美國CAFC基因工程專利訴訟案例分析

Abstract

美國CAFC基因工程專利訴訟案例分析 Case Studies on the CAFC Genetic Engineering Patent Suits 學生: 劉慧德(8865502) 指導教授: 劉尚志博士 國立交通大學科技管理研究所 論 文 摘 要 近年來，我國生物技術正要大力發展之際，而先進美國數十年的發展，正好是台灣的最佳借鏡。何以見得呢?回顧1953年，美國生物學家James Watson和Francis Crick共同發現DNA，初探遺傳訊息(基因)從何而來。再至1980年左右，遺傳基因工程興起，而近十年，美國政府及民間賽雷拉公司競相投入「人類基因組解讀計畫」，又美國基因相關專利逐年成長，近幾年更是激增。(請參見本碩士論文Fig. 5) 因之，生物科技(尤其基因工程)勢必掀起另一波熱潮。全球生物科技產業紛紛摩拳擦掌，一場場基因專利權爭奪戰的戰火陸續開打。基此，本碩士論文歸納美國聯邦巡迴法院專利糾紛17案例，計有：(a)進步性(1 case),(b)均等論)(1 case),(c )敘述性要求(1 case),(d)最佳實施例要求(1 case),(e)不具可實施性(1 case),(f)對行使權利的懈怠和禁反言(1 case),(g)專利範圍的解讀(3 cases),(h)舉證及驗證(證據的內容) (3 cases),(i)一事不再理(2 cases),(j)不正當行為/不潔淨的手(2 cases),(k)專利權利失效(lapse) (1 case),(l)誘導侵權(1 case),(m)喪失利益補償和合理銷售損失權利金(1 case),(n)授權糾紛(2 cases),(o)與"要求告知"有關的特權保護資料(1 case),由法律各層面彰顯技術面創新之適法性及合理性。 在技術面，台灣生技產業發展如下技術/產品之一：「人類生長荷爾蒙、均勻造血素、蛋白質工程、融合蛋白質、合成人類胰島素、抗病毒植物、合成殺蟲劑、基因表現、幹細胞分離方法(用於骨髓移植)、HIV檢測方法等」，需要了解或精研本論文所述及的專利訴訟案例。一則避免侵權，受制於人，二則有益於台灣生物技術良性的發展。

Abstract This study reviews 17 cases of US CAFC (Court of Appeals for the Federal Circuit) patent suits associated with biotechnology. It aims to analyze the core issues of technological disputes in the industrial development. To begin with, this research presents the milestones of biotechnology development. James Watson and Francis Crick firstly discovered DNA with double helix form, which reveals the infrastructure of the genetic code, in 1953. The research of genetic engineering grew rapidly during the 1980s, and many genetic phenomena were disclosed. The "Human Genome Interpretation Project" conducted by the USA released preliminary results in June 2000. The biotechnology development has led to an increase of patent number grow exponentially during the last five years. The 17 cases contained in this thesis include the following legal subjects: (a) inventive step(1 case), (b) doctrine of equivalent(1 case), (c) descriptive requirement(1 case), (d) best mode requirement(1 case), (e) nonenablement (1 case), (f) patent right laches and file wrapper estoppel(1 case), (g) interpretation of claims(3 cases), (h) lack of evidence(3 cases), (i) dismissal without prejudice(2 cases), (j) inequitable conduct(2 cases), (k) patent right lapse(1 case), (l) licensing dispute(2 cases), (m) discovery problem (1 case). In short, the legality and technical aspects are discussed in terms of legal judgement in each specific case. It is also pointed out in this study that human growth hormone, erythropoietin, protein engineering, fusion protein, human insulin, gene expression, synthetic insecticide, and HIV detection method, are of values for further research.