臺灣人文及社會科學引文索引資料庫系統

:::

詳目顯示

回上一頁
第 1 筆 / 總合 1 筆   第一頁 上一頁 下一頁 最後一頁
/1頁
題名：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
書刊名：智慧財產評論
作者：夏禾／陳鋕雄 引用關係
作者(外文)：Hsia, Ho／Chen, Chih-hsiung
出版日期：2014
卷期：12:1
頁次：頁117-191
主題關鍵詞：資料專屬權；專利權；專利要件；非新成分新藥；橘皮書；Data exclusivity；Patent right；The requirements of patent；Non-compound new drug；Patent and exclusivity information addendum
原始連結：連回原系統網址new window
相關次數：
  • 被引用次數被引用次數:期刊(2) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:2
  • 共同引用共同引用:13
  • 點閱點閱:29
藥品的資料專屬權制度從誕生至今一直是個充滿爭議的制度，其中一個重要的爭議即為資料專屬權制度與專利制度間在實質功能上的競合關係。從製藥產業的發展歷史來看，專利制度在學名藥之簡易上市程序出現後，開始在製藥產業中扮演起舉足輕重的角色，發揮著提供藥品研發誘因的實質功能。而當製藥產業已經存在有此一強力的誘因機制時，何以制度上還需要資料專屬權來提供更多的誘因，誠為一值得進一步探究的問題。本文透過文獻分析與實證研究的結果，認為：考量到專利制度在製藥產業的實務運作模式，不同類型的專利以及不同類型的藥品技術，均會影響專利保護實質的範圍與效果；加以學名藥廠對專利連結機制下的paragraph IV挑戰制度之操作日益成熟，資料專屬權對於藥品研發所能提供之誘因及影響性，其實經常是被低估的。進一步言之，資料專屬權的存在，讓藥開發藥廠有更強大的誘因，去將具醫療價值的治療成分開發成消費者能夠近用的藥品。此外，在專利取得因KSR案後之實務趨勢而日益困難的非新成分新藥領域，資料專屬權的重要性更可能會超越專利，成為主要的誘因提供機制。爰此，本文以為資料專屬權實為一有效的政策工具，可望能填補專利制度運用到製藥產業的缺陷，有助於新藥上市法規體系之完整性，以及公益與私益間的平衡。
Pharmaceutical data exclusivity has been a controversial system since the day it was created, and one of the important controversies is the competitive relationship between the practical function of the data exclusivity system and that of patent system. If we trace back to the history of pharmaceutical industry, it can be noticed that after the ＂abbreviated new drug application＂ system was introduced in this area, patent system started to exert its function of supplying inducement to encourage the research and development of pharmaceutical products. However, since we already have this powerful system to supply inducement, is it necessary for us to have the data exclusivity system? In this article, we use documentary analysis and positive research to show that in practical operation of the pharmaceutical industry, different kinds of patents and pharmaceutical technologies may influence the protective effect of the patents; moreover, generic pharmacies are getting familiar with the paragraph IV challenge approach under patent linkage system, the possibility for patents to be revoked is way higher than before. Because of the practical situations stated above, we think the inducement and the effect of data exclusivity are always underestimated in fact. To be more specific, data exclusivity system can supply more sufficient inducement to research-based pharmacies, urging them to develop the valuable pharmaceutical ingredient to real pharmaceutical products which are available to the consumers. In addition, because of the practical trend of the post-KSR era that it's more difficult to get non-compound patents, data exclusivity may act as a protagonist supplying ample inducement to the invention and development of noncompound new drugs. In conclusion, data exclusivity can be an effective tool of policy which is possible to be used to make up the flaws of the real practice of patent system in pharmaceutical industry, helping to perfect the legal system related to new drug approval system and the balance between public interest and private interest.
期刊論文
1.鄭慧文、余萬能、林鴻柱(20110600)。藥品新適應症資料專屬權適法性之探討。醫事法學，18(1)，33-43。new window  延伸查詢new window
2.Kuhlik, Bruce N.(2004)。The Assault on Pharmaceutical Intellectual Property。The University of Chicago Law Review，71(1)，93-109。  new window
3.阮富枝(20070607)。學名藥藥名仿單是否侵害原廠藥品仿單之著作權(下)--兼論藥事法第40條之2藥品資料專屬權。司法周刊，1341，2-3。  延伸查詢new window
4.Roin, Benjamin N.(2009)。Unpatentable Drug and the Standards of Patentability。TEX. L. REV.，87，503。  new window
5.Grabowski, Henry(2011)。Implementation of the Biosimilar Pathway: Economic and Policy Issues。SETON HALL L. REV.，41，511。  new window
6.Campbell, Eric G.(2003)。Data-Sharing and Data-Withholding in Genetics and the Life Sciences: Results of a National Survey of Technology Transfer Officers。J. HEALTH CARE L. &POL'Y，6，241。  new window
7.Adelman, David E.、Holman, Christopher M.(2010)。Misplaced Fears in the Legislative Battle over Affordable Biotech Drugs。IDEA，50，565。  new window
8.Reichman, Jerome H.(2009)。Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach。MARQ. INTELL. PROP. L. REV.，13，1。  new window
9.O'Reilly, James T.(1985)。Knowledge is Power: Legislative Control of Drug Industry Trade Secrets。U. CIN. L. REV.，54，1。  new window
10.Addison, Katherine N.(2011)。The Impact of the Biosimilars Provision of the Health Care Reform Bill on Innovation Investments。J. MARSHALL REV. INTELL. PROP. L.，10，553。  new window
11.Morgan, Maxwell R.(2010)。Regulation of Innovation under Follow-on Biologics Legislation: FDA Exclusivity as an Efficient Incentive Mechanism。COLUM. SCI. & TECH. L. REV.，11，93。  new window
12.Ünlü, Mich. Mustafa(2010)。It is Time: Why the FDA should Start Disclosing Drug Trial Data。TELECOMM. & TECH. L. REV.，16，511。  new window
13.Furrow, Michael Enzo(2008)。Pharmaceutical Patent Life-cycle Management after KSR v. Teleflex。FOOD & DRUG L.J.，63，275。  new window
14.Lyndon, Mary L.(2007)。Secrecy and Access in an Innovation Intensive Economy: Reordering Information Privileges in Environmental, Health, and Safety Law。U. COLO. L. REV.，78，465。  new window
15.Eisenberg, Rebecca S.(2007)。The Role of FDA in Innovation Policy。MICH. TELECOMM. TECH. L. REV.，13，345。  new window
16.Eisenberg, Rebecca S.(2005)。The Problem of New Uses。YALE J. HEALTH POL'Y L. & ETHICS，5，717。  new window
17.McGarity, Thomas O.、Shapiro, Sidney A.(1980)。The Trade Secret Status of Health and Safety Testing Information: Reforming Agency Disclosure Policies。Harvard Law Review，93(5)，837-888。  new window
18.Su, Yi-Chen(2010)。American Patent System for Biotechnology Medication and Pharmaceutical Invention in the Post-KSR ERA。MARQ. INTELL. PROP. L. REV.，14，321。  new window
19.Chafee Jr., Zechariah(1940)。Unfair Competition。HARV. L. REV.，53，1289。  new window
20.Fellmeth, Aaron Xavier(2004)。Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data under the TRIPS Agreement。Harvard International Law Journal，45，443。  new window
21.Baker, Brook K.(2008)。Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage。AMERICAN JOURNAL OF LAW& MEDICINE，34，303。  new window
22.Duff, John F.(2007)。KSR v. Teleflex: Predictable Reform of Patent Substance and Procedure in the Judiciary。Michigan Law Review First Impressions，106，34-38。  new window
23.楊崇森(19861100)。美國法上營業秘密之保護。中興法學，23，247-308。new window  延伸查詢new window
研究報告
1.工業技術研究院(2007)。資料專屬權對我國製藥產業的影響研究。  延伸查詢new window
2.Grabowski, Henry(2008)。Data Exclusivity Periods for Biologics: Updating Prior Analyses and Responding to Critiques。  new window
學位論文
1.范曉雰(2010)。資料專屬權對製藥產業之影響(碩士論文)。東海大學。  延伸查詢new window
2.胡宏達(2009)。藥品智慧財產權於藥品查驗登記程序中之保護(碩士論文)。東吳大學。  延伸查詢new window
3.李芳全(2010)。建構我國學名藥法制之研究(碩士論文)。國立交通大學。  延伸查詢new window
圖書
1.林志六(2008)。新藥開發與臨床試驗。秀威資訊。  延伸查詢new window
2.Patrick, Graham L.、吳天賞(2007)。藥物化學。藝軒。  延伸查詢new window
3.張靜(2007)。營業秘密的基礎理論。經濟部智慧財產局。  延伸查詢new window
4.SCHACTER, BERNICE(2006)。THE NEW MEDICINES: HOW DRUGS ARE CREATED, APPROVED, MARKETED, AND SOLD。  new window
5.BEERS, DONALD O.(1999)。GENERIC AND INNOVATOR DRUGS: A GUIDE TO FDA APPROVAL REQUIREMENTS。  new window
6.楊代華(2008)。處方藥產業的法律戰爭：藥品試驗資料之保護。元照。new window  延伸查詢new window
7.張靜(2007)。營業秘密法及相關智權問題。經濟部智慧財產局。  延伸查詢new window
8.Babbie, Earl、林佳瑩、徐富珍、邱泯科、陳佳穎、蔡毓智、姜馨彥(2004)。研究方法：基礎理論與技巧。臺北市：雙葉書廊。  延伸查詢new window
9.謝銘洋、古清華、丁中原、張凱娜(1996)。營業秘密法解讀。臺北：月旦出版公司。  延伸查詢new window
10.劉國讚(2009)。專利實務論。元照。  延伸查詢new window
圖書論文
1.楊培侃(201005)。論美國自由貿易協定資料專屬保護規範之現況與影響。2009科技發展與法律規範雙年刊：科學管制、學術研究自由與多元民主價値。新學林。  延伸查詢new window
2.Pugatch, Meir Perez(2006)。International Property, Data Exclusivity, Innovation and Market Access。NEGOTIATING HEALTH。  new window
3.Weissman, Robert(2006)。Data Protection: Options for Implementation。NEGOTIATING HEALTH。  new window
4.Roffe, Pedro(2006)。ChristophSpennemann, Johanna von Braun, From Paris to Doha: The WTO Doha Declaration on the TRIPS Agreement and Public Health。NEGOTIATING HEALTH。  new window
5.Love, James、Weissman, Robert(2006)。Protection of Pharmaceutical Test Data: A Policy Proposal。CONSUMER PROJECT ON TECHNOLOGY。  new window
6.Correa, Carlos Maria(2006)。Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements。Negotiating Health: Intellectual Property and Access to Medicines。UK：USA：Earthscan。  new window
 
 
 
 
第一頁 上一頁 下一頁 最後一頁 top
:::
無相關著作
 
QR Code
QRCODE

臺灣人文及社會科學引文索引資料庫

目前上線人數：1063（臺灣：1061，外國：2） ／ 本年度總使用人次：1855660 ／ 訪客人次（自102年09月）：67652258
國家圖書館著作權聲明 Copyright © 2013 All rights reserved.
本館地址: 100201臺北市中山南路20號． 本館地圖及交通資訊．
總機：(02)23619132．最佳瀏覽解析度為1024x768以上