生技製藥產業屬於技術密集工業，研發投資高，若研發成果被抄襲，將使投入資金付諸流水，故專利權保護可謂生技製藥產業命脈。在台灣有許多生技專利判決因揭露不充分而不予專利，惟我國法在充分揭露性發展歷程短，判決案例累積不多，不如美國發展成熟。故本研究探討美國生物技術專利充分揭露性發展脈絡，比較台灣與美國專利法以及判決，深入探討後給予建議。並目標整理不同生物技術專利，包含分子生物學衍生技術，如重組DNA、反義RNA，藉由基因調控產生蛋白質及其類似物、抗體、疫苗等，針對不同技術整理申請專利常見之核駁理由及法院無效之理由。
就美國專利法及美國判決研究方面，美國專利法為一成文法，美國判決見解屬於判例法(case law)，本研究整理美國與生物揭露要件有關重要判決，了解美國專利法第112條第一項對於生技專利充分揭露要求演進的脈絡，以及對生技製藥專利的影響。本研究將聚焦於「書面描述要件」與「可實施性要件」兩者。而在我國專利法及台灣判決研究方面，著重在台灣實務對生物技術專利揭露要求的探討，以專利法第26條第1項、第2項為核心延伸至審查基準及因生物技術申請專利而生的訴訟，整理出我國對生物技術專利的充分揭露要求。
我國判決研究以「發明專利」、「生物」為關鍵詞人工檢索自民國92年至今(民國106年/01)行政法院、最高行政法院、智慧財產法院生物技術專利與充分揭露有關判決，以該系爭專利有同時申請美國與我國專利的判決為優先研究目標，除此之外選擇於美國與我國都有訴訟之生物技術，以該技術所生之判決，觀察我國在生物技術專利對充份揭露要求判準的演進以及與美國實務的異同。
根據本研究比較，我國與美國專利法發展脈絡不同，我國專利法說明書的可據以實現要件與請求項界定申請專利範圍分別規範在專利法第26條第1項與第2項。美國早期無請求項只有說明書，故早期美國說明書除了可據以實現的功能之外尚扮演著界定申請專利範圍的角色，書面說明要求即是因此而發展。我國的說明書可據以實現的功能與美國可據以實現要件相似為不刊之論，而我國專利法是否包含美國專利法書面說明要求，我國學者有許多不同看法。本研究就探討我國專利審查基準、我國法院判決後，認我國說明書應明確且充分揭露與請求項需為說明書所支持皆有隱含書面說明要求意涵。美國與我國在專利法揭露要件上法制設計不同，有若干重疊，亦有些微差距。於判準，我國法院判準與美國法院判準有許多不同，在某些判準的認定較為嚴格，如：我國對過度實驗要求較嚴格，建議申請時提供詳細實驗參數，發明涉及生物材料時，提供寄存等，於我國申請專利時應特別注意。

Biotechnology industry is a technology-intensive industry and R & D investment is high in this field. If the R & D results were copied, the fund would go down the drain. Therefore, the patent protection can be described as the lifeblood of the biotechnology industry. In Taiwan, many biotechnology patents were rejected due to the lack of full, clear and sufficient disclosure. The development process of Taiwanese paten law is shorter than the U.S., the accumulated relevant judgments are not as many as the U.S. This thesis studies the development history of the U.S. biotechnology disclosure requirements, comparing Taiwanese Patent Act and judgments with the U.S. Patent Act and judgments, and gives some advices. The biotechnological patents categories of the research include technologies derived from molecular biology such as recombinant DNA, antisense RNA technology, gene regulation technology, analogues of proteins, and antibodies, etc. This thesis aims to sort out the information of rejection reasons for the application of patent and the reasons for the patent invalidity decision made by the court.
In the study of the U.S. Patent Act and American judgment research, the U.S. Patent Act is a statutory law, the United States judgments is case law. This thesis sorts out the U.S. important judgments in respect of biotechnology Patent disclosure requirements, to understand evolution of the first paragraph of the U.S. Patent Act Article 112, which regulates disclosure requirements, and how the disclosure requirements impact of biotechnology patent. This thesis focuses on both "written description requirement" and "enablement requirement." In the study of Taiwanese Patent Act and judgments, the thesis focuses on actual situation field. This thesis sorts out Taiwanese important judgments in respect of biotechnology patent disclosure requirements, Patent Act Article 26 and Taiwanese Examination Guidelines.
According to this thesis, the developments of the U.S. and Taiwanese Patent Act are different. The provisions of Taiwanese Patent Act in respect to disclosure requirements describe in the Patent Act Article 26 first and second paragraph. In the early days, The U.S. patent specifications only had a description without claims. The functions of description not only made inventions “enablement” but also defined the scope of application, thus led to the development of “written description.” The provisions of Taiwanese and U.S. Patent Act in respect to “enablement” are similar. But Taiwanese scholars have many different views about whether Taiwanese Patent Act has connotation about “written description.” After the study on the Taiwanese Patent Act, Examination Guidelines on patent, and the verdicts, the viewpoint of this thesis is that Taiwanese Patent Act article 26 Article first and second paragraph both have connotation about “written description”.
Some Taiwanese and U.S. provisions in respect to disclosure requirements are similar and some are various. There are many differences between the judgments of the Taiwanese and U.S. courts, in some cases, this thesis considers certain judgments of Taiwanese courts are more stringent than judgments of U.S. courts. For example, because the criteria for requirements of excessive experimentation is more stringent in Taiwan, it is suggested that detailed experimental parameters should be provided, and it is better to provide storage when the invention relates to biological materials.

一、中文文獻
專書
中華民國專利審查基準103年修正版本
中華民國專利審查基準106年修正版本
林洲富(2014)。《專利法:案例式》，五南圖書出版股份有限公司。
楊崇森(2008)。《專利法理論與應用》，三民出版社。
經濟部智慧財產局(2014)。《專利法逐條釋義》，經濟部智慧財產局。
鄭中人（2002）。《專利法逐條釋論》，五南出版社。
期刊論文
王偉霖(2011)。〈美國專利訴訟書面說明要求之研究─兼論對我國專利審查及訴訟之啟示研究成果報告(精簡版) 〉，《行政院國家科學委員會專題研究計畫成果報告》，頁1-20。
何建志(2004)。〈生物技術專利之最適範圍---產業政策與法律分析〉，《臺大法學論叢》，33期5卷，頁153-214。
周围(2014)。〈生物医药领域专利申请权利要求延展及其常见问题分析中国医药生物技术〉，《法学评论》，9期6卷，頁480-483。
陳文吟(2008)。〈由美國實務經驗探討基礎科學專利對生物科技的影響〉，《臺北大學法學論叢》，67期，頁115-173。
智財局(2004)。〈新專利法答客問〉，《智慧財產月刊》，66期，頁79。
鄭中人（2005）。〈專利說明書記載不明確之法律效果－評最高行政法院九十一年度判字第二四二二號判決〉，《月旦法學雜誌》，126期，頁218-228。
鄭中人（2006）。〈發明與充分揭露及可實施性之混淆－評最高行政法院94年度判字第01632號〉，《全國律師》，10卷12期，頁27-39。
學位論文
尹重君(2002)。《美國專利法揭露充分性要件之研究》。國立交通大學科技法律研究所學位論文。
郭仲偉(2005)。《生技醫藥相關發明之專利要件探討-以美國與我國為例》。國立政治大學法律學碩士班學士後法學組學位論文。
蘇仁濬(2011)。《專利法揭露要求之研究》。臺灣大學科際整合法律學研究所學位論文。
網路資源
經濟部生技醫藥產業發展推動小組. 生物技術產業單一窗口. 2017 6/3 2017 [cited 2017 6/3].
世界衛生組織. [4/30] 2017; Available from: http://www.who.int/en/.
葉雲卿(2014)。<專利說明書的揭露要求—以生物科技專利為例>，《北美月刊》，111期。
中文判決
88年智專(五)01076字第138741號專利核駁審定書。
92年智專三(四)01102字第09220493780號再審查核駁理由先行通知書。
93年智專三(四)0110 2字第09320105960號再審查核駁審定書。
智慧財產法院98年行專更(一)第6號判決。
智慧財產法院99年行專訴字第57號判決。
台北高等行政法院93年度訴字第2348號判決。
台北高等行政法院94訴字第3828號判決。
台北高等行政法院95年訴字第3963號判決。
台北高等行政法院95年訴字第4319號判決。
最高行政法院96年度判字第1745號判決。
智慧財產法院97年行專訴字第78號判決。
智慧財產法院100年行專訴字第95號判決。
智慧財產法院101年行專訴字第42號判決。
二、外文文獻
專書及期刊
2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, para. 1, “Written Description” Requirement [R-07.2015].
2164 The Enablement Requirement [R-11.2013]
Biotechnology Patent & Business Strategies, 718 PLI/PAT. 155, 164 (2002).
Cantor, A.E., Using the Written Description and Enablement Requirements to Limit Biotechnology Patents. Harv. JL & Tech., 2000. 14: p. 267.
Donner, I.H., Patent prosecution: law, practice, and procedure. 2007: BNA Books.
Grubb Philip, W., Patents for Chemicals, Pharmaceuticals and Biotechnology. Oxford. DECISIÓN DIAMOND V. CHAKRABARTY, 1999. 447: p. 79-136.
Infectious clones of RNA viruses and vaccines and diagnostic assays derived thereof.
Lodish, H., Molecular cell biology. 2008: Macmillan.
Rachel Krevans, Current Issues in Biotech Patent Litigation, Biotechnology Law
Sampson, M., The evolution of the enablement and written description requirements under 35 USC § 112 in the area of biotechnology. Berkeley Technology Law Journal, 2000: p. 1233-1274.
Stolpa, J.C., Toward Aligning the Law with Biology-The Federal Circuit's about Face in Enzo Biochem, Inc. v. Gen-Probe, Inc. Minn. Intell. Prop. Rev., 2002. 4: p. i.
Upadhaya, S.A., The Postmodern Written Description Requirement: An Analysis of the Application of the Heightened Written Description Requirement to Original Claims. Minn. Intell. Prop. Rev., 2002. 4: p. i.
外文判決
AbbVie Deutschland GmbH v. Janssen Biotech, Inc. . 759 F.3d 1285 (Fed. Cir. 2014).
Amgen , Inc. v. Chugai Pharmaceutical Co. 927 F. 2d 1200 ,（Fed. Cir. 1991）
Centocor Ortho Biotech, Inc. v. Abbott Laboratories. 636 F.3d 1341 ,(Fed Cir.2011).
Enzo Biochem Inc.v. GenProbe Inc. 323 F.3d 956, 960 (Fed. Cir. 2002).
ENZO BIOCHEM, INC., Plaintiff-Appellant, v. CALGENE, INC., Defendant-Cross Appellant. 188 F.3d 1362 (Fed. Cir. 1999).
Fiers v. Revel. 984 F.2d 1164, 25 U.S.P.Q.2d (BNA) 1601(Fed. Cir. 1993).
In re Argoudelis. 434 F 2d.(CCPA. 1970).
In re Barker. 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977)
In re Bell. 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993).
In re Deuel. 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995).
In re Gay. 309 F.2d 769, 772 (C.C.P.A. 1962).
In re Lukach. 442 F.2d 967, 169 USPQ 795 (CCPA 1971).
In re Oda. 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).
In Re Robert Goodman, Vic C. Knauf, Catherine M. Houch and Luca Comai. 11 F.3d 1046 (Fed. Cir. 1993).
In re Ruschig. 379 F.2d at 996.
In re Vaeck. 947 F.2d 488 (Fed. Cir. 1911).
In re Wands. 858 F.2d 731 (Fed. Cir. 1988).
In re Wright. 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989).
Pitney Bowers Inc. v. Hewlett-Packard Co. 182 F.3d 1298, 1305 (Fed. Cir 1999).
Regents of the University of California v. Eli Lilly. 119 F.3d 1559, 43 USPQ2d 1398 (Fed Cir 1997).
Tronzo v. Biomet, Inc. 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998).
Univ. of Rochester v. G.D. Searle & Co. 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
Vas-Cath. 935 F.2d at 1563, 19 USPQ2d at 1116