Patent term extension is available to patents relating to pharmaceutical products (excluding animal drugs) in Taiwan. An extension application should be filed within three months from the date the approval certificate is obtained and at least six months before the patent is due to expire.
Furthermore, an extension application can be based on only “one” approval certificate and for only “one” patent having claims directed to a specific product that corresponds to the active ingredient(s) and/or the use of the active ingredient(s) specified on the approval certificate. The patent term can be extended for a maximum of five years.
The applicant of an extension application basically should be the patentee. If the patentee is not the holder of the approval certificate, an assignment recordal shall be conducted.
It is advisable to file an extension application soon after the regulatory approval is obtained. The requisite documents include, in addition to a copy of the publication of the patented invention and a photocopy of the approval certificate, documents showing the time period required for obtaining an assessment report issued by an authorized organization and documents issued by the competent authorities showing the time periods of domestic or foreign clinical trials. Moreover, the relevancy between the approved product (or the product and its use) and the claims of the patent whose term is to be extended, and the period during which the patent cannot be enforced (based on a listing of the time periods of the domestic or foreign clinical trials) need be specified in the application.
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The above contents are intended as general discussion of the subject matter only and shall not be deemed as legal advice to any particular case or issue.