Making a Patent Deposit
(A) Obligations of the Depositor
(i) Universal Requirements – (of the depositor) Depositors must indicate their intention to submit a deposit to CellBank Australia by completing and submitting the mandatory “international deposit forms” (Form BP/1, BP/2 or BP/3) along with a Biohazard Risk Assessment Form (Rule 6.1(a)). At least 48 hours before the microorganism is dispatched, CellBank Australia must be informed of the number of ampoules being sent, the method of transportation and the estimated time of arrival. If dispatch is by air, CellBank Australia must be told the flight number and destination, waybill number and handling agent for delivery. CellBank Australia does not require a special form to be completed in the event of a later indication or amendment of the scientific description and/or proposed taxonomic designation, or for a request for attestation that CellBank Australia has received such information. The depositor must be able to furnish samples of deposits when those originally deposited are depleted. CellBank Australia can prepare batches of deposited samples if the depositor is unable to furnish samples to replace depleted stocks. It is the responsibility of the depositor to check the authenticity of samples of batches prepared by the CBA. The depositor will be responsible for the shipping of samples to be authenticated.  (ii) Requirements of IDAs Official Notifications to the Depositor. The receipt and viability statement are issued on mandatory “international forms” BP/4 and BP/9, respectively, but standard forms are not used for other official notifications. Unofficial Notifications to the Depositor. If requested, CellBank Australia will telephone, fax or email the date of deposit and accession number after the microorganism has been received, but before the official receipt is issued. The result of the viability test will be communicated before the issue of a viability statement only where the viability of the deposit is unacceptably low. Supply of Information to a Patent Agent. CellBank Australia does not routinely ask the depositor for the name and address of his or her patent attorney. However, if requested, it will send copies of the receipt and viability statement to both the depositor and the patent attorney.
(B) Obligations of the IDA
(i) Kinds of Microorganisms Accepted Human and animal cell lines and hybridomas that can be preserved in liquid nitrogen vapour without significant change to or loss of their properties or viability (Rule 3.1(b) (iii)). Material submitted to CellBank Australia for deposit must be in the form of frozen cultures. The minimum number of replicates that must be provided by the depositor when making the deposit is 12. Note that: No patent deposit should be sent to CellBank Australia without a Biohazard Risk Assessment having been first received and reviewed by CellBank Australia. Following favourable review of a Risk Assessment the customer will be invited to ship the material for deposit. Biohazard Risk Assessment form can be accessed from the CellBank Australia website. The official language of CellBank Australia is English. Communications in any other language are not accepted. The CellBank Australia application form, which the depositor is required to complete, binds the depositor to: provide material only in the required form and quantity; provide a Biohazard Risk Assessment Form; pay all necessary fees including all charges for the transportation of deposits to CellBank Australia; observe the terms and conditions of the Budapest Treaty; accept the terms and conditions of deposit of samples in CellBank Australia. Import and/or Quarantine Regulations. Deposits must be covered by the appropriate regulatory documentation before being accepted. The customer will be advised to obtain the regulatory documentation once CellBank Australia has received a Biohazard Risk Assessment Form from the customer. CellBank Australia does not list Budapest Treaty deposits in its published catalogue.  (ii) Extension or Limitation of the Kinds of Microorganisms Accepted Genetically modified organisms evaluated as Activity Class 2 to 4 cannot be accepted until CellBank Australia has obtained authorization from the Office of The Gene Regulator (OTGR). CellBank Australia has to pay a fee for this authorization and this will be charged to the customer. A time of several weeks should be allowed for this approval process. (iii) Refusal to Accept a Microorganism CellBank Australia reserves the right to refuse to accept any material for deposit that, in the opinion of the CellBank Australia, presents an unacceptable risk or is technically unsuitable to handle. CellBank Australia will only accept organisms that do not significantly change after long-term storage at the appropriate temperature. CellBank Australia may refuse deposits that have not been packed in sufficient dry ice to keep them frozen during transit.  (iv) Acceptance of the Original Deposit Form BP/1 must be completed and sent to CellBank Australia with a Biohazard Risk Assessment Form notifying of depositor's intent to submit an Original Deposit.  Where a depositor elects to submit a New Deposit within CellBank Australia, replacing the previous shipment due to lack of suitable viability, export/import restrictions or ‘other’ reasons then Form BP/2 must be completed and sent to CellBank Australia with a Biohazard Risk Assessment Form notifying of depositor's intent to submit a revised deposit.  If a New Deposit from another IDA is to be submitted to CellBank Australia then Form BP/3 must be completed and sent to CellBank Australia notifying of depositor's intent to submit along with the reason for making a new deposit along with a Biohazard Risk Assessment Form.  (v) Conversion of Deposits Made Outside the Budapest Treaty Deposits made outside the provisions of the Budapest Treaty may be converted by the original depositor to Budapest Treaty deposits, whether or not they were originally deposited for patent purposes. However, any deposits previously made are subject, on conversion, to the storage fee normally levied for Budapest Treaty deposits. The administrative requirements for conversion are the same as those to be met in respect of an original deposit, except that requirements relating to shipping procedures do not apply. For the purposes of the Treaty, the date of deposit is held to be the date on which the culture collection acquired IDA status, not the earlier date on which CellBank Australia physically received the microorganism.  (vi) Issuance of Receipt Having received and accepted a microorganism for deposit (or having converted an existing deposit), CellBank Australia will notify the depositor of this fact by issuing an official receipt in respect of that deposit (Rule 7.1). CellBank Australia will acknowledge receipt of the following deposits with the respective Receipt forms:  Receipt in the case of an Original Deposit – Form BP/4 Receipt in the case of a New Deposit – Form BP/5 Receipt in the case of a New Deposit with another IDA – Form BP/6  (vii) Viability Testing and Statement CellBank Australia will perform viability testing as soon as possible after receiving a microorganism for deposit. The average length of time required for testing the viability of the various kinds of microorganisms accepted by CellBank Australia is given below, but depositors should realize that, in some cases, viability testing might take longer. Customers will be advised of this prior to deposit being accepted.  Animal cell cultures - 10 days (or up to 15 days) Human cell cultures - 10 days (or up to 15 days) Hybridoma cultures – 10 days (or up to 15 days)  Cell lines with viability determined to be greater than 60% are deemed to be suitable for deposit and under Rule 10.2(a) (i), a mandatory “international form” Form BP/9 will be issued as a receipt acknowledging the viability of the deposit. In the case of viability of deposits being determined to be below 60% the depositor must resubmit 12 vials of their deposited microorganism with Form BP/5 and a new Biological Risk Assessment Form.  (viii) Storage of Microorganisms Under rule 9.1, a deposit made to CellBank Australia will be stored in a viable and uncontaminated state for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism was received and for a period of at least 30 years after the date of the deposit. Deposited vials are individually bar-coded and held across three vapour-phase liquid nitrogen storage systems (with a total capacity of 55,000 vials) at a temperature range of -160oC to -190oC. A continuously monitored storage system issues alerts regarding any increase in temperature, and triggers a computer controlled alarm cascade, with staff notification out of hours through automated SMS mobile messaging. A custom designed database enables tracking of the vial position and depositor details.