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Applications Involving Biological Material

From Part I: Preliminary Examination Chapter 1: Preliminary Examination of Invention Patent Applications

1 Verification of Applications Involving Biological Materials

For applications involving biological materials, in addition to ensuring the application complies with the relevant provisions of the patent law and its implementing regulations, applicants must also complete the following procedures:

(1) Deposit a sample of the biological material at an International Depository Authority (IDA) recognized by the State Intellectual Property Office, either before the date of application or, at the latest, on the date of application (for applications claiming priority, on the priority date).

(2) Indicate in the request and description the name, address, date of deposit, and deposit number of the entity where the biological material sample is deposited, as well as the taxonomic designation of the biological material (including the Latin name).

(3) Provide information in the application documents regarding the characteristics of the biological material.

(4) Submit a certificate of deposit and a viability statement issued by the depository within four months from the date of application.

During preliminary examination, for applications that have submitted a certificate of deposit within the prescribed period, examiners should verify the following based on the certificate of deposit:

(1) Depository

The depository should be an International Depository Authority (IDA) recognized by the State Intellectual Property Office. If it does not meet the requirements, the examiner should issue a notification that the biological material sample is considered not deposited.

(2) Date of Deposit

The date of deposit should be before the date of application or on the date of application (for applications claiming priority, on the priority date). If it does not meet the requirements, the examiner should issue a notification that the biological material sample is considered not deposited.

However, if the date of deposit indicated on the certificate of deposit is after the required priority date but before the date of application, the examiner should issue a notification to correct procedures, requesting the applicant to withdraw the claim of priority or declare that the content of the biological material related to the deposit certificate does not claim priority, within a specified period. If there is no response within the time limit or the correction still does not meet the requirements, the examiner should issue a notification that the biological material sample is considered not deposited.

(3) Consistency between the Deposit and Viability Certificates and the Request

The deposit and viability certificates should be consistent with the items filled out in the request. If inconsistent, the examiner should issue a notification to correct, instructing the applicant to make corrections within a specified period. If not corrected within the period, the examiner should issue a notification that the biological material sample is considered not deposited.

During preliminary examination, if the deposit certificate is not submitted within the specified period, the biological material sample is considered not deposited, and the examiner should issue a notification to that effect. If the applicant does not submit a viability statement for the biological material within four months from the date of application and does not provide a valid reason for not submitting the statement, the biological material sample is considered not deposited, and the examiner should issue a notification to that effect.

If the biological material sample dies during the deposit process, unless the applicant can provide evidence that the death of the biological material sample was not their fault, the biological material sample is considered not deposited, and the examiner should issue a notification to that effect. If the applicant provides evidence, they may re-deposit a new sample identical to the original within four months from the date of application, with the original deposit date being considered as the date of deposit.

For patent applications involving biological materials, applicants should separately state in the request and description the taxonomic designation of the biological material, the name, address, date of deposit, and deposit number of the entity where the biological material sample is deposited, and ensure consistency (see Section 9.2.1 of Chapter 10 in Part 2 of this Guide). If not stated in both the request and description at the time of application, the applicant must correct this within four months from the date of application. If not corrected within the period, it is considered that the deposit was not made. If the request and description are inconsistent, the applicant may correct this after receiving a notification from the Patent Office, within a specified period. If not corrected within the period, it is considered that the deposit was not made.

2 Restoration of Deposit

After the examiner issues a notification that the biological material sample is considered not deposited, if the applicant has valid reasons, they may initiate the restoration procedure in accordance with the provisions of Paragraph 2, Article 6 of the Implementing Regulations of the Patent Law. In addition to other valid reasons, valid reasons related to the non-deposit or non-viability of the biological material sample include:

(1) The depository failed to issue a deposit or viability certificate within four months from the date of application and has issued a certification document;

(2) The biological material sample died during the submission process, and the applicant can provide evidence proving that the death of the biological material sample was not their fault.