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’s 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.
Recommended Citation
Ping-Hsun Chen,
Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan,
30 J.L. & Health
55
(2017)
available at https://engagedscholarship.csuohio.edu/jlh/vol30/iss1/3
Included in
Chemical and Pharmacologic Phenomena Commons, Health Law and Policy Commons, Medical Jurisprudence Commons, Medicinal and Pharmaceutical Chemistry Commons, Pharmaceutical Preparations Commons, Pharmaceutics and Drug Design Commons, Pharmacy Administration, Policy and Regulation Commons