The Legislative Yuan passed the Amendment to Pharmaceutical Affairs Act on Dec 29th, 2017 in Taiwan, to establish patent linkage system and give data exclusivity for new indication. After President announcement on Jan 31th, the data exclusivity for new indication is effective immediately and the enforcement date of patent linkage system will be set by the Executive Yuan.  

It is a milestone that Taiwan moves forward on focusing pharmaceutical intellectual property protections. Initially, there is 5-year of exclusivity for new chemical entity and biologics. Based on the new Pharmaceutical Affairs Act, there is a 3-year of data exclusivity for a new indication with international data, and it might be extended to a 5-year protection for those with domestic clinical trials.    

After implementing the patent linkage, the license holder of a new drug is required to list patent information. It is also required that the applicant of a generic license with declaration stating that it is no infringe to its corresponding new drug, notifies the patentee and the holder of a new drug. Once patentee files the lawsuit within 45 days after receiving notification, TFDA will stay 12 months for approval. During the stay period, review process is still undergoing without any suspending. The first generic holder challenging the patent successfully will receive a 12-month of market exclusivity.

The Amendments to Pharmaceutical Affairs Act will protect the intellectual property of invention company, as we as reducing the risk of patent infringement of generic drug company.