Taiwan Patent Term Extension Explained

 The new Patent Act of Taiwan (hereinafter referred to as “the Act”) came into effect on January 1, 2013. The Act included some amendments to the regulations related to patent term extension. For pharmaceutical companies that are interested in seeking patent term extension in Taiwan, the relevant rules are hereby explained.

Patents Eligible to Seek Patent Term Extension

According to articles 53 and 147 of the Act, only patents covering pharmaceutical or agrochemical inventions (including product per se inventions, manufacturing process inventions and use inventions), and which are filed after January 23, 1994 are eligible to seek patent term extension.

“Pharmaceutical product” referred to in the Act does not include any veterinary drug. Further, patents covering medical devices and apparatuses, intermediates, catalysts, or manufacturing equipment used in the manufacture of any drug product or agricultural chemical are not eligible to seek patent term extension.

Person(s) Entitled to Apply for Patent Term Extension

An application for patent term extension must be filed by a patentee or a TIPO-recorded exclusive licensee. If two or more persons jointly own a patent, each owner may filean extension application independently.

Timing for Filing an Application for Patent Term Extension

An application for patent term extension must be filed with TIPO within three (3) months from the date of the first government permit involved in the application (to be explained below). However, no application for patent term extension can be filed within six (6) months before the expiration of the original patent term.

Government Permit vs. Patent Term Extension

Since several permits may be endorsed to different claims in one grant patent, “first government permit” refers to the first permit endorsed for the same active ingredient with the same purpose of use. Since active ingredients of different purposes of use may obtain different permits, each active ingredient/purpose may be held as the first permit and can form the basis for application of patent term extension. Nevertheless, a grant patent can only enjoy one term extension.

 In addition, the first government permit is only allowed to be used once in an application for extension. If patent term extension is sought for two or more patents based on the same government permit, TIPO may request the patentee to elect one of the patents for patent term extension. Alternatively, TIPO may grant extension to the patent with the earliest filing date and reject the remaining applications.

Calculation of Period of Patent Term Extension

The maximum period of patent term extension is five (5) years, and such a maximum period may be applied for if the length of time required for obtaining government approval exceeds five (5) years.

The period of patent term extension is not to exceed the length of time when a patent cannot be practiced due to the absence of the government permit. 

Further, the eligible period is (a) the sum of the domestic and foreign clinical trial periods recognized by a competent authority, (b) the sum of the domestic and foreign field trial periods conducted for obtaining a government permit, or (c) the domestic examination period for the application of a pharmaceutical permit or an agrochemical registration. Whichever calculation is used, it will be necessary to subtract the period(s) during which an omission is attributable to the applicant, of any overlap between the periods of conducting domestic and foreign clinical trial(s) or field trial(s), and of any overlap between the periods of conducting clinical trial(s) or field trial(s) and completing the application and examination for a permit.

In cases where TIPO deems that the period for obtaining a government permit exceeds the term for extension requested by the applicant, the approved term will be limited to the term requested by the applicant.

If a clinical (field) trial commences before a patent publication date, the period of obtaining a government permit will be calculated from the day following the publication date.

If, on the other hand, a clinical (field) trial commences after the publication date of a patent, the period of obtaining a government permit will be calculated from the day following the date of commencement of the clinical (field) trial.