Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) If a micro‑organism is deposited with a prescribed depositary institution, a person may, in the approved form, request the Commissioner to grant the certification referred to in Rule 11.3 (a) of the Budapest Treaty in respect of the deposit.
(2) As soon as practicable after receiving a request, the Commissioner must decide whether to:
(a) comply with the request; or
(b) impose such conditions as are reasonable, including a condition that the person give security for damages for any breach of the undertaking referred to in paragraph (4) (c) given by:
(i) the person; or
(ii) another person who has been nominated as a skilled addressee; or
(c) refuse that request.
(3) If the application is for a standard patent, the applicant may, at any time before the specification relating to the application is open for public inspection, notify the Commissioner that a sample of the deposited micro‑organism is only to be provided in a period mentioned in subregulation (3A) to a person who is:
(a) a skilled addressee without an interest in the invention; and
(b) nominated by the person who made the request.
(3A) For subregulation (3), the period is:
(a) before the patent is granted on that application; or
(b) before the application has lapsed or been withdrawn or refused.
(4) The Commissioner must comply with a request in respect of a patent application or patent:
(a) if the specification relating to that application or patent is open to public inspection; and
(b) unless the Commissioner is reasonably satisfied that the nominated person is not entitled to rely on the deposit for the purposes of the Act; and
(c) if the person making the request or the person nominated as a skilled addressee has undertaken to use that micro‑organism only for experimental purposes or in relation to:
(i) opposition proceedings under Chapter 5 of the Act in relation to the grant of a standard patent on that application; or
(ii) opposition proceedings under section 101M of the Act in relation to an innovation patent; or
(iii) relevant proceedings in relation to the patent;
and not to make that micro‑organism, or a culture derived from that micro‑organism, available to another person; and
(d) unless the Commissioner is reasonably satisfied that the undertaking given by the person making the request or the person nominated as a skilled addressee was not given in good faith; and
(e) if:
(i) the Commissioner has been notified under subregulation (3); and
(ii) the patent referred to in that subregulation has not been granted; and
(iii) the application referred to in that subregulation has not lapsed or been withdrawn or refused; and
(iv) the Commissioner is reasonably satisfied that the person nominated as a skilled addressee is a skilled addressee without an interest in the invention; and
(f) if:
(i) the request is in respect of a patent; and
(ii) the person making that request is a person to whom the patentee has granted a licence under section 133 of the Act; and
(iii) the Commissioner is reasonably satisfied that the licence provides that the person making the request has a right to obtain a sample of that micro‑organism; and
(g) if:
(i) the request is in respect of a patent; and
(ii) the person making that request is a person who may exploit the invention under section 163 of the Act; and
(iii) the Commissioner is reasonably satisfied that the terms for the exploitation of the invention provide that the person making the request has a right to obtain a sample of that micro‑organism.
(5) Before making a decision under subregulation (2), the Commissioner must give the person making the request, the applicant or patentee concerned and any other person who apparently has an interest in the request, an opportunity to be heard.
(6) If the Commissioner makes a decision under subregulation (2), he or she must inform the person who made the request, the applicant or patentee concerned and any other person who apparently has an interest in the request, of the decision, and the reasons for the decision, by notice in writing given as soon as practicable after the date of the decision.