Taiwan Executive Yuan approves draft amendment to Article 60-1 of Taiwan Patent Act
E220224Y1 | Jun. 2022（E268）
According to the Taiwan IPO’s press release, with an aim for Taiwan’s access to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and for operating in coordination with the implementation of the patent linkage system introduced to the Pharmaceutical Affairs Act as of August 20, 2019, the draft amendment for inserting Article 60-1 of the Taiwan Patent Act was passed at the Executive Yuan’s meeting on February 24, 2022.
Key points of the draft amendment are introduced in brief as follows.
For rounding off the implementation and operation of the patent linkage system, the patentee of a new drug may file a patent infringement lawsuit against a generic drug permit applicant during the examination of the generic drug permit application where the application is filed with a declaration that the listed patent(s) corresponding to the new drug is not infringed by the generic drug for which the drug permit is applied or the listed patent(s) should be revoked, so as to clear any possible infringement disputes. Also, where the patentee of a new drug fails to file such a lawsuit within a designated time limit, the generic drug permit applicant may initiate an action to seek a declaratory judgment confirming non-infringement by the generic drug for which the permit application is filed. (Released 2022.02.24)