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    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。
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    (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。
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    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。
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    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。
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    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。
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    (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).
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    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).
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    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:[法律與科技整合研究所] 學位論文

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