TIPS^®  Taiwan Intellectual Property Special

Proposed Guidelines on Examination of Patent Term Extension Applications

New guidelines on examination of patent term extension applications have been released for comments by Taiwan’s Intellectual Property Office (TIPO). In essence, the proposed guidelines provides an examining standard for recognition and approval of patent term extension, major issues are summarized below for your reference.

(1) Medical device for either pharmaceutical composition or pesticide composition is excluded form the subject qualified for application of patent term extension.

(2) For application of patent term extension on a pharmaceutical composition and the manufacturing method thereof, “the date of issuance of the first certificate of approval” means the date that the applicant actually obtains the permit (i.e., the delivery date); however, in the case for application of patent term extension on a pesticide composition and the manufacturing method thereof, the same term represents the date the granting office notify the applicant of this permit (i.e., notification date).

(3) In case when more than one permit have been issued in the certificate of approval, the applicant may choose one permit for application of patent term extension on the basis of a pharmaceutical composition or a pesticide composition or the manufacturing method thereof.

(4) Whenever an application of patent term extension is deemed unqualified upon examination, TIPO shall notify the applicant of the decision in advance and specify a time limit within which a response shall be submitted.