BUDAPEST TREATY REGULATIONS

Rule 1. Abbreviated Expressions and Interpretation of the Word "Signature"

1.1 "Treaty"

In these Regulations, the word "Treaty" means the Budapest Treaty on the International
Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.

1.2 " Article"

In these Regulations, the word "article" refers to the specified Article of the Treaty

1.3 "Signature"

In these Regulations, the word "signature" is used, it shall be understood that, where the law of the State on the territory of which an international depositary authority is located requires the use of a seal instead of a signature, the said word shall mean "seal" for the purposes of that authority.

Rule 2. International Depositary Authorities

2.1 Legal Status

Any international depositary authority may be a government agency, including any public institution attached to a public administration other than the central government, or a private entity.

2.2 Staff and Facilities

The requirements referred to in Article 6(2)(ii) shall include in particular the following:

(i) the staff and facilities of any international depositary authority must enable the said authority to store the deposited microorganisms in a manner which ensures that they are kept viable and uncontaminated;

(ii) any international depositary authority must, for the storage of microorganisms, provide for sufficient safety measures to minimize the risk of losing microorganisms deposited with it.

2.3 Furnishing of Samples

The requirements referred to in Article 6(2)(viii) shall include in particular the requirement that any international depositary authority must furnish samples of deposited microorganisms in an expeditious and proper manner.

Rule 3. Acquisition of the Status of International Depositary Authority

3.1 Communication

(a) The communication referred to in Article 7(1) shall be addressed to the Director General, in the case of a Contracting State, through diplomatic channels or, in case of an intergovernmental industrial property organization, by its chief executive officer.

(b) The communication shall:

(i) indicate the name and address of the depositary institution to which the communication relates;

(ii) contain detailed information as to the said institution to which the requirements specified in Article 6(2), including information on its legal status, scientific standing, staff and facilities;

(iii) where the said depositary institution intends to accept for deposit only certain kinds of microorganisms, specify such kinds;

(iv) indicate the amount of any fees that the said institution will, upon acquiring the status of international depositary authority, charge for storage, viability statements and furnishing of samples of microorganisms;

(v) indicate the official language or languages of the said institution;

(vi) where applicable, indicate the date referred to in Article 7(1)(b).

3.2 Processing of the Communication

If the communication complies with Article 7(1) and Rule 3.1, it shall be promptly notified by the Director General to all Contracting States and intergovernmental industrial property organizations and shall be promptly published by the International Bureau.

3.3 Extension of the List of Kinds of Microorganisms Accepted

The Contracting State or intergovernmental industrial property organization having made the communication referred to in Article 7(1) may, at any time thereafter, notify the Director General that its assurances are extended to specified kinds of microorganisms to which, so far, the assurances have not extended. In such a case, and as far as the additional kinds of microorganisms are concerned, Article 7 and Rules 3.1 and 3.2 shall apply, mutatis mutandis.

Rule 4. Termination or Limitation of the Status of International Depositary Authority

4.1 Request; Processing of Request

(a) The request referred to in Article 8(1)(a) shall be addressed to the Director General as provided in Rule 3.1 (a).

(b) The request shall:

(i) indicate the nome and address of the international depositary authority concerned;

(ii) where it relates only to certain kinds of microorganisms, specify such kinds;

(iii) indicate in detail the facts on which it is based.

(c) If the request complies with paragraphs (a) and (b), it shall be promptly notified by the Director General to all Contracting States and intergovernmental industrial property organizations.

(d) Subject to paragraph (e), the Assembly shall consider the request not earlier than six and not later than eight months from the notification of the request.

(e) Where, in the opinion of the Director General, respect of the lime limit provided for in paragraph (d) could endanger the interests of actual or potential depositors, he may convene the Assembly for a date earlier than the date of the expiration of the six-month period provided for in paragraph (d).

(f) If the Assembly decides to terminate, or to limit to certain kinds of microorganisms, the status of international depositary authority, the said decision shall become effective three months after the date on which it was made.

4.2 Communication; Effective date; Processing of Communication

(a) The communication referred to in Article 8(2)(a) shall be addressed to the Director General as provided in Rule 3.1(a).

(b) The communication shall:

(i) indicate the name and address of the international depositary authority concerned;

(ii) where it relates only to certain kinds of microorganisms, specify such kinds;

(iii) where the Contracting State or intergovernmental industrial property organization making the communication desires that the effects provided for in Article 8(2)(b) take place on a date later than at the expiration of three months from the date of the communication, indicate the later date.

(c) Where paragraph (b)(iii) applies, the effects provided for in Article 8(2)(b) shall take place on the date indicated under that paragraph in the communication; otherwise, they shall take place at the expiration of three months form the date of the communication.

(d) The Director General shall promptly notify all Contracting States and intergovernmental industrial property organizations of any communication received under Article 8(2) and of its effective date under paragraph (c). A corresponding notice shall be promptly published by the International Bureau.

4.3 Consequences for Deposits

In the case of a termination or limitation of the status of international depositary authority under Article 8(1), 8(2), 9(4), or 17(4), Rule 5.1 shall apply, mutatis mutandis.

Rule 5. Defaults by the International Depositary Authority

5.1 Discontinuance of Performance of Functions in Respect of Deposited Microorganisms

(a) If any international depositary authority temporarily or definitively discontinues the performance of any of the tasks it should perform under the Treaty and these Regulations in relation to any microorganisms deposited with it, the Contracting State or intergovernmental industrial property organization which, in respect of that authority, has furnished the assurances under Article 6(1) shall;

(i) ensure, the fullest extent possible, that samples of all such microorganisms are transferred promptly and without deterioration or contamination from the said authority ("the defaulting authority") to another international depositary authority ("the substitute authority");

(ii) ensure, to the fullest extent possible, that all mail or other communications addressed to the defaulting authority, and all files and other relevant information in the possession of the authority, in respect of the said microorganisms are promptly transferred to the substitute authority;

(iii) ensure, to the fullest extend possible, that the defaulting authority promptly notifies all depositors affected of the discontinuance of the performance of its functions and the transfers effected;

(iv) promptly notify the Director General of the fact and the extent of the discontinuance in question and of the measures which have been taken by the said Contracting State or intergovernmental industrial property organization under (i) to (iii).

(b) The Director General shall promptly notify the Contracting States and the intergovernmental industrial property organizations as well as the industrial property offices of the notification received under paragraph (a)(iv); the notification of the Director General and the notification received by him shall be promptly published by the International Bureau.

(c) Under the applicable patent procedure it may be required that the depositor shall, promptly after receiving the receipt referred to in Rule 7.5, notify to any industrial property office with which a patent application was filed with reference to the original deposit the new accession number given to the deposit by the substitute authority.

(d) The substitute authority shall retain in an appropriate form the accession number given by the defaulting authority, together with the new accession number.

(e) In addition to any transfer effected under paragraph (a) (i), the defaulting authority shall, upon request by the depositor, transfer, as far as possible, a sample of any microorganism deposited with it together with copies of all files and other relevant information referred to in paragraph(a)(ii) to any international depositary authority indicated by the depositor other than the substitute authority, provided that the depositor pays any expenses to the defaulting authority resulting form the said transfer. The depositor shall pay the fee for the storage of the said sample to the international depositary authority indicated by him.

(f) On the request of any depositor affected, the defaulting authority shall retain, as far as possible, samples of the microorganisms deposited with it.

5.2 Refusal To Accept Certain Kinds of Microorganisms

(a) If any international depositary authority refuses to accept for deposit any of the kinds of microorganisms which it should accept under the assurances furnished, the Contracting State or intergovernmental industrial property organization which, in respect of that authority, has made the declaration referred to in Article 7 (1)(a) shall promptly notify the Director General of the relevant facts and he measures which have been taken.

(b) The Director General shall promptly notify the other Contracting States and intergovernmental industrial property organizations of the notification received under paragraph (a); the notification of the Director General and the notification received by him shall be promptly published by the International Bureau.