Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan

Author: Ping-Hsun Chen

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.

Citation: Chen, Ping-Hsun, Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan (2017). Journal of Law and Health, Vol. 30, No. 1, pp. 55-79 (August 2017). Available at SSRN: https://ssrn.com/abstract=3290083