Budapest Notification No. 267
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication of the Government of Australia Relating to the Acquisition of the Status of International Depositary Authority by the Lady Mary Fairfax CellBank Australia (CBA)

The Director General of the World Intellectual Property Organization (WIPO) presents his compliments to the Minister for Foreign Affairs and has the honor to notify him of the receipt, on December 16, 2009, of a written communication dated December 11, 2009, from the Government of Australia, relating to the acquisition of the status of International Depositary Authority by the Lady Mary Fairfax CellBank Australia (CBA), which states that this Depositary Institution is located on the territory of Australia and includes a Declaration of Assurances to the effect that the Institution complies and will continue to comply with the requirements concerning the acquisition of the status of International Depositary Authority specified in Article 6(2) of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28, 1977, and amended on September 26, 1980.

Pursuant to Article 7(2)(b), the Lady Mary Fairfax CellBank Australia (CBA) shall acquire the status of International Depositary Authority under the Budapest Treaty on February 22, 2010, that is, on the day of publication of this notification.

February 22, 2010

Text of the Communication from the Government of Australia Relating to the Acquisition of the Status of International Depositary Authority by the Lady Mary Fairfax CellBank Australia (CBA)

[Original: English]

COMMUNICATION

The Australian Permanent Mission presents its compliments to the Director General of the World Intellectual Property Organization and has the honour to refer to the process laid out for the acquisition of International Depositary Authority Status under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (Budapest Treaty).

The Australian Permanent Mission forwards for your consideration the enclosed nomination by Australia of Lady Mary Fairfax CellBank Australia as an International Depositary Authority and accompanying information in accordance with Article 7 of the Budapest Treaty. We would be grateful for your consideration of this matter.

ANNEX

I have the honour to refer to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure done at Budapest on 28 April 1977 ("the Treaty") and nominations for the status of International Depositary Authority (IDA). I have the further honour to advise of Australia's nomination of Lady Mary Fairfax CellBank Australia (CBA) as Australia's second International Depositary Authority (IDA), in addition to Australia's currently recognised IDA, the National Measurement Institute (NMI). There will be no overlap in the type or class of microorganisms deposited by NMI and CBA.

CBA's function as an IDA in accordance with Article 7 of the Treaty is set out below. The Government of Australia furnishes its assurances that CBA complies with the requirements specified in Article 6(2) of the Treaty.

CBA was established in 2007 by a joint venture of the Children's Medical Research Institute (CMRI), Cure Cancer Australia Foundation and National Breast Cancer Foundation and by an Enabling Grant of the National Health and Medical Research Council of Australia. It is located at 214 Hawkesbury Rd, Westmead, NSW, 2145, Australia.

The facility provides cell lines to the research community, both within Australia and overseas. CBA is designed to act as a secure repository for cell lines. The facility enables scientists to access quality-controlled cell lines for experimental work and promotes good cell practice in research. It is a not-for-profit cell culture facility, purpose built with clean room grade laboratories, quality control testing, sample base logging and secure cryostorage. The facility is primarily a repository for both novel and long-established cell lines, staffed by four full-time, fully qualified and highly experienced personnel.

CBA is equipped with the necessary facilities to perform the scientific and administrative tasks required of an IDA under this treaty. It offers identification testing of human cell lines using accepted gold standard, short tandem repeat (STR) profiling. The liquid nitrogen storage systems are connected to a building-wide alarm system, with continuous monitoring of storage temperature and remote alarms.

As a scientific institution CBA necessarily performs, and will continue to perform its function in an impartial and objective manner.

CBA has an agreement with the UK based Health Protection Agency, to store approximately 700 of its European Collection of Cell Cultures (ECACC) cell lines in liquid nitrogen for distribution as requested throughout Australia and New Zealand.

CBA will accept for deposit, human and animal cell lines and hybridomas that can be preserved in liquid nitrogen vapour without significant damage to or loss of their properties or viability.

Microorganisms accepted for deposit by CBA will be examined for viability and stored as prescribed in the Regulations under the Treaty. CBA will not at this time accept for deposit, genetically modified organisms requiring physical containment level 3 or 4 (PC3 or PC4). Deposits should be accompanied by a favourable Biohazard Risk Assessment statement.

CBA will, in accordance with the Regulations, issue to the depositor a receipt and any required viability statement.

Patent cultures will be bar-coded, and stored in three vapour-phase liquid nitrogen storage systems, with custom designed database to track inventory of the cryopreserved vials, and depositor details. Only authorised CBA and CMRI's IT staff will have access to the database. CBA will comply with confidentiality requirements prescribed in the Regulations.

CBA will also furnish samples of deposited microorganisms under the conditions and in conformity with the procedures prescribed in the Regulations.

In accordance with Rule 6.3(a) of the Regulations, CBA requires before it will accept microorganisms for deposit:

(i) that a deposit of a microorganism should be in adequate form and adequate quantity to enable CBA to carry out properly its duties under the Regulations;

(ii) that the written statement referred to in Rule 6.1(a) or 6.2(a) be drafted in English;

(iii) that the fee for storage referred to in Rule 12.1(a)(i) be paid; and

(iv) that the depositor complete an Application Form for the purposes of the administrative procedures of CBA.

The official language of CBA is English.

The fees, in Australian dollars, that CBA will charge for storage, viability statements and furnishings of samples of microorganisms are set out below:

Prices

Fees plus GST, where applicable, are payable to CellBank Australia.