The patent linkage system under the Pharmaceutical Affairs Act (namely, Article 48-3 to 48-22, Article 92-1, and Article 100-1) was amended and promulgated on January 31, 2018 and put into effect on August 20, 2019. According to Article 48-13 of the Act, when a generic drug manufacturer declares the invalidity of a new drug’s patents or their generic drug’s non-infringement during the application for marketing authorization of their generic drug, the new drug patent holder may file a lawsuit for patent infringement within 45 days after receiving the generic drug manufacturer’s declaration. In view of this, the legal basis of claims pertaining to infringement exclusions and prevention in Paragraph 1 of Article 96 of the Patent Law currently in effect may still require other supporting measures.
The Taiwan Intellectual Property Office previously proposed a draft amendment to the Patent Law on March 30, 2016 as a response. A public hearing for the amendment was held on April 13 of the same year. After ample consultation with various sectors and deliberation and approval by the Cabinet, a request in writing was sent on August 5, 2016 from the Cabinet to the Congress for the draft amendment’s review. Note that originally it was drafted for Taiwan to gain entry into the Trans-Pacific Partnership (TPP), but since the US withdrew from the TPP in 2017, the trade agreement became the Comprehensive and Progressive Agreement on Trans-Pacific Partnership (CPTPP) headed by Japan. The original legislators reviewing the proposal finished their term in office before passing it, and the legislators’ successors could not continue the review. Therefore, the Cabinet re-announced the Draft Amendment of Article 60-1 of the Patent Act on January 30, 2020. Due to the ample consultation with external sectors done previously and the amendment’s prior approval by the Cabinet, the time it took for this promulgation was shortened to seven days.
Specifically, the draft amendment clearly stipulates that if a generic drug manufacturer claims the invalidity of a new drug's patents or their generic drug’s non-infringement during the application for marketing authorization of their generic drug, the new drug patent holder may file a lawsuit during the review process of the generic drug in accordance with the legal basis for claims in Paragraph 1 of Article 96 of the Patent Act. If those holders do not file a suit, applicants for a generic drug license may also file a declaratory judgment lawsuit; these measures may strengthen the operation of Taiwan’s patent linkage system.
The patent linkage system under the Pharmaceutical Affairs Act (namely, Article 48-3 to 48-22, Article 92-1, and Article 100-1) has been in effect for over half a year now. Therefore, there have already been several generic drug manufacturers that have declared the invalidity of a new drug’s patents or their generic drug’s non-infringement during their application for marketing authorization. There are also new drug patent holders that have filed patent infringement lawsuits within 45 days after receiving declarations. As a result, it is expected that the review of the previously mentioned draft amendment will be expedited, and before the completion of the amendment, explanations on the modifications of the draft amendment will help establish and refine the legal basis of claims of each case.