Biotechnology Law Report最新文献_第7页

AstraZeneca AB v. Mylan Pharms. Inc. 阿斯利康诉迈兰制药案。公司。

IF 0.2 4区生物学

Biotechnology Law Report Pub Date : 2022-04-04 DOI: 10.1089/blr.2022.29267.cmh

Christopher M. Holman

引用次数: 0

Selected Developments in Biotechnology Law and the Biotechnology Industry 生物技术法和生物技术产业的若干发展

IF 0.2 4区生物学

Biotechnology Law Report Pub Date : 2022-04-01 DOI: 10.1089/blr.2022.29266.sjz

Steven J. Zweig

引用次数: 0

Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II 化学属索赔在联邦巡回法院真的“死亡”了吗?:第二部分

IF 0.2 4区生物学

Biotechnology Law Report Pub Date : 2022-04-01 DOI: 10.1089/blr.2022.29264.cmh

Christopher M. Holman

{"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}

引用次数: 0

Novartis Pharms. Corp. v. Accord Healthcare, Inc. 诺华制药。公司诉雅阁医疗保健公司案

IF 0.2 4区生物学

Biotechnology Law Report Pub Date : 2022-03-31 DOI: 10.1089/blr.2022.29268.cmh

Christopher M. Holman

引用次数: 0

Patents Cannot Be Blamed for Inequitable Access to COVID-19 Vaccines 不公平获得新冠肺炎疫苗不能归咎于专利

IF 0.2 4区生物学

Biotechnology Law Report Pub Date : 2022-03-25 DOI: 10.1089/blr.2022.29265.us

Raildo Duarte, Hasan Irfan Khan, Alejandro Luna, Ramadan Amin, Charul Yadav, U. Storz

引用次数: 1

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. 根据35 U.S.C.§112:Horizon Pharma, Inc.诉Dr. Reddy's Laboratories Inc.的教训，作为权利要求条款的药物制剂不能“瞄准”血浆浓度-时间剖面。