TIPO to Publish “Guidelines for Taiwan-Japan Cooperation on the Deposit of Biological Materials in Relation to Patent Procedure”

At the end of 2014, the Memorandum for Cooperative Program on the Mutual Recognition of the Deposit of Biological Materials for the Purpose of Patent Procedure (the Cooperative Program) was signed between the Taiwan Intellectual Property Office (TIPO) and the Japan Patent Office (JPO). Under the principles of the Budapest Treaty, the Cooperative Program serves the purpose of saving patent applicants’ redundant efforts to deposit multiple duplicates of the biological materials, or microorganisms, in each respective country where the application is filed.

TIPO announced on June 1^st, 2015 that the Cooperative Program would be officially launched on June 18^th, 2015, and then released its “Guidelines for Taiwan-Japan Cooperation on Deposit of Biological Materials in Relations to Patent Procedure”(the Guidelines.) The Guidelines provide a procedural standard for a series of measures for depositing biological materials under the Cooperative Program. A digest of the Guidelines is below.

1.    Jurisdiction of the deposit:

For matters of deposit, the laws of the country where the deposit is made shall govern. For matters of furnishing of biological materials, instead, the laws of the country where the patent application is filed shall govern.

2.    Mutual recognition of the deposit in each other’s designated depository institute:

The scope of recognition includes the detailed fact and date of deposit, as well as requiring the sample provided by the designated depository being indeed the deposited biological material.

The designated depositories are the Food Industry Research and Development Depository institute (FIRDI) of Taiwan, International Patent Organism Depositary of National Depositary institute of Technology and Evaluation (NITE-IPOD) of Japan, and NITE Patent Microorganisms Depositary (NPMD) of Japan.

3.    Failure to furnish deposited biological materials:

When a designated depository is unable to furnish the deposited biological material, the depository shall notify the applicant for re-submission.

Re-submission of biological materials should be made to the original receiving depository. In either of following two events, re-submission may be made to another depository designated by the competent authority of either country: 1) The original receiving depository is no longer qualified as the designated depository for some or all kinds of biological materials that the applicant was submitting; or 2) Failure to furnish due to import and export restrictions.

Upon re-submission of biological materials, the applicant shall provide an affidavit testifying that the re-submitted biological material is the same as the original copy. If the biological materials will be viable based on all originally submitted documents and the re-submission is made within three (3) months from the notification of the depository, the original deposit date may be deemed as the deposit day. [1]

4.    Import and export restriction:

If the biological materials concerned are of potential hazards to safety, health, or environment, and restriction on import and export of the biological materials is found necessary, the restriction shall be implemented accordingly.

5.    Formality requirements for the deposit:

Except for re-submission, applying for deposit of biological materials should be in writing and should specify the information below:

1) Name, address of residence, or business establishment of the deposit applicant;

2) Detailed description of culturing, preservation, and viability test of the biological materials;

3) Identification number or symbol provided by the applicant; and

4) Description of the properties that the biological material is, or potentially is, hazardous to health or environment.

The deposit applicant may provide nomenclature of the biological material based on taxonomy. Deposit is not revocable after issuance of a deposit receipt.

6.    Formality requirements of re-submission:

For re-submission of biological materials, applicant shall provide a copy of the certificate of deposit, a copy of the latest viability statement, an affidavit of the deposit applicant, and other necessary information, including the reason of re-submission.

7.    Grounds for refusal of deposit:

The grounds for refusal of deposit are that:

1) The biological materials are those not acceptable for deposit;

2) The property of biological material is so special that a deposit is technically not feasible; and

3) Loss of biological materials or inability to accept the deposit based on scientific reasons upon application for deposit or re-submission.

The designated depository shall notify the facts of the deposit refusal to the applicant in writing for the applicant’s corrections.

Upon acceptance of the application for deposit or that of re-submissions, the date of the deposit shall be the original deposit day or the re-submission day, except for failure to re-submit within three (3) months from the notification of failure to furnish.

8.    Viability test:

The depository shall conduct viability test over the submitted biological materials and issue a certificate of deposit for the same when the submitted material is tested as viable. Amendment or correction of nomenclature;

9.    Nomenclature:
The nomenclature of the deposited biological materials can be later amended or corrected if the applicant fails to provide the information upon application.

10. Duration of deposit:

The deposited biological materials shall be maintained in the depository for at least five (5) years after receiving the latest application for furnishing.  The depository shall adopt any necessary measures to keep its viability and prevent it from contamination for at least 30 years from the date of deposit.

11. Timing for viability test:

Viability test shall be conducted immediately upon the application for deposit, re-submission, or transfer of biological material cultures. The depository shall conduct viability test at any time upon a request by the deposit applicant, or do so at a reasonable time interval based on the kinds of biological materials and their possible conditions for maintenance, or for some necessary technical reasons.

12. Application for furnishing:

An eligible applicant for furnishing will be a related competent authority, a deposit applicant, an individual guaranteed by the deposit applicant, or an individual entitled to furnishing.

13. Fees:

Fees may be charged for deposit, viability statement, furnishing of biological materials. No discriminatory rate of fees shall apply owing to nationality, residence, or business establishment of the deposit applicant.

14. Retroactivity:

The Guidelines may still apply to applications that the deposits are made before the effectiveness of the Guidelines while the application for patent is filed after the same.