Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/125029
|
| Title: | 美國專利佈局之分析-以吉利德公司之C型肝炎藥物為例
Analysis of patent portfolio in the United States - Case study of Gilead Sciences, Inc. in Hepatitis C Drugs |
| Authors: | 鄭聖諭
Cheng, Sheng-Yu |
| Contributors: | 陳桂恒
Chan, Keith
鄭聖諭
Cheng, Sheng-Yu |
| Keywords: | 專利檢索
專利延續
C肝
IPC
橘皮書
Patent search
Patent continuation
HCV
IPC
Orange book |
| Date: | 2018 |
| Issue Date: | 2019-08-07 17:04:41 (UTC+8) |
| Abstract: | 本研究主要探討吉利德公司在美國的C型肝炎專利佈局策略，以個案研究的方式深入研究吉利德公司在專利相關的實際作為，並建議臺灣藥廠如何在美國專利制度下進行專利佈局以求自保。2011年至2017年C型肝炎藥物的市場上共有6家藥廠參與，並有11款的C型肝炎新藥上市，其中4款為吉利德公司所有。吉利德公司的專利共693件，且核准的專利數量逐年增加，顯示吉利德公司在研發及專利上持續投入大量資源。吉利德公司之C型肝炎專利共有196件，而物質專利的數量一直以來皆比其他類型來的多，且總是先申請物質專利，後續再申請組合物、適應症、製備方法、固定劑量組合等專利，顯示吉利德公司投入相當多的資源在物質專利。本研究認為吉利德公司使用組合式專利佈局，特別是吉利德公司的4種C型肝炎藥物中皆有使用到的物質專利組成最重要的核心，並於核心專利周圍再佈局其他專利以達到最佳的保護效果。2012年後吉利德公司陸續與多家藥廠及大學產生訴訟或提交仲裁，已終結的案件對吉利德公司都為正面效果或沒有產生明顯的負面效果，但仍有許多件訴訟到2017年底還在進行當中，但目前為止可看出吉利德公司的專利佈局可以有效防止自身專利被侵害，或可在專利侵權訴訟中順利脫身。
This study mainly explored the patent portfolio strategy of Gilead Sciences, Inc. (Gilead) in the United States regarding HCV, and conducted in-depth research on the actual patent-related practices of Gilead in a case-study manner, and suggested how Taiwanese pharmaceutical companies could conduct patent portfolio under United States patent system for self-protection. From 2011 to 2017, there were 6 pharmaceutical companies involved in the market of HCV drugs, and 11 new HCV drugs were launched, 4 of which were owned by Gilead. There were 693 patents owned by Gilead, and the number of issued patents were subsequently increased year by year, showing that Gilead has continued to invest substantial resources in R&D and applying for patent. Gilead owned 196 HCV patents, and the number of material patents was more than other types. Furthermore, Gilead always filed material patents first, followed by the patents regarding composition, indication, preparation method, fixed-dose composition, etc., indicating that Gilead has invested considerable resources in material patents. This study believed that Gilead used the form of composition patent portfolio. Particularly, the most important core was composed of the material patents used in Gilead’s all 4 HCV drugs, surrounded by other patents to achieve the best protective effect. After 2012, Gilead successively involved in several litigations and arbitrations with some pharmaceutical companies and universities. The terminated cases did not show any obvious negative effect on Gilead. Although there were many litigations still in progress at the end of 2017, so far it could show that Gilead’s patent portfolio could effectively prevent its patent from being infringed, or it could successfully get out in the patent infringement lawsuits. |
| Reference: | 中文部分
中文書籍
1. 王世仁 (2010)。生物科技專利導論-專利策略實務與迴避設計。新北：全華圖書。
2. 王世仁、王世堯 (2003)。智慧財產權剖析-論生物科技專利策略與實務。臺北：全華科技圖書。
3. 周延鵬 (2006)。虎與狐的智慧力-智慧資源規劃9把金鑰，第二版。臺北：天下文化。
4. 陳達仁 (2007)。專利檢索與分析，經濟部智慧財產局智慧財產培訓學院教材，第二版。臺北：國立臺灣大學科技整合法律學研究所。
5. 陳達仁、黃慕萱 (2009)。專利資訊檢索、分析與策略。臺北：華泰文化。
6. 曾陳明汝、蔡明誠 (2009)。兩岸暨歐美專利法，3版，頁286。臺北：新學林。
7. 楊智傑 (2014)。專利法，頁5-7。臺北：新學林。
8. 魯明德 (2014)。解析專利資訊，第四版。新北：全華圖書。
9. 謝曉光 (2010)。專利分類，經濟部智慧財產局智慧財產培訓學院教材，第二版。臺北：國立臺灣大學科技整合法律學研究所。
中文期刊
10. 朱淑尹 (2015)。美國專利連結制度中專利登錄的介紹與探討，智慧財產權月刊，196，20-33。
11. 阮明淑、梁峻齊 (2009)。專利指標發展研究。圖書館學與資訊科學，35，2，88-106。
12. 施雅儀 (2014)。從美國Myriad 案探討經分離DNA之專利適格性。智慧財產權月刊，189，48-69。
13. 徐立峰 (2015)。藥物的上市登記與管理。科學發展，505，6-11。
14. 張哲倫 (2015)。專利連結之歷史、緣由及其政策功能。智慧財產權月刊，196，5-19。
15. 葉士緯、洪菁蔓、周光宇 (2016)。我國導入臨時申請案制度之可行性探討。智慧財產權月刊，205，40-64。
16. 葉嘉新 (2006)。用以支持新藥臨床試驗進行的臨床前要求。臨床試驗中英文季刊，1，9-15。
17. 劉俊人、許景盛、高嘉宏 (2012)。慢性C型肝炎治療的新進展：從干擾素到直接抗病毒藥物。內科學誌，23，383-391。
18. 謝佩真、郭行道、卓文春、廖永樑、林靖南 (2009)。C型肝炎病毒基因分型及其臨床重要性。內科學誌，20，309-319。
19. 鍾順昌、廖啟成、陳玉芬 (2000)。美國專利早期公開制度對生物科技專利的影響。智慧財產權月刊，24，1-8。
碩博士論文
20. 吳東哲 (2015)。藥品的核准前專利爭端解決程序－美國專利連結為借鏡 (碩士論文)。國立政治大學法律科際整合研究所，臺北。
21. 高鼎懿 (2008)。美國專利延續案與布局策略之分析 (碩士論文)。國立交通大學管理學院碩士在職專班科技法律組，新竹。
研究報告
22. 理律法律事務所 (2014)。美國專利連結與橘皮書登錄制度研究，經濟部智慧財產局103年度委託研究報告。
其他
23. 馮志峰、吳佳珍、林詩莉 (2016)。申請美國專利的省錢之道 – 善用臨時申請案（Provisional Application for Patent）。網址：http://www.phycos.com.tw/articles/187。最後瀏覽日期：2018年4月22日。
24. 黃蘭閔 (2017)。分割案未能適用35 U.S.C 121保護的案例，北美智權報196期。網址：http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Laws/IPNC_171018_0201.htm。最後瀏覽日期：2018年5月17日。
25. 經濟部智慧財產局 (2015)。國際專利分類答客問，網址：https://www.tipo.gov.tw/public/Data/55614141571.pdf。最後瀏覽日期：2018年6月3日。
26. 潘榮恩 (2014)。美國專利延續案的操作討論。網址：http://enpan.blogspot.tw/2014/11/blog-post_17.html。最後瀏覽日期：2018年4月22日。
英文部分
英文書籍
27. Granstrand, Ove (1999). The Economics and Management of Intellectual Property. Northampton, MA: Edward Elgar.
英文期刊
28. Assefa, Yibeltal, Peter S. Hill, Anar Ulikpan, & Owain D. Williams (2017). Access to medicines and hepatitis C in Africa: Can tiered pricing and voluntary licencing assure universal access, health equity and fairness?. Globalization and Health, 13:73. doi: 10.1186/s12992-017-0297-6
29. Choo, Qui-Lim, George Kuo, Amy J. Weiner, Lacy R. Overby, Daniel W. Bradley, & Michael Houghton (1989). Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science, 244, 359-362.
30. DiMasi, Joseph A., Henry G. Grabowski, & Ronald W. Hansen (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs, Journal of Health Economics, 47, 20-33.
31. Iyengar, Swathi, Kiu Tay-Teo, Sabine Vogler, Peter Beyer, Stefan Wiktor, Kees de Joncheere, & Suzanne Hill (2016). Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis. PLOS Medicine, 5. doi: 10.1371/journal.pmed.1002032
32. Kaitin, KI (2010). Deconstructing the Drug Development Process: The New Face of Innovation. Clinical Pharmacology and Therapeutics, 87(3): 356–361. doi: 10.1038/clpt.2009.293
33. Moradpour, Darius, Francois Penin, & Charles M. Rice (2007). Replication of hepatitis C virus. Nature Reviews Microbiology, 5:453-463. doi: 10.1038/nrmicro1645
34. Poole, Raewyn M. (2014). Daclatasvir + Asunaprevir: First Global Approval. Drugs, 74:1559-1571. doi: 10.1007/s40265-014-0279-4.
35. Rosenthal, Elana S. & Camilla S. Graham (2016). Price and affordability of direct-acting antiviral regimens for hepatitis C virus in the United States. Infectious Agents and Cancer, 11:24. doi: 10.1186/s13027-016-0071-z
36. Scheel, Troels K. H. & Charles M. Rice (2013). Understanding the hepatitis C virus life cycle paves the way for highly effective therapies. Nat Med., 19(7): 837-849. doi: 10.1038/nm.3248
37. Shah, Nihar, Tracey Pierce, & Kris V. Kowdley (2013). Review of direct-acting antiviral agents for the treatment of chronic hepatitis C. Expert Opin. Investig. Drugs, 22(9): 1107-21. doi: 10.1517/13543784.2013.806482
38. Sternitzke, Christian (2010). Knowledge sources, patent protection, and commercialization of pharmaceutical innovations. Research Policy, 39, 810-821. doi:10.1016/j.respol.2010.03.001
39. Sternitzke, Christian (2013). An exploratory analysis of patent fencing in pharmaceuticals: The case of PDE5 inhibitors. Research Policy, 42, 542-551.
40. The Polaris Observatory HCV Collaborators (2017). Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. The Lancet Gastroenterology & Hepatology, 2, 161-176.
41. Wagner, Stefan & Simon Wakeman (2016). What do patent-based measures tell us about product commercialization? Evidence from the pharmaceutical industry. Research Policy, 45, 5, 1091-1102. doi: 10.1016/j.respol.2016.02.006
法院判決
42. Gilead Sciences, Inc. v. Merck & Co., Inc., Case No. 13-cv-04057-BLF (U.S. District Court, N.D. California, 2016).
43. Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc., Case No. 13-cv-01987 (U.S. District Court, Delaware, 2016).
44. Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 299 F. Supp. 3d 1034 (U.S. District Court, Minnesota, 2017).
新聞稿
45. Gilead Sciences (2006). Gilead Sciences to Acquire Myogen, Inc. for $2.5 Billion. Retrieved from: http://www.gilead.com/news/press-releases/2006/10/gilead-sciences-to-acquire-myogen-inc-for-25-billion.
46. Gilead Sciences (2015). Gilead Sciences Announces Acquisition of Phenex Pharmaceuticals’ Development Program for Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases. Retrieved from: http://www.gilead.com/news/press-releases/2015/1/gilead-sciences-announces-acquisition-of-phenex-pharmaceuticals-development-program-for-nonalcoholic-steatohepatitis-nash-and-other-liver-diseases.
47. Gilead Sciences (2017). Gilead Sciences Completes Acquisition of Kite Pharma, Inc.. Retrieved from:http://www.gilead.com/news/press-releases/2017/10/gilead-sciences-completes-acquisition-of-kite-pharma-inc.
48. Johnson & Johnson (2013). Japanese Health Authority Approves SOVRIAD™ for the Treatment of Genotype-1 Chronic HCV Infection. Retrieved from: http://www.investor.jnj.com/releasedetail.cfm?releaseid=793648.
研究報告
49. World Health Organization (2014). Guidelines for the Screening, Care and Treatment of Persons with Hepatitis Infection.
50. World Health Organization (2015). WHO Model List of Essential Medicines, 19th list.
51. World Health Organization (2016). Global health sector strategy on viral hepatitis 2016-2021.
52. World Health Organization (2017). Global hepatitis report.
53. World Health Organization (2017). WHO Model List of Essential Medicines, 20th list.
54. World Intellectual Property Organization (2017). Guide to the International Patent Classification.
其他
55. Cooley, Multi-billion dollar win for Gilead Sciences in bet-the-company arbitration, website: https://www.cooley.com/news/insight/case-in-point/hoffman n-la-roche-v-gilead.
56. Narin, Francis (2000). Tech-Line Background Paper, version of 19.
57. U. S. Food and Drug Administration, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, website: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. |
| Description: | 碩士
國立政治大學
科技管理與智慧財產研究所
105364108 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G1053641081 |
| Data Type: | thesis |
| DOI: | 10.6814/NCCU201900465 |
| Appears in Collections: | [科技管理與智慧財產研究所] 學位論文
|
Files in This Item:
| File |
Size | Format | |
|---|
| 108101.pdf | 5606Kb | Adobe PDF2 | 506 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
