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基孔肯雅热的专利视角。

A patent perspective on chikungunya.

机构信息

Council of Scientific & Industrial Research-Unit for Research and Development of Information Products, (CSIR-URDIP), Pune, 411008, India.

出版信息

Acta Trop. 2019 Nov;199:105131. doi: 10.1016/j.actatropica.2019.105131. Epub 2019 Aug 8.

DOI:10.1016/j.actatropica.2019.105131
PMID:31401192
Abstract

Chikungunya is a viral disease caused by chikungunya virus (CHIKV) belonging to the Alphavirus genus and transmitted to humans by mosquitoes of Aedes spp. Nearly 40 countries in Asia, Africa, Europe, and the Americas have documented chikungunya cases. Most recent severe outbreaks have occurred in Indian Ocean islands of Réunion and Mauritius and India. There is no specific drug treatment for the disease, neither is there a standardized vaccine available for prevention of the disease. The present review gives a global perspective on patents filed pertaining to chikungunya. The United States has been the top patent filing jurisdiction followed by China, Europe, and India. The patents have been classified into categories of therapeutics, diagnostics, and vaccines. Maximum patent documents fall under the therapeutics category, in which patent applications are predominantly related to chemically derived drugs. They include nucleic acid analogues, various other host and virus enzyme/protein inhibitors. Patents on biological or plant derived drugs are being filed relatively recently. In the category of diagnostics, immunoassay based tests seemed to be of choice until the year 2005, whereas, patent filings for molecular diagnostics have now surpassed those with immunoassay techniques. In the vaccines category, vaccines based on viral vectors appear to be emerging as the preferred vaccine platform with the majority of patents filed in the years 2014-2017. Corporate sector has the most patent filings to its credit, followed closely by academic institutions. Pasteur Institut along with Chinese Agency for Science, Technology and Research is the top patent filing entity in chikungunya related technology space. Presently, nine vaccine products, three antiviral drugs and one mRNA based gene therapy are under development. Three vaccine products have been given fast track designation by US Food and Drug Administration (FDA) to expedite review and facilitate the development of a vaccine to prevent a serious or life-threatening condition and fill an unmet medical need. Similarly, one vaccine has been given PRIME (Priority Medicines) status by the European Medicines Agency (EMA).

摘要

基孔肯雅热是由基孔肯雅病毒(CHIKV)引起的病毒性疾病,属于甲病毒属,通过 Aedes spp 蚊子传播给人类。亚洲、非洲、欧洲和美洲近 40 个国家都有基孔肯雅热病例记录。最近的严重疫情发生在印度洋的留尼汪岛和毛里求斯以及印度。目前尚无针对该疾病的特效药物治疗方法,也没有标准化疫苗可用于预防该疾病。本综述提供了全球范围内与基孔肯雅热相关专利的视角。美国一直是专利申请的主要地区,其次是中国、欧洲和印度。这些专利分为治疗、诊断和疫苗三大类。最大数量的专利文件属于治疗类别,其中专利申请主要与化学衍生药物有关。这些药物包括核酸类似物、各种其他宿主和病毒酶/蛋白抑制剂。最近才开始提交基于生物或植物来源药物的专利。在诊断类别中,免疫测定为基础的测试似乎是首选,直到 2005 年,而现在基于分子诊断的专利申请已经超过了免疫测定技术。在疫苗类别中,基于病毒载体的疫苗似乎正在成为首选的疫苗平台,2014 年至 2017 年期间提交的专利数量最多。企业部门的专利申请数量最多,其次是学术机构。巴斯德研究所与中国科学技术部是基孔肯雅热相关技术领域专利申请最多的机构。目前,有九种疫苗产品、三种抗病毒药物和一种基于 mRNA 的基因治疗正在开发中。三种疫苗产品已被美国食品和药物管理局(FDA)指定为快速通道,以加快审查并促进预防严重或危及生命的疾病和满足未满足医疗需求的疫苗的开发。同样,一种疫苗被欧洲药品管理局(EMA)授予 PRIME(优先药物)地位。

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