Patent Linkage and Data Exclusivity are two major issues highlighted in the negotiation of the Trade and Investment Framework Agreement (TIFA) and the Trans-Pacific Partnership (TPP) between Taiwan and the US. The Taiwanese government had agreed in a TIFA negotiation meeting that the Pharmaceutical Affairs Law would be revised to provide the data exclusivity rights for new drugs and new indications and to fully implement the patent linkage system. Hence, the Legislative Yuan passed the third reading of the amendment of the Pharmaceutical Affairs Law on the 29th of December, 2017.
The key points of the Patent Linkage System and the Data Exclusivity Protection are about strengthening the linkage between drug marketing approval and the disclosure of patent information, as well as allowing drug companies to clarify any patent disputes within a certain period of time. The purpose of patent linkage is to force generic companies to be well aware of the status of the patent(s) corresponding to the originator’s products. Generic drug companies should avoid any patent conflicts while carrying on their R&D projects. The system will, therefore, help local industry to improve.
According to the amendment, generic drug companies will have to inform the MOHW and the originators of their application for the marketing approval for generic products. If the originators have concerns over patent infringement, the originators may file a lawsuit which will lead to the MOHW’s suspension of the issuance of the generic drug marketing approval for 12 months for investigation. In situations where a generic drug company wins a lawsuit, the market exclusivity right for a certain period of time will be granted to the generic drug company.
【2017-12-29/ Radio Taiwan International】