These Operational Directions (hereinafter referred to as “the Directions”) are formulated to strengthen cooperative ties between Taiwan and Japan, to reduce the burden of applicants having to repeat the process of making a deposit, to implement the provisions set forth in Paragraph 5, Article 27 of the Patent Act, and to carry out the terms stated in the Mutual Cooperation in the Field of Deposit of Microorganism s for the Purposes of Patent Procedure between Taiwan and Japan.
In the event an applicant files a patent application in the Republic of China and deposits biological materials in a depository located in Japan and designated by the Japan Patent Office, Ministry of Economy, Trade and Industry (hereinafter referred to as “JPO”), such deposit shall be governed by Japanese laws and regulations. However, persons qualified for requesting to be furnished a sample and the grounds for requesting to be furnished a sample shall be governed by Paragraph 1 of Article 13 and Paragraph 1 of Article 14 of the Regulations for the Deposit of Biological Materials for Patent Application.
In the event an applicant files a patent application to the JPO and deposits biological materials in the depository located in the Republic of China and designated by the Taiwan Intellectual Property Office, Ministry of Economic Affairs (hereinafter referred to as “TIPO”), such deposit shall be governed by the Regulations for the Deposit of Biological Materials for Patent Application, unless otherwise provided in the Directions. However, persons qualified for requesting to be furnished a sample and the grounds for requesting to be furnished a sample shall be governed by Japanese laws and regulations and such request shall be filed in accordance with the forms attached to the Directions.
The terms used in the Directions are defined as follows:
(1) the Treaty: Budapest Treaty on the International Recognition of the Deposit of Microorganisms for th e Purposes of Patent Procedure;
(2) depositor: the natural person or legal entity transmitting the biological materials to a Designated Depository, which receives and accepts the biological materials, and any successor in title of the said natural person or le gal entity.
(3) Designated Depository: a depository designated by the relevant specific agency of either side, which provides for the receipt, acceptance and storage of biological materials and the furnishing of samples thereof;
(4) patent procedure: any administrative or judicial procedure relating to a patent application or a patent;
(5) publication for the purposes of patent procedure: the official publication, or the official laying open for public inspection, of a patent
application or a patent;
(6) relevant specific agency: the specific agency administrates patent affairs of either side, i.e., TIPO or JPO;
(7) international depositary authority: a depository which has acquired the status of international depositary authority as described in Article 7 of the Treat y; and
(8) biological materials: this term may be deemed by either side to be synonymous with the term “microorganisms”
With respect to biological materials that are or will be deposited pursuant to the Directions, in the event the restriction of export or import thereof is necessary in view of security or the danger s for health or the environment, such restriction may be made in accordance with the laws and regulations.
In order to qualify for the status of Designated Depository, any Designated Depository must be located in the territory of the desig nating relevant specific agency.
If any Designated Depository refuses to accept deposit of any of the kinds of biological materials which it should accept, the designating relevant specific agency will promptly no tify the relevant specific agency of another side of the relevant facts and the measures which have been taken.
The new deposit made under Point 5 shall be made by providing a copy of the certificate of deposit of the previous deposit, a copy o f the most recent viability statement of the biological materials which was the subject of the previous deposit indicating that the biological materials are viable, the statement proscribed under Paragraph 3 of Point 5, and a written request bearing the si gnature or seal of the depositor and containing the followings:
(1) the indications referred to in Paragraph 1 of Point 10, unless the new deposit is made with the Designated Depository with which the original deposit was made;
(2) a declaration stating the reason for making the new deposit and an indication of the date on which the depositor received the notification referred to in Paragraph 1 of Point 5 or, as the case may be, the date of the publication referred to in Paragraph 5 of the same point; and
(3) where a s cientific description and/or proposed taxonomic designation was/were indicated in connection with the previous deposit, the most recent scientific description and/or proposed taxonomic designation as communicated to the Designated Depository with which the previous deposit was made.
For the purposes of the preceding paragraph and Paragraph 4 of Point 13, “previous deposit” means the original deposit where the new deposit has not been preceded by one or more other new deposits, or the most recent of those o ther new deposits, where the new deposit has been preceded by one or more other new deposits.
The Designated Depositories, in order to proceed with deposit affairs, may charge a fee:
(1) for storage;
(2) for issuance of viability statements, unless otherwise provided for in Paragraph 6 of Point 16; and
(3) for furnishing of samples, unless otherwise provided for in Paragraph 6 of the preceding point.
The fee for storage referred to in the preceding paragraph shall be for the whole duration of the storage of the biological materials as described in Paragraph 1 o f Point 15.
The amount of any fee shall not vary on account of the nationality, domicile or residence or business establishment of the depositor, or on account of the domicile or residence or business establishment of the person or entity requesting issua nce of a viability statement or furnishing of samples.
The time period regulated in the Directions shall be calculated as follows:
(1) When a period is expressed as one year or a certain number of years, computation shall start on the day following the day on which the relevant event occurred, and the period shall expire in the relevant subsequent year in the month having the same name and on the day having the same number as the month and the day on which the said event occurred, provided that if the releva nt subsequent month has no day with the same number the period shall expire on the last day of that month.
(2) When a period is expressed as one month or a certain number of months, computation shall start on the day following the day on which the relevant event occurred, and the period shall expire in the relevant subsequent month on the day which has the same number as the day on which the said event occurred, provided that if the relevant subsequent month has no day with the same number the period shall expire on the last day of that month.
(3) When a period is expressed as a certain number of days, computation shall start on the day following the day on which the relevant event occurred, and the period shall expire on the day on which the last day of the cou nt has been reached.
Where the request of deposit of biological materials has been filed prior to the implementation of the Directions and the relevant patent application for invention is filed to the relevant specific agency after such implementation, the Directions may also apply.
(REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraph 1 of Article 17)
(REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraph 2 of Article 17)
(REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraphs 3 and 4 of Article 17)
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