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題名 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作者 翁維駿
Wong, Wei-Chyun貢獻者 馮震宇
翁維駿
Wong, Wei-Chyun關鍵詞 原料藥廠
專利申請
申請策略
API firms
Patent Application
Application Strategy日期 2021 上傳時間 4-八月-2021 14:56:54 (UTC+8) 摘要 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.參考文獻 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，201902. 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，2017，1204. 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，199105. 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=123. 中化製藥http://www.ccpg.com.tw/chinese/02_products/01_detail.aspx?SID=34. 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#209445. Fluoxetine https://en.wikipedia.org/wiki/Fluoxetine6. 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 1999:0111. 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) 描述 碩士
國立政治大學
經營管理碩士學程(EMBA)
103932176資料來源 http://thesis.lib.nccu.edu.tw/record/#G0103932176 資料類型 thesis dc.contributor.advisor 馮震宇 zh_TW dc.contributor.author (作者) 翁維駿 zh_TW dc.contributor.author (作者) Wong, Wei-Chyun en_US dc.creator (作者) 翁維駿 zh_TW dc.creator (作者) Wong, Wei-Chyun en_US dc.date (日期) 2021 en_US dc.date.accessioned 4-八月-2021 14:56:54 (UTC+8) - dc.date.available 4-八月-2021 14:56:54 (UTC+8) - dc.date.issued (上傳時間) 4-八月-2021 14:56:54 (UTC+8) - dc.identifier (其他 識別碼) G0103932176 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/136385 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 經營管理碩士學程(EMBA) zh_TW dc.description (描述) 103932176 zh_TW dc.description.abstract (摘要) 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。 zh_TW dc.description.abstract (摘要) 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. en_US dc.description.tableofcontents Acknowledgement i摘 要 iiAbstract iii目 錄 iv第一章 研究緒論 1第一節 研究背景與動機 1一、研究背景 1二、研究動機 3第二節 方向目的 4第三節 預期貢獻 5一、學術研究方面 5二、實務運作方面 5第四節 研究限制 5一、個案研究之限制 5二、實務導向之限制 6第五節 論文結構 6第二章 文獻探討 7第一節 原料藥廠之探討 7第二節 產業專利之探討 13一、 專利之探討 13二、 專利申請重要原則之說明 15三、 製藥產業專利特性與專利類型 16第三節 專利申請策略之探討 17一、策略之探討 17二、專利申請策略之探討 22第三章 研究架構與方法 28第一節 研究架構 28一、自變項－原料藥廠 28二、應變項－專利申請策略之探討 29第二節 研究方法 30一、研究方式 30二、研究對象 31三、資料蒐集分析 32四、研究流程 34第四章 個案分析 35第一節 個案公司經營發展之說明 35一、沿革 35二、運作 37三、專利 41四、產品 42五、組織 45第二節 個案公司營運環境之分析 49第三節 個案公司專利申請Duloxetine案例之說明 57第四節 個案公司專利申請大麻二酚案例之說明 61第五章 結論與建議 66第一節 結論 66第二節 建議 68一、個案公司的改進 69二、對未來研究的進行 69三、「營業秘密」觀念的導入 69參考文獻 71 zh_TW dc.format.extent 2950774 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0103932176 en_US dc.subject (關鍵詞) 原料藥廠 zh_TW dc.subject (關鍵詞) 專利申請 zh_TW dc.subject (關鍵詞) 申請策略 zh_TW dc.subject (關鍵詞) API firms en_US dc.subject (關鍵詞) Patent Application en_US dc.subject (關鍵詞) Application Strategy en_US dc.title (題名) 原料藥廠專利申請策略之研究－以某公司為例 zh_TW dc.title (題名) Study of patent application strategy for API firms－ a case of study en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 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，201902. 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，2017，1204. 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，199105. 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=123. 中化製藥http://www.ccpg.com.tw/chinese/02_products/01_detail.aspx?SID=34. 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#209445. Fluoxetine https://en.wikipedia.org/wiki/Fluoxetine6. 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 1999:0111. 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) zh_TW dc.identifier.doi (DOI) 10.6814/NCCU202100880 en_US
