Article Content  
Title Regulations for Ratifying Extension of Patent Term  
Amended Date  2018.04.11  
  Article 1    These Regulations are formulated pursuant to 
Paragraph 5, Article 53  of the Patent Act 
(hereinafter referred to as “the Act”). 
Article 2    The so-called “central competent authority in 
charge of the business ” in these Regulations shall 
be Ministry of Health  and Welfare, 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. patent certificate number;  
2. title of inventio n; 
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 copies 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 acceptance 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 certificate for 
specifying  the approved extensi on thereto.  
Article 4    Regarding  pharmaceuticals or the ir manufacturing 
procedures , the periods of time allowable in a 
request for patent term extension include:  
1. the period of domestic and/or foreign clinical 
trials 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 Subparagraph 1 of the preceding 
paragraph s hall be limited to those sent by the 
Specific Patent Agency to the central competent 
authority in charge of the business and confirmed by 
the latter for issuing pharmaceutical approval.  
Where the request for patent term extension is made 
pursuant to Paragr aph 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 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 the ir 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 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 pharmaceutical approval.  
Article 6    Regarding  agrichemicals or the ir 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 b e limited to those sent by the 
Specific Patent Agency to the central competent 
authority in charge of the business and confirmed by 
the latter for issuing agrichemical approval.  
Where the request for patent term extension is made pursuant to Paragraph 1, t he 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 the ir 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 photocop y 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 cannot 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 exploited for the purpose of 
obtaining a regulatory approval  exceeds the 
requested extension, the  extended period to be 
granted s hall be limited to the requested extension.  
Article 10    These regulations shall en ter into force on  April 1, 
2018.