Pub Date : 2021-10-01DOI: 10.1089/blr.2021.29249.st
J. Fabre, Sarah Taylor
{"title":"Supplementary Protection Certificates in Europe: Clarity at Last?","authors":"J. Fabre, Sarah Taylor","doi":"10.1089/blr.2021.29249.st","DOIUrl":"https://doi.org/10.1089/blr.2021.29249.st","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46541669","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 : 2021-10-01DOI: 10.1089/blr.2021.29246.cmh
Christopher M. Holman
{"title":"In Minerva v. Hologic, the U.S. Supreme Court Reins in the Equitable Doctrine of Assignor Estoppel","authors":"Christopher M. Holman","doi":"10.1089/blr.2021.29246.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29246.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49561744","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 : 2021-10-01DOI: 10.1089/blr.2021.29248.nl
Na Li, Xiang Yu
A novel coronavirus pneumonia broke out in early 2020 in China. In order to find a certain cure, China has turned its attention to Remdesivir, which is produced by Gilead. At the initial stage, Chi...
{"title":"Observation on the Admission Situation of the Anti-Coronavirus Drug “Remdesivir” in China","authors":"Na Li, Xiang Yu","doi":"10.1089/blr.2021.29248.nl","DOIUrl":"https://doi.org/10.1089/blr.2021.29248.nl","url":null,"abstract":"A novel coronavirus pneumonia broke out in early 2020 in China. In order to find a certain cure, China has turned its attention to Remdesivir, which is produced by Gilead. At the initial stage, Chi...","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42563024","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 : 2021-08-26DOI: 10.1089/blr.2021.29245.jc
Jiajv Chen, Jiayu Huang, Xuekai Xie
China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China's biobanks have collected a large number of biologi...
{"title":"Legal and Ethical Challenges in the Construction of China's Biobanks","authors":"Jiajv Chen, Jiayu Huang, Xuekai Xie","doi":"10.1089/blr.2021.29245.jc","DOIUrl":"https://doi.org/10.1089/blr.2021.29245.jc","url":null,"abstract":"China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China's biobanks have collected a large number of biologi...","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"1 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41449473","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 : 2021-08-02DOI: 10.1089/blr.2021.29241.cmh
Christopher M. Holman By
{"title":"In re Huping Hu: Quantum Entanglement, Medical Innovation, and Patentability on the Scientific “Fringe”","authors":"Christopher M. Holman By","doi":"10.1089/blr.2021.29241.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29241.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45806719","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 : 2021-08-01DOI: 10.1089/blr.2021.29243.sjz
Steven J. Zweig
{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2021.29243.sjz","DOIUrl":"https://doi.org/10.1089/blr.2021.29243.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"32 10","pages":"219-221"},"PeriodicalIF":0.2,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527708","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 : 2021-08-01DOI: 10.1089/blr.2021.29240.cmh
D. Missing
Pacific Biosciences of California, Inc. (PacBio) sued Oxford Nanopore Technologies, Inc. and Oxford Nanopore Technologies, Ltd. (collectively, Oxford), accusing Oxford of infringing several of its patents, including U.S. Patent Nos. 9,546,400 and 9,772,323. The patents describe and claim methods for using nanopore technology to sequence DNA and other nucleic acids. A jury found all asserted claims infringed but also determined that they are invalid under 35 U.S.C. 112 for lack of enablement. The district court denied PacBio's motion for judgment as a matter of law (and for a new trial) on enablement. The district court also denied PacBio's request that the court grant a new trial because of Oxford's improper remarks during opening, remarks that included references to the potential applications of its accused products to the then-emerging global COVID-19 crisis. PacBio argued that the remarks caused prejudice that could not be remedied by the curative instruction the district court gave at PacBio's request. On appeal, the Federal Circuit affirmed. Regarding enablement, the court noted that it is not enough that relevant artisans knew how to perform some "nanopore sequencing'' before the priority date of the patents, and that the jury had substantial evidence of non-enablement of the full claim scope. Notably, PacBio had no evidence of actual reduction to practice of its own that would undermine Oxford's evidence of non-enablement. As PacBio acknowledged, its reduction to practice was constructive only, i.e., took the form of its description in patent applications, without any accompanying real-world reduction to practice. The Federal Circuit did not see a basis for disturbing the district court's assessment that there was an insufficient likelihood that the improper opening remarks had an adverse impact on the ultimate verdict to justify a new trial in this case.
{"title":"Pac. Biosciences of California, Inc. v. Oxford Nanopore Techs., Inc. United States Court of Appeals of the Federal Circuit, 2021 996 F.3d 134","authors":"D. Missing","doi":"10.1089/blr.2021.29240.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29240.cmh","url":null,"abstract":"Pacific Biosciences of California, Inc. (PacBio) sued Oxford Nanopore Technologies, Inc. and Oxford Nanopore Technologies, Ltd. (collectively, Oxford), accusing Oxford of infringing several of its patents, including U.S. Patent Nos. 9,546,400 and 9,772,323. The patents describe and claim methods for using nanopore technology to sequence DNA and other nucleic acids. A jury found all asserted claims infringed but also determined that they are invalid under 35 U.S.C. 112 for lack of enablement. The district court denied PacBio's motion for judgment as a matter of law (and for a new trial) on enablement. The district court also denied PacBio's request that the court grant a new trial because of Oxford's improper remarks during opening, remarks that included references to the potential applications of its accused products to the then-emerging global COVID-19 crisis. PacBio argued that the remarks caused prejudice that could not be remedied by the curative instruction the district court gave at PacBio's request. On appeal, the Federal Circuit affirmed. Regarding enablement, the court noted that it is not enough that relevant artisans knew how to perform some \"nanopore sequencing'' before the priority date of the patents, and that the jury had substantial evidence of non-enablement of the full claim scope. Notably, PacBio had no evidence of actual reduction to practice of its own that would undermine Oxford's evidence of non-enablement. As PacBio acknowledged, its reduction to practice was constructive only, i.e., took the form of its description in patent applications, without any accompanying real-world reduction to practice. The Federal Circuit did not see a basis for disturbing the district court's assessment that there was an insufficient likelihood that the improper opening remarks had an adverse impact on the ultimate verdict to justify a new trial in this case.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44266026","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 : 2021-08-01DOI: 10.1089/blr.2021.29238.cmh
{"title":"In re Huping Hu United States Court of Appeals of the Federal Circuit, 2021 No. 2019-2104, 2021 WL 1016437 (non-precedential)","authors":"","doi":"10.1089/blr.2021.29238.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29238.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44893635","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 : 2021-08-01DOI: 10.1089/blr.2021.29242.ps
Penny Simmons
{"title":"Review of the UK's R&D Tax Reliefs—A Good News Story for the UK's Life Sciences Sector?","authors":"Penny Simmons","doi":"10.1089/blr.2021.29242.ps","DOIUrl":"https://doi.org/10.1089/blr.2021.29242.ps","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43489645","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 : 2021-07-06DOI: 10.1089/BLR.2021.29237.CMH
Christopher M. Holman
{"title":"Bio-Rad Lab'ys, Inc. v. Int'l Trade Comm'n United States Court of Appeals of the Federal Circuit, 2021996 F.3d 1302","authors":"Christopher M. Holman","doi":"10.1089/BLR.2021.29237.CMH","DOIUrl":"https://doi.org/10.1089/BLR.2021.29237.CMH","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48801371","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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