Pub Date : 2022-04-04DOI: 10.1089/blr.2022.29267.cmh
Christopher M. Holman
{"title":"AstraZeneca AB v. Mylan Pharms. Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29267.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29267.cmh","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":"49063010","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 : 2022-04-01DOI: 10.1089/blr.2022.29266.sjz
Steven J. Zweig
{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2022.29266.sjz","DOIUrl":"https://doi.org/10.1089/blr.2022.29266.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"73 6","pages":"55-57"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527817","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 : 2022-04-01DOI: 10.1089/blr.2022.29264.cmh
Christopher M. Holman
A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision finding Amgen’s claims reciting genuses of monoclonal antibodies to be invalid for lack of enablement. Death raise important issues for pharmaceutical innovation, a number of which I address in this second installment (“Part II”) of a two-part article). I begin by explaining why it is that I disagree with a particular assertion made in Death, i.e., the suggestion that patentees could circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. The article then reviews a substantial number of judicial decisions involving chemical genus claims, and basically show that there is little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law. ∗ Christopher M. Holman, Professor of Law, University of Missouri-Kansas City School of Law; Senior Scholar, Center for Intellectual Property x Innovation Policy (CIP-2), George Mason University, Antonin Scalia Law School; and Executive Editor, Biotechnology Law Report.
{"title":"Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29264.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29264.cmh","url":null,"abstract":"A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision finding Amgen’s claims reciting genuses of monoclonal antibodies to be invalid for lack of enablement. Death raise important issues for pharmaceutical innovation, a number of which I address in this second installment (“Part II”) of a two-part article). I begin by explaining why it is that I disagree with a particular assertion made in Death, i.e., the suggestion that patentees could circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. The article then reviews a substantial number of judicial decisions involving chemical genus claims, and basically show that there is little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law. ∗ Christopher M. Holman, Professor of Law, University of Missouri-Kansas City School of Law; Senior Scholar, Center for Intellectual Property x Innovation Policy (CIP-2), George Mason University, Antonin Scalia Law School; and Executive Editor, Biotechnology Law Report.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"32 7","pages":"58-77"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527722","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 : 2022-03-31DOI: 10.1089/blr.2022.29268.cmh
Christopher M. Holman
{"title":"Novartis Pharms. Corp. v. Accord Healthcare, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29268.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29268.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43655306","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 : 2022-03-25DOI: 10.1089/blr.2022.29265.us
Raildo Duarte, Hasan Irfan Khan, Alejandro Luna, Ramadan Amin, Charul Yadav, U. Storz
In view of the inequitable distribution of COVID-19 vaccines, several initiatives have been discussed to waive respective patent rights. This article provides a fact-based multinational study on patent rights protecting BioNTech-Pfizer's vaccine BNT162b2. We conclude that although there actually is a vaccine shortage in many countries, patents cannot be blamed as the scapegoat for said situation.
{"title":"Patents Cannot Be Blamed for Inequitable Access to COVID-19 Vaccines","authors":"Raildo Duarte, Hasan Irfan Khan, Alejandro Luna, Ramadan Amin, Charul Yadav, U. Storz","doi":"10.1089/blr.2022.29265.us","DOIUrl":"https://doi.org/10.1089/blr.2022.29265.us","url":null,"abstract":"In view of the inequitable distribution of COVID-19 vaccines, several initiatives have been discussed to waive respective patent rights. This article provides a fact-based multinational study on patent rights protecting BioNTech-Pfizer's vaccine BNT162b2. We conclude that although there actually is a vaccine shortage in many countries, patents cannot be blamed as the scapegoat for said situation.","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"1 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41262645","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 : 2022-03-03DOI: 10.1089/blr.2022.29262.phc
Ping-hsun Chen
{"title":"A Pharmaceutical Formulation as a Claim Term Cannot “Target” a Plasma Concentration-Time Profile Under 35 U.S.C. § 112: A Lesson from Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc.","authors":"Ping-hsun Chen","doi":"10.1089/blr.2022.29262.phc","DOIUrl":"https://doi.org/10.1089/blr.2022.29262.phc","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44905762","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 : 2022-02-01DOI: 10.1089/blr.2021.29257.sr
Jonathan D. Kimball, S. Ragavan
{"title":"AI (Re)Defining Pharmaceutical Exclusivities","authors":"Jonathan D. Kimball, S. Ragavan","doi":"10.1089/blr.2021.29257.sr","DOIUrl":"https://doi.org/10.1089/blr.2021.29257.sr","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42018448","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 : 2022-02-01DOI: 10.1089/blr.2022.29263.sjz
Steven J. Zweig
{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2022.29263.sjz","DOIUrl":"https://doi.org/10.1089/blr.2022.29263.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"73 3","pages":"1-3"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527711","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 : 2022-02-01DOI: 10.1089/blr.2022.29261.cmh
Christopher M. Holman
{"title":"ModernaTx, Inc. v. Arbutus Biopharma Corp.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29261.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29261.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"70 2","pages":"46-53"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527721","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 : 2022-01-31DOI: 10.1089/blr.2021.29258.pf
Patrick Foong
{"title":"The Drawing-Up of Laws on Research Involving Human Embryos in Australia: Lack of an Islamic Voice","authors":"Patrick Foong","doi":"10.1089/blr.2021.29258.pf","DOIUrl":"https://doi.org/10.1089/blr.2021.29258.pf","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46532193","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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