English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  Items with full text/Total items : 113656/144643 (79%)
Visitors : 51731944      Online Users : 582
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
Scope Tips:
  • please add "double quotation mark" for query phrases to get precise results
  • please goto advance search for comprehansive author search
    •  Adv. Search
    Home ‧ Login ‧ Upload ‧ Help ‧ About ‧ Administer Goto mobile version


    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/114416


    Title: 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
    Exploring the Concept of Non-Reliance Obligation under Pharmaceutical Data Exclusivity Regime with Emphasis on the Implications of Bayer v. Canada
    Authors: 楊培侃
    Yang, Pei-Kan
    Keywords: 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 Exclusivity;Unfair Commercial Use;Non-Reliance;Undisclosed Information;Test Data;Generic Drugs;Patent Drugs;Bioequivalence Test;Comparative Test
    Date: 2015-06
    Issue Date: 2017-11-07 10:43:19 (UTC+8)
    Abstract: 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。
    Data exclusivity is designed to protect undisclosed clinical data from disclosure and unfair commercial use for a certain exclusive period 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 under the TRIPS Agreement, and the meaning of ＂nonreliance＂ 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 ＂nonreliance＂ 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.
    Relation: 政大法學評論, 141, 51-107
    Data Type: article
    DOI 連結: http://dx.doi.org/10.3966/102398202015060141002
    DOI: 10.3966/102398202015060141002
    Appears in Collections:[政大法學評論 TSSCI] 期刊論文

    Files in This Item:

    File Description SizeFormat
    141-2.pdf1842KbAdobe PDF2308View/Open


    All items in 政大典藏 are protected by copyright, with all rights reserved.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏，無償提供學術研究與公眾教育等公益性使用，惟仍請適度，合理使用本網站之內容，以尊重著作權人之權益。商業上之利用，則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作，已盡力防止侵害著作權人之權益，如仍發現本網站之數位內容有侵害著作權人權益情事者，請權利人通知本網站維護人員(nccur@nccu.edu.tw)，維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - Feedback