Amendments to Taiwan Patent Law

In order to clarify the patent linkage system, an amendment to the Patent Law was passed in April 2022. Previously, a patentee or an exclusive licensee of a patent for a new drug could prevent the Taiwan FDA from issuing a drug approval of an equivalent generic drug for a period of up to 12 months if the relevant information was listed by the FDA or the patentee (or licensee) had filed an infringement lawsuit within 45 days after receipt of a mandatory notification from the generic drug applicant that it believes the patent is either invalid or not infringed and has informed the FDA likewise.