Where a request for certification authorising release of a sample is granted, the Commissioner will issue a certificate which is the third page of 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).

On the certification, the Commissioner declares that the certified party has a right to a sample of the micro-organism identified in the request for certification under the law governing patent procedure of the Office, and that the Office is satisfied that the conditions prescribed by such a law have been met.

In Australia the certified party is:

the person making the request for a certification to authorise the release of a sample; or
a skilled addressee without an interest in the invention nominated by the person making the request for certification, if the restrictive access provision has been invoked (reg 3.25A).

Procedure for Issuing Certification

When the certification for release is ready to be issued, the Supervising Examiner CHEM 1 will forward the Form BP/12 to the Assistant Director COG, who will attach a seal to the form. The completed certification for release is then signed by the Assistant General Manager (OEP).

The certification for release, together with a covering letter, is sent to the requestor. A copy of the certification for release (together with a covering letter) is also sent to the applicant (or patentee). A further copy of the certification is placed on the case file.

Limited Use Undertaking

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is not required in the case of a request relating to a patent application that has lapsed, or is refused or withdrawn, or a patent that has expired, ceased or been revoked.

Once a sample of the micro-organism has been released, it may only be used for certain purposes. Thus the requestor, or the person nominated as the skilled addressee (a person without an interest in the invention to whom certification may be granted), must give the undertaking that they:

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.

The period of the undertaking is:

in the case of a request in respect of a patent application, the period beginning when the request is granted and ending when:

i. the application lapses, or is refused or withdrawn; or

ii. a patent granted on the application expires, ceases or is revoked.

in the case of a request in respect of a patent, the period beginning when the request is granted and ending when the patent expires, ceases or is revoked.

Conditions on Granting Certification for Release

The Commissioner may impose conditions as are reasonable in granting the certification for release (reg 3.25G). These can include a security for a breach of the undertaking regarding the use of the micro-organism, or that the release is to be effected to an independent third party and that the third party must make an undertaking regarding the use of the micro-organism and destroy the sample once the experiments required by the requestor are performed (see New York University v Nissin Molecular Biology Institute Inc (1994) AIPC 91-090 and also Merck & Co Inc and Niblack Inc (1992) AIPC 90-866).