2018-03-302024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/662217摘要：2017年12月底立法院通過藥事法修正及增訂專利連結專章，本議題為臺灣與美國之「貿易暨投資架構協議」（US-Taiwan Trade and Investment Framework Agreement，簡稱TIFA）及其他雙邊貿易協定之高度關注項目。 本研究計畫因應藥事法修正-第四章之一西藥之專利連結草案之規劃施行，將分成為三個部分執行本計畫。第一部分為執行藥事法專利連結之子法與配套制度研擬：包括公平交易相關通報等遵循事項之辦法研擬，並因應未來法規之施行，研擬藥事法施行細則及藥品查驗登記審查準則等行政及法規作業之修正內容，並協助中央衛生主管機關建立專利登錄程序與作業規範。第二部分為建立我國專利連結制度「橘皮書」資訊系統，包括評估未來建置藥品專利登載平臺及資料庫之軟/硬體需求。第三部分乃針對子法研擬與橘皮書資料庫建置等議題，蒐集產官學院各界意見及納入子法與資料庫研擬。 <br> Abstract: The Legislative Yuan passed the Amendment of Pharmaceutical Affairs Act introducing the legal framework of patent linkage in December 2017, since the issues of pharmaceutical patent protection have been drawn attention during the negotiation of the US-Taiwan Trade and Investment Framework Agreement (TIFA) and Free Trade Agreements (FTAs). The aim of this project is to draft the implementation rules and pharmaceutical database &#8222;orange book“ in Taiwan. The first part of this project is to propose the implementation rules of patent linkage, including the guideline on pharmaceutical patent agreements among pharmaceutical manufacturers. The second part of this project is to establish the pharmaceutical database &#8222;orange book“. Finally, the opinions, recommendation and suggestions delivered by both the public and private sectors will be taken into consideration while drafting the rules and establishing database.專利藥品專利專利連結藥事法patentpharmaceutical patentpatent linkagedrug approval-patent linkagePharmaceutical Affairs Act