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題名 生物相似性藥品之產業分析與法律評估: 以上市許可規範與智慧財產權為核心
The industry analysis and legal assessment of biosimilars: focusing on approval regulations and intellectual property rights作者 李昕彥
Li, Hsin Yen貢獻者 沈宗倫
Shen, Chung Lun
李昕彥
Li, Hsin Yen關鍵詞 生物相似性藥品
生物藥品價格競爭與創新法
專利舞蹈
專利資訊交換機制
可互換性
自動替換
適應症外推
法定專屬權
Biosimilar
Biologics Price Competition and Innovation Act
Patent dance
Patent information exchange mechanism
Interchangeability
Automatic substitution
Extrapolation
Statutory exclusivity日期 2016 上傳時間 4-Jan-2017 12:00:41 (UTC+8) 摘要 生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。
Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R&D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets.參考文獻 一、 中文資料(一) 書籍1. 王旻、譚樹華，生物製藥技術，2004年7月。2. 忻凌偉，先導化合物最佳化：組合式化學簡介，特定標的之新藥開發，教育部顧問室生物技術科技人才培育先導型計畫醫藥基因生物技術教學資源中心，2005年。3. 張靜，營業秘密法及相關智權問題，2007年2月，2版。4. 劉國讚，專利法之理論與實用，2014年1月，2版。5. 謝銘洋，智慧財產權法，2016年3月，6版。6. 饒秀珍，生醫新視野：生技產業投資停看聽，2014年5月。(二) 期刊論文1. 李素華，專利權讓與之給付義務與權利瑕疵擔保-臺灣高等法院九十五年度上字第一○三二號民事判決，月旦裁判時報，第11期，2011年11月。2. 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，2012年6月。3. 沈宗倫，由專利法教示因果關係論專利進步性：以組合專利與類似組合專利為中心，臺大法學論叢，第42卷第2期，2013年6月。4. 沈宗倫，專利法之基本用語與法律體系概述，月旦法學教室，第141期，2014年7月。5. 林宗緯，Hatch-Waxman法案及我國既有法規之比較-對我國引進專利連結制度之建議，萬國法律，第201期，2015年6月。6. 夏禾、陳鋕雄，資料專屬權與專利保護制度之競合：以美國藥品上市法制為中心，智慧財產評論，第12卷第1期，2014年5月。7. 張哲倫、李素華，專利法之經濟結構-經濟分析理論對於臺灣專利制度運作之啟發，月旦法學雜誌，第234期，2014年11月。8. 許曉芬，從歐洲醫藥產業看競爭法對智慧財產權之限制，萬國法律，第203期，2015年10月。9. 陳文吟，由美國法制探討生物藥品專利，月旦民商法雜誌，第4期，2004年6月。10. 陳文吟，從美國核准動物專利之影響評估動物專利之利與弊，台大法學論叢，26卷4期，1997年7月。11. 陳文吟，論兼採專利制度與資料專屬權鼓勵醫藥品研發之必要性，專利師，第21期，2015年4月。12. 陳桂恒、吳東哲，TPP下的「特定藥品上市之相關措施」-以美國「專利連結」、「專利舞蹈」為例，萬國法律，第206期，2016年4月。13. 傅冬卿、陳鋕雄，論生物相似藥品上市審查規範：以美國生物相似藥品價格競爭與創新法為師或為鑑?，智慧財產評論，11卷2期，2013年10月。14. 馮震宇，藥品專利與競爭法之互動-從學名藥逆向付款爭議談起，專利師，第10期，2012年7月。15. 黃千惠等，紅血球生成素引起之抗體導致的純紅血球再生不良：一病例報告，台灣內科學誌，第20卷第1期，2009年2月。16. 黃珮珍、王立達，專利法對醫藥衍生發明之合理評價-以已知物質衍生物為中心，成大法學，第23期，2012年6月。17. 黃慧嫺，專利連結(Patent Linkage)-藥品研發與競爭之阻力或助力？談藥品查驗登記程序與專利權利狀態連結之發展(下)，科技法律透析，21卷3期，2009年2月。18. 黃慧嫺，談製藥技術研發成果之特別保護機制(下)-以美國藥物法規為例，科技法律透析，第19卷第9期，2007年9月。19. 楊崇森，美國法上之營業秘密保護，中興法學，第23期，1986年11月。(三) 學位論文1. 何孟璁，論生物相似性藥品之上市規範與智慧財產保護，國立臺灣大學科際整合法律學研究所碩士論文， 2009年6月。2. 沈雅慧，由學名藥侵權訴訟評估均等論在生物相似藥侵權訴訟的影響-以美國為例，國立政治大學法學院在職專班碩士論文，2016年3月。3. 楊子弘，論生物相似性藥品之上市規範-以美國、臺灣及中國大陸為核心，國立清華大學科技法律研究所碩士論文，2012年4月。4. 楊馥璟，醫藥品上市審查規範與專利權保護之研究-從學名藥到生物相似藥品之演進，國立政治大學法律科際整合研究所碩士論文，2014年6月。(四) 法規命令1. 生技新藥產業發展條例 (2007年7月4日)2. 生物相似性單株抗體藥品查驗登記基準 (2015年12月4日)3. 專利法 (2014年1月22日)4. 營業秘密法 (2013年1月30日)5. 醫師法 (2012年12月19日)6. 藥事法 (2015年12月2日)7. 藥品查驗登記審查準則-生物相似性藥品 (2008年11月21日)8. 藥師法 (2014年7月16日)(五) 研究報告1. 勤業眾信聯合會計師事務所，生物相似性藥品商機觀察從全球發展看台灣機會，2016年。二、外文資料(一) 書籍1. 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國立政治大學
法律科際整合研究所
102652022資料來源 http://thesis.lib.nccu.edu.tw/record/#G1026520221 資料類型 thesis dc.contributor.advisor 沈宗倫 zh_TW dc.contributor.advisor Shen, Chung Lun en_US dc.contributor.author (Authors) 李昕彥 zh_TW dc.contributor.author (Authors) Li, Hsin Yen en_US dc.creator (作者) 李昕彥 zh_TW dc.creator (作者) Li, Hsin Yen en_US dc.date (日期) 2016 en_US dc.date.accessioned 4-Jan-2017 12:00:41 (UTC+8) - dc.date.available 4-Jan-2017 12:00:41 (UTC+8) - dc.date.issued (上傳時間) 4-Jan-2017 12:00:41 (UTC+8) - dc.identifier (Other Identifiers) G1026520221 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/105607 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法律科際整合研究所 zh_TW dc.description (描述) 102652022 zh_TW dc.description.abstract (摘要) 生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。 zh_TW dc.description.abstract (摘要) Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R&D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets. en_US dc.description.tableofcontents 第一章 緒論 1第一節 研究動機與目的 1第二節 研究方法與範圍 4第三節 論文架構 4第二章 生技醫藥產業之現況及發展 6第一節 製藥產業概況 6第一項 新藥核准趨勢 6第二項 全球製藥產業發展概況與趨勢 12第二節 製藥產業特性 25第一項 製藥產業的生態系統 25第二項 藥品的研究開發與臨床試驗 29第三節 生物相似性藥品市場趨勢與發展機會 50第一項 全球生物藥品市場概況與發展趨勢 50第二項 生物相似性藥品之市場機會及競爭分析 56第三項 台灣生物相似性藥品的機會與策略建議 73第三章 生物相似性藥品之開發與製造 76第一節 生物藥品之製造概述 76第一項 生物藥品之本質特性 76第二項 生物藥品之製程依賴性 78第三項 製程對生物藥品生理活性之影響 81第二節 生物相似性藥品之開發與分析定性 83第一項 生物相似性藥品之開發流程 83第二項 分析科學之不足 91第三項 基礎研究之誘因缺乏 94第四章 生物相似性藥品之審查規範與上市法制 97第一節 美國醫藥品上市審查法制之沿革 97第一項 美國學名藥之上市審查制度 97第二項 美國生物相似性藥品之上市許可規範 99第二節 生物相似性藥品之適應症外推及可互換性 101第一項 適應症外推之核准 101第二項 可互換性認定之構成要件 104第三項 治療轉換之可行性 105第四項 可互換性取得之鼓勵機制 107第五項 生物相似性藥品替換機制之立法化 109第三節 美國核准前專利爭端解決程序 116第一項 專利舞蹈 116第二項 BPCIA專利爭端解決制度之可能濫用 129第四節 歐盟與台灣之生物相似性藥品上市法規 134第一項 歐盟生物相似性藥品上市審查規範之立法 134第二項 台灣生物相似性藥品之上市規範與挑戰 135第五章 生物藥品之智慧財產權佈局與管理 139第一節 生物藥品之製程保護策略與營業秘密 139第一項 專利與營業秘密之間的互斥性 139第二項 專利權與營業秘密保護之選擇 141第二節 專利保護制度與法定專屬權之競合及運用 144第一項 專利制度之基本內涵 144第二項 專利保護對鼓勵醫藥品研發與創新之重要性 147第三項 藥品法定專屬權之特性與功能 157第四項 藥品專利權與專屬權之異同與競合 166第三節 生物藥品專屬權保護之綜合分析 169第一項 美國與歐盟生物藥品專屬權制度之比較 170第二項 生物新藥之合理專屬保護期 171第六章 結論與建議 175參考文獻 179 zh_TW dc.format.extent 4389785 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G1026520221 en_US dc.subject (關鍵詞) 生物相似性藥品 zh_TW dc.subject (關鍵詞) 生物藥品價格競爭與創新法 zh_TW dc.subject (關鍵詞) 專利舞蹈 zh_TW dc.subject (關鍵詞) 專利資訊交換機制 zh_TW dc.subject (關鍵詞) 可互換性 zh_TW dc.subject (關鍵詞) 自動替換 zh_TW dc.subject (關鍵詞) 適應症外推 zh_TW dc.subject (關鍵詞) 法定專屬權 zh_TW dc.subject (關鍵詞) Biosimilar en_US dc.subject (關鍵詞) Biologics Price Competition and Innovation Act en_US dc.subject (關鍵詞) Patent dance en_US dc.subject (關鍵詞) Patent information exchange mechanism en_US dc.subject (關鍵詞) Interchangeability en_US dc.subject (關鍵詞) Automatic substitution en_US dc.subject (關鍵詞) Extrapolation en_US dc.subject (關鍵詞) Statutory exclusivity en_US dc.title (題名) 生物相似性藥品之產業分析與法律評估: 以上市許可規範與智慧財產權為核心 zh_TW dc.title (題名) The industry analysis and legal assessment of biosimilars: focusing on approval regulations and intellectual property rights en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 一、 中文資料(一) 書籍1. 王旻、譚樹華，生物製藥技術，2004年7月。2. 忻凌偉，先導化合物最佳化：組合式化學簡介，特定標的之新藥開發，教育部顧問室生物技術科技人才培育先導型計畫醫藥基因生物技術教學資源中心，2005年。3. 張靜，營業秘密法及相關智權問題，2007年2月，2版。4. 劉國讚，專利法之理論與實用，2014年1月，2版。5. 謝銘洋，智慧財產權法，2016年3月，6版。6. 饒秀珍，生醫新視野：生技產業投資停看聽，2014年5月。(二) 期刊論文1. 李素華，專利權讓與之給付義務與權利瑕疵擔保-臺灣高等法院九十五年度上字第一○三二號民事判決，月旦裁判時報，第11期，2011年11月。2. 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，2012年6月。3. 沈宗倫，由專利法教示因果關係論專利進步性：以組合專利與類似組合專利為中心，臺大法學論叢，第42卷第2期，2013年6月。4. 沈宗倫，專利法之基本用語與法律體系概述，月旦法學教室，第141期，2014年7月。5. 林宗緯，Hatch-Waxman法案及我國既有法規之比較-對我國引進專利連結制度之建議，萬國法律，第201期，2015年6月。6. 夏禾、陳鋕雄，資料專屬權與專利保護制度之競合：以美國藥品上市法制為中心，智慧財產評論，第12卷第1期，2014年5月。7. 張哲倫、李素華，專利法之經濟結構-經濟分析理論對於臺灣專利制度運作之啟發，月旦法學雜誌，第234期，2014年11月。8. 許曉芬，從歐洲醫藥產業看競爭法對智慧財產權之限制，萬國法律，第203期，2015年10月。9. 陳文吟，由美國法制探討生物藥品專利，月旦民商法雜誌，第4期，2004年6月。10. 陳文吟，從美國核准動物專利之影響評估動物專利之利與弊，台大法學論叢，26卷4期，1997年7月。11. 陳文吟，論兼採專利制度與資料專屬權鼓勵醫藥品研發之必要性，專利師，第21期，2015年4月。12. 陳桂恒、吳東哲，TPP下的「特定藥品上市之相關措施」-以美國「專利連結」、「專利舞蹈」為例，萬國法律，第206期，2016年4月。13. 傅冬卿、陳鋕雄，論生物相似藥品上市審查規範：以美國生物相似藥品價格競爭與創新法為師或為鑑?，智慧財產評論，11卷2期，2013年10月。14. 馮震宇，藥品專利與競爭法之互動-從學名藥逆向付款爭議談起，專利師，第10期，2012年7月。15. 黃千惠等，紅血球生成素引起之抗體導致的純紅血球再生不良：一病例報告，台灣內科學誌，第20卷第1期，2009年2月。16. 黃珮珍、王立達，專利法對醫藥衍生發明之合理評價-以已知物質衍生物為中心，成大法學，第23期，2012年6月。17. 黃慧嫺，專利連結(Patent Linkage)-藥品研發與競爭之阻力或助力？談藥品查驗登記程序與專利權利狀態連結之發展(下)，科技法律透析，21卷3期，2009年2月。18. 黃慧嫺，談製藥技術研發成果之特別保護機制(下)-以美國藥物法規為例，科技法律透析，第19卷第9期，2007年9月。19. 楊崇森，美國法上之營業秘密保護，中興法學，第23期，1986年11月。(三) 學位論文1. 何孟璁，論生物相似性藥品之上市規範與智慧財產保護，國立臺灣大學科際整合法律學研究所碩士論文， 2009年6月。2. 沈雅慧，由學名藥侵權訴訟評估均等論在生物相似藥侵權訴訟的影響-以美國為例，國立政治大學法學院在職專班碩士論文，2016年3月。3. 楊子弘，論生物相似性藥品之上市規範-以美國、臺灣及中國大陸為核心，國立清華大學科技法律研究所碩士論文，2012年4月。4. 楊馥璟，醫藥品上市審查規範與專利權保護之研究-從學名藥到生物相似藥品之演進，國立政治大學法律科際整合研究所碩士論文，2014年6月。(四) 法規命令1. 生技新藥產業發展條例 (2007年7月4日)2. 生物相似性單株抗體藥品查驗登記基準 (2015年12月4日)3. 專利法 (2014年1月22日)4. 營業秘密法 (2013年1月30日)5. 醫師法 (2012年12月19日)6. 藥事法 (2015年12月2日)7. 藥品查驗登記審查準則-生物相似性藥品 (2008年11月21日)8. 藥師法 (2014年7月16日)(五) 研究報告1. 勤業眾信聯合會計師事務所，生物相似性藥品商機觀察從全球發展看台灣機會，2016年。二、外文資料(一) 書籍1. 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