In order to obtain a sample of a micro-organism deposit, the person requiring the sample must firstly request a certification from the Commissioner authorising the release. The request for the release of a sample:

must be made in the approved form;

AND

must relate to a micro-organism:
that is the subject of a patent application or patent; or
the use, modification or cultivation of which is the subject of a patent application or patent;

AND MAY

nominate another person as a skilled addressee. The skilled addressee is a person without an interest in the invention to whom the Commissioner’s certification may be granted.

(reg 3.25 and Rule 11.1)

Request Requirements

The request must be made in the approved form (see P/00/031 Request for Commissioner's Certification Authorising Release of a Sample of a Micro-Organism). A single request may be used for any number of micro-organisms, provided the micro-organisms are disclosed in the one application. The time for filing a request is on or after the date on which the application is open to public inspection (OPI). Note, however, that a request will not be granted in respect of a PCT application that has not entered the national phase (reg 3.25B(5)).

Where a request is made by an individual on behalf of a company, the request (and undertaking relating to the use of the micro-organism sample) should explicitly state that the requestor is acting “on behalf of” the company.

Undertaking by Requestor

Note: An undertaking is not required in the case of a request relating to a patent application that has lapsed, or is refused or withdrawn, or a patent that has expired, ceased or been revoked.

The person making the request (or the person nominated as the skilled addressee; see above), must give an undertaking relating to the use of the micro-organism sample (reg 3.25C). The undertaking is that the person:

will not make the micro-organism, or a culture derived from the micro-organism, available to another person; and
will only use the sample for:
- experimental purposes; or
- in relation to opposition proceedings under Chapter 5 or sec 101M, or relevant proceedings in relation to the patent.

Examiners should assume that an undertaking is valid, unless there is reason to doubt its veracity.

Examiners should note the following:

The details on the undertaking should reflect the current status of the application or patent.
The undertaking must be clearly associated with the relevant micro-organism deposit. For example, for a paper form where the relevant micro-organism is identified on the first page and the undertaking is given on the second page, the name of the relevant micro-organism and the accession number to which the undertaking is given must be stated on the second page (Re Merck & Co Inc and Niblack (1992) AIPC 90-866).
A sample may be used for any of the above purposes. Therefore, it is not necessary to make a separate request if, for example, a sample was initially obtained pre-acceptance and then was subsequently required in opposition or revocation proceedings (New York University v Nissin Molecular Biology Institute Inc (1994) AIPC 91-069).
The term "experimental purposes" should be construed analogously to experimental uses of an invention that do not give rise to infringement of a patent (New York University v Nissin Molecular Biology Institute Inc supra). However, the term should not be interpreted as being restricted to "in Australia" and must refer to experimental purposes anywhere in the world (New York University v Nissin Molecular Biology Institute Inc supra). This condition also applies to the undertaking of not making a sample available to others.

Form BP/12

The request must be accompanied by Form BP/12 - Request for the Furnishing of Samples of Deposited Microorganisms pursuant to Rule 11.3(a) (see 2.7 Annex A – Form BP/12). The first and second pages of the form are to be completed by the person making the request. The third page of the form is the certification given by the Commissioner (see 2.7.6.3 Grant of Certification Authorising Release).

Failure to Meet Requirements

Where the request does not meet the necessary requirements, the Supervising Examiner CHEM 1 should inform the person making the request of that fact (see, for example, 2.7 Annex C – Letter to Person Making Request for Certification).