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題名 我國藥品專利權期間延長制再探討
Re-discussion on the pharmaceutical patent term extension system作者 江庭誼
Chiang, Ting-Yi貢獻者 王文杰
江庭誼
Chiang, Ting-Yi關鍵詞 藥品專利權期間延長制度
藥品專利保護
學名藥
專利策略
Pharmaceutical patent term extension system
Pharmaceutical patent protection
Generic drugs
Patent strategy日期 2014 上傳時間 2-Sep-2020 12:24:58 (UTC+8) 摘要 專利制度對於醫藥產業的作用有目共睹，有十分積極地作用。但藥品專利權過度保護產生了諸多弊端，對於藥品專利權的適度平衡成為必然。平衡制度中的藥品專利權期間延長制度，亦為重要的一環。藥品專利權延長制度主要為鼓勵專利藥的研發。但由於專利藥的高昂價格和產能制約等原因，學名藥的存在具有重要的意義。無專利藥，則藥廠無研發新藥動力；無學名藥，則公民生命權和健康權無法得到良好的保障。因此藥品專利權延長制度的設計中對雙方權利的平衡至關重要。世界各國對於藥品專利權延長制度大多有詳細之規定。美國規定有「藥價競爭與專利權期間回復法案」（Drug Price Competition and Patent Term Restoration Act）；歐盟規定有歐盟藥品補充保護證書制度(SPC， Supplementary Protection Certificate)；日本和我國亦對於藥品專利權延長制度有詳細規定。我國於西元1994年制訂最初版本之藥品專利權制度，並未妥善考慮對於國內產業之保護，在實踐操作過程中，亦為學者和實務界所詬病，現行修正的專利法，仍尚存在著較有利於專利權人之不合宜情形。比較我國制度與他國制度，本文認為，應以我國產業實際出發，對於學名藥廠給予更多的保護和扶植。在「第一次許可證之取得」的定義、專利權延長期間之核定，以及在專利權延長期間之計算上，我國現行制度尚可因應我國產業發展之現實而進行改進。因此，依我國的產業發展現況，本文建議，在「第一次許可證之取得」的認定上，不應給予多個許可證的選擇，應限縮第一次許可證之認定範圍，只判斷有效成分，減低第一次許可證選擇機會。在專利權延長期間之核定上，有兩個選擇，如果不分國內或國外之無法實施之臨床試驗期間全部納入計算，應採美國之作法為試驗期間之1/2計算，如果不納入國外試驗期間計算無法實施專利之期間，則可全額納入在國內臨床試驗期間作計算。最後，在專利權延長期間之計算上，如無限制上市後之獨佔期間，恐放寬了獨佔時間，應加註上市後至專利到期日止不可超過14年。
The role of the patent system for the pharmaceutical industry is obvious to all, and it has a very positive effect. However, the excessive protection of drug patent rights has produced many drawbacks, and a proper balance of drug patent rights has become inevitable. The extension of the drug patent right period in the balance system is also an important part.The main purpose of the drug patent extension system is to encourage the research and development of patented drugs. However, due to the high price of patented drugs and production capacity constraints, the existence of generic drugs is of great significance. Without patented drugs, pharmaceutical companies have no incentive to develop new drugs; without generic drugs, citizens’ right to life and health cannot be well protected. Therefore, the design of the drug patent right extension system is very important to the balance of the rights of both parties. Most countries in the world have detailed regulations on the extension of patent rights for medicines. The United States provides for the "Drug Price Competition and Patent Term Restoration Act" the European Union provides for the EU Supplementary Protection Certificate (SPC); Japan and Taiwan also have drug patent rights extension system has detailed regulations.Taiwan formulated the initial version of the drug patent system in 1994, and did not properly consider the protection of the domestic industry. In the course of practice, it was also criticized by scholars and practitioners. The current revised patent law still has relatively high unsuitable circumstances that are beneficial to the patentee. Comparing Taiwan`s system with other countries` systems, this article believes that we should start from the reality of Taiwan`s industry and give more protection and support to scientific-name pharmaceutical factories. In terms of the definition of "first license acquisition", the verification of the patent right extension period, and the calculation of the patent right extension period, Taiwan`s current system can still be improved in accordance with the reality of Taiwan`s industrial development.Therefore, according to the current state of Taiwan’s industrial development, this article suggests that in determining the "first license acquisition", multiple license options should not be given, and the scope of the first license should be limited and only judged active ingredients, reducing the chance of first license selection. There are two options for the approval of the patent extension period. If all the clinical trial periods that cannot be implemented in domestic or foreign countries are included in the calculation, the US method should be adopted as the half of the trial period. The period during which the patent cannot be implemented during the external trial period can be fully included in the domestic clinical trial period for calculation. Finally, in the calculation of the extension of the patent right period, if the exclusive period after the unrestricted listing, the exclusive period may be relaxed, it should be noted that the period from the listing to the expiration date of the patent should not exceed 14 years.參考文獻 參考文獻一、中文資料（一）書籍1. 李鑫煒，（2000）。《體系、變革與全球化進程》。中國社會科學出版社。2. 林彩瑜，（2009）。《貿易與公共衛生之法律問題 - 世界貿易組織法律研究（二）》。3. 曾陳明汝，（2004）。《兩岸暨歐美專利法》。學林文化總經銷。4. 楊崇森，（2003）。《專利法理論與應用》。三民書局股份有限公司。5. 羅昌發，（1997）。《GATT/WTO 與我國貿易》。永然文化。（二）期刊論文1. 吳玉和，熊延峰，（2008）。《中美兩國有關Bolar例外的理論與實踐》。中國專利與商標，第三期。2. 李森堙，（2001）。《巴西與Roche專利藥價之爭以降價40%收場》。科技法律透析，第13 卷第10 期。3. 林彩瑜，（2004）。《WTO TRIPS 協定下醫藥專利與公共健康之問題及其解決方向》。政大法學評論，第七十八期。4. 林聖富，（1996）。《專利資訊與專利檢索》。智慧財產權管理季刊，第十期。5. 倪貴榮，（2003）。《WTO 知識產權保護與公共健康議題之發展趨勢》。經社法制論叢，第三十一期。6. 唐曉帆，（2005）。《歐盟藥品補充保護證書 (SPC) 制度簡介》。電子智慧財產權，第十期。7. 徐揮彥，（2003）。《與貿易有關之知識產權協議下有關藥品專利與健康權問題之研究》。貿易調查專刊，第九期。8. 陳文吟，（2002）。《探討因應醫藥品專利之合理措施》。國立中正大學法學集刊，第八期。9. 陳嘉宏，2007。《2006 年台灣各產業景氣趨勢調查報告》。西藥製藥產業。10. 單偉光，沈錫明，孫國君，（2009）。《「Bolar 例外」的由來及對我國仿製藥企業的影響》。新西部：理論版，第十六期。11. 賀德芬，2003。《保護科技類知識產權之經驗交流計畫》。智慧財產與國家發展。12. 遊宏樞，（2004）。《保護競爭的兩難-談「資料專屬權」（Data Exclusivity）》。藥業市場。13. 蔡明誠，2004年11月3日。《國際專利調和趨勢對我國專利制度之影響》。專利法制發展學術研討會，經濟部知識產權主辦，臺灣大學法律學院科技、倫理與法律研究中心執行。14. 謝銘洋，（1995）。《專利進口權與平行輸入》。月旦法學雜誌，第二期。（三）碩博士學位論文1. 王崇豪（2002）。《WTO 體系下我國政府治理模式調適之研究》，台大政治學研究所碩士論文，台北。2. 謝季峰（2004）。《WTO 知識產權規範與藥品可近性的研究---探討藥品專利保護政策與公共衛生的平衡點》，陽明大學衛生福利研究所碩士論文，台北。3. 陳翠華（2006）。《我國醫藥專利權期間延長制度之探討》，私立世新大學法律學研究所碩士，台北。（四）網際網絡1. 曾念國，<製藥產業技術研發動向系列 - 2004美國製藥產業研發資金投入概況>，ITIS智網，2005年3月25日報導，http://www.itis.org.tw。2. 賴瓊雅，<老藥新開拓藥物開發新捷徑，生技醫藥產業評析>，ITIS智網，2014年2月12日報導，http://www.itis.org.tw。二、外文資料（一）專書論文1. Adelman M J, Rader R R, Thomas J R, (2009). Cases and materials on patent law.2. Australia, (2004). Law Reform Commission. Genes and ingenuity: report: gene patenting and human health, Virago Press.3. Correa C M, (2001). Trends in drug patenting: case studies, Corregidor.4. De Carvalho N P, (2010). The TRIPS regime of patent rights, Kluwer law international.5. Federal Trade Commission, Innovation T P, (2003). The Proper Balance of Competition and Patent Law and Policy, Federal Trade Commission, Washington.6. Fromm-Russenschuck V, Duggal R, (2004). WTO und TRIPs: unmittelbare Auswirkungen auf die Rechtspraxis, Wolters Kluwer Deutschland.7. Hensen S, Brewster A, Asher J, et al, (2006). The Effects of Patenting AAAS in the Scientific Community, American Association for the Advancement of Science.8. Kraßer R, Bernhardt W, (2004). Patentrecht: ein Lehr-und Handbuch zum deutschen Patent-und Gebrauchsmusterrecht, europäischen und internationalen Patentrecht, CH Beck.9. Kühnen T, (2008). Patentgesetz mit Europäischem Patentübereinkommen: Kommentar auf der Grundlage der deutschen und europäischen Rechtsprechung, Carl Heymann.10. Niioka H, (2003). Klinische Versuche im Patentrecht: eine rechtsvergleichende Untersuchung des europäischen US-amerikanischen und japanischen Patentschutzes von pharmazeutischen Erfindungen, Heymann.11. Weisbrot D, Opeskin B, Finlay A, (2004). Gene Patenting and Human Health.（二）期刊1. Adamini S, Maarse H, Versluis E, et al, (2009). Policy making on data exclusivity in the European Union: From industrial interests to legal realities, Journal of Health Politics, Policy and Law, 34(6): 979-1010.2. Chambers S A, (1994). Exhaustion Doctrine in Biotechnology, Idea, 35: 289.3. De Larena L R, (2005). What Copyright Teaches Patent Law About" Fair Use" and Why Universities Are Ignoring the Lesson, Or. L. Rev., 84: 779-1227.4. Eisenberg R S, (1987). Proprietary rights and the norms of science in biotechnology research. Yale Law Journal, 177-231.5. Heller M A, Eisenberg R S, (1998). Can patents deter innovation? The anticommons in biomedical research, Science, 280 (5364): 698-701.6. Henning-Bodewig F, (2001). Harmonisierung und Globalisierung//Geistiges Eigentum im Dienst der Innovation, Nomos, 125-139.7. Kingham R F, Castle G H, (2000). Data and marketing exclusivity for pharmaceuticals in the European community, Food & Drug LJ, 55: 209.8. Kur A, (2005). The TRIPS agreement ten years later-A conference commemorating the 10th anniversary of the TRIPS agreement. IIC-international review of intellectual property and competition law, 36(5): 558-562.9. Lemley M A, (1996). Economics of Improvement in Intellectual Property Law, Tex. L. Rev., 75: 989.10. Macek T, Mackova M, Káš J, (2000). Exploitation of plants for the removal of organics in environmental remediation. Biotechnology advances, 18(1): 23-34.11. Ohana G, Hansen M, Shah O, (2003). Disclosure and Negotiation of Licensing Terms Prior to Adoption of Industry Standards: Preventing Another Patent Ambush?, European Competition Law Review, 24(12): 644-656.12. Reichman J H, Franklin J A, (1999). Privately legislated intellectual property rights: Reconciling freedom of contract with public good uses of information. University of Pennsylvania Law Review, 875-970.13. Rott P W. TRIPS-Abkommen, Menschenrechte, Sozialpolitik und Entwicklungslände, (2003). Gewerblicher Rechtsschutz und Urheberrecht, Internationaler Teil, 103-118.（三）判例1. Amgen, lnc. v. International Trade Commission, (2008). 519 F.3d 1343.2. Elan. Transdermal Ltd. v. Cygnus Therapeutics Systems, (1992). 24 U.S.P.Q. 2d 1926.3. Intermedics, lnc., v. Ventritex, lnc., (1993). 991 F.2d 808.4. Integra Lifescience v. Merck KGaA., (2005). 125 S.Ct.2372.5. Roche Products v. Bolar Pharm. Co., (1984). 753 F.2d 858. 描述 碩士
國立政治大學
法學院碩士在職專班
99961033資料來源 http://thesis.lib.nccu.edu.tw/record/#G0099961033 資料類型 thesis dc.contributor.advisor 王文杰 zh_TW dc.contributor.author (Authors) 江庭誼 zh_TW dc.contributor.author (Authors) Chiang, Ting-Yi en_US dc.creator (作者) 江庭誼 zh_TW dc.creator (作者) Chiang, Ting-Yi en_US dc.date (日期) 2014 en_US dc.date.accessioned 2-Sep-2020 12:24:58 (UTC+8) - dc.date.available 2-Sep-2020 12:24:58 (UTC+8) - dc.date.issued (上傳時間) 2-Sep-2020 12:24:58 (UTC+8) - dc.identifier (Other Identifiers) G0099961033 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/131680 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法學院碩士在職專班 zh_TW dc.description (描述) 99961033 zh_TW dc.description.abstract (摘要) 專利制度對於醫藥產業的作用有目共睹，有十分積極地作用。但藥品專利權過度保護產生了諸多弊端，對於藥品專利權的適度平衡成為必然。平衡制度中的藥品專利權期間延長制度，亦為重要的一環。藥品專利權延長制度主要為鼓勵專利藥的研發。但由於專利藥的高昂價格和產能制約等原因，學名藥的存在具有重要的意義。無專利藥，則藥廠無研發新藥動力；無學名藥，則公民生命權和健康權無法得到良好的保障。因此藥品專利權延長制度的設計中對雙方權利的平衡至關重要。世界各國對於藥品專利權延長制度大多有詳細之規定。美國規定有「藥價競爭與專利權期間回復法案」（Drug Price Competition and Patent Term Restoration Act）；歐盟規定有歐盟藥品補充保護證書制度(SPC， Supplementary Protection Certificate)；日本和我國亦對於藥品專利權延長制度有詳細規定。我國於西元1994年制訂最初版本之藥品專利權制度，並未妥善考慮對於國內產業之保護，在實踐操作過程中，亦為學者和實務界所詬病，現行修正的專利法，仍尚存在著較有利於專利權人之不合宜情形。比較我國制度與他國制度，本文認為，應以我國產業實際出發，對於學名藥廠給予更多的保護和扶植。在「第一次許可證之取得」的定義、專利權延長期間之核定，以及在專利權延長期間之計算上，我國現行制度尚可因應我國產業發展之現實而進行改進。因此，依我國的產業發展現況，本文建議，在「第一次許可證之取得」的認定上，不應給予多個許可證的選擇，應限縮第一次許可證之認定範圍，只判斷有效成分，減低第一次許可證選擇機會。在專利權延長期間之核定上，有兩個選擇，如果不分國內或國外之無法實施之臨床試驗期間全部納入計算，應採美國之作法為試驗期間之1/2計算，如果不納入國外試驗期間計算無法實施專利之期間，則可全額納入在國內臨床試驗期間作計算。最後，在專利權延長期間之計算上，如無限制上市後之獨佔期間，恐放寬了獨佔時間，應加註上市後至專利到期日止不可超過14年。 zh_TW dc.description.abstract (摘要) The role of the patent system for the pharmaceutical industry is obvious to all, and it has a very positive effect. However, the excessive protection of drug patent rights has produced many drawbacks, and a proper balance of drug patent rights has become inevitable. The extension of the drug patent right period in the balance system is also an important part.The main purpose of the drug patent extension system is to encourage the research and development of patented drugs. However, due to the high price of patented drugs and production capacity constraints, the existence of generic drugs is of great significance. Without patented drugs, pharmaceutical companies have no incentive to develop new drugs; without generic drugs, citizens’ right to life and health cannot be well protected. Therefore, the design of the drug patent right extension system is very important to the balance of the rights of both parties. Most countries in the world have detailed regulations on the extension of patent rights for medicines. The United States provides for the "Drug Price Competition and Patent Term Restoration Act" the European Union provides for the EU Supplementary Protection Certificate (SPC); Japan and Taiwan also have drug patent rights extension system has detailed regulations.Taiwan formulated the initial version of the drug patent system in 1994, and did not properly consider the protection of the domestic industry. In the course of practice, it was also criticized by scholars and practitioners. The current revised patent law still has relatively high unsuitable circumstances that are beneficial to the patentee. Comparing Taiwan`s system with other countries` systems, this article believes that we should start from the reality of Taiwan`s industry and give more protection and support to scientific-name pharmaceutical factories. In terms of the definition of "first license acquisition", the verification of the patent right extension period, and the calculation of the patent right extension period, Taiwan`s current system can still be improved in accordance with the reality of Taiwan`s industrial development.Therefore, according to the current state of Taiwan’s industrial development, this article suggests that in determining the "first license acquisition", multiple license options should not be given, and the scope of the first license should be limited and only judged active ingredients, reducing the chance of first license selection. There are two options for the approval of the patent extension period. If all the clinical trial periods that cannot be implemented in domestic or foreign countries are included in the calculation, the US method should be adopted as the half of the trial period. The period during which the patent cannot be implemented during the external trial period can be fully included in the domestic clinical trial period for calculation. Finally, in the calculation of the extension of the patent right period, if the exclusive period after the unrestricted listing, the exclusive period may be relaxed, it should be noted that the period from the listing to the expiration date of the patent should not exceed 14 years. en_US dc.description.tableofcontents 目 次第一章 緒論 1第一節 研究動機 1第二節 研究方法與研究範圍 3第三節 論文章節架構 4第二章 製藥產業中的專利法律規範 5第一節 藥品專利權保護之相關法律規範 5第二節 藥品專利權限制之相關法律規範 13第三節 藥品專利權過度保護之弊端 19第四節 藥品專利權適度限制之合理性與正當性 29第三章 專利藥與學名藥法律保護之衝突 37第一節 名詞定義 37第二節 新藥與學名藥之間的關係 38第三節 製藥產業中的法律保護衝突 40第四章 各國藥品專利權期間延長制度之比較 49第一節 美國藥品專利權期間延長制度 49第二節 歐洲藥品專利權期間延長制度 57第三節 日本藥品專利權期間延長制度 66第四節 我國藥品專利權期間延長制度 71第五節 各國藥品專利權期間延長制度之比較 76第五章 我國制度下製藥產商專利策略探討 81第一節 藥品研發中的智慧財產權 81第二節 專利藥廠之專利策略 83第三節 學名藥藥商之專利策略 91第六章 結論與建議 98第一節 結論 98第二節 思考與建議 99參考文獻 102 zh_TW dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0099961033 en_US dc.subject (關鍵詞) 藥品專利權期間延長制度 zh_TW dc.subject (關鍵詞) 藥品專利保護 zh_TW dc.subject (關鍵詞) 學名藥 zh_TW dc.subject (關鍵詞) 專利策略 zh_TW dc.subject (關鍵詞) Pharmaceutical patent term extension system en_US dc.subject (關鍵詞) Pharmaceutical patent protection en_US dc.subject (關鍵詞) Generic drugs en_US dc.subject (關鍵詞) Patent strategy en_US dc.title (題名) 我國藥品專利權期間延長制再探討 zh_TW dc.title (題名) Re-discussion on the pharmaceutical patent term extension system en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 參考文獻一、中文資料（一）書籍1. 李鑫煒，（2000）。《體系、變革與全球化進程》。中國社會科學出版社。2. 林彩瑜，（2009）。《貿易與公共衛生之法律問題 - 世界貿易組織法律研究（二）》。3. 曾陳明汝，（2004）。《兩岸暨歐美專利法》。學林文化總經銷。4. 楊崇森，（2003）。《專利法理論與應用》。三民書局股份有限公司。5. 羅昌發，（1997）。《GATT/WTO 與我國貿易》。永然文化。（二）期刊論文1. 吳玉和，熊延峰，（2008）。《中美兩國有關Bolar例外的理論與實踐》。中國專利與商標，第三期。2. 李森堙，（2001）。《巴西與Roche專利藥價之爭以降價40%收場》。科技法律透析，第13 卷第10 期。3. 林彩瑜，（2004）。《WTO TRIPS 協定下醫藥專利與公共健康之問題及其解決方向》。政大法學評論，第七十八期。4. 林聖富，（1996）。《專利資訊與專利檢索》。智慧財產權管理季刊，第十期。5. 倪貴榮，（2003）。《WTO 知識產權保護與公共健康議題之發展趨勢》。經社法制論叢，第三十一期。6. 唐曉帆，（2005）。《歐盟藥品補充保護證書 (SPC) 制度簡介》。電子智慧財產權，第十期。7. 徐揮彥，（2003）。《與貿易有關之知識產權協議下有關藥品專利與健康權問題之研究》。貿易調查專刊，第九期。8. 陳文吟，（2002）。《探討因應醫藥品專利之合理措施》。國立中正大學法學集刊，第八期。9. 陳嘉宏，2007。《2006 年台灣各產業景氣趨勢調查報告》。西藥製藥產業。10. 單偉光，沈錫明，孫國君，（2009）。《「Bolar 例外」的由來及對我國仿製藥企業的影響》。新西部：理論版，第十六期。11. 賀德芬，2003。《保護科技類知識產權之經驗交流計畫》。智慧財產與國家發展。12. 遊宏樞，（2004）。《保護競爭的兩難-談「資料專屬權」（Data Exclusivity）》。藥業市場。13. 蔡明誠，2004年11月3日。《國際專利調和趨勢對我國專利制度之影響》。專利法制發展學術研討會，經濟部知識產權主辦，臺灣大學法律學院科技、倫理與法律研究中心執行。14. 謝銘洋，（1995）。《專利進口權與平行輸入》。月旦法學雜誌，第二期。（三）碩博士學位論文1. 王崇豪（2002）。《WTO 體系下我國政府治理模式調適之研究》，台大政治學研究所碩士論文，台北。2. 謝季峰（2004）。《WTO 知識產權規範與藥品可近性的研究---探討藥品專利保護政策與公共衛生的平衡點》，陽明大學衛生福利研究所碩士論文，台北。3. 陳翠華（2006）。《我國醫藥專利權期間延長制度之探討》，私立世新大學法律學研究所碩士，台北。（四）網際網絡1. 曾念國，<製藥產業技術研發動向系列 - 2004美國製藥產業研發資金投入概況>，ITIS智網，2005年3月25日報導，http://www.itis.org.tw。2. 賴瓊雅，<老藥新開拓藥物開發新捷徑，生技醫藥產業評析>，ITIS智網，2014年2月12日報導，http://www.itis.org.tw。二、外文資料（一）專書論文1. 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