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題名 美國藥物專利布局與其相應之研究開發與法規活動 - 以諾華藥廠之Gleevec®為例
Drug Patent Deployment in the United States of America with the Corresponding Research, Development and Regulatory Activities - A Case of Gleevec® by Novartis Group作者 吳豐江
Wu, Eric F.C.貢獻者 陳桂恒
Chan, Keith
吳豐江
Wu, Eric F.C.關鍵詞 藥
專利
諾華
策略
drug
patent
novartis
strategy日期 2015 上傳時間 4-Jan-2016 16:57:45 (UTC+8) 摘要 專利是各藥廠及生技公司保護藥物利潤的重要手段之一，全世界各國因藥物專利而起的侵權訴訟亦持續增加，也因此專利已成為藥廠及生技公司的必爭之地。過去台灣於美國的專利申請量全世界排名第五，但實際從專利而獲得的利益卻非對等，由此可見過去台灣企業在專利的佈局與利用尚待精進。近年來，台灣藥業及生技業蓬勃發展，許多研發成果亦開始走向臨床階段，然生技公司仍需有更完整專利佈局方能立足全球生技業。因此，本研究透過研究國際諾華大藥廠的基利克膜衣錠之美國專利佈局，以及專利佈局與研究開發時程之對應關係，總體觀察國際藥廠對於一小分子化學藥物所執行之專利佈局情況，並依據其專利佈局結果，歸納、分析及提出適用於台灣生技公司之專利佈局策略。美國的專利制度對於全世界的影響相當廣泛，再且其國內藥物市場亦屬全球最大，因此本研究將專注分析基利克膜衣錠於美國之專利佈局策略。 本研究係透過研閱、分析與分類與基利克膜衣錠相關之專利及研發資訊，並透過文獻檢索方法彙整其研究與發展之各事件及其時程，及透過分析與拆解專利之申請專利範圍，組織歸納並統計其專利之類型(其主張之標的物)、申請時程、專利申請時程與研發時程的關係，以及其美國專利家族(主張優先權的各種延續案)及各國專利家族之應用狀況。 本研究結果顯示，諾華大藥廠針對基利克膜衣錠在美國至少提出超逾40件以上之專利申請，且其涵蓋面向甚廣，至包含化合物專利、晶形專利、衍生物專利、用途專利、代謝物專利、鹽類專利、合成方法專利以及合併療法專利等，是一相當全面性的專利佈局。此外，本研究亦發現其各類型之專利申請時間點，與其研發成果產出時間點有一定關係。由此現象可見，其研發團隊與智慧財產團隊有緊密的互動關係。依據基利克膜衣錠的專利佈局結果以及考量台灣生技業的資源受限情況，本研究提出下列建議以提供台灣生技業作為其專利佈局策略之思考。(1) 於有限資源中，仍須投入資源申請關鍵專利，其中關鍵專利至少包含化合物專利以及晶形專利。關鍵專利重要之處在於，其所主張的保護範圍在各種專利類型中是最廣的同時也最難迴避。(2) 一般而言，專利的申請可在研發成果產生後的一至二年左右提出。研發成果包含一般實驗室的功能性試驗，以及/或初步動物實驗結果。於此一時點提出是為了確保申請之專利具新穎性及進步性，同時又不因過早提出申請而致使專利期覆蓋藥物實際上市銷售期的時間縮短。然而，專利申請時間尚須考量相同領域的競爭程度、技術發展水平以及標的物商業化之潛力等。(3) 於全球各國提出關鍵專利申請。先於各大醫藥國提出專利申請，後再利用優先權制度擴展專利保護的國家。(4) 利用美國專利制度之彈性。美國專利制度包含臨時案、延續案、分割案等，這些彈性提供了生技公司一段較長的時間來產生更多研發成果、評估是否持續執行研發專案、延後正式專利申請及申請費用、研究競爭對手佈局等，因此對於生技公司而言是一重要手段。 總結而言，藥物之專利佈局並非僅是向專利局提出申請如此而已，其需要一縝密、多面向且事先規劃的專利佈局。藥物的專利佈局包含的面向相當廣泛，涉及了藥物研發各類資訊與產出的了解、各種法規事件之掌握、全球各國專利制度的深入了解與應用，以及研發團隊與智慧財產團隊之緊密合作等。儘管專利佈局涉及之知識、技能與人員深且廣，然所需投入之資源並非集中於同一時間點，而是遍佈整個藥物的產品生命週期，若能掌握本研究所提出四點架構性建議，台灣生技公司應能在早期研究開發階段，將投入資源所產生的效益最大化，達到同時具有效能與效率的專利佈局。
Patenting is one of the most important measures in securing the profits of a drug and has gained traction in the pharmaceutical and biotechnology industries for several decades. However, in Taiwan, past experience in obtaining and utilizing patent rights has not been a successful story. In addition, a small biotechnology company is usually in tight budget and needs a cost effective and feasible patenting strategy. With the booming development of biotechnology companies in Taiwan, the study aims to provide Taiwanese companies insights of patenting strategies and delineating the relationships between the patents and the corresponding research and development (R&D) and regulatory activities. The study focused on the drug patenting strategy in the United States (US) since its patent system is one of the most influential and is the largest pharmaceutical market in the world. Gleevec, which is developed by Novartis group, is a global blockbuster and has accumulated billion dollars of sales around the world. The study takes Gleevec as a case study object and analyzes its patent deployments in US. In terms of the scope of the strategy, the study focuses on the patent types (the subject matter), patent application time, filing time in correspondence with the R&D and regulatory events, and the resulting patent families (including US patents claiming priority of previously filed applications and the same invention filed globally). Patents and independent claims are studied and are categorized into several categories which are predetermined according to the patent types. Literature research is conducted to delineate the timeline of R&D and regulatory events. The study showed a comprehensive patent deployment of Gleevec in US and the patent deployment is in dynamic relationships with the R&D and regulatory events of a drug. Protecting a drug through patents requires professional understanding of patents and patent systems, close collaboration between R&D team and patent team, and a well-organized deployment strategy. Based on Gleevec patent deployment in US, the study provides the following insights for a biotechnology companies in Taiwan. First, dedicate capital resources at least in obtaining key patents, mainly compound patents and crystalline form patents. These key patents have the biggest scope of protection of a drug. Second, in general, file patents around one to two years after the first laboratory results and/or preliminary animal study results. This is to insure the validity of the patents and yet won`t cut short too much of the sales protection period. However, the filing time is also subject to considerations including the competition status in the same field, the overall scientific development and the commercial potential of the candidates. Third , file the key patents globally in early stages. Obtaining patents in different countries could expand protection geographically. Last, taking advantage of the flexibility of the US patent system. The flexibility gives a company a prolonged period to evaluate the potential of the candidate, defer patent timing and costs and make the final decision. In summary, patent deployment isn`t just applying patents in the patent office. It require a detailed and comprehensive plan. A patent deployment plan needs various professionals who have deep knowledge in drug research, clinical development, regulatory activities and global patent regulations and who are very experienced in utilizing the knowledge. It also requires these professionals to complement their knowledge with other professionals and to work closely. Despite such resources might require a lot of capital resources, these resources are not a lump sum cost, instead, the cost are dispersed throughout the whole product life cycle. If a biotechnology company with limited resources could employ the aforementioned suggestion, it would maximize the cost benefit of patent deployment plan and generate a patent deployment with effectiveness and efficiency.參考文獻 Books:Andreas Hubel, et al., Biopatent Law: Patent Strategies and Patent Management (1st ed. 2012).PhilipW. Grubb and Peter R. Thomsen, Patents for Chemicals, Pharmaceuticals, and Biotechnology (5th ed. 2010).Raymond G. Hill, Humphrey P. Rang, Drug Discovery & Development (2nd ed. 2013).Rick Ng, Drugs: From Discovery to Approval (2nd ed. 2009).Y.P. Jou, Marketing Intellectual Property-Business Model Extracting Value from Intellectual Property (1st ed. 2010).Y.P. 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國立政治大學
科技管理與智慧財產研究所
993610051資料來源 http://thesis.lib.nccu.edu.tw/record/#G0993610051 資料類型 thesis dc.contributor.advisor 陳桂恒 zh_TW dc.contributor.advisor Chan, Keith en_US dc.contributor.author (Authors) 吳豐江 zh_TW dc.contributor.author (Authors) Wu, Eric F.C. en_US dc.creator (作者) 吳豐江 zh_TW dc.creator (作者) Wu, Eric F.C. en_US dc.date (日期) 2015 en_US dc.date.accessioned 4-Jan-2016 16:57:45 (UTC+8) - dc.date.available 4-Jan-2016 16:57:45 (UTC+8) - dc.date.issued (上傳時間) 4-Jan-2016 16:57:45 (UTC+8) - dc.identifier (Other Identifiers) G0993610051 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/80324 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理與智慧財產研究所 zh_TW dc.description (描述) 993610051 zh_TW dc.description.abstract (摘要) 專利是各藥廠及生技公司保護藥物利潤的重要手段之一，全世界各國因藥物專利而起的侵權訴訟亦持續增加，也因此專利已成為藥廠及生技公司的必爭之地。過去台灣於美國的專利申請量全世界排名第五，但實際從專利而獲得的利益卻非對等，由此可見過去台灣企業在專利的佈局與利用尚待精進。近年來，台灣藥業及生技業蓬勃發展，許多研發成果亦開始走向臨床階段，然生技公司仍需有更完整專利佈局方能立足全球生技業。因此，本研究透過研究國際諾華大藥廠的基利克膜衣錠之美國專利佈局，以及專利佈局與研究開發時程之對應關係，總體觀察國際藥廠對於一小分子化學藥物所執行之專利佈局情況，並依據其專利佈局結果，歸納、分析及提出適用於台灣生技公司之專利佈局策略。美國的專利制度對於全世界的影響相當廣泛，再且其國內藥物市場亦屬全球最大，因此本研究將專注分析基利克膜衣錠於美國之專利佈局策略。 本研究係透過研閱、分析與分類與基利克膜衣錠相關之專利及研發資訊，並透過文獻檢索方法彙整其研究與發展之各事件及其時程，及透過分析與拆解專利之申請專利範圍，組織歸納並統計其專利之類型(其主張之標的物)、申請時程、專利申請時程與研發時程的關係，以及其美國專利家族(主張優先權的各種延續案)及各國專利家族之應用狀況。 本研究結果顯示，諾華大藥廠針對基利克膜衣錠在美國至少提出超逾40件以上之專利申請，且其涵蓋面向甚廣，至包含化合物專利、晶形專利、衍生物專利、用途專利、代謝物專利、鹽類專利、合成方法專利以及合併療法專利等，是一相當全面性的專利佈局。此外，本研究亦發現其各類型之專利申請時間點，與其研發成果產出時間點有一定關係。由此現象可見，其研發團隊與智慧財產團隊有緊密的互動關係。依據基利克膜衣錠的專利佈局結果以及考量台灣生技業的資源受限情況，本研究提出下列建議以提供台灣生技業作為其專利佈局策略之思考。(1) 於有限資源中，仍須投入資源申請關鍵專利，其中關鍵專利至少包含化合物專利以及晶形專利。關鍵專利重要之處在於，其所主張的保護範圍在各種專利類型中是最廣的同時也最難迴避。(2) 一般而言，專利的申請可在研發成果產生後的一至二年左右提出。研發成果包含一般實驗室的功能性試驗，以及/或初步動物實驗結果。於此一時點提出是為了確保申請之專利具新穎性及進步性，同時又不因過早提出申請而致使專利期覆蓋藥物實際上市銷售期的時間縮短。然而，專利申請時間尚須考量相同領域的競爭程度、技術發展水平以及標的物商業化之潛力等。(3) 於全球各國提出關鍵專利申請。先於各大醫藥國提出專利申請，後再利用優先權制度擴展專利保護的國家。(4) 利用美國專利制度之彈性。美國專利制度包含臨時案、延續案、分割案等，這些彈性提供了生技公司一段較長的時間來產生更多研發成果、評估是否持續執行研發專案、延後正式專利申請及申請費用、研究競爭對手佈局等，因此對於生技公司而言是一重要手段。 總結而言，藥物之專利佈局並非僅是向專利局提出申請如此而已，其需要一縝密、多面向且事先規劃的專利佈局。藥物的專利佈局包含的面向相當廣泛，涉及了藥物研發各類資訊與產出的了解、各種法規事件之掌握、全球各國專利制度的深入了解與應用，以及研發團隊與智慧財產團隊之緊密合作等。儘管專利佈局涉及之知識、技能與人員深且廣，然所需投入之資源並非集中於同一時間點，而是遍佈整個藥物的產品生命週期，若能掌握本研究所提出四點架構性建議，台灣生技公司應能在早期研究開發階段，將投入資源所產生的效益最大化，達到同時具有效能與效率的專利佈局。 zh_TW dc.description.abstract (摘要) Patenting is one of the most important measures in securing the profits of a drug and has gained traction in the pharmaceutical and biotechnology industries for several decades. However, in Taiwan, past experience in obtaining and utilizing patent rights has not been a successful story. In addition, a small biotechnology company is usually in tight budget and needs a cost effective and feasible patenting strategy. With the booming development of biotechnology companies in Taiwan, the study aims to provide Taiwanese companies insights of patenting strategies and delineating the relationships between the patents and the corresponding research and development (R&D) and regulatory activities. The study focused on the drug patenting strategy in the United States (US) since its patent system is one of the most influential and is the largest pharmaceutical market in the world. Gleevec, which is developed by Novartis group, is a global blockbuster and has accumulated billion dollars of sales around the world. The study takes Gleevec as a case study object and analyzes its patent deployments in US. In terms of the scope of the strategy, the study focuses on the patent types (the subject matter), patent application time, filing time in correspondence with the R&D and regulatory events, and the resulting patent families (including US patents claiming priority of previously filed applications and the same invention filed globally). Patents and independent claims are studied and are categorized into several categories which are predetermined according to the patent types. Literature research is conducted to delineate the timeline of R&D and regulatory events. The study showed a comprehensive patent deployment of Gleevec in US and the patent deployment is in dynamic relationships with the R&D and regulatory events of a drug. Protecting a drug through patents requires professional understanding of patents and patent systems, close collaboration between R&D team and patent team, and a well-organized deployment strategy. Based on Gleevec patent deployment in US, the study provides the following insights for a biotechnology companies in Taiwan. First, dedicate capital resources at least in obtaining key patents, mainly compound patents and crystalline form patents. These key patents have the biggest scope of protection of a drug. Second, in general, file patents around one to two years after the first laboratory results and/or preliminary animal study results. This is to insure the validity of the patents and yet won`t cut short too much of the sales protection period. However, the filing time is also subject to considerations including the competition status in the same field, the overall scientific development and the commercial potential of the candidates. Third , file the key patents globally in early stages. Obtaining patents in different countries could expand protection geographically. Last, taking advantage of the flexibility of the US patent system. The flexibility gives a company a prolonged period to evaluate the potential of the candidate, defer patent timing and costs and make the final decision. In summary, patent deployment isn`t just applying patents in the patent office. It require a detailed and comprehensive plan. A patent deployment plan needs various professionals who have deep knowledge in drug research, clinical development, regulatory activities and global patent regulations and who are very experienced in utilizing the knowledge. It also requires these professionals to complement their knowledge with other professionals and to work closely. Despite such resources might require a lot of capital resources, these resources are not a lump sum cost, instead, the cost are dispersed throughout the whole product life cycle. If a biotechnology company with limited resources could employ the aforementioned suggestion, it would maximize the cost benefit of patent deployment plan and generate a patent deployment with effectiveness and efficiency. en_US dc.description.tableofcontents ENGLISH ABSTRACT III中文摘要 VLIST OF FIGURES VIILIST OF TABLES VIIICHAPER 1： INTRODUCTION 11.1 RESEARCH BACKGROUND 11.2 RESEARCH OBJECTIVE 21.3 RESEARCH METHOD 41.4 RESEARCH RESTRICTION AND LIMITATION 51.5 ABBREVIATED TERMINOLOGIES 6CHAPER 2： PATENT RIGHTS IN BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRY 82.1 INTELLECTUAL PROPERTY RIGHT 82.2 PATENT 92.3 DRUG PATENTS 112.3.1 COMPOUND PATENTS 122.3.2 FORMULATION PATENT 142.3.3 METHOD/ PROCESS PATENT 142.3.4 USE PATENT 15CHAPER 3： RESEARCH AND DEVELOPMENT AND REGULATORY PROCESS IN BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES 163.1 RESEARCH AND DEVELOPMENT PROCESS 163.1.1 Drug Discovery 173.1.2 Drug Development 223.2 REGULATORY PROCESS OF DRUG APPROVAL 27CHAPER 4： HISTORY OF GLEEVEC 304.1 GLEEVEC 304.2 RESEARCH AND DEVELOPMENT PROCESS OF GLEEVEC 314.3 REGULATORY PROCESS OF DRUG APPROVAL 37CHAPER 5： THE PATENT DEPLOYMENT OF GLEEVEC IN THE UNITED STATES 395.1 DEFINE SCOPE OF ANALYSIS 395.2 ANALYSIS METHOD & TOOL 485.2.1 Software Tool 485.2.2 Tree Diagram Establishment 485.2.3 Definition of Patent Preamble Tree Diagram 535.2.4 Definition of Patent Body Tree Diagram 555.2.5 Categorization of the Claims 565.2.6 Output of Figures and Tables 615.3 RESULT ANALYSIS 615.3.1 Matrix Analysis 615.3.2 Timeline Analysis 65CHAPER 6： DISCUSSIONS ON THE PATENTING STRATEGIES OF GLEEVEC 746.1 PATENT TYPES IN PROTECTING THE DRUG 746.2 RELATIONSHIPS BETWEEN PATENT FILING TIME AND R&D AND REGULATORY EVENTS 826.3 PATENT FAMILY 856.4 OVERALL DISCUSSION 87CHAPER 7： CONCLUSION 88REFERENCE 93APPENDIX 98APPENDIX I 98APPENDIX II 104APPENDIX III 121 zh_TW dc.format.extent 1354310 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0993610051 en_US dc.subject (關鍵詞) 藥 zh_TW dc.subject (關鍵詞) 專利 zh_TW dc.subject (關鍵詞) 諾華 zh_TW dc.subject (關鍵詞) 策略 zh_TW dc.subject (關鍵詞) drug en_US dc.subject (關鍵詞) patent en_US dc.subject (關鍵詞) novartis en_US dc.subject (關鍵詞) strategy en_US dc.title (題名) 美國藥物專利布局與其相應之研究開發與法規活動 - 以諾華藥廠之Gleevec®為例 zh_TW dc.title (題名) Drug Patent Deployment in the United States of America with the Corresponding Research, Development and Regulatory Activities - A Case of Gleevec® by Novartis Group en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) Books:Andreas Hubel, et al., Biopatent Law: Patent Strategies and Patent Management (1st ed. 2012).PhilipW. 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