Promulgated on June 1, 2015; entered into force on June 18, 2015. Download
Promulgated on June 1, 2015; entered into force on June 18, 2015. Download
1
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.
2
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.
3
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”
4
Through this mutual cooperation between TIPO and JPO, the deposit of biological materials made for the purposes of patent procedure at a Designated Depository by one side shall be recognized for the purposes of patent procedure by the specific patent agency of the other side. The scope of the recognition referred to in the preceding paragraph shall include the fact and date of deposit provided by the Designated Depository and the sample as furnished directly from the deposited biological materials. The relevant specific agency of the other side may request a copy of certificate of deposit issued by the said Designated Depository indicating the deposit made pursuant to Paragraph 1. The Designated Depositories referred to in Paragraph 1 shall mean respectively the Food Industry Research and Development Institute (FIRDI) of Republic of China, and the International Patent Organism Depositary, National Institute of Technology and Evaluation (NITE-IPOD) and the Patent Microorganisms Depositary, National Institute of Technology and Evaluation (NPMD) of Japan.
5
In the event a Designated Depository of either side cannot furnish samples of the deposited biological materials for any reason, including where such biological materials is no longer viable or where the furnishing of the samples would require that they be sent abroad and the sending or the receipt of the samples abroad is prevented by export or import restrictions, the Designated Depository shall promptly notify the depositor of such inability, and indicate the cause thereof. Unless otherwise provided for in Paragraph 6, the depositor may make a new deposit of the biological materials which w as originally deposited. The new deposit shall be made with the Designated Depository with which the original deposit was made. In the event of any of the followings, however, the deposit may be made to another Designated Depository of either side: (1) where the Designated Depository with which the original deposit was made has ceased to have the status of Designated Depository, either entirely or in respect of the kind of biological materials to which the deposited biological materials belong, or where the De signated Depository with which the original deposit was made discontinues, temporarily or definitively, the performance of its functions in respect of deposited biological materials; or (2) where the furnishing of samples is prevented by export or import restrictions. The new deposit made pursuant to Paragraph 1 or 2 shall be accompanied by a statement signed by the depositor alleging that the newly deposited biological materials are the same as those originally deposited. Unless otherwise provided for in this Point, the new deposit will be treated as if it had been made on the date on which the original deposit was made where all the preceding statements concerning the viability of the originally deposited biological materials indicated that the biologic al materials were viable and where the new deposit was made within three (3) months after the date on which the depositor received the notification referred to in Paragraph 1. Where the furnishing of samples is prevented by the cause prescribed in Subparagraph 1 of Paragraph 2 and the depositor does not receive the notification referred to in Paragraph 1 within six (6) months after the date on which the termination or limitation of the status of a Designated Depository or the discontinuance of deposits was published by the relevant specific agency, the three month time limit referred to in the preceding paragraph will be counted from the date of the said publication. Where the deposited biological materials have been transferred to another Designated Depository of each side or another international depositary authority and that Designated Depository or that authority is in a position to furnish samples of such biological materials, the depositor cannot make a new deposit of the biological materials which we re originally deposited. In the event the deposited biological materials have been transferred to another international depositary authority and the acquiring of samples of those biological materials from that authority is prevented, the relevant specific agency may require the depositor to make a new deposit.
6
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.
7
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.
8
If any Designated Depository temporarily or definitively discontinues the performance of any of the tasks it should perform, the designating relevant specific agency shall adopt following measures: (1) measure to ensure that samples of all such biological materials are transferred promptly and without deterioration or contamination from the said Designated Depository (hereinafter referred to as “Original Depository”) to another Designated Depository of each side or another international depo sitary authority (hereinafter referred to as “Receiving Depository”); (2) measure to ensure that all mails or other communications addressed to the Original Depository, and all files and other relevant information in the possession of that depository, in respe ct of the said biological materials are promptly transferred to the Receiving Depository; (3) measure to ensure that the Original Depository promptly notifies all depositors affected by the discontinuance of the performance of its functions and the transfers e ffected; and (4) promptly notify the relevant specific agency of another side of the fact and the extent of the discontinuance in question and of the measures which have been taken by the said side under the preceding three (3) subparagraphs. Where the depositor receives a certificate of deposit from the Receiving Depository stating the new accession number given to the original deposit, the relevant specific agency with which a patent application was filed shall be notified of the new accession number b y the depositor. The Receiving Depository shall retain in an appropriate form the accession number given by the Original Depository, together with the new accession number. On the request of any depositor affected, the Original Depository shall retain, a s far as possible, samples of the biological materials deposited with it.
9
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.
10
The request of deposit, except the new deposit made under Point 5, (hereinafter referred to as “original deposit”), shall be made by providing the biological materials and a written request which bears the signature or seal of the depositor and contains the followings: (1) the name and domicile, residence or business establishment of the depositor; (2) details of the conditions necessary for the cultivation of the biological materials, for their storage and for testing their viability and also, where a mixture of biological materials is deposited, descriptions of the components of the mixture and at least one of the methods permitting the checking of their presence; (3) an identification reference (number, symbols, etc.) given by the depositor to the biological materials; and (4) an indication of the properties of the biological materials which are or may be dangerous to health or the environment, or an in dication that the depositor is not aware of such properties. The depositor may include in the written request referred to in the preceding paragraph the scientific description and/or proposed taxonomic designation of the deposited biological materials. The depositor may not withdraw the deposit after receiving the certificate of deposit issued by the Designated Depository.
11
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.
12
The Designated Depositories, in order to proceed with deposit affairs, may require the depositor to follow prescribed necessary form and quantity of the biologi cal materials as well as document format and fee requirements. The document relating the request of deposit and written statement shall be in the language, or in any of the languages, specified by relevant specific agencies. Unless otherwise provided for by laws and regulations, the depositor and the Designated Depository may enter into a contract on the scope of their obligations. In the event of any of the following situations, the Designated Depository shall refuse to accept the deposit of biological materials and immediately notify the depositor in writing of such refusal and of the reasons therefor: (1) where the biological materials are not the types acceptable to the Designated Depository; (2) where the properties of the biological materials are so exceptional that the Designated Depository is technically not in a position to perform the tasks in relation to them; or (3) where the original or new deposit is received in a condition which clearly indicates that the biological materials are missing or which precludes for scientific reasons the acceptance of the biological materials. A Designated Depository shall receive a request of deposit that is in absence of the situations mentioned in the preceding paragraph, is in compliance with Point 10 or 11, and is in compliance with Paragraph 1 and 2 of this Point. For any noncompliance, the Designated Depository shall promptly notify the depositor to rectify the noncompliance. When the biological materials have been accepted as the original or new deposit, except where the new deposit does not fall under Paragraph 4 of Point 5, the date of that original or new deposit, as the case may be, shall be the date on which the biological materials were received by the Designated Depository.
13
With respect of each deposit of biological materials effected with or transferred to, the Designated Depository shall perform viability test and issue a certificate of deposit to the depositor when the biological materials are proved to be viable. The certificate of deposit shall bear the signature or seal of the person having the power to represent the Designated Depository or any other person duly authorized by the said person. Any words or letters in the certificate of deposit in characters other than those of the Latin alphabet shal l also appear therein transliterated in characters of the Latin alphabet. The certificate of deposit of original deposit shall contain following items: (1) the name and address of the Designated Depository; (2) the name and domicile, residence or business establi shment of the depositor; (3) the date of original deposit as defined in Paragraph 6 of Point 12; (4) the identification reference (number, symbols, etc.) given by the depositor to the biological materials; (5) the accession number given by the Designated Depository to the deposit of biological materials; and (6) where the depositor has provided the scientific description and/or proposed taxonomic designation of the biological materials pursuant to Paragraph 2 of the Point 10, the scientific description and/or proposed taxo nomic designation. The certificate of deposit of new deposit shall contain following items and be accompanied by a copy of certificate of deposit of the previous deposit and a copy of the most recent viability statement of the biological materials which w ere the subject of the previous deposit indicating that the biological materials were viable: (1) the name and address of the Designated Depository; (2) the name and domicile, residence or business establishment of the depositor; (3) the date of original deposit as de fined in Paragraph 6 of Point 12; (4) the identification reference (number, symbols, etc.) given by the depositor to the biological materials; (5) the accession number given by the Designated Depository to the new deposit; (6) the relevant reason and date as stated by the depositor pursuant to Subparagraph 2, Paragraph 1 of Point 11; (7) where the depositor has provided the scientific description and/or proposed taxonomic designation of the biological materials pursuant to Subparagraph 3, Paragraph 1 of the Point 11, the s cientific description and/or proposed taxonomic designation; and (8) the accession number given to the previous deposit. The Designated Depository, when acting as the Receiving Depository mentioned in Paragraph 1 of Point 8, shall issue to the depositor, in respect of each deposit in relation with which a sample is transferred, a certificate of deposit which contains following items: (1) the name and address of the Receiving Depository; (2) the name and domicile, residence or business establishment of the depositor; (3) the date on which the transferred biological materials were received by the Receiving Depository, i.e. the date of the transfer; (4) the identification reference (number, symbols, etc.) given by the depositor to the transferred biological materials; (5) the access ion number given by the Receiving Depository to the transferred biological materials; (6) the name and address of the Original Depository; (7) the accession number given by the Original Depository to the transferred biological materials; and (8) where the depositor ha s provided the scientific description and/or proposed taxonomic designation of the biological materials pursuant to Paragraph 2 of Point 10 or Subparagraph 3, Paragraph 1 of the Point 11, or provided or modified the scientific description and/or proposed taxonomic designation after deposit pursuant to Point 14, such scientific description and/or proposed taxonomic designation. On request of any person entitled to receive a sample of the deposited biological materials, the Designated Depository shall commun icate to such person the most recent scientific description and/or proposed taxonomic designation referred to in Paragraph 2 of Point 10, Subparagraph 3, Paragraph 1 of Point 11, or Subparagraph 3, Paragraph 2 of Point 14.
14
Where the depositor did not provide the scientific description and/or taxonomic designation of the deposited biological materials, he or she may provide it afterward or modify the provided content. The provision or modification mentioned in the preceding paragraph shall be made in a written notification to the Designated Depository with which the deposit is made. The written notification shall bear the signature or seal of the depositor and contain the following items: (1) the name and domicile, residence or business establishment of the depositor; (2) the accession number given by the Designated Depository to the deposit of biological materials; (3) the scientific description and/or proposed taxonomic designation of the biological materials; and (4) in the case of an modification, the last preceding scientific description and/or proposed taxonomic designation. On the request of the depositor, the Designated Depository shall list the items mentioned in the preceding paragraph and the date the written notification is received by it in writing, and rep ly to the depositor.
15
Any biological materials deposited with a Designated Depository shall be stored by it, with all the care necessary to keep them viable and uncontaminated, for a period of at least five years after the most recent request for the furnishing of a sample of the deposited biological materials were received by the said Designated Depository and, in any case, for a period of at least 30 years after the date of the deposit. No Designated Depository will give information to anyone whether any biological materials have been deposited with it pursuant to the Directions. The Designated Depository is under the obligation to keep confidential any biological materials deposited with it and relevant information; it shall not provide information concerning any biological materials deposited with it except when providing a sample pursuant to the Directions.
16
The Designated Depository shall test the viability of each biological material deposited with it at the following timing: (1) promptly after any original deposit, new original, or transference referred to in Point 10, 11 or 8; (2) at reasonable intervals, depending on the kind of biological materials and their possible storage conditions, or at any time, if necessary for technical reasons; and (3) at any t ime, on the request of the depositor. The Designated Depository shall issue a viability statement to these persons listed in the events of the following: (1) to the depositor, promptly after any original deposit, new original, or transference referred to in Point 10, 11 or 8; (2) to the depositor, on his request, at any time after the original deposit, new original, or transference; and (3) to the person and entity, other than the depositor, who requests samples of the deposited biological materials to be furnished in line with Point 17, on his or its request, together with or at any time after such furnishing of samples. The viability statement shall indicate whether the biological materials are or are no longer viable and shall contain following items: (1) the name and address of the Designated Depository; (2) the name and domicile, residence or business establishment of the depositor; (3) the date referred to Subparagraph 3, Paragraph 3 of Point 13 or, where a new deposit or a transfer has been made, the most recent of the dates referred to in Subparagraph 3, Paragraph 4 or Subparagraph 3, Paragraph 5 of same point; (4) the accession number given by the Designated Depository to the deposit of biological materials; (5) the date of the viability test to which it refers; and (6) information o n the conditions under which the viability test has been performed, in the event that the results of the viability test were negative. The viability statement issued in accordance with Subparagraph 2 or 3 of Paragraph 2 shall refer to the most recent viab ility test. As to languages and signature or seal, Paragraph 2 of Point 13 shall apply mutatis mutandis to the viability statement. The issuance of the viability statement in accordance with Subparagraph 1 of Paragraph 2 or to the relevant specific agencies shall be free of charge. The viability statement issued for other situations shall be charged in accordance with Point 19.
17
Any Designated Depository shall furnish a sample of any deposited biological materials to the relevant specific agency. Su ch relevant specific agency shall make the request of sample furnishing in line with Annex 1 and declare following items: (1) an application referring to the deposit of the biological materials that have been filed with that relevant specific agency for the gr ant of a patent and that the subject matter of that application involves the said biological materials or the use thereof; (2) such application is pending before that relevant specific agency or has led to the grant of a patent; (3) the sample is needed for the pu rposes of a patent procedure having effect in the said side; and (4) the said sample and any information accompanying or resulting from it will be used only for the purposes of the said patent procedure. Any Designated Depository shall furnish a sample of any deposited biological materials to following requesters who file the request in line with Annex 2: (1) to the depositor; and (2) to any person or entity that is authorized by the depositor, provided that the request is accompanied by a declaration of the depositor authorizing the requested furnishing of a sample. Any Designated Depository shall furnish a sample of any deposited biological materials to any person or entity that is entitled to be furnished a sample under the law governing patent procedure before the relevant specific agency. The person or entity entitled to be furnished a sample mentioned in the preceding paragraph shall make the request in line with Annex 3 on which the relevant specific agency certificates the following items: (1)an application referring to the deposit of that biological materials have been filed with that relevant specific agency for the grant of a patent and that the subject matter of that application involves the said biological materials or the use thereof; (2)the application has been published, or is yet to be published but the conditions for furnishing a sample are deemed to be fulfilled in line with the law governing patent procedure before the relevant specific agency, where the applicable provision of the said law or any court decision as the basis of pre publishing sample furnishing shall be cited; and (3)the person or entity requesting the furnishing of samples has a right to receive a sample of the biological materials under the law governing patent procedure before th e relevant specific agency, or where the person or entity requesting the furnishing of samples has affixed his or her signature or seal on a form of the relevant specific agency and the conditions for furnishing a sample are deemed to be fulfilled in line with the law governing patent procedure before the relevant specific agency on the basis of such signature or seal.
18
Any request, declaration, certification or communication referred to in the preceding point shall be made in accordance with the following: (1) in the official language or one of the official languages of the Designated Depository; and (2) in writing, bearing a signature or seal and be dated. The request, declaration or certification referred to in Paragraph 1, 2, 4 of the preceding point shall contain the following items: (1) the name and domicile, residence or business establishment of the person or entity requesting to be furnished a sample; (2) the accession number given to the deposit; (3) where the request is made pursuant to Paragraph 1 of the preceding point, the filing date and number of the patent application or the publication date and certificate number of patent referring to the deposit; and (4) where the request is made pursuant to Paragraph 4 of the preceding point, the items referred to in Subparagraph 3 of the paragraph and the name and address of the relevant specific agency which has made the certification. The container in which the sample furnished is placed shall be marked by the Designated Depository with the ac cession number given to the deposit and be accompanied by a copy of the certificate of deposit referred to in Point 13, an indication of any properties of the biological materials which are or may be dangerous to health or the environment and, upon request , an indication of the conditions which the Designated Depository employs for the cultivation and storage of the biological materials. The Designated Depository having furnished a sample to any party other than the depositor shall notify the depositor in writing of that fact, the date on which the said sample was furnished, and the name and domicile, residence or business establishment of the person or entity to whom or to which the sample was furnished. The said notification shall be accompanied by copies of relevant documents including the request and declaration. The furnishing of samples referred to in Paragraph 1 of the preceding point shall be free of charge. Where the furnishing of samples is made pursuant to Paragraph 2 or 3 of the preceding point shall be charged in accordance with Point 19. In respect of patents granted and published by any relevant specific agency, lists of the accession numbers given by the Designated Deposit ory to the deposits of the biological materials referred to in the said patents may from time to time be communicated to any Designated Depository by such relevant specific agency. In respect of deposited biological materials whose accession numbers have been so communicated, the relevant specific agency will not be required to provide certification of the items prescribed in the preceding paragraph.
19
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.
20
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.
21
Where the request of deposit of biological material has be en 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.
Annex 1
Appendix IV_Application Form For Furnishing Biological Material (REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraph 1 of Article 17)
Annex 2
Appendix IV_Application Form For Furnishing Biological Material (REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraph 2 of Article 17)
Annex 3
Appendix IV_Application Form For Furnishing Biological Material (REQUEST FOR THE FURNISHING OF SAMPLES OF DEPOSITED BIOLOGICAL MATERIALS pursuant to paragraphs 3 and 4 of Article 17)