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5.6.7.6 Complete Disclosure Micro-Organisms and Other Life Forms

Date Published

Key Legislation:

Patents Act: 

  • s6 Deposit requirements
  • s18 Patentable inventions
  • s40 Specifications 
  • s41 Specifications: micro-organisms
  • s102 What amendments are not allowable?
  • s223 Extensions of time  

Patents Regulations:

  • reg 3.1 Prescribed documents: patent applications
  • reg 3.25 Request for Commissioner's certification authorising release of sample of a micro-organism
  • reg 3.25A Request for certification--micro-organism subject of application for standard patent
  • reg 3.23 Documents in accepted applications and patents involving micro-organisms
  • reg 3.29 Notification that a deposit requirement has ceased to be satisfied
  • reg 3.30 Prescribed period: deposit requirements taken to be satisfied
  • reg 3.31 Application for declaration that deposit requirements are not satisfied

Budapest Treaty:

PCT Administrative Instructions:

  • Annex C Instructions Relating to the Presentation of Nucleotide and Amino Acid Sequence

PCT standards:

Overview

Specifications relating to biological material are required to satisfy the requirements of clear enough and complete enough disclosure as for any other technology. However, particular issues can arise with adequately describing the invention in words, or describing it in a manner that it is repeatable.

The Budapest Treaty provides a mechanism whereby the requirements of clear enough and complete enough disclosure of the invention can be met by making a deposit of reproducible biological material with a recognised International Depositary Authority (IDA). Where such a deposit is made, third parties are able to obtain samples of the biological material from the IDA with the approval of the Commissioner. In this way the invention is made available to the public, even though a written description may be inadequate to describe the invention in words and/or in a repeatable manner.

In order for an applicant to rely on the Budapest Treaty mechanism to provide a clear enough and complete enough disclosure of the invention, the following criteria must be satisfied:

  • A sample of the biological material must have been filed with an IDA on or before the filing date of the complete specification;
  • The specification must include the characteristics of the biological material;
  • The specification must include the name of the IDA and its deposit number by the OPI date; and
  • The deposit must have been made with the IDA under the provisions of the Budapest Treaty, such that samples are available under the Rules of that Treaty.

In general, an applicant is not required to use the Budapest Treaty deposit mechanism. However, if:

  • the invention relates to the use, modification or cultivation of a specific micro-organism;
  • performance of the invention requires having a sample of that micro-organism; and
  • that micro-organism is not reasonably available to a person in Australia (even if the micro-organism itself is not located in Australia);

the applicant must rely upon the Budapest Treaty deposit mechanism in order to provide a description of the micro-organism (s41(2)).

Note: The Budapest Treaty relates to the deposit of micro-organisms, however the reference to 'micro-organism' is not intended to limit its application only to micro-organisms per se. Rather, it relates to a wide range of biological materials, including bacteria and other prokaryotes, fungi (including yeast and mushrooms), algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, seeds and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes.

General Considerations and Definitions

Definitions

Life forms

Includes whole living organisms, and cells and reproductive material derived there from. Thus the term encompasses plants, animals, viruses, vectors, micro-organisms, plasmids and plant and animal cells and cell lines. Living organisms include transgenic forms, varieties and strains.

Micro-organism 

The term is not defined in the Act or the Budapest Treaty.  The Office interprets the term "micro-organism" (as used in the Act) to include any biological materials accepted for deposit with a prescribed depository institution, for the purposes of the Budapest Treaty, in accordance with the rules relating to micro-organisms.  Examples of micro-organisms include bacteria and other prokaryotes, fungi including yeast, mushrooms, algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, seeds and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes

Exclusions Under Subsections 18(2) and 18(3)

Human beings and biological process for their generation are excluded from patentable subject matter for standard patents and innovation patents under s18(2).

Plants and animals and biological processes for their generation are excluded from patentable subject matter for innovation patents under s18(3). For the purposes of innovation patents, the definition of a “plant” is taken to include fungi and algae (see 5.6.15.4 Examination of Innovation Patents -Ground (3): Subsections 18(2) and (3)).​​​​​​​

Patentable Subject Matter

For information on the patentability of living organisms, see:

General Requirements of the Description

If the invention is or involves a life form, then an enabling disclosure of the life form is required in order to meet the requirements of s40(2).  This can be done either by describing the life form in words, drawings, graphics, photographs and/or sequence listings in the specification, or if the life form is a micro-organism, by making a deposit under the Budapest Treaty.  There must be sufficient information in the specification to enable the person skilled in the art to perform the claimed invention in a repeatable manner.

Description in Words

If the applicant chooses to describe a life form in words, then the specification must include a clear enough and complete enough disclosure of the life form itself, as well as the best method of performing the invention known to the applicant.  The ‘best method of performing the invention’ refers to the method by which a living organism with the same traits as the organism of the invention may be reproduced (see 5.6.7.6 Best Method of Performance of an Invention Involving a Life Form below).

Where the invention resides in a new bacterial strain, animal or plant variety, or other life form, the specification may require considerable detail.  This may include, for example, the full morphological, biochemical and taxonomic characteristics of the life form.  Further information regarding the requirements for plant varieties is provided in Some Specific Requirements for the Written Description of Plant Varieties below.

Deposit Under the Budapest Treaty

If the applicant makes a deposit under the Budapest Treaty, this can be used to satisfy the requirements of a clear enough and complete enough disclosure, including repeatability, under s41(1).  However, a deposit alone may not satisfy the requirements of s40(2)(a), and further information may be needed to sufficiently enable a claimed invention (see The Budapest Treaty below).

Section 18 Considerations

Where the claimed invention is a new living organism, the usefulness requirements of s18(1)(c) must also be satisfied.  An intended purpose or use of a new organism needs to be more than a generic use which could be applied to other members of that species.  If the intended use is only a generic use, then a lack of usefulness objection may apply (see 5.6.8.19 Useful (Utility)).  

Claims to organisms may also not meet the manner of manufacture requirements (see 5.6.8.12 Micro-Organisms and Other Life Forms).

Other Considerations

The description of a plant or animal variety will usually contain the name of the new variety.  Examiners should assume that where the name of a variety is derived from a person's name, permission from that person (or their legal representative) has been granted for the use of the name (s50(2)), unless there is some reason to doubt this.

Some Specific Requirements for the Written Description of Plant Varieties

When describing a plant variety in words, characteristics which may be included are:

  • leaf characteristics (e.g. shape and length);
  • flower characteristics (e.g. colour, size, number of petals, presence or absence of sepals, pollen morphology, carpal and stamen number, etc.);
  • stem characteristics (e.g. branching habits);
  • root characteristics;
  • fruit characteristics;
  • herbicide or pest resistance (if any); and
  • scientific testing characteristics (e.g. isozyme analysis, DNA fingerprinting etc.), if available.

Note: The description of these characteristics should not rely on subjective terms, e.g. robust, tall, bright etc.

Photographs may also be included in the specification. These should capture each of the major characteristics used to describe the plant variety. If the colour of a flower is important, then the colour should be identified with reference to a standard horticultural colour chart (see also 5.3.2.3 Drawings, Graphics and Photographs).​​​​​​​​​​​​​​​​​

Best Method of Performance of an Invention Involving a Life Form

In order to satisfy the best method of performance requirements, the specification must disclose all steps necessary to repeatably produce the life form.  These may include selective breeding, or methods involving mutation or genetic modification.

In the case of a plant variety produced by standard breeding techniques, all of the breeding methods and crosses used to produce the variety must be disclosed. Furthermore, the parents of the variety must be either available to the public in Australia (for example, commercially available or in an accessible deposit) or meet the requirements of s40(2)(a) themselves.

Note: A deposit made under the Budapest Treaty meets the requirements for best method of performing the invention.

The Issue of Repeatability

The main difference between inventions involving living and non-living systems is that many processes involving living systems are not 100% repeatable. In some cases the probability of repeating the invention, even using the best method known to the applicant, can be very low.

Each art has its own standard of repeatability and this must be taken into consideration when assessing repeatability of an invention. The issue when considering repeatability is not the numerical probability of achieving the specified result, but whether the result can be reproduced to a practical level acceptable to a person skilled in the art.

The result of chance mutation is not patentable on the grounds of lack of practical repeatability. For example, in a case involving the 'Scarlet Queen Elizabeth' rose, it was held that the process of production of the plant was not sufficiently disclosed because it was a chance genetic mutation. It was estimated that the probability of repeating this mutation was 1 in 100,000,000, which was impractical, if not impossible, given the methods of reproduction available at that time.

In situations where the repeatability is doubtful, but there is no clear indication that the invention is the result of a chance mutation, it is Office practice to accept that a best method of performance is established by the presence of a description of the process and a statement in the specification such as:

"It is practical to repeat the invention using current state of the art techniques to carry out the number of trials necessary to achieve the desired result."

It should be noted that some microbiological work which is automated and/or carried out by computer involves millions of trials, and such numbers may clearly be practical in certain fields.

Note: The requirement of repeatability may be met through a deposit under the Budapest Treaty (see The Budapest Treaty below).

The Budapest Treaty

Introduction

Subsection 40(2) requires that the complete specification disclose the invention in a clear enough and complete enough manner, including the best method of performing the invention.  These requirements cannot be easily met where it is impossible to provide an enabling disclosure of a micro-organism in words, or where there are issues with reproducing the micro-organism.

Section 41 provides that s40(2) can be satisfied by depositing a sample of the micro-organism in a depository. The deposit of a sample of the micro-organism will only be recognised for the purposes of s41 if it has been made as prescribed by s6.

Australia is a signatory to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, which provides that:

"Contracting States which allow or require the deposit of microorganisms for the purposes of patent procedure shall recognize, for such purposes, the deposit of a microorganism with any international depositary authority". (Article 3)

Under the terms of the Budapest Treaty, a depositary must qualify for the status of an International Depositary Authority (IDA) (Article 6 and Article 7). The Treaty also requires the deposit to have been made in accordance with Rule 6.

A list of the recognised IDAs is available from WIPO.  

Note: The International Patent Organism Depositary (IPOD), National Institute of Technology and Evaluation (NITE), was formerly known as the National Institute of Bioscience and Human-Technology, Agency of Industrial Science and Technology (NIBH).

Note: The All-Russian Collection of Industrial Microorganisms (VKPM) was formerly known as the Russian National Collection of Industrial Microorganisms (VKPM).

Enabling Disclosure of a Micro-Organism by Satisfying the Deposit Requirements

Section 41(1) states that to the extent than an invention in a complete specification is a micro-organism, then the specification is taken to comply with s40(2)(a) where the deposit requirements specified in s6 have been met.

Note: The Budapest Treaty provides a means for the applicant to provide an enabling disclosure of the invention.  Thus, if the description or claims refer to a deposited micro-organism, but the claimed invention can be disclosed in a clear enough and complete enough manner without the need to rely on the deposit, then the requirements of s40(2)(a) are considered to be met.  In these circumstances, there is no statutory basis for requesting that the applicant comply with the Budapest Treaty requirements.

For example, the mere reference to a micro-organism deposit in the specification, e.g. by accession number, does not necessarily mean that the applicant is using the deposited material to comply with the s40(2)(a) requirements.  Examiners should consider whether access to the deposited material is a necessary requirement in order to perform the invention, as it is claimed.  If examiners are satisfied from the information on file that the same material is available from another source (e.g. the specification indicates it is commercially available), then they may reasonably conclude that the applicant does not need to rely on the Budapest Treaty deposit to satisfy the requirements of s40(2)(a).

Inventions Involving the Use, Modification or Cultivation of a Micro-Organism

Section 41(2) states that where:

a. an invention involves the use, modification or cultivation of a micro-organism and not the micro-organism per se; and

b. a person skilled in the relevant art could not reasonably expect to be able to perform the invention without first having a sample of the micro-organism; and

c. the micro-organism is not reasonably available to a person skilled in the relevant art in Australia;

then the applicant can satisfy the s40(2)(a) requirement if and only if, the deposit requirements specified in s6 have been satisfied.

Office practice is to regard a micro-organism as being reasonably available, if the specification discloses a method by which the public can access a sample of the deposit. For example:

  • if the applicant identifies in the specification a commercial source through which a sample of the micro-organism can be obtained;
  • if a sample is freely available from any source, the applicant must name a source from which the public can obtain a sample of the micro-organism; or
  • if a sample of the micro-organism was available, under Rule 11 of the Budapest Treaty, at the filing date of the complete application, the applicant must:
    • identify the published specification (including foreign specifications), which was published before the filing date of the applicant's complete application in which the deposit was used for the purpose of patent procedure;
    • disclose the accession number of the deposit; and
    • name the International Depositary Authority (IDA) from which a sample can be furnished under the Rules of the Treaty. 

Note:  A deposit is regarded as being reasonably available provided the deposit relied on has been made under the Budapest Treaty and the deposit details disclosed in a document published by the filing date of the complete application.

Note: A micro-organism may be taken to be reasonably available, even if it is not reasonably available from an IDA within Australia (s41(3)).

Examiners should note that, particularly in literature references, the mere mention of an accession number at a particular depositary may not establish that the deposit is available, as it is common to have private (total limiting), or restrictive (e.g. Budapest Treaty) deposits, as well as freely available (no limitation) deposits in an accredited IDA.

If there is any doubt about the availability, examiners should raise an objection that the invention does not meet the requirements of s40(2)(a), as it is not clear if the micro-organism is reasonably available. If the uncertainty is related to the "reasonably available" aspect of the deposit, examiners should add a note to reiterate Office practice on the meaning of the term "reasonably available" (outlined above).​​​​​​​

Deposit Requirements Affecting the Priority Date of a Divisional Application

Chapter 3 of the Regulations specifies that if a divisional application relies on the deposit requirements to satisfy s40, then the application can only claim priority from the parent or other ancestor if the deposit requirements for that micro-organism were satisfied in the parent or other ancestor at the time the divisional application was filed.

The Deposit Requirements

Types of Deposits Under the Budapest Treaty

There are three types of deposits recognised under the Budapest Treaty:

Original Deposit

A sample of a micro-organism is deposited in an IDA for the first time (Rule 6.1).

New Deposit

Where an IDA can no longer furnish a sample of an original deposit of a micro-organism for any reason, in particular:

  • the original deposit is no longer viable; or
  • export and/or import restrictions prevent the sample being sent overseas;

a new deposit of the originally deposited micro-organism can be made.

In the former situation, the deposit is made with the same IDA, whereas the latter involves two different IDAs which are usually located in different countries (Rule 6.2).

Transfer Deposit

Where an IDA has lost its status as an accredited IDA in respect of any micro-organism concerned, samples of all such micro-organisms may be transferred to another IDA (Rule 5.1).

Note:  Not all depositories in which a PCT applicant can deposit a micro-organism are accredited depositary institutions under the Budapest Treaty. A list of the recognised IDAs is available from WIPO.

Deposit Requirements Under Section 6

Section 6 prescribes the deposit requirements which an applicant must satisfy for the purposes of s41(1).  Under s6, the deposit requirements in relation to a micro-organism are taken to be satisfied if:

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

b. the specification includes, at that date, such relevant information on the characteristics of the micro-organism as is known to the applicant; and

c. at all times since the end of the 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

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

Note: There is no requirement that the specification includes the date on which the micro-organism deposit was made.  (This was previously required by s6(c)(ii), since repealed).

The Section 6 Provisions Explained

Meaning of “prescribed depositary institution”

Section 6(a) requires that a micro-organism be deposited with a “prescribed depositary institution”.  Under s6(c), the specification is required to include the name of the “prescribed depositary institution” from which samples of the micro-organism are obtainable.  Section 6(d) requires that samples of the micro-organism have been obtainable from the “prescribed depositary institution” at all times since the filing date of the specification.

The term "prescribed depositary institution" includes an International Depositary Authority (IDA) under Rule 3 of the Budapest Treaty.  A list of the recognised IDAs is available from WIPO.  

Note: The International Patent Organism Depositary (IPOD), National Institute of Technology and Evaluation (NITE), was formerly known as the National Institute of Bioscience and Human-Technology, Agency of Industrial Science and Technology (NIBH).

Meaning of “relevant information on the characteristics of the micro-organism”

At filing, the specification is required to include “relevant information on the characteristics of the micro-organism” as is known to the applicant (s6(b)).  In general, this is satisfied by indicating the scientific name of the deposited micro-organism(s). Full morphological, biochemical and taxonomic characteristics of the micro-organism are usually not required, or may not be known to the applicant at the date of filing of the specification.

Meaning of “the end of the prescribed period”

In s6(c), "the end of the prescribed period" means either:

  • where a deposited micro-organism has ceased to be reasonably available, the end of the prescribed period is 3 months from the date specified in the declaration made by the Commissioner or a prescribed court that the specification does not comply with s40.

    (see s42(1), s42(2) and reg 1.5(1)(a))

OR

  • in any other case, the end of the prescribed period is the end of the day immediately before the day on which the specification becomes open to public inspection (OPI), or immediately before acceptance, whichever occurs earlier.

    (see reg 1.5(1)(b))

For national phase applications, the OPI date is the day on which:

  • PCT international publication occurs; or
  • a notice is published in the Official Journal, if that is earlier.

Meaning of “has included”

Section 6(c) requires that the specification “has included” the name of the prescribed depositary institution from which samples of the micro-organism are obtainable and the file, accession or registration number of the deposit.

The issue of whether a specification "has included" the s6(c) information arises when examiners consider if the requirements of s40 and s41 have been satisfied, or when an applicant seeks to insert information under s104.

The specification has not included the information relating to the deposit if the relevant information was:

  • absent

    i.e. no information relating to the deposit was previously disclosed in the specification;

OR

  • incomplete

    i.e. information relating to the deposit was previously present, but that information was incomplete, e.g. the file, accession or registration number was omitted;

OR

  • incorrect and a hindrance

    i.e. information relating to the deposit was previously present, but that information was incorrect (e.g. the deposit number was wrong), and the incorrect information would have hindered a person seeking access to the deposit.

Note: If incorrect information relating to the deposit was previously present, but the error would not have hindered a person seeking access to the deposit (e.g. if the file, accession or registration number contains an obvious mistake), then the specification “has included” the s6(c) information.

For national phase applications, the reference to a deposit may be disclosed on a separate sheet furnished under Rule 13bis.4, and is taken to be included in the description of the PCT application. The separate sheet can be Form PCT/RO/134 or a copy of the deposit receipt from an IDA.

If the specification does not include the required information, it cannot be inserted into the specification on or after OPI without a sec 223 extension of time (see Insertion or alteration of s6(c) information - deposit requirements).

Section 6 Examination Practice

An applicant can only rely on a micro-organism deposit to satisfy the requirements of s40(2)(a) (i.e. clear enough and complete enough disclosure or full description) if the deposit requirements of s6 have been met (see Deposit Requirements Under Section 6).  

Specifically, s6(c) requires that the specification has included, at all times since the end of the prescribed period:

  • the name of the prescribed depositary institution from which samples of the micro-organism are obtainable; and
  • the file, accession or registration number of the deposit.

If the requirements of s6(c) have not been met, an objection should be taken that the complete specification does not comply with sec 40(2)(a) (see, for example, PERP codes [E70] and [E70A]).

Where sec 6(c) information has not been included in the specification, it may be possible to insert the material under sec 104, provided a sec 223 extension of time is granted.  For information on when an extension of time is required, and the processing of sec 104 amendments to include sec 6(c) information, see Insertion or alteration of s6(c) information - deposit requirements.

Deposit Receipt and Notice of Entitlement to Rely on Deposit

Where a micro-organism is deposited with a prescribed depositary institution, the applicant is required to file:

  • a copy of the deposit receipt issued by the prescribed depositary institution.  If the receipt is not in English, a translation of the receipt must be provided. (For translations filed before or on 25 September 2019, a certificate of verification for the translation must also be provided).  

The receipt attests that the depositary received and accepted a sample of the micro-organism which has been deposited under the Budapest Treaty. It should bear the signature of the person(s) having the power to represent the authority, or an official who is duly authorised by that person.

AND

  • a notice of entitlement stating the applicant's right to rely on a deposited micro-organism for the purpose of patent procedure and providing support for such entitlement.

(see s29(1) and reg 3.1(2))

The time for filing the documents is:

  • before acceptance of a patent application (reg 3.1(2)); or
  • for accepted applications or patents, within 3 months of the date of receipt of the micro-organism by the depositary (reg 3.23(2)).

Examination Practice

Examiners should review the contents of the deposit receipt and its time of filing as outlined in Contents of the Receipt below. The accession number and name of the institution disclosed in the specification should be consistent with those on the receipt.  Where there are any inconsistencies, or information is missing from the receipt, an objection should be taken (see, for example, PERP codes [E72] – [E74]).

If a copy of the deposit receipt, a (verified) translation of the receipt (where necessary) and/or a notice of entitlement to rely on the deposit have not been provided, an objection should be taken (see, for example, PERP codes [E71] and [E75]). 

Contents of the Receipt

Original Deposit

Rule 7.3 requires that the receipt for an original deposit under the Budapest Treaty should contain at least the following:

  • the name and address of the International Depositary Authority (IDA);
  • the name and address of the depositor;
  • the date of original deposit of the micro-organism;
  • the identification reference given by the depositor to the micro-organism;
  • the accession number given by the IDA to the deposit; and
  • a reference to the fact that the deposit is or is not accompanied by a written statement which contains a scientific description and/or a proposed taxonomic designation of the micro-organism.

Deposits other than those made under the Budapest Treaty may be accepted by IDAs. Examiners should therefore ensure that the receipt explicitly indicates that the deposit was made under the Budapest Treaty.

Note: The date of the deposit normally means the date when the depositary receives and accepts a sample of a micro-organism which was deposited under the Budapest Treaty as shown on the official receipt. However, following an understanding reached by the Assembly of the Budapest Union (1981 and 1990), a depositor may request that a deposit made with an accredited IDA, but outside the scope of the Budapest Treaty, be converted into a Budapest Treaty deposit. In such cases, the applicable national law determines whether the earlier date can be recognised.

New Deposit

Rule 7.4 requires that the receipt for a new deposit is issued by the International Depositary Authority (IDA) which holds the new deposit and should contain at least the following:

  • the name and address of the IDA holding the new deposit;
  • the name and address of the depositor;
  • the date of the new deposit of the micro-organism;
  • the identification reference given by the depositor to the micro-organism;
  • the accession number given by the IDA to the new deposit;
  • the accession number of the previous deposit;
  • the reason for making the new deposit;
  • the date on which the depositary received the information from the previous IDA stating why it cannot furnish a sample; and
  • where a scientific description and/or taxonomic designation was indicated with the previous deposit, supply the most recent scientific description and/or proposed taxonomic designation of the deposit sent to the previous IDA.

The applicant must supply a copy of the receipt for the previous deposit, if the date of the new deposit is after the filing date of the patent application.

Transfer Deposit

When an International Depositary Authority (IDA) temporarily or definitively discontinues the performance of any of the tasks of an IDA, samples of the affected micro-organisms can be transferred to another IDA.

The latter IDA should issue a receipt for the transferred deposit. The contents of a transfer receipt should:

  • contain the same details as those for the original deposit, except that the IDA referred therein is the one which holds the transferred deposit, the accession number is that of the transferred deposit and the date of the transfer replaces the date of the original deposit;
  • disclose the name and address of the IDA from which the transfer was effected and the old accession number given by the previous IDA; and
  • indicate whether a scientific description of the deposit was sent to the previous IDA (Rule 7.5).

In addition, the applicant should disclose the date on which the latter IDA received the information from the previous IDA stating why it cannot furnish a sample.

Release of a Sample of Deposit

Under s6(d), it is a requirement that a sample of a micro-organism has been obtainable from a prescribed depositary institution at all times since the filing of the specification.  The term "prescribed depositary institution" includes an International Depositary Authority (IDA) under Rule 3 of the Budapest Treaty.

A sample of a micro-organism deposited under the Budapest Treaty can be obtained from an IDA under Rule 11.3. The procedures for the release of a sample, including any restrictions on that release, are outlined in the following sections.

Request for Release

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 s101M, 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:

  1. The details on the undertaking should reflect the current status of the application or patent.
  2. 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).
  3. 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).
  4. 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 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 Grant of Certification Authorising Release below).

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, Annex C – Letter to Person Making Request for Certification).

Consideration of Request for Release

After receiving a request for certification authorising release of a sample, the Commissioner must invite submissions on the matter from:

the person who made the request;

(reg 3.25(3))

Where submissions are filed within the time specified, these will be taken into consideration by the Commissioner.  Notwithstanding this, the Commissioner must grant the certification where the requirements of reg 3.25B are met.  However, the Commissioner may impose certain conditions on granting certification for release.

The Commissioner will notify the relevant parties of any decision regarding the request for release as soon as practicable after the date of the decision (reg 3.25H).

Note: A request will not be granted in respect of a PCT application that has not entered the national phase (reg 3.25B(5)).

Note: Where there is a pending decision on a request for a certification authorising release of a micro-organism, and the applicant or patentee files proposed s104 amendments relating to s6(c) information (i.e. the name of the prescribed depositary institution and/or the file, accession or registration number of the deposit), the procedures outlined in 5.7.6.1 Insertion or alteration of s.6(c) information - deposit requirements should be followed.

Procedure for Informing Applicant or Patentee of Request

The applicant (or patentee) must be informed that a request for the Commissioner's certification authorising release of a sample of a micro-organism has been made.

The Supervising Examiner CHEM 1 must send the applicant a covering letter (see Annex D – Notification to Applicant of Request for Release), together with:

  • a copy of the request for certification (Form P/00/031);
  • a copy of the undertaking by the requestor (Form P/00/031);
  • copies of any correspondence sent to the requestor; and
  • copies of any Form BP/12 (2.7 Annex A – Form BP/12).

The micro-organism requested for release must be a Budapest Treaty deposit. If there is no evidence on file that it is a Budapest Treaty deposit, a statement indicating that the Office has assumed that the deposit was made under the Rules of the Budapest Treaty must be included in the covering letter to the applicant (see Annex D – Notification to Applicant of Request for Release).

The applicant has one month from the date of the letter to provide submissions, if any.

The Supervising Examiner CHEM 1 will handle any further correspondence that relates to formality issues.  However, other matters of substance, such as security, should be referred to the Assistant General Manager (OEP) (see also Conditions on Granting the Certification for Release).

Grant of Certification Authorising Release

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 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 CEG, 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 s101M, 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).

Restrictive Access Provision

Under reg 3.25A, access to a sample of a deposited micro-organism may be restricted.  The applicant may notify the Commissioner at any time before a specification which discloses an invention involving a micro-organism becomes open to public inspection (OPI), that a sample of the deposited micro-organism is only to be provided to a person who is:

  • a skilled addressee without an interest in the invention; and
  • is nominated by the person who made the request for the certification authorising release of the sample.

The time period during which access to the sample is restricted begins when the specification becomes OPI and ends when:

  • a patent is granted on that application; or
  • the application lapses, or is withdrawn or refused.

The Commissioner may, under the provisions of s223, extend the time for making the notification.  However, the Commissioner will not grant an extension of time until any pending requests for certification authorising release of a sample have been dealt with.  Furthermore, if any request for certification is received before the grant of the s223 request, the s223 request is likely to be refused.

Restrictive Access Provisions for National Phase Applications and Processing of Requests

A PCT applicant may make use of the restrictive access provision, even though an application has not yet entered the national phase.  In this situation, there will be no Ecase for the application when the restrictive access notification is received, as an Ecase is only created upon national phase entry in Australia.

When CEG receives a notification, this will be forwarded to the Supervising Examiner CHEM 1. The supervising examiner should:

  1. Check that the notification has been made before OPI, is directed to the Australian Patent Office or the Commissioner and is consistent with reg 3.25A.
  2. Prepare a letter to the applicant or attorney as indicated in Annex B – Notification Regarding Release.
  3. Forward the letter to CEG, who will then send it to the applicant or attorney.

Notification that Deposit Requirements have Ceased to be Satisfied

Under reg 3.29(1), a person other than the applicant or patentee may notify the Commissioner that the deposit requirements of s6(c) or s6(d) have ceased to be satisfied.  These requirements are that:

  • at all times since the end of the 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

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

The Commissioner must provide the applicant or patentee with a copy of the notice as soon as practicable (reg 3.29(2)).

If examiners have any reason to believe that a deposited micro-organism, which has been relied upon for compliance with s40, is no longer viable, the matter is to be referred to the Supervising Examiner CHEM 1 for the possible issuing of a notification under reg 3.29(3) to the applicant or patentee.

In order for a notification to be issued, the Commissioner need only learn of facts which may establish that a deposit requirement referred to in reg 3.29(1) has ceased to be satisfied. It is not necessary for the Commissioner to be satisfied that the deposit is not viable.

If there is a notice under reg 3.29(1) on file, and the applicant or patentee files proposed s104 amendments relating to s6(c) information (i.e. the name of the prescribed depositary institution and/or the file, accession or registration number of the deposit), the procedures outlined in 5.7.6.1 Insertion or alteration of s6(c) information - deposit requirements should be followed.

The New Deposit

If the requirements of s6(c) or s6(d) cease to be satisfied, the applicant or patentee may take steps at a later time to ensure that the period during which the requirements were not satisfied may be disregarded (s41(4)).

These steps are discussed in further detail below.

Steps Required When s6(d) Not Satisfied

Where the requirements of s6(d) cease to be satisfied:

  • The applicant or patentee must make a new deposit of the same micro-organism with an IDA.  
  • The prescribed period for making the new deposit is from the date that the requirement ceases to be satisfied to:
    • the end of the period 3 months after the applicant, patentee or depositor of the micro-organism has received/been given certain notifications regarding the deposit requirements (reg 3.30(c)(i) to 3.30(c)(iii)); or
    • the day on which the new deposit is made (reg 3.30(c)(iv)).
  • A copy of the new deposit receipt must be filed before acceptance (reg 3.1(2)), or in the case of an accepted application or patent, within 3 months of the date of receipt of the micro-organism by the IDA (reg 3.23(2)).
  • If a notice of entitlement is filed after the deposit requirements cease to be satisfied, it should reflect the details of the new deposit.  Otherwise, the original notice will suffice.
  • Where the new deposit is made outside the prescribed period specified above, the applicant or patentee must apply for an extension of time under s223.  Once the extension has been granted, the new deposit is deemed to have been made within the prescribed period.

Steps Required When s6(c) Not Satisfied

Where the requirements of s6(c) cease to be satisfied:

  • The applicant or patentee must amend the specification to insert the details of the new deposit, i.e. the name of the prescribed depositary institution and the file, accession or registration number of the deposit.  
  • The prescribed period for amending the specification starts on the date that the requirement ceases to be satisfied and ends on the date of allowance of the amendment, unless:
  • the applicant, patentee or depositor of the micro-organism has received/been given certain notifications regarding the deposit requirements; and
    • the applicant or patentee has not asked for leave to amend the specification in the following 3 month period.
      (reg 3.30(d)(i) and 3.30(d)(ii)); see also below)
    • Where reg 3.30(d)(i) and/or reg 3.30(d)(ii) apply (see above), the applicant or patentee must apply for an extension of time under s223 in order to amend the specification.  Once the extension has been granted, the amendment is deemed to have been allowed within the prescribed period.

Annexes

Annex A - Form BP/12

https://ipagov.sharepoint.com/sites/PatentsManual/SiteAssets/2.7_Annex_A_-_Form_BP-12.pdf​​​​​​​​​​​​​​

Annex B - Notification Regarding Release

Dear

I acknowledge receipt of the notice under Regulation 3.25A filed 20 January 2010 with respect to application PCT/USXXXX/XXXXXX.  As the notice has been received before the publication date of the application, the notice is effective with respect to the samples of materials deposited in accordance with the Budapest Treaty and disclosed in the patent application under the provision of the Regulation.

To ensure that our records are updated when this application enters the national phase in Australia, it would be appreciated if the applicant acknowledges this letter and notification under Regulation 3.25A when the request to enter the national phase is made.

Yours sincerely

Annex C - Letter to Person Making Request for Certification

Dear

Thank you for your request under Regulation 3.25 for a certification authorising release of a sample of micro-organism ATCC CRL-12345.  However, the request must be accompanied by a completed Form BP/12 - Request for the Furnishing of Samples of Deposited Microorganisms pursuant to Rule 11.3(a) of the Budapest Treaty.

Yours sincerely

Annex D - Notification to Applicant of Request for Release

Dear

A request under Regulation 3.25(1) for the release of a sample of micro-organism ATCC CRL-12345 has been received by the office.  As there is no evidence on file that micro-organism ATCC CRL-12345 is a Budapest Treaty deposit, the office has assumed that the deposit was made under the Rules of the Budapest Treaty.

Please find enclosed copies of the request for certification, undertaking by the requestor, correspondence sent to the requestor and Form BP/12 for micro-organism ATCC CRL-12345.

In accordance with Regulation 3.25(3), before the Commissioner makes a decision, you are entitled to make submissions on the matter. You are therefore requested to, within one month of the date of this letter, provide submissions (if any) that you believe are appropriate to this matter.

Yours sincerely

Amended Reasons

Amended Reason Date Amended

Published for testing
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