| 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。 | 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。 | 3. | Junod, Valerie(2004)。Drug Marketing Exclusivity under United States and European Union Law。Food and Drug Law Journal,59,479。 | 4. | Sell, Susan K.(2002)。Intellectual Property, Development, and Human Rights。Fla. J. Int'l L.,14,193。 | 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。 延伸查詢 | 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。 | 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。 延伸查詢 | 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。 | 9. | Edvinsson, Leif、Sullivan, Patrick(1996)。Developing a model for managing intellectual capital。European Management Journal,14(4),356-364。 | 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 | 11. | 林志六。七七公告與行政法之一般原則。藥政法規,10。 延伸查詢 | 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 | 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。 延伸查詢 | 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。 | 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)。 | 16. | Garboski, H.、Vernon, J.、DiMasi, J. A.(2002)。Returns on Rearch and Development for 1990s New Drug Introduction。Pharmacoeconomics,20S,11-29。 | 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。 | 18. | Padden, Michael、Jenkins, Thomas(20040223)。Food and Drug Law: Hatch-Waxman Changes。The National Law Journal。 | 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 | 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)。 | 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。 | 研究報告1. | EGA。A Better Pill to Swallow--Myths and Realities of the Pharmaceutical Industry。European Generic Medicines Association。 | 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 | 圖書1. | Pharmaceutical Research and Manufacturers of America(2003)。Pharmaceutical Industry Profile 2003。Washington, DC:PHRMA。 | 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 | 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 | 4. | 吳庚(1995)。行政法之理論與實用。臺北:三民書局。 延伸查詢 | 5. | 施啟揚(1993)。民法總則。台北:三民書局。 延伸查詢 | 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 | 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 | 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 | 9. | 蔡明誠(1998)。發明專利法研究。國立台灣大學法學院圖書部。 延伸查詢 | 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 | 11. | Danzon, P. M.(1997)。Pharmaceutical Price Regulation: National Policies versus Global Interest。Washington D.C.:American Enterprise Institute。 | 12. | Lee, Chi-Jen(1993)。Development and Evaluation of Drugs: From Laboratory through Licensure to Market。CRC press。 | 13. | Nick, Bertolotti(1994)。Valuing Intellectual Property。New York:John Wiley & Sons。 | 14. | Parisian, M. D. S.(2001)。FDA Inside and Out。Fast Horse Press。 | 15. | Smith, M. C.、Kolossa, E. M.、Perkins, G.、Sirker, Bruce R.(2002)。Pharmaceutical Marketing Principles, Environment, and Practice。Binghamton:Haworth Inc.。 | 16. | de Ridder, Jonathan。Data Exclusivity: Further Protection for Pharmaceuticals。Thompson Leagal & Regulatory Limited。 | 17. | Landou, R.、Achilladelis, S.、Scriabine, A.(1999)。Pharmaceutical Innovation - Revolutionizing Hunan Health。Chemical Heritage Press。 | 18. | Correa, Carlos María(2002)。Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreements。South Center。 | 單篇論文1. | de Ridder, Jonathan(2003)。Data Exclusivity: Further Protection for Pharmaceiticals,Allens Arthur Robinson Law Firm。 | 2. | NIHCH(2002)。A Primer: Generic Drugs, Patents and the Pharmaceutical Marketplace。 | 3. | NICH。Prescription Drugs and Intellectual Property Protection- finding right balance between access and innovation。 | 4. | Argentina(19900514)。Communication from Argentina, Brazil, China, Colombia, Cuba, Egypt, India, Nigeria, Peru, Tanzania and Uruguay(MTN.GNG/NG11/W/71)。 | 5. | Japan(19990515)。Main Elements of a Legal Text for TRIPS(MTN.GNG/NG11/W/74)。 | 其他1. | Animal Protection Institute。Fact Sheet: Animal Testing and Alternatives,http://www.api4animals.org/88.htm。 | 2. | (2004)。The Hatch-Waxman Act: Promoting Competition and Strengthening Patents,Catalina & Associates, Counselors at Law。 | 3. | EGA。Competition and Affordability in Biopharmaceuticals,http://www.egagenerics.com。 | 4. | (2000)。EGA Position Paper: Data Exclusivity--A Major Obstacle to Innovation and Competition in the EU Pharmaceutical Sector。 | 5. | IFPMA(2005)。A Review of Existing Data Exclusivity Legislation in Selected Countries-Fifth Revised Version,www.ifpma.org/documents/NR2799/DataExclusivity_2005.pdf。 | |