The Director General of the World Intellectual Property Organization (WIPO) presents his compliments to the Minister for Foreign Affairs and has the honor to notify him of the receipt from the Government of Japan, on May 18, 2005, of a written communication dated May 13, 2005 (ref. ST/WP/130), relating to Changes in the Internet Addresses, Requirements of Deposit, Furnishing of Sample, Schedule of Fees and Guidance for Depositors of the National Institute of Technology and Evaluation, Patent Microorganisms Depositary (NPMD), an international depositary authority under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28, 1977, as amended on September 26, 1980 (see Budapest Notification No. 215 of April 1, 2004).
June 20, 2005
Text of the Communication by the Permanent Mission of the Government of Japan Relating to Changes in the Internet Addresses, Requirements of Deposit, Furnishing of Sample, Schedule of Fees and Guidance for Depositors of the National Institute of Technology and Evaluation, Patent Microorganisms Depositary (NPMD)
[Original: English]
COMMUNICATION
The Permanent Mission of Japan to the International Organizations in Geneva presents its compliments to the World Intellectual Property Organization (WIPO) and, in relation to the Budapest Treaty on the International Recognition of Microorganisms for the Purposes of the Patent Procedure, has the honour to transmit attached herewith the communication from its home Government regarding Changes in the Internet Addresses, Requirements of Deposit, Furnishing of Sample, Schedule of Fees and Guidance for Depositors of the National Institute of Technology and Evaluation, Patent Microorganisms Depositary (NPMD), an International Depositary Authority.
The Permanent Mission of Japan to the International Organizations in Geneva avails itself of this opportunity to renew to the World Intellectual Property Organization the assurances of its highest consideration.
ANNEX
The National Institute of Technology and Evaluation, Patent Microorganisms Depositary (NPMD) has modified its information as follows:
The Government of Japan guarantees that NPMD will continue to fulfill the requirements specified in Article 6(2) of the Treaty.
The Government of Japan understands that this communication shall be disclosed to all the Contracting States and the Intergovernmental Industrial Property Offices.
JP - JAPAN
NATIONAL INSTITUTE OF TECHNOLOGY AND EVALUATION, PATENT MICROORGANISMS DEPOSITARY (NPMD)
2-5-8 Kazusakamatari
Kisarazu-city
Chiba 292-0818
Telephone: (81) 438 20 5580
Facsimile: (81) 438 20 5581
E-mail: npmd@nite.go.jp
Internet: http://www.nbrc.nite.go.jp/npmd/
1. Requirements for Deposit
(a) Kinds of Microorganisms that May be Deposited
Bacteria, actinomycetes, yeasts, archea, fungi, bacteriophages and plasmids (in hosts or not in hosts), EXCEPT:
- microorganisms which belong to biosafety level 3 or level 4 according to the NITE (National Institute of Technology and Evaluation) Classification.
- microorganisms which call for containment measures level P3 or P4 as described in the Ministerial Ordinance stipulating Containment Measures to be Taken in Type 2 Use of Living Modified Organisms for Research and Development (2004), which is based on the Law concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (2003).
(b) Technical Requirements and Procedures
(i) Form and Quantity
The NPMD accepts microorganisms for deposit in any one of lyophilized or frozen preparations. The depositor should send the NPMD 20 ampoules or tubes of each strain.
(ii) Time Required for Viability Testing
The average length of time required for testing the viability of the microorganisms is as follows, but in some cases viability testing may take longer than the figures indicated below.
- bacteria, actinomycetes and yeasts: 4 to 6 days
- fungi: 7 days
- bacteriophages: 9 days
- plasmids: 1 day
(iii) Depositor Checks and Renewal of Stocks
The NPMD stores samples originally supplied by the depositor, and does not subculture material supplied by the depositor. The NPMD requires the depositor to supply the samples to replenish diminishing stocks. If requested, the NPMD makes its own preparations by subculture from material supplied by the depositor at an additional fee. In this case, the NPMD requires the depositor to test for authenticity of samples prepared by the NPMD and to inform the NPMD of the result.
(c) Administrative Requirements and Procedures
(i) General
Language. The official language of the NPMD is Japanese. Requests for the furnishing of samples may be in Japanese or English.
Contract. The NPMD enters into a written contact with the depositor by which the latter is bound.
- to provide the necessary information requested by the NPMD;
- to replenish the microorganism at his own expense if the NPMD is no longer able to furnish samples of it;
- not to withdraw the deposit during the required storage period.
Import and/or Quarantine Regulations. Any of the microorganisms which belong to biosafety level 2 according to the NITE Classification are subject to import and/or quarantine regulations. Further information can be obtained from Yokohama Plant Protection Station or Animal Quarantine Station administrated by the Ministry of Agriculture, Forestry and Fisheries of Japan. http://www.maff.go.jp/eindex
(ii) Making the Original Deposit
Requirements to Be Met by the Depositor. Depositors are required to complete the equivalent of model form BP/1, in addition to the NPMD form 2 (Acknowledgement and Agreement for Original Deposit under the Budapest Treaty). In the event of later indication or amendment of the scientific description and/or proposed taxonomic designation, and a request for attestation that the NPMD has received such information, the depositor must complete model form BP/7.
Official Notifications to the Depositor. The receipt and viability statement are issued on mandatory "international forms" BP/4 and BP/9, respectively. Attestation of receipt of a later indication or amendment of the scientific description and/or proposed taxonomic designation is issued on model form BP/8.
Unofficial Notifications to the Depositor. The NPMD will inform the date of deposit and "provisional" accession number before the official receipt is issued, but the depositor must recognize that this information becomes official only on completion of the viability test and the payment.
Supply of Information to a Patent Agent. The NPMD does not ask the depositor for the name and address of his patent agent, if requested, the NPMD will supply the receipt and the viability statement through the depositor's patent agent.
(iii) Converting a Previous Deposit
Deposits made outside the provisions of the Budapest Treaty may be converted by the original depositor to Budapest Treaty deposits provided they were originally made for patent purposes. The administrative requirements for conversion are the same as those to be met in respect of an original deposit made under the Treaty, except that the depositor is also required to supply a copy of the receipt of the previous deposit. The storage fee will be charged to the original depositor for conversion.
(iv) Making a New Deposit
The depositor will be required to complete model form BP/2 when making a new deposit, and to supply copies of the relevant documents specified in Rule 6.2. The receipt and the viability statement for a new deposit are issued on mandatory "international forms" BP/5 and BP/9, respectively.
2. Furnishing of Samples
(a) Requests for Samples
The NPMD advises third parties of the correct procedures to follow in order to make a valid request and supplies the request forms used by Japan Patent Office. Request forms used by other individual industrial properties office must be obtained from the appropriate industrial property offices.
Requesting parties are required to complete the NPMD form 14 (Acknowledgement and Agreement for Furnishing and Use of Samples) to comply with health and safety requirements.
All samples of microorganisms furnished by the NPMD may be from preparations supplied by the depositor.
(b) Notification of the Depositor
Depositors are notified on model form BP/14 when samples of their microorganism have been furnished to third party.
(c) Cataloguing of Budapest Treaty Deposits
The NPMD does not publish any catalogue.
3. Schedule of Fees
| (a) | Storage | Yen |
| - original deposits | 139,000 | |
| - new deposits | 19,000 | |
| (b) | Communication under Rule 7.6 | 2,000 |
| (c) | Issuance of viability statement | |
| - (i) if the viability test is to be carried out | 34,000 | |
| - (ii) based on the last viability test | 2,000 | |
| (d) | Furnishing of a sample | 6,000 |
| (e) | Attestation under Rule 8.2 | 2,000 |
| (f) | Issuance of some kinds of certification | 2,000 |
Japanese consumption tax at the rate of 5% will be charged for (a) and (c)(i).
4. Guidance for Depositors
The NPMD provides pamphlets for the guidance of prospective depositors.
(b) List of Kinds of Microorganisms Accepted by IDAs (continued)
| NIBSC (GB) |
NMLHC (CA) |
NPMD (JP) |
NRCA (RU) |
NRRL (US) |
PCM (PN( �/td> |
VKM (RU) |
VKPM (RU) |
||
| Algae | |||||||||
| Animal viruses | |||||||||
| Animal cell cultures | |||||||||
| Bacteria (pathogenic) | X | ||||||||
| Bacteria (non-pathogenic) | X | ||||||||
| Bacteriophages | X | ||||||||
| Embryos | |||||||||
| Eukaryotic DNA | |||||||||
| Fungi (pathogenic) | X | ||||||||
| Fungi (non-pathogenic) | X | ||||||||
| Human cell cultures | |||||||||
| Hybridomas | |||||||||
| Molds | |||||||||
| Murine embryos | |||||||||
| Mycoplasma | |||||||||
| Nematodes | |||||||||
| Oncogenes | |||||||||
| Plant cell cultures | |||||||||
| Plant viruses | |||||||||
| Plasmids (in hosts) | X | ||||||||
| Plasmids (not in hosts) | X | ||||||||
| Protozoa (parasitic) | |||||||||
| Protozoa (non-parasitic) | |||||||||
| Protozoa (pathogenic) | |||||||||
| RNA | |||||||||
| Seeds | |||||||||
| Yeasts (pathogenic) | X | ||||||||
| Yeasts (non-pathogenic) | X |