BY JACK T. W. WEI

Although a patent term should not be extendable in principle, TIPO may authorize an extension of a granted patent in the field of pharmaceuticals, agrochemicals, or the manufacturing process thereof as compensation, in case there is a certain period of time during which the patent right cannot be utilized.

In order to improve the patent term extension system, TIPO is thoroughly reviewing relevant regulations. In addition, since the Examination Guidelines for Patent Term Extension were put into effect on January 1, 2013, certain regulations regarding examination practice have been questioned and, in response, will be amended for better clarity.
 

a)  Amendments to the Patent Act (under discussion)

Article 53 of the Patent Act is to be amended by limiting the full period of a Patent term upon acquiring a corresponding permit license (calculated from the date of the permit license being acquired to the expiry of the extended patent term).

b)  Amendments to the Relevant Examination Guidelines for Patent Term Extension (under discussion)
 

Issue I.     Recognition of the active ingredient(s) recited in the first permit license.

Issue II.    Loosening the criteria for determining a first permit license.

Issue III.   Consistency of the criteria for determining the commencement and expiry dates of domestic and foreign clinical trials of a pharmaceutical.

Issue IV.   Reconsidering whether time required for domestic filing of an agrochemical registration should include the preliminary examination process.

Issue V.    Clarifying the conditions that Article 9 of the Regulations for Ratifying Extension of Patent Term is applicable.

1 106年6月20日召開「專利權期間延長制度修法諮詢暨延長基準修訂議題說明會議」會議資料, Taiwan Intellectual Property Office (June 3, 2017). Retrieved from https://www.tipo.gov.tw/ct.asp?xItem=625785&ctNode=7127&mp=1
2 Patent Engineer in Patent Division