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題名 論製藥產業之實驗實施免責
The Experimental Use Exemption of Pharmaceutical Industry
作者 張睿麟
Chang, Jui Lin
貢獻者 馮震宇
Fong, Jerry G.
張睿麟
Chang, Jui Lin
關鍵詞 實驗實施免責
研究免責
藥價競爭與專利期限回覆法案藥價競爭與專利期限回復法案
研究例外
學名藥
Hatch-Waxman法案
Experimental Use Exemption
Research Exemption
Drug Price Competition and Patent Term Restoration Act
Research Exception
Generic Drug
Hatch-Waxman Act
日期 2007
上傳時間 17-Sep-2009 14:18:11 (UTC+8)
摘要 隨著醫療科技的進展，人類對於疾病的成因、機轉、病程、及治療，在不斷地研究突破下，有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品，正是人類對抗疾病最關鍵、也最普遍的方式之一，對公共衛生的重要性自不待言。

其中，由於生命科學的本質使然，開發新的藥品對於研究發展的倚賴，遠勝於其他產業，因此，創新研發藥廠對於開發一項新藥的平均投資，已達十三億美元之譜；此外，由於藥物對人體的生理功能、體內恆定能造成極大的影響，因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制，使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間，使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而，因為智慧財產之保護，也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一，亦為世界各國所大力推動。在推動學名藥產業上，實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究，美國普通法上以及成文法上實驗實施免責的探討，我國實驗實施免責之規定與判決之研究，來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題，以及相對應的可能改進方案。

本文第二章本章先行探討製藥產業之特質；第三章討論美國普通法上實驗實施免責之概念，並歸結出美國普通法上實驗實施免責的三項適用要件；第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響；第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定，並由學者論述以及相關判決中，探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題，並提出可能之解決方案。
With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt.

Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems.

The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.
參考文獻 一、 中文
（一） 專書
1. 姜保健，《一粒藥丸的故事》，瀛舟出版社，2003年12月。
2. 郭壽康、韋貴紅，藥品專利與發展中國家公共健康問題，《專利法研究2004》，知識產權出版社，2005 年。
3. 曾陳明汝，兩岸暨歐美專利法，學林文化，2004年，128頁。
4. 楊崇森，專利法理論與應用，三民書局，2003年7月。
5. 經濟部智慧財產局，專利法逐條釋義，2002年，135頁。
（二） 期刊論文
1. 石凱元，專利侵權之試驗免責—由美國Merck KGaA v. Integra Lifescience Inc.案例看我國藥事法四十條之二修正案，萬國法律，第143期，2005年10月。
2. 石凱元，專利權效力所不及—關於專利法第57調修正草案，萬國法律，第149期，2006年10月。
3. 朱美虹，專利侵權之實驗免責及其影響—以美國Merck KGaA v. Integra Lifescience Inc.為例（上），萬國法律，第142期，2005年8月。
4. 李崇僖，專利法上實驗免責之研究，智慧財產權月刊75期，民國94年3月。
5. 李鎂，解讀專利法第57條—兼論台灣嘉義地方法院90年易字第82號判決，智慧財產權，第49期，91年10月。
6. 林于令、侯春岑，新藥與學名藥的戰爭—淺談Hatch-Waxman法案及其最新修正，萬國法律，第136期，2004年8月。
7. 周惠菁，生技製藥產業涉及專利法及競爭法之爭議問題研究，國立政治大學法律學系碩士論文，民國94年，24頁。
8. 洪聖濠，以Canada-Patent Protection of Pharmaceutical Product 案為例分析TRIPS第三十條例外條款的解釋趨向，科技法律透析，2005 年4 月。
9. 孫小萍，我國專利法及藥事法上試驗例外之研究，政大智慧財產評論，第三卷第二期，2005年10月。
10. 黃慧嫺，歐洲國家製藥產業試驗免責之適用範圍分析，科技法律透析2005年2月。
11. 黃慧嫺，簡介美國學名藥競爭規範及新近鼓勵學名藥近用之措施，技術尖兵，民國93年3月第111期。
12. 黃慧嫺，論製藥產業研發活動試驗免責之適用—以美國法院之相關判決見解演進為例，科技法律透析，2006年1月。
13. 黃文鴻、謝季峰，藥品創新與專利保護關連之探討，政大智慧財產評論，第2卷第2期。
14. 鄧曉芳，日本學名藥發展現況及相關法律爭議簡介，科技法律透析，2003年10月。
15. 鄭師安，從新近判決看我國實驗實施例外法規於藥品領域之適用，科技法律透析，2006年4月。
（三） 學位論文
1. 王世晞，製藥產業之演進、現況與趨勢，國立台灣大學商學研究所，92年度碩士論文。
2. 邱凱迪，WTO與貿易有關之智慧財產權協定與公共健康之研究－以醫藥專利問題為中心，東吳大學法律研究所，92學年度碩士論文。
3. 梁明輝，製藥產業之競合模式初探－以兩岸為例，國立台灣大學工業工程研究所，91學年度碩士論文。
4. 梁錦釧，資料專屬權對國內醫藥產業之影響，世新大學法律研究所，94學年度碩士論文。
5. 蘇建智，藥品查驗登記制度與智慧財產權保護，私立東吳大學法律研究所碩士論文。
（四） 網站資料
1. http://bbsc.imb.sinica.edu.tw/biotech/13_15.pdf, last visited on May 19, 2008.
2. 經濟部智慧財產局，專利侵害鑑定基準，第二章第二節，http://www.tipo.gov.tw/patent/patent_law/criterion/patent_law_4_1_2.asp last visited on June 2, 2008
（五） 產業報告
1. 生物技術開發中心，醫藥產業年鑑2007，民國97年。
2. 行政院經濟建設委員會，挑戰2008:國家發展重點計畫，2005年1月31日。
（六） 新聞
1. 美國學名藥廠老闆，返台大創業，民國九十三年五月十四日，工商時報，第十四版，謝柏宏報導。
二、 英文
（一） 專書
1. Black’s Law Dictionary 619 (8th ed. 2004).
2. PISANO, GARY P., TECHNOLOGICAL INNOVATION AND ECONOMIC PERFORMANCE (Benn Steil et al. eds., 2000).
(二) 期刊論文
1. Brignati, Michael J., Ph.D., Access to the Safe Harbor: Bioterrorism, Influenza, and the Supreme Court’s Interpretation of the Research Exemption from Patent Infringement, 13 J. Intell. Prop. L. 375 (2006).
2. Brooks, et al., Integrin αvβ3 Antagonists Promote Tumor Regression by Inducing Apoptosis of Angiogenic Blood Vessels, 79 Cell 1157, December, 1994; Brooks, Clark, and Cheresh Requirement of Vascular Integrin αvβ3 for Angiogenesis, 264 Science 569, April (1994).
3. Caltrider, Steven P. & Davis, Paula, The Experimental Use Defense: Post-Madey v. Duke and Integra LifeSciences I Ltd. V. Merck KGaA, 86 J. Pat. & Trademark Off. Soc’y 1011 (2004).
4. Castellano, Richard A., Patent Law for New Medical Uses of Known Compounds and Pfizer’s Viagra Patent, 46 IDEA 283 (2006).
5. Cai, Michelle, Madey v. Duke University: Shattering the Myth of Universities’ Experimental Use Defense, 19 Berkeley Tech. L.J. 175 (2004).
6. Coggio, Brian D. & Cerrito, F. Dominic, The Safe Harbor Provision of the Hatch-Waxman Act: Present Scope, New Possibilities, and International Considerations, 57 Food & Drug L.J. 161 (2002).
7. DeFranco, Denise W. & Levy, Carla Miriam & Pogach, Miriam L., The Experimental Use Exemption: Looking Towards a Legislative Alternative, 6 J. High Tech. L. 93（2006）.
8. Derzko, Natalie M., A Local and Comparative Analysis of the Experimental use exemption－Is Harmonization Appropriate?, 44 IDEA 1 (2003).
9. Engelberg, Alfred B., Special Patient Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, 39 J. L. & Tech 393 (1999).
10. Eisenberg, Rebecca S., Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989).
11. Eisenberg, Rebecca S., supra note 44, at 1019；Michael R. Taylor & Jerry Cayford, American Patent Policy, Biotechnology, and African Agriculture: The Case for Policy Change, 17 Harv. J.L. & Tech. 321, 360 (2004); Paul Devinsky & Mark G. Davis, 2003 Patent Law Secisions of the Federal Circuit, 53 Am. U. L. Rev. 773 (2004).
12. Eidson, B. Scott, How Safe is the Harbor? Considering the Economic Implications of Patent Infringement in Section 241(e)(1) Analysis, 82 Wash. U. L.Q. 1169 (2004).
13. Ebert, Lawrence B., In Favor of The Federal Circuit Position in Merck v. Integra, 87 J. Pat. & Trademark Off. Soc`y 321 (2005).
14. Friel, Thomas J., Jr. & Nitta, Chad T., Patent Infringment: The 35 U.S.C. § 271(E)(1) Safe Harbor Exemption, 34-AUG Colo. Law. 103, (2005).
15. Grabowski, Henry, Patents, Innovation, and Access to New Pharmaceuticals, 5(4) Journal of International Economic Law 849 (2002).
16. Jackson, Benjamin G., Merck v. Integra: Bailing Water without Plugging the Hole, 20 BYU J. Pub. L. 579, 580（2006）
17. Kochi N. et al, Immunohistochemical study of fibronectin in human glioma and meningioma., Acta Neuropathologica. 59(2):119-26 (1983).
18. Kunin, Stephen G. & Therkorn, Linda S., Workshop on Future Public Policy and Ethical Issues Facing the Biotechnology Industry: Patent Issues Likely to Directly Affect The Development Of The Agricultural and Microbial Biotech Industry Over The Next Five Years, 86 J. Pat. & Trademark Off. Soc`y 501 (2005).
19. Ruoslahti E., Fibronectin and its integrin receptors in cancer., Advances in Cancer Research. 76:1-20 (1999).
20. Lawrence B. Ebert, The Impact of World War I on Present Day Patent Issues, Intellectual Property Today, February, 35 (2005).
21. Lawrence B. Ebert, Intellectual Property at the Supreme Court and Before Congress, Intellectual Property Today, April, 10 (2005).
22. Ladd, Alison, Integra v. Merck: Effects on the Cost and Innovation of New Drug Products, 13 J.L. & Pol`y 311 (2005).
23. Mireles, Michael S., An Examination of Patents, Licensing, Research Tools and the Tragedy of the Anticommons in Biotechnology Innovations, 38 U. Mich. J. L. Reform 141 (2003).
24. Mossinghoff, Gerald J., Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process, 54 Food & Drug L. J. 187 (1999).
25. Migliorini, Robert A., The Narrowed Experimental Use Exemption to Patent Infringement and Its Application to Patented Computer Software, 10 Computer L. Rev. & Tech. J. 135 (2006).
26. Mueller, Janice M., The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development, 56 Baylor L. Rev. 917, (2004).
27. Miller, Jennifer, Sealing the Coffin on the Experimental use exemption, 2003 Duke L. & Tech. Rev. 12, 18（2003）.
28. McPherson, Jonathan, The Impact of the Hatch-Waxman Act`s Safe Harbor Provision on Biomedical Research Tools after Merck Kgaa v. Integra Lifesciences I, Ltd., 10 Mich. St. J. Med. & Law 369, (2006).
29. Noud, Thomas P. & Meiklejohn, Paul T., The Developing Law Of Pharmaceutical Patent Enforcement, 88 J. Pat. & Trademark Off. Soc`y 437 (2006).
30. Omer, Assad, Access to Medicines: Transfer of Technology and Capacity Building, 20 WIS. INTL. L. J. 551 (2002).
31. O`Connor, Daniel J. & Valoir, Tamsen, The Supreme Court Tilts Toward Drug Developers After Merck v. Integra, 5 Chicago-Kent Journal of Intellectual Property 124 (2006).
32. Owens, Jennifer L., Not Quite Dead Yet: The Near Fatal Wounding of Experimental use exemption and Its Impact on Public Universities, 3 J. Telecomm. & High Tech. L. 453（2003）.
33. Pedchenko V., Alpha(v)beta3 and alpha(v)beta5 integrins bind both the proximal RGD site and non-RGD motifs within noncollagenous (NC1) domain of the alpha3 chain of type IV collagen: implication for the mechanism of endothelia cell adhesion., Journal of Biological Chemistry. 279(4):2772-80, 2004 Jan 23.
34. Restaino, Leslie Gladstone & Rumore, Martha, Safe Harbor or Unchartered Seas?; Integra v. Merck Currents, 14 New Jersey Lawyer A5 (2005).
35. Robinson, William, The Law of Patents for Useful Inventions §898 (1890), quoted in Janice M. Mueller, No “Dilettante Affair”: Rethinking the Experimental use exemption to Patent Infringement for Biomedical Research Tools, 76 WASH. L. REV. 1 (2001).
36. Ruess, Peter, Accepting Exceptions?: A Comparative Approach to Experimental Use in U.S. and German Patent Law, 10 Marq. Intell. Prop. L. Rev. 81, 89（2006）.
37. Stanburg, Katherine J., What Does the Public Get?Experimental Use and the Patent Bargain, Wis. L. Rev. 81 (2004).
38. Experimental use exemptionSewell, David G., Rescuing Sciecnce from the Courts:An Appeal to Amending the Patent Code to Protect Academic Research in the Wake of Madey vs. Duke University, 93 Geo. L.J. 759, 763 (2005).Experimental use exemption
39. Sahu, Pradip K. & Mrksich, K. Shannon, The Hatch-Waxman Act: When Is Research Exempt from Patent Infringement?, 22 NO. 4 Intell. Prop. L. Newsl. 23 (2004).
40. Experimental use exemptionStandburg, Katherine J., What Does the Public Get? Experimental Use and the Patent Bargain, 2004 Wis. L. Rev. 81 (2004).
41. Soehnge, Holly, The Drug Price Competition and Patent Term Restoration Act of 1984: Fine-Tuning the Balance between the Interests of Pioneer and Generic Drug Manufactureres, 58 Food Drug L.J. 51 (2003).
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(三) 產業報告
1. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008).
2. Pharmaceutical Research and Manufacturers of America, Drug Discovery and Development—Understanding the R & D Process, 1-9 (Washington, DC: PhRMA, 2008).
3. World Health Organization and World Trade Organization Secretariats, WTO Agreement and Public Health, (Geneva, WTO, 2002).
(四) 網站資料
1. Gregory J. Glover, Competition in the Pharmaceutical Marketplace, http://www.ftc.gov/opp/intellect/020319gregoryjglover.pdf (last reviewed: May 20, 2008), at 3.
2. The New York Times, Court Invalidates a Patent That Pfizer Holds for Lipitor, http://www.nytimes.com/2006/08/03/business/03drug.html?ex=1168750800&en=6fa7fd234907530d&ei=5070 (last reviewd: May 14th, 2008).
3. National Institute of Health, Report of the National Institutes of Health (NIH) Working Group on Research Tools, http://www.nih.gov/news/researchtools/index.htm#analys (last reviewed: May 13th, 2008).
4. http://www.fda.gov/cder/handbook/preclin.htm (last reviewed: June 27, 2008).
5. http://www.abpi.org.uk/Details.asp?ProductID=323 (last reviewed: June 27, 2008).
6. http://www.fda.gov/CDER/REGULATORY/applications/nda.htm, (last reviewed: June 27, 2008).
描述 碩士
國立政治大學
法律科際整合研究所
94652008
96
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0946520081
資料類型 thesis
dc.contributor.advisor 馮震宇zh_TW
dc.contributor.advisor Fong, Jerry G.en_US
dc.contributor.author (Authors) 張睿麟zh_TW
dc.contributor.author (Authors) Chang, Jui Linen_US
dc.creator (作者) 張睿麟zh_TW
dc.creator (作者) Chang, Jui Linen_US
dc.date (日期) 2007en_US
dc.date.accessioned 17-Sep-2009 14:18:11 (UTC+8)-
dc.date.available 17-Sep-2009 14:18:11 (UTC+8)-
dc.date.issued (上傳時間) 17-Sep-2009 14:18:11 (UTC+8)-
dc.identifier (Other Identifiers) G0946520081en_US
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/32739-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 法律科際整合研究所zh_TW
dc.description (描述) 94652008zh_TW
dc.description (描述) 96zh_TW
dc.description.abstract (摘要) 隨著醫療科技的進展，人類對於疾病的成因、機轉、病程、及治療，在不斷地研究突破下，有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品，正是人類對抗疾病最關鍵、也最普遍的方式之一，對公共衛生的重要性自不待言。

其中，由於生命科學的本質使然，開發新的藥品對於研究發展的倚賴，遠勝於其他產業，因此，創新研發藥廠對於開發一項新藥的平均投資，已達十三億美元之譜；此外，由於藥物對人體的生理功能、體內恆定能造成極大的影響，因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制，使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間，使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而，因為智慧財產之保護，也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一，亦為世界各國所大力推動。在推動學名藥產業上，實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究，美國普通法上以及成文法上實驗實施免責的探討，我國實驗實施免責之規定與判決之研究，來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題，以及相對應的可能改進方案。

本文第二章本章先行探討製藥產業之特質；第三章討論美國普通法上實驗實施免責之概念，並歸結出美國普通法上實驗實施免責的三項適用要件；第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響；第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定，並由學者論述以及相關判決中，探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題，並提出可能之解決方案。		zh_TW
dc.description.abstract (摘要) With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt.

Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems.

The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.		en_US
dc.description.tableofcontents 第一章 導論
第一節 研究動機與研究目的 1
第二節 研究方法與研究範圍 2
第一項 研究範圍 2
第二項 研究方法 3
第三節 本文架構 3
第二章 藥品開發、專利保護、與製藥產業
第一節 製藥產業之特質 6
第一項 跨領域而複雜的產業分工與結構 6
第二項 嚴格的產品上市審核與醫療衛生法規之管理 7
第三項 高度仰賴研發之產業 7
第四項 產品開發期長、研發成本高、產業風險大、投資報酬優 9
第二節 專利藥之開發、審核與上市流程 10
第一項 發現階段 11
第一款 發現前階段－瞭解疾病 11
第二款 標的鑑別—選擇藥物影響的標的分子 11
第三款 標的確認—測試標的物並確認其於疾病中之角色 11
第四款 藥物發現—找出有可能製成藥物的「領先化合物」 12
第五款 早期安全性測試—對於有潛力的化合物進行初步測試 12
第六款 領先化合物最佳化（Lead Optimization）—改變化性結構以增進特性 12
第七款 臨床前測試—實驗室以及動物試驗來決定藥物對於人體試驗之安全性 13
第二項 發展階段（The Development Process） 13
第一款 測試新藥申請（Investigational New Drug, IND）—聯邦食品暨藥物管理局及機構審查委員會審核安全性 13
第二款 第一期臨床試驗（Phase 1 Clinical Trial）—針對小群健康志願者之初步人體試驗 14
第三款 第二期臨床試驗（Phase 2 Clinical Trial）—針對小群罹病志願者之人體試驗 14
第四款 第三期臨床試驗（Phase 3 Clinical Trial）—對大群體的病人測試安全性及有效性 15
第五款 新藥申請（New Drug Application, NDA）以及許可—申請聯邦食品暨藥物管理局的許可 15
第六款 生產製造 15
第七款 第四期臨床試驗以及後續研究 16
第三節 學名藥之審核、上市流程 16
第一項 在1984年Hatch-Waxman Act之前的學名藥上市程序 16
第二項 在1984年Hatch-Waxman Act之後的學名藥上市程序 16
第四節 專利保護對製藥產業的重要性 18
第五節 結語 19
第三章 美國普通 法上之實驗實施免責
第一節 普通法上之實驗實施免責的源起 20
第一項 Whittemore v. Cutter案 21
第 二 項 Sawin v. Guild 案 22
第二節 普 通法上實驗實施免責之發展 22
第一項 Poppenhusen v. New York Gutta Percha Comb Co.案 23
第二項 Poppenhusen v. Falke案 23
第三項 Ruth v. Stearns-Roger Manufacturing Co.案 24
第四項 Pitcarin v. United States案 25
第五項 Deuterium Corp. v. United States案 26
第六項 Embrex Inc. v. Service Engineering Corp.案 26
第七項 Madey v. Duke University案 27
第八項 小結 30
第三節 普通法上實驗實施免責之適用判斷原則 30
第四節 結語 32
第四章 美國成文法上關於藥品發明之實驗實施免責
第一節 成文法制定緣起－ROCHE PRODUCTS, INC. V. BOLAR PHARMACEUTICAL CO.案 33
第一項 本案事實 33
第二項 法律爭點 33
第三項 法院見解 34
第四項 小結 35
第二節 藥品價格競爭與專利有效期回復法案（THE HATCH-WAXMAN ACT） 36
第一項 專利藥專利期限之回復與安全港條款 36
第二項 由判決解析安全港條款之適用範圍 38
第一款 安全港條款所涵蓋的專利種類 38
第一目 Eli Lilly & Co. v. Medtronic, Inc.案 38
第二目 Infigen, Inc. v. Advanced Cell Technology, Inc.案 40
第三目 Chartex International PLC v. M.D. Personal Products Corp.案 40
第四目 AbTox, Inc. v. Exitron Corporation案 40
第五目 Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc.案 41
第六目 小結 42
第二款 安全港條款所涵蓋的專利實施 42
第一目 Scripps Clinic & Research Found. v. Genentech, Inc. 案 42
第二目 Intermedics, Inc. v. Ventritex, Inc.案 42
第三目 Amgen, Inc. v. Hoechst Marion Roussel, Inc.案 43
第四目 小結 43
第三節 安全港條款適用之最新進展－INTEGRA LIFE SCIENCES, LTD. V. MERCK KGAA 44
第一項 Integra LifeSciences, Ltd. v. Merck KGaA案之背景 44
第二項 美國聯邦上訴法院判決-對避風港條款範圍之限縮性解釋 46
第三項 美國聯邦最高法院判決-對避風港條款之擴張性解釋 46
第四項 聯邦最高法院於Integra v. Merck 案之判決對生物醫學產業的影響 48
第一款 關於研究工具（research tool）的議題 48
第二款 對於基礎科學研究（Basic Scientific Research）之影響 49
第三款 對於先端研發機構的影響 50
第四款 對於大藥廠（Large Pharmaceutical Company）之影響 50
第四節 結語 51
第五章 TRIPS規範以及我國法之實驗實施免責
第一節 國際公約下之實驗實施免責—貿易有關之智慧財產權協定第三十條 52
第一項 貿易有關之智慧財產權協定第三十條之內容與解析 52
第二項 加拿大醫藥品專利保護案（Canada Patent Protection of Pharmaceutical Product）. 52
第一款 本案事實 53
第二款 爭端解決小組之見解 53
第二節 我國實驗實施免責之相關規定 54
第一項 專利法第五十七條第一項第一款之實驗實施免責規定 55
第一款 沿革 55
第二款 我國專利法上實驗實施免責規定適用法律要件之解析 55
第一目 「為研究、教學或試驗」 56
第二目 「無營利行為」 58
第三目 以受專利保護之發明本身為試驗標的 59
第二項 藥事法第四十條之二第五項之學名藥實驗實施免責規定 59
第一款 緣起 59
第二款 我國藥事法上學名藥實驗實施免責規定適用法律要件之解析 60
第一目 「新藥」專利權 60
第二目 「藥商」 60
第三目 「申請查驗登記前」 61
第四目 「研究、教學或試驗」 61
第三項 我國製藥領域實驗實施免責相關判決解析 62
第一款 台北地方法院93年度智字第77號判決 62
第一目 本案事實 62
第二目 本案爭點 62
第三目 法院見解 63
第四目 解析 64
第二款 台灣高等法院94年上字第26號判決 64
第三款 台灣最高法院96年台上字第1710號判決 65
第一目 背景 65
第二目 法院見解 65
第三目 解析 66
第三節 結語...........................................................66
第六章 結論
第一節 研究發現 67
第一項 專利保護對於製藥產業之必要性 67
第二項 以實驗實施免責鼓勵學名藥產業，為公眾健康上之必要 67
第三項 美國普通法上實驗實施免責無學名藥產業之適用 68
第四項 美國成文法上藥品實驗實施免責範圍界定寬鬆，頗引疑慮 69
第五項 TRIPS容許學名藥實驗實施免責，然一般性免責尚未明確 70
第六項 我國專利法與藥事法實驗實施免責範圍過窄，不利醫藥產業發展 71
第二節 建議 71
第一項 刪除專利法第五十七條第一項第一款「無營利行為」要件 71
第二項 明確界定並放寬藥事法上實驗實施免責之適用範圍 72
第三項 醫藥實驗實施免責應回歸專利法 73
第四項 研究工具之使用納入實驗實施免責之範疇是否合宜，值得進一步探討 74
參考文獻 75
附錄一 81
附錄二 82		zh_TW
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dc.language.iso en_US-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0946520081en_US
dc.subject (關鍵詞) 實驗實施免責zh_TW
dc.subject (關鍵詞) 研究免責zh_TW
dc.subject (關鍵詞) 藥價競爭與專利期限回覆法案藥價競爭與專利期限回復法案zh_TW
dc.subject (關鍵詞) 研究例外zh_TW
dc.subject (關鍵詞) 學名藥zh_TW
dc.subject (關鍵詞) Hatch-Waxman法案zh_TW
dc.subject (關鍵詞) Experimental Use Exemptionen_US
dc.subject (關鍵詞) Research Exemptionen_US
dc.subject (關鍵詞) Drug Price Competition and Patent Term Restoration Acten_US
dc.subject (關鍵詞) Research Exceptionen_US
dc.subject (關鍵詞) Generic Drugen_US
dc.subject (關鍵詞) Hatch-Waxman Acten_US
dc.title (題名) 論製藥產業之實驗實施免責zh_TW
dc.title (題名) The Experimental Use Exemption of Pharmaceutical Industryen_US
dc.type (資料類型) thesisen
dc.relation.reference (參考文獻) 一、 中文zh_TW
dc.relation.reference (參考文獻) （一） 專書zh_TW
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dc.relation.reference (參考文獻) （三） 學位論文zh_TW
dc.relation.reference (參考文獻) 1. 王世晞，製藥產業之演進、現況與趨勢，國立台灣大學商學研究所，92年度碩士論文。zh_TW
dc.relation.reference (參考文獻) 2. 邱凱迪，WTO與貿易有關之智慧財產權協定與公共健康之研究－以醫藥專利問題為中心，東吳大學法律研究所，92學年度碩士論文。zh_TW
dc.relation.reference (參考文獻) 3. 梁明輝，製藥產業之競合模式初探－以兩岸為例，國立台灣大學工業工程研究所，91學年度碩士論文。zh_TW
dc.relation.reference (參考文獻) 4. 梁錦釧，資料專屬權對國內醫藥產業之影響，世新大學法律研究所，94學年度碩士論文。zh_TW
dc.relation.reference (參考文獻) 5. 蘇建智，藥品查驗登記制度與智慧財產權保護，私立東吳大學法律研究所碩士論文。zh_TW
dc.relation.reference (參考文獻) （四） 網站資料zh_TW
dc.relation.reference (參考文獻) 1. http://bbsc.imb.sinica.edu.tw/biotech/13_15.pdf, last visited on May 19, 2008.zh_TW
dc.relation.reference (參考文獻) 2. 經濟部智慧財產局，專利侵害鑑定基準，第二章第二節，http://www.tipo.gov.tw/patent/patent_law/criterion/patent_law_4_1_2.asp last visited on June 2, 2008zh_TW
dc.relation.reference (參考文獻) （五） 產業報告zh_TW
dc.relation.reference (參考文獻) 1. 生物技術開發中心，醫藥產業年鑑2007，民國97年。zh_TW
dc.relation.reference (參考文獻) 2. 行政院經濟建設委員會，挑戰2008:國家發展重點計畫，2005年1月31日。zh_TW
dc.relation.reference (參考文獻) （六） 新聞zh_TW
dc.relation.reference (參考文獻) 1. 美國學名藥廠老闆，返台大創業，民國九十三年五月十四日，工商時報，第十四版，謝柏宏報導。zh_TW
dc.relation.reference (參考文獻) 二、 英文zh_TW
dc.relation.reference (參考文獻) （一） 專書zh_TW
dc.relation.reference (參考文獻) 1. Black’s Law Dictionary 619 (8th ed. 2004).zh_TW
dc.relation.reference (參考文獻) 2. PISANO, GARY P., TECHNOLOGICAL INNOVATION AND ECONOMIC PERFORMANCE (Benn Steil et al. eds., 2000).zh_TW
dc.relation.reference (參考文獻) (二) 期刊論文zh_TW
dc.relation.reference (參考文獻) 1. Brignati, Michael J., Ph.D., Access to the Safe Harbor: Bioterrorism, Influenza, and the Supreme Court’s Interpretation of the Research Exemption from Patent Infringement, 13 J. Intell. Prop. L. 375 (2006).zh_TW
dc.relation.reference (參考文獻) 2. Brooks, et al., Integrin αvβ3 Antagonists Promote Tumor Regression by Inducing Apoptosis of Angiogenic Blood Vessels, 79 Cell 1157, December, 1994; Brooks, Clark, and Cheresh Requirement of Vascular Integrin αvβ3 for Angiogenesis, 264 Science 569, April (1994).zh_TW
dc.relation.reference (參考文獻) 3. Caltrider, Steven P. & Davis, Paula, The Experimental Use Defense: Post-Madey v. Duke and Integra LifeSciences I Ltd. V. Merck KGaA, 86 J. Pat. & Trademark Off. Soc’y 1011 (2004).zh_TW
dc.relation.reference (參考文獻) 4. Castellano, Richard A., Patent Law for New Medical Uses of Known Compounds and Pfizer’s Viagra Patent, 46 IDEA 283 (2006).zh_TW
dc.relation.reference (參考文獻) 5. Cai, Michelle, Madey v. Duke University: Shattering the Myth of Universities’ Experimental Use Defense, 19 Berkeley Tech. L.J. 175 (2004).zh_TW
dc.relation.reference (參考文獻) 6. Coggio, Brian D. & Cerrito, F. Dominic, The Safe Harbor Provision of the Hatch-Waxman Act: Present Scope, New Possibilities, and International Considerations, 57 Food & Drug L.J. 161 (2002).zh_TW
dc.relation.reference (參考文獻) 7. DeFranco, Denise W. & Levy, Carla Miriam & Pogach, Miriam L., The Experimental Use Exemption: Looking Towards a Legislative Alternative, 6 J. High Tech. L. 93（2006）.zh_TW
dc.relation.reference (參考文獻) 8. Derzko, Natalie M., A Local and Comparative Analysis of the Experimental use exemption－Is Harmonization Appropriate?, 44 IDEA 1 (2003).zh_TW
dc.relation.reference (參考文獻) 9. Engelberg, Alfred B., Special Patient Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, 39 J. L. & Tech 393 (1999).zh_TW
dc.relation.reference (參考文獻) 10. Eisenberg, Rebecca S., Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989).zh_TW
dc.relation.reference (參考文獻) 11. Eisenberg, Rebecca S., supra note 44, at 1019；Michael R. Taylor & Jerry Cayford, American Patent Policy, Biotechnology, and African Agriculture: The Case for Policy Change, 17 Harv. J.L. & Tech. 321, 360 (2004); Paul Devinsky & Mark G. Davis, 2003 Patent Law Secisions of the Federal Circuit, 53 Am. U. L. Rev. 773 (2004).zh_TW
dc.relation.reference (參考文獻) 12. Eidson, B. Scott, How Safe is the Harbor? Considering the Economic Implications of Patent Infringement in Section 241(e)(1) Analysis, 82 Wash. U. L.Q. 1169 (2004).zh_TW
dc.relation.reference (參考文獻) 13. Ebert, Lawrence B., In Favor of The Federal Circuit Position in Merck v. Integra, 87 J. Pat. & Trademark Off. Soc`y 321 (2005).zh_TW
dc.relation.reference (參考文獻) 14. Friel, Thomas J., Jr. & Nitta, Chad T., Patent Infringment: The 35 U.S.C. § 271(E)(1) Safe Harbor Exemption, 34-AUG Colo. Law. 103, (2005).zh_TW
dc.relation.reference (參考文獻) 15. Grabowski, Henry, Patents, Innovation, and Access to New Pharmaceuticals, 5(4) Journal of International Economic Law 849 (2002).zh_TW
dc.relation.reference (參考文獻) 16. Jackson, Benjamin G., Merck v. Integra: Bailing Water without Plugging the Hole, 20 BYU J. Pub. L. 579, 580（2006）zh_TW
dc.relation.reference (參考文獻) 17. Kochi N. et al, Immunohistochemical study of fibronectin in human glioma and meningioma., Acta Neuropathologica. 59(2):119-26 (1983).zh_TW
dc.relation.reference (參考文獻) 18. Kunin, Stephen G. & Therkorn, Linda S., Workshop on Future Public Policy and Ethical Issues Facing the Biotechnology Industry: Patent Issues Likely to Directly Affect The Development Of The Agricultural and Microbial Biotech Industry Over The Next Five Years, 86 J. Pat. & Trademark Off. Soc`y 501 (2005).zh_TW
dc.relation.reference (參考文獻) 19. Ruoslahti E., Fibronectin and its integrin receptors in cancer., Advances in Cancer Research. 76:1-20 (1999).zh_TW
dc.relation.reference (參考文獻) 20. Lawrence B. Ebert, The Impact of World War I on Present Day Patent Issues, Intellectual Property Today, February, 35 (2005).zh_TW
dc.relation.reference (參考文獻) 21. Lawrence B. Ebert, Intellectual Property at the Supreme Court and Before Congress, Intellectual Property Today, April, 10 (2005).zh_TW
dc.relation.reference (參考文獻) 22. Ladd, Alison, Integra v. Merck: Effects on the Cost and Innovation of New Drug Products, 13 J.L. & Pol`y 311 (2005).zh_TW
dc.relation.reference (參考文獻) 23. Mireles, Michael S., An Examination of Patents, Licensing, Research Tools and the Tragedy of the Anticommons in Biotechnology Innovations, 38 U. Mich. J. L. Reform 141 (2003).zh_TW
dc.relation.reference (參考文獻) 24. Mossinghoff, Gerald J., Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process, 54 Food & Drug L. J. 187 (1999).zh_TW
dc.relation.reference (參考文獻) 25. Migliorini, Robert A., The Narrowed Experimental Use Exemption to Patent Infringement and Its Application to Patented Computer Software, 10 Computer L. Rev. & Tech. J. 135 (2006).zh_TW
dc.relation.reference (參考文獻) 26. Mueller, Janice M., The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development, 56 Baylor L. Rev. 917, (2004).zh_TW
dc.relation.reference (參考文獻) 27. Miller, Jennifer, Sealing the Coffin on the Experimental use exemption, 2003 Duke L. & Tech. Rev. 12, 18（2003）.zh_TW
dc.relation.reference (參考文獻) 28. McPherson, Jonathan, The Impact of the Hatch-Waxman Act`s Safe Harbor Provision on Biomedical Research Tools after Merck Kgaa v. Integra Lifesciences I, Ltd., 10 Mich. St. J. Med. & Law 369, (2006).zh_TW
dc.relation.reference (參考文獻) 29. Noud, Thomas P. & Meiklejohn, Paul T., The Developing Law Of Pharmaceutical Patent Enforcement, 88 J. Pat. & Trademark Off. Soc`y 437 (2006).zh_TW
dc.relation.reference (參考文獻) 30. Omer, Assad, Access to Medicines: Transfer of Technology and Capacity Building, 20 WIS. INTL. L. J. 551 (2002).zh_TW
dc.relation.reference (參考文獻) 31. O`Connor, Daniel J. & Valoir, Tamsen, The Supreme Court Tilts Toward Drug Developers After Merck v. Integra, 5 Chicago-Kent Journal of Intellectual Property 124 (2006).zh_TW
dc.relation.reference (參考文獻) 32. Owens, Jennifer L., Not Quite Dead Yet: The Near Fatal Wounding of Experimental use exemption and Its Impact on Public Universities, 3 J. Telecomm. & High Tech. L. 453（2003）.zh_TW
dc.relation.reference (參考文獻) 33. Pedchenko V., Alpha(v)beta3 and alpha(v)beta5 integrins bind both the proximal RGD site and non-RGD motifs within noncollagenous (NC1) domain of the alpha3 chain of type IV collagen: implication for the mechanism of endothelia cell adhesion., Journal of Biological Chemistry. 279(4):2772-80, 2004 Jan 23.zh_TW
dc.relation.reference (參考文獻) 34. Restaino, Leslie Gladstone & Rumore, Martha, Safe Harbor or Unchartered Seas?; Integra v. Merck Currents, 14 New Jersey Lawyer A5 (2005).zh_TW
dc.relation.reference (參考文獻) 35. Robinson, William, The Law of Patents for Useful Inventions §898 (1890), quoted in Janice M. Mueller, No “Dilettante Affair”: Rethinking the Experimental use exemption to Patent Infringement for Biomedical Research Tools, 76 WASH. L. REV. 1 (2001).zh_TW
dc.relation.reference (參考文獻) 36. Ruess, Peter, Accepting Exceptions?: A Comparative Approach to Experimental Use in U.S. and German Patent Law, 10 Marq. Intell. Prop. L. Rev. 81, 89（2006）.zh_TW
dc.relation.reference (參考文獻) 37. Stanburg, Katherine J., What Does the Public Get?Experimental Use and the Patent Bargain, Wis. L. Rev. 81 (2004).zh_TW
dc.relation.reference (參考文獻) 38. Experimental use exemptionSewell, David G., Rescuing Sciecnce from the Courts:An Appeal to Amending the Patent Code to Protect Academic Research in the Wake of Madey vs. Duke University, 93 Geo. L.J. 759, 763 (2005).Experimental use exemptionzh_TW
dc.relation.reference (參考文獻) 39. Sahu, Pradip K. & Mrksich, K. Shannon, The Hatch-Waxman Act: When Is Research Exempt from Patent Infringement?, 22 NO. 4 Intell. Prop. L. Newsl. 23 (2004).zh_TW
dc.relation.reference (參考文獻) 40. Experimental use exemptionStandburg, Katherine J., What Does the Public Get? Experimental Use and the Patent Bargain, 2004 Wis. L. Rev. 81 (2004).zh_TW
dc.relation.reference (參考文獻) 41. Soehnge, Holly, The Drug Price Competition and Patent Term Restoration Act of 1984: Fine-Tuning the Balance between the Interests of Pioneer and Generic Drug Manufactureres, 58 Food Drug L.J. 51 (2003).zh_TW
dc.relation.reference (參考文獻) 42. Steffe, Eric K. & Shea, Timothy J., Jr., Drug Discovery Tools and the Clinical Research Exemption from Patent Infringement, 22 Biotechnology L. Rep. 369 (2003).zh_TW
dc.relation.reference (參考文獻) 43. Stuart, Tara, Has the Supreme Court Incorrectly Expanded §271(e)(1) to Risk a Regulatory Taking?, 5 J. MARSHALL REV. INTELL. PROP. L. 216 (2006).zh_TW
dc.relation.reference (參考文獻) 44. Shannon KE., Anti-metastatic properties of RGD-peptidomimetic agents S137 and S247., Clinical & Experimental Metastasis. 21(2):129-38, 2004.zh_TW
dc.relation.reference (參考文獻) 45. Weiswasser, Elizabeth Stotland & Danzis, Scott D., The Hatch-Waxman Act: History, Structure, and Legacy, 71 Antitrust L.J. 585 (2003).zh_TW
dc.relation.reference (參考文獻) 46. Wegner, Harold C., Post-Merck Experimental Use and the “Safe Harbor,” 15 Fed. Circuit B.J. 12 (2005).zh_TW
dc.relation.reference (參考文獻) 47. Yoho, Sarah M., Reformation of the Hatch-Waxman Act, an Unnecessary Resolution, 27 Nova L. Rev. 527 (2003).zh_TW
dc.relation.reference (參考文獻) (三) 產業報告zh_TW
dc.relation.reference (參考文獻) 1. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008).zh_TW
dc.relation.reference (參考文獻) 2. Pharmaceutical Research and Manufacturers of America, Drug Discovery and Development—Understanding the R & D Process, 1-9 (Washington, DC: PhRMA, 2008).zh_TW
dc.relation.reference (參考文獻) 3. World Health Organization and World Trade Organization Secretariats, WTO Agreement and Public Health, (Geneva, WTO, 2002).zh_TW
dc.relation.reference (參考文獻) (四) 網站資料zh_TW
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dc.relation.reference (參考文獻) 2. The New York Times, Court Invalidates a Patent That Pfizer Holds for Lipitor, http://www.nytimes.com/2006/08/03/business/03drug.html?ex=1168750800&en=6fa7fd234907530d&ei=5070 (last reviewd: May 14th, 2008).zh_TW
dc.relation.reference (參考文獻) 3. National Institute of Health, Report of the National Institutes of Health (NIH) Working Group on Research Tools, http://www.nih.gov/news/researchtools/index.htm#analys (last reviewed: May 13th, 2008).zh_TW
dc.relation.reference (參考文獻) 4. http://www.fda.gov/cder/handbook/preclin.htm (last reviewed: June 27, 2008).zh_TW
dc.relation.reference (參考文獻) 5. http://www.abpi.org.uk/Details.asp?ProductID=323 (last reviewed: June 27, 2008).zh_TW
dc.relation.reference (參考文獻) 6. http://www.fda.gov/CDER/REGULATORY/applications/nda.htm, (last reviewed: June 27, 2008).zh_TW