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研究生:張至潔
研究生(外文):Chih-Jie Chang
論文名稱:生物相似藥上市申請面臨之專利問題
論文名稱(外文):Patent issues that biosimilars will encounter when applying for marketing
指導教授:謝銘洋謝銘洋引用關係
指導教授(外文):Ming-Yan Shieh
口試委員:李素華沈宗倫
口試委員(外文):Su-Hua LeeChung-Lun Shen
口試日期:2022-02-08
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:科際整合法律學研究所
學門:法律學門
學類:專業法律學類
論文種類:學術論文
論文出版年:2022
畢業學年度:110
語文別:中文
論文頁數:142
中文關鍵詞:生物製藥生物相似藥專利舞蹈專利連結
外文關鍵詞:biologicsbiosimilarpatent dancepatent linkage
DOI:10.6342/NTU202200439
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隨著科技進步,藥物發展迅速,出現多種新型態藥物,生物製藥是其中一種重要的藥物型態,此類藥物是以細胞或細菌為生產工廠產生之藥物,具有高專一性及低副作用的優點。近年來各大生物製藥廠的專利陸續到期,其他藥廠可以開始生產這些專利到期的生物製藥,但在生物製藥領域中,由於製程相異,可能影響到蛋白質立體結構或後修飾,造成分子結構有差異但療效相同之情形,故由其他藥廠生產的生物製藥稱為「生物相似藥」只能視為相似產品,這也是「生物相似藥」之名稱由來。由於生物製藥入門門檻高、研發困難、須耗費大量金錢及時間成本,且失敗率高,除世界知名大廠外,多數藥廠選擇從門檻較低之生物相似藥研發方向著手。隨著多項生物製藥專利將屆期,生物相似藥上市申請案增多,原生物製藥廠與生物相似藥廠間之專利侵權案例也逐漸累積。本論文先由生物製藥的特性、生產製程等技術資訊進行了解,接著分析比較生物相似藥在美國經由專利舞蹈制度與我國經由專利連結制度的上市程序,之後藉由美國生物相似藥上市時相關侵權案例,再進一步分析我國生物相似藥上市可能面臨之專利侵權問題,最後嘗試針對我國生物相似藥上市申請制度及生物製藥相關規範提出分析與建議。
With the advancement of technology and the rapid development of drugs, a variety of new types of drugs have emerged, and biologics are one of the important types of drugs. In recent years, the patents of major biopharmaceutical factories have expired one after another, and other pharmaceutical factories can start producing biopharmaceuticals whose patents have expired. However, in the field of biologics, different manufacturing processes may affect the three-dimensional structure or post-modification of proteins, resulting in different molecular structures but the same therapeutic effect. Therefore, biologics produced by other pharmaceutical companies are called "biosimilar drugs" which only can be regarded as similar products. Due to the high barriers to entry of biopharmaceuticals, the difficulty of research and development, the cost of a lot of money and time, and the high failure rate, except for world-renowned manufacturers, most pharmaceutical companies choose to start from the research and development direction of biosimilar drugs with lower thresholds. With the expiry of a number of biopharmaceutical patents, the number of biosimilar drug listing applications has increased, and the patent infringement cases between the original biopharmaceutical factory and the biosimilar drug factory have also gradually accumulated. This paper firstly understands the characteristics of biopharmaceuticals, production process and other technical information, and then analyzes and compares the listing procedures of biosimilar drugs in the United States through the patent dance system and Taiwan through the patent linkage system. Then, based on the related infringement cases of biosimilar drugs in the United States, we will further analyze the patent infringement problems that may be faced by biosimilar drugs in Taiwan. Finally, it tries to put forward analysis and suggestions on the application system of biosimilar drugs in Taiwan and related norms of biopharmaceuticals.
目錄
誌謝 1
中文摘要 2
英文摘要 3
目錄 5
圖表目錄 10
第一章 緒論 11
第一節 研究動機 11
第二節 研究目的 13
第三節 研究方法 14
第四節 研究架構 14
第二章、藥物演進、類型、生物製藥研發上市流程及市場、生物相似藥 16
第一節、藥物演進 16
一、天然藥物時代 17
二、化學合成時代 17
三、生物技術時代 17
第二節、藥物的分類-小分子藥物與生物製藥 18
一、分子結構 18
二、生產製程 19
三、藥效及副作用 21
第三節、美國生物製藥研發及上市 24
一、發現階段 24
二、發展階段 26
三、監管審查和核准-完整數據資料評估及製造計劃 29
四、核准後研究及監控 30
第四節、生物製藥的競爭者-生物相似藥 35
一、何謂生物相似藥 35
二、生物相似藥的成本與售價 38
第五節、生物製藥與生物相似藥在藥物市場之發展 39
一、生物製藥與生物相似藥對藥物市場影響 39
二、生物相似藥上市對生物製藥之影響 40
第六節、我國生物製藥與生物相似藥相關規範 43
一、生物製藥與生物相似藥定義 43
二、我國生物製藥研發上市及監管流程 44
第七節、小結 50
第三章 美國對於生物製藥之專利與政策保護 52
第一節 美國專利制度 52
一、專利類型 52
二、專利申請案類型 53
三、申請審查流程 54
四、核准專利之保障 56
第二節、美國生物製藥專利保護與資料專屬權 56
一、藥物專利特別規定-專利期間延長 56
二、資料專屬權 58
三、生物製藥專利申請 61
第三節、生物相似藥上市申請規範 68
一、一般藥物規範-藥品價格競爭與專利期延長法案 68
二、生物製藥之獨特規範-生物藥品價格競爭與創新法 72
第四節、小結 77
第四章、美國生物相似藥之專利侵權訴訟案例 79
第一節、Filgrastim 與Pegfligrastim之相關介紹 79
一、原生物分子-顆粒球聚落刺激因子(G-CSF) 79
二、G-CSF相關生物製藥 80
三、Filgrastim在生物製藥市場分析 82
第二節、Neupogen及Neulasta相關專利 85
一、美國專利US5580755A號 85
二、美國專利US5824784A號 85
第三節、Neupogen及Neulasta之相關訴訟 86
一、Amgen vs. Sandoz 86
二、Amgen vs.Apotex 99
三、Amgen vs. Coherus Biosciences 106
第四節、小結 110
第五章、我國生物製藥發展及案例分析 113
第一節、我國生物製藥產業發展現況 113
一、優惠措施 114
二、政府研究單位研發成果技轉業界 114
三、生技相關法規制定與修正 115
四、我國生物相似藥之發展 115
第二節、我國生物製藥之相關專利制度與資料專屬權 118
一、 專利權期間延長 118
二、專利連結制度 119
三、資訊專屬權 120
四、我國與美國相關制度之比較 121
第三節、相關案例分析 123
一、聯亞生物相似藥UB-851 123
二、 可能爭點整理 123
第四節、小結 128
第六章、對於我國生物相似藥相關規範之檢討與建議 130
第一節、藥事法 130
一、生物製藥定義 130
二、專利連結制度 131
第二節、專利法因應修正 132
參考文獻及書目 134
一、中文參考文獻 134
二、外文參考文獻 136
一、中文參考文獻
1.中國醫藥大學附設醫院衛教單張(2021),《類風濕性關節炎之症狀與診斷》,載於: https://www.cmuh.cmu.edu.tw/HealthEdus/Detail?no=4769
2.李青松(2020),《退燒藥也會致命?阿斯匹靈與雷氏症候群》,載於:http://www.kgh.com.tw/health/06-13.HTML
3.李素華(2018),〈簡析藥事法修法:新適應症資料專屬權與專利連結專章〉,《科學月刊》,435期,載於: https://www.scimonth.com.tw/archives/584
4.李林璦(2019),〈美國「專利舞蹈」機制 平衡藥價競爭與鼓勵創新〉,《環球生技雜誌》
5.奇美衛教資訊網(2020),《類風濕關節炎的診斷與治療》,載於: https://www.chimei.org.tw/main/cmh_department/59012/info/7390/A7390114.html
6.《阿斯匹靈的8種功效及副作用(8點使用禁忌請小心)》(2021), 載於:https://formulawave.com/aspirin-benefits-side-effects/
7.朱淑尹(2015),〈美國專利連結制度中專利登錄的介紹與探討〉,《智慧財產權月刊》,196:20-33
8.林哲良(2021),〈生物相似藥夯,台廠以小搏大突圍國際市場〉,《鏡周刊》,載於: https://www.mirrormedia.mg/story/20210825ind001/
9.吳元熙(2021),〈 CDMO是什麼?生技界「台積電模式」,為何讓郭董大砸50億元投資?〉,《數位時代》,載於: https://www.bnext.com.tw/article/65295/cdmo
10.紀畊宇(2017),〈以「系爭專利與被控侵權物之差異能否輕易完成」作為均等侵權之判斷因素〉,載於: https://www.leeandli.com/TW/Newsletters/5927.htm
11.何娜瑩、林均郁(2019),〈論生物藥品準用專利連結制度對我國藥廠智慧財產權策略之影響〉,《全國律師》,23(5):52-59
12.柯昱安(2021),〈配合藥事法之專利法第60條之1之修正與實務現況〉,《台一雙週專利電子報》,284
13.陳紀勳、詹明曉(2018),〈生物相似性藥品之臨床審查考量〉,《當代醫藥法規月刊》,92:1-5
14.陳翠華(2018),〈我國醫藥品專利權期間延長制度之探討(下) 〉,《智慧財產權月刊》,115:86-113
15.高詠文、彭德仁(2019),〈政策舞蹈 —生物藥與專利連結制度淺析〉,《全國律師》,23:5,P37-50
16.陳文吟(2013),〈由Myriad案探討因應基因專利之合理措施〉,《專利師》,13:25-43
17.张璐瑶 (2020),〈生物医药行业之投资趋势篇—化学药与生物药差异化发展,关注产业链投资机会〉,《行业研究•行业跟踪》。
18.張卓然(2021),《甲氨蝶呤(Methotrexate) 》,載於: https://www.healthymatters.com.hk/zh/medicines/methotrexate-in-hong-kong/
19.葉雲卿(2018),〈美國生物科技專利之適格性判斷之進展〉,《北美智權報》,218期
20.葉雲卿(2018),〈如何判斷生物科技專利之發明概念〉,《北美智權報》,220
21.廖瑋婷(2018),〈臺美 TIFA 對藥品核准前專利爭端解決程序之要求—以美國 BPCIA 之專利舞蹈為中心〉,《貿易政策論叢》,29:89-128
22.楊智傑(2017),〈美國生物製劑藥之專利連結制度:2017年Sandoz v. Amgen案〉,《北美智權報》,第189期
23.蔣大中(理律法律事務所)(2014),〈美國專利連結與橘皮書登錄制度研究〉,經濟部智慧財產局103年度委託研究報告
24.施雅儀(2014),〈從美國Myriad 案探討經分離DNA之專利適格性〉,《智慧財產權月刊》,189:48-69
25.經濟部智慧財產局(2015),〈美國發明專利申請須知〉,載於: https://www.tipo.gov.tw/tw/dl-15189-c9aa573e8920414ca6545e1e8f614abe.html
26.鄭志雄(2021), 《簡介紅血球生成素(EPO)治療慢性腎衰竭貧血》,載於: http://www.kidney.org.tw/know/k8.html
27.蕭世裕 (2004),〈化學製藥與生物製藥產業〉,《科學發展》,373,3-13。
28.衛生福利部食品藥物管理署(2020),《生物相似性藥品查驗登記基準》,載於:http://regulation.cde.org.tw/doc_data_display?sid=2349&doctype2=
29.衛生福利部食品藥物管理署(2016),《「我國新藥與疫苗研究開發、上市流程及相關法規之妥適性」專案報告》, 載於: https://dep.mohw.gov.tw/clu/cp-619-8219-122.html
30.衛生福利部食品藥物管理署(2002),《藥品臨床試驗一般基準》,載於: https://www.fda.gov.tw/TC/siteList.aspx?sid=4254&pn=9
31.經濟部工業局,2021生技產業白皮書
32.GeneOnLine (2017),〈為什麼生物藥是全球市場主流? 了解生物藥和傳統化學藥的差異〉,載於: https://geneonline.news/insights-into-the-popularity-of-biologic-drugs-from-studying-the-differences-between-biologics-and-traditional-pharmaceutical-drug/

二、外文參考文獻
1.Andrew Storaska et al. (2021), Changes to the Purple Book: Progress in Transparency, JDSUPRA, In: https://www.jdsupra.com/legalnews/changes-to-the-purple-book-progress-in-6749919/
2.Ana Sofia Pina, Abid Hussain, Ana Cecília A. Roque (2009). An Historical Overview of Drug Discovery. Ligand-Macromolecular Interactions in Drug Discovery, 572:3-12
3.CDC (2015), Multistate Outbreak of Fungal Meningitis and Other Infections, In: https://www.cdc.gov/hai/outbreaks/meningitis.html
4.Cheryl Scott (2014), Unwanted Immunogenicity: From Risk Assessment to Risk Management , BioPrpcess Internation, In: https://bioprocessintl.com/analytical/downstream-validation/unwanted-immunogenicity-risk-assessment-risk-management/
5.Dehns (2019), Patenting biotechnological inventions , Dehans, In: https://www.dehns.com/about/
6.Dehns (2020), Patenting of medical biotech inventions, In: https://www.dehns.com/about/
7.Emily Miller (2021) Humira | What Is Humira Used For and How Do You Use It? In: https://www.drugwatch.com/humira/
8.European Patent Office (2020), Biotechnology patents at the EPO,(2020), https://www.epo.org/news-events/in-focus/biotechnology-patents.html
9.FDA website (2020). Biosimilar and Interchangeable Products,In:https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
10.FDA website (2017), NDA and BLA Approvals , In: https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/nda-and-bla-approvals
11.FDA website (2017), Biosimilar and Interchangeable Products, In: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-product
12.FDA website (2021), Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, In: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry
13.FDA website (2021), FDA-Approved Biosimilar Products, In: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
14.FDA (2020), Exclusivity and Generic Drugs: What does it mean?, In: https://www.fda.gov/files/drugs/published/Exclusivity-and-Generic-Drugs--What-Does-It-Mean-.pdf
15.Fabian Gaessler & Stefan Wanger (2019), Patents, Data Exclusivity,and the Development of New Drugs, Review of Economics and Statistics, In: https://ssrn.com/abstract=3401226
16.FDA (2020), Frequently Asked Questions on Patents and Exclusivity, In: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity
17.FDA/ CDER (2014), New Chemical Entity Exclusivity Determinations for Certain Fixed -Combination Drug Products - Guidance for Industry, In: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-chemical-entity-exclusivity-determinations-certain-fixed-combination-drug-products
18. FDA/CDER(2015),Patents and Exclusivity, In:https://www.fda.gov/media/92548/download
19.FDA (2020), ANDA Submissions–Amendments and Requests for Final Approval to Tentatively Approved ANDAs, In: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/anda-submissions-amendments-and-requests-final-approval-tentatively-approved-andas
20.FDA(2019), Biosimilar Product Regulatory Review and Approval, In:https://www.fda.gov/media/151061/download
21.Federal Circuit Provides Guidance on Statements in Patent Dance Letters and Sunovion in Amgen v Apotex (2017), Big Molecule Watch website, In: https://www.bigmoleculewatch.com/2017/11/14/federal-circuit-provides-guidance-on-statements-in-patent-dance-letters-and-sunovion-in-amgen-v-apotex/
22.Innocenti R et al., (2019), Lenograstim and filgrastim in the febrile neutropenia prophylaxis of hospitalized patients: efficacy and cost of the prophylaxis in a retrospective survey, DevoPress, 27: 21-27
23.James Netterwald (2009), Virus stalls Genzyme plant, Nature Biotechnology, 27:681
24.Jacqueline R. Berman et al. (2021) , Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book, BioPress Online, In: https://www.bioprocessonline.com/doc/patent-transparency-for-biologics-biosimilars-the-revamped-purple-book-0001
25.Joanna Zielińska & Włodzimierz Bialik (2016), Recent changes on the biopharmaceutical market after the introduction of biosimilar G-CSF products, Oncology in Clinical Practice, 12(4) :144–152
26.Kirsty D. Ratanji et al. (2014), Immunogenicity of therapeutic proteins: Influence of aggregation, J. Immunotoxicol, 11(2): 99–109.
27.Laura Elizabeth Lansdowne (2020). Exploring the Drug Development Process,In:https://www.technologynetworks.com/drug-discovery/articles/exploring-the-drug-development-process-331894
28.Leslie A. Pray (2008). Discovery of DNA Structure and Function: Watson and Crick,Nature Education,1(1):100
29.Lori M. Brandes &Tarja H. Naukkarinen (2020),Patent Term Extension, Sterne Kessler, In: https://www.sternekessler.com/news-insights/publications/patent-term-extension
30.Marco Guerrini et al. (2008), Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events, Nature Biotechnology, 26:669-75
31.Mary Lou Zett (2020), Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions, biosimilar development, In: https://www.biosimilardevelopment.com/doc/mapping-the-development-of-a-biosimilar-candidate-analytical-regulatory-decisions-0001
32.Mary Lou Zett (2020), Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions,In: https://www.biosimilardevelopment.com/doc/mapping-the-development-of-a-biosimilar-candidate-analytical-regulatory-decisions-0001
33.Michael A. Carrier & Carl J. Minniti III (2018), BIOLOGICS: THE NEW ANTITRUST FRONTIER, UNIVERSITY OF ILLINOIS LAW REVIEW, In: https://ssrn.com/abstract=2982190
34.Murry Aitken & Michel KLeinrock (2020), Biosimilars in the United States 2020–2024, The IQVIA Institute Institute, In: https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
35.Michael A. Carrier & Carl J. Minniti III (2018), BIOLOGICS: THE NEW ANTITRUST FRONTIER, 2018 U. Ill. L. Rev. 1
36.Megan Brewster & Pallab Singh (2019), Intellectual Property Protection for Biologics, Academic Entrepreneurship for Medical and Health Scientists, 1 : (3)
37.Megan Brewster & Pallab Singh (2019), Intellectual Property Protection for Biologics, Academic Entrepreneurship for Medical and Health Scientists, 1(3): 11,In: https://repository.upenn.edu/ace/vol1/iss3/11/
38.Megan Brewster & Pallab Singh (2019), Intellectual Property Protection for Biologics, Academic Entrepreneurship for Medical and Health Scientists ,1 (3): 11.
39.Nuventra website (2020). Points to Consider in Drug Development of Biologics and Small Molecules. In: https://www.nuventra.com/resources/blog/small-molecules-versus-biologics/
40.Nuventra website (2020), What are the Regulatory Differences Between an NDA and BLA?, In: https://www.nuventra.com/resources/blog/regulatory-differences-between-an-nda-bla/
41.Nicole Casadevall et al. (2002), Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin, N Engl J Med , 346:469-475
42.Nicholas Jones & Alexander Bruce Dean (2012), Current patenting trends for biologics versus small molecules, Pharm. Pat. Analyst , 1: 225–227
43.Pharmaceutical Research and Manufacturers of America website (2015), Biopharmaceutical Research & Development: The Process Behind New Medicines, In:http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
44.Paul W. Barone & Michael E. Wiebe (2020), Viral contamination in biologic manufacture and implications for emerging therapies , Nature Biotechnology, 38:563-572
45.Paul Chamberlain (2006), Immunogenicity for Biologics: Do We Have the Right Tools to Assess Risk?, Journal of Immunotoxicology, 3:111-113
46.Ryan Conrad & Randall Lutter (2019), Generic Competition and Drug Prices:
New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices, FDA , In: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices
47.Ryan Conrad & Randall Lutter (2019),Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices,FDA,In: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices
48.Sean Lim (2021),The Process and Costs of Drug Development, In: https://theskepticalchemist.com/process-costs-drug-development/
49.Science History Institute (2017). Recombinant-DNA (rDNA) technology In:https://www.sciencehistory.org/historical-profile/herbert-w-boyer-and-stanley-n-cohen
50.Samantha McGrail (2021). Key Differences in Small Molecule, Biologics Drug Development. In:https://pharmanewsintel.com/news/key-differences-in-small-molecule-biologics-drug-development
51.Sadhana Chitale et al. (2020), Understanding the basics of patenting , Nature Biotechnology, 38: 263–270
52.Victoria Rees (2020), Preventing contamination during biopharmaceutical production, europeanpharmaceuticalreview, In: https://www.europeanpharmaceuticalreview.com/article/119747/preventing-contamination-during-biopharmaceutical-production/
53.Yang Li (2020), Does It Still Take Two to Tango? A Modern Interpretation of the BPCIA’s Patent Dance, JIPEL, In: https://jipel.law.nyu.edu/vol-9-no-1-4-li/
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