The Budapest Treaty provides a mechanism whereby patent applicants can sufficiently “describe” a biological invention by making a deposit of biological material with a recognised international depositary authority. To avail of this mechanism, however, applicants must meet strict deadlines, including when the deposit is made and when details of the deposit are included in the patent specification.
In GloFish, LLC  APO 52, the Australian Patent Office ruled that the time for making a deposit under the Budapest Treaty cannot be extended.
GloFish, LLC (“GloFish”) sought to rely on the Budapest Treaty when seeking patent protection for its transgenic Siamese fighting fish (Betta splendens). The genetically modified fish, referred to as “Bettas”, display fluorescent colours when exposed to light of certain wavelengths.
GloFish filed five U.S. provisional applications on 13 November 2018, each covering one of their red, green, orange, blue and purple Bettas. A PCT application claiming priority from the provisional applications was filed on 13 November 2019.
GloFish was unable to obtain enough fish sperm to meet the deposit requirements of the American Type Culture Collection (ATCC), which is a recognised international depositary authority, until 13 February 2020. The sperm samples were deposited at the ATCC on 20 February 2020.
On 11 August 2020, GloFish amended the PCT application under Article 34 to add the deposit details to the PCT specification.
After entering the Australian national phase, GloFish requested two extensions of time – one to include details of the deposits in the patent specification as required under section 6(c) of the Patents Act 1990, and another to deposit the biological material as required under subsections (a) and (d).
Section 6 of the Patents Act 1990 stipulates that 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 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 publication date], 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
(iii) 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.
In other words, section 6(a) relates to the need for a deposit to have been made before the filing date, and section 6(d) relates to the need for the deposit to have been continuously available since the filing date. Section 6(c) relates to the need for the deposit details to have been present in the specification since the specification was published.
The question asked of the Delegate was whether an extension of time could be sought under section 223 of the Patents Act 1990 to satisfy the requirements of section 6.
Section 223(2) provides that, where, because of:
(a) an error or omission by the person concerned or by his or her agent or attorney; or
(b) circumstances beyond the control of the person concerned;
a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may, on application made by the person concerned in accordance with the regulations, extend the time for doing the act.
To summarise, therefore, GloFish sought:
- an extension of four months to deposit the fish sperm, pursuant to section 6(a) and (d).
- an extension of three months to include details of the deposit in the patent specification, pursuant to section 6(c).
The Delegate first considered whether making a deposit is a relevant act that must be done within a certain time for the purposes of section 223(2). In order for a request under section 223(2) to be applicable, the Delegate reasoned that section 6(a) would have to be interpreted such that the filing date of the patent application creates an implied time limit for depositing the microorganism, which would end on the same date. This proposition – that the act of filing creates a time period that has already expired – would be absurd, the Delegate found. Until the patent application is filed, there is no requirement to make any biological deposit and so no deadline to be met.
Given that a Budapest Treaty deposit constitutes, at least in part, the description of an invention, the Delegate observed that filing an application before a deposit has been made is akin to filing an application before the development of the invention has been completed. The Delegate drew the analogy of filing a patent application to a new gene sequence before the sequencing had taken place, and later filing a sequence listing once the sequencing had been completed.
The Delegate therefore concluded that the time for depositing a microorganism under section 6(a) cannot be extended. Since the deposit was not made before the filing date, and the time for doing so cannot be extended, the Delegate considered it unnecessary to determine whether the time for including details of the deposit in the patent specification under section 6(c) could be extended.
Although the Delegate did not address the question of whether the time for including details of the deposit in the patent specification under section 6(c) can be extended, the Patent Manual of Practice and Procedure indicates that such extensions are available since, unlike the Delegate’s construction of subsection (a), subsection (c) describes an act that must be done within a certain time, namely, prior to publication of the application.
Statutory deadlines around biological deposits vary between jurisdictions, and so the ability to remedy a patent specification lacking deposit details after publication can be particularly critical for foreign applicants of Australian national phase applications. If, however, the deposit itself has not be made before the filing date, an extension of time is unlikely to be available to make the deposit. Therefore, when relying on the Budapest Treaty, applicants should ensure deposits are made prior to filing a first application.