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    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/101273


    Title: 處方藥品試驗資料保護之研究─以資料專屬權為中心
    Other Titles: Protection of Test Data of Prescription Drugs under TRIPs
    Authors: 楊代華
    Keywords: Patent;Brand-Name Drugs;Generic Drugs;Drug Test Data;Hatch-Waxman Act;Data Exclusivity;Trips;Unfair Competition;Trade Secret
    Date: 2007-04
    Issue Date: 2016-09-05 11:39:31 (UTC+8)
    Abstract: 在歐美國家的強大貿易談判壓力下，我國立法院於民國九十四年一月二十一日完成藥事法第四十條之二的立法，同年二月五日由總統公布實施，進入實施資料專屬權制度的時期。資料專屬權乃以處方藥品試驗資料為保護對象，由美國首先立法，利用貿易談判、國際協定向外推動的法律制度；本文認為資料專屬權制度之法理基礎，乃係對於試驗資料權利人營業秘密之保護，以防止來自其他藥廠之不公平競爭。；這項制度之經濟上意義，則在於藉由賦予藥品試驗資料權利人一段資料專屬權期間，要求學名藥廠必須進行其考量本身資力及市場後，不可能自己實施的藥品安全性及有效性試驗，使因而間接獲得市場獨占利益的試驗資料權利人，得到足以回收其藥品試驗資料投資之機會。\\rTRIPs第三十九條第三項規範保護藥品試驗資料的國際最低標準，它的保護標的限於藥廠為了取得於申請國第一次提出之「新化學成分」藥品之上市許可，所提出其花費相當時間、金錢始取得，而未經揭露之必要試驗或其他資料。會員國對於符合此項條件之資料，負有避免其被不公平商業使用之義務。本文認為所謂「不公平商業使用」，係指未提供藥品試驗資料權利人回收其對於試驗資料所為投資之機會，所為客觀上足以使得他人自其試驗資料獲得商業上利益的一切使用或應用試驗資料的行為；所以如果政府機關於「參考」藥品試驗資料權利人所提出藥品試驗資料時，未提供任何使其得以回收對於試驗資料所為投資之機會，即應認為政府機關此等參考行為，屬於「不公平的商業使用」行為。因此，資料專屬權制度可謂符合TRIPs第三十九條第三項所規範保護藥品試驗資料之標準；但如果會員國能夠建立另外一套賦予藥品試驗資料權利人回收其對於藥品試驗資料所為投資機會之制度，同樣也可以符合TRIPs第三十九條第三項的最低保護標準，並不一定必須採取資料專屬權之保護模式。
    Under the strong pressure from the United States, the Legislative Yuan of R.O.C. has passed the Pharmaceutical Affairs Act article 40-2(2)(3)(4) which was promulgated on February 5, 2005 by the president and brought R.O.C. into an era of data exclusivity. Data exclusivity was created by the United States, by whom this system was forced through all over the world by means of trade negotiations and international agreements. The protection object of data exclusivity is the test data of prescription drugs. This thesis concludes that the legal principle of data exclusivity is the protection of the trade secrets residing in the test data of prescription drugs from unfair competitions from other drug companies, and owing to the financial incapability of generic companies to undergo the safety and effectiveness test by themselves, what data exclusivity actually results is that the owner of the original test data acquires a period of non-competition market exclusivity , and hence gets an opportunity to profit from their investment to the test data. TRIPs article 39(3) provides the least protection standard for test data of prescription drugs. It demands members who requires as a condition of approving the marketing of pharmaceutical products which utilize new chemical entities that first applied in this member country, must protect the submitted test or other data which is undisclosed, the origination of which involves a considerable effort, against unfair commercial use. This thesis construes “unfair commercial use” as acts using or referring to the test data that bring commercial benefits for other companies without providing any opportunity for the owner of the original test data to recoup from his investment to the test data. Thus, data exclusivity system excels the TRIPs standard. However, the “unfair commercial use” language of article 39(3) only indicates some form of protection against naked exploitation of the test data is required. TRIPs does not encompass a data exclusivity obligation for member countries.
    Relation: 政大智慧財產評論, 5(1), 133-153
    NCCU Intellectual Property Review
    Data Type: article
    Appears in Collections:[智慧財產評論] 期刊論文

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