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    题名: 專利強制授權制度對醫藥產業發展與藥物可近性之拮抗——各國法制比較與我國法制展望
    Struggle of patent compulsory license on the development of pharmaceutical industry and medicine accessibility of the public ——Comparative study of the law in major countries and prospect of Taiwan
    作者: 陳冠綾
    Chen, Kuan Ling
    贡献者: 沈宗倫
    陳冠綾
    Chen, Kuan Ling
    关键词: 強制授權
    專利法
    藥物可近性
    公共衛生
    Compulsory license
    Patent law
    Accessibility of medicines
    Public health
    日期: 2017
    上传时间: 2017-09-13 15:00:03 (UTC+8)
    摘要: 智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。
    本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。
    The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients.
    This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines.
    In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions.
    Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system.
    Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines.
    Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system.
    Chapter 6 analyzes the history of Taiwan`s patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.
    參考文獻: 參考文獻
    一、中文資料
    書籍
    1.劉國讚，（2015年9月）。專利法之理論與實用（三版）。台北市：元照出版社。
    2.G.H.C. Bodenhausen，（2000年4月）。巴黎公約解讀 (陳文吟, Trans.)，經濟部智慧財產局。

    期刊論文
    1.王立達，(2004)。從 TRIPS 協定與公眾健康爭議論專利強制授權之功能與侷限，科技法學評論, 1(1)，頁215-246。
    2.何之邁 & 林怡君，（2006年）。荷蘭皇家飛利浦光碟案判決評析以公平交易法對於「獨占」之規範為中心，月旦民商法雜誌，頁91-105
    3.牛惠之，（2006）。淺論認定國家緊急情況與強制授權克流感的正當性與必要性. 台灣本土法學，79，頁4-12。
    4.劉孔中，(2007)。以關鍵設施理論限制專利強制授權之範圍。公平交易季刊，第十五卷第一期，P.25-58。
    5.洪千雯. (2007). 以 WTO 規範探討 TRIPS 協定關於國家緊急情況的認定機制-從我國克流感專利強制授權案出發. 臺灣國際法季刊, 4(1), 157-207.
    6.牛惠之，（2008年2月1日）。從WTO自由貿易論「杜哈TRIPS 協定與公共衛生宣言」對「國家緊急危難或其他緊急狀況」的解釋與潛在爭議——兼論預防原則的適用，第七屆國際經貿法學學術發展研討會論文集。
    7.鍾仕偉，（2008）。未來我國專利法制之發展方向介紹，智慧財產季刊第66期。中華民國全國工業總會保護智慧財產權委員會，頁20-26。
    8.楊智傑(2008)，如何解決藥物近用落差與研發落差？－TRIPS 下各種解決方案與大學專利政策之檢討，台灣科技法律與政策論叢，5(2)，P.69-124.
    9.黃慧嫺，(2009)。專利連結 (Patent Linkage)-藥品研發與競爭之阻力或助力? 談藥品查驗登記程序與專利權利狀態連結之發展 (上)，科技法律透析，21(2)，頁24-37。
    10.江素慧，(2009)。自由貿易協定之潮流及其對公共衛生與健康之影響。臺灣國際研究季刊，5(2)，105-138。
    11.王立達 & 陳蔚奇，(2010)。學名藥上市審查之專利連結制度: 從美國經驗檢證其存立基礎與制度設計。臺大法學論叢，39(4)，349-406。
    12.陳豐年，（2011）。專利權之歷史溯源與利弊初探。智慧財產權月刊，156 期，頁63-87。
    13.夏禾 & 陳鋕雄，(2014)。資料專屬權與專利保護制度之競合: 以美國藥品上市法制為中心。智慧財產評論，12(1)，117-191。
    14.劉孔中，（2014）。論台灣不斷退步的專利強制授權及供政府使用法制。月旦民商法雜誌，44，頁73-90。

    博碩士學位論文
    1.蕭彩綾(2000)。美國法上專利強制授權之研究。未出版之碩士論文，國立中正大學，法律學研究所，嘉義縣。
    2.陳蔚奇(2009)。論美國專利連結制度於我國實行之妥適性，未出版之碩士論文，國立交通大學，科技法律研究所，新竹市。

    網際網路
    1.經濟部智慧財產局：https://www.tipo.gov.tw/mp.asp?mp=1
    2.衛生福利部疾病管制署：http://www.cdc.gov.tw/rwd/professional

    二、英文資料
    書籍部分
    1.Hilty, R. and Liu, K. (2015). Compulsory licensing. Heidelberg: Springer.
    2.Xiong, P. (2012). An international law perspective on the protection of human rights in the TRIPS Agreement: An interpretation of the TRIPS Agreement in relation to the right to health. Martinus Nijhoff Publishers.
    3.Bartels, H. G., Beyer, P., Kampf, R., Krattiger, A., Mirza, Z., Taubman, A., & Watal, J. (2012). Promoting access to medical technologies and innovation. Intersections between public health intellectual property and trade.

    專書論文
    1.Lu, Y., Hernandez, P., Abegunde, D., & Edejer, T. The World Medicines Situation 2011: Medicine Expenditures. 2011. Geneva, Switzerland: World Health Organization, 3.
    2.Gopalakrishnan, N. S., & Anand, M. (2015). Compulsory Licence Under Indian Patent Law. In Compulsory Licensing (pp. 11-42). Springer Berlin Heidelberg.
    3.Correa, C. M. (2015). The use of compulsory licences in Latin America. In Compulsory Licensing (pp. 43-60). Springer Berlin Heidelberg.
    4.Maume, P. (2015). Compulsory Licensing in Germany. In Compulsory Licensing (pp. 95-120). Springer Berlin Heidelberg.
    5.Frankel, S., & Lai, J. C. (2015). Recognised and Appropriate Grounds for Compulsory Licences: Reclaiming Patent Law’s Social Contract. In Compulsory Licensing (pp. 149-164). Springer Berlin Heidelberg.
    6.Ong, B. (2015). Compulsory Licences of Pharmaceutical Patents to Remedy Anti-Competitive Practices Under Article 31 (k) of the TRIPS Agreement: Can Competition Law Facilitate Access to Essential Medicines?., In Compulsory Licensing (pp. 235-265). Springer Berlin Heidelberg.
    7.Banerjee, A. (2016). The Law and Politics of Pharmaceutical Patents in India. In Innovation and IPRs in China and India (pp. 143-158). Springer Singapore.

    期刊
    1.Besen, S. M., & Raskind, L. J. (1991). An introduction to the law and economics of intellectual property. The Journal of Economic Perspectives, 5(1), 3-27.
    2.Murthy, D. (2001). The future of compulsory licensing: deciphering the Doha Declaration on the TRIPS Agreement and public health. Am. U. Int`l L. Rev., 17, 1299.
    3.Bass, N. A. (2002). Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century. Geo. Wash. Int`l L. Rev., 34, 191.
    4.Macdonald, S. (2004). When means become ends: considering the impact of patent strategy on innovation. Information Economics and Policy, 16(1), 135-158.
    5.Ford, N. (2004). Patents, access to medicines and the role of non-governmental organisations. Journal of Generic medicines, 1(2), 137-145.
    6.Kapczynski, A., Chaifetz, S., Katz, Z., & Benkler, Y. (2005). Addressing global health inequities: An open licensing approach for university innovations. Berkeley Technology Law Journal, 1031-1114.
    7.Ram, P. (2005). India`s New TRIPS-Complaint Patent Regime between Drug Patents and the Right to Health. Chi.-Kent J. Intell. Prop., 5, 195.
    8.Encaoua, D., Guellec, D., & Martinez, C. (2006). Patent systems for encouraging innovation: Lessons from economic analysis. Research policy, 35(9), 1423-1440.
    9.Tsai, G. (2008). Canada`s access to medicines regime: Lessons for compulsory licensing schemes under the WTO Doha Declaration. Va. J. Int`l L., 49, 1063.
    10.Reichman, J. H. (2009). Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options. The Journal of Law, Medicine & Ethics, 37(2), 247-263.
    11.Lybecker, K. M., & Fowler, E. (2009). Compulsory licensing in Canada and Thailand: comparing regimes to ensure legitimate use of the WTO rules. The Journal of Law, Medicine & Ethics, 37(2), 222-239.
    12.Kohler, J. C., Lexchin, J., Kuek, V., & Orbinski, J. (2010). Canada`s Access to Medicines Regime: Promise or Failure of Humanitarian Effort?. Healthcare Policy, 5(3), 40.
    13.Mercurrio, B., & Tyagi, M. (2010). Treaty interpretation in WTO dispute settlement: the outstanding question of the legality of local working requirements. Minn. J. Int`l L., 19, 275.
    14.Suwan-In, N. (2012). Compulsory License, a Long Debate on Trips Agreement Interpretation: Discovering the Truth of Thailand`s Imposition on Pharmaceutical Patents. Asian J. WTO & Int`l Health L & Pol`y, 7, 225.
    15.Moonka, R., & Mukherjee, S.（2016），Marriage between Innovation Bride and Competition Groom: The way Forward. CPJ Global Review. Vol. VIII No. 1
    16.Kapczynski, A., & Kesselheim, A. S. (2016). ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Affairs, 35(5), 791-797.
    17.Duggan, M., Garthwaite, C., & Goyal, A. (2016). The market impacts of pharmaceutical product patents in developing countries: Evidence from India. The American Economic Review, 106(1), 99-135.
    18.Weatherall, K. (2016). Safeguards for Defendant Rights and Interests in International Intellectual Property Enforcement Treaties. Am. U. Int`l L. Rev., 32, 211.

    網際網路
    1.World Health Organization：http://www.who.int/en/
    2.World Trade Organization：https://www.wto.org/
    3.World Intellectual Property Organization：http://www.wipo.int/portal/en/index.html
    4.U.S. Food & Drug Administration（FDA）：https://www.fda.gov/
    5.Nair, G. G. (2008). Impact of TRIPS on Indian pharmaceutical industry., J INTELLEC PROP RIGHTS, SEPTEMBER 2008, P.438，Available at http://nopr.niscair.res.in/handle/123456789/2029
    6.Ho, Cynthia M., Patent Breaking or Balancing? Separating Strands of Fact from Fiction Under TRIPS (February 14, 2009). North Carolina Journal of International Law and Commercial Regulation, Vol. 34, 2009; Loyola University Chicago School of Law Public Law and Legal Theory Research Paper Series No. 2009-003. Available at SSRN: https://ssrn.com/abstract=1218944
    7.Ho, Cynthia M., Complicated Compulsory Licenses: The Waiver/Article31bis `Solution` (February 2, 2011). Cynthia M. Ho, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS, Oxford University Press, April 2011; Loyola University Chicago School of Law Research Paper No. 2011-032. Available at SSRN: https://ssrn.com/abstract=1922825
    8.Abbott, Frederick M., Intellectual Property and Public Health: Meeting the Challenge of Sustainability (November 15, 2011). Global Health Programme Working Paper No. 7/2011; FSU College of Law, Public Law Research Paper No. 566. Available at SSRN: https://ssrn.com/abstract=1965458 or http://dx.doi.org/10.2139/ssrn.1965458
    9.Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements (December, 27 2011). Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 14, April 2004. Available at SSRN: https://ssrn.com/abstract=1977300
    10.Abbott, Frederick M., Review: The Trilateral Study on Health, Intellectual Property, and Trade: The Virtue in Paving a Cleared Roadway (June 7, 2013). Journal of International Economic Law, Vol. 16, No. 2, Pgs. 493-503 (Oxford University Press 2013). Available at SSRN: https://ssrn.com/abstract=2276641
    11.Abbas, Muhammad Zaheer, Pros and Cons of Compulsory Licensing: An Analysis of Arguments (December 16, 2013). International Journal of Social Science and Humanity, Vol. 3, No. 3, May 2013. Available at SSRN: https://ssrn.com/abstract=2368116
    12.Ho, Cynthia M., Should All Drugs Be Patentable?: A Comparative Perspective (March 7, 2015). Vanderbilt Journal of Entertainment & Technology Law, Vol. 17, 2015; Loyola University Chicago School of Law Research Paper No. 2015-015. Available at SSRN: https://ssrn.com/abstract=2575147
    13.Abbott, Frederick M., Trade in Medicines (September 11, 2015). in TRADE AND HEALTH: TOWARDS BUILDING A NATIONAL STRATEGY 117-40 (eds. R. Smith et al.), World Health Organization (2015); FSU College of Law, Public Law Research Paper No. 770; FSU College of Law, Law, Business & Economics Paper No. 16-5. Available at SSRN: https://ssrn.com/abstract=2659277
    描述: 碩士
    國立政治大學
    法律科際整合研究所
    102652006
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    数据类型: thesis
    显示于类别:[法律科際整合研究所] 學位論文

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