Patent term extension explained
The new Patent Act came into effect on January 1, 2013. The new act contains some amendments to regulations governing patent term extension.
Patents eligible for patent term extension
According to Articles 53 and 147 of the act, only patents covering pharmaceutical or agrichemical inventions (including product per se inventions, manufacturing process inventions and use inventions), and filed after January 23, 1994, are eligible for patent term extension.
The pharmaceutical products referred to in the act do not include any veterinary drugs. Further, patents covering medical devices and apparatuses, intermediates, catalysts, or manufacturing equipment used in the manufacturing process of any drug product or agricultural chemical are not eligible for patent term extension.
Who may apply?
An application for patent term extension must be filed by a patentee. If two or more persons jointly own the patent, each of them may file the extension application independently according to the joint ownership.
Timing
An application for patent term extension must be filed with the Taiwan Intellectual Property Office (TIPO) within three months of the date of the first government permits involved in the application. However, no application for patent term extension maybe filed in the six months prior to the expiration of the original patent term.
Government permit v patent term extension
Since several permits may be endorsed to different claims in one granted patent, the so-called ‘first government permit’ refers to the first permit endorsed for the same active ingredient with the same purpose of use. Since active ingredients with different purposes of use may obtain different permits, each of them may be held as the first permit and can be used as a basis for an application for patent term extension. Nevertheless, a granted patent can only enjoy one term extension.
“THE PERIOD OF PATENT TERM EXTENSION CANNOT EXCEED THE LENGTH OF TIME WHEN THE PATENT CANNOT BE PRACTISED DUE TO THE ABSENCE OF A GOVERNMENT PERMIT.”
In addition, the same 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, the TIPO may request the patentee to elect one of the patents for patent term extension. Alternatively, the TIPO may grant an extension to the patent with the earliest filing date and reject the remaining applications.
Calculation of the extension period
The maximum period of patent term extension is five years if the length of time required for obtaining the government approval exceeds five years. The period of patent term extension cannot exceed the length of time when the patent cannot be practised due to the absence of a government permit.
Further, the eligible period is the sum of the domestic and foreign clinical trial period(s) recognised by the competent authority, or the domestic and foreign field trial period(s) conducted for obtaining a government permit, or the domestic examination period for the application of a pharmaceutical permit or an agrichemical registration.
Whichever calculation is used, it will subtract the period(s) during which an omission is attributable to the applicant, the overlap between the periods of conducting the domestic and foreign clinical trial(s) or field trial(s), and the overlap between the periods of conducting the clinical trial(s) or field trial(s) and completing the application and examination for a permit.
If the period for obtaining the 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 the trial commences before the patent publication date, the period for obtaining the government permit shall be calculated from the day following the publication date.
If, on the other hand, the trial commences after the publication date of the patent, the period for obtaining the government permit shall be calculated from the day following the commencing date of the trial.
