Regulations Governing the Determination of Patent Term Extension  
 
1.Promulgated on January 01, 1997  
2.Revised on October 6, 1999  
3.Revised on March 3, 2004; entered into force on July 1,2004  
4.Revised on December 28, 2012; entered into force on January 1, 2013  
5.Revised on April 11, 2018; entered into force on April 1, 2018.  
6. Revised on June 28, 2023; entered into force on July 1, 2023.  
 
Article 1  
These Regulations are formulated purs uant to Paragraph 5, Article 53 of the Patent 
Act (hereinafter referred to as “the Act”).  
Article 2  
The term“central competent authority in charge of the business”referred to in these 
Regulations shall be Ministry of Health and Welfare for pharmaceuticals,  or Council 
of Agriculture, Executive Yuan for agrichemicals.  
Article 3  
A request for patent term extension pursuant to Article 53 of the Act shall be made 
in writing and signed or sealed by the patentee or an agent thereof indicating the 
following:  
1. pat ent certificate number;  
2. title of invention;  
3. patentee’s name, nationality, domicile/residence or business establishment; name 
of representative, if any;  
4. reason(s) and term for extension; and  
5. date of the regulatory approval first obtained.  
Two co pies of the regulatory approval obtained in accordance with applicable laws 
and domestic and/or foreign document(s) of proof regulatory approval application 
shall be provided together with the written request referred to in the preceding 
paragraph.  
Upon ac ceptance of the request referred to in Paragraph 1, the Specific Patent 
Agency shall publish contents of the request form.  
When the request for patent term extension is granted, the Specific Patent Agency 
shall notify the patentee to provide the patent cer tificate for specifying the approved 
extension thereto.  
Article 4  
Regarding pharmaceuticals or their manufacturing procedures, the periods of time 
allowable in a request for patent term extension include:  1. the period of domestic and/or foreign clinical t rials conducted for obtaining a 
pharmaceutical approval from the central competent authority in charge of the 
business; and  
2. the examination period for domestic regulatory approval.  
The “domestic and/or foreign clinical trials” referred to in Subparagrap h 1 of the 
preceding paragraph shall be limited to those confirmed to be necessary for issuing 
pharmaceutical approval by the central competent authority in charge of the 
business . 
Where the request for patent term extension is made pursuant to Paragraph 1 , the 
time period attributable to the requester’s omission of act, the overlapping time 
period between domestic and foreign clinical trials, and the overlapping  time  period 
between clinical trials and examination period for regulatory approval, shall be 
deducted from the period to be granted extension.  
Article 5  
When requesting patent term extension for pharmaceuticals or their manufacturing 
procedures, the following documents shall be provided:  
1. document(s) of proof and a list regarding the time period o f domestic and/or 
foreign clinical trials and the commencement and expiration thereof;  
2. document(s) of proof regarding the examination period for domestic regulatory 
approval and the commencement and expiration thereof; and  
3. a photocopy of the pharmace utical approval.  
Article 6  
Regarding agrichemicals or their manufacturing procedures, the periods of time 
allowable in a request for patent term extension include:  
1. the period of domestic and/or foreign field tests conducted for obtaining an 
agrichemical  approval from the central competent authority in charge of the business; 
and 
2. the examination period for domestic regulatory approval;  
The “domestic and/or foreign field tests” referred to in Subparagraph 1 of the 
preceding paragraph shall be limited to  those sent by the Specific Patent Agency to 
the central competent authority in charge of the business and confirmed to be 
necessary by the latter for issuing agrichemical approval.  
Where the request for patent term extension is made pursuant to Paragraph 1, the 
time period attributable to the requester’s omission of act, the overlapping time 
period between domestic and foreign field tests, and the overlapping time period 
between field tests and examination period of regulatory approval, shall be deducted 
from the period to be granted extension.  
Article 7  When requesting patent term extension for agrichemicals or their manufacturing 
procedures, the following documents shall be provided:  
1. document(s) of proof and a list regarding the time period of domestic  and/or 
foreign field tests and the commencement and expiration thereof;  
2. document(s) of proof regarding the examination period of domestic regulatory 
approval and the commencement and expiration thereof; and  
3. a photocopy of the agrichemical approval.  
Article 8  
Where the commencement of a domestic or foreign test predates publication of a 
patent application, the time period in which the invention cannot be exploited for 
the purpose of obtaining a regulatory approval shall be calculated from the 
publication date; where the commencement of a domestic or foreign test is predated 
by publication of a patent application, the time period shall be calculated from the 
commencement of the test.  
The expiration of the time period in which the invention canno t be exploited for the 
purpose of obtaining a regulatory approval shall be one day before such approval is 
obtained.  
Article 9  
After examination of the request for patent term extension, in the event that the 
time period in which the invention cannot be ex ploited for the purpose of obtaining 
a regulatory approval exceeds the requested extension, the extended period to be 
granted shall be limited to the requested extension.  
Article 10  
These regulations shall enter into force on April 1, 2018.  
The amendment p romulgated on June 28, 2023 shall enter into force on July 1, 2023.