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題名：醫藥發明之專利個案探討：以我國長青樹藥品專利為例
書刊名：國立臺灣大學法學論叢
作者：李素華
作者(外文)：Lee, Su-hua
出版日期：2012
卷期：41:2
頁次：頁647-723
主題關鍵詞：醫藥發明；醫藥專利；代謝物；組合藥品；藥品併用；學名藥；專利權；公共衛生；可專利性；Pharmaceutical invention；Pharmaceutical patent；Metabolite；Combination preparation；Combination therapy；Generic medicine；Patent right；Public health；Patentability
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(8) 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:6
  • 共同引用共同引用:101
  • 點閱點閱:306
〈摘要〉 專利法賦予發明人於一定期間享有排他性權利，其乃鼓勵醫藥研發之重要制度。相較於其他產業，醫藥領域之研發成本高及風險大，法律制度上應使醫藥業者之研究成果獲得足夠保護及享有研發誘因。相對的，醫藥發明若受到過廣的智慧財產保護，不僅不利於學名藥廠參與競爭，亦對公共衛生政策之落實有不利影響。近年來，醫藥專利權行使而阻礙學名藥上市及醫藥領域之「長青樹專利」問題，在國際間引起關注與討論，醫藥業者不當利用專利策略之現象，亦已在我國浮現。本文以我國准予之活性代謝物、組合藥品及藥品併用醫藥組成物等專利個案為例，探討醫藥發明之可專利性標準及其權利行使問題。
Abstract Patent law plays a decisive role in stimulating the development of new medical products by offering an exclusive right as incentive for investing in expensive and long-term research. Without patents, existing medical products would not have been invented, and innovative and better medical products needed to overcome the diseases would not be developed. However, the tendency of patent protection expansion and the inadequate enforcement of patent rights in the pharmaceutical fields seem to impede the access of medicine and adversely affect the implementation of public health. Also the issues over patent-related barriers to market entry for generic medicines and "evergreening patents" in pharmaceutical industry have aroused strong opinions from the public in recent years. It is noteworthy that the inappropriate development and implementation of pharmaceutical patent strategy occur in Taiwan too. This article reviews the patentability of pharmaceutical inventions and enforcement of patent rights from Taiwan Jurisprudence, using the active metabolite, combination preparation and compositions of combination therapies as examples.
期刊論文
1.Fellmeth, Aaron Xavier(2004)。Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data under the TRIPS Agreement。Harvard International Law Journal，45，443。  new window
2.李素華(20070300)。論試驗實施例外及其在醫藥專利權適用之問題。華岡法粹，37，191-229。new window  延伸查詢new window
3.林宜男、許佳惠(20050300)。WTO醫藥專利與公共健康議題之研析--兼論我國未來之發展趨勢。清華科技法律與政策論叢，2(1)，205-257。new window  延伸查詢new window
4.倪貴榮(20030100)。WTO智慧財產權保護與公共健康議題之發展趨勢。經社法制論叢，31，129-158。  延伸查詢new window
5.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
6.張仁平(20011200)。臺灣中草藥專利保護之回顧與前瞻。智慧財產權月刊，36，3-22。new window  延伸查詢new window
7.熊誦梅(20080900)。從藥品仿單談著作權之保護界線及行政法對民刑法之規範效應--評學名藥藥品仿單之相關法院裁判及檢察實務。月旦法學，160，265-278。new window  延伸查詢new window
8.林首愈、賴文智(20071000)。我國學名藥品的仿單著作權問題。智慧財產權月刊，106，74-93。new window  延伸查詢new window
9.黃慧嫺、王怡蘋(20090800)。藥品仿單涉及的著作權問題之另一種思考--從禾利行vs.美時化學製藥案談起。科技法律透析，21(8)，36-60。  延伸查詢new window
10.Lee, Su-Hua(2011)。專利物品「使用」行為之意涵。月旦法學雜誌，191，205-215。  延伸查詢new window
11.Childs, D. W.(2005)。The World Health Organization’s prequalification program and its potential effect on data exclusivity laws。Food & Drug Law Journal，2005(60)，79-97。  new window
12.Kadidal, S.(1996)。Digestion as infingement: The problem of pro-drugs。Journal of the Patent and Trademark Office Society，78，241-274。  new window
13.Gassner, U. M.(2004)。Unterlagenschutz im Europäischen Arzneimittelrecht。GRUR Int.，2004，983-994。  new window
14.Koenig, C.、Müller, E.-M.(2000)。EG-rechtliche Privilegierung der Hersteller von Arzneimitteln für seltene Krankheiten (Orphan Medicinal Products) durch Einräumung von Alleivertxiebsrechten versus Patentrecht。GRUR Int，2000，121-129。  new window
15.Suchy, H.(1992)。Patentrestlaufzeit neuerer pharmazeutischer Wirkstoffe。GRUR，1992，7-13。  new window
會議論文
1.Wang, Richard Li-Dar(2010)。託古改制或重新出發：從Bilski案看美國方法專利標的適格之最新發展。台北。  延伸查詢new window
2.Lee, Su-Hua(2010)。兼顧創新研發與公共衛生：生技及醫藥專利權保護與實施之省思。台北。  延伸查詢new window
3.Goddar, H.(2009)。The provision and case law of contributory patent infringement in Germany。Taipei。  new window
學位論文
1.李素華(2006)。從公共衛生之觀點論醫藥專利權之保護與限制(博士論文)。臺灣大學。new window  延伸查詢new window
2.王世晞(2004)。製藥產業之演進、現況、與趨勢(碩士論文)。國立臺灣大學。  延伸查詢new window
3.Kao, Yun-Wen(2009)。組合藥品可專利性要件之探討：以我國第592696號專利為例。國立清華大學。  延伸查詢new window
4.Su, Chien-Chih(2004)。藥品查驗登記制度與智慧財產權保護。東吳大學。  延伸查詢new window
圖書
1.楊代華(2008)。處方藥產業的法律戰爭：藥品試驗資料之保護。元照。new window  延伸查詢new window
2.Kieff, F. S.、Newman, P.、Schwartz, H. F.、Smith, H. E.(2008)。Principles of patent law: Cases and materials。New York：Thomson Reuters。  new window
3.Thomas, John R.(2005)。Pharmaceutical patent law。D.C.：BNA Books。  new window
4.Müller, Eva-Maria(2003)。Die Patentfähigkeit von Arzneimitteln: der gewerbliche Rechtsschutz für pharmazeutische, medizinische und biotechnologische Erfindungen。Springer。  new window
5.林彩瑜(2009)。貿易與公共衛生之法律問題：世界貿易組織法律研究。台北：元照。  延伸查詢new window
6.謝銘洋(2011)。智慧財產權法。台北：謝銘洋。  延伸查詢new window
7.楊崇森(2007)。專利法理論與運用。台北：三民書局股份有限公司。  延伸查詢new window
8.蔡明誠(2000)。發明專利法研究。臺北：蔡明誠。new window  延伸查詢new window
9.Kraßer, Rudolf(2009)。Patentrecht: ein Lehr- und Handbuch zum deutschen Patent und Gebrauchsmusterrecht, Europäischen und Internationalen Patentrecht。C.H. Beck。  new window
10.Chen, Jau-Hua、Chong, Ching-Hu、Chang, Nei-Wen、Cheng, Yao-Chen(2010)。學名藥試驗免責規範之探討。基因體醫學研發倉噺與智慧財產權。台北。new window  延伸查詢new window
11.Intellectual Property Office, Ministry of Economic Affairs(2009)。專利審査基準。台北。  延伸查詢new window
12.Wang, Tze-Chien(2006)。侵櫂行為法(ニ)：特殊侵權行為。台北。  延伸查詢new window
13.Lee, Su-Hua、Shieh, Ming-Yan(2010)。生技醫療產業所面對之新興專利課題－基因檢測、細胞治療與基因治療之專利保護與權利限制。基因體醫學研發倉噺與智慧財產權。台北。new window  延伸查詢new window
14.Lee, Su-Hua(2010)。基因及基因醫藥之專利法制發展趨勢。基因體醫學研發倉噺與智慧財產權。台北。new window  延伸查詢new window
15.Lin, Chou-Fu(2011)。專利法。台北。  延伸查詢new window
16.Sun, Hsiao-Ping(2008)。處方藥產業的法律戰爭：專利侵權之學名藥實驗例外。台北。  延伸查詢new window
17.Thomas, G.(2003)。Fundamentals of medicinal chemistry。New York。  new window
18.Grubb, P. W.、Thomsen, P. R.(2010)。Patents for chemicals, pharmaceuticals and biotechnology: Fundamentals of global law, practice and strategy。New York。  new window
19.Mueller, Janice M.(2009)。Patent law。Aspen Publishers。  new window
20.Benkard, G.(2006)。Patentgesetz: GebrauchsmustergesetzPatG。München。  new window
21.Busse, R.(2003)。Patentgesetz: unter Berücksichtigung des Europäischen Patentübereinkommens und des Patentzusammenarbeitsvertrags。Berlin。  new window
22.Kühnen, T.、Geschke, E.(2010)。Die Durchsetzung von Patenten。Köln：Carl Heymanns。  new window
23.Niioka, H.(2003)。Klinische Versuche im Patentrecht: eine rechtsvergleichende Untersuchung des europäischen, U. S. -amerikanischen und japanischen Patentschutzes von pharmazeutischen Erfindungen。Köln。  new window
24.Schulte, R.(2008)。Patentgesetz mit Europäischem Patentübereinkommen。Köln。  new window
25.Wolfrum, R.、Stoll, P.-T.、Franck S.(2002)。Die Gewährleistung freier Forschung an und mit Genen und das Interesse an der wirtschaftlichen Nutzung ihrer Ergebniss。Franlcfurt am Main。  new window
26.Deutsch, E.、Spickhoff, A.(2003)。Medizinrecht: Arztrecht, Arzneimittelrecht, Medizinprodukterecht und Transfassionsrecht。Berlin。  new window
其他
1.Federal Trade Commission(2003)。To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy，http://www.ftc.gov/os/2003/10/innovationrptsummary.pdf， 2008/08/28。  new window
2.Intellectual Property Office, Ministry of Economic Affairs(2004)。專利侵害鑑定要點(草案)，台北。  延伸查詢new window
3.American Chamber of Commerce in Taipei(2010)。2010 Taiwan white paper，http://www.amcham.com.tw/component/option.com_docman/task.cat_view/gid.260/ltemid.377/。  new window
4.Baker, D.(2005)。Bird flu fears: Is there a better way to develop drugs?，http://www.cepr.net/documents/publications/intellectual_property_2005_10.pdf。  new window
5.Glover, G. J.(2002)。Competition in the Pharmaceutical Marketplace，http://www.flc.gov/opp/intellect/020319gregoryjglover.pdf。  new window
6.European Commission(2008)。Pharmaceutical sector inquiry: Preliminary report，http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf。  new window
7.Fair Trade Commission & Department of Justice(2004)。Improving health care: A dose of competition，http://www.ftc.gov/reports/healthcare/040723healthcarerpt.pdf。  new window
8.Pharmaceutical Research and Manufacturers of America(2010)。New Drug Approvals in 2010，http://www.phrma.org/sites/default/files/422/newdrugapprovalsin2010.pdf。  new window
9.New, W.(2011)。Indian supreme court to hear Novartis challenge to India’s patent law，http://www.ip-watch.org/weblog/2011/09/06/indian-supreme-court-to-hear-novartis-challenge-to-india-patent-law/?utm_source=post&utm_medium=email&utm_campaign=alerts。  new window
10.Organisation for Economic Co-operation and Development(2002)。Genetic inventions, intellectual property rights and licensing practices，http://www.oecd.org/dataoecd/42/21/2491084.pdf。  new window
11.Shu, Ge(2001)。The Japanese patent examination and training system，http://www.jpo.go.jp/torikumi_e/kokusai_e/asia_ip_。  new window
12.Brain, C.(2011)。India: Novartis hearing postponed，http://www.ip-watch.org/weblog/2011/11/30/india-novartis-hearing-postponed/?utm_source=post&utm_medium=email&utm_campaign=alerts。  new window
13.Bucknell, D.(2008)。Stop press — Pfizer and Ranbaxy Settle Lipitor dispute (mostly) Worldwide，http://www.inondaq.com/article.asp?articleid=62114。  new window
14.Congressional Budget Office(2011)。27 preserve access to Affordable Generics Act，http://aging.seuate.gov/publications/s27.pdf。  new window
15.Correa, C. M.(2001)。Trends in drug patents - Case studies. Buenos Aires: Ediciones Corregidor，http://apps.who.int/medicinedocs/fr/d/Js4915e/l.html。  new window
16.European Commission(2011)。2nd report on the monitoring of patent settlements, period: January-December 2010，http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/patent。  new window
17.European Commission(2009)。Pharmaceutical sector inquiry: Final report，http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf。  new window
18.Fair Trade Commission(2002)。Generic drug entry prior to patent expiration - An FTC study，http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf。  new window
 
 
 
 
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