Taipei High Administrative Court's Latest Ruling: Patent Information of "Category II New Drugs" Allowed to be Submitted in Patent Linkage Registration System

Roger Chang/Jill Niu/Kate Shu-Yin Chu/ Joyce Liou

Katherine Juang/Julie Wu/Powei Huang

Regarding the scope of the "new drugs" for which the patent information thereof can be submitted in the Patent Linkage Registration System under Article 48-3 of the Pharmaceutical Affairs Act ("PAA"), the competent authority (i.e., the Food and Drug Administration (the "TFDA") under the Ministry of Health and Welfare) previously determined that it is limited to the pharmaceutical preparations with "new active ingredient", "new therapeutic combination" or "new administration route", as stipulated under Article 7 of the PAA (i.e., "New Drugs" or "Category I New Drugs"), and does not include pharmaceutical preparations with "new dosage form", "new usage dose" or "new unit strength" (i.e., "Category II New Drugs"). However, when the TFDA first launched the Patent Linkage Registration System, accounts were already set up thereby specifically for the marketing authorization ("MA") holders of Category II New Drugs to submit their patent information in such system.  It is our firm's opinion that the TFDA's subsequent decisions to delete such accounts and remove the patent information of such Category II New Drugs from the Patent Linkage Registration System (the "Decisions") are in fact in contravention of the legislative intent of such system. Lee and Li then represented the affected MA holders to appeal against the Decisions and to initiate administrative actions against the TFDA.

Regarding this highly contentious issue, on December 29, 2022, the Taipei High Administrative Court, in response to the two administrative actions instituted by the plaintiffs represented by Lee and Li, overturned the TFDA's Decisions as well as the subsequent determinations on the administrative appeals against the Decisions, and ordered the TFDA to reinstate the patent information of the plaintiffs' Category II New Drugs in the Patent Linkage Registration System.

Such rulings are not only a victory for the two MA holders that we represented, but will also have a significant impact on the rights of all the pharmaceutical companies that market Category II New Drugs in Taiwan. Lee and Li will provide the court's reasoning of such rulings after we receive the full version of the judgment. Please do not hesitate to contact us if your company wishes to submit the patent information of your Category II New Drugs in the Patent Linkage Registration System.