Newsletter
Legislative Yuan Passes Draft Amendments to Article 60-1 of the Patent Act, Wherein Grounds for Claiming Infringement for Patent Linkage Litigation Are Specified
On January 31, 2018, the patent linkage system was established in Taiwan by introducing amendments to the Pharmaceutical Affairs Act (hereinafter the "PAA"), which formally commenced on August 20, 2019. According to Article 48-3 of the PAA, after collecting the new drug permit, the holder of said permit shall list the patent information of the approved new drug with the Taiwan Food and Drug Administration (hereinafter the "TFDA"); thereafter, if another pharmaceutical company applies for a generic drug permit and declares, in accordance with Article 48-9, Paragraph 1, Subparagraph 4 of the PAA (commonly called 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 after receiving such certification, and notify the TFDA, who will then stay the issuance of the generic drug permit within twelve 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, there have been several cases in which the defendants argued 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.
To specify the grounds for claiming infringement arising from patent linkage, on February 24, 2022, the Executive Yuan's 3791st meeting passed "Draft Amendments to Article 60-1 of the Patent Act," clearly stipulating that after receiving the Paragraph IV Certification, the patentee may request removal or prevention of patent infringement in accordance with the provision of Article 96-1, Paragraph 1 of the Patent Act. In addition, in the event that 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 an action of declaratory judgment with respect to confirming 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 initiate action to obtain a court decision sooner, to remove potential ambiguity over legal status.
On April 15, 2022, the Legislative Yuan passed the aforementioned draft amendments to Article 60-1 of the Patent Act. The effective date thereof is to be decided by the Executive Yuan.