On 31 January 2018, the patent linkage system was established in Taiwan through the introduction of amendments to the Pharmaceutical Affairs Act (PAA), which formally took effect on 20 August 2019.

Under article 48-3 of the PAA, after collecting a new drug permit, the holder of such permit may provide the Taiwan Food and Drug Administration (TFDA) with patent information about the approved new drug. Thereafter, if another pharmaceutical company applies for a generic drug permit and declares, in accordance with article 48-9(1)(4) of the PAA (commonly referred to as "paragraph IV certification"), that "the patent(s) listed for the new drug has not been infringed" or "the patent(s) listed for the new drug shall be revoked", the patentee of the new drug patents may file a patent infringement action within 45 days of receiving such certification and notify the TFDA.

The TFDA will then stay the issuance of the generic drug permit within 12 months so as to enable the patentee and the alleged patent infringer to resolve the infringement dispute. However, since the Patent Act stipulates no special provisions regarding the grounds for claiming infringement arising from patent linkage, defendants have argued in several cases that there was no legal basis for the patentee to file the litigation as the act of applying for a generic drug permit does not constitute patent infringement.

On 24 February 2022, to specify the grounds for claiming infringement arising from patent linkage, the Executive Yuan passed the Draft Amendments to Article 60-1 of the Patent Act. The amendments clearly stipulate that after receiving paragraph IV certification, the patentee may request the removal or prevention of patent infringement in accordance with article 96-1(1) of the Patent Act.

In addition, if the holder of the new drug permit fails to file the patent infringement litigation within the prescribed period, the article entitles the applicant for the generic drug permit to file a declaratory judgment action to confirm whether the generic drug infringes the patents listed for the new drug. In this case, the applicant of the generic drug permit will be allowed to initiate action to obtain a court decision sooner, to remove potential ambiguity over legal status.

On 15 April 2022, the Legislative Yuan passed the aforementioned draft amendments to article 60-1 of the Patent Act, and the effective date thereof is 1 July 2022.

For further information on this topic please contact Hsiu-Ru Chien or Elina Yu at Lee and Li Attorneys at Law by telephone (+886 2 2763 8000) or email ([email protected] or [email protected]). The Lee and Li Attorneys at Law website can be accessed at www.leeandli.com.