政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/32739
English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  Items with full text/Total items : 113318/144297 (79%)
Visitors : 51032847      Online Users : 917
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
Scope Tips:
  • please add "double quotation mark" for query phrases to get precise results
  • please goto advance search for comprehansive author search
    •  Adv. Search
    Home ‧ Login ‧ Upload ‧ Help ‧ About ‧ Administer Goto mobile version


    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/32739


    Title: 論製藥產業之實驗實施免責
    The Experimental Use Exemption of Pharmaceutical Industry
    Authors: 張睿麟
    Chang, Jui Lin
    Contributors: 馮震宇
    Fong, Jerry G.
    張睿麟
    Chang, Jui Lin
    Keywords: 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
    Date: 2007
    Issue Date: 2009-09-17 14:18:11 (UTC+8)
    Abstract: 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.
    Reference: 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).
    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).
    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).
    44. Shannon KE., Anti-metastatic properties of RGD-peptidomimetic agents S137 and S247., Clinical & Experimental Metastasis. 21(2):129-38, 2004.
    45. Weiswasser, Elizabeth Stotland & Danzis, Scott D., The Hatch-Waxman Act: History, Structure, and Legacy, 71 Antitrust L.J. 585 (2003).
    46. Wegner, Harold C., Post-Merck Experimental Use and the “Safe Harbor,” 15 Fed. Circuit B.J. 12 (2005).
    47. Yoho, Sarah M., Reformation of the Hatch-Waxman Act, an Unnecessary Resolution, 27 Nova L. Rev. 527 (2003).
    (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).
    Description: 碩士
    國立政治大學
    法律科際整合研究所
    94652008
    96
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0946520081
    Data Type: thesis
    Appears in Collections:[Graduate Institute of Law and Interdisciplinary Studies] Theses

    Files in This Item:

    File Description SizeFormat
    008101.pdf61KbAdobe PDF21633View/Open
    008102.pdf144KbAdobe PDF22051View/Open
    008103.pdf143KbAdobe PDF21368View/Open
    008104.pdf127KbAdobe PDF22108View/Open
    008105.pdf230KbAdobe PDF21804View/Open
    008106.pdf356KbAdobe PDF212929View/Open
    008107.pdf283KbAdobe PDF22712View/Open
    008108.pdf287KbAdobe PDF23492View/Open
    008109.pdf302KbAdobe PDF22991View/Open
    008110.pdf214KbAdobe PDF21670View/Open
    008111.pdf154KbAdobe PDF22416View/Open
    008112.pdf123KbAdobe PDF21620View/Open


    All items in 政大典藏 are protected by copyright, with all rights reserved.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏，無償提供學術研究與公眾教育等公益性使用，惟仍請適度，合理使用本網站之內容，以尊重著作權人之權益。商業上之利用，則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作，已盡力防止侵害著作權人之權益，如仍發現本網站之數位內容有侵害著作權人權益情事者，請權利人通知本網站維護人員(nccur@nccu.edu.tw)，維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - Feedback