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題名 後續創新藥品專利保護和可及性的兩難
The Dilemma of Patent Protection and Accessibility for Follow-on Pharmaceutical Innovation作者 陳培志 貢獻者 沈宗倫
陳培志關鍵詞 藥品專利
後續創新藥品
藥品可及性
藥品上市審查
Pharmaceutical patent
Follow-on pharmaceutical innovation
Accessibility
Drug approval regulations日期 2024 上傳時間 1-Feb-2024 13:02:52 (UTC+8) 摘要 藥品產業最獨特之處是其與生命健康息息相關，而生命健康的價值異於其他商品，難以用市場價格衡量。除此之外，藥品產業還有其他特點，包括巨額的研發投資、漫長的開發週期、高度的不確定性以及藥品研發完成後相對較低的單位製造成本。藥品專利制度透過授予研發者一定時間的專屬權，取得市場獨佔優勢以利回收研發投入，研發藥廠得以持續投入研發創新。因此藥品專利保護對於推動藥品創新至關重要。雖然立意良善，也確實推動藥品研發，然而伴隨而來的高昂藥價卻限制了藥品的可及性(accessibility)，反而違背了研發藥品治療疾病的初衷。 在保護專利和維護病人權益之間取得平衡仍然是藥品產業利益相關者和政策制定者持續面臨的挑戰。而藥品後續創新(follow-on innovation)專利使得問題更加複雜。本質上，創新不論大小皆是研發的漸進過程，而在藥品領域漸進性的持續改良也是開創性突破的基礎。然而，並非所有的創新改良皆值得享有專利保護。區分何種藥品後續創新具有臨床價值而值得給予專利並非易事，因為專利審查通常在臨床試驗結果取得之前，而且對於藥品進入人體內的生化反應了解仍有侷限，尚無準則可以精準預測實際臨床療效。 儘管授予後續創新藥品專利可以鼓勵研發藥廠持續投入創新藥品研發，但同時也給予藥廠濫用專利制度的機會利用手段(例如,專利叢林和專利長青)不當延長獨占期限，限縮了藥品可及性，最終損害了公共衛生及病人用藥的權益，反而違背了藥品治病的初衷。本文將先就後續創新藥品可專利性標準的當前問題進行討論，試圖在促進創新和確保藥品可及性之間取得一個平衡，也藉此點出僅依賴專利制度解決此一困境的局限性。 鑒於問題的複雜性和專利制度的侷限性，本文提議超越專利制度的限制，充分利用與藥品上市相關的其他監管法規和政策，從更全面的角度，整合可運用的機制，或許可以在專利保護與病人權益之間找到一個更好的平衡。
The most distinctive aspect of the pharmaceutical industry lies in its profound connection with life and health, where the value of life and health differs from that of other commodities, making it challenging to quantify through market prices. The pharmaceutical industry also possesses other distinct characteristics, including substantial research and development investments, extended developmental timelines, inherent uncertainties, and relatively low manufacturing costs post-drug development. As a result, patent protection becomes imperative to incentivize ongoing R&D investments that drive innovation within this sector. While well-intentioned, this system has the side effect of high drug prices limiting accessibility, contradicting the initial purpose of drugs to help patients treat diseases. Striking a balance between safeguarding innovation and upholding patent rights remains an ongoing challenge for both industry stakeholders and policymakers. The situation is further compounded by the concept of follow-on innovation within pharmaceutical R&D. Continual enhancement inherently accompanies any innovation process, and in the realm of pharmaceuticals, incremental advancements lay the foundation for groundbreaking medical breakthroughs. However, distinguishing which follow-on innovations have clinical value is challenging because patent examination occurs before clinical results are obtained, and there are limitations in understanding the biochemical reactions of drugs within the human body, with no guidelines to accurately predict actual clinical efficacy. While the patent framework effectively encourages sustained investment in innovative medications, it has at times been exploited through practices like patent thickets and patent evergreening, which excessively prolong exclusivity periods, ultimately impairing the integrity of patent rights. This paper aims to deliberate on prevailing challenges concerning follow-on pharmaceutical innovation and patentability standards, striving to present a balanced perspective that fosters innovation while ensuring accessibility. It also underscores the limitations of relying solely on the patent system to resolve this conundrum. In light of these complexities, the paper advocates transcending the confines of the patent system and capitalizing on supplementary regulations and policies encompassing drug development. 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國立政治大學
法學院碩士在職專班
105961021資料來源 http://thesis.lib.nccu.edu.tw/record/#G0105961021 資料類型 thesis dc.contributor.advisor 沈宗倫 zh_TW dc.contributor.author (Authors) 陳培志 zh_TW dc.creator (作者) 陳培志 zh_TW dc.date (日期) 2024 en_US dc.date.accessioned 1-Feb-2024 13:02:52 (UTC+8) - dc.date.available 1-Feb-2024 13:02:52 (UTC+8) - dc.date.issued (上傳時間) 1-Feb-2024 13:02:52 (UTC+8) - dc.identifier (Other Identifiers) G0105961021 en_US dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/149686 - 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) 105961021 zh_TW dc.description.abstract (摘要) 藥品產業最獨特之處是其與生命健康息息相關，而生命健康的價值異於其他商品，難以用市場價格衡量。除此之外，藥品產業還有其他特點，包括巨額的研發投資、漫長的開發週期、高度的不確定性以及藥品研發完成後相對較低的單位製造成本。藥品專利制度透過授予研發者一定時間的專屬權，取得市場獨佔優勢以利回收研發投入，研發藥廠得以持續投入研發創新。因此藥品專利保護對於推動藥品創新至關重要。雖然立意良善，也確實推動藥品研發，然而伴隨而來的高昂藥價卻限制了藥品的可及性(accessibility)，反而違背了研發藥品治療疾病的初衷。 在保護專利和維護病人權益之間取得平衡仍然是藥品產業利益相關者和政策制定者持續面臨的挑戰。而藥品後續創新(follow-on innovation)專利使得問題更加複雜。本質上，創新不論大小皆是研發的漸進過程，而在藥品領域漸進性的持續改良也是開創性突破的基礎。然而，並非所有的創新改良皆值得享有專利保護。區分何種藥品後續創新具有臨床價值而值得給予專利並非易事，因為專利審查通常在臨床試驗結果取得之前，而且對於藥品進入人體內的生化反應了解仍有侷限，尚無準則可以精準預測實際臨床療效。 儘管授予後續創新藥品專利可以鼓勵研發藥廠持續投入創新藥品研發，但同時也給予藥廠濫用專利制度的機會利用手段(例如,專利叢林和專利長青)不當延長獨占期限，限縮了藥品可及性，最終損害了公共衛生及病人用藥的權益，反而違背了藥品治病的初衷。本文將先就後續創新藥品可專利性標準的當前問題進行討論，試圖在促進創新和確保藥品可及性之間取得一個平衡，也藉此點出僅依賴專利制度解決此一困境的局限性。 鑒於問題的複雜性和專利制度的侷限性，本文提議超越專利制度的限制，充分利用與藥品上市相關的其他監管法規和政策，從更全面的角度，整合可運用的機制，或許可以在專利保護與病人權益之間找到一個更好的平衡。 zh_TW dc.description.abstract (摘要) The most distinctive aspect of the pharmaceutical industry lies in its profound connection with life and health, where the value of life and health differs from that of other commodities, making it challenging to quantify through market prices. The pharmaceutical industry also possesses other distinct characteristics, including substantial research and development investments, extended developmental timelines, inherent uncertainties, and relatively low manufacturing costs post-drug development. As a result, patent protection becomes imperative to incentivize ongoing R&D investments that drive innovation within this sector. While well-intentioned, this system has the side effect of high drug prices limiting accessibility, contradicting the initial purpose of drugs to help patients treat diseases. Striking a balance between safeguarding innovation and upholding patent rights remains an ongoing challenge for both industry stakeholders and policymakers. The situation is further compounded by the concept of follow-on innovation within pharmaceutical R&D. Continual enhancement inherently accompanies any innovation process, and in the realm of pharmaceuticals, incremental advancements lay the foundation for groundbreaking medical breakthroughs. However, distinguishing which follow-on innovations have clinical value is challenging because patent examination occurs before clinical results are obtained, and there are limitations in understanding the biochemical reactions of drugs within the human body, with no guidelines to accurately predict actual clinical efficacy. While the patent framework effectively encourages sustained investment in innovative medications, it has at times been exploited through practices like patent thickets and patent evergreening, which excessively prolong exclusivity periods, ultimately impairing the integrity of patent rights. This paper aims to deliberate on prevailing challenges concerning follow-on pharmaceutical innovation and patentability standards, striving to present a balanced perspective that fosters innovation while ensuring accessibility. It also underscores the limitations of relying solely on the patent system to resolve this conundrum. In light of these complexities, the paper advocates transcending the confines of the patent system and capitalizing on supplementary regulations and policies encompassing drug development. This broader approach is proposed as a means to address the limitations intrinsic to an exclusive reliance on the patent system. en_US dc.description.tableofcontents 第一章 緒論 1 第一節 研究背景 1 第一項 製藥產業概觀 3 第二項 藥品的相關法規 17 第二節 問題意識 25 第一項 藥品後續創新的雙面刃 27 第二項 專利判斷標準難以一體適用 31 第三項 其他藥品相關法規或可協力 32 第三節 研究範圍及架構 32 第二章 藥品後續創新及其價值 34 第一節 藥品的後續創新及常見的分類 34 第一項 什麽是藥品後續創新 34 第二項 藥品創新的常見分類 40 第二節 後續創新的價值 54 第一項 持續的後續創新往往是突破性創新的基礎 54 第二項 後續創新藥品可以提高療效或安全性 55 第三項 對於開發中國家的價值 55 第三章 化學藥品後續創新專利 58 第一節 化學藥品相關的專利制度演進 58 第一項 Hatch-Waxman Act 和其後的專利制度與藥品法規演進 59 第二項 與貿易有關的智慧財產權協定 (簡稱 TRIPS) 64 第二節 專利發明的要件 66 第一項 產業利用性（Industrial Application, Utility） 67 第二項 新穎性 (Novelty) 74 第三項 進步性 (Inventive step, 非顯而易見性 Non-obviousness) 77 第三節 化學藥品發明專利進步性判斷 86 第一項 前導化合物分析 (Lead Compound Analysis) 89 v 第二項 相鄰同系物 (Adjacent Homologues) 91 第三項 非相鄰的同系物 (Remote Homologues) 93 第四項 同分異構物 (同素異形體 Isomers) 93 第四節 藥品後續創新可專利性指引及審查基準 104 第一項 後續創新專利判斷上的常見爭議 106 第二項 藥品發明可專利性討論及相關的指引 113 第三項 美國、印度、台灣對於後續創新藥品的專利審查標準 121 第五節 對於藥品後續創新專利議題的淺見 136 第一項 應鼓勵後續創新促進製藥產業發展 136 第二項 善用新科技工具幫助專利審查 138 第四章 專利制度與其他相關制度連結及互補 140 第一節 其他與藥品相關法規 143 第一項 專利期間調整及回復 144 第二項 專利連結 146 第三項 資料 (實驗數據) 專屬權 149 第二節 保險給付 151 第一項 保險給付藥品訂價 152 第二項 台灣和美國保險給付規定及給付價格制定 154 第三節 市場競爭 157 第四節 政府或非營利機構的獎勵機制和控制機制 159 第五節 專利與其他藥品相關法規政策之間的協作 163 第一項 各機關之間的合作可以彌補專利制度的不足 164 第二項 分程度和分階段給予適當的獎勵或保護機制 167 第五章 結論 170 參考資料 173 zh_TW dc.format.extent 2939494 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0105961021 en_US dc.subject (關鍵詞) 藥品專利 zh_TW dc.subject (關鍵詞) 後續創新藥品 zh_TW dc.subject (關鍵詞) 藥品可及性 zh_TW dc.subject (關鍵詞) 藥品上市審查 zh_TW dc.subject (關鍵詞) Pharmaceutical patent en_US dc.subject (關鍵詞) Follow-on pharmaceutical innovation en_US dc.subject (關鍵詞) Accessibility en_US dc.subject (關鍵詞) Drug approval regulations en_US dc.title (題名) 後續創新藥品專利保護和可及性的兩難 zh_TW dc.title (題名) The Dilemma of Patent Protection and Accessibility for Follow-on Pharmaceutical Innovation en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 一、 中文資料 (一) 文獻期刊 1. 李素華，醫藥發明之專利個案探討：以我國長青樹藥品專利為例，臺大法學論叢，第41卷第2期，頁647-723，2012年6月。 2. 廖麗香、吳佳蓉，血管收縮素轉化酶抑制劑，台灣醫學，第2卷第5期，頁566-574，1998年。 3. 尹守信，淺析美國專利法上之新穎性要件，智慧財產權月刊，第78卷，頁52-70，2005年。 4. 李蘇、秦叔逵，氘代藥物及其在抗腫瘤新藥研發中的應用前景，臨床腫瘤學雜誌，第25卷第12期，頁1138-1143，2020年。 5. 吳東哲，專利連結的另一半 — 談以專利法明定擬制侵權與確認訴訟之必要性與爭議，專利師，第39期，2019年10月。 6. 馮霄蟬、楊悅，美國鼓勵藥物取代政策，中國衛生政策研究，第12卷第2期，頁7-14，2019年2月。 (二) 法院判決 1. 智慧財產及商業法院111年度民專上字第6號判決。 2. 智慧財產及商業法院110年度行專訴字第67號判決。 3. 智慧財產法院 102 年民專訴字第 111 號民事判決。 (三) 法規命令 1. 專利法(2022年5月)。 2. 專利審查基準(2020年)。 3. 全民健康保險藥物給付項目及支付標準(2022)。 4. 藥事法(2018年1月)。 5. 全民健康保險藥物給付項目及支付標準(2022年12月)。 6. 全民健康保險藥品價格調整作業辦法(2023年3月)。 (四) 政府文件 1. 藥事法修正草案之外界疑慮說明，衛生福利部食品藥物管理署，2018年。 2. 藥事法修正案簡要說明，衛生福利部食品藥物管理署，2018年。 (五) 網路資料 1. 陳藝菁，同分異構物（Isomer），科學 Online (2010)，available at https://highscope.ch.ntu.edu.tw/wordpress/?p=3395 (last visited Feb. 3) 2. 健保28 守護大家 Leave No One Behind - Health For All In Taiwan, 衛生福利部中央健康保險署 (2023)，available at https://www.nhi.gov.tw/-Content_List.aspx?n=34D1C9E227F442B7&topn=4864A82710DE35ED (last visited Jul. 19, 2023) 3. 醫藥科技評估，財團法⼈醫藥品查驗中心available at https://www.cde.org.tw/HTA/ (last visited Jul. 22, 2023) 4. 重磅首仿！全球首個創新晶型「沙庫巴曲纈沙坦鈉片」在中國獲批，醫藥魔方(2023), available at https://bydrug.pharmcube.com/news/detail/-a73110980e9006ebb1da7ca5597aefce (last visited Aug. 25, 2023) 5. 5+2產業創新計畫, 國家發展委員會(2023), available at https://www.ndc.gov.tw/Content_List.aspx?n=9D024A4424DC36B9 (last visited Aug. 25, 2023) 6. 回顧那些年，台灣成功推進全球上市的新藥, 國家生技醫療產業促進會, available at https://ibmi.taiwan-healthcare.org/zh/bio_highlights_detail.php?-REFDOCID=0qy8wkdyl6fa31c0#:~:text=%E7%B4%AF%E8%A8%88%E6%88%91%E5%9C%8B%E9%80%9A%E9%81%8E%E7%94%9F%E6%8A%80,%E4%BB%A5%E5%8F%8A%E7%B4%8D%E7%96%BC%E8%A7%A3%C2%AE%20 (last visited Aug. 25, 2023) 二、 外文資料 (一) Book 1. 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