Chapter 4-1 of the Pharmaceutical Affairs Act was promulgated on Jan. 31, 2018, requiring disclosure of new drug patent information and enabling a 12-month stay on marketing approvals for generic drugs involved in patent disputes to clear up said disputes. In order to encourage generic drug makers, to propel the upgrading of Taiwan’s pharmaceutical industry, and to expand their reach in global markets, the first generic drug in each case to successfully contest patent claims or demonstrate design-arounds will be granted 12-month marketing exclusivity.

In accordance with the Pharmaceutical Affairs Act, the Ministry of Health and Welfare (MOHW) drafted the Regulations for Patent Linkage of Drugs with the following focuses: I. the method and the scope of submission of patent information, the amendment and deletion thereof, and the listing and publication of said patent information; II. the declaration made by the applicant for a generic drug permit, the written notification over application review procedures and the issuance of a drug permit; III. the notification to the new drug permit holder of final and binding judgment confirming infringement in complaints filed by the patentee or exclusive licensee; IV. the approval of marketing exclusivity; V. the applicability to applications for new drugs not having a new ingredient and biosimilar drugs; VI. the exclusion of indications, declarations and other matters that shall be abided by.

Following a period in which stakeholder input on the draft was collected between Sept. 11, 2018 and Jan. 31, 2019, the Regulations for Patent Linkage of Drugs was announced on July 1, 2019. The regulations explicitly apply to biosimilar drugs to ensure patent protection for biologic drugs. The regulations also include the May 15, 2019 meeting resolution exempting biosimilar drugs that received central competent health authority approval for clinical trials prior to Chapter 4-1 of the Pharmaceutical Affairs Act taking effect, with the purpose of appropriately providing for a grace period.

In the wake of the patent linkage, the MOHW will also continue to devise contingency measures with relevant government agencies to expedite drug approvals for the domestic market to help with efforts to expand to offshore markets.

【2019-07-01 / Taiwan Food and Drug Administration】