Regulations on Microorganism Deposit
The microorganism deposit for the purpose of patent procedure in the Korean Collection for Type Cultures (KCTC) as International Depository Authorities (IDAs) is performed by following the guide in accordance with the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
Article 1 (Purpose)
- The purpose of these regulations is to regulate the deposit and furnishing of microorganisms for the purposes of patent procedures.
Article 2 (Request of deposit)
- With the exceptions described in Article 6, one who is supposed to deposit a microorganism (hereinafter called “a depositor”) or an agent thereof must submit the microorganism to be deposited and a request for deposit of Form 1 to the Director of the KCTC.
Article 3 (Types of microorganisms)
- ① A depositor must submit a microorganism to the KCTC according to the following quantity considerations:
- 1. Strains including bacteria, Streptomyces, fungi, yeasts, or plasmid: 10 cryovials or 2 active cultured plates or 2 freeze-dried ampules.
- 2. Recombinant DNA, viruses, bacteriophage, microalgae, plant cell lines, animal cell lines, hybridoma, fertilized eggs of animals, eukaryotes, DNA, or RNA: 20 vials
② The microorganism should be submitted in freeze-dried conditions except those that are inappropriate for freeze-drying.
Article 4 (Rejection of deposit)
- ① The Director of the KCTC may reject the deposit of microorganisms in the following cases:
- 1. The microorganism to be deposited dose not belonging to the types defined by Article 3.
- 2. The necessary work procedures that should be conducted by the KCTC according to the Patent Act may not be conducted due to the technical reasons which come from the exceptional properties of the microorganism to be deposited.
- 3. The microorganism is deposited in a definitely dead condition or in a condition that does not allow deposition for a scientific reason.
- ② In cases where the deposition is rejected by the regulations of Article 1, the Director of the KCTC shall notify the depositor by sending a written notification of rejection in Form 2.
Article 5 (Deposition of Microorganism)
- ① The Director of the KCTC should deposit any microorganisms requested to be deposited, except in the following cases:
- 1. The requirements in Article 3 are not satisfied.
- 2. The method of deposition violates the present regulations.
- 3. The deposition fee according to paragraph 1, Article 14 is not paid.
- ② In cases where a request for deposition corresponds to any of the subparagraphs 1 to 3 of paragraph 1, the Director of the KCTC shall notify the case to the depositor by sending a written notification requiring the depositor to satisfy the requirements by a specifically appointed date.
- ③ In cases where the depositor is required to supplement the deposition process according to the regulations of paragraph 2 making appropriate supplementation, the Director of the KCTC must deposit the microorganism that is requested to be deposited.
Article 6 (Decision of Withdrawal)
- ① The Director of the KCTC may consider the withdrawal of deposition in cases where one who has been required to supplement a deposition process according to the regulations of Article 5, paragraph 2 fails to perform the supplementation within a specifically appointed period.
- ② The Director of the KCTC must notify the depositor the reason for deciding to withdraw the deposition.
Article 7 (Issuing of Deposition Certificate)
- In cases where the microorganism is deposited by a deposition request, the Director of the KCTC shall issue a deposition certificate of Form 3 to the depositor according to the Patent Act.
Article 8 (Re-deposit)
- ① In cases where an abnormality is found with regard to a deposited microorganism, a deposited microorganism has died, or the Commissioner of the Korean Intellectual Property Office recognizes the need, the Director of the KCTC must immediately record the reason for the case on a written request for microorganism deposit and notify the case to the depositor by using the written request for microorganism deposit of Form 4.
- ② A depositor who has received the notification of the case must re-deposit the microorganism within a specifically appointed period from the day of receiving the notification by using a written microorganism re-deposit request of Form 5.
Article 9 (Furnishing)
- ① The Director of the KCTC may furnish a deposited microorganism sample according to Article 4, paragraph 1 of the Enforcement Decree of the Patent Act by the request made by one of the following persons
- 1. Commissioner of the Korean Intellectual Property Office.
- 2. Depositor or a person who has acquired permission from the depositor
- 3. A person who is qualified about the distribution of a microorganism sample according to the laws and regulations
- ② The request according to Article 1 should be made by using a written distribution request of Form 6.
Article 10 (Rejection of Distribution)
- In cases where a microorganism related to the request of Article 9, paragraph 1 is dangerous or is worried to be dangerous to the health or environment, or the one requesting is considered to be incapable of managing the microorganism, the Director of the KCTC may reject the furnishing of the microorganism.
Article 11 (Notification of Furnishing)
- The Director of the KCTC shall notify the depositor by using the written notification of furnishing of Form 7 the furnishing of the microorganism deposited by the depositor according to the regulations of Article 9, paragraph 1.
Article 12 (Verification of Microorganism Survival)
- ① To verify microorganism survival, the depositor may submit to the Director of the KCTC the written survival test request of Form 8.
- ② The Director of the KCTC may ask the depositor to submit a recovering agent and a medium for verifying the microorganism.
- ③ ④ The Director of the KCTC may issue a certificate of survival of Form 9 after verifying the survival of the microorganism.
Article 13 (Recording of Scientific Properties and Taxonomic Position)
- ① A depositor who has not recorded a written deposit may request the scientific properties and the taxonomic position of the deposited microorganism may record the information later.
- ② A depositor may modify the scientific properties and the taxonomic position of the deposited microorganism that have already been recorded.
- ③ The recording referred to in paragraph 1 and the modification referred to in paragraph 2 should be performed by using a written record of scientific properties and taxonomic position of Form 10.
- ④ A depositor who has performed the recording referred to in paragraph 1 and the modification referred to in paragraph 2 may request a certificate about the recording and the modification by filling Form 10.
- ⑤ The Director of the KCTC may issue a certificate of Form 11 by the request referred to in paragraph 4.
Article 14 (Fee)
- ① A person who corresponds to one of the following items should pay a predetermined fee:
- 1. A person who submits a request for deposit or re-deposit according to Article 2 or Article 8.
- 2. A person who requests the distribution of a sample according to the regulations referred to in Article 9, paragraph 1.
- 3. A person who requests a Certificate of Survival according to the regulations referred to in Article 12, paragraph 1.
- 4. A person who requests a certificate of the medication of scientific properties and taxonomic position according to the regulations referred to in Article 13, paragraph 4.
- ② The regulations referred to in paragraph 1 are not applied to cases where the one who is obliged by the regulation to pay the fee is the Korean Intellectual Property Office.
- ③ The fee should be paid by a single payment, and the fee that has already been paid shall not be refunded.
Article 15 (Disposal of Microorganism)
- ① The microorganism that has been rejected to be deposited according to the regulations referred to in Article 4, paragraph 1, the microorganism whose deposit has been withdrawn according to the regulations referred to in Article 6, paragraph 1 may be arbitrarily disposed by the KCTC.
- ② KCTC shall decide the disposal of the deposited microorganism after receiving decision from the depositor by notifing to a depositor who’s deposition period is closed to expiration.
(etc) Article 16 (Others)
- ① The name of a depositor may be modified by a report for changing the depositor’s name. A document that certifies the reason for changing the name should be submitted.
- ② A depositor or an agent of the depositor should submit a report for changing records to modify the records.
- ① (Enforcement Date) These regulations shall be enforced from April 1, 2001.
- ② (Interim Measure) The storage and deposit performed according to the previous regulations for the deposit and distribution of microorganisms for the purposes of patent procedure and the enforcement methods thereof prior to the effective date of the present regulations shall be considered as effective actions taken according to the present regulations.
- ③ (Abolishment) The previous regulations for the deposit and distribution of microorganisms for the purposes of patent procedure shall be abolished at the same time when the present regulations are enforced.