1- 1 "Treaty"

According to this Implementing Regulation, the term "Treaty" refers to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedures.

1- 2 "Article"

According to this Implementing Regulation, the term "Article" refers to the article specified in the Treaty.

1- 3 "Signature"

According to this Implementing Regulation, if the law of the state in which the international deposit authority is located requires the use of a seal instead of a signature, it is understood that the term "Signature" means "Seal" for the purposes of this authority.

2- 1 Legal Status

The International Deposit Authority may be a public entity, including any public institution affiliated with a public administration other than the central government, or a private facility.

2- 2 Staff and Facilities

The conditions referred to in Article 6 (2) "2" specifically include the following:

• "1" The staff and facilities of the International Deposit Authority must allow the mentioned authority to preserve the deposited microorganisms in a manner that ensures their viability and prevents contamination;

• "2" In order to preserve the microorganisms, the International Deposit Authority must make adequate security arrangements to minimize the risks of loss of the deposited microorganisms.

2- 3 Provision of Samples

The conditions referred to in Article 6 (2) "8" specifically include a requirement that the International Deposit Authority must provide samples of the deposited microorganisms in a prompt and appropriate manner.

3- 1 Notification

• (A) The notification referred to in Article 7 (1) shall be directed to the Director General through diplomatic channels if it concerns a contracting state, or through the Chief Executive if it concerns an intergovernmental organization.

• (B) The notification should include the following:

  • "1" A statement of the name and address of the deposit institution to which the notification relates;

  • "2" Detailed information about the mentioned institution's ability to meet the requirements specified in Article 6 (2), including information about its legal status, scientific level, staff, and facilities;

  • "3" If the mentioned institution intends to limit the acceptance of certain types of microorganisms as deposits, specify these types;

  • "4" A statement of the fees charged by the mentioned institution, after it acquires the legal status of an international deposit authority, for the preservation of microorganisms, issuance of declarations of viability, and provision of samples thereof;

  • "5" A statement of the official language or languages of the mentioned institution;

  • "6" A statement of the date referred to in Article 7 (1) (B) if applicable.

3- 2 Action on the Notification

If the notification is in accordance with the provisions of Article 7 (1) and Rule 3- 1, the Director General shall immediately notify all contracting states and intergovernmental organizations for industrial property, and the International Bureau shall publish it immediately.

3- 3 Expanding the List of Accepted Types of Microorganisms

A contracting state or an intergovernmental organization for industrial property that submitted the notification referred to in Article 7 (1) may notify the Director General at any later time that its guarantees include specific types of microorganisms that were not included in the guarantees until that time. In this case, Article 7 and Rules 3- 1 and 3- 2 shall apply with the necessary modifications regarding the additional types of microorganisms.

4- 1 Claim; Action on the Claim

• (A) The claim referred to in Article 8 (1) (A) shall be sent to the Director General in accordance with the provisions of Rule 3- 1 (A).

• (B) The claim shall include the following:

  • "1" Name and address of the relevant International Deposit Authority;

  • "2" If the claim pertains only to certain types of microorganisms, specify these types;

  • "3" A detailed statement of the facts on which the claim is based.

• (C) If the claim is in accordance with the provisions of paragraphs (A) and (B), the Director General shall notify all contracting states and international governmental organizations for industrial property immediately.

• (D) Subject to the provisions of paragraph (E), the Assembly shall consider the claim after being notified of it for at least six months and at most eight months.

• (E) If the Director General believes that adhering to the deadline stipulated in paragraph (D) would jeopardize the interests of actual or potential depositors, he may call the Assembly to meet on a date prior to the expiration of the six-month deadline stipulated in paragraph (D).

• (F) If the Assembly decides to terminate the legal status of the International Deposit Authority or restrict it to certain types of microorganisms, the said decision shall become effective three months after the date it is made.

4- 2 Notification; Actual Date; Action on the Notification

• (A) The notification referred to in Article 8 (2) (A) shall be sent to the Director General in accordance with the provisions of Rule 3- 1 (A).

• (B) The notification shall include the following:

  • "1" Name and address of the relevant International Deposit Authority;

  • "2" If the notification pertains only to certain types of microorganisms, specify these types;

  • "3" A statement of a later date after three months from the date of the notification, if the contracting state or the international governmental organization for industrial property wishes the effects stipulated in Article 8 (2) (B) to occur on that later date.

• (C) In the case of applying paragraph (B) "3", the effects stipulated in Article 8 (2) (B) shall occur on the date specified under this paragraph in the notification, otherwise they shall occur three months after the date of the notification.

• (D) The Director General shall immediately notify all contracting states and international governmental organizations for industrial property of each notification he receives under Article 8(2), and of its actual date under paragraph (C). The International Bureau shall publish a statement to that effect immediately.

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4- 3 Consequences of Deposits

In the event of the cessation or restriction of the legal status of the International Deposit Authority under Articles 8 (1) or 8 (2) or 9 (4) or 17 (4), Rule 5- 1 shall apply with the necessary modifications.

5-1 Suspension of Functions Regarding Deposited Microorganisms

• (1) If an International Depositary Authority, whether temporarily or permanently, ceases to perform the functions assigned to it under the Treaty and these Implementing Regulations concerning the microorganisms deposited with it, the contracting state or the governmental international organization for industrial property that provided the guarantees under Article 6(1) to the mentioned authority shall:

  • "1" ensure, as far as possible, the immediate transfer of samples of all these microorganisms without any damage or contamination from the mentioned authority ("the incapacitated authority") to another International Depositary Authority ("the alternative authority");

  • "2" ensure, as far as possible, the immediate forwarding of all correspondence or other notifications sent to the incapacitated authority to the alternative authority, as well as all relevant files and other information held by that authority regarding these microorganisms;

  • "3" ensure, as far as possible, that the incapacitated authority immediately notifies all concerned depositors of the suspension of its functions and the transfer procedures it has undertaken;

  • "4" immediately notify the Director General of the cessation of the incapacitated authority's functions and the scope thereof, and the measures taken by the contracting state or the governmental international organization for industrial property under items "1" to "3".

• (b) The Director General shall immediately notify the other contracting states and the other governmental international organizations for industrial property and industrial property offices of the notification received under paragraph (a) "4". The International Bureau shall immediately publish the Director General's notification and the notification received.

• (c) Based on the procedures applicable to patents, the depositor receiving the receipt referred to in Rule 7-5 may be required to immediately notify the industrial property office that received the patent application, referring to the original deposit with the new serial number granted by the alternative authority for deposit.

• (d) The alternative authority shall appropriately retain the serial number granted by the incapacitated authority, in addition to the new serial number.

• (e) In addition to any transfer made under paragraph (a) "1", the incapacitated authority shall, as far as possible and at the request of the depositor, transfer a sample of any microorganism deposited with it, as well as copies of all correspondence or any other notification, and all other relevant files and information referred to in paragraph (a) "2", to any other International Depositary Authority specified by the depositor, other than the alternative authority, provided that the depositor pays all expenses incurred for this transfer to the incapacitated authority. The depositor shall also pay the storage fees for this sample to the International Depositary Authority specified.

• (f) At the request of the concerned depositor, the incapacitated authority shall retain, as far as possible, samples of the microorganisms deposited with it.

5-2 Refusal to Accept Certain Types of Microorganisms

• (a) If an International Depositary Authority refuses to accept any type of microorganism that it is required to accept under the guarantees provided to it, the contracting state or the governmental international organization for industrial property that provided this authority with the announcement referred to in Article 7 (1) (a) shall immediately notify the Director General of the mentioned facts and the measures taken.

• (b) The Director General shall immediately notify the other contracting states and the other governmental international organizations for industrial property of the notification received under paragraph (a). The International Bureau shall immediately publish the Director General's notification and the notification received.

6- 1 Original Deposit

• (A) The microorganism sent by the depositor to the International Deposit Authority, unless Rule 6-2 is applied, must be accompanied by a written announcement signed by the depositor and containing the following:

  • "1" A statement indicating that the deposit was made under the Treaty and a commitment not to withdraw it during the period specified in Rule 9-1;

  • "2" The name and address of the depositor;

  • "3" A detailed description of the necessary conditions for the cultivation, preservation, and testing of the microorganism's viability, as well as, in the case of depositing a mixture of microorganisms, a description of the components of the mixture and at least one method to verify their presence;

  • "4" The distinguishing reference (number or code, for example) assigned by the depositor to the microorganism;

  • "5" A statement of the characteristics of the microorganism that represent or may represent a risk to health or the environment, or a statement indicating that the depositor is not aware of such characteristics.

• (B) It is strongly recommended that the written announcement referred to in paragraph (A) include the scientific description and/or proposed taxonomic designation of the deposited microorganism.

6- 2 New Deposit

• (A) Subject to paragraph (B), in the case of making a new deposit under Article 4, the microorganism sent by the depositor to the International Deposit Authority must be accompanied by a copy of the previous deposit receipt, a copy of the latest announcement regarding the viability of the microorganism that was the subject of the previous deposit, indicating that the microorganism is viable, and a written announcement signed by the depositor containing the following:

  • "1" The information referred to in Rule 6-1 (A) "1" to "5";

  • "2" An announcement stating the reason that necessitates making a new deposit based on Article 4 (1) (A), and an announcement confirming that the microorganism that is the subject of the new deposit is the same microorganism that was the subject of the previous deposit, and a statement of the date on which the depositor received the notification referred to in Article 4 (1) (A), or a statement of the publication date referred to in Article 4 (1) (E) as applicable;

  • "3" In the case of providing a scientific description and/or proposed taxonomic designation related to the previous deposit, the latest scientific description and/or proposed taxonomic designation as communicated to the International Deposit Authority where the previous deposit was made.

• (B) In the case of making the new deposit with the International Deposit Authority where the previous deposit was made, paragraph (A) "1" does not apply.

• (C) For the purposes of paragraphs (A) and (B) and Rule 7-4, the term "previous deposit" means:

  • "1" If the new deposit is preceded by one or more new deposits: the latest of these other new deposits;

  • "2" If the new deposit is not preceded by one or more new deposits: the original deposit.

6- 3 Requirements of the International Deposit Authority

• (A) The International Deposit Authority may require the following:

  • "1" Deposit of the microorganism in the form and quantity necessary for the purposes of the Treaty and these Implementing Regulations;

  • "2" Submission of a form prepared by the aforementioned authority to be completed by the depositor as required for the administrative procedures of the aforementioned authority;

  • "3" The written announcement referred to in Rule 6-1(A) or 6-2(A) to be drafted in the language or one of the languages specified by the aforementioned authority, noting that this specification must include, in any case, the official language or languages stipulated in Rule 3-1(B) "5";

  • "4" Payment of the preservation fee referred to in Rule 12-1(A) "1";

  • "5" The depositor shall enter into a contract with the aforementioned authority that defines the responsibilities of each party, if permitted by the applicable law.

• (B) The International Deposit Authority shall communicate these requirements and any amendments thereof to the International Bureau.

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6- 4 Acceptance Procedures

(A) The International Deposit Authority shall refuse to accept the microorganism and shall notify the depositor of the refusal in writing and immediately, stating the reasons for the refusal,

• "1" If the microorganism does not belong to the type of microorganism covered by the guarantees provided under Rule 3-1(B) "3" or 3-3;

• "2" If the microorganism has such exceptional characteristics that the International Deposit Authority is technically unable to perform the functions assigned to it under the Treaty and these Implementing Regulations; or

• "3" If the deposit is received in a manner that clearly indicates that the microorganism is missing or excludes the acceptance of the microorganism for scientific reasons.

• (B) Subject to paragraph (A), the International Deposit Authority shall accept the microorganism if all the requirements of Rule 6-1(A) and Rule 7-3(A) are met. If these requirements are not met, the International Deposit Authority shall notify the depositor of this fact immediately and in writing, and invite them to fulfill these requirements.

• (C) If the microorganism is accepted as an original deposit or as a new deposit, the date of the original deposit or new deposit shall be, as applicable, the date on which the International Deposit Authority received the microorganism.

• (D) The International Deposit Authority, at the request of the depositor and provided that all the requirements referred to in paragraph (B) are met, shall consider that the deposited microorganism received before the aforementioned authority acquired the legal status of the International Deposit Authority, was received for the purposes of the Treaty on the date it acquired this legal status.

7- 1 Issuance of the Receipt

The International Deposit Authority shall issue to the depositor, for each deposit of a microorganism with it or transferred to it, a receipt in which it certifies the receipt and acceptance of the microorganism.

7- 2 Form; Languages; Signature

• (A) The receipt referred to in Rule 7- 1 shall be on a form known as the "International Form," and the Director-General shall determine its model in the languages specified by the Assembly.

• (B) Words or characters written in the receipt in non-Latin characters must also be written in Latin characters.

• (C) The receipt should bear the signature of the competent person or persons authorized to represent the International Deposit Authority, or the signature of any other employee of the said authority duly authorized by the mentioned person or persons.

7- 2 Contents in the Case of Original Deposit

The receipt referred to in Rule 7- 1 and issued in the case of an original deposit shall indicate that it is issued by the Deposit Institution as an International Deposit Authority under the Treaty, and it shall include at least the following information:

• "1" Name of the International Deposit Authority and its address;

• "2" Name of the depositor and his address;

• "3" Date of the original deposit as specified in Rule 6- 4 (C);

• "4" The distinguishing reference (number or code, for example) assigned by the depositor to the microorganism;

• "5" The serial number assigned by the International Deposit Authority to the deposit;

• "6" If the written announcement referred to in Rule 6- 1 (A) includes the scientific description and/or proposed taxonomic designation of the microorganism, reference to that fact.

7- 3 Contents in the Case of New Deposit

The receipt referred to in Rule 7- 1 and issued in the case of a new deposit under Article 4 shall be accompanied by a copy of the previous deposit receipt (as understood in Rule 6- 2 (C)), and a copy of the latest announcement regarding the viability of the microorganism that was the subject of the previous deposit (as understood in Rule 6- 2 (C)), indicating that the microorganism is viable, and shall include at least the following:

• "1" Name of the International Deposit Authority and its address;

• "2" Date of the new deposit as specified in Rule 6- 3 (C);

• "3" Date of the new deposit as specified in Rule 6- 4 (C);

• "4" The distinguishing reference (number or code, for example) assigned by the depositor to the microorganism;

• "5" The serial number assigned by the International Deposit Authority to the new deposit;

• "6" Statement of the relevant reason and relevant date, as mentioned by the depositor under Rule 6- 2 (A) "2";

• "7" In the case of applying Rule 6- 2 (A) "3", reference to the fact that the depositor provided a scientific description and/or proposed taxonomic designation;

• "8" The serial number assigned to the previous deposit (as understood in Rule 6- 2 (C)).

7- 5 Receipt in the Case of Transfer

The International Deposit Authority to which samples of microorganisms are transferred under Rule 5- 1 (A) "1" shall issue to the depositor a receipt for each deposit associated with the transferred sample, indicating that the receipt was issued by the Deposit Institution as an International Deposit Authority under the Treaty, and that it includes at least the following:

• "1" Name of the International Deposit Authority and its address;

• "2" Name of the depositor and his address;

• "3" The date on which the International Deposit Authority received the transferred sample (date of transfer);

• "4" The distinguishing reference (number or code, for example) assigned by the depositor to the microorganism;

• "5" The serial number assigned by the International Deposit Authority;

• "6" Name and address of the International Deposit Authority from which the transfer was made;

• "7" The serial number assigned by the International Deposit Authority from which the transfer was made;

• "8" If the written announcement referred to in Rule 6- 1 (A) or 6- 2 (A) includes the scientific description and/or proposed taxonomic designation of the microorganism, or if this scientific description and/or proposed taxonomic designation has been mentioned or amended later under Rule 8- 1, reference to this fact.

7- 6 Notification of the Scientific Description and/or Proposed Taxonomic Designation

Upon request of any party entitled to receive a sample of the microorganism under Rules 11- 1 or 11- 2 or 11- 3, the International Deposit Authority shall notify him of the latest scientific description and/or the latest proposed taxonomic designation, referred to in Rules 6- 1 (B) or 6- 2 (A) "3" or 8- 1 (B) "3".

8- 1 Notification

• (A) If the scientific description and/or the taxonomic designation of the microorganism is not specified at the time of deposit, the depositor may later state them or amend them if they have been stated.

• (B) This subsequent statement or amendment shall be made by a written notification signed by the depositor and sent to the international deposit authority, and shall include the following:

  • "1" Name of the depositor and their address;

  • "2" The serial number assigned by the aforementioned authority;

  • "3" The proposed scientific description and/or taxonomic designation of the microorganism;

  • "4" In the case of an amendment, the previous scientific description and/or the previously proposed taxonomic designation.

8- 2 Attesting

Upon the request of the depositor who made the notification referred to in Rule 8- 1, the international deposit authority shall issue a certificate indicating the data referred to in Rule 8- 1 (B) "1" to "4", and the date of receipt of this notification.

9- 1 Duration of Storage

The International Deposit Authority shall keep every microbial entity deposited with it, with all necessary care for its viability and contamination-free status, for a period of no less than five years after the said authority receives the latest request for a sample of the deposited microbial entity, and in all cases for a period of no less than 30 years after the date of deposit.

9- 2 Confidentiality

The International Deposit Authority shall not disclose to any person any information about any microbial entity deposited with it under the Treaty. Furthermore, it shall not disclose to any person any information about any microbial entity deposited with it under the Treaty, unless that person is an authority or a natural or legal person entitled to obtain a sample of that microbial entity under Rule 11, and subject to the same conditions stipulated in that rule.

10- 1 Obligation to Test

The International Deposit Authority shall test the viability of each deposited microorganism:

• "1" immediately after each deposit referred to in Rule 6 or after each transfer referred to in Rule 5- 1;

• "2" at reasonable intervals, depending on the type of microorganism and the applicable preservation conditions, or at any time if required for technical reasons;

• "3" at any time upon the request of the depositor.

10- 2 Announcement Regarding Viability

• (a) The International Deposit Authority shall issue an announcement regarding the viability of the deposited microorganism:

  • "1" in favor of the depositor, shortly after each deposit referred to in Rule 6 or after each transfer referred to in Rule 5- 1;

  • "2" in favor of the depositor upon their request, at any time after the deposit or transfer;

  • "3" in favor of the Industrial Property Office, or any authority other than the aforementioned office, or any natural or legal person other than the depositor, to whom samples of the deposited microorganism were provided in accordance with Rule 11, upon their request at the same time the sample was provided or at any time thereafter.

• (b) The announcement regarding viability shall indicate whether the microorganism is viable or no longer viable, and shall include the following:

  • "1" the name and address of the International Deposit Authority issuing it;

  • "2" the name and address of the depositor;

  • "3" the date referred to in Rule 7- 3 "3", or the most recent of the two dates referred to in Rules 7- 4 "3" and 7- 5 "3" in the case of a new deposit or transfer;

  • "4" the serial number assigned by the aforementioned International Deposit Authority;

  • "5" the date of the test to which the announcement relates;

  • "6" information about the conditions under which the viability test was conducted, provided that this information was requested by the party to whom the announcement was issued, and the test results were negative.

• (c) In the case of applying paragraph (a) "2" or "3", the announcement regarding viability shall relate to the most recent viability test.

• (d) Regarding the form, languages, and signature, Rule 7- 2 applies to the announcement regarding viability with the necessary modifications.

• (e) The announcement regarding viability is issued free of charge in the cases referred to in paragraph (a) "1", or if requested by an Industrial Property Office. The fee due under Rule 12- 1 (a) "3" for any other announcement regarding viability is imposed on the party requesting the announcement, and must be paid before or at the time of submitting the request.