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    Please use this identifier to cite or link to this item: http://nccur.lib.nccu.edu.tw/handle/140.119/117183


    Title: Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan
    Authors: 陳秉訓
    Chen, Ping-Hsun
    Contributors: 科管智財所
    Date: 2017-07
    Issue Date: 2018-05-17 16:47:50 (UTC+8)
    Abstract: The Trans-Pacific Partnership (“TPP”) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’ patent linkage system allows a pioneer drug company to register patents claiming (a) a material; (b) a combination or formula; or (c) pharmaceutical use. The scope of patentees who may benefit from the mechanism is larger than what is required. In addition, the system requires a generic drug company to notify the patentee at the time of filing the drug application if the generic drug company asserts invalidity or non-infringement which the generic drug company must prove. Furthermore, the health authority is allowed to stay the issuance of a generic drug permit while the patentee is suing the generic drug company in the court.
    Relation: Journal of Law and Health, Vol.30, No.1, pp.55-79
    Data Type: article
    Appears in Collections:[科技管理與智慧財產研究所] 期刊論文

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