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作者姓名(中文):杜芸璞
作者姓名(英文):Yun-pu Tu
論文名稱(中文):從人權關懷出發-論藥物專利強制授權
論文名稱(外文):Study of Compulsory Licensing-When Human Rights Meet Pharmaceutical Patents
指導教授姓名(中文):劉國讚
指導教授姓名(英文):Kuo-Tsan Liu
口試委員姓名(中文):廖承威
陳士章
口試委員姓名(英文):none
none
學位類別:碩士
校院名稱:國立臺灣科技大學
系所名稱:專利研究所
學號:M10124001
出版年(民國):103
畢業學年度:102
學期:2
語文別:英文
論文頁數:86
中文關鍵詞:健康權藥物近用權強制許可藥物專利
外文關鍵詞:Right to HealthAccess to MedicinesCompulsory LicensingPharmaceutical Patents
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人們總想健康、長存,以實現設定在人生中每個階段的目標,或簡簡單單地渴望有更多餘韻與所珍視者相處;誠然,「健康」扮演著人生舉足輕重的角色,致使基本人權中涵蓋著「健康權」應不容置喙。然維持健康狀態,僅有良善的生活環境、均衡的營養、或規律的運動是不足的—人會病、會傷,需要藥物的協助與治療;因此,「藥物近用權」隨之而來以補充、支持健康權。
然則,財產權亦是另一項基本人權,且智慧財產權又被歸類於財產權之中;如此,「健康權/藥物近用權」與「智慧財產權」之間所生的衝突,並不是一個易解的問題,反之,應更細緻地處理了。這篇論文,著眼於討論這兩者間的其中一種衝突形式—藥品專利的強制授權,以2005年的克流感案,針對TRIPS和杜哈宣言所規範的國家緊急情況認定為客體。
我相信正義存在於人性尊嚴之中,無論貧賤;當藥品成為專利而升抬價格,適當的強制授權制度介入使價格合理些。而法律回歸人本,我們該尋找制度設計背後的價值取捨,並確立是真切地具有社會的功能性,而非止於邏輯推衍或計算利潤成本。在現有的知識基礎之上,我盼能開展地更深刻,覓得支持保障智慧財產制度運行的同時,亦兼顧健康權和藥物近用權的正義。
本論文以比較研究強化國際觀點,佐以文獻分析,併附參與研討會、工作坊以蒐集想法和回應,試圖處理強制授權的正義和正當性課題;最終,有了結果和建議,即根據不同的情況,有更多樣的強制授權選擇形式,或另闢溪徑,訴諸於國家徵用的手段。
Normally, people want to stay “healthy”, to live longer, to realize the goals set in each stages of life, or simply ask for more time spending with their love ones—“health” indeed plays big parts of our lives, which makes it no doubts that “Human Rights” contain the “Right to Health”. Yet, to maintain in healthy condition, sometimes only good living environment, balancing nutrition, or regular sports are not enough—people get sick or injury and need the help of medications or medical treatments, so, follow by the “Right to Health”, we need “Access to Medicines” to complete and supplement.
However, “Property” is another basic “Human Right”. As “Intellectual Property” (“IP”) are also one kind of “Property”, the conflicts between “right to health/access to medicines” v. “IP rights” are not a trivial question; rather, something could be think more. In this thesis, I mainly discuss one of the conflict—the compulsory licensing in pharmaceutical patents, using the “Tamiflu case” in 2005, as a case analysis focusing on the issue of “National Emergency” under the TRIPS and Doha Declaration regarding to grant compulsory licensing.
I believe in justice of human dignity is ought to be accessed to anyone regardless poor or wealth—while the pharmaceutical patents sustain the high price level of drugs, proper compulsory licensing may help to change into affordable prices. With law belongs to humanities, we should seek for the values that are really functional to the society, rather than simply resort to logical deduction or cost-benefit analysis. I long to explore deeper so as to seek the justice behind all the knowledge I’ve known up till now to support the IP policy, meanwhile, taking care of the right to health and access to medicines.
By comparative research to facility international perspective with literature analysis of paper works, as well as entering conferences and workshop to collect the idea and feedbacks, I deal with the justice and legitimacy of compulsory licensing in pharmaceutical patents; and finally, reach the conclusion and recommendation that to reform the R.O.C. IP law to cover more choices of granting compulsory licensing or trying the resort to “Public Use” or “National Use” under different level of needs.
Contents
Abstract i
Acknowledgments v

Chapter 1 Introduction 1
1.1 My Motivation...............................1
1.1.1 Intellectual Property Right.....................1
1.1.2 Reflection.....................2
1.1.3 Basic needs of everybody.....................3
1.1.4 in the Hope of.....................6

1.2 Research target—Pharmaceutical Patents.................7
1.2.1 Tragedy of the Commons......................7
1.2.2 Anti-Tragedy of the Commons & Patent Thicket.........8
1.2.3 Pharmaceutical Patents.......................10

1.3 Research Methods & Process........................10
1.3.1 Literature Analysis.........................11
1.3.2 Comparative Research.......................11
1.3.3 Dealing with Justice and Legitimacy................11

1.4 Related Work................................12
1.4.1 to Put the Environment in to Consideration.............13
1.4.2 Measurements on Both Sides....................14
1.4.3 Never too late, the Access to Medicines!..............15
1.4.4 More Evidence required......................16
1.4.5 Other Suggestions.........................17

Chapter 2 Human Rights 19
2.1 Introduction.................................19

2.2 The rights that should be bound with....................21
2.2.1 in the R.O.C Constitutional Law..................22
2.2.2 The Act to Implement.......................23

2.3 Right to Health and Access to Medicines..................24
2.3.1 Where can be found?........................24
2.3.2 Human Rights for Both Ways...................25
2.4 The Implementation of Nations.......................27
2.4.1 United States............................27
2.4.2 United Kingdom..........................28
2.4.3 South Africa............................30
2.4.4 Taiwan...............................31

2.5 Summary..................................36

Chapter 3 Compulsory Licensing 39
3.1 Introduction.................................39

3.2 Compulsory licensing on TRIPS......................40
3.2.1 TRIPS Agreement.........................40
3.2.2 Article 31..............................41

3.3 The Doha Declaration............................42

3.4 Domestic Regulations and Implementations................44
3.4.1 Compulsory Licensing in the R.O.C Patent Law..........44
3.4.2 Domestic law making and TRIPS..................46
3.4.3 Compulsory Licensing with Pharmaceutical Patents........47

3.5 Summary..................................51

Chapter 4 Case Analysis 53
4.1 Introduction.................................53

4.2 Tamiflu and Compulsory Licensing................................. 54
4.2.1 What happened? .................................54
4.2.2 under What Conditions? The Decision made by TIPO..................... 56

4.3 Discussion .................................57
4.3.1 Observation from Fundamental Rights.............................58

4.4 Why not Definite the Conditions? .................................63
4.4.1 Whereas Profession ................................ Reaf.64
4.4.2 Points in Legal Rules........................65
4.4.3 Foresight and Hindsight......................65

4.5 Summery..................................66

Chapter 5 Conclusions 68
5.1 Always Incentive..............................68

5.2 More choices of Compulsory Licensing..................69
5.2.1 Cross Licensing after Compulsory Licensing...........69
5.2.2 Public Use or National Use.....................70

5.3 Reaffirm the idea of diminishing the ambiguous...................70
References

Journal Papers

1. A. H. Maslow, a Theory of Human Motivation, 1943.

2. 牛惠之, 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.

3. Garrett Hardin, The Tragedy of the Commons, Science 162, 1968.

4. Australian Government, Pharmaceutical Patents Review, Background and Suggested Issues Paper, 2012.

5. 劉孔中, Essential Facility Doctrine, Compulsory Licensing of Patents and the Fair Trade Act, 公平交易季刊, vol.15, 2007.

6. Wu, Chuan-Feng, Health, Science, and Human Rights, Biennial Review of Law, Science and Technology, 2011.

7. 鍾騏, 美國哈佛大學法學院國際法課程介紹, 國際法教育現狀與展望—各國經驗與臺灣之比較研究, 許耀明主編, 2011.

8. 吳全峰, 健康、科學與人權, 2011科技發展與法律規範雙年刊, 中央研究院法律學研究所, 2011.

9. 克流感專利技術經強制授權, The Lee and Li Attorney of Law journal, March, 2006.

10. 廖福特, 引進國際人權準則—比較分析與台灣借鏡, 國際人權法—議題分析與國內實踐, 2007.

11. 顏上詠 and 周于舜, Legal Justification on Taiwan's Compulsory Licensing on Tamiflu in the Perspectives of Global Health Governance.

12. Alicia Ely Yamin, Not just a tragedy: Access to Medications as a Right under International Law, Trustees of Boston University and by the Project on Technology.

13. Stephen P. Marks, Access to Essential Medicines as a Component of the Right to Health, Health: A Human Rights Perspective.

14. Kathleen S. Swendiman, Legislative Attorney, Health Care: Constitutional Rights and Legislative Powers, 2012.

15. Rudolf, V. Van Puymbroeck, Basic Survival Needs and Access to Medicines- Coming to Grips with TRIPS: Conversation + Calculation, Journal of Law, Medicine & Ethics.

16. Lisett Ferreira, Access to Affordable HIV/AIDS Drugs: The Human Rights Obligations of Multinational Pharmaceutical Corporations, Fordham Law Review, vol. 71.

Books

1. 姚竭靖, 藥品專利保護優化研究, 2012.

2. Karl Larenz, translated by 陳愛娥, 法學方法論, 2008.

3. 劉國讚, 專利法之理論與實用, 2012.

Master/ PhD Theses

1. 江亮頡, 藥品專利強制授權之研究--兼評智財局克流感強制處分, 世新大學碩士論文.

2. 薛宇廷, 強制授權制度於經濟全球化時代之角色--WTO公共衛生相關議題研究, 銘傳大學碩士論文.

3. 李素華, 從公共衛生觀點論醫藥專利權之保護與限制, 國立台灣大學博士論文.

4. 楊岳平, 世界貿易組織下涉及公共衛生之強制授權制度—評臺灣智慧財產局2005克流感強制授權案, 中華經濟研究院 (台灣WTO中心) 優等論文.

5. 尤明村, 醫藥品強制授權研究--以克流感為例, 世新大學碩士論文.

Presentation & News

1. 大紀元, 羅氏計畫自行授權 克流感強制授權延後定案.

2. Lawrence O. Gostin, Healthy People, Healthy Communities: Toward a healthier, safer world.

3. Edwin Cameron, patents and Public Health: Principle, Politics and Paradox, Inaugural British Academy Law Lecture, held at the University of Edinburgh, 19th October, 2004.

Legal Instruments

1. The R.O.C Patent Law (1960): Art. 4, Items below are not granted patent right:Chemistry products, food, and pharmaceutical product.

2. Article 155 of the R.O.C Constitutional Law: The State, in order to promote social welfare, shall establish a social insurance system. To the aged and the infirm who are unable to earn a living, and to victims of unusual calamities, the State shall give appropriate assistance and relief.

3. The new version of R.O.C. Patent Law

4. Act to Implement the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights (2009): Art. 1 This Act is made to implement the International Covenant on Civil and Political Rights and the International Covenant on

5. Act to Implement the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights: Art. 2 Human rights protection provisions in the two Covenants have domestic legal status.

6. The Chinese Title of these laws and regulations.

7. South Africa Constitution, sec. 27, 39 (1) & (2).

8. Grootboom v. Republic of South Africa, 2000 (11) BCLR 1169.

9. International Covenant on Economic, Social and Cultural Rights, Art. 15.

Internet & Government Information

1. 2013 Best Companies selecting standard, Department of Labor, Taipei City Government, http://www.bola.taipei.gov.tw/public/Attachment/393015274787.pdf (last visited 2014/2/24)

2. Human Rights Quotes, http://www.brainyquote.com/quotes/keywords/human_rights.html#TYfVZCQFBVqeUA2h.99 (last visited 2014/2/26)

3. The UDHR Preamble, http://www.un.org/en/documents/udhr/ (last visited 2014/3/1)

4. Drugs.com, http://www.drugs.com/tamiflu.html (lase visited 2014/4/4)

5. Library of Congress, Taiwan: Two International Human Rights Covenants Ratified, http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205401218_text (last visited 2014/ 03/ 03)

6. Human Rights In Health Care, www.humanrightsinhealthcare.nhs.uk (last visited201/03/03)

7. 兩公約施行監督聯盟, http://covenants-watch.blogspot.tw/ (last visited 2014/03/15)

8. The separate Doha Declaration explained, http://www.wto.org/english/tratop_e/trips_e/healthdeclexpln_e.htm (last visited 2014/03/14)

9. The 2011-2012 Human Rights in Healthcare Program, http://www.humanrightsinhealthcare.nhs.uk/Library/whats_new/humanrights_in_health_and_socialcare_event_october_15th_london/human_rights_november_event_aintree/human_rights_report.pdf (last visited 2014/ 03/ 03)

10. 中華民國初次報告經社文公約審查委員會提交之問題清單及政府機關回應, http://www.humanrights.moj.gov.tw/public/Attachment/32191158102.pdf (last visited: 2014/03/17)

11. Community of Liberty, What Is the Difference between Positive and Negative Rights? http://www.communityofliberty.org/topics/question-of-the-week-17/ (last visited 2014/03/12)

12. U.S. Constitution, Article 6, http://www.usconstitution.net/xconst_A6.html (last visited 2014/3/3)

13. The legislative reasons of Art. 90, Law Bank, http://db.lawbank.com.tw/FLAW/FLAWDAT0201.aspx?lsid=FL011249&bp=7 (last visited 2014/4/8)

14. TRIPS, Art. 31(l). http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm (last visited 2014/4/7)
 
 
 
 
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