Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/136385
|
| Title: | 原料藥廠專利申請策略之研究－以某公司為例
Study of patent application strategy for API firms－ a case of study |
| Authors: | 翁維駿
Wong, Wei-Chyun |
| Contributors: | 馮震宇
翁維駿
Wong, Wei-Chyun |
| Keywords: | 原料藥廠
專利申請
申請策略
API firms
Patent Application
Application Strategy |
| Date: | 2021 |
| Issue Date: | 2021-08-04 14:56:54 (UTC+8) |
| Abstract: | 醫藥一日千里的進展，促使多數人都認為醫藥領域充滿各種商機與利得。然而，產業源頭的原料藥業，雖然其開發增長快速，但利潤率相對較低，開發費時甚久且信任建立亦相當耗時，加上發展原料藥不僅要有技術，更需具有保護專利的能力。因此，本研究的進行，乃基於如上背景，並期協助原料藥廠掌握發展專利申請策略之困境認定與並克服，而協助個案公司建立專利申請策略並提升整體營運績效。所以，本研究即從產業面的原料藥廠產業、標的面的產業專利與策略面的專利申請策略等進行文獻探討。並且，以我國知名的原料藥廠之公司進行個案研究。從個案分析中，可知個案公司的經營發展與營運環境，更以個案公司Duloxetine與大麻二酚的專利申請兩案例進行深入探討。最後的結論，可知我國的原料藥廠而言，業務多屬學名藥的製造銷售，且物質專利與應用專利皆屬於他方，則製程專利的佈局最為重要，再以成本考量，專利佈局應採Ad hoc blocking and inventing around方式。而製程專利的擁有，主要讓客戶安心購買使用而不會有被控告侵權疑慮。而對個案公司的建議，就是堅持要求個案公司擁有所開發出的製程專利(往往很多新藥公司會要求製造商讓與製造技術)，方能確保個案公司製造的優先權且穩定長期的獲利。對於未來研究的建議，可於研究資料的增加、研究方法的改進與研究方向的拓展。
Intellectual property rights especially patents are the bedrock of the pharmaceutical industry as the industry solely rely on the innovation that can be monetized in the future. API (Active Pharmaceutical Ingredient) industry is the basic sector in pharma industry where innovation as well as protection of process development is a key issue and of major concern. In this research thesis, adoption of patents application strategy for API firms was based on literature study and “ad hoc blocking and inventing around” was identified as the most suitable strategy. Also delineates in this thesis, a case study of a Taiwanese API company was presented which above mentioned strategy was properly applied. Examples in this case study, Duloxetine and Cannabidiol, were given to demonstrated that business in the stated items was successfully developed. |
| Reference: | 中文部分
01. 生技產業白皮書及台灣經濟研究院產經資料庫，2019
02. 旭富製藥科技股份有限公司，108年公開年報
03. 經濟部智慧財產局，認識專利，臺北市：行政院，2017，12
04. 楊國樞、文崇一、吳聰賢、李亦園，「社會及行為科學研究方法」，東華出版社，1991
05. 吳琮璠，「資訊管理個案研究方法」，資訊管理學報1997，4 卷1 期：07-17頁
網頁部分
1. 科睿唯安 CPhI China 2017 精選專文https://clarivate.com.tw/blog/2017/06/13/the-changing-dynamics-of-global-api-manufaturing/
2. 台灣神隆股份有限公司http://www.scinopharm.com.tw/investor.asp?ptype=12
3. 中化製藥http://www.ccpg.com.tw/chinese/02_products/01_detail.aspx?SID=3
4. U.S. Food and Drug Administration, Orange Book https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=021427#20944
5. Fluoxetine https://en.wikipedia.org/wiki/Fluoxetine
6. Duloxetine重鬱症治療的專利 https://en.wikipedia.org/wiki/Duloxetine
英文部分
1. Persistence Market Research, “Active Pharmaceutical Ingredient Market”, (July, 2016)
2. Andrews, Kenneth Richmond, “The concept of corporate strategy”, Richard D. Irwin, Homewood, (1971).
3. Henry Mintzberg and Joseph Lampel, “Reflecting on the Strategy Process”, Sloan Management Review, Vol.40(3), 21-30, (1999).
4. Porter, Michael “What is strategy?”, Harvard Business Review, Vol. 74(6), 61–78, (1996).
5. Porter, Michael. “Towards a dynamic theory of Strategy,” Strategic Management Journal, Vol. 12, 95-117, (1991).
6. Gary Hamel, “Strategy as Revolution”, Harvard Business Review, Vol. 74(4), 69–82, (1996).
7. W. Chan Kim and Renée Mauborgne, “Value Innovation: The Strategic Logic of High Growth”, Harvard Business Review, Vol. 75(1), 103-112, (2004).
8. W. Chan Kim and Renée Mauborgne, “Blue Ocean Strategy: How to Create Uncontested Market Space and Make the Competition Irrelevant”, Harvard Business School Press, Boston, (2005).
9. William W. Fisher III and Felix Oberholzer-Gee, “Strategic Management of Intellectual Property: An Integrated Approach”, California Management Review, Vol. 55(4), 157-183, (2013).
10. Ove Granstrand, Strategic Management of Intellectual Property, CIM Working Paper 1999:01
11. Widelski, J. and Kukula-Koch, W. A. Chapter 17 - Psychoactive Drugs. in Pharmacognosy (Badal, S., and Delgoda, R. eds.), Academic Press, Boston, 363-374, (2017).
12. McPartland, J. M. and Small, E. A classification of endangered high-THC cannabis (Cannabis sativa subsp. indica) domesticates and their wild relatives. PhytoKeys, 144, 81-112, (2020).
13. Rohbeck, E.; Eckel, J. and Romacho, T. Cannabinoid Receptors in Metabolic Regulation and Diabetes. Physiology (Bethesda) 36, 102-113, (2021).
14. Cristino, L.; Bisogno, T. and Di Marzo, V. Cannabinoids and the expanded endocannabinoid system in neurological disorders. Nat Rev Neurol, 16, 9-29, (2020).
15. Breijyeh, Z.; Jubeh, B.; Bufo, S. A.; Karaman, R. and Scrano, L. Cannabis: A Toxin-Producing Plant with Potential Therapeutic Uses. Toxins (Basel), 13, (2021)
16. Wijnen, B.; Armstrong, N.; Ramaekers, B.; Witlox, W.; Westwood, M.; Fayter, D.; Ryder, S.; Buksnys, T.; Worthy, G.; Misso, K.; Grimm, S.; Kleijnen, J. and Joore, M. Cannabidiol for Adjuvant Treatment of Seizures Associated with Lennox-Gastaut Syndrome and Dravet Syndrome: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. Pharmacoeconomics, 38, 1043-1053. (2020) |
| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
103932176 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0103932176 |
| Data Type: | thesis |
| DOI: | 10.6814/NCCU202100880 |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
|
Files in This Item:
| File |
Description |
Size | Format | |
|---|
| 217601.pdf | | 2881Kb | Adobe PDF2 | 121 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
