Please use this identifier to cite or link to this item: https://ah.lib.nccu.edu.tw/handle/140.119/70334
題名: 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性藥品之演進
A Study on the Pharmaceutical Products Approval Regulation and Patent Protection: The Development of Legislation from Generic Drug to Biosimilar
作者: 楊馥璟
Yang, Fu Ching
貢獻者: 沈宗倫
Shen, Chung Lun
楊馥璟
Yang, Fu Ching
關鍵詞: 生物相似性藥品
生物藥品價格競爭與創新法案
藥品價格競爭及專利回復法案
專利連結
資料專屬
biosimilar
Biologics Price Competition and Innovation Act
Hatch-Waxman Act
patent linkage
data exclusivity
日期: 2013
上傳時間: 1-Oct-2014
摘要: 美國於1984年通過「藥品價格競爭及專利回復法」(又稱為Hatch-Waxman Act),其立法目的在解決美國長期以來原廠藥專利期屆滿後學名藥遲未上市,而導致藥價高昂的問題。該法案核心內容包括簡易新藥申請程序、專利連結制度、180天市場專屬期及試驗免責、專利期間回復及資料專屬期。本法案在美國實施30年,確實達到降低藥價及促進藥品市場競爭的目的,但同時也引發許多限制競爭的負面效應及批評。而隨著生物科技進步發展出的第一批生技藥品,在 2000年專利陸續屆滿。隨之而來的是製藥產業對於「生物相似性藥品」的上市審查問題。然生技藥品與化學藥品的本質差異,不宜直接適用學名藥之簡易新藥上市程序。美國對此爭議遲至2010年始由國會通過「生物藥品價格競爭與創新法案」(Drug Price Competition and Patent Restoration Act, 簡稱BPCIA),其中涉及專利權規定,仍保有專利有效性與上市審查之連結機制及資料專屬保護制度。惟本法案修正專利連結制度而改採專利資訊交換,並給予新生物新藥12年資料專屬期。美國國會希望透過本法提供生物相似性藥品快速上市審查之途徑,並在藥品上市前提早解決專利爭端,同時兼顧保護原廠生技藥品的研發成果。\n 本論文將以美國藥品上市法案Hatch-Waxman Act及BPCIA二項法案為研究主軸,並輔以歐盟的立法例為對照。第二章將針對化學藥品及生物藥品之特性與差異作為說明上市審查規範基礎。本文第三章及第四章介紹美國、歐盟與我國學名藥及生物相似性藥品上市審查法規及專利權涉及爭議,第五章則針對美國BPCIA中有關上市前專利爭端解決程序、12年資料專屬期及可替換性生物相似性藥品專屬期可能引發之爭議與負面效應進行探討與剖析。第六章則總結本論文之論述並提出建議,提供我國政府未來修法之參考。
In 1984, U.S. Congress enacted the Drug Price Competition and Patent Restoration Act (the “Hatch-Waxman Act”) that resolves the problem of high drug prices resulting from the time gap between the expiration of patents about brand-name pharmaceuticals and the late marketing of low-cost generic drugs. The core provisions in this Act includes an Abbreviated New Drug Application (hereinafter “ANDA”), patent linkage system, 180-day exclusivity, experimental use exception, term restoration and data exclusivity. The Hatch-Waxman Act indeed has raised criticism about much unexpected anticompetitive effect in pharmaceutical market during past thirty years, but it has archived the original purpose of legislation that would lower the drug prices and promote the pharmaceutical market competition. With biotechnology development, the patents for the first generation of biological medicines by recombinant gene technology have gradually expired since 2000. Consequently, the question has emerged on whether the specific approval procedure for “Biosimilar” is necessarily legislated to serve as a guidance for the pharmaceutical industry. However, due to fundamental differences between biologics and traditional pharmaceuticals the ANDA, as such, dosen`t work well to these biologics. As a consequence, the Biologics Price Competition and Innovation Act (hereinafter “BPCIA”) was enacted by U.S. Congress and takes effects in 2010. Regarding patent system, BPCIA still retain the provisions about the linking FDA approval to the outcome of patent litigation as well as data exclusivity. However, distinct from the patent linkage under Hatch-Waxman Act, BPCIA additionally stipulates the exchanges of patent information between the reference sponsor and the biosimilar applicant, and 12-year exclusivity period for reference drug. By this Act, U.S. Congress purports to facilitate the guidance of establishment for biosimilar application, and concern in resolving patent disputes between the reference drug sponsor and the biosimilar applicant prior to FDA approval. Securing the innovation of reference drugs is also within the gist of this Act.\n Firstly, the thesis will focus on the approval of pharmaceuticals under the Hatch-Waxman Act and the BPCIA, and comparative studies extending to the legislation of European Union. The second chapter will illustrate the characteristics of both chemical and biological medicines, and establish the basis for further comparison about the two medicines under the procedure of FDA approval. Chapters three and four will elucidate the approval regulations about pharmaceuticals and biosimilars respectively, and the related issue on patent in U.S., European Union and Taiwan. The fifth chapter will introduce the pre-approval patent resolution process, 12-year data exclusivity, and exclusivity for the first approved interchangeable biosimilar and discuss their negative effect. The sixth chapter concludes with suggestions to our government on amending the related laws in the future.
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EMINET, January 2011, available at http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_market_012011_en.pdf(last visited 03/29/2014).\n11.Taiwan Pharmaceuticals and Healthcare Report Q1 2013, Business Monitor International, December 26, 2012, available at http://www.marketresearch.com/Business-Monitor-International-v304/Taiwan-Pharmaceuticals-Healthcare-Q1-7288168/(last visited 03/29/2014).\n12.The Global Use of Medicines: Outlook Through 2015, May 2011, available at http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/Global_Use_of_Medicines_Report.pdf(last visited 02/23/2014).\n13.U.S Food and Drug Administration, Taste of Raspberries, Taste of DeathThe 1937 Elixir Sulfanilamide Incident, June 1981, at http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/(last visited 01/27/2014).\n14.U.S Food and Drug Administration, The 1906 Food and Drugs Act and Its Enforcement, FDA History Part I, at http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm (last visited 01/27/2014).\n15.合一生技股份有限公司,產品資訊,http://www.onenessbio.com.tw/Cht/ugC_SinglePage.asp?hidSinglePageID=6. 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描述: 碩士
國立政治大學
法律科際整合研究所
98652010
102
資料來源: http://thesis.lib.nccu.edu.tw/record/#G0986520101
資料類型: thesis
Appears in Collections:學位論文

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