Pub Date : 2022-07-29DOI: 10.1089/blr.2022.29278.lj
Li Jiang, Han Yang
{"title":"Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China","authors":"Li Jiang, Han Yang","doi":"10.1089/blr.2022.29278.lj","DOIUrl":"https://doi.org/10.1089/blr.2022.29278.lj","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42399409","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}
Pub Date : 2022-07-26DOI: 10.1089/blr.2022.29275.cmh
Christopher M. Holman
{"title":"A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29275.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29275.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43641301","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}
Pub Date : 2022-07-25DOI: 10.1089/blr.2022.29276.cip
Christopher M. Holman
{"title":"Univ. of Massachusetts v. L'Oreal S.A.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29276.cip","DOIUrl":"https://doi.org/10.1089/blr.2022.29276.cip","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49025587","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}
Pub Date : 2022-07-22DOI: 10.1089/blr.2022.29274.nho
N. Ho
{"title":"The Fate of FTC v. Actavis, Inc. in the Biosimilar Context—Does and Should the FTC v. Actavis Decision Apply to Reverse Patent Settlements Between Brand Drug and Biosimilar Manufacturers?","authors":"N. Ho","doi":"10.1089/blr.2022.29274.nho","DOIUrl":"https://doi.org/10.1089/blr.2022.29274.nho","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43689241","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}
Pub Date : 2022-06-07DOI: 10.1089/blr.2022.29270.pf
Peng Feirong, M. Tian, Chen Junhua
Covid-19 has spread quickly throughout China and the entire world. According to the World Health Organization, there is a public health emergency that is of global significance (WHO). Controlling the drug supply is essential since this hazardous pandemic has seriously jeopardized global public security. This essay starts by looking at the current condition of COVID-19, analyzes the requirements for required drug patent licensing in different countries, points out the problems with mandatory drug patent licensing in China, and finally offers practical suggestions for forced pharma patent licensing. China and the rest of the world have experienced rapid Covid-19 spread. There is an international public health emergency, according to the World Health Organization (WHO). The majority of China's pharmaceutical companies were founded relatively recently, and they are currently producing copycat medications. The government needs to properly understand the value of the compulsory patent licensing system and offer the necessary support to ensure a successful rollout. The government can implement specific policies, add a special fund for drug development, offer loans to pharmaceutical companies, hire qualified staff for drug research and development, and generally strengthen China's pharmaceutical industry. Pharmaceutical companies are the manufacturers of drugs under the obligatory patent licensing system. Pharmaceutical companies should develop their overall strength, increase their ability to produce drugs, and have enough resources to meet social requirements and guarantee public health and safety. To increase the rate of development, it is vital to promote international collaboration and actively introduce foreign innovative systems and industrial facilities.
{"title":"China's Challenges in Implementing Compulsory Drug Patent Licenses and its Response in the Context of COVID-19","authors":"Peng Feirong, M. Tian, Chen Junhua","doi":"10.1089/blr.2022.29270.pf","DOIUrl":"https://doi.org/10.1089/blr.2022.29270.pf","url":null,"abstract":"Covid-19 has spread quickly throughout China and the entire world. According to the World Health Organization, there is a public health emergency that is of global significance (WHO). Controlling the drug supply is essential since this hazardous pandemic has seriously jeopardized global public security. This essay starts by looking at the current condition of COVID-19, analyzes the requirements for required drug patent licensing in different countries, points out the problems with mandatory drug patent licensing in China, and finally offers practical suggestions for forced pharma patent licensing. China and the rest of the world have experienced rapid Covid-19 spread. There is an international public health emergency, according to the World Health Organization (WHO). The majority of China's pharmaceutical companies were founded relatively recently, and they are currently producing copycat medications. The government needs to properly understand the value of the compulsory patent licensing system and offer the necessary support to ensure a successful rollout. The government can implement specific policies, add a special fund for drug development, offer loans to pharmaceutical companies, hire qualified staff for drug research and development, and generally strengthen China's pharmaceutical industry. Pharmaceutical companies are the manufacturers of drugs under the obligatory patent licensing system. Pharmaceutical companies should develop their overall strength, increase their ability to produce drugs, and have enough resources to meet social requirements and guarantee public health and safety. To increase the rate of development, it is vital to promote international collaboration and actively introduce foreign innovative systems and industrial facilities.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47302687","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}
Pub Date : 2022-06-06DOI: 10.1089/blr.2022.29271.pf
Patrick Foong, Grace Borsellino
Every element of society was disrupted by the rapid development of the COVID-19 pandemic, including the healthcare system, the supply chain, the economy, and interpersonal relationships. Safety and public health of the general public, patients, essential personnel, and healthcare professionals were among the numerous emerging considerations. Clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on other diseases in some regions, and clinical research was halted or terminated in deference to the pressing demands of patient care. Decisions had to be made quickly, and flexibility and rethinking were required due to the fact that knowledge of the disease and understanding of its treatment (and prevention) increased, as well as the fact that the intensity and severity of infection varied over time and by location. In an effort to improve future preparedness, this paper addresses the ethical difficulties in decision-making and competing ethical pressures during the epidemic. In a short period of time, the medical and science communities have made outstanding progress. We must apply what we have learned thus far to a "second wave," should one occur, or, in the absence of one, to the subsequent pandemic, in order to accelerate development. To do this, we need leadership, preparation, and strategy. Global collaboration is required to enable insights obtained in one location to be transferred to the next and to build upon knowledge rather than reinvent it as the wave of infectiousness spreads across nations. For this to happen, there must be agreed-upon common, objective endpoints and their definitions, collection of adverse safety events, electronic data capture and cloud computing, commitments to share protocols, consents, and common terminologies and ways of recording symptoms, co-morbidities, demographic and non-demographic characteristics of the individuals.
{"title":"Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis","authors":"Patrick Foong, Grace Borsellino","doi":"10.1089/blr.2022.29271.pf","DOIUrl":"https://doi.org/10.1089/blr.2022.29271.pf","url":null,"abstract":"Every element of society was disrupted by the rapid development of the COVID-19 pandemic, including the healthcare system, the supply chain, the economy, and interpersonal relationships. Safety and public health of the general public, patients, essential personnel, and healthcare professionals were among the numerous emerging considerations. Clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on other diseases in some regions, and clinical research was halted or terminated in deference to the pressing demands of patient care. Decisions had to be made quickly, and flexibility and rethinking were required due to the fact that knowledge of the disease and understanding of its treatment (and prevention) increased, as well as the fact that the intensity and severity of infection varied over time and by location. In an effort to improve future preparedness, this paper addresses the ethical difficulties in decision-making and competing ethical pressures during the epidemic. In a short period of time, the medical and science communities have made outstanding progress. We must apply what we have learned thus far to a \"second wave,\" should one occur, or, in the absence of one, to the subsequent pandemic, in order to accelerate development. To do this, we need leadership, preparation, and strategy. Global collaboration is required to enable insights obtained in one location to be transferred to the next and to build upon knowledge rather than reinvent it as the wave of infectiousness spreads across nations. For this to happen, there must be agreed-upon common, objective endpoints and their definitions, collection of adverse safety events, electronic data capture and cloud computing, commitments to share protocols, consents, and common terminologies and ways of recording symptoms, co-morbidities, demographic and non-demographic characteristics of the individuals.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42103322","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}
Pub Date : 2022-06-06DOI: 10.1089/blr.2022.29273.cmh
Christopher M. Holman
{"title":"Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29273.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29273.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47523866","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}
Pub Date : 2022-06-06DOI: 10.1089/blr.2022.29269.sjz
S. Zweig
{"title":"Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption","authors":"S. Zweig","doi":"10.1089/blr.2022.29269.sjz","DOIUrl":"https://doi.org/10.1089/blr.2022.29269.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47611181","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}
Pub Date : 2022-06-06DOI: 10.1089/blr.2022.29272.cmh
Christopher M. Holman
{"title":"The Broad Institute Scores Another Victory in Its Battle with the University of California over the Patenting of CRIPSR","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29272.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29272.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45033391","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}
Pub Date : 2022-04-04DOI: 10.1089/blr.2021.29257.sr.correx
{"title":"Correction to: AI (Re)Defining Pharmaceutical Exclusivities, by Jonathan Kimball and Srividhya Ragavan, Biotechnol Law Rep 2022;41(1):23–29; doi: 10.1089/blr.2021.29257.sr","authors":"","doi":"10.1089/blr.2021.29257.sr.correx","DOIUrl":"https://doi.org/10.1089/blr.2021.29257.sr.correx","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45241911","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}
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