Patenting in the Life Sciences: Biological deposits and the Budapest Treaty

For patent applicants seeking to protect biological material, for example microorganisms, it is a requirement that the biological material be deposited at a depositary authority in the country for which patent protection is sought.

To alleviate the burden of a patent applicant depositing biological material in each individual country for which patent protection is desired, in 1977 the “Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure” (“Budapest Treaty”) was established, which enables a patent applicant to make a single biological deposit at an International Depositary Authority (IDA), which would be recognised by all member states of the Budapest Treaty, in addition to several regional patent offices, such as the European Patent Office, the Eurasian Patent Organisation (EAPO) and the African Regional Intellectual Property Organisation (ARIPO). To date, there are currently 87 contracting parties who are members of the Budapest Treaty. This includes Australia, New Zealand, United States, Canada, Japan, Singapore, China, and many others including a range of European countries such as the United Kingdom, Switzerland, France, Spain and Italy.

Biological deposits made to a depositary authority are retained for at least 30 years, regardless of any changes that may occur to the status of the related patent application. Deposits cannot be removed from storage once the deposit has been made.

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Whilst the Budapest Treaty does not specifically define the term “microorganism”, biological materials accepted as a deposit, include: bacteria and other prokaryotes, fungi including yeast, mushrooms, algae, eukaryotic cells, protozoa, cell lines, viruses, spores, hybridomas, plant tissue cells, seed and hosts containing materials for example, vectors, cell organelles, plasmids, genes, chromosomes and nucleic acids, including DNA and RNA.

Where the invention concerns discovery of a new living organism, the new living organism must have properties that have been modified such that they display some beneficial advantage (Ranks Hovis McDougall Ltd’s Application (1976) AOJP 3915), even if a deposit has been made under the Budapest Treaty. In other words, it must be a manner of manufacture, in order to be patentable.

Filing a biological deposit

At least in Australia, the biological deposit must be available at all times, from the date of filing the patent application. The patent application must include the name of the IDA that received the biological deposit, and the accession or registration number of the deposit, as provided by the IDA.

It is essential to appreciate that different countries have different provisions and regulations, and therefore different deadlines, for filing a biological deposit. For example, in New Zealand, although a micro-organism deposit is required to be made prior to the filing date of the patent application (similar to Australia), a deposit receipt can be filed with the New Zealand Patent Office, up to 12 months from the date of the first Examination Report, with a possible extension of time (under regulation 147 of the New Zealand Patent Regulations 2014).

In Europe, the biological deposit must be made on or before the filing date of the patent application. Information on accession number and depositary institution must be included in the European patent application at the time of filing. This is because in Europe, the addition of this information at a later stage is not permitted once the application is filed, which means that if the opportunity is missed early on, the information can no longer be added to the application.

However, interestingly, in the US, a biological deposit can be made after filing of the patent application, in response to an enablement rejection during prosecution of the patent application.

Sufficiency, enablement and best method requirements

Depositing the biological material can be used to satisfy the enablement requirement of a written description in Australia (Section 41(1) of the Patents Act), which requires that the specification encompass a “clear enough and complete enough disclosure of the life form”.

In Europe, in order for the deposit to be used for satisfying sufficiency requirements, the biological deposit must be made on or before the filing date of the patent application, or before the priority date if there are embodiments of the invention that rely on the deposit for sufficiency purposes. Since no further amendments are permitted to the description of European patent applications after filing, if a microorganism deposit was made to satisfy a requirement of sufficiency, this requirement will never be met in the absence of deposit information that was omitted from the patent application at the time of filing.

With regards to the US, and as discussed briefly above, a biological deposit can be made after filing of the patent application, in response to an enablement rejection.

However, Applicants must be aware that in some instances a deposit alone may be insufficient to satisfy the requirements of sufficiency and/or enablement, and as such further information may be required to fully describe the invention (section 40(2)(a) of the Patents Act). For example, a detailed written description of the life form, which include details on the taxonomy, morphology or biochemical or other characteristics, a drawing, photograph, or in the case of nucleic acids, a sequence listing could be supplied. The enablement requirement is only satisfied if it is considered that a person skilled in the art is able to identify and be able to replicate the invention as described, without undue burden. For Plant Varieties, some further specific requirements are necessary to fully describe the plant species, although this will be discussed in a separate article.

Importantly, there are some instances in which a biological material may not need to be deposited to satisfy the enablement requirement. This includes situations whereby the micro-organism may be obtainable via other means, whether this is through a commercial source or through any other freely available public source.

With respect to the “best method” requirements, this refers to the best method for performing the invention, which may include methods for introducing genetic modifications, or selective breeding. Submission of a deposit under the Budapest Treaty is typically sufficient to satisfy this requirement.

Replacing biological deposits

Whilst the Budapest Treaty does enable Applicants to make a single deposit at an IDA to have their biological material recognised across all member states of the Treaty, it is important to note that occasionally the Applicant may be requested to make a new deposit, to replace the original deposit.

Given that the biological material is kept by a depositary authority or IDA for at least 30 years, it is generally recommended that Applicants ensure they have access to their own material deposit for the same length of time. Situations in which a replacement may be required include where the original deposit may no longer be viable, or if there are restrictions related to the import and/or export of the material overseas.

Under the Patents Act a replacement deposit must be made within 3 months, or prior to the date on which the application becomes open to public inspection, or immediately before acceptance of the patent application, whichever is earlier.

Importantly, if a new replacement deposit is required, the date on which the replacement deposit is made becomes the new deposit date, which may lead to some issues with enablement and sufficiency of disclosure in most jurisdictions, if the second date of deposit is after the priority date of the patent application. However, the US presents as an exception to this, in that deposits are required to be made prior to grant of the patent.

How do I request access to a micro-organism deposit?

In Australia, any person seeking access to a micro-organism deposit must make an undertaking that the deposit is not to be distributed to others and will only be used for experimental purposes or for opposition purposes. The only time it is not necessary to make an undertaking, as per above, is if the patent application which discloses the same micro-organism deposit, has lapsed, ceased, expired, withdrawn or revoked. 

Furthermore, in Australia a request for release of a micro-organism must be made in an approved form, which requires making a request to the Commissioner to authorise release of the deposit. A request for such can be made at any time once the application is open to public inspection. A single request can be used for multiple micro-organisms, as long as the micro-organisms have been disclosed in a single application. Requests also cannot be made with respect to PCT applications that have yet to enter national phase.

Even if a request gets granted, the Australian Commissioner may choose to impose conditions concerning the release of the microorganism. For example, a security may be required in case of a breach of the undertaking regarding the use of the microorganism, or that the release is to be received by a third party, who must make an undertaking regarding use of the microorganism, and that the sample will be destroyed once any experiments involving use of the microorganism have been concluded.

It is important to appreciate that the criteria for requesting access to a micro-organism deposit does vary from jurisdiction to jurisdiction. Specifically, the requirements tend to depend on the rules of individual countries or regional patent offices, in which the deposit has been made. For example, in New Zealand, any interested party can make a request to IPONZ for access to a microorganism sample. In other words, no legal entitlement is required to obtain a sample, as IPONZ will normally certify these requests. On the other hand, in the US, a person requesting access to a microorganism deposit must be determined to be legally entitled to such, by the Patent Office.

In Europe, an Applicant is able to make a request to the European Patent Office (under Rule 32 EPC), to only authorize a third party access to their micro-organism deposit, if the patent application is in order for grant, otherwise the only persons able to receive authorization are experts. Having these provisions in place in Europe, helps to protect the Applicant from potential exploitation of their micro-organism deposit by competitors who may have malicious intent. 

Along similar lines, in Australia, before an application becomes open to public inspection, the applicant can request that samples are only provided once the application becomes open to public inspection. It could also be specified that the sample only be released to a skilled addressee who does not have an interest in the invention of the patent application. Such requests are only applicable up until the time when the patent is granted, revoked, ceased or withdrawn.

It is usual for most jurisdictions to specify that upon grant of access to a micro-organism deposit, the deposit may only be used for the purposes of conducting experimental work and cannot be further distributed, similar to the Australian rules as mentioned above. 

What happens if the biological material was not deposited at the time of filing the patent application?

It may be possible to amend the specification to include details of the deposit, if the application has not yet been made public to open inspection, or if the application has not yet been accepted. If an application becomes accepted without inclusion of the required details of the depositary authority and/or the accession or registration number, an amendment to the accepted patent application will only be allowed if an extension of time has been granted. If for any reason, the biological material was not deposited on time, the Applicant would be unable to rely on the Budapest Treaty, and moreover it may also lead to difficulties during prosecution of the associated patent application.

The question of whether an extension of time can be applied for making a micro-organism deposit in Australia, was discussed in the case of GloFish (GloFish, LLC [2022] APO 52). In this case, patent protection was sought for transgenic Siamese fighting fish (Betta splendens), which can display a range of fluorescent ornamental colours, including green, orange, red, purple and blue, when the fish are exposed to light of a certain wavelength.

GloFish had requested an extension of time under section 223 (2) of the Patents Act, for making a micro-organism deposit, in order to satisfy the requirements of section 6 of the Patents Act. Section 223 (2) outlines provisions relevant to the granting of an extension of time in the event that an error, omission or circumstances beyond the control of the person had occurred. The provisions apply to “a relevant act that is required to be done within a certain time”.  The meaning of the term “a relevant act” was discussed as referring to “… an action (other than a prescribed action) in relation to a patent, a patent application, or any proceedings under this Act.” Whilst making a micro-organism deposit was not explicitly excluded in the Regulations, the Delegate also did not consider the same to fall under the definition of a “relevant act”.

In fact, it was discussed that the purpose of section 223 that “an act is required to be done if the omission to do the act attracts, for example the loss of a right or privilege, rather than merely resulting in the loss of an opportunity of gaining a right or privilege”. Thus, depositing a micro-organism was not considered an act that was required to be done within a certain time.

The Delegate in GloFish reminded Applicants that the purpose of the Budapest Treaty is to assist Applicants in satisfying the description requirements of the Patents Act, where it is not possible to describe the invention in words. It was emphasised that section 223 is not appropriate to rely on in situations whereby errors have caused the specification as filed to be insufficient in fully describing the invention. For example, in situations where a sequence listing was inadvertently omitted, or where the wrong gene has been sequenced. Under the former, this type of error could be addressed via the provisions of subsection 102(3) which relate to a “clerical error or obvious mistake”. However, for the latter scenario, the same provision would not apply.

Whilst the case of GloFish focused largely on whether an extension of time could apply for making a biological deposit in Australia, noticeably the Delegate in that case did not discuss the scenario of whether an extension of time could apply to include deposit details in a patent application, where these details were not included prior to publication of the specification. In considering the interpretations above concerning “a relevant act that is required to be done within a certain time”, we speculate that an extension of time may be granted in those instances, since the period of time concerned is before publication of the specification, which contrasts with the act of depositing a micro-organism to which the Delegate contends is not an act “required to be done within a certain time”.  

What about divisional applications?

If a microorganism deposit is made on a divisional application, the only way in which that divisional application may claim priority from an earlier parent application, is if the deposit was also made in the parent application at the time the divisional application was filed.

Lessons learnt

We recommend life science patent Applicants check in advance with their patent attorney what the requirements are for depositing and furnishing of their micro-organism deposits, in their overseas jurisdictions of interest. As general advice, we advise that micro-organism deposits be made at the earliest possible opportunity, prior to filing the first patent application. Given that Australia’s stance is not to grant an extension of time for depositing a biological material, and that no further information can be added to the description section of a European patent application after filing, it is best to work towards these stricter guidelines so that patent applicants seeking international patent protection can be reassured of validity of their life science patent application, with respect to best method and enabling disclosures, amongst other description requirements.

If you have any questions in relation to any of the above, please do not hesitate to contact our team for further information.

Vanessa Yeung
written by Vanessa Yeung, Patent and Trade Mark Attorney