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    Title: 美國植物藥新藥專利佈局及其研發合作活動 ─ 以Veregen® 和Mytesi®為例
    Patent deployment for botanical drug in United States of America with relative research, development and cooperation activities : a case of Veregen® and Mytesi®
    Authors: 廖志文
    Liao, Chih Wen
    Contributors: 陳桂恒
    Chan, Keith
    廖志文
    Liao, Chih Wen
    Keywords: 植物藥新藥
    專利
    策略
    Botanical drug
    Patent
    Strategy
    Date: 2017
    Issue Date: 2017-06-01 09:56:48 (UTC+8)
    Abstract: 植物藥新藥 ( botanical drug ) 的出現,讓各地歷史悠久的傳統生藥學 ( 或藥用植物學 ) 在這幾年逐漸現代化,而相對地,原來位居醫藥開發主流的小分子化學和生物製劑,加入了新的成員,一樣嚴謹的科學審查標準,但讓植物藥新藥有更多應用和更大市場。

    2004年在美國公佈了「Botanical Drug Products」指引,2006年第一件植物藥新藥Veregen®核准上市,接著2012年Mytesi®亦取得核准上市,2015年美國公布「Botanical Drug Development Guidance for Industry」草案,2016年底公布了正式指引:「Botanical Drug Development Guidance for Industry」,在這期間,中國藥物學專家屠呦呦 ( Tu Youyou ) 以「青蒿素」( artemisinin ) 一藥,共同取得2015年諾貝爾醫學獎,這系列的進展,說明了這個領域正在健康的發展中。也正因此,本研究欲藉由兩個已上市的植物藥新藥為材料,利用專利檢索分析、功效矩陣檢視,最後輔以法規和商業活動時間軸的呈現,來觀察植物藥新藥開發垂直的如何推進,水平的如何和他人合作,這種實證式的回溯性研究,更可讓國內開發者,以貼近實務的各種角度,檢視自己的整體開發風險和報酬。

    而最後研究結果顯示,Veregen®開發過程,由於4位開發者的發展方向及其內部產品,都不是直接競爭者,而且在契約exclusive license和exclusive sub-license利益風險共享架構下,4者的全部專利的組合運用可以達到最好的效益,專利應用上有著較多方面的保護及後續開發潛力,而開發關係人對內對外都有較低的專利訴訟風險。而Fulyzaq® ( 已更名為Mytesi® ) 開發到上市主要有3位開發者,藉由本研究的檢索分析,可以發現到在當時2位接手的開發者,其發展方向、內部產品及專利佈局,是很強的潛在競爭,存在非常高的法律風險,而在最後三位共同開發者互相提起訴訟,也消耗了產品在市場取得更佳報酬的潛力,雖然在合作前也都預防性的簽署了共同開發協議 ( Collaboration Agreement )。

    最後,由二者研究內容歸納,植物藥新藥的開發,需要不會的找會的,缺資金的找有資金的,開放式的接捧合作,才能在這麼高風險的新藥開發上,取得最可能成功的路徑;而除了選題的謹慎,積極的專利資源投入,才是預防風險、提高報酬的最佳方式,這包括成果儘早申請專利、臨時申請案及PCT運用、專利申請分割或延續案的應用、相關專利的藥物生命周期延長,最後,深入而全面的檢索分析專利更是絶對重要。
    Reference: 中文部分
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    法院判決
    Napo Pharmaceuticals Inc. v. Salix Pharmaceuticals Inc., 651214/2011 (N.Y. Sup. May 5, 2011).

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    Description: 碩士
    國立政治大學
    科技管理與智慧財產研究所
    103364213
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G1033642131
    Data Type: thesis
    Appears in Collections:[科技管理與智慧財產研究所] 學位論文

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