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 p ursuant 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 invention;  
3. patentee’s name, nationality, domicile/residence or 
business est ablishment; 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 
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 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 shall 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 i s 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 
period between clinical trials and examination period for 
regulat ory 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 li st 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 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 
conduc ted 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 precedi ng paragraph shall 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 agrichemical approval.  
Where the request for patent term extension is made  
purs uant 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, s hall 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 tim e 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 wh ich 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 shall be limited to the 
requested extension.  
Article 10   These regulations shall enter into force on April 1,  
2018.