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題名：藥品創新與專利保護關聯之探討
書刊名：政大智慧財產評論
作者：黃文鴻／謝季峰
作者(外文)：Huang, Weng-foung／Hsieh, Chi-feng
出版日期：2004
卷期：2:2
頁次：頁25-50
主題關鍵詞：藥品；專利保護；製藥產業；Pharmaceutical industries；Innovation；Patent protection
原始連結：連回原系統網址new window
相關次數：
  • 被引用次數被引用次數:期刊(4) 博士論文(2) 專書(1) 專書論文(0)
  • 排除自我引用排除自我引用:4
  • 共同引用共同引用:34
  • 點閱點閱:103
一般公認依賴專利保護生存程度最甚的產業，非製藥產業與化學產業莫屬，製藥產業的競爭優勢來自創新成果所取得的專利，但從事以研發為主要基礎的製藥產業風險相當大，研發一種新藥大約需要十至十五年，一個化學成分只有四千到萬分之一的機率能夠上市，新藥能夠上市一般的成本是八億美元。所以製藥產業一貫主張，沒有專利保護，根本無法提供研發的原動力，專利保護期對製藥產業而言是絕對必要的獲利回收期。本文先就智財權保護制度加以探討，瞭解專利保護制度存在的意義，接下來將就製藥產業何以倚賴專利保護甚密加以剖析，從新藥研發的成本、上市的困難到競爭的激烈，說明製藥產業極力主張專利保護才有新藥的原因。 但專利保護是否導致藥品價格居高不下，一直為各界所關注，本文透過文獻的收集和整理，針對專利保護對藥價的影響以及專利保護對於藥品研發重要性探討，雖然未能得出一明確的結論，但仍對欲瞭解此一議題之讀者提供一清晰的視野。
It is generally agreed that pharmaceutical and chemical industries rely substantially in the provision of patent protection. The pharmaceutical industry achieves its competition advantages by the patenting of innovations. However, there are tremendous risks in the research based pharmaceutical industry. It generally takes ten to fifteen years to successfully develop and launch a new drug, a chemical only has an odd of one in four thousands to ten thousands of being approved and marketed to the market with an average cost of US$802 million dollars. The research based pharmaceutical industry persistently advocates that the protection of pharmaceutical innovation (i.e., patent protection) is the prime motivation impetus to the pharmaceutical industry in order to sustain the return on research and development. This article discusses the intellectual property regulations, and to substantiate the existence of patent protection, it is followed by analysis of the patent protection to the core survival of research based pharmaceutical industry. The reasons of patent protection to pharmaceutical innovation as advocated by the pharmaceutical industry will also be discussed in the light of the development cost of new drugs, regulatory hurdles, and market competition if a new drug is approved to market. Whether patent protection has resulted in high drug prices beyond reach has been a hotly debated issue. This article discusses the effects of patenting on the drug prices and significance on drug research and development based on comprehensive literature review. Although there is no absolute conclusion that might possibly be obtained, it attempts to provide a clearer view of this issue for the readers who may have interests and concerns in this topic.
期刊論文
1.張鴻仁、戴雪詠(19931200)。加拿大藥品支付及給付制度。衛生報導，3(12)=34，2-11。  延伸查詢new window
2.楊耀塘(20000700)。我國加入WTO後對主要產業的影響。產業調查與技術季刊，134，61-73。  延伸查詢new window
3.簡榮宗(20020600)。加入WTO對我國專利法制之影響。智慧財產權，42，44-60。new window  延伸查詢new window
4.羅昌發(19950400)。WTO 下之智慧財產權保護與貿易自由化之關係。工業財產權與標準，25，1-21。  延伸查詢new window
5.Dhavan, R.、Harris, S.、Jain, M.(1990)。Whose in Interest ? Independent India's Patent Law and Policy。Journal of the Indian Law Institute，32(4)，429-477。  new window
6.DiMasi, J. A.、Grabowski, H. G.、Lasagna, L.(1991)。The Costs of Innovation in the Pharmaceutical Industry。Journal of Health Economics，10，107-142。  new window
7.Attaran, Amir、Lee, Gillespie-White(2001)。Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?。The JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION，286(15)，1890。  new window
8.Rozek, R.(1990)。Benefits and Costs of Intellectual Property Protection in Developing Countries。Journal of World Trade Law，24，75-102。  new window
9.Wilson, D.、Cawthorne, P.、Ford, N.(1999)。Global trade and access to medicines: Aids treatments in Thailand。The Lancet，354，1893-1895。  new window
10.蔡明誠(20011200)。加入WTO對我國智慧權保護法制的影響。月旦法學，79，47-58。new window  延伸查詢new window
會議論文
1.黃文鴻(2002)。健保藥價政策與產業發展。2002健保藥價政策與產業發展研討會，(會議日期: 2002/11/27)。台北。  延伸查詢new window
2.World Health Organization、World Trade Organization Secretariats(2001)。Report of the workshop on differential pricing and financing of essential drugs。The workshop on differential pricing and financing of essential drugs，Norwegian Foreign Affairs Ministry, Global Health Council (會議日期: 2001/04/08-04/11)。Høsbjør。  new window
研究報告
1.Pharmaceutical Research and Manufactures' Association(1999)。Submission of PhRMA for the "Super 301" Report on Intellectual Property Barriers。Washington：Pharmaceutical Research and Manufactures' Association。  new window
2.Working Group 2 of the Commission on Macroeconomics and Health(2001)。Global Public Goods for Health: New Strategies for the 21st Century。  new window
學位論文
1.王睦齡(2002)。專利法上平行輸入與耗盡原則之研究(碩士論文)。國立中正大學。  延伸查詢new window
2.蕭彩綾(2000)。美國法上專利強制授權之研究(碩士論文)。國立中正大學。  延伸查詢new window
3.歐陽瑾儒(2002)。我國加入世界貿易組織對本國製藥業之衝擊與因應策略之研擬(碩士論文)。國立陽明大學。  延伸查詢new window
圖書
1.Nuechterlein, Donald Edwin(1991)。America Recommitted: United States National Interests in a Restructured World。Lexington, Kentucky：University Press of Kentucky。  new window
2.Apple, R. D.、薛桂文、楊智明(2002)。健康的騙局。臺北：時報。  延伸查詢new window
3.林柳君(2000)。閣樓上的林布蘭。台北：經典傳訊文化股份有限公司。  延伸查詢new window
4.張禹治(1997)。專利奇兵。臺北：時報。  延伸查詢new window
5.楊美齡(1996)。阿斯匹靈戰爭。臺北：月旦出版社。  延伸查詢new window
6.黃文鴻(2002)。台灣加入世界貿易組織後對製藥產業與醫療服務業影響之研究。行政院衛生署。  延伸查詢new window
7.羅昌發(1994)。由雙邊貿易架構通往多邊體系的中美智慧財產權保護關係貿易關係之法律問題：國際經貿研究法。臺北：月旦出版社。  延伸查詢new window
8.嚴麗娟(2001)。生物科技大商機。台北：聯經。  延伸查詢new window
9.Oxfam(2002)。Beyond Philanthropy。Oxfam。  new window
10.Oxfam(2001)。Fatal side effects: Medicine patents under the microscope: Cut the cost。Oxford：Oxfam GB。  new window
11.Oxfam(2001)。Patent injustice: how world trade rules threaten the health of poor people。Oxford：Oxfam。  new window
12.董霖(1995)。國際公法與國際組織。台北：台灣商務印書館股份有限公司。  延伸查詢new window
13.Andrews, Lori B.、Nelkin, Dorothy、廖月娟(2001)。出賣愛因斯坦：人體組織販賣市場。台北市：時報文化公司。  延伸查詢new window
14.Sen, Amartya Kumar、劉楚俊(2001)。經濟發展與自由。臺北市：先覺出版股份有限公司。  延伸查詢new window
15.Pharmaceutical Research and Manufactures of America(2002)。Industry Profile 2002。Washington, DC：PhRMA。  new window
16.Pharmaceutical Research and Manufactures' Association(1999)。Pharmaceutical Industry Profile 1999。Washington, DC：Pharmaceutical Research and Manufactures' Association。  new window
17.Reekie, W. D.(1996)。Medicine Prices and Innovations。London：IEA health and Welfare Unit。  new window
18.Robinson, J.(2001)。Prescription Games: Money, Ego and Power Inside the Global Pharmaceutical Industry。Toronto：McClelland & Stewart。  new window
19.(2000)。WHO Medicines Strategy: Framework for Action in Essntial Drugs and Medicines Policy 2000-2003。World Health Organization。  new window
20.WHO(1988)。How to develop and implement a national drug policy。WHO。  new window
21.WHO(2000)。WHO Medicines Strategy: 2000-2003。Geneva：WHO。  new window
22.World Health Organization(2000)。The World Health Report 1999: Making a Difference。Geneva：World Health Organization。  new window
23.World Bank Group(2000)。World Development Report 2000/2001: Attacking Poverty。New York：Oxford University Press。  new window
24.World Health Organization(2001)。The World Health Report 2000: Health Systems: Improving Performance。Geneva：World Health Organization。  new window
25.World Health Organization(2002)。The World Health Report 2001: Stop exclusion--Dare to care。Geneva：World Health Organization。  new window
26.WTO(2001)。TRIPS and pharmaceutical patents。WTO。  new window
27.Ryan, Michael P.(1998)。Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property。Washington, DC：Brookings Institution Press。  new window
28.World Health Organization、World Trade Organization Secretariats(2002)。WTO Agreements and Public Health。Geneva：WTO。  new window
29.張苙雲、吳思華、李仁芳、蔡敦浩(19990000)。網絡臺灣：企業的人情關係與經濟理性。臺北：遠流。new window  延伸查詢new window
30.Beck, Ulrich、孫治本(1999)。全球化危機：全球化的形成、風險與機會。臺北：臺灣商務印書館。  延伸查詢new window
31.Dye, Thomas R.(1978)。Understanding Public Policy。Englewood Cliffs, NJ：Prentice-Hall。  new window
其他
1.黃文鴻(20011100)。產業政策與我國生技製藥的發展。  延伸查詢new window
2.Oxfam(2001)。Where is the Money? G8 promises, G8 failures。  new window
3.WHO。Health Reform and Drugs Financing:Selected Topics, Action Programme on Essential Drugs，Geneva。  new window
 
 
 
 
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