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題名:臺灣創新藥與學名藥專利之平衡與發展--以美國、臺灣學名藥之豁免為例
書刊名:財產法暨經濟法
作者:王芳
作者(外文):Wang, Fang
出版日期:2019
卷期:56
頁次:頁135-179
主題關鍵詞:創新藥學名藥專利藥品Hatch-Waxman法案Bolar例外試驗豁免BiosimilarGeneric drugPatented drugHatch-Waxman ActBolar exceptionExperimental exemption
原始連結:連回原系統網址new window
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  • 被引用次數被引用次數:期刊(0) 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:0
  • 共同引用共同引用:59
  • 點閱點閱:4
期刊論文
1.Hess, Andrew M.、Rothaermel, Frank T.(2011)。When are assets complementary? Star scientists, strategic alliances, and innovation in the pharmaceutical industry。Strategic Management Journal,32(8),895-909。  new window
2.李素華(2006)。論強制授權制度在醫藥專利權之適用。生物倫理通訊,21,57-75。  延伸查詢new window
3.王立達(20040400)。從TRIPS協定與公眾健康爭議論專利強制授權之功能與侷限。科技法學評論,1(1),215-246。new window  延伸查詢new window
4.Levin, Richard C.、Klevorick, Alvin K.、Nelson, Richard R.、Winter, Sidney G.、Gilbert, Richard、Griliches, Zvi(1987)。Appropriating the returns from industrial research and development。Brookings Papers on Economic Activity,36(3),783-831。  new window
5.Raubicheck, Charles、White, Barry S.、Kowalski, Thomas J.、Brown, Daniel G.、Leahy, Amy、Fekete, Pamela(2003)。Integra v. Merck: A mixed bag for research tool patents。Nature Biotechnology,21(9),1099-1101。  new window
6.張仁平(20050900)。醫療方法專利的國際制度比較與趨勢探討。智慧財產權月刊,81,57-95。new window  延伸查詢new window
7.Mansfield, E.(1986)。Patents and Innovation: an Empirical Study。Management Science,32(2),173-181。  new window
8.Jung, Kate Y.(2014)。HATCH-Waxman's Safe-Harbor Provision for Pharmaceutical Development: A Free Ride for Patent Infringers?。The John Marshall Review of Intellectual Property Law,13,445-462。  new window
9.傅冬卿、陳鋕雄(20131200)。論生物相似性藥品上市審查規範:以美國生物藥品價格競爭與創新法為師或為鑒?。智慧財產評論,11(2),107-171。new window  延伸查詢new window
10.Hagedoorn, John、Wang, N.(2012)。Is there complementarity or substitutability between internal and external R&D strategies?。Research Policy,41(6),1072-1083。  new window
11.丁錦希(2006)。美國藥品專利期延長制度淺析--Hatch-Waxman法案對我國醫藥工業的啟示。中國醫藥工業雜誌,37,114-117。  延伸查詢new window
12.朱向珺、邵蓉(2006)。美國Hatch-Waxman法案及其對我國藥品註冊制的啟示。中國藥業,15(17),16-17。  延伸查詢new window
13.李嘉沂、劉馥寧(2008)。Trips之下首例藥品強制授權輸往盧旺達。科貿法訊,76,1-3。  延伸查詢new window
14.胡瀟瀟(2010)。藥品專利「Bolar例外」制度的利益平衡--兼評「Bolar例外」在美國的創立、發展及其啟示。求索,2010(1),150-151。  延伸查詢new window
15.黃珮珍、王立達(20120600)。專利法對醫藥衍生發明之合理評價--以已知物質衍生物為中心。成大法學,23,35-82。new window  延伸查詢new window
16.梁志文(2009)。論TRIPS協議下的國家自主性--知識產權正義論的視角。法治研究,2009(5),15-22。  延伸查詢new window
17.程永順、吳莉娟(2018)。創新與仿製的平衡與發展--評Hatch-Waxman法案對美國醫藥產業的貢獻。科技與法律,2018(1),1-9。  延伸查詢new window
18.褚童(2013)。論藥品試驗數據保護中的數據獨占保護制度。金陵法律評論,2013(1),296-306。  延伸查詢new window
19.趙軼姝、姚建軍(2008)。從美國專利法規定的「Bolar Exception」引發的思考--兼評中國專利法第十一條的適用。知識產權,18(2),66-69。  延伸查詢new window
20.趙曦(2009)。創新藥與仿製藥的較量--美國HATCH-WAXMAN法案簡介。中國發明與專利,2009(10),80-81。  延伸查詢new window
21.樓杜鵑(2011)。藥品專利Bolar例外條款的發展和應用。中國發明與專利,2011(7),80-82。  延伸查詢new window
22.鬱慶華(2013)。我國仿製藥與原研藥的一致性評價。上海醫藥,2013(5),35-37。  延伸查詢new window
23.Hofer, Adam N.、Abraham, J. M.、Moscovice, I.(2011)。Expansion of Coverage under the Patient Protection and Affordable Care Act and Primary Care Utilization。The Milbank Quarterly,89(1)。  new window
24.Galasso, Alberto、Schankerman, Mark(2010)。Patent Thickets, Courts, and the Market for Innovation。The RAND Journal of Economics,41(3),472-503。  new window
25.Chobin, N.(2006)。What Can We Learn from AbTox Case?。OR Manager,22(8)。  new window
26.Coggio, B. D.、Cerrito, F. D.(2002)。The Safe Harbor Provision of the Hatch-Waxman Act: Present Scope, New Possibilities, and International Considerations。Food and Drug Law Journal,57(2)。  new window
27.Goodson, S. H.(2010)。Drug Discovery and the Impact of the Safe Harbor Provision of the Hatch-Waxman Act。Current Topics in Medicinal Chemistry,10(18)。  new window
28.Guttag, Eric W.(2004)。Immunizing University Research from Patent Infringement。Industry and Higher Education,18(3)。  new window
29.Maiti, Rituparna、Bhatia, Vikas、Padhy, Biswa Mohan、Hota, Debasish(2015)。Essential Medicines: An Indian Perspective。Indian Journal of Community Medicine,40(4)。  new window
30.Miewald, R.(1981)。Administrative Science Quarterly。The American Review of Public Administration,15(1),59-61。  new window
31.Mossinghoff, Gerald J.(1987)。Research-Based Pharmaceutical Companies: The Need for Improved Patent Protection Worldwide。Journal of Law & Technology,1987。  new window
32.Moy, B.(2011)。American Society of Clinical Oncology Policy Statement: Opportunities in the Patient Protection and Affordable Care Act to Reduce Cancer Care Disparities。Journal of Clinical Oncology,29(28)。  new window
33.Nussbaum, L. P.、Radice, J. D.(2009)。Where Do We Go Now? The Hatch Waxman Act Twenty-Five Years Later: Successes, Failures, and Prescriptions for the Future。Rutgers Law Journal,41(1/2)。  new window
34.Rosenkopf, L.、McGrath P.(2011)。Advancing the Conceptualization and Operationalization of Novelty in Organizational Research。Organization Science,22(5)。  new window
35.Sahu, Pradip K.、Mrksich, K. Shannon(2005)。Intellectual Property Law: The Hatch-Waxman Act: When Is Research Exempt From Patent Infringement?。ABA Journal,22(2)。  new window
36.Wharton, Jacob S.(2003)。'Orange Book' Listing of Patents under the Hatch-Waxman Act。Saint Louis University Law Journal,47。  new window
研究報告
1.Cohen, Wesley M.、Nelson, Richard R.、Walsh, John P.(2002)。Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not)。  new window
學位論文
1.母佳(2010)。BOLAR例外適用法律問題研究(碩士論文)。西南政法大學。  延伸查詢new window
2.林瑞芬(2011)。專利強制授權對專利權人權益影響之研究-- 以醫藥品專利為中心(碩士論文)。南台科技大學。  延伸查詢new window
圖書
1.Adelman, Martin J.、Rader, Randall R.、Klancnik, Gordon P.、鄭勝利、劉江彬(2011)。美國專利法。知識產權出版社。  延伸查詢new window
2.Correa, Carlos M.(2000)。Intellectual Property Rights, The WTO and Developing Countries。  new window
3.Mansfield, E.(1982)。Technology Transfer, Productivity, and Economic Policy。W. W. Norton and Company。  new window
4.經濟部工業局(2016)。2016生技產業白皮書。臺北市:行政院經濟部工業局。  延伸查詢new window
5.中國化學製藥工程學會(2018)。中國製藥工業發展報告。  延伸查詢new window
6.中國科技部社會發展司(2009)。生物醫藥發展戰略報告:專利篇。  延伸查詢new window
7.中國醫學科學院、中國醫藥工業資訊中心、中國食品藥品研究院(2017)。中國仿製藥藍皮書。  延伸查詢new window
8.侯慶辰(2019)。醫藥專利產業化。  延伸查詢new window
9.王建英(2005)。美國藥品申報與法規管理。  延伸查詢new window
10.Benssen, J.、Meurer, M. J.(2008)。Patent Failure--How Judges, Bureaucrats, And Lawyers Put Innovator At Risk。  new window
11.Federal trade Commission(2003)。To Prompt Innovation: The Proper Balance of Competition And Patent Law And Policy。  new window
12.Virts, J. R.、Weston, J. F.(1981)。Expectations and the Allocation of Research and Development Resources, Drugs and Health: Economic Issues and Policy Objective。  new window
13.Taylor, Christopher T.、Silberston, Z. Aubrey(1973)。The Economic Impact of the Patent System: A Study of the British Experience。Cambridge University。  new window
14.陳文吟(2006)。我國專利制度之研究。五南。new window  延伸查詢new window
其他
1.Food and Drug Administration。Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations,http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm。  new window
2.Cheryl and ein(20141114)。藥品開發上市攻防戰--專利法規,https://www.stockfeel.com.tw/專利法規/。  延伸查詢new window
3.生物類似藥VS.化學仿製藥,https://www.instrument.com.cn/news/20160328/187320.shtml。  延伸查詢new window
4.(20180307)。深度解碼專利連結:創新藥企、仿製藥企你們準備好了嗎?,http://ip.people.com.cn/n1/2018/0307/c179663-29852301.html。  延伸查詢new window
5.楊柳青(20171101)。美國原研藥VS仿製藥三部曲:仿製藥公司的矛,https://www.sohu.com/a/201682771_100002916。  延伸查詢new window
6.(20180709)。誰是印度仿製藥之王:太陽製藥等收穫來自世界的黃牌,http://finance.sina.com.cn/chanjing/gsnews/2018-07-09/doc-ihezpzwt6903462.shtml。  延伸查詢new window
7.諸葛明(20130317)。藥品專利保護VS藥品試驗數據保護--不同國家藥品專利保護與藥品試驗數據保護屆滿期的計算,https://wenku.baidu.com/view/7c0008292f60ddccda38a059.html。  延伸查詢new window
8.學名藥介紹/問答集,http://www.tgpa.org.tw/page/about/index.aspx?kind=321。  new window
9.AASM(2018)。Policy Solutions to Lower Prescription Drug Costs,https://accessiblemeds.org/advocacy。  new window
10.Chen, Ying,Dikan, Jennifer,Heller, Jennifer,da Silva, Jorge Santos(20180717)。Five things to know about biosimilars right now,https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/five-things-to-know-about-biosimilars-right-now。  new window
11.European Generics Medicines Association。The Role of Generic Medicines In Sustaining Healthcare Systems: A European Perspective,https://www.medicinesforeurope.com/wp-content/uploads/2016/03/infographic-ims.pdf。  new window
12.FDA。ANDA Submissions--Content and Format of Abbreviated New Drug Applications; ANDA FILLING CHECKLI,http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm。  new window
13.Government of Canada。Canada's Access to Medicines Regime,https://www.canada.ca/en/health-canada/services/canada-access-medicines-regime.html。  new window
14.IQVIA(2019)。The Global Use of Medicine in 2019 and Outlook to 2023,https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf?=1554560868890。  new window
15.Mahn, Terry G.,Doyle, Brian J.(2013)。Hatch-Waxman Developments: Artificial Infringement by Artifical Drugs,https://www.fr.com/news/hatch-waxman-developments-artificial-infringement-by-artificial-drugs/。  new window
16.WHO(2018)。Ten years review: Access to medicines,http://www.who.int/publications/10-year-review/en/。  new window
圖書論文
1.鄭師安(2005)。模糊未明之歐美生技學名要規範。生技法律解碼。  延伸查詢new window
 
 
 
 
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