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Regulation
Ratifying Extension to Patent Term |
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| Revised on October 6,
1999
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Article 1
These Regulations are enacted in accordance with Paragraph 3, Article 52
of the Patent Law (hereinafter referred to as “this Law”).
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Article 2
The central competent authority stipulated in these Regulations refers to
Department of Health, Executive Yuan for pharmaceuticals and Council of
Agriculture, Executive Yuan for agrichemicals.
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Article 3
Application for extension to patent term under Article 51 of this
Law should be made by submitting a written application signed or sealed
by the patentee or his agent and indicating the following information:
- patent number;
- title of invention;
- patentee’s name and address; if the patentee is a judicial person
, the business name and address and the name of its representative.
- reasons and term for extension;
- date of the certificate of approval first obtained; and
- date of application (year/month/day).
A copy of the certificate of approval obtained in accordance
with the law and the local or foreign documentary evidence in duplicate
should be submitted together with the preceding written application.
Upon acceptance of the application referred to in the
first paragraph, the Patent Authority should publish the contents of the
application.
When the application for patent term extension is approved, the Patent
Authority should notify the patentee to submit the Letters Patent so that
the approved extended term can be specified in the Letters Patent.
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Article 4
The period of time eligible for applying for patent term extension
on pharmaceuticals or the manufacture processes thereof includes:
- the period of conducting domestic clinical tests recognized by the
central competent authority;
- the period of examining the application for registration;
- if the application for patent term extension is based on the period
of conducing clinical tests in a foreign country, the period of the
clinical tests recognized by the marketing approval of the country of
production.
The time period of the applicant’s failure to utilize for obtaining the
certificate of approval, the overlapping time period of conducting clinical
tests in this country and those in a foreign country, and the overlapping
period between the clinical tests and the examination of application for
registration should be deducted from the approved extended period of time
applied in accordance with the preceding paragraph.
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Article 5
Application for extension to patent term concerning pharmaceuticals
or the manufacture processes thereof shall be made by submitting a copy
of the certificate of approval for pharmaceuticals and the following documentary
evidence issued by the central competent authority:
- documentary evidence containing the time period of the domestic clinical
tests and the beginning and finishing dates thereof;
- documentary evidence containing the period of examining the registration
and the beginning and finishing dates thereof.
If the application for extension to patent term is made based on the
time period of conducting clinical tests in a foreign country, in addition
to the documents specified in the preceding paragraph, documents verifying
the time period of such tests with indication of the beginning and finishing
dates and the approval of the applied extended time period issued by the
concerned competent authority of the country of production should be submitted.
Where no application for extension to patent term was filed abroad, documents
verifying the approval of the applied extended time period is not required.
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Article 6
The period of time eligible for applying for patent term extension
on agricultural chemicals or the manufacture processes thereof includes:
- the period of conducting domestic tests recognized by the central
competent authority;
- the period of examining the application for registration;
- if the application for patent term extension is based on the time
period of conducting tests abroad, the time period of the tests certified
by the competent authority of the country of production.
The longest time taken for one of the tests conducted
abroad shall be considered the time period eligible for extension to patent
term referred in the preceding paragraph. However, if the tests are sequential,
the time taken for each test may be added up for calculation of the time
period eligible for extension to patent term referred in the preceding
paragraph.
The time period of the applicant’s failure to utilize for obtaining the
certificate of approval, the overlapping time period of conducting tests
in this country and those in a foreign country, and the overlapping period
between the tests and the examination of application for registration
should be deducted from the approved extended period of time applied in
accordance with the preceding paragraph.
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Article 7
Application for extension to patent term concerning agricultural
chemicals or the manufacture processes thereof shall be made by submitting
the following documentary evidence:
- document issued by the central compenent authority approving the conduct
of a commissioned field test;
- registration document approved and examined acceptable by the central
compenent authority; and
- copy of the certificate of agricultural chemicals
If the application for extension to patent term is made based on the
time period of conducting tests in a foreign country, in addition to the
documents specified in the preceding paragraph, documents verifying the
time period of such tests with indication of the beginning and finishing
dates and the approval of the applied extended time period issued by the
concerned competent authority of the country of production should be submitted.
Where no application for extension to patent term was filed abroad, documents
verifying the approval of the applied extended time period is not required.
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Article 8
Where the beginning date of a test ratified by the central competent authority
is later than the publication date of the patent, the time period of obtaining
the approval certificate shall be calculated from the next day after the
test starts.
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Article 9
The object of the extended patent term shall be limited to the effective
ingredients or use identified in the approval certificate.
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Article 10
These regulations shall take effect from the date of promulgation.
Article 7 and 10 revised on October 6,1999. and retroactive effected
on July 1,1999.
NOTE:In case of any discrepancy between
the English version and the Chinese text of the Law, the Chinese text
shall prevail.
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