基因科技的研發成果除了得做為研究工具外，終端產品服務如基因檢測或基因治療等則皆具有醫療功能效益，不僅有高度潛能發展成個人化醫療的應用，更有助於減緩國家於健康財政的支出負擔。此外，以基因科學為技術基礎的生物科技產業，亦多被各國列為重點發展的產業類別，且現今尚處於持續向上攀升的態勢。然而，有鑑於基因科技同時具備生物不確定性和累積創新特性，造成專利法在其發展上雖扮演極重要的推動角色，但因為成果多具有上位且必要近用的性質，而與專利法所保障的發明性質以及所享有排他權能呈現某程度上的扞格牴觸，進而在實際適用上產生諸多疑義和問題。是以，究竟如何透過調整和再造專利法和相關法規範的解釋，解決現行適用上的問題，並且增進基因科技的研發動能，促成基礎研究的承接和鼓勵後續創新和商業化，最終帶動整體生技產業的蓬勃發展，實乃本論文的問題核心和研究目標。
對此，本論文將聚焦於基因科技研發成果的專利保護要件解釋上的疑義，以及生技專利的授權實務所面臨的困境應如何處理此二議題，並以美國的法制規範和實務見解作為討論模板，透過文獻回顧和比較分析法，輔以技術評價、產業影響評估和政策評析，提出一整體宏觀性的最佳政策模型，且逐一具體套用至各該政策槓桿的解釋和運用中。是以，本論文乃嘗試透過一次到位的方式，使專利適用於基因科技發明上，得直接調整成最佳的適用狀態，以節省逐步微調或立法再造的成本和不效率，並且真正達成生技產業創新發展之目標。
首先，於第二章詳盡介紹基因序列、基因改良之生物材料、基因檢測和治療方法，以及胚胎幹細胞此四個研發領域的技術內容，以及基因科學在產官學的互動實務和發展現況，並點出歷經誘因機制的轉變所生的適用疑義和近用問題。其次，在第三章則是先探求經濟政策擬定和執行的法理基礎，並闡釋專利法和相關法制具有經濟政策容納性和得依據技術特性予以調整的性質。再者，依憑上開理論基礎提出一較佳的政策模型，即區分專利保護和專利行使階段，前者的專利保護要件的解釋上，應貫徹貼近技術實務和充分誘因保障的政策思維。並且挑選爭議性較高的專利適格性、產業利用性、進步性和據以實施性，以及附隨相關的書面揭露要件，在第四章具體討論適用在本論文所選擇的技術子領域的專利保護要件判斷上，進而提供全面性的實務見解認識和橫向的比較基礎加以介紹和評析。相對的，後者的部分則是依據現行仍維持尚屬公開的授權風氣，僅需採取低度的管制密度的合宜近用政策思維，以維持市場具備適度的自主型塑空間。因此，在第五章就專利近用相關的爭議類型所涉及的專利濫用、相關授權約款細節、授權促進措施、所能主張的試驗免責範疇，以及強制授權、法定授權和介入權的討論中，透過立基於本論文提出的政策模型，加以檢視實務見解和競爭法指導原則所闡釋的合法判斷之妥適性，並且逐一選擇合適的技術子類型作為評論的模板，提供縱向的具體應用情形評估。
最後，在第六章結論的部分，除了重申此政策模型的適宜性，並嘗試將此模型套用至歐洲和我國的專利法和相關法制的解釋和適用上，並提出相關革新的建議，促成各國的專利法制的實際適用均得引介此政策模型，進而成功促成各國生技產業創新發展之目的。

The biotechnology inventions can serve as research tools as well as some end services such as genetic testing or gene therapy. Not only can the biotechnology inventions apply to personal medical treatment, but they can also alleviate the burden on public health subsidization of government. Besides, the biotechnology industry is growing prosperously and its development is also on the top priority of many countries. To deal with the biotechnology uncertainties, patent law ensures great incentives in the innovation of biotechnology R&D. Nevertheless, the nature of the biotechnology inventions, which is hard to distinguish with natural phenomena or is somehow essential for follow-up improvements, makes it hard to become the subject matter of patent law, and conflicts with patent’s exclusive right. In order to spur the innovations of biotechnology and commercialization of basic research, the core issues are how to solve the problems mentioned above.
The dissertation focuses on two parts. One is the adjustment of patent law interpretations in biotechnology inventions’ patentability. The other is the solution to the difficulty of the biotechnology patent access. The dissertation intends to propose an optimal policy model, which can be applied to policy levers in patent law interpretations concretely, through literature reviewing, technical analysis, industrial impact assessment and policy consideration of United States’ legal system and related court opinions.
The optimal policy model divides patent law into two parts: patent protection and patent using. For patent protection, the explanations of patent law should take technical practices into considerations and ensure ample incentives for biotechnology research and development. For patent using, since the licensing practice of patented inventions still keeps sharing and common in the marketplace nowadays, only loose regulations are needed to ensure the useful access to patented inventions.
Chapter four introduces the application of the model to specific subfields, including related court opinions and optimal interpretations of invention’s patentability, useful, nonobviousness, enablement and written description. Chapter five discusses about various types of the patent access controversies, inclusive of patent misuse, licensing clause, licensing-facilitated measurement, research exemption, compulsory licensing and march-in right issues. Still, by applying the model to selected subfield inventions, chapter five evaluates the appropriateness of court opinions and antitrust guidelines. Finally, the conclusion restates the appropriateness of the policy model, and tries to influence the interpretations and applications of Europe and Taiwan patent law.
Overall, the dissertation tries to optimize the interpretations and applications of patent law once and for all in order to promote the biotechnology industry developments and reduce the cost and inefficiency of continual further legislations.

第一節 中文部分

第一項 專書
1.王偉霖、劉江彬，國際技術移轉制度理論與實務:兼論台灣立法與產學研因應之策略，2010年9月。
2.林子儀等人，憲法-權力分立，二版，2008年9月。
3.陳敏，行政法總論，8版，頁966，2013年9月。
4.經濟部智慧財產局，專利法逐條釋義，2014年9月版。

第二項 專書論文
1.許宗力，權力分立與機關忠誠－以德國聯邦憲法法院裁判為中心，收錄於: 法與國家權力（二），頁293-342，2007年1月。
2.陳文吟，探討修改「進步性」專利要件以因應生物科技發展的必要性-以美國法為主，載：生物科技與專利法，頁311-345，2011年9月。
3.陳文吟，探討基因治療相關發明專利暨其必要之因應措施，收錄於: 生物科技與專利法，頁183-239，2011年9月。
4.陳櫻琴，管制革新之法律基礎與政策調適，載：管制革新，頁1-67，2001年4月。
5.陳新民，憲法財產權保障與公益徵收之概念，載：憲法基本權利之基本理論(上)，五版，頁285-354，1999年6月。
6.徐筱菁，國家干預經濟活動之憲法基礎與界限，載：管制革新，頁69-112，2001年4月。
7.湯德宗，美國權力分立的理論與實務，收錄於: 權力分立新論: 卷一: 憲法結構與動態平衡，三版，頁385-420，2005年4月。
8.湯德宗，大法官有關「權力分立原則」解釋案之研析，收錄於:權力分立新論: 卷二: 違憲審查與動態平衡，三版，頁305-426，2005年4月。
9.蘇永欽，部門憲法—憲法釋義學的新路徑?，載:部門憲法，頁3-31，2006年1月。
10.蘇永欽，經濟憲法作為政治與經濟關係的基本規範－從昔日德國的爭議來看今日台灣的回應之道，載：新世紀經濟法制之建構與挑戰─廖義男教授六秩誕辰祝壽論文集，頁127-161，2002年9月。

第三項 期刊論文
1.王文宇，從財產權之保障論釋字第三四九號解釋，載：民商法理論與經濟分析(一)，頁89-129，2000年5月。
2.宋皇志，瓶頸設施理論在智慧財產權之適用，月旦法學雜誌，第115期，頁160-179，2004年12月。
3.何美瑩、許維蓉和鄭中人，變動中的可專利客體適格性判斷標準——「Mayo v. Promethus案」之後，專利師，第10期，頁23-56，2012年7月。
4.何曜任，美國法專利權濫用理論──對我國法之啟示，政大智慧財產評論，第9卷第2期，頁1-41，2011年12月。
5.李治安，由AMP v. Myriad Genetics, Inc.案談基因專利之適格性，智慧財產評論，12卷2期，頁1-46，2014年12月。
6.李崇僖，再探基因專利問題：美國經驗省思，第224期，頁304-307，2014年1月。
7.李素華，競爭秩序維護與智財權行使正當性之關係—以美歐技術標準制定按之最新發展為例，萬國法律，第134期，頁23-33，2004年4月。
8.李素華，論試驗實施例外及其在醫藥專利權適用之問題，華岡法粹，第37期，頁191-229，2007年3月。
9.李素華，專利權行使與公平交易法—以近用技術標準之關鍵專利為中心，公平交易季刊，第16卷第2期，頁85-121，2008年4月。
10.李素華，基因研究成果之專利保護及權利範圍──從美歐新近個案談基因專利權對公共衛生之影響，收錄於: 2011科技發展與法律規範雙年刊，頁85-87，2012年12月。57-129
11.李素華和張哲倫，專利之制度目的及權利本質──法院在其中之關鍵角色及功能，月旦法學雜誌，第232期，頁191-222，2014年9月。
12.李素華和謝銘洋，生技醫療產業所面對新興專利課題——基因檢測、細胞治療與基因治療之專利保護與權利限制，台灣科技法律與政策論叢，第4卷第2期，頁49-100，2007年6月。
13.吳秀明，專利聯盟(Patent Pool)與公平會之聯合行為管制(下)-以「飛利浦光碟案」中弔詭的競爭關係為核心，月旦法學雜誌，175期，頁85-101，2009年12月。
14.吳秀明和楊坤樵，憲法與我國經濟部分之基本秩序，載:部門憲法，頁207-277，2006年1月。
15.林佳和，時間、現實與規範性：憲法變遷，月旦法學雜誌，218期，頁28-43，2013年6月。
16.范建得、洪子洵和侯門，論基因專利實務發展及其評析，第143期，頁373-416，2015年12月。
17.張哲倫，專利濫用、幫助侵權與競爭法─專利濫用理論之過去與未來，全國律師，12卷10期，頁68-86，2008年10月。
18.張哲倫和李素華，專利法之經濟結構─經濟分析理論對於台灣專利制度運作之啟發，月旦法學雜誌，第234期，頁229-262，2014年11月。
19.曾勝珍，以美國經驗探討基因專利之法制研究，法令月刊，62卷12期，頁168-201，2011年12月。
20.許曉芬，歐洲專利規範中之「公序良俗」條款檢驗標準：以人類胚胎幹細胞專利為例，中正財經法學，第二期，頁53-89，2011年1月。
21.陳文吟，由Myriad案探討因應基因專利之合理措施，專利師，第13期，頁25-43，2013年4月。
22.陳文吟, 由美國專利實務探討專利侵害之實驗免責，臺北大學法學論叢，第64期，頁85-120，2007年12月。
23.陳英鈐，人類胚胎幹細胞專利與胚胎保護──一部98/44/EC指令各自表述，科技法學評論，第3卷第1期，頁75-132，2006年4月。
24.陳秉訓，論申請人類之診斷、治療或外科手術方法專利之再思考，專利師，第18期，頁1-17，2014年7月。
25.陳龍昇，「自然法則」運用與個人化醫療診斷方法專利適格性判斷──從美國Mayo v. Prometheus案判決談起，高大法學論叢，11卷1期，頁163-234，2015年9月。
26.陳昭華、鍾靜湖等人，基因有關研究工具授予專利之探討: 以基因專利之審查為中心，台大法學論叢，第39卷第1期，頁403-447，2010年2月。
27.陳櫻琴和程明修，經濟法研究之新趨勢─簡介史托伯教授一九九八年版「經濟行政法」，月旦法學雜誌，第67期，頁191-202，2000年12月。
28.黃文儀，論方法發明之可專利性，專利師，第16期，頁1-29，2014年1月。
29.許忠信，智慧財產權之濫用與限制競爭防止法之適用-由美國法與日本法看我國公平交易法第四十五條，全國律師，12卷10期，頁5-26，2008年10月。
30.簡維克，「從美國1996年新通訊法案例探討電信市場下的不對稱管制（下）」，萬國法律雜誌，第123期，頁37-49，2002年06月。
31.葉舜華和歐師維，抗體專利之說明書揭露——從美國Centocor Ortho Biotech, Inc. v. Abbott Labs.案談起，專利師，第8期，頁72-81，2012年1月。
32.劉孔中，公平法與智慧財產權法的衝突與調和，月旦法學雜誌，104期，頁93-111，2004年1月。
33.劉孔中，以關鍵設施理論限制專利強制授權之範圍，公平交易季刊，第 15卷第1期，頁25-58，2007年1月。
34.劉尚志和林三元，科技法律之本質與範圍，月旦法學雜誌，第166期，頁111-135，2009年3月。
35.熊誦梅，不當行使專利權之法律效果及救濟途徑－從美國法上之專利地痞、專利濫用及智慧財產授權準則談起，全國律師，12卷10期，頁56-67，2008年10月。
36.蔡坤旺、沈立明和陳恕琮，先驅性發明面臨之專利挑戰，專利師，第9期，頁42-63，2012年4月。
37.詹鎮榮，公經濟法: 第一講: 公經濟法之概念、體系與新趨勢，月旦法學教室，75期，頁59-68，2009年1月。
38.詹鎮榮，公經濟法：第二講：經濟憲法，月旦法學教室，80期，頁65-74，2009年6月。
39.詹鎮榮，電信法上不對稱管制措施之形塑及界限——最高行政法院100年度判字第1860號等系列判決評析，中研院法學期刊，第16期，頁71-126，2015年3月。
40.謝銘洋，方法專利侵害及損害賠償──最高法院96年度台上字第1710號民事判決評析，法令月刊，60卷11期，頁23-26，2009年11月。
41.謝銘洋、宋皇志和李素華，從歐洲觀點看幹細胞相關發行之可專利性，月旦法學雜誌，第118期，頁63-89，2005年3月。

第四項 學位論文
1.吳珮琳，生物材料專利對科技發展之衝擊及其可能管制方式之探討─以胚胎幹細胞為例，國立成功大學法學研究所碩士學位論文，2005年8月。
2.孫玉苓，人類胚胎幹細胞研究之法律管制及發明之專利保護，國立交通大學科技法律研究所碩士學位論文，2004年6月。
3.胡舜文，以哈佛鼠為核心論基因轉殖動物之可專利性及其產業利用，國立清華大學科技法律研究所碩士學位論文，2005年8月。
4.張睿麟，論製藥產業之實驗實施免責，政治大學法律科際整合研究所碩士論文，2008年6月。
5.黃秋蓮，專利權及著作權濫用原則與競爭法規之互動—以美國法為借鏡，國立臺灣大學法律學研究所碩士論文，2012年12月。
6.蔡奉真，全球化趨勢下發明專利立法政策之比較研究－以公共衛生與發明專利為例，國立臺灣大學法律學研究所碩士論文， 2005年6月。
7.劉昱儒，專利權耗盡理論之公法研究－兼論美國最高法院Quanta Computer, Inc. v. LG Electronics, Inc. (2008)判決，國立政治大學法學院碩士在職專班學位論文， 2008年7月。
8.劉旻憲，智慧財產權之憲法保障基礎，私立東海大學法律學系研究所碩士論文， 2012年7月。
9.劉晏慈，KSR案對美國生物科技專利顯而易知性審查標準之影響—兼論對我國專利審查之啟示，頁183-84，臺灣大學科際整合法律學研究所碩士論文，2011年7月。
10.顏利真，標準必要專利之競爭法議題探討─以FRAND授權案件為中心，國立臺灣大學科際整合法律學研究所碩士論文，2013年。
11.蘇靜雅，美國專利法上書面說明要件之探討——由產業及技術領域區別適用觀點切入，國立交通大學科技法律研究所，2012年7月。
12.蘇柏榮, 生物材料移轉契約之研究─以財產歸屬與拒絕交易為中心，國立清華大學科技法律研究所碩士論文，2009年7月。

第二節 英文部分

第一項 專書
1.BRIAN G. BRUNSVOLD et al., DRAFTING PATENT LICENSE AGREEMENTS (7th ed. 2012).
2.DAN L. BURK AND MARK A. LEMLEY, THE PATENT CRISIS AND HOW THE COURTS CAN SOLVE IT (2009).
3.CARLOS CORREA, INTEGRATING PUBLIC HEALTH CONCERNS INTO PATENT LEGISLATION IN DEVELOPING COUNTRIES (2000).
4.ANTHONY GIDDENS, CAPITALISM AND MODERN SOCIAL THEORY: AN ANALYSIS OF THE WRITINGS (1971).
5.BERNALD R. GLICK et al., MOLECULAR BIOTECHNOLOGY : PRINCIPLES AND APPLICATION OF RECOMBINATION DNA (4th ed. 2010).
6.PHILIP W. GRUBB AND PETER R. THOMSEN, PATENTS FOR CHEMICALS, PHARMACEUTICALS, AND BIOTECHNOLOGY: FUNDAMENTALS OF GLOBAL LAW, PRACTICE AND STRATEGY (5th ed. 2010).
7.IRINA HARACOGLOU, COMPETITION LAW AND PATENTS A FOLLOW-ON INNOVATION PERSPECTIVE IN THE BIOPHARMACEUTICAL INDUSTRY (Edward Elgar ed. 2008).
8.ROBERT L. HARMON et al., PATENTS AND THE FEDERAL CIRCUITS (10th ed. 2011).
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