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基于表位的专利权利要求的复兴。

The rebirth of epitope-based patent claims.

出版信息

Hum Antibodies. 2024;32(2):35-49. doi: 10.3233/HAB-240006.

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.

摘要

背景

治疗性抗体和 T 细胞受体的专利保护是使药物进入市场的重要工具。鉴于研发和监管批准的大量支出,赞助商希望在给定的时间内对其药物享有独占权。有不同的类别可以保护治疗性抗体和 T 细胞受体。其中一种类别是基于表位的专利主张,关于这一点,在不同的司法管辖区,存在不同的可专利性标准,此外,这些标准还不断被法院和立法者修改。

目的

本文试图解释基于表位的专利主张的可专利性问题。

方法

为此,对各自的法律规定和法院判决进行了概述。

结果

研究表明,法院和立法者不断修改各自的可专利性标准。

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到这些发展。

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