On May 4, 2022, the amended Article 60-1 of the Patent Act was published and will be implemented on July 1, 2022.
The addition of “Article 60-1 of the Patent Act” is a supporting act of the “Patent Linkage System” of the Pharmaceutical Affairs Act. The patent linking system is a CPTPP regulation that provides early clarification of generic drug and new drug patent rights at the stage of generic drug application for drug marketing approval to see whether there is solutions for infringement disputes.
A. Key points of correction
1. If the drug license applicant declares that the patent right of the new drug published by the owner of the new drug license should be revoked or that the patent right is not infringed, the patentee may, after receiving the notice, follow Article 96-1 of the Patent Act to request removal or prevention of infringement.
2. In order to take into account the rights and interests of the generic drug factory, if the patentee of the new drug fails to file an infringement lawsuit within the prescribed time limit, the generic drug factory may file a confirmation lawsuit on whether the patent infringement is constituted, so as to avoid the possibility of risk of being accused after the generic drug is marketed.
B. Article content
When an applicant of a drug permit makes a declaration in accordance with Item 4 of Article 48-9 of the Pharmaceutical Affairs Act with respect to the patent(s) of the approved new drug listed by the holder of said new drug permit, the patentee of said new drug may, upon receipt of the notification of said declaration, demand to stop or prevent such infringement in accordance of Paragraph 1 of Article 96.
Should the patentee not file a complaint against the aforementioned applicant of said drug permit within the period specified in Paragraph 1 of Article 48-13 of the Pharmaceutical Affairs Act, the applicant may initiate an action for a declaratory judgment to dictate whether the drug for which they applied for a drug permit infringes the patent.
Source: Intellectual Property Office
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