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作者(中):姜璿
論文名稱(中):WTO架構下為解決國際公共衛生危機之強制授權制度研究
指導教授(中):楊光華
學位類別:碩士
校院名稱:國立政治大學
系所名稱:國際經營與貿易學系
出版年:2007
畢業學年度:96
語文別:中文
論文頁數:61
中文關鍵詞:強制授權學名藥藥品專利
英文關鍵詞:TRIPS
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公共健康與藥品專利之間的衝突與調和,一直是世界貿易組織(World Trade Organization,以下簡稱WTO)各會員國所關注的焦點;儘管全球經濟發展迅速,但多數低度開發及開發中國家,卻因為無法獲得足夠且平價的醫療資源及藥品,而有大量人口死於可治療之疾病,人類最基本的健康權在該些國家境內仍無法獲得基本的保護;故WTO 在2001、2003及2005年分別通過數個宣言及決議,試圖透過該些決議,來解決該些國家境內日益嚴重的公共健康問題,並試圖調和藥品專利保護與公共衛生間的衝突。然而,該些決議仍必須透過各國修正內國法律來加以實踐,故本文以加拿大和印度之內國法修正為例,分析後發現該些國家修正專利相關法規後所建立之學名藥品出口機制對於解決上述公衛問題之效果其實相當有限,再加上始終對強制授權機制持反對意見的美國,透過其於國際社會強大之影響力,進一步的阻礙了各國的實踐,故WTO允許透過強制授權出口平價學名藥品至不具製藥能力國家之機制,對於落後國家之實際影響,仍有待未來進一步的觀察。
第一章 緒論..........1
第一節 研究動機及目的..........1
第二節 研究架構..........3
第二章 WTO架構下醫藥專利強制授權之發展.........4
第一節 藥品專利與公共衛生間之衝突..........4
第二節 「TRIPS協定與公共衛生宣言」..........6
第三節 WTO「執行TRIPS協定與公共衛生宣言第六段之決議」..........9
第四節 TRIPS協定修正草案...........12
第三章 因應第六段執行決議之內國法律修正—以加拿大、印度為例......13
第一節 加拿大..........15
第一項 加拿大專利及專利強制授權制度簡介..........15
第二項 加拿大專利及食品藥物法修正法案..........15
一、明確列舉可供強制授權之藥品清單..........18
二、適用範圍及於非WTO會員之國家但不及於非政府組織..........19
三、針對協商時間設限以加速並確保強制授權之授予...........22
四、「以合理商業條件協商不成」要件之適用..........24
五、明確訂定補償金之計算標準...........25
第三項 小結...........25
第二節 印度...........26
第一項 印度專利及專利強制授權制度簡介..........26
第二項 2004年專利法修正條例下之強制授權制度........28
一、申請人須於藥品受專利保護滿三年後方可提出申請.........29
二、進口國必須先行於國內獲得強制授權許可..........29
三、並未限制可供強制授權之藥品..........30
第三項 2005年專利法修正法案通過後之重要改變..........30
一、「進口國須先於國內獲得強制授權許可」要件之改變..........30
二、定義「合理協商期間」通常不得超過六個月..........31
第四項 小結...........32
第三節 印度與加拿大強制授權機制之主要差異...........34
第一項 藥品範圍限制之有無..........34
第二項 申請時點限制之有無..........35
第三項 進口國資格限制之有無..........35
第四項 補償金計算標準之有無..........35
第五項 「以合理商業條件協商不成」要件之適用..........36
第四章 未因應第六段執行決議進行修法之國家—以美國為例..........37
第一節 美國專利及專利強制授權制度簡介..........37
第二節 美國對於國際間強制授權案例之態度..........38
第一項 南非強制授權案..........39
第二項 巴西強制授權案..........40
第三節 美國對於公衛宣言及第六段執行決議之立場..........42
第四節 美國專利法之修正草案..........45
第五節 小結...........49
第五章 結論...........50
中文:
1. 李素華,〈落實WTO醫藥專利強制授權決議—加拿大研擬專利法修正〉,《科技法律透析》,2004年2月(2004)
2. 林宜男、許佳惠,〈WTO醫藥專利與公共健康議題之研析 — 間論我國未來之發展趨勢〉,《清華科技法律與政策論叢》,第二卷,第一期(2005)
3. 林男錡,〈WTO架構下藥品專利強制授權問題之研究〉,天主教輔仁大學財經法律學研究所碩士論文(2004)。
4. 林岳峰,〈世界貿易組織相關協定對公共衛生及藥品可近性之影響〉,《疫情報導》,行政院衛生署疾病管制局,第二十卷第十期(2004)。
5. 徐揮彥,〈與貿易有關之智慧財產權協定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(2003)。
6. 陳文吟,〈論專利法上醫藥品專利期間之延長—以美國為例〉,《華岡法粹》,第二十四期(1996)。
7. 楊光華,〈從專利特許實施個案論我國對TRIPS協定義務之履行〉,《政大法學評論》,第二十五期(2007)。
8. 蔡奉真,〈全球化趨勢下發明專利立法政策之比較研究—以公共衛生和發明專利為例〉,台灣大學法律學研究所碩士論文(2005)。
9. 鄭師安,〈論國際間醫藥品強制授權修法趨勢〉,《科技法律透析》,2005年7月(2005)。
10. 蕭彩綾,〈美國法上專利強制授權之研究〉,國立中正大學法律研究所碩士論文(2004)。

中文網站資料:
1. 行政院衛生署WHO主題網,「世界貿易組織規範與公共衛生DOHA宣言『TRIPS與公衛宣言』」,
2. 經濟部智慧財產局,「專利法新增第76條之1 及第76條之2修正說明」,
http://www.joupo.com/chinese/main-c10d3.htm/。
3. 經濟部智慧財產局,「追求卓越、促進產業發展 — 專利法特進一步研修」,
http://www.tipo.gov.tw/service/news/ShowNewsContent.asp?postnum=6081&for
m=news。

英文:
1. Abbott, Frederick M., Canada and the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, The North-South Institute, Ottawa (2003).
2. Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements, 14 QUNO Occasional Paper (2004).
3. Abbott, Frederick M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, 99 Am. J. Int’l L. 317 (2005).
4. Abbott, Frederick M., WTO TRIPS Agreement and Its Implementations for Access to Medicines in Developing Countries prepares for the British Commission on Intellectual Property Rights ,Study Paper 2a (2003).
5. Chase, Steve and Scoffield, Heather, Ottawa Leans Toward Limits on Cheap-Drug Distribution; Export of Generics to Poor Countries Likely to Target Only AIDS, Malaria and TB for Now, a9 GLOBE & MAIL (2003).
6. Curti, Andrea M., The WTO Dispute Settlement Understanding: An Unlikely Weapon in the Fight Against AIDS, 4, 27, Am J. Law Med., 469 (2001).
7. Dean, Sierra, India’s Controversial New Patent Regime: The End of Affordable Generics? , 40 Int’l Law. 725 (2006).
8. Dhavan R., Harris, L., and Jain M., Power Without esponsibility on Aspects of Indian Patent Legislation, J. Indian L. Institute 33 (1991).
9. Elliott, Richard, Pledges and pitfalls: Canada’s legislation on compulsory licensing of pharmaceuticals for export, 1 International Journal Intellectual Property Management 96 (2006).
10. Hoen, Ellen‘t, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Lone Way from Seattle to Doha, 3, 27, Chicago Journal of International Law. 39
(2002).
11. Inside U.S. Trade, Drug Companies Push for limits on Disease Coverage in Drug Patent Deal (2002).
12. Inside U.S. Trade, EU Proposal on Scope of TRIPS and Health Compromise Faces Criticism (2003).
13. Inside U.S. Trade, Tokyo Meeting Fails to Dislodge Impasse on TRIPS and Health (2003).
14. Inside U.S. Trade, Industry Says Drug Law Violates WTO, But No WTO Case Seen (2005).
15. Marc, Patrick, Compulsory Licensing and the South Africa Medicines Act 0f 1997: Violation or compliance of the Trade Related Aspects of Intellectual Property Rights Agreement, 21 New York Law Journal of International & comparative Law 112 (2001).
16. Mitchell, Amanda, Tamiflu, the Taking clause, and Compulsory Licenses: An Exploration of the Government’s Options for Accessing Medical Patents, 95 Cal. L. Rev. 535 (2007).
17. Narayanan, Prakash and Penner, Mark D., Amendments to the Canadian Patent Act to Address Drug Access: Is Help on the Way? , 60 FOOD & DRUG L. J. 465 (2005).
18. Sands, Katharine W., Prescribing Drugs: India Values Their Compulsory Licensing Provision – Should the United States Follow in India’s Footsteps?, 29 Houston J. Int’l L. 191 (2006)
19. Sell, Susan K., TRIPS and the Access to Medicines Campaign, 20 WIS. Int’l L. J. 481 (2002).
20. Valach Jr., Anthony, TRIPS: Protecting the Rights of Patent Holders and addressing the Public Health Issues in Developing Countries, 4 CHI.-KENT J INTELL. PROP, 156, p172 (2005).
21. Vandoren, Paul and Van Eeckhaute, Jean Charles, The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Making It Work, 6 J. WORLD INTELL. PROP. L. 779 (2003).

英文網站資料:
1. Binceletto, Susan, Use of Patented Products for International Humanitarian Purposes Regulations(2005), available at http://canadagazette.gc.ca/partII/2005/20050601/html/sor143-e.html#REFa (last visited at June 30, 2007)
2. Canada’s Access to Medicine Regime, Introduction of the Import Mechanism of Pharmaceutical Medicines in Canada(2006), available at http://camr-rcam.hc-sc.gc.ca/index_e.html (last visited at June 30, 2007)
3. Canadian HIV/AIDS Legal Networks, available at http://www.aidslaw.ca/ (last visited at June 30, 2007)
4. Canadian HIV/AIDS Legal Network, Legal Network Release 13-Point Plan To Implement To Fix Canada’s Access To Medicines Regime (2007), available at http://www.aidslaw.ca/publications/interfaces/downloadDocumentFile.php?ref=707/ (last visited at June 30, 2007)
5. Canadian HIV/AIDS Legal Networks, Statement on Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act(2004), available at http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=449 (last visited at June 30, 2007)
6. Correa, Carlos M. Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health(2004), available at http://www.wto.int (last visited at June 30, 2007)
7. Doctors Without Borders, Prognosis: Short-term Relief, Long-term Pain The future of generic medicines made in India (2005), available at http://www.doctorswithoutborders.org/publications/ideas/indiapatents2005.cfm (last visited at June 30, 2007)
8. Dyer, Geoff and Pilling, David, “Brazil sees Aids programme threatened by drug prices”, Financial Times (2001), available at www.ft.com (last visited at June 30,
2007)
9. Elliot, Richard, Getting the Regime Right: Compulsory Licensing of Pharmaceuticals for Export, Brief to House of Commons, Standing Committee on Industry, Science and Technology, Regarding Canada’s Access to Medicines Regime (2007), available at http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=705 (last visited at June 30, 2007)
10. Elliott, Richard, Time To Deliver Or Not (2006), available at http://www.aidslaw.ca.vs4.korax.net/publications/interfaces/downloadFile.php?ref=845 (last visited at June 30, 2007)
11. Gupta, Amit Sen, Changes in New Patents Bill (2005), available at http://www.cptech.org/ip/health/c/india/gupta03222005.html (last visited at June 30, 2007)
12. Health Gap Global Access Project Press Release, The Impact f India’s amended Patents Acton Access Affordable HIV Treatment (2005), available at http://www.healthgap.org/press_releases/05/020105_HGAP_FS_INDIA_IPR.pdf/ (last visited at June 30,2007)
13. Norwegian Ministry of Foreign Affairs, Consultation-Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health in Norwegian Law(2004), available at http://www.dep.no/ud/engelsWp2500832/p30003923/032121-290003/index-doc000-n-n-a.html (last visited at June 30, 2007)
14. Press Release, Government of India, Enough Safeguards in Patetns Act to Prevent Price Rise—Domestic Pharma Industry Interests Fully Protected: Kamal Nath(Apr. 4, 2005), http://pib.nic.in/release/release.asp?relid=8345(last visited at June 30, 2007)
15. The Jean Chr’etien Pledge to Africa Act, available at
http://www2.parl.gc.ca/HousePublications/Publication.aspx?pub=bill&doc=c-56&parl=37&ses=2&language=E (last visited at June 30, 2007)
16. WHO Model List of Essential Medicines(2007), available at http://www.who.int/medicines/publications/essentialmedicines/en/index.html/ (last visited t June 30, 2007)
17. WTO Official Website of TRIPS and Public Health, available at http://www.wto.org/english/tratop_e/TRIPS_e/public_health_e.htm (last visited at June 30, 2007)
(此全文未授權公開)
書名頁
謝辭
摘要
目錄
第一章 緒論
第二章 WTO架構下醫藥專利強制授權之發展
第三章 因應第六段執行決議之內國法律修正—以加拿大、印度為例
第四章 未因應第六段執行決議進行修法之國家—以美國為例
第五章 結論
參考文獻
 
 
 
 
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