Pub Date : 2022-01-31DOI: 10.1089/blr.2022.29259.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 first installment (“Part I”) of a two-part article. I begin by providing some excerpts from Judge Lourie’s concurrence in the Federal Circuit’s denial of en banc rehearing of Amgen v. Sanofi, in which he refutes the key arguments raised in Death and by Amgen. I then take a deep dive, exploring what in particular we mean when we refer to a patent claim as a “chemical genus claim,” an important term that is subject to different interpretations. Those who use the term, including the authors of Death, often do so without explicitly defining it, which can result in some lack of clarity. In the remainder of this Part I, I reanalyze the judicial decisions upon which Death bases its claim, and explain why, in my view, the article does not actually substantiate its claim of a marked shift in the Federal Circuit’s interpretation and application of 112(a). ∗ Christopher M. Holman, Professor of Law, University of Missouri-Kansas City School of Law; Senior Fellow, Center for Intellectual Property x Innovation Policy (CIP-2), George Mason University, Antonin Scalia Law School; and Executive Editor, Biotechnology Law Report.
2020年一篇题为“属权利要求的死亡”(“死亡”)的法律评论文章旨在记录联邦巡回法院对《美国法典》第35编第112(A)条的使能关系和书面描述要求，特别是适用于化学属权利要求的解释的戏剧性转变。据《死亡》的提交人说，几乎不可能获得一种化学属的主张，在面对根据第112(a)条提出的涉及范围过大的挑战时，这种主张将被维持为有效。在安进诉赛诺菲案(Amgen v. Sanofi)中，死亡被广泛引用，该案要求最高法院推翻联邦巡回法院的裁决，该裁决认定安进公司列举单克隆抗体基因的权利要求因缺乏使能而无效。死亡为制药创新提出了重要的问题，我将在两部分文章的第一部分(“第一部分”)中讨论其中的一些问题。首先，我提供一些摘自法官劳里在联邦巡回法院驳回安进诉赛诺菲案全院再审时的意见，他在其中驳斥了《死亡》案和安进案中提出的关键论点。然后，我将深入探讨，当我们将专利权利要求称为“化学属权利要求”时，我们的意思是什么，这是一个重要的术语，可以有不同的解释。那些使用这个术语的人，包括《死亡》的作者，往往没有明确地定义它，这可能会导致一些缺乏清晰度。在本第一部分的其余部分，我将重新分析死亡案所依据的司法判决，并解释为什么在我看来，该条实际上并没有证实其关于联邦巡回法院对第112(a)条的解释和适用发生了显著转变的主张。*克里斯托弗·m·霍尔曼，密苏里大学堪萨斯城法学院法学教授;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高级研究员;《生物技术法律报告》执行编辑。
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Pub Date : 2022-01-24DOI: 10.1089/blr.2022.29260.cmh
Christopher M. Holman
{"title":"ModernaTx, Inc. v. Arbutus Biopharma Corp.","authors":"Christopher M. Holman","doi":"10.1089/blr.2022.29260.cmh","DOIUrl":"https://doi.org/10.1089/blr.2022.29260.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2022-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49208917","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 : 2021-12-02DOI: 10.1089/blr.2021.29252.cmh
Christopher M. Holman
{"title":"In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy","authors":"Christopher M. Holman","doi":"10.1089/blr.2021.29252.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29252.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42167666","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 : 2021-12-02DOI: 10.1089/blr.2021.29253.cmh
Christopher M. Holman
{"title":"Juno Therapeutics, Inc. v. Kite Pharma, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2021.29253.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29253.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44903255","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 : 2021-12-01DOI: 10.1089/blr.2021.29256.cmh
Christopher M. Holman
{"title":"GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2021.29256.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29256.cmh","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44511574","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 : 2021-12-01DOI: 10.1089/blr.2021.29255.sjz
Steven J. Zweig
{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2021.29255.sjz","DOIUrl":"https://doi.org/10.1089/blr.2021.29255.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"80 1","pages":"369-371"},"PeriodicalIF":0.2,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527709","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 : 2021-12-01DOI: 10.1089/blr.2021.29254.jl
Li Jiang
{"title":"14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China","authors":"Li Jiang","doi":"10.1089/blr.2021.29254.jl","DOIUrl":"https://doi.org/10.1089/blr.2021.29254.jl","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":" ","pages":""},"PeriodicalIF":0.2,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41531420","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.2021.29247.cmh
Christopher M. Holman
{"title":"Minerva Surgical, Inc. v. Hologic, Inc.","authors":"Christopher M. Holman","doi":"10.1089/blr.2021.29247.cmh","DOIUrl":"https://doi.org/10.1089/blr.2021.29247.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":"41914101","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.2021.29250.sjz
Steven J. Zweig
{"title":"Selected Developments in Biotechnology Law and the Biotechnology Industry","authors":"Steven J. Zweig","doi":"10.1089/blr.2021.29250.sjz","DOIUrl":"https://doi.org/10.1089/blr.2021.29250.sjz","url":null,"abstract":"","PeriodicalId":55354,"journal":{"name":"Biotechnology Law Report","volume":"50 1","pages":"291-293"},"PeriodicalIF":0.2,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138527704","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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