月旦知識庫
  1. 熱門:
 
首頁 臺灣期刊   法律   公行政治   醫學   財經   社會學   教育   其他 大陸期刊   核心   非核心 DOI文章
查看詳細全文
篇名
論藥品資料專屬保護之不引據義務——以加拿大拜爾案為中心
並列篇名
Exploring the Concept of Non-Reliance Obligation under Pharmaceutical Data Exclusivity Regime with Emphasis on the Implications of Bayer v. Canada
作者 楊培侃
中文摘要
資料專屬保護制度,旨在保障藥商為取得新藥上市許可所有新藥安全性與有效性之試驗資料免受他人不公平之商業使用。此等新興的智慧財產保護形態首見於北美自由貿易協定第1711條,加拿大據此採取資料專屬保護制度,然對於該制度下要求衛生主管機關不得引據研發藥廠所提試驗資料,何謂「不引據」或「非依賴」之概念,引發拜爾案對此問題之熱烈爭議。因此,本文擬就加拿大拜爾案所涉資料專屬保護之法令,探討「不引據」概念在資料專屬保護制度下之可能解釋及其意涵,分析寬嚴不同之解釋對研發藥廠與學名藥廠利益之消長,並尋求平衡藥品研發創新與公共健康價值之可能解釋,提供我國藥事法第40條之2解釋適用之參考。
英文摘要
Data exclusivity is designed to protect undisclosed clinical data from disclosure and unfair commercial use for a certain exclusive peri-od of time. Generated by innovators, such test data are submitted to the health authority for the examination of the safety and effectiveness of a new drug before marketing. Data exclusivity is granted to the innovators for their considerable efforts put forth in generating those test data. Generally, no one can rely on those submitted data for a subsequent application for a new drug approval. Such new type of intellectual property firstly appeared in Article 1711 of the North American Free Trade Agreement, and was incorporated under Article 39.3 of the TRIPS Agreement and subsequent bilateral free trade agreements. However, the concept of “unfair commercial use” has never been clearly defined un-der the TRIPS Agreement, and the meaning of “non-reliance” has been interpreted differently from country to country. As a leading case on data exclusivity, the Canadian case, Bayer v. Canada, offered useful resources to clarify the issues surrounding the meaning of “non-reliance”. This study attempts to explore the concept of “non-reliance” under the pharmaceutical data exclusivity regime based on Bayer v. Canada. This study suggests a possible compromised interpretation of “non-reliance” with a view to balance pharmaceutical innovation and public health, and argues that Article 40-2 of the Pharmaceutical Affairs Act is consistent with the above compromised interpretation. This study also proposes several options for amendments.
起訖頁 51-107
關鍵詞 資料專屬保護不公平商業使用不引據(非依賴)未揭露資訊試驗資料學名藥專利藥生體相等性比較試驗Data ExclusivityUnfair Commercial UseNon-RelianceUndis-closed InformationTest DataGeneric DrugsPatent DrugsBi-oequivalence TestComparative Test
刊名 政大法學評論  
期數 201506 (141期)
出版單位 國立政治大學法律學系
DOI 10.3966/102398202015060141002  複製DOI
QRCode
該期刊-上一篇 從迷失的身分重新找尋食品攙偽假冒管制的可能途徑——以食品身分標準為分析焦點
該期刊-下一篇 零售市場投資產品之法律糾紛、訴訟風險及投資人保護——臺灣有關連動債及共同基金訴訟之實證研究
 

新書閱讀



最新講座


優惠活動




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