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題名:處方藥產業的法律戰爭:藥品試驗資料之保護-
作者:楊代華
出版日期:2008
出版項:臺北:元照出版社
集叢:學術專論
ISBN:9789866842535
主題關鍵詞:醫藥法規藥品管理處方藥製藥業
學門:法律學
資料類型:專書
相關次數:
  • 被引用次數被引用次數:期刊(5) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:5
  • 共同引用共同引用:0
  • 點閱點閱:43
期刊論文
1.Childs, David W.(2005)。The World Health Organization's Prequalification Program and Its Potential Effect on Data Exclusivity Laws。Food and Drug Law Journal,60,79。  new window
2.Correa, Carlos M.(2004)。Bilateralism in Intellectual Property: Defeating the WTO System for Access to medicine。Case W. Res. J. Int'l L.,36,83-84。  new window
3.Junod, Valerie(2004)。Drug Marketing Exclusivity under United States and European Union Law。Food and Drug Law Journal,59,479。  new window
4.Sell, Susan K.(2002)。Intellectual Property, Development, and Human Rights。Fla. J. Int'l L.,14,193。  new window
5.黃文鴻、謝季峰(20041000)。藥品創新與專利保護關聯之探討。政大智慧財產評論,2(2),25-50。new window  延伸查詢new window
6.Bontis, Nick、Dragonetti, Nicola C.、Jacobsen, Kristine、Roos, Goran(1999)。The knowledge toolbox: A review of the tools available to measure and manage intangible resources。European Management Journal,17(4),391-402。  new window
7.許志義(20021000)。知識經濟對競爭政策的挑戰及其因應之道。公平交易季刊,10(4),61-108。new window  延伸查詢new window
8.Skillington, G. Lee、Solovy, Eric M.(2003)。The Protection of Test and Other Data Required by Article 39.3 of the TRIPS Agreement。Northwestern Journal of International Law & Business,24,1。  new window
9.Edvinsson, Leif、Sullivan, Patrick(1996)。Developing a model for managing intellectual capital。European Management Journal,14(4),356-364。  new window
10.李素華(20040100)。第三世界必要藥品近用爭議與TRIPS協定專利強制授權決議之最新進展。科技法律透析,16(1),39-45。  延伸查詢new window
11.林志六。七七公告與行政法之一般原則。藥政法規,10。new window  延伸查詢new window
12.陳恆德。台灣未來銜接性試驗可能的要求與評估機制。藥政法規,8。  延伸查詢new window
13.謝文雀、胡同來、游蓓怡(20040900)。Competitive Strategies for International Research-Based Pharmaceutical Company。臺北科技大學學報,37(2),163-171。new window  延伸查詢new window
14.Fellmeth, Aaron Xavier(2004)。Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protecting of Marketing Approval Data under the Trips Agreement。Harvard International Law Journal,45(2),443-502。  new window
15.Mossinghoff, Gerald J.(1999)。Overview of The Hatch-Waxman Act and Its Impact on the Drug Developing Process。The Food and Drug Law Journal,54(2)。  new window
16.Garboski, H.、Vernon, J.、DiMasi, J. A.(2002)。Returns on Rearch and Development for 1990s New Drug Introduction。Pharmacoeconomics,20S,11-29。  new window
17.Eurek, Sarah E.(2003)。Hatch-Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better?。Duke Law & Technology Review,2(1),1-14。  new window
18.Padden, Michael、Jenkins, Thomas(20040223)。Food and Drug Law: Hatch-Waxman Changes。The National Law Journal。  new window
19.黃慧嫺(20040400)。淺談歐盟學名藥規範之新近發展。科技法律透析,16(4),9-14。  延伸查詢new window
會議論文
1.Waters, David(2003)。The Need to Protect Clinical Research Data of New Pharmaceuticals。Seminar on IPR Protection and Enforcement between Taiwan and Europe,(會議日期: October 7-8, 2003)。  new window
2.Perez, Meir(2004)。Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access。UNCTAD-ICTSD Dialogue on Ensuring Policy Options for Affordable Access to Essential Medicines conference,(會議日期: 12-16 Oct. 2004)。Bellagio:University of Haifa。  new window
研究報告
1.EGA。A Better Pill to Swallow--Myths and Realities of the Pharmaceutical Industry。European Generic Medicines Association。  new window
學位論文
1.林國塘(2003)。均等論在專利審查時適用之研究(碩士論文)。世新大學。  延伸查詢new window
圖書
1.Pharmaceutical Research and Manufacturers of America(2003)。Pharmaceutical Industry Profile 2003。Washington, DC:PHRMA。  new window
2.劉尚志、王敏銓、張宇樞、林明儀(2005)。美台專利訴訟--實戰暨裁判解析。元照出版有限公司。  延伸查詢new window
3.羅傳賢(2000)。行政程序法論。臺北:五南圖書出版股份有限公司。  延伸查詢new window
4.吳庚(1995)。行政法之理論與實用。臺北:三民書局。new window  延伸查詢new window
5.施啟揚(1993)。民法總則。台北:三民書局。  延伸查詢new window
6.劉江彬、黃俊英(1998)。智慧財產的法律與管理。台北:華泰文化事業股份有限公司。  延伸查詢new window
7.財團法人生物技術開發中心(2003)。2003醫藥產業年鑑。國家圖書館出版品。  延伸查詢new window
8.Robinson, Jeffery、廖月娟(2002)。一顆價值十億的藥丸。時報文化出版企業股份有限公司。  延伸查詢new window
9.蔡明誠(1998)。發明專利法研究。國立台灣大學法學院圖書部。new window  延伸查詢new window
10.羅明通(2004)。著作權法論。台英國際商務法律事務所。  延伸查詢new window
11.Danzon, P. M.(1997)。Pharmaceutical Price Regulation: National Policies versus Global Interest。Washington D.C.:American Enterprise Institute。  new window
12.Lee, Chi-Jen(1993)。Development and Evaluation of Drugs: From Laboratory through Licensure to Market。CRC press。  new window
13.Nick, Bertolotti(1994)。Valuing Intellectual Property。New York:John Wiley & Sons。  new window
14.Parisian, M. D. S.(2001)。FDA Inside and Out。Fast Horse Press。  new window
15.Smith, M. C.、Kolossa, E. M.、Perkins, G.、Sirker, Bruce R.(2002)。Pharmaceutical Marketing Principles, Environment, and Practice。Binghamton:Haworth Inc.。  new window
16.de Ridder, Jonathan。Data Exclusivity: Further Protection for Pharmaceuticals。Thompson Leagal & Regulatory Limited。  new window
17.Landou, R.、Achilladelis, S.、Scriabine, A.(1999)。Pharmaceutical Innovation - Revolutionizing Hunan Health。Chemical Heritage Press。  new window
18.Correa, Carlos María(2002)。Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreements。South Center。  new window
單篇論文
1.de Ridder, Jonathan(2003)。Data Exclusivity: Further Protection for Pharmaceiticals,Allens Arthur Robinson Law Firm。  new window
2.NIHCH(2002)。A Primer: Generic Drugs, Patents and the Pharmaceutical Marketplace。  new window
3.NICH。Prescription Drugs and Intellectual Property Protection- finding right balance between access and innovation。  new window
4.Argentina(19900514)。Communication from Argentina, Brazil, China, Colombia, Cuba, Egypt, India, Nigeria, Peru, Tanzania and Uruguay(MTN.GNG/NG11/W/71)。  new window
5.Japan(19990515)。Main Elements of a Legal Text for TRIPS(MTN.GNG/NG11/W/74)。  new window
其他
1.Animal Protection Institute。Fact Sheet: Animal Testing and Alternatives,http://www.api4animals.org/88.htm。  new window
2.(2004)。The Hatch-Waxman Act: Promoting Competition and Strengthening Patents,Catalina & Associates, Counselors at Law。  new window
3.EGA。Competition and Affordability in Biopharmaceuticals,http://www.egagenerics.com。  new window
4.(2000)。EGA Position Paper: Data Exclusivity--A Major Obstacle to Innovation and Competition in the EU Pharmaceutical Sector。  new window
5.IFPMA(2005)。A Review of Existing Data Exclusivity Legislation in Selected Countries-Fifth Revised Version,www.ifpma.org/documents/NR2799/DataExclusivity_2005.pdf。  new window
 
 
 
 
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