臺灣博碩士論文加值系統

隨著科技進步，藥物發展迅速，出現多種新型態藥物，生物製藥是其中一種重要的藥物型態，此類藥物是以細胞或細菌為生產工廠產生之藥物，具有高專一性及低副作用的優點。近年來各大生物製藥廠的專利陸續到期，其他藥廠可以開始生產這些專利到期的生物製藥，但在生物製藥領域中，由於製程相異，可能影響到蛋白質立體結構或後修飾，造成分子結構有差異但療效相同之情形，故由其他藥廠生產的生物製藥稱為「生物相似藥」只能視為相似產品，這也是「生物相似藥」之名稱由來。由於生物製藥入門門檻高、研發困難、須耗費大量金錢及時間成本，且失敗率高，除世界知名大廠外，多數藥廠選擇從門檻較低之生物相似藥研發方向著手。隨著多項生物製藥專利將屆期，生物相似藥上市申請案增多，原生物製藥廠與生物相似藥廠間之專利侵權案例也逐漸累積。本論文先由生物製藥的特性、生產製程等技術資訊進行了解，接著分析比較生物相似藥在美國經由專利舞蹈制度與我國經由專利連結制度的上市程序，之後藉由美國生物相似藥上市時相關侵權案例，再進一步分析我國生物相似藥上市可能面臨之專利侵權問題，最後嘗試針對我國生物相似藥上市申請制度及生物製藥相關規範提出分析與建議。

With the advancement of technology and the rapid development of drugs, a variety of new types of drugs have emerged, and biologics are one of the important types of drugs. In recent years, the patents of major biopharmaceutical factories have expired one after another, and other pharmaceutical factories can start producing biopharmaceuticals whose patents have expired. However, in the field of biologics, different manufacturing processes may affect the three-dimensional structure or post-modification of proteins, resulting in different molecular structures but the same therapeutic effect. Therefore, biologics produced by other pharmaceutical companies are called "biosimilar drugs" which only can be regarded as similar products. Due to the high barriers to entry of biopharmaceuticals, the difficulty of research and development, the cost of a lot of money and time, and the high failure rate, except for world-renowned manufacturers, most pharmaceutical companies choose to start from the research and development direction of biosimilar drugs with lower thresholds. With the expiry of a number of biopharmaceutical patents, the number of biosimilar drug listing applications has increased, and the patent infringement cases between the original biopharmaceutical factory and the biosimilar drug factory have also gradually accumulated. This paper firstly understands the characteristics of biopharmaceuticals, production process and other technical information, and then analyzes and compares the listing procedures of biosimilar drugs in the United States through the patent dance system and Taiwan through the patent linkage system. Then, based on the related infringement cases of biosimilar drugs in the United States, we will further analyze the patent infringement problems that may be faced by biosimilar drugs in Taiwan. Finally, it tries to put forward analysis and suggestions on the application system of biosimilar drugs in Taiwan and related norms of biopharmaceuticals.

目錄
誌謝 1
中文摘要 2
英文摘要 3
目錄 5
圖表目錄 10
第一章 緒論 11
第一節 研究動機 11
第二節 研究目的 13
第三節 研究方法 14
第四節 研究架構 14
第二章、藥物演進、類型、生物製藥研發上市流程及市場、生物相似藥 16
第一節、藥物演進 16
一、天然藥物時代 17
二、化學合成時代 17
三、生物技術時代 17
第二節、藥物的分類-小分子藥物與生物製藥 18
一、分子結構 18
二、生產製程 19
三、藥效及副作用 21
第三節、美國生物製藥研發及上市 24
一、發現階段 24
二、發展階段 26
三、監管審查和核准-完整數據資料評估及製造計劃 29
四、核准後研究及監控 30
第四節、生物製藥的競爭者-生物相似藥 35
一、何謂生物相似藥 35
二、生物相似藥的成本與售價 38
第五節、生物製藥與生物相似藥在藥物市場之發展 39
一、生物製藥與生物相似藥對藥物市場影響 39
二、生物相似藥上市對生物製藥之影響 40
第六節、我國生物製藥與生物相似藥相關規範 43
一、生物製藥與生物相似藥定義 43
二、我國生物製藥研發上市及監管流程 44
第七節、小結 50
第三章 美國對於生物製藥之專利與政策保護 52
第一節 美國專利制度 52
一、專利類型 52
二、專利申請案類型 53
三、申請審查流程 54
四、核准專利之保障 56
第二節、美國生物製藥專利保護與資料專屬權 56
一、藥物專利特別規定-專利期間延長 56
二、資料專屬權 58
三、生物製藥專利申請 61
第三節、生物相似藥上市申請規範 68
一、一般藥物規範-藥品價格競爭與專利期延長法案 68
二、生物製藥之獨特規範-生物藥品價格競爭與創新法 72
第四節、小結 77
第四章、美國生物相似藥之專利侵權訴訟案例 79
第一節、Filgrastim 與Pegfligrastim之相關介紹 79
一、原生物分子-顆粒球聚落刺激因子(G-CSF) 79
二、G-CSF相關生物製藥 80
三、Filgrastim在生物製藥市場分析 82
第二節、Neupogen及Neulasta相關專利 85
一、美國專利US5580755A號 85
二、美國專利US5824784A號 85
第三節、Neupogen及Neulasta之相關訴訟 86
一、Amgen vs. Sandoz 86
二、Amgen vs.Apotex 99
三、Amgen vs. Coherus Biosciences 106
第四節、小結 110
第五章、我國生物製藥發展及案例分析 113
第一節、我國生物製藥產業發展現況 113
一、優惠措施 114
二、政府研究單位研發成果技轉業界 114
三、生技相關法規制定與修正 115
四、我國生物相似藥之發展 115
第二節、我國生物製藥之相關專利制度與資料專屬權 118
一、 專利權期間延長 118
二、專利連結制度 119
三、資訊專屬權 120
四、我國與美國相關制度之比較 121
第三節、相關案例分析 123
一、聯亞生物相似藥UB-851 123
二、 可能爭點整理 123
第四節、小結 128
第六章、對於我國生物相似藥相關規範之檢討與建議 130
第一節、藥事法 130
一、生物製藥定義 130
二、專利連結制度 131
第二節、專利法因應修正 132
參考文獻及書目 134
一、中文參考文獻 134
二、外文參考文獻 136

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