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    题名: 美國植物藥新藥專利佈局及其研發合作活動 ─ 以Veregen® 和Mytesi®為例
    Patent deployment for botanical drug in United States of America with relative research, development and cooperation activities : a case of Veregen® and Mytesi®
    作者: 廖志文
    Liao, Chih Wen
    贡献者: 陳桂恒
    Chan, Keith
    廖志文
    Liao, Chih Wen
    关键词: 植物藥新藥
    專利
    策略
    Botanical drug
    Patent
    Strategy
    日期: 2017
    上传时间: 2017-06-01 09:56:48 (UTC+8)
    摘要: 植物藥新藥 ( botanical drug ) 的出現，讓各地歷史悠久的傳統生藥學 ( 或藥用植物學 ) 在這幾年逐漸現代化，而相對地，原來位居醫藥開發主流的小分子化學和生物製劑，加入了新的成員，一樣嚴謹的科學審查標準，但讓植物藥新藥有更多應用和更大市場。

    2004年在美國公佈了「Botanical Drug Products」指引，2006年第一件植物藥新藥Veregen®核准上市，接著2012年Mytesi®亦取得核准上市，2015年美國公布「Botanical Drug Development Guidance for Industry」草案，2016年底公布了正式指引：「Botanical Drug Development Guidance for Industry」，在這期間，中國藥物學專家屠呦呦 ( Tu Youyou ) 以「青蒿素」( artemisinin ) 一藥，共同取得2015年諾貝爾醫學獎，這系列的進展，說明了這個領域正在健康的發展中。也正因此，本研究欲藉由兩個已上市的植物藥新藥為材料，利用專利檢索分析、功效矩陣檢視，最後輔以法規和商業活動時間軸的呈現，來觀察植物藥新藥開發垂直的如何推進，水平的如何和他人合作，這種實證式的回溯性研究，更可讓國內開發者，以貼近實務的各種角度，檢視自己的整體開發風險和報酬。

    而最後研究結果顯示，Veregen®開發過程，由於4位開發者的發展方向及其內部產品，都不是直接競爭者，而且在契約exclusive license和exclusive sub-license利益風險共享架構下，4者的全部專利的組合運用可以達到最好的效益，專利應用上有著較多方面的保護及後續開發潛力，而開發關係人對內對外都有較低的專利訴訟風險。而Fulyzaq® ( 已更名為Mytesi® ) 開發到上市主要有3位開發者，藉由本研究的檢索分析，可以發現到在當時2位接手的開發者，其發展方向、內部產品及專利佈局，是很強的潛在競爭，存在非常高的法律風險，而在最後三位共同開發者互相提起訴訟，也消耗了產品在市場取得更佳報酬的潛力，雖然在合作前也都預防性的簽署了共同開發協議 ( Collaboration Agreement )。

    最後，由二者研究內容歸納，植物藥新藥的開發，需要不會的找會的，缺資金的找有資金的，開放式的接捧合作，才能在這麼高風險的新藥開發上，取得最可能成功的路徑；而除了選題的謹慎，積極的專利資源投入，才是預防風險、提高報酬的最佳方式，這包括成果儘早申請專利、臨時申請案及PCT運用、專利申請分割或延續案的應用、相關專利的藥物生命周期延長，最後，深入而全面的檢索分析專利更是絶對重要。
    參考文獻: 中文部分
    期刊論文
    1.鄧哲明，新藥的研發流程概論，科學月刊，第四十四卷第二期，2013年12月。
    2.張仁平，由我國開放用途申請標的論用途發明專利之保護與審查（下），智慧財產權月刊76 期。
    3.張如華(茶改場)，近十年全球茶葉產銷概況，茶訊，2012年1日號。
    4.詹智傑，男性人類乳突病毒感染的臨床病徵與處置，愛之關懷，75期，2011年6月。
    5.譚健民，肝性腦病變治療策略成效的分析，台灣醫界，53卷6期，頁14-17，2010年。
    6.高鼎懿，美國專利延續案與布局策略之分析，國立交通大學科法組，2008年。

    研究報告
    DCB, YEARBOOK OF PHARMACEUTICAL INDUSTRY (2015).

    網路資訊
    1.葉嘉新，用以支持新藥臨床試驗進行的臨床前要求， http://www2.cde.org.tw/DATA/CDEDOC/Documents/用以支持臨床試驗進行的臨床前要求.pdf (最日：2016年12月26日)。
    2.行政院農業委員會，日本茶產業現況與新研發技術研習，http://report.nat.gov.tw/ReportFront/report_download.jspx?sysId=C10404313&fileNo=001 (最後瀏覽日：2016年12月26日)。
    3.中國醫學科學院腫瘤醫院腫瘤研究所，http://www.cicams.ac.cn/ (最後瀏覽日：2016年12月12日)。
    4.蔡呈芳，菜花，https://www.ntuh.gov.tw/derm/healthcareCenter/healthCenter/菜花.aspx (最後瀏覽日：2016年12月28日)。
    5.趙安平，一個準中藥的外國血統，http://paper.people.com.cn/jksb/html/2007-11/15/content_31767755.htm (最後瀏覽日：2016年12月27日)。
    6.新光醫院，腹瀉 ( Diarrhea)，http://www.skh.org.tw/gi/manual/manual-05.htm (最後瀏覽日：2016年12月12日)。
    7.葉雲卿，淺談醫藥專利典型權利請求項，http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/publish-18.htm (最後瀏覽日：2016年12月26日)。


    英文部分
    專書
    1.PHILIP W. GRUBB & PETER R. THOMSEN, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY: FUNDAMENTALS OF GLOBAL LAW, PRACTICE AND STRATEGY, OXFORD UNIVERSITY PRESS (2010).
    2.CLARK SULLIVAN, TYPES OF PHARMACEUTICAL PATENTS, AND THEIR ROLE IN PREVENTING GENERIC COMPETITION, FUTURE MEDICINE, P.20-36 (2016).
    3.LIXIN ZHANG & ARNOLD L. DEMAIN, NATURAL PRODUCTS: DRUG DISCOVERY AND THERAPEUTIC MEDICINE, HUMANA PRESS (2005).

    期刊論文
    1.Farnsworth, N. R., Morris, R. W., Higher Plants--The Sleeping Giant of Drug Development., AMER. J. PHARM., 148(2):46-52 (1976).
    2.Cragg GM, Newman DJ, Snader KM, Natural Products in Drug Discovery and Development., JOURNAL OF NATURAL PRODUCTS, 60(1):52-60 (1997).
    3.Kyungseop Ahn, Worldwide Trend of Botanical Drug and Strategies for Developing Global Drugs, BMB REP. 2016, pii:3725 (Dec 20, 2016).
    4.Sau L. Lee, Evolution of Traditional Medicines to Botanical Drugs, THE ART AND SCIENCE OFTRADITIONAL MEDICINE, s32 (Jan 2015).
    5.Xiang Lei, Status And Thoughts of Chinese Patent Medicines Seeking Approval in The US Market, CHIN J INTEGR MED., 20(6):403-8 (Jun 2014).
    6.Alan L. Harvey, Natural Products in Drug Discovery, DRUG DISCOV TODAY, 13(19-20):894-901 (Oct 2008).
    7.Quinn, R.J. et al. Developing A Drug-Like Natural Product Library., J. NAT. PROD., 71, 464–468 (2008).
    8.Singh, S.B., Barrett, J.F. , Empirical Antibacterial Drug Discovery - Foundation in Natural Products, BIOCHEM. PHARMACOL., 71, 1006–1015 (2006).
    9.Kaufman DW, et al., Recent Patterns of Medication Use in the Ambulatory Adult Population of the United States: The Slone Survey, JAMA., 16;287(3):337-44 (Jan 2002).
    10.Tony Yuqi Tang , LI Fang-zhou, and Janyne Afseth, Review of the Regulations for Clinical Research in Herbal Medicines in USA, CHIN J INTEGR MED, 20(12):883-893 (Dec 2014).
    11.Lisa Larrimore Ouellette, How Many Patents Does It Take to Make a Drug ? Follow-On Pharmaceutical Patents and University Licensing, 17 MICH. TELECOMM. TECH. L. REV., 299 (2010).
    12.Dennis B. Worthen, American Pharmaceutical Patents: From a Historical Perspective, AMERICAN PHARMACEUTICAL PATENTS, Vol.7 No.6 (Nov 2003).
    13.Valerie R. Yanofsky, et al., Genital Warts: A Comprehensive Review, J CLIN AESTHET DERMATOL, 5(6): 25–36 (Jun 2012).
    14.Sarah C. Forester and Joshuad D. Lambert, Antioxidant Effects of Green Tea, MOL NUTR FOOD RES., 55(6): 844–854 (Jun 2011).
    15.Kanti Bhooshan Pandey and Syed Ibrahim Rizvi, Plant Polyphenols as Dietary Antioxidants In Human Health and Disease, OXID MED CELL LONGEV., 2(5): 270–278 (Nov 2009).
    16.Cheng Peng, et al., Biology of Ageing and Role of Dietary Antioxidants, BIOMED RES INT., 2014: 831841 (2014).
    17.Smitha Malireddy, et al., Phytochemical Antioxidants Modulate Mammalian Cellular Epigenome: Implications in Health and Disease, ANTIOXID REDOX SIGNAL., 17(2): 327–339 (Jul 2012).
    18.Stockfleth E and Meyer T., The Use of Sinecatechins (Polyphenon E) Ointment for Treatment of External Genital Warts, EXPERT OPIN BIOL THER., 12(6):783-93 (Jun 2012).
    19.Stockfleth E and Meyer T., Sinecatechins (Polyphenon E) Ointment for Treatment of External Genital Warts and Possible Future Indications, EXPERT OPIN BIOL THER., 14(7):1033-43 (Jul 2014).
    20.Stephen K. Tyring, Sinecatechins: Effects on HPV-Induced Enzymes Involved in Inflammatory Mediator Generation, J CLIN AESTHET DERMATOL., 5(1): 19–26 (Jan 2012).
    21.Stephen K. Tyring, Effect of Sinecatechins on HPV-Activated Cell Growth and Induction of Apoptosis, J CLIN AESTHET DERMATOL., 5(2): 34–41 (Feb 2012).
    22.Rimas J. Orentas, Reading the Tea Leaves of Tumor-Mediated Immunosuppression., CLINICAL CANCER RESEARCH, Vol.19 Issue 5 (Mar 2013).
    23.David Russo, et al., A New Patent-Based Approach for Technology Mapping in the Pharmaceutical Domain, PHARM. PAT. ANALYST, 2(5),611-627 (2013).
    24.Jannuzzi AH, Vasconcellos AG, de Souza CG., Specificities Of Patent Protection In The Pharmaceutical Industry: Modalities And Traits Of Intellectual Property, CAD SAUDE PUBLICA., 24(6):1205-18 (Jun 2008).
    25.Jones K, Review Of Sangre De Drago (Croton Lechleri) --A South American Tree Sap In The Treatment Of Diarrhea, Inflammation, Insect Bites, Viral Infections, And Wounds: Traditional Uses To Clinical Research., J ALTERN COMPLEMENT MED. , 9(6):877-96 (2003).
    26.Desmarchelier C.,et al., Effects Of Sangre De Drago From Croton Lechleri Muell.-Arg. On The Production Of Active Oxygen Radicals., J ETHNOPHARMACOL., 58(2):103-8 (1997).
    27.Fischer H, et al., A Novel Extract SB-300 from the Stem Bark Latex of Croton Lechleri Inhibits CFTR-Mediated Chloride Secretion in Human Colonic Epithelial Cells, J ETHNOPHARMACOL., 93(2-3):351-7 (2004).
    28.Verkman AS, Lukacs GL, Galietta LJ., CFTR Chloride Channel Drug Discovery--Inhibitors as Antidiarrheals and Activators for Therapy of Cystic Fibrosis, CURR PHARM DES, 12(18):2235-47 (2006).
    29.Lukmanee Tradtrantip, et al., Crofelemer, An Antisecretory Antidiarrheal Proanthocyanidin Oligomer Extracted from Croton Lechleri, Targets Two Distinct Intestinal Chloride Channels, MOL PHARMACOL, 77(1): 69–78 (Jan 2010).
    30.Cottreau, J.; Tucker, A.; Crutchley, R.; Garey, K. W., Crofelemer for the Treatment of Secretory Diarrhea, EXPERT REVIEW OF GASTROENTEROLOGY & HEPATOLOGY, 6 (1): 17–23 (2012).
    31.Newman, et al., High-Resolution C NMR Studies of Proanthocyanidin Polymers (Condensed Tannins), NAG. RES. COMM., 25: 118-124 (1987).
    32.Ubillas, et al., SP-303, an Antiviral Oligomeric Proanthocyandin from the Latex of Croton lecheri (Sangre de Drago), PHYTOMEDICINE, 1: 77-106 (1994).
    33.Gabriel, et al., CFTR and Outward Rectifying Chloride Channels Are Distinct Proteins with a Regulatory Relationship, NATURE, 363:263-266 (1993).
    34.DuPont, Pathogenesis of Traveler`s Diarrhea, CHEMOTHERAPY, 41(suppl 1): 33-39 (1995).
    35.Davenport SE, et al., Deregulated Expression and Function of CFTR and Cl- Secretion After Activation of The Ras and Src/Pymt Pathways in Caco-2 Cells, BIOCHEM BIOPHYS RES COMMUN, 229(2):663-72 (1996).
    36.Gabriel SE, et al., A Novel Plant-Derived Inhibitor of cAMP-Mediated Fluid and Chloride Secretion, AM J PHYSIOL., 276(1 Pt 1): G58-63 (1999).
    37.Craig, Shaman Gets Positive Efficacy Data on Diarrhea Drug, BIOWORLD TODAY, 7(164): 1-2 (1996).
    38.Crutchley RD., et al., Crofelemer, A Novel Agent for Treatment of Secretory Diarrhea, ANN PHARMACOTHER, 44(5):878-84 (2010).
    39.Biswal S, Crofelemer: In HIV Associated Diarrhea and Secretory Diarrhea - A Patent Perspective, RECENT PAT ANTIINFECT DRUG DISCOV., 9(2):136-43 (2014).
    40.Smith PD, et al., NIH Conference. Gastrointestinal Infections in AIDS, ANN INTERN MED., 1;116(1):63-77 (1992).
    41.H Knobel, et al., Impact of Different Patterns of Nonadherence on the Outcome of Highly Active Antiretroviral Therapy in Patients with Long-Term Follow-Up, HIV MEDICINE, Vol.10, 364-369 (2009).
    42.Himanshu Gupta, et al., Patent Protection Strategies, J PHARM BIOALL SCI, Vol2 Issue1 (Jan 2010).
    43.Adriana Campos Moreira, et al., Pharmaceutical Patents on Plant Derived Materials in Brazil: Policy, Law and Statistics, WORLD PATENT INFORMATION, Vol.28, Issue 1, P.34-42 (Mar. 2006).
    44.Wu, Eric F.C., Drug Patent Deployment in the United States of America with the Corresponding Research, Development and Regulatory Activities - A Case of Gleevec® by Novartis Group, NATIONAL CHENGCHI UNIVERSITY (TIIPM), (2015).
    45.Percy H. Carter, et al., Investigating Investment in Biopharmaceutical R&D, NATURE REVIEWS DRUG DISCOVERY 15, 673–674 (2016).
    46.Dirk Calcoen, et al., What Does It Take to Produce A Breakthrough Drug ?, NATURE REVIEWS DRUG DISCOVERY 14, 161–162 (2015).
    47.Andrew Moore, The Big and Small of Drug Discovery, EMBO REP., 4(2), 114–117 (Feb 2003).
    48.Michael Hay, Clinical Development Success Rates for Investigational Drugs, NATURE BIOTECHNOLOGY 32, 40-51 (Jan 2014).
    49.Aaron S Kesselheim, Trends in Utilization of FDA Expedited Drug Development and Approval Programs, 1987-2014: Cohort Study, BMJ 2015, 351:h4633 (2015).
    50.David Taylor, The Pharmaceutical Industry and the Future of Drug Development, PHARMACEUTICALS IN THE ENVIRONMENT, pp. 1-33 (2015).
    51.Shaw T Chen, New Therapies from Old Medicines, NATURE BIOTECHNOLOGY 26, 1077-1083 (2008).

    法院判決
    Napo Pharmaceuticals Inc. v. Salix Pharmaceuticals Inc., 651214/2011 (N.Y. Sup. May 5, 2011).

    官方資訊
    1.EPO, 7.1 Second or Further Medical Use of Known Pharmaceutical Products, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vi_7_1.htm (last visited Jan 20, 2017).
    2.FDA, VEREGEN™ Label Information, NDA 21-902.
    3.U.S. FDA, Botanical Drug Development Guidance for Industry, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458484.pdf (last visited Jan 12, 2017).
    4.U.S. FDA, Learn About Drug and Device Approvals, https://www.fda.gov/ForPatients/Approvals/default.htm (last visited Jan 10, 2017).
    5.U.S. FDA, The Drug Development Process, https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm (last visited Jan 12, 2017).
    6.SEC, Press Release , https://www.sec.gov/Archives/edgar/data/864268/000089109207005399/e29528ex99_1.htm (last visited Dec 29, 2016).
    7.CDER, Medical Review (No.21-902), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000_medr.pdf (last visited Dec 27, 2016).
    8.CDER, Approved Labeling (No.21-902), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000_prntlbl.pdf (last visited Dec 26, 2016).
    9.FDA, HIGHLIGHTS OF PRESCRIBING INFORMATION , http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202292s000lbl.pdf (last visited Dec 18, 2016).
    10.CDER, Clinical Pharmacology and Biopharmaceutics Review(s), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000ClinPharmR.pdf (last visited Dec 18, 2016).
    11.National Institute of Allergy and Infectious Diseases (NIAID), AIDS-Related Diarrhea (Apr 1,1995), https://aidsinfo.nih.gov/news/175/aids-related-diarrhea (last visited Dec 17, 2016).
    12.UNPA, Comments Of The Utah Natural Products Alliance , http://www.fda.gov/ohrms/dockets/dockets/04n0454/04n-0454-c000014-01-vol5.pdf (last visited Dec 17, 2016).
    13.Morgan Lewis, Generally Recognized as Safe (“GRAS”) Notice for Green Tea Catechin – Kao Comoration, http://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm269121.pdf (last visited Dec 27, 2016).
    14.Amino Up Chemical, GRAS Exemption Clain for Oligonol®, http://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm388598.pdf (last visited Dec 28, 2016)

    公司官網
    1.Epitome Pharmaceuticals Limited., official website: http://epitomepharm.com/ (last visited Dec 27, 2016).
    2.Medigene AG, official website: http://www.medigene.com/ (last visited Dec 27, 2016).
    3.Mitsui Norin Co. Ltd., official website : http://www.polyphenon.jp/en/about/index.html (last visited Dec 27, 2016).
    4.Mitsui Norin Co.,Ltd., History of Mitsui Norin and Polyphenon, http://www.polyphenon.jp/en/about/index.html (last visited Dec 27, 2016).
    5.Medigene, Company Profile, http://www.medigene.com/company/company-profile (last visited Dec 27, 2016).
    6.Epitome Pharmaceutical, Polyphenon® E for the treatment of HPV infections, http://epitomepharm.com/product01a.htm (last visited Dec 27, 2016).
    7.Mitsui Norin, Regarding Investments for Securing Raw Materials for Polyphenon E, http://www.polyphenon.jp/en/info/20050305.html (last visited Dec 27, 2016).
    8.Mitsui Norin, Information, http://www.polyphenon.jp/en/info/20050105.html (last visited Dec 27, 2016).
    9.Mitsui Norin, About Mitsui Norin Co., Ltd., http://www.polyphenon.jp/en/about/index.html (last visited Dec 29, 2016).
    10.Medigene, Company Strategy, http://www.medigene.com/company/company-strategy (last visited Dec 31, 2016).
    11.Medigene, Immunotherapies, http://www.medigene.com/products-pipeline/development-projects/immunotherapies (last visited Dec 31, 2016).
    12.Mitsui Norin, Major health benefits of tea catechins, http://www.polyphenon.jp/en/12function/index.html (last visited Dec 31, 2016).
    13.Epitome, official website, http://epitomepharm.com/product01a.htm (last visited Dec 31, 2016).
    14.Medigene, Immunotherapies , http://www.medigene.com/products-pipeline/development-projects/immunotherapies (last visited Dec 31, 2016).
    15.Medigene, Publications , http://www.medigene.com/products-pipeline/development-projects/immunotherapies/publications (last visited Dec31, 2016).
    16.Medigene, 3-Months Report 2016, http://www.medigene.com/sites/default/files/report/3-months_report_2006_engl_gs_1147074140.pdf (last visited Dec 31, 2016).
    17.Glenmark Pharm., The International Centre for Dispute Resolution Has Ruled in Favor of Glenmark Pharmaceuticals Ltd on the Arbitration Claim It Filed Against Napo Pharmaceuticals, Inc., http://www.glenmarkpharma.com/sites/default/files/Glenmark_press_release_aug_23_0.pdf (last visited Dec 18, 2016).
    18.Napo Pharmaceuticals, official website: http://napopharma.com/?page_id=222 (last visited Jan 2, 2017)
    19.Glenmark Pharmaceutical, official website: http://www.glenmarkpharma.com/ (last visited Dec 23, 2016).
    20.Salix Pharmaceutical, https://www.salix.com/products (last visited Dec 23, 2016).
    21.Indena, Pharmaceutical , http://www.indena.com/pharmaceutical/ (last visited Dec 31, 2016).

    網路資訊
    1.Sau Lee, Botanical Drug Development and Quality Standards, http://pqri.org/wp-content/uploads/2015/10/01-PQRI-Lee-Botanicals-20151.pdf (last visited Jan 10, 2017).
    2.MPA Business Services, Types of Pharmaceutical Patent - Product, Process, Formulation and Method, http://mpasearch.co.uk/product-process-formulation-patents (last visited Jan 20, 2017).
    3.Leman consulting S.A., Pharmaceutical Product Patenting Strategies, http://www.lemanconsulting.ch/doc/GB_PATENT_Product_patenting_strategies.pdf (last visited Jan 20, 2017).
    4.Morgan Stanley, Medigene, http://globaldocuments.morningstar.com/documentlibrary/document/997d200074ea3762.msdoc/original (last visited Jan 3, 2017).
    5.Evaluate™, MediGene Settles Patent Dispute with the Loyola University and MedImmune, http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=35564 (last visited Dec 31, 2016).
    6.PRNewswire, Shaman Licenses Normal Stool Formula to GNC, https://www.thefreelibrary.com/Shaman+Licenses+Normal+Stool+Formula+to+GNC.-a063555788 (last visited Dec 17, 2016).
    7.Bloomberg, Company Overview of Shaman Pharmaceuticals Inc., http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=37883 (last visited Dec 18, 2016).
    8.Bloomberg, Company Overview of Napo Pharmaceuticals, Inc., http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=12827020 (last visited Dec 23, 2016)
    9.Evaluate™, Glenmark Pharmaceuticals Ltd and Napo Pharmaceuticals Inc Annouce Collaboration Agreement on Napo`s Novel Anti-Diarrheal Product Crofelemer, http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=100268 (last visited Dec 18, 2016).
    10.The Free Library, Napo Pharmaceuticals Announces License of Crofelemer to Salix Pharmaceuticals, https://www.thefreelibrary.com/Napo+Pharmaceuticals+Announces+License+of+Crofelemer+to+Salix...-a0190295622 (last visited Dec 18, 2016).
    11.Kurt Orzeck, Salix Wins Jury Verdict In Breach Suit Over Napo Drug, https://www.law360.com/articles/513229/salix-wins-jury-verdict-in-breach-suit-over-napo-drug (last visited Dec 18, 2016).
    12.Business Wire, Napo Terminates Glenmark Pharmaceuticals for Failure to Commercially Develop Crofelemer, http://www.businesswire.com/news/home/20111212006268/en/Napo-Terminates-Glenmark-Pharmaceuticals-Failure-Commercially-Develop (last visited Dec 18, 2016).
    13.Mumbai, Glenmark Wins Case Against US` Napo Pharma, http://www.business-standard.com/article/companies/glenmark-wins-case-against-us-napo-pharma-112082400031_1.html (last visited Dec 18, 2016).
    14.Business Wire, Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy, https://www.drugs.com/nda/crofelemer_120207.html (last visited Dec 18, 2016).
    15.Kathleen Doheny, 2 Weeks of Antibiotic Therapy Relieves IBS, http://www.webmd.com/ibs/news/20110105/2-weeks-of-antibiotic-therapy-relieves-ibs (last visited Dec 23, 2016).
    16.Wikipedia, Croton lechleri , https://en.wikipedia.org/wiki/Croton_lechleri (last visited Dec 12, 2016).
    17.HealthDay, FDA Warns of Overdoses of Anti-Diarrhea Drug, http://www.webmd.com/digestive-disorders/news/20160608/fda-anti-diarrhea-drug-abuse (last visited Dec 13, 2016).
    18.John Carroll, The Top 15 Spenders in the Global Drug R&D Business: 2017, https://endpts.com/special/top-research-budgets-in-pharma-and-biotech/ (last visited May 4, 2017).
    19.Ben Hirschler, New Drug Approvals Fall to Six-Year Low in 2016, http://www.reuters.com/article/us-pharmaceuticals-approvals-idUSKBN14M08R (last visited May 4, 2017).
    20.FDA (CDER), Novel Drugs Summary 2016, https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm534863.htm (last visited May 5, 2017).
    21.USTOP, General Information About 35 U.S.C. 161 Plant Patents, https://www.uspto.gov/patents-getting-started/patent-basics/types-patent-applications/general-information-about-35-usc-161 (last visited May 3, 2017)
    描述: 碩士
    國立政治大學
    科技管理與智慧財產研究所
    103364213
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G1033642131
    数据类型: thesis
    显示于类别:[科技管理與智慧財產研究所] 學位論文

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