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1 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 75

2 ( 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. last visited on May 19, 經濟部智慧財產局, 專利侵害鑑定基準, 第二章第二節, _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 (8 th 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 76

3 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 (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 (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): (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. 77

4 & 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): , 2004 Jan Restaino, Leslie Gladstone & Rumore, Martha, Safe Harbor or 78

5 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, 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 79

6 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, (last reviewed: May 20, 2008), at The New York Times, Court Invalidates a Patent That Pfizer Holds for Lipitor, 800&en=6fa7fd d&ei=5070 (last reviewd: May 14 th, 2008). 3. National Institute of Health, Report of the National Institutes of Health (NIH) Working Group on Research Tools, (last reviewed: May 13 th, 2008) (last reviewed: June 27, 2008) (last reviewed: June 27, 2008) (last reviewed: June 27, 2008). 80

公平交易法損害賠償制度之功能與詮釋

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