataj, Xhon SkËnderi
Biobanks, as repositories for biological samples and associated data, play a pivotal role in advancing biomedical research and enabling personalized medicine on a global scale. However, the cross-border operation of biobanks faces intricate legal challenges arising from diverse regulatory frameworks across jurisdictions. This article offers a comprehensive analysis of the complexities surrounding cross-border biobanking within the European Union (EU), focusing on EU legislation and the notable legal precedents set by the European Court of Justice (ECJ). Additionally, it examines the efficacy of utilizing Private International Law mechanisms to navigate the legal intricacies inherent in biobanking activities. The initial section scrutinizes existing EU legislation governing biobanks, identifying potential areas of conflict and disparity stemming from variations in laws among member states. Particular attention is given to data protection, informed consent, and the transportation of biological samples. Subsequently, the study delves into significant ECJ rulings pertaining to biobanking and data sharing, emphasizing the legal principles established by the court in the context of cross-border biobanking. The third section explores the importance of Private International Law instruments in addressing the challenges posed by EU legislation and case law. It investigates the application of choice of law, jurisdiction, and recognition and enforcement of judgments to resolve conflicts between biobanks operating in different legal jurisdictions. Moreover, the study highlights the potential of international conventions and treaties in promoting harmonization within cross-border biobanking practices. By illuminating how legal theories and frameworks can facilitate efficient cross-border biobanking collaborations, this article offers valuable insights for policymakers, legal professionals, and biobank administrators. It provides recommendations to enhance international cooperation within the intricate legal landscapes of biotechnology and intellectual property. Leveraging Private International Law enables the pursuit of harmonized biobanking practices, thus propelling significant advancements in scientific knowledge and medical discoveries.
生物银行作为生物样本和相关数据的存储库,在推进生物医学研究和实现全球范围内的个性化医疗方面发挥着关键作用。然而,生物银行的跨境运营面临着来自不同司法管辖区不同监管框架的复杂法律挑战。本文对欧盟(EU)内部跨境生物银行的复杂性进行了全面分析,重点关注欧盟立法和欧洲法院(ECJ)制定的著名法律先例。此外,它还考察了利用国际私法机制来导航生物银行活动中固有的法律复杂性的有效性。第一部分详细审查了现有的欧盟生物银行立法,确定了成员国之间法律差异造成的潜在冲突和差异。特别注意数据保护、知情同意和生物样品的运输。随后,该研究深入探讨了欧洲法院关于生物银行和数据共享的重要裁决,强调了法院在跨境生物银行背景下建立的法律原则。第三部分探讨了国际私法文书在应对欧盟立法和判例法带来的挑战方面的重要性。它调查了法律选择的应用,管辖权,以及判决的承认和执行,以解决在不同法律管辖区经营的生物银行之间的冲突。此外,该研究强调了国际公约和条约在促进跨境生物银行实践协调方面的潜力。通过阐明法律理论和框架如何促进有效的跨境生物库合作,本文为政策制定者、法律专业人士和生物库管理人员提供了宝贵的见解。它提出了在生物技术和知识产权的复杂法律环境中加强国际合作的建议。利用国际私法可以追求统一的生物银行做法,从而推动科学知识和医学发现的重大进步。
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引用次数: 0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc. 赛诺菲-安万特德国有限公司诉迈兰制药案。公司。
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29324.cip
CHRISTOPHER M. HOLMAN
Biotechnology Law ReportAhead of Print Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.United States Court of Appeals of the Federal Circuit, 2023 66 F.4th 1373Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMANEdited for Biotechnology Law Report by CHRISTOPHER M. HOLMANChristopher M. Holman is a Professor of Law at the University of Missouri–Kansas City School of Law; a Senior Scholar at the Center for the Protection of Intellectual Property x Innovation Policy (C-IP) at George Mason University, Antonin Scalia Law School; and the Executive Editor of Biotechnology Law Report.*The synopsis is original content and the decision itself has been condensed for ease of readability.Search for more papers by this authorPublished Online:25 Sep 2023https://doi.org/10.1089/blr.2023.29324.cipAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 0Issue 0 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN.Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc..Biotechnology Law Report.ahead of printhttp://doi.org/10.1089/blr.2023.29324.cipOnline Ahead of Print:September 25, 2023PDF download
赛诺菲-安万特德国有限公司诉迈兰制药前生物技术法律报告。CHRISTOPHER M. Holman是密苏里-堪萨斯城大学法学院的法学教授;乔治梅森大学安东宁·斯卡利亚法学院知识产权保护与创新政策中心(C-IP)高级学者;也是《生物技术法律报告》的执行主编。*摘要是原创内容,为了便于阅读,决定本身已被浓缩。搜索本文作者的更多论文出版在线:2023年9月25日https://doi.org/10.1089/blr.2023.29324.cipAboutSectionsView文章查看全文pdf /EPUB权限和引文下载CitationsTrack引文添加到收藏回到出版物共享分享在facebook上推特链接在redditemail查看文章figuresreferencesrelateddetails卷0发行0信息版权2023,Mary Ann Liebert, Inc.,出版商引用这篇文章:编辑为生物技术法律报告由CHRISTOPHER M. HOLMAN。赛诺菲-安万特德国有限公司诉迈兰制药案。生物技术法律报告。打印前://doi.org/10.1089/blr.2023.29324.cipOnline打印前:2023年9月25日pdf下载
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引用次数: 1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws 联邦巡回法院重申药物安全和有效性是FDA的问题,而不是专利法的问题
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29320.cmh
CHRISTOPHER M. HOLMAN
Biotechnology Law ReportAhead of Print Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent LawsBy CHRISTOPHER M. HOLMANBy CHRISTOPHER M. HOLMANChristopher M. Holman is a Professor of Law at the University of Missouri-Kansas City School of Law; a Senior Scholar at the Center for Intellectual Property x Innovation Policy (C-IP) at George Mason University, Antonin Scalia Law School; and the Executive Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:25 Sep 2023https://doi.org/10.1089/blr.2023.29320.cmhAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 0Issue 0 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:By CHRISTOPHER M. HOLMAN.Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws.Biotechnology Law Report.ahead of printhttp://doi.org/10.1089/blr.2023.29320.cmhOnline Ahead of Print:September 25, 2023PDF download
联邦巡回法院重申药物安全和有效性是FDA的问题,而不是专利法CHRISTOPHER M. Holman CHRISTOPHER M. Holman是密苏里大学堪萨斯城法学院的法学教授;乔治梅森大学安东宁·斯卡利亚法学院知识产权与创新政策中心(C-IP)高级学者;也是《生物技术法律报告》的执行主编。搜索本文作者的更多论文出版在线:2023年9月25日https://doi.org/10.1089/blr.2023.29320.cmhAboutSectionsView文章查看全文pdf /EPUB权限和引文下载CitationsTrack引文添加到收藏回到出版物共享在facebook上分享推特链接在redditemail查看文章figuresreferencesrelateddetails卷0发行0信息版权2023,Mary Ann Liebert, Inc.,出版商引用本文:by CHRISTOPHER M. HOLMAN。联邦巡回法院重申药物安全和有效性是FDA的问题,而不是专利法的问题。生物技术法律报告。打印前://doi.org/10.1089/blr.2023.29320.cmhOnline打印前:2023年9月25日pdf下载
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引用次数: 0
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings 欧洲专利局基因组编辑技术专利概况,重点关注crispr相关异议程序
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29326.ah
ANDREAS HEISEKE, HANS-RAINER JAENICHEN
In technologies for editing genomic DNA, cellular repair mechanisms are employed which facilitate manipulation of the genomic DNA. When a double-stranded DNA break is introduced at specific sites in the genome, the cellular repair mechanism takes over and facilitates targeted genome editing via non-homologous end-joining (NHEJ), thereby creating so-called insertion or deletion mutations (indels) at the cleaved target site. Alternatively, if a suitable donor polynucleotide is present, the donor can be integrated at the cleaved target site in the genome via homology-directed repair. In the last decades, four major DNA cutting tools were developed that paved the way for successful genome editing, i.e., meganucleases, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) (CRISPR-Cas9) systems. Patent protection for each one of these genome editing tools was obtained at the European Patent Office (EPO). In the last decade, since its elucidation in 2012, several parties tried to obtain broad patent protection for CRISPR-Cas9. This article focuses on the genome editing tools, patents that were granted for these technologies and, particularly, on opposition proceedings regarding CRISPR-Cas9 patents that relate to CRISPR-Cas9-mediated genome editing.
在编辑基因组DNA的技术中,细胞修复机制被用来促进基因组DNA的操作。当双链DNA断裂在基因组的特定位点被引入时,细胞修复机制接管并通过非同源末端连接(NHEJ)促进靶向基因组编辑,从而在被切割的目标位点产生所谓的插入或删除突变(indel)。或者,如果存在合适的供体多核苷酸,则可以通过同源定向修复将供体整合到基因组中被切割的靶位点。在过去的几十年里,四种主要的DNA切割工具被开发出来,为成功的基因组编辑铺平了道路,即巨核酶、锌指核酸酶(ZFNs)、转录激活因子样效应核酸酶(TALENs)和聚集规律间隔的短回传重复序列(CRISPR)/CRISPR相关蛋白9 (Cas9) (CRISPR-Cas9)系统。这些基因组编辑工具中的每一个都在欧洲专利局(EPO)获得了专利保护。在过去的十年中,自2012年阐明以来,多方试图为CRISPR-Cas9获得广泛的专利保护。本文重点关注基因组编辑工具,这些技术的专利授权,特别是与CRISPR-Cas9介导的基因组编辑相关的CRISPR-Cas9专利的异议程序。
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引用次数: 0
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine 中国在新冠肺炎药品全球供应链中的表现观察
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29325.yd
NA LI, YUPENG DONG, XIANG YU
Since the outbreak of the pandemic, China has made progress in the research and development (R&D) of COVID-19 drugs and vaccines and has participated in the global supply chain. In terms of therapeutic drugs, the vast majority of the Chinese domestic market had been occupied by foreign drugs. Chinese self-developed drugs have been gradually expanding their domestic market share, but they have not yet emerged in overseas markets. In terms of vaccines, the inactivated vaccine developed in China had a large global market share, and the nasal spray adenovirus vaccine developed there was unique. The mRNA vaccine developed in China, however, has not yet achieved significant scale. In the future, China's pattern in the COVID-19 medicine supply chain will change, and its share in the international market should also expand. The COVID-19 pandemic has entered its fourth year. Countries carried out drug and vaccine R&D, and gradually built a medicine supply chain to respond to the public health crisis. In the supply chain, there was a need for both cooperation and competition among countries. China is a populous country with a very large medicine market. China has had a strong pharmaceutical production capacity and a certain scale in drug R&D. In the supply chain of COVID-19 medicine, China's current role and future situation are therefore worth analyzing.
新冠肺炎疫情发生以来,中国在抗疫药物和疫苗研发方面取得积极进展,积极参与全球供应链。在治疗药物方面,中国国内市场的绝大部分已经被外国药品占领。中国自主研发的药物在国内市场份额逐步扩大,但在海外市场尚未出现。在疫苗方面,中国研制的灭活疫苗在全球占有很大的市场份额,中国研制的鼻喷剂腺病毒疫苗是独一无二的。然而,中国开发的mRNA疫苗尚未达到显著的规模。未来,中国在新冠肺炎药品供应链中的格局将发生变化,在国际市场中的份额也将扩大。2019冠状病毒病大流行已进入第四个年头。各国开展药物和疫苗研发,逐步构建应对公共卫生危机的药品供应链。在供应链上,各国之间既需要合作,也需要竞争。中国是一个人口众多的国家,医药市场非常大。中国具有较强的药品生产能力和一定的药物研发规模。因此,在新冠肺炎药物供应链中,中国目前的角色和未来的情况值得分析。
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引用次数: 0
United Therapeutics Corp. v. Liquidia Techs., Inc. 联合治疗公司诉利奎迪亚技术公司案。公司。
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29323.cip
CHRISTOPHER M. HOLMAN
Biotechnology Law ReportAhead of Print United Therapeutics Corp. v. Liquidia Techs., Inc.United States Court of Appeals of the Federal Circuit, 2023 74 F.4th 1360Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMANEdited for Biotechnology Law Report by CHRISTOPHER M. HOLMANChristopher M. Holman is a Professor of Law at the University of Missouri–Kansas City School of Law; a Senior Scholar at the Center for the Protection of Intellectual Property x Innovation Policy (C-IP) at George Mason University, Antonin Scalia Law School; and the Executive Editor of Biotechnology Law Report.*The synopsis is original content and the decision itself has been condensed for ease of readability.Search for more papers by this authorPublished Online:25 Sep 2023https://doi.org/10.1089/blr.2023.29323.cipAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 0Issue 0 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN.United Therapeutics Corp. v. Liquidia Techs., Inc..Biotechnology Law Report.ahead of printhttp://doi.org/10.1089/blr.2023.29323.cipOnline Ahead of Print:September 25, 2023PDF download
生物技术法律报告:联合治疗公司诉利奎迪亚技术公司案。CHRISTOPHER M. Holman是密苏里大学堪萨斯城法学院的法学教授;乔治梅森大学安东宁·斯卡利亚法学院知识产权保护与创新政策中心(C-IP)高级学者;也是《生物技术法律报告》的执行主编。*摘要是原创内容,为了便于阅读,决定本身已被浓缩。搜索本文作者的更多论文出版在线:2023年9月25日https://doi.org/10.1089/blr.2023.29323.cipAboutSectionsView文章查看全文pdf /EPUB权限和引文下载CitationsTrack引文添加到收藏回到出版物共享分享在facebook上推特链接在redditemail查看文章figuresreferencesrelateddetails卷0发行0信息版权2023,Mary Ann Liebert, Inc.,出版商引用这篇文章:编辑为生物技术法律报告由CHRISTOPHER M. HOLMAN。联合治疗公司诉利奎迪亚技术公司案。生物技术法律报告。打印前://doi.org/10.1089/blr.2023.29323.cipOnline打印前:2023年9月25日pdf下载
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引用次数: 1
Selected Developments in Biotechnology Law and the Biotechnology Industry 生物技术法和生物技术产业的若干发展
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-10-01 DOI: 10.1089/blr.2023.29327.sjz
Steven J. Zweig
Biotechnology Law ReportAhead of Print Selected Developments in Biotechnology Law and the Biotechnology IndustryBy Steven J. ZweigBy Steven J. ZweigSteven J. Zweig is the Managing Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:25 Sep 2023https://doi.org/10.1089/blr.2023.29327.sjzAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 0Issue 0 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:By Steven J. Zweig.Selected Developments in Biotechnology Law and the Biotechnology Industry.Biotechnology Law Report.ahead of printhttp://doi.org/10.1089/blr.2023.29327.sjzOnline Ahead of Print:September 25, 2023PDF download
《生物技术法律报告》出版前生物技术法律和生物技术产业精选发展斯蒂文·j·茨威格斯蒂文·j·茨威格斯蒂文·j·茨威格是《生物技术法律报告》主编。搜索本文作者的更多论文出版在线:2023年9月25日https://doi.org/10.1089/blr.2023.29327.sjzAboutSectionsView文章查看全文pdf /EPUB权限和引文下载CitationsTrack引文添加到收藏回到出版物共享在facebook上分享推特链接在redditemail查看文章figuresreferencesrelateddetails卷0发行0信息版权2023,玛丽·安·利伯特,Inc.,出版商引用本文:由史蒂文·j·茨威格。生物技术法和生物技术产业的若干发展。生物技术法律报告。打印前://doi.org/10.1089/blr.2023.29327.sjzOnline打印前:2023年9月25日pdf下载
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引用次数: 0
In re Couvaras 在re Couvaras
4区 生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2023-09-25 DOI: 10.1089/blr.2023.29321.cip
CHRISTOPHER M. HOLMAN
Biotechnology Law ReportAhead of Print In re CouvarasUnited States Court of Appeals of the Federal Circuit, 2023 70 F.4th 1374Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMANEdited for Biotechnology Law Report by CHRISTOPHER M. HOLMANChristopher M. Holman is a Professor of Law at the University of Missouri–Kansas City School of Law; a Senior Scholar at the Center for the Protection of Intellectual Property x Innovation Policy (C-IP) at George Mason University, Antonin Scalia Law School; and the Executive Editor of Biotechnology Law Report.*The synopsis is original content and the decision itself has been condensed for ease of readability.Search for more papers by this authorPublished Online:25 Sep 2023https://doi.org/10.1089/blr.2023.29321.cipAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 0Issue 0 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN.In re Couvaras.Biotechnology Law Report.ahead of printhttp://doi.org/10.1089/blr.2023.29321.cipOnline Ahead of Print:September 25, 2023PDF download
美国联邦巡回上诉法院,2023 70 f .4 1374生物技术法律报告编辑CHRISTOPHER M. Holman编辑CHRISTOPHER M. Holman是密苏里大学堪萨斯城法学院的法学教授;乔治梅森大学安东宁·斯卡利亚法学院知识产权保护与创新政策中心(C-IP)高级学者;也是《生物技术法律报告》的执行主编。*摘要是原创内容,为了便于阅读,决定本身已被浓缩。搜索本文作者的更多论文出版在线:2023年9月25日https://doi.org/10.1089/blr.2023.29321.cipAboutSectionsView文章查看全文pdf /EPUB权限和引文下载CitationsTrack引文添加到收藏回到出版物共享分享在facebook上推特链接在redditemail查看文章figuresreferencesrelateddetails卷0发行0信息版权2023,Mary Ann Liebert, Inc.,出版商引用这篇文章:编辑为生物技术法律报告由CHRISTOPHER M. HOLMAN。在re Couvaras。生物技术法律报告。打印前://doi.org/10.1089/blr.2023.29321.cipOnline打印前:2023年9月25日pdf下载
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引用次数: 0
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Biotechnology Law Report
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