{"title":"The rebirth of epitope-based patent claims.","authors":"Ulrich Storz","doi":"10.3233/HAB-240006","DOIUrl":null,"url":null,"abstract":"BACKGROUND\nPatent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers.\n\n\nOBJECTIVE\nThis article tries to explain the patentability issues related to epitope-based patent claims.\n\n\nMETHODS\nFor this purpose, an overview is given on the respective legal provisions and court decisions.\n\n\nRESULTS\nThe study reveals that the respective patentability standards are constantly changed by courts and lawmakers.\n\n\nCONCLUSIONS\nCompanies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.","PeriodicalId":53564,"journal":{"name":"Human Antibodies","volume":"40 2","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Human Antibodies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3233/HAB-240006","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
BACKGROUND
Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers.
OBJECTIVE
This article tries to explain the patentability issues related to epitope-based patent claims.
METHODS
For this purpose, an overview is given on the respective legal provisions and court decisions.
RESULTS
The study reveals that the respective patentability standards are constantly changed by courts and lawmakers.
CONCLUSIONS
Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.
背景治疗性抗体和 T 细胞受体的专利保护是帮助药物进入市场的重要工具。鉴于研发和监管审批花费巨大，申办者希望其药物在一定时期内享有独占权。治疗性抗体和 T 细胞受体有不同的保护类别。其中一类是基于表位的专利要求，不同的司法管辖区有不同的可专利性标准，而且法院和立法者也在不断修改这些标准。结论开发治疗性抗体或 T 细胞受体的公司需要在战略规划中考虑这些发展。
期刊介绍：
Human Antibodies is an international journal designed to bring together all aspects of human hybridomas and antibody technology under a single, cohesive theme. This includes fundamental research, applied science and clinical applications. Emphasis in the published articles is on antisera, monoclonal antibodies, fusion partners, EBV transformation, transfections, in vitro immunization, defined antigens, tissue reactivity, scale-up production, chimeric antibodies, autoimmunity, natural antibodies/immune response, anti-idiotypes, and hybridomas secreting interesting growth factors. Immunoregulatory molecules, including T cell hybridomas, will also be featured.
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