篇名

藥品研發與近用──從藥事法專利連結專章及資料專屬權談起   免費試閱

並列篇名

Innovation and Access to Medicine: Implementation of Patent Linkage and Data Exclusivity in Taiwan

作者
中文摘要

臺灣於2019年8月20日生效施行專利連結。藥事法除了以專利連結制度強化藥品專利權行使,亦賦予新成分與新適應症新藥資料專屬權保護。本文認為,藥品智慧財產保護有助於臺灣之藥品近用、加速新藥上市與本土製藥產業發展。臺灣已有能力上市新劑型藥品之藥廠,需要專利連結與資料專屬權提供更多誘因,以利於從事藥品研發。

英文摘要

On 20 August 2019 the newly established patent linkage has taken effect in Taiwan. Apart from that the patent linkage enhancing the enforcement of pharmaceutical patents, the Pharmaceutical Affairs Act provides data exclusivity protection on the new chemical entity (NCE) and new indication drugs. This article is of the opinion that intellectual property protection for pharmaceuticals is essential for access to medicines, acceleration of launching innovation drug and establishment of domestic pharmaceutical industry in Taiwan. Domestic companies which are capable of launching new dosage forms of existing drugs need more incentives provided by patent linkage and data exclusivity to undertake R&D.

起訖頁

007-019

出版單位
DOI

10.3966/241553062019120038001  複製DOI  DOI查詢

QRCode

數位整合服務
產品服務
讀者服務專線:+886-2-23756688   傳真:+886-2-23318496   地址:臺北市館前路28號7樓

Copyright © 元照出版 All rights reserved. 版權所有,禁止轉貼節錄
TOP