Section 43: Deposit requirements for micro-organisms

(1) The deposit requirements are satisfied in relation to a micro-organism to which a specification relates if, and only if,—

(a) the micro-organism was, on or before the filing date of the specification, deposited with a prescribed depositary institution in accordance with the rules relating to micro-organisms; and

(b) the applicant for the patent provides to the Commissioner, within the prescribed period, a receipt for the deposit from the prescribed depositary institution; and

(c) the specification includes, at the filing date of the specification, all relevant information on the characteristics of the micro-organism that is known to the applicant; and

(d) at all times since the end of the prescribed period, the specification has included—

(i) the name of a prescribed depositary institution from which samples of the micro-organism are obtainable as provided by the rules relating to micro-organisms; and

(ii) the file, accession, or registration number of the deposit given by the institution; and

(e) at all times since the filing date of the specification, samples of the micro-organism have been obtainable from a prescribed depositary institution as provided by those rules.

(2) For the purposes of subsection (1)(b), the receipt for the deposit must be in the prescribed form (if any).

Compare: Patents Act 1990 s 6 (Aust)

Regulation 59 Deposit requirements for micro-organisms

(1) The prescribed period for the purposes of section 43(1)(b) of the Act is 12 months after the date of issue of the first examination report under section 65 of the Act.

(2) The prescribed form of receipt for the purposes of section 43(2) of the Act is a copy of a receipt issued by a prescribed depositary institution under rule 7 of the Budapest Regulations, and, if that receipt is not in English, the applicant must provide a verified translation of the receipt.

(3) In this regulation, Budapest Regulations—

(a) means the regulations made under the Budapest Treaty; and

(b) includes any amendments from time to time made to those regulations.

Compare: Patents Regulations 1991 r 3.23(2) (Aust)

Deposit requirements

1. When a specification relates to a micro-organism and requires a deposit, a sample of the micro-organism must be deposited at a prescribed depositary institution on or before the filing date.

2. Section 5 provides definitions for both a prescribed depositary institution and an international depositary authority (IDA). A list of international depositary authorities under the Budapest Treaty is provided by WIPO. At present there are no prescribed depositary institutions in New Zealand.

3. There are three types of deposit that can be made under the Budapest Treaty:

i. Original deposits – a first-time deposit (Rule 6.1);

ii. New deposits where the original deposit is no longer available from the institution (Rule 6.2); and

iii. Transfer deposits, where the institution no longer qualifies as an IDA, and deposits made there can be moved to another IDA (Rule 5.1).

4. A copy of the deposit receipt must be provided to the Commissioner within 12 months from the date of the first examination report. The receipt should be a copy of the receipt issued by the depositary institution (section 43(1)(b)). The information contained within the receipt must meet the requirements of Rule 7 of the Budapest Regulations (regulation 59(2)), more particularly Rule 7.4.

5. Rule 7.4 of the Budapest Regulations:

(i) the name and address of the international depositary authority;

(ii) the name and address of the depositor;

(iii) the date of the new deposit as defined in Rule 6.4(c);

(iv) the identification reference (number, symbols, etc.) given by the depositor to the microorganism;

(v) the accession number given by the international depositary authority to the new deposit;

(vi) an indication of the relevant reason and the relevant date as stated by the depositor in accordance with Rule 6.2(a)(ii);

(vii) where Rule 6.2(a)(iii) applies, a reference to the fact that a scientific description and/or a proposed taxonomic designation has/have been indicated by the depositor;

(viii) the accession number given to the previous deposit (within the meaning of Rule 6.2(c)).”

6. The specification of the complete specification must include all relevant information relating to the characteristics of the micro-organism known to the applicant at the time of filing of the application (section 43(1)(c)). The information must be present in the original complete specification at the time of filing of the application. Relevant information includes, but is not limited to, morphological, taxonomic and biochemical characteristics, and scientific name of the micro-organism.

7. In addition to information on the characteristics of the micro-organism, the specification must also include the name of the IDA, the file, accession or registration number of the deposit made in accordance with the Budapest Treaty. This information must be present within the specification no later than the end of the period prescribed by regulation 59.

8. Further information about the Budapest Treaty can be found on the International Patents page of the IPONZ website.

Failure to meet deposit requirements

9. Failure to comply with the deposit requirements will prevent an application being placed in order for acceptance and means that the application will be considered void (section 71(1)) as the complete specification would not comply with section 39(1)(a) and (b) as set out in section 42(1).

10. Where an applicant could not have been reasonably expected or required to provide a receipt, then applicants may request an extension of time to file the deposit receipt using regulation 147.

11. An assessment of each request for an extension of time under regulation 147 will be required based upon the specific circumstances and supporting evidence of each particular case before determining whether an extension should be granted. An extension of time under regulation 147 will be granted only under exceptional circumstances, and should not be deemed to be ‘as of right’ following the making of a request.

12. A request under regulation 147 should be made at the time of filing a deposit receipt or as soon as is reasonably possible thereafter.