2017-08-222024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/656984摘要：藥品之智慧財產保護事宜，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）之高度關注項目，而建立專利連結制度與擴大藥品之資料專屬保護，亦為美方要求我國採行之主要政策之一。 近年我國致力於推動生技產業發展，藥品智慧財產之保障亦為政策推行之一環，近期，我國的生醫產業創新推動方案中，亦將行政院藥事法部分條文修正草案及建置專利連結制度等落實藥品智慧財產保護之制度，視為提升創新效能、推動生醫產業發展之配套法規。 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，將分成為兩個部分執行本計畫，第一部分為修法之法規分析與配套研擬；第二部分為專利連結之執行準備。 法規分析與配套研擬部分，包括就行政院版/立委版之條文比較及修正條文研擬及修法意見之提供，以及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。 執行準備的部分，將配合招標單位之需求設計藥品登錄專利表格、學名藥申請案專利聲明表格，並評估未來建置藥品專利登載平臺及資料庫之軟/硬體需求。 此外，本研究計畫將持續蒐集整理美、加、韓等國家專利連結制度之運作現況與法令規定，做為我國法規及制度執行之規劃參考，以完善我國專利連結制度俾利政策推行。 <br> Abstract: In recent year, the importance of drug approval-patent linkage, particularly “patent linkage”, emerges during the negotiation of the Free Trade Agreements (FTAs). Countries entering into FTAs with the USA, including Australia, Canada, Singapore and South Korea, have created the patent linkage or similar system to strengthen intellectual property protection for pharmaceuticals. After Taiwan announced to amend Pharmaceutical Affairs Act and Patent Act and to establish patent linkage in quest of closer trade relation with the USA, domestic generic drug industry expressed concerns over the potential adverse effect on access to less-expensive drug and the public health. The current “IPR-declaration mechanism” is criticized by branded drug makers that assert Taiwan should establish a proper system to effectively prevent marketing of patent-infringing generic drug. After considering the domestic legal system and generic industry, the draft Amendment of Pharmaceutical Affairs Act introducing the legal framework of patent linkage was proposed by the TFDA and approved by the Executive Yuan in August 2016. The aim of this project is to establish the patent linkage, including the relative regulations and orange book in Taiwan.專利藥品專利專利連結藥事法patentpharmaceutical patentpatent linkagedrug approval-patent linkagePharmaceutical Affairs Act