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題名 Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan
作者 陳秉訓
Chen, Ping-Hsun
貢獻者 科管智財所
日期 2017-07
上傳時間 17-May-2018 16:47:50 (UTC+8)
摘要 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.
關聯 Journal of Law and Health, Vol.30, No.1, pp.55-79
資料類型 article
dc.contributor 科管智財所zh_TW
dc.creator (作者) 陳秉訓zh_TW
dc.creator (作者) Chen, Ping-Hsunen_US
dc.date (日期) 2017-07
dc.date.accessioned 17-May-2018 16:47:50 (UTC+8)-
dc.date.available 17-May-2018 16:47:50 (UTC+8)-
dc.date.issued (上傳時間) 17-May-2018 16:47:50 (UTC+8)-
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/117183-
dc.description.abstract (摘要) 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.en_US
dc.format.extent 648776 bytes-
dc.format.mimetype application/pdf-
dc.relation (關聯) Journal of Law and Health, Vol.30, No.1, pp.55-79zh_TW
dc.title (題名) Analysis of the Proposed TPP-Related Patent Linkage System in Taiwanen_US
dc.type (資料類型) article