:::

詳目顯示

回上一頁
題名:由智財法律制度與紛爭處理形塑台灣醫藥品生命週期發展
作者:蘇嘉瑞
作者(外文):Su, Chia-Jui
校院名稱:國立交通大學
系所名稱:科技法律研究所
指導教授:陳鋕雄
學位類別:博士
出版日期:2016
主題關鍵詞:生命週期管理法學實證分析智慧財產權紛爭醫藥品專利專利連結Lifecycle managementEmpirical legal analysisI.P. disputesPharmaceuticalsPatent linkage
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(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:0
  • 點閱點閱:3
在生技製藥的國際競爭上,智財法律制度、藥政管理機制與產業發展策略常常交互影響,故有關醫藥品智財法律制度與紛爭處理模式的法學研究上,若能結合實證研究、管理理論與類型化架構,將能建立起智財法律管理與市場競爭策略的整體生態鏈視野。
本研究係以藥物生命週期管理(Pharmaceutical Lifecycle Management, PLM)理論,依據競爭藥品在時間軸上的相對定位,從產業化角度來對台灣智財法院藥品專利訴訟進行法學實證與比較法分析,建構起台灣醫藥品智財紛爭的生命週期模型,而能在藥品生態系裡將智財法律實務與產業管理理論對接。藥品智財紛爭類型化及整體操作模型,則包含了試驗免責、長青專利、暫時禁制令、專利侵權、仿單著作、藥品商標、專利連結及不公平競爭等實務紛爭。
最後並以策略管理觀點,利用產品類型化的法學實證分析、生命週期化的智財紛爭模型、以及國際貿易化的專利立法制度等不同視角,對台灣智財法律制度及製藥產業發展提出建議。
In the international competition of pharmaceutical industries, intellectual property (IP) , pharmaceutical administration and industrial development often interact with each other. Therefore, to combine empirical legal studies, management theory and structuralized operation model, will be able to establish the whole ecological perspective on intellectual property management and market competition strategy.
Under the theory of pharmaceutical lifecycle management (PLM), by comparing the patented and generic drugs on the time frame, this research firstly analyzes the patent litigations of Intellectual Property Court in Taiwan through empirical and comparative legal analysis. By integrating judicial studies and business management, the operation model of PLM on pharmaceutical IP disputes includes research exemption, evergreen patents, injunction orders, patent infringements, labeling copyrights, trademarks squatting, patent linkage and unfair competition and other substantive disputes.
Finally, this research proposes legislative and industrial suggestions on pharmaceutical IP systems from three interdisciplinary perspectives including pharmaceutical orientation of empirical legal study, LCM modelization of IP dispute strategy, and global trade consideration of IP legislation system.
一、中文書籍

1. 汪渡春,公平交易法,增訂五版,五南出版社,2013年8月。

2. 劉尚志編著,台灣專利法制與判決實證,初版,元照出版社,2015年5月。

3. 劉國讚,專利法之理論與實用,元照出版社,二版,2014年1月。

4. 謝銘洋,智慧財產權法,四版,元照出版社,2013年


二、中文期刊

1. 王立達、陳師敏,專利間接侵權之制度規範:我國判決實證研究與法制建議,科技法學評論,11卷2期,頁41-86,2014年。

2. 王立達、陳蔚奇,學名藥上市審查之專利連結制度:從美國經驗檢證其存立基礎與制度設計,國立臺灣大學法學論叢,第39卷第4期,頁349-406,2010年12月。

3. 李素華; 醫藥發明之專利個案探討:以我國長青樹藥品專利為例,國立臺灣大學法學論叢,41期2卷,頁647-723 ,2012年06月。

4. 李森堙,研究工具與查驗登記試驗免責:談美國判決見解與我國專利法修正,科技法律透析,第21卷 第11期,頁2-6,2009年11月。

5. 李謀進,全民健保政策對藥品生命週期的影響 — 以Cefamezin, Stilnox為例,藥學雜誌,第27卷第1期,2011年3月。

6. 林建興、呂紹誠、彭光裕,服務導向架構治理系統研發,電信研究,40期6卷,頁681-698,2010年12月。

7. 林首愈,專利扣合機制之介紹以及引進我國法制之評估,臨床試驗中英文季刊,第2 卷,2頁,2007年8月。

8. 許芳銘,電子檔案生命週期管理,檔案季刊,9期3卷,頁4-17,2010年9月。

9. 許義明,論生技方法之可專利性--從In re Bilski判決談起,萬國法律,第178期,頁2-12,2011年8月。

10. 陳鋕雄、劉庭妤,公眾健康與消費者自主權的平衡—重估我國保健食品的法制架構,司法新聲,107期,頁32-46,2013年7月。

11. 陳豐年,論醫藥品強制授權:兼評2011年臺灣專利法相關修正,智慧財產權,第175期,頁55-99,2013年7月。

12. 陳俞沛,全民健保法律關係與責任歸屬之變遷,臺灣法學雜誌,第163期,頁163,2010年11月。

13. 黃國昌,法學實證研究方法初探,月旦法學雜誌,第175期,頁142-153,2009年。

14. 黃慧嫺、王怡蘋,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,頁50,2009年8月11

15. 世昌,生技藥品商機引爆各國生物相似性藥品查驗爭議,生技與醫療器材報導,第118期,頁9,2009年5月。

16. 莊春發;市場的迷思:論市場定義在公平交易法應用之困境,產業結構與公平交易法,中央研究院中山人文社會科學研究所專書(32),翟宛文主編,頁173-177,1994年6月。

17. 馮震宇,藥品專利與競爭法之互動--從學名藥逆向付款爭議談起,專利師,第10期,頁98-125,2012年07月。

18. 傅冬卿、陳鋕雄,論生物相似藥品上市審查規範:以美國生物藥品價格競爭與創新法為師或為鑒?智慧財產評論第11卷第2期,頁107-172,2013年12月;

19. 張弘欣、陸大榮、萬鍾汶,關係管理對研發委外作業績效之影響―以台灣生技產業委託研究為例,生物產業科技管理叢刊,第三卷第二期,頁45-76,2012年。

20. 熊誦梅,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,第160期,頁268-269,2008年9月。

21. 趙振傑,企業專利佈局與訴訟策略分析:以行動智慧裝置為例,成功大學電信管理研究所101年度碩士論文,頁19-27。

22. 劉尚志、林三元、宋皇志,走出繼受,邁向立論:法學實證研究之發展,科技法學評論,第3卷第2期,2006年10月。

23. 劉尚志、湯舒涵、張添榜,專利進步性要件之判決分析;由美國專利案例觀照台灣最高法院及最高行政法院判決,台灣法學雜誌,220期,頁99-116,2013年3月。

24. 劉尚志、何彥蓉,公平會管制事業警告函管制效果之實證研究─以懸疑效果為中心,公平交易季刊,第十七卷,第三期,頁51-97,2009年。。

26. 劉尚志、王俊凱、王思穎,美國專利損害賠償之計算方法,智慧財產訴訟新制專題研究,1-45頁,智慧財產法院,2010年25. 蔡惠如,「原創性」概念於著作權訴訟之運作,智慧財產權,149 期,頁100-105,2011年5月。

27. 蔡惠如,著作權合理使用概括規定之回顧與前瞻,智慧財產權,209期,頁4-25,2016年5月。

28. 劉孔中,論市場調查在商標法及公平交易法之應用,臺大法學論叢,26卷2期,頁173-195 (1997年1月)

29. 蕭郁溏、陳誌雄,從比較法觀點建構台灣專利連結制度,萬國法律,200期,頁92-11,2015年04月。 

30. 蘇嘉瑞、何曜琛,學名藥法律爭議--以試驗免責與仿單免責為例,生技法律解析,新學林出版股份有限公司,頁45-48,2012年3月。


二、外文書籍期刊

1. Alfred C. Server, Application of the Hatch-Waxman Act’s Safe Harbor Provision Following Momenta, 13 J. MARSHALL REV. INTELL. PROP. L. 1 (2013).

2. Andrew W. Torrance, Physiological Steps Doctrine, 23 Berkeley Tech. L.J. 1741, 1748-99 (2008)

3. Aaron S. Kesselheim, Lindsey Murtagh & Michelle M. Mello, Pay for Delay Settlements of Disputes over Pharmaceutical Patents, N Engl J Med 2011; 365:1439-1445, (October 2011)

4. Bret Dickey, Jonathan Orszag & Laura Tyson, An Economic Assessment of Patent Settlements in the Pharmaceutical Industry, 19 ANNALS HEALTH L. 367, 369 (2010)

4. Charles W. L. Hill, International Business Competing in the Global Marketplace, 6th ed. McGraw-Hill. (2007)

5. Chia-Jui Su, “Branded or Generic,” the Legal Analysis and Strategic Management of Pharmaceutical Patent Disputes—The Taiwan Model,, 3 NTUT J. of Intell. Prop. L. & Mgmt. 102 (2014)

6. Crane, Daniel A, Actavis, the Reverse Payment Fallacy, and the Continuing Need for Regulatory Solution, Minn. J. L. Sci. & Tech.15, no. 1 (2014): 51-9.

7. C. Scott Hemphill & Bhaven N. Sampat, Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals , 31 J. HEALTH ECON. 327–339, at 327-28 (2012 March)

8. Daniel Chow, Lessons from Pfizer's Disputes Over its Viagra Trademark in China, 27 Md. J. Int'l L. 82. at 98-102. (2012)

9. David Kennedy, Joseph E. Stiglitz, chapter 8:“ Institutional Design for China’s Innovation System: Implications for Intellectual Property Rights”, Law and Economics with Chinese Characteristics: Institutions for Promoting Development in the Twenty-First Century, Oxford University Press (2013)

10. Epstein, Richard A. and Kieff, F. Scott, Questioning the Frequency and Wisdom of Compulsory Licensing for Pharmaceutical Patents, 78 UNIVERSITY OF CHICAGO LAW REVIEW 71-93 (2011)

11. Fisher III, William W., and Felix Oberholzer-Gee., Strategic Management of Intellectual Property: An Integrated Approach, California Management Review 55, no. 4: 157–183. (Summer 2013)

12. Frederick M. Abbott, Review: The Trilateral Study on Health, Intellectual Property, and Trade: The Virtue in Paving a Cleared Roadway, J Int Economic Law 16 (2): 493-503. (2013)

13. Herbert J. Hovenkamp, Anticompetitive Patent Settlements and the Supreme Court’s Actavis Decision (Symposium: The Future of Reverse Payments in the Wake of FTC v. Actavis, Inc), 15 Minnesota Journal of Law, Science & Technology 3 (2014).

14. Himanshu Gupta, Suresh Kumar, Saroj Kumar Roy, R. S. Gaud, Patent protection strategies, J Pharm Bioallied Sci. 2010 Jan-Mar; 2(1): 2–7.

15. Jay P. Kesan, Gwendolyn G. Ball, How Are Patent Cases Resolved? An Empirical Examination of the Adjudication and Settlement of Patent Dispute, Washington University Law Review, Vol 84, No 2, 2006, 237-312; at 262-264

16. Jean 0. Lanjouw, A New Global Patent Regime for Diseases: U.S. and International Legal Issues, 16 HARV. J.L. & TECH. 85, 94-95 (2002); Robin C. Feldman, Rethinking Rights in Biospace, 79 Cal. L. REV. 1, 30 (2005)

17. Jiangyong Lu, Shangjin Wei, Yahong Li, Zhigang Tao, Penelope Chan. Viagra in China: A Prolonged Battle over Intellectual Property Rights, Asia Case Research Ctr. & Columbia Bus. Sch., at 90-92 (2010)

18. John C. O'Quinn, Protecting Private Intellectual Property from Government Intrusion: Revisiting SmithKline and the Case for Just Compensation, 29 PEPP . L.A. L. REV . L. REV. 435, at 465 (2002 April)

17. John R. Allison, Mark A. Lemley & Joshua Walker, Patent Quality and Settlement Among Repeat Patent Litigants, 99 Georgetown Law Review 677, at 678 (2011)

18. John Stark, Product Lifecycle Management: 21st Century Paradigm for Product Realisation, Springer publication, (Aug 2011)

19. Lee Epstein & Gary King, Exchange: Empirical Research and the Goals of Legal Scholarship:The Rules of Inference, 69 U. CHI. L. REV. 1, 19. at 3. (2002)

20. Lucas Miller, Has the Fight over Isolated DNA's Patent-Eligibility Opened a Trapdoor for Intellectual Property Rights to Other Extracted or Purified Substances?, 8 J. Health & Biomed. L. 471 (2013)

21. Mark A. Lemley & Carl Shapiro, Probabilistic Patents, 19 J. ECON. PERSP. 75, 91 (2005).

22. Martin A. Voet, Chapter 8: Putting it All Together, Product Life-Cycle Management, The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fourth Edition), at 151-16 (November, 2013)

23. Mei-Hsin Wang, Recent Patent Litigation on Pharmaceuticals in Great China, 2 NTUT J. OF INTELL. PROP. L. & MGMT. 58, at 60-62 (2013)

24. Michael Murray, Copyright, Originality, and the End of the Scenes a Faire and Merger Doctrines for Visual Works, 58 Baylor L. Rev. 779, at 787 (2006);

25. Raymond Vernon, International Investment And International Trade In The Life Cycle, the Quarterly Journal of Economics 80(2), 190-207 (1966)

26. Richard Li-dar Wang and Pei-Chen Huang, Patent Protection of Pharmacologically Active Metabolites: Theoretical and Technological Analysis on the Jurisprudence of Four Regions, 29 Santa Clara Computer & High Tech. L.J. 489 (2013).

27. Robin Feldman, Ending Patent Exceptionalism & Structuring The Rule Of Reason:The Supreme Court Opens The Door For Both, 15 Minn. J. L. Sci. & Tech. 61 (2014)

28. Rita Torre, Intellectual Property Rights vs. access to medicines: the impact on the CSR strategy of pharmaceutical companies: the case of GlaxoSmithKline,, dissertation, 26-30, (2013), http://repositorio.ucp.pt/handle/10400.14/13195

29. Scafidi, Susan, The "Good Old Days" of TRIPS: The U.S. Trade Agenda and the Extension of Pharmaceutical Test Data Protection, Yale Journal of Health Policy, Law, and Ethics: Vol. 4: Iss. 2, Article 7. 341-352 (2004)

30. Sergio Terzi, Abdelaziz Bouras, Debashi Dutta, Marco Garetti, Dimitris Kiritsis, Product Lifecycle Management - From Its History To Its New Role, Int. J. Product Lifecycle Management, Vol. 4, No 4, 360-387 (2010)

31. S. J. Liu, Strategic Management of Intellectual Assets: The Financial Service Platform UXB2B, Chinese Taipei, Strategic Intellectual Asset Management for Emerging Enterprises, pp.127-140,Asia-Pacific Economic Cooperation (APEC) Human Resource Development Working Group, Capacity Building Network (2010)

32. Sunny Chang, Combating Trademark Squatting in China: New Developments in Chinese Trademark Law and Suggestions for the Future, 34 Nw. J. Int'l L. & Bus. 337 (2014).

33. Tony Ellery, Neal Hansen, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand (Wiley eds. May 2012)

34. Tsai-Fang Chen, The Implications of ACTA for Asia’s Plurilateral Trade Agreements Regarding the Enforcement of Intellectual Property Rights, 8 Asian Journal of WTO & International Health Law and Policy 507 (2013)

35. Vincenzo Denicolò, Luigi Alberto Franzoni, The contract theory of patents, International Review of Law and Economics 23, 365–380. at 365. (2004)

36. William Choi, Bruce Den Uyl and Mat Hughes; Pay-For-Delay Practices in the Pharmaceutical Sector: Lundbeck, Actavis, and Others, Journal of European Competition Law & Practice 5 (1): 44-52. (2014)

37. Zoee Lynn Turrill, Finding The Patent Balance: The Novartis Glivec Case And The Trips Compliance Of India's Section 3(D) Efficacy Standard, 44 Geo. J. Int'l L. 1555 (2012).


三、碩博士論文

1. 何孟璁,論生物相似性藥品之上市規範與智慧財產保護,臺灣大學科際整合法律學研究所2009年度碩士論文

2. 張正輝,應用產品生命週期管理改善新產品開發之生產衝突研究,國立成功大學工程管理碩士在職專班104年度碩士論文

3. 魏瑞光,企業購併後產品生命週期管理系統之整合發展影響因子的研究─以I公司為例,國立政治大學經營管理碩士學程(EMBA)103年度碩士論文


四、網路資料

1. 林富傑,大陸智財法院發展與省思http://www.cnfi.org.tw/kmportal/front/bin/ptdetail.phtml?Part=magazine10404-541-9。(最後點閱時間: 20171201)

2. 李樹人、江慧珺,2016國內藥品銷售排名 癌症用藥占半數,2017-02-24 03:09聯合報 台北報導; https://udn.com/news/story/7266/2304328 (最後點閱時間: 20171201)

3. 黃欣,扳倒武田,健亞新藥官司勝訴,工商時報 https://tw.news.yahoo.com扳倒武田-健亞新藥官司勝訴-213000604.html (最後點閱時間: 20171201)

4. 陳秉訓,專利連結制度修法之系列觀察—I:立法目的;北美智權報168期,2016年9月21日,http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Industry_Economy/IPNC_160921_0705.htm (最後點閱時間: 20171201

5. 黃瑞媛,漫談憂鬱症: 臺大醫院http://epaper.ntuh.gov.tw/health/201103/health_2.html (最後點閱時間: 20171201)

6. 彭嚴燕,學名藥發展契機與挑戰,國家實驗室科技產業資訊室,2010年2月24曰,http://cdnet.stpi.org.tw/techroom/market/bio/2010/bio_10_001.htm

7. 魏怡嘉,「血好油,降血脂藥花健保近52億」;2017年02月24日 中國時報台北報導,http://www.chinatimes.com/newspapers/20170224000406-260114 (最後點閱時間: 20171201)

8. 鄭鴻達,專利連結條文有疑義,藥事法草案過初審仍待協商,自由時報2017-05-25, http://news.ltn.com.tw/news/politics/breakingnews/2079360 (最後點閱時間: 20171201)

9. 鄭崇生,川普簽署命令,美正式退出TPP;中央社:2017/01/24;http://www.cna.com.tw/news/firstnews/201701240010-1.aspx (last visit 2017/12/01)

10. 龍瑞雲,衛署:醫學中心上限今年19家,中央社2013年5月12日,https://tw.news.yahoo.com/%E8%A1%9B%E7%BD%B2-%E9%86%AB%E5%AD%B8%E4%B8%AD%E5%BF%83%E4%B8%8A%E9%99%90%E4%BB%8A%E5%B9%B419%E5%AE%B6-110417533.html。 (最後點閱時間: 20171201)

11. 中央健康保險署,新制健保藥價調整改革上路(1030327); https://www.mohw.gov.tw/cp-16-22298-1.html (最後點閱時間: 20171201)

12. 科化生技許弘卿 戰勝Merck alendronate (Fosamax)專利! http://alveice.blogspot.tw/2011/07/merck-alendronate-fosamax.html (最後點閱時間: 20171201)

13. 台灣東洋:東洋與禮來專利訴訟之和解聲明| 鉅亨網新聞中心2010/10/14,https://news.cnyes.com/news/id/3192875鉅亨網 (最後點閱時間: 20171201)

14. 健亞新聞稿:「本公司對日本武田藥品工業(股)公司要求侵權損害賠償之賠償金,已於今日匯入本公司指定帳戶」公開資訊觀測站重大訊息公告 2012.08.16 https://www.moneydj.com/KMDJ/News/NewsViewer.aspx?a=b2639aa2-ad20-4420-b389-aa6b9484f376 (最後點閱時間: 20171201)

15. 行政院新聞稿:行政院會通過「藥事法」部分條文修正草案 2016/08/04 http://www.mohw.gov.tw/news/572255971 (最後點閱時間: 20171201)

16. 豪森醫藥公司簡介,可參見http://www.hansoh.cn/index.html (最後點閱時間: 20171201)

17. 臺大醫院新藥進用申請作業相關規定.doc (104年10月27日第229次藥委會修正通過版) https://www.ntuh.gov.tw/phr/DocLib3/ (最後點閱時間: 20171201)

18智慧財產法院簡介http://ipc.judicial.gov.tw/ipr_internet/index.php?option=com_content&view=article&id=12&Itemid=100054 (最後點閱時間: 20171201)

19. 2003:Pfizer and Pharmacia Merger, http://www.pfizer.com/about/history/pfizer_pharmacia (last visit 2017/12/01)

20. BBC NEWS, China Court in Viagra Crackdown, (Dec. 28, 2006, 9:57 AM), http://news.bbc.co.uk/2/hi/business/6213835.stm (last visit 2017/12/01)

21. Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study. 2002, https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf (last visit 2017/12/01)

22. FDA issues draft guidance on biosimilar product development, available at http://www.fda. gov/newsevents/newsroom/pressannouncements/ucm291232.htm (last visit 2017/12/01)

23. Google, Facts about Google’s acquisition of Motorola, http://www.google.com/press/motorola/ (last visit 2017/12/01)

24.. Generic Drug Facts , at https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm#f1;以及imshealth.com. Quintiles IMS Institute: Reports. http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports (last visit 2017/12/01)

25. Larry Page, Lenovo to acquire Motorola Mobility, January 29, 2014; http://googleblog.blogspot.tw/2014/01/lenovo-to-acquire-motorola-mobility.html (last visit 2017/12/01)
.
26. Members: List Of Pic/S Participating Authorities, available at http://www.picscheme.org/members.php (last visit 2017/12/01)

27. Melanie Lee, Samuel Shen, Apple pays $60 million to settle China iPad trademark dispute, http://www.reuters.com/article/2012/07/02/us-apple-china-idUSBRE86104320120702 (last visit 2017/12/01)

28. Michael Wann, The Next Chapter: An open letter from Steve Ballmer and Stephen Elop: Microsoft to acquire Nokia’s devices & services business, license Nokia’s patents and mapping services , Sept. 03, 2013, http://www.microsoft.com/en-us/news/press/2013/sep13/09-02announcementpr.aspx (last visit 2017/12/01)

29. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, at http://www.accessdata.fda.gov/scripts/cder/ob/ default.cfm (last visit 2017/12/01)

30. Robert Kaminsky, Pharmaceutical Lifecycle Management Prior to Healthcare Reform, August 30, 2010 at 8:21 AM; https://medspanresearch.wordpress.com/2010/08/30/pharmaceutical-lifecycle-management-prior-to-healthcare-reform/ (last visit 2017/12/01)

31. Unified Patent Court in E.U., at https://www.unified-patent-court.org/ (last visit 2017/12/01)

32. Xinhua, Lan Hongguan, China to consider intellectual property court, 人民网 http://english.people.com.cn/90785/8458097.html (last visit 2017/12/01)
 
 
 
 
第一頁 上一頁 下一頁 最後一頁 top
:::
無相關著作
 
無相關點閱
 
QR Code
QRCODE