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題名 從公共健康之角度論雙邊貿易協定對於醫藥品專利連結制度之影響
Impact of Bilateral Trade Agreement on Pharmaceutical Patent Linkage: Perspectives from Public Health作者 劉力逢
Liu, Li-Feng貢獻者 許耀明
Hsu Yao-Ming
劉力逢
Liu, Li-Feng關鍵詞 醫藥品專利權
專利連結
學名藥
CPTPP協定
製藥產業
公共衛生
Pharmaceutical Patent
Patent Linkage
Generic Drug
CPTPP
Pharmaceutical Industry
Public Health日期 2026 上傳時間 2-Feb-2026 12:18:37 (UTC+8) 摘要 醫藥品在全球貿易中向來是重要的談判標的，而醫藥品專利權作為智慧財產權的一環，其牽涉範圍極為廣泛，包含藥品可近性、國際貿易、公共衛生以及相關人權議題。在多邊或雙邊貿易體制下，醫藥品專利制度逐漸受到重視，並逐步形成一套相當完善的國際規範與制度。自1995年「與貿易有關的智慧財產權協定」(Agreement on Trade Related Aspects of Intellectual Property Rights, 簡稱TRIPS)生效後，後續許多國際貿易協定，如雙邊貿易協定TRIPS-plus、「跨太平洋夥伴關係協定」(The Trans-Pacific Partnership, 簡稱TPP)、「跨太平洋夥伴全面進步協定」(Comprehensive and Progressive Agreement for Trans-Pacific Partnership, 簡稱CPTPP) 等，其制度設計皆以TRIPS為基礎，並進一步建構醫藥品專利權制度。近年來，國際貿易協定更普遍導入醫藥品專利連結制度，進而突顯出許多制度運作上的矛盾與問題。此制度不僅加深專利新藥與學名藥之間的利益衝突，亦影響製藥產業的研發動能，甚至使醫藥品專利權與公共衛生之間的平衡逐漸失衡，其影響之層面與複雜度不容忽視。 CPTPP協定已於2018年底正式生效，為亞太地區最具影響力且標準最高的大型經濟整合協定。若我國能順利加入CPTPP協定，不僅在貿易、投資、關稅、通關及各項法規調和等方面享有實質優惠，更有助於提升整體經濟競爭力。基於國家長期發展之考量，我國積極推動加入CPTPP協定，並陸續修訂國內相關法規，以符合其規範與標準。其中，智慧財產權領域為優先調整之重點。自2019年8月起，我國正式將專利連結制度導入《藥事法》，《專利法》亦於2022年4月15日三讀通過增訂第60條之1等相關規範，期望藉由建立完善的醫藥品專利連結制度，以促進我國製藥產業發展。 本文旨在探討在日益複雜的國際貿易協定架構下，醫藥品專利連結制度是否對公共衛生健康造成實質衝擊。對我國製藥藥廠而言，專利連結制度可視為跨時代的產業變革，其影響層面涵蓋全民健保制度下藥品藥價問題、我國製藥藥廠與學名藥產業的競爭發展，以及我國民眾的藥品可近性與用藥安全等。因此，如何調和各項政策與制度，使民眾得以獲取維繫生命健康所需之醫藥品，並減少國際貿易對公共健康人權所可能造成之侵害，已成為我國經濟與產業政策亟需面對的重要課題。
Pharmaceuticals play an important social and economic role in international trade. Pharmaceutical patents are also a kind of intellectual property right and becoming more complicate together with global economic development. Under the multilateral or bilateral trade system, pharmaceutical patent right has become more prosperous; and gradually established international provision and systems. In recent years, international trade agreements have widely introduced pharmaceutical patent linkage systems. The impact of pharmaceutical patent linkage is extensive and complex, its impact on pharmaceutical industry and public health. Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) is one of the most modern trade agreements and entered into force on December 30, 2018. This agreement is the most important and highest standard large-scale economic integration agreement in the Asia Pacific region. If one country can join the CPTPP agreement, the country could enjoy some special preference for trade and need to be more in line with international standards; Taiwan officially applied to join the CPTPP for external trade development and represents an important process to grow our long-term economy. In recent years, our government has been preparing for CPTPP and continue to revising domestic regulations to meet the standards of the CPTPP agreement. Furthermore, Taiwan already introduced the pharmaceutical patent linkage system in August, 2019 and revised the patent law in April, 2022. Through the pharmaceutical patent linkage system, look forward to improving and facilitating domestic pharmaceutical industry. Finally, this thesis attempts to explore whether the pharmaceutical patent linkage system would cause widely conflicts for public health under international trade agreement. Pharmaceutical patent linkage system is an innovative regulation for domestic pharmaceutical industry in Taiwan, its not only impact on drug price and the development of domestic pharmaceutical industry but also accessibility and safety. Therefore, how to balance the regulations and make easier for people to get necessary medicines is one of the most important issues for Taiwan.參考文獻 中文文獻 (一) 中文專書 1. 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(2022)., from https://cms-lawnow.com/en/ealerts/2022/12/comparative-study-patent-linkage-systems-in-apac (last visited Oct. 14, 2024). 17. Fergusson, Ian F. & Williams, Brock R. TPP Countries Sign New CPTPP Agreement without U.S. Participation, report, March 9, 2018; Washington D.C.., from https://digital.library.unt.edu/ark:/67531/metadc1156728/m1/2/ (last visited Feb. 10, 2025). 描述 碩士
國立政治大學
法學院碩士在職專班
111961024資料來源 http://thesis.lib.nccu.edu.tw/record/#G0111961024 資料類型 thesis dc.contributor.advisor 許耀明 zh_TW dc.contributor.advisor Hsu Yao-Ming en_US dc.contributor.author (Authors) 劉力逢 zh_TW dc.contributor.author (Authors) Liu, Li-Feng en_US dc.creator (作者) 劉力逢 zh_TW dc.creator (作者) Liu, Li-Feng en_US dc.date (日期) 2026 en_US dc.date.accessioned 2-Feb-2026 12:18:37 (UTC+8) - dc.date.available 2-Feb-2026 12:18:37 (UTC+8) - dc.date.issued (上傳時間) 2-Feb-2026 12:18:37 (UTC+8) - dc.identifier (Other Identifiers) G0111961024 en_US dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/161392 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法學院碩士在職專班 zh_TW dc.description (描述) 111961024 zh_TW dc.description.abstract (摘要) 醫藥品在全球貿易中向來是重要的談判標的，而醫藥品專利權作為智慧財產權的一環，其牽涉範圍極為廣泛，包含藥品可近性、國際貿易、公共衛生以及相關人權議題。在多邊或雙邊貿易體制下，醫藥品專利制度逐漸受到重視，並逐步形成一套相當完善的國際規範與制度。自1995年「與貿易有關的智慧財產權協定」(Agreement on Trade Related Aspects of Intellectual Property Rights, 簡稱TRIPS)生效後，後續許多國際貿易協定，如雙邊貿易協定TRIPS-plus、「跨太平洋夥伴關係協定」(The Trans-Pacific Partnership, 簡稱TPP)、「跨太平洋夥伴全面進步協定」(Comprehensive and Progressive Agreement for Trans-Pacific Partnership, 簡稱CPTPP) 等，其制度設計皆以TRIPS為基礎，並進一步建構醫藥品專利權制度。近年來，國際貿易協定更普遍導入醫藥品專利連結制度，進而突顯出許多制度運作上的矛盾與問題。此制度不僅加深專利新藥與學名藥之間的利益衝突，亦影響製藥產業的研發動能，甚至使醫藥品專利權與公共衛生之間的平衡逐漸失衡，其影響之層面與複雜度不容忽視。 CPTPP協定已於2018年底正式生效，為亞太地區最具影響力且標準最高的大型經濟整合協定。若我國能順利加入CPTPP協定，不僅在貿易、投資、關稅、通關及各項法規調和等方面享有實質優惠，更有助於提升整體經濟競爭力。基於國家長期發展之考量，我國積極推動加入CPTPP協定，並陸續修訂國內相關法規，以符合其規範與標準。其中，智慧財產權領域為優先調整之重點。自2019年8月起，我國正式將專利連結制度導入《藥事法》，《專利法》亦於2022年4月15日三讀通過增訂第60條之1等相關規範，期望藉由建立完善的醫藥品專利連結制度，以促進我國製藥產業發展。 本文旨在探討在日益複雜的國際貿易協定架構下，醫藥品專利連結制度是否對公共衛生健康造成實質衝擊。對我國製藥藥廠而言，專利連結制度可視為跨時代的產業變革，其影響層面涵蓋全民健保制度下藥品藥價問題、我國製藥藥廠與學名藥產業的競爭發展，以及我國民眾的藥品可近性與用藥安全等。因此，如何調和各項政策與制度，使民眾得以獲取維繫生命健康所需之醫藥品，並減少國際貿易對公共健康人權所可能造成之侵害，已成為我國經濟與產業政策亟需面對的重要課題。 zh_TW dc.description.abstract (摘要) Pharmaceuticals play an important social and economic role in international trade. Pharmaceutical patents are also a kind of intellectual property right and becoming more complicate together with global economic development. Under the multilateral or bilateral trade system, pharmaceutical patent right has become more prosperous; and gradually established international provision and systems. In recent years, international trade agreements have widely introduced pharmaceutical patent linkage systems. The impact of pharmaceutical patent linkage is extensive and complex, its impact on pharmaceutical industry and public health. Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) is one of the most modern trade agreements and entered into force on December 30, 2018. This agreement is the most important and highest standard large-scale economic integration agreement in the Asia Pacific region. If one country can join the CPTPP agreement, the country could enjoy some special preference for trade and need to be more in line with international standards; Taiwan officially applied to join the CPTPP for external trade development and represents an important process to grow our long-term economy. In recent years, our government has been preparing for CPTPP and continue to revising domestic regulations to meet the standards of the CPTPP agreement. Furthermore, Taiwan already introduced the pharmaceutical patent linkage system in August, 2019 and revised the patent law in April, 2022. Through the pharmaceutical patent linkage system, look forward to improving and facilitating domestic pharmaceutical industry. Finally, this thesis attempts to explore whether the pharmaceutical patent linkage system would cause widely conflicts for public health under international trade agreement. Pharmaceutical patent linkage system is an innovative regulation for domestic pharmaceutical industry in Taiwan, its not only impact on drug price and the development of domestic pharmaceutical industry but also accessibility and safety. Therefore, how to balance the regulations and make easier for people to get necessary medicines is one of the most important issues for Taiwan. en_US dc.description.tableofcontents 第一章、緒論 1 第一節、研究動機 1 第二節、研究目的與方法 3 第三節、研究架構 4 第二章、多邊、區域與雙邊貿易協定下智慧財產權保護與公共衛生之關係 5 第一節、WTO智慧財產權協定TRIPS 7 第一項、TRIPS協定源起與背景 7 第二項、TRIPS協定之立法原則與執行 8 第三項、TRIPS協定之公共健康與爭議 11 第二節、跨太平洋夥伴全面進步協定CPTPP 17 第一項、CPTPP協定源起與修正背景 17 第二項、CPTPP協定主要內容 19 第三項、我國為加入CPTPP之效益與布局 23 第三節、美國與各國之自由貿易協定FTA：以韓國為例 25 第一項、雙邊自由貿易之興起 25 第二項、雙邊自由貿易協定之實際影響 26 第三項、美韓自由貿易協定US-Korea FTA 29 第四節、小結 30 第三章、貿易協定下醫藥品專利保護之延伸及制度 32 第一節、醫藥品專利保護之概況 33 第一項、醫藥品專利保護之源起與背景 33 第二項、醫藥品專利保護之重要性 35 第三項、醫藥品專利保護之利益與衝突 36 第二節、醫藥品專利保護之內容 38 第一項、醫藥品專利保護之意義與項目 38 第二項、貿易協定下醫藥品專利保護之變化 45 第三項、醫藥品生命週期與專利之管理 47 第三節、醫藥品專利保護之外國立法制度：以美國為例 48 第一項、美國醫藥品專利保護之歷史背景 48 第二項、美國醫藥品專利保護之立法制度 50 第三項、美國與歐盟醫藥品專利保護之比較 53 第四節、小結 55 第四章、醫藥品專利連結制度 57 第一節、美國醫藥品專利連結制度 58 第一項、美國專利連結制度之核心機制與內容 58 第二項、美國專利連結制度之國際影響 60 第二節、外國醫藥品專利連結立法制度：以韓國為例 62 第一項、韓國專利連結制度之源起 62 第二項、韓國專利連結制度之內容 63 第三項、韓國專利連結制度之影響 68 第三節、CPTPP下之醫藥品專利連結制度 70 第一項、CPTPP專利連結制度之源起 70 第二項、CPTPP專利連結制度之規範與要求 71 第四節、小結 74 第五章、CPTPP下我國醫藥品專利連結制度與公共健康之平衡 76 第一節、我國醫藥品專利連結制度 77 第一項、貿易協定下我國醫藥品專利之發展歷程 77 第二項、我國為加入CPTPP之修法過程 79 第三項、我國專利連結制度與各國之比較 80 第二節、CPTPP對於我國全民健康保險之影響 86 第一項、我國全民健保之源起與現況 86 第二項、我國全民健保之藥價政策及CPTPP規範 87 第三項、CPTPP下全民健保與公共健康之調和 91 第三節、CPTPP對於我國國內製藥產業之影響 93 第一項、我國國內製藥產業之概況 93 第二項、我國製藥產業新藥研發之挑戰 96 第三項、CPTPP下我國製藥產業之檢討與展望 102 第四節、CPTPP對於我國學名藥之影響 105 第一項、我國學名藥廠之概況 105 第二項、CPTPP下之專利連結對我國學名藥廠之衝擊 107 第三項、CPTPP下之學名藥廠與公共健康之調和 111 第五節、小結 114 第六章、結論及建議 116 第一節、研究結論 116 第二節、建議 117 參考文獻 119 中文文獻 119 英文文獻 128 zh_TW dc.format.extent 3295242 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0111961024 en_US dc.subject (關鍵詞) 醫藥品專利權 zh_TW dc.subject (關鍵詞) 專利連結 zh_TW dc.subject (關鍵詞) 學名藥 zh_TW dc.subject (關鍵詞) CPTPP協定 zh_TW dc.subject (關鍵詞) 製藥產業 zh_TW dc.subject (關鍵詞) 公共衛生 zh_TW dc.subject (關鍵詞) Pharmaceutical Patent en_US dc.subject (關鍵詞) Patent Linkage en_US dc.subject (關鍵詞) Generic Drug en_US dc.subject (關鍵詞) CPTPP en_US dc.subject (關鍵詞) Pharmaceutical Industry en_US dc.subject (關鍵詞) Public Health en_US dc.title (題名) 從公共健康之角度論雙邊貿易協定對於醫藥品專利連結制度之影響 zh_TW dc.title (題名) Impact of Bilateral Trade Agreement on Pharmaceutical Patent Linkage: Perspectives from Public Health en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 中文文獻 (一) 中文專書 1. 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