Department of Anesthesia and Intensive Care, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Intensive Care Unit, Emergency Hospital, Cluj-Napoca, Romania.
Expert Opin Ther Pat. 2023 Jan-Jun;33(5):339-348. doi: 10.1080/13543776.2023.2220883. Epub 2023 Jun 6.
Emerging immunotherapies are pushing the boundaries of cancer treatment, with chimeric antigen receptor (CAR)-T cell therapy being one of the most advanced. Due to the increasingly crowded CAR-T cell field, patenting and protecting the intellectual property of these CAR-T cells implies a good knowledge of the legal landscape.
The present manuscript focuses on the challenges regarding the patenting process of CAR-T technology, beginning with a description of the main characteristics of CAR-T cells and their functionalities, continuing with the legal landscape applicable to patenting processes, and concluding by presenting the potential strategies to overcome the impediments that can appear when trying to patent CAR-T cells. It is meant to offer insights for those who are exploring possible patenting options in CAR-T cells territory. PubMed and Patenscope databases were used for patent and literature searching (2013-2023).
There is no one-size-fits-all solution in this matter and the medical evolution of this therapy will certainly bring out even more challenges. Comprehensive knowledge of the intellectual property, exposure to potential litigation, growing competition, and the high price of therapy, are strikingly relevant in the broader landscape. Future endeavors would be to take steps toward the harmonization of the CAR-T patenting procedure.
新兴的免疫疗法正在推动癌症治疗的边界,嵌合抗原受体 (CAR)-T 细胞疗法是最先进的疗法之一。由于 CAR-T 细胞领域日益拥挤,对这些 CAR-T 细胞的知识产权进行专利保护和保护意味着对法律环境有很好的了解。
本文主要关注 CAR-T 技术专利申请过程中的挑战,首先描述 CAR-T 细胞的主要特征及其功能,然后介绍适用于专利申请过程的法律环境,并最后提出克服在尝试为 CAR-T 细胞申请专利时可能出现的障碍的潜在策略。这旨在为那些在 CAR-T 细胞领域探索可能的专利申请选择的人提供一些见解。使用 PubMed 和 Patenscope 数据库进行专利和文献搜索(2013-2023 年)。
在这个问题上没有一刀切的解决方案,这种疗法的医学发展肯定会带来更多的挑战。全面了解知识产权、潜在诉讼的暴露、竞争的加剧以及治疗的高昂价格,在更广泛的背景下具有明显的相关性。未来的努力将是朝着协调 CAR-T 专利申请程序迈出一步。