Biotechnology Law Report最新文献

{"title":"Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law","authors":"Christopher M. Holman","doi":"10.1089/blr.2023.29331.cmh","DOIUrl":"https://doi.org/10.1089/blr.2023.29331.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"113 8","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138623190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?","authors":"Ashtyn Oakley","doi":"10.1089/blr.2023.29329.aso","DOIUrl":"https://doi.org/10.1089/blr.2023.29329.aso","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"24 3","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139245088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law","authors":"Laura Çami, Ilda MuÇmataj, Xhon SkËnderi","doi":"10.1089/blr.2023.29328.xs","DOIUrl":"https://doi.org/10.1089/blr.2023.29328.xs","url":null,"abstract":"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.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136038097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.","authors":"CHRISTOPHER M. HOLMAN","doi":"10.1089/blr.2023.29324.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29324.cip","url":null,"abstract":"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","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136079713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws","authors":"CHRISTOPHER M. HOLMAN","doi":"10.1089/blr.2023.29320.cmh","DOIUrl":"https://doi.org/10.1089/blr.2023.29320.cmh","url":null,"abstract":"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","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135323892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings","authors":"ANDREAS HEISEKE, HANS-RAINER JAENICHEN","doi":"10.1089/blr.2023.29326.ah","DOIUrl":"https://doi.org/10.1089/blr.2023.29326.ah","url":null,"abstract":"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.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135323907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine","authors":"NA LI, YUPENG DONG, XIANG YU","doi":"10.1089/blr.2023.29325.yd","DOIUrl":"https://doi.org/10.1089/blr.2023.29325.yd","url":null,"abstract":"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.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"153 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135323908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"United Therapeutics Corp. v. Liquidia Techs., Inc.","authors":"CHRISTOPHER M. HOLMAN","doi":"10.1089/blr.2023.29323.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29323.cip","url":null,"abstract":"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","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136079712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2023.29327.sjz","DOIUrl":"https://doi.org/10.1089/blr.2023.29327.sjz","url":null,"abstract":"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","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135323905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In re Couvaras","authors":"CHRISTOPHER M. HOLMAN","doi":"10.1089/blr.2023.29321.cip","DOIUrl":"https://doi.org/10.1089/blr.2023.29321.cip","url":null,"abstract":"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","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135859265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}