The Budapest Treaty provides a mechanism by which patent applicants can sufficiently “describe” a biological invention by depositing biological material with a recognized international depository authority. However, to benefit from this mechanism, applicants must respect strict deadlines, in particular when the deposit is made and when the details of the deposit are included in the specification of the patent.
In GloFish, LLC  OAP 52the Australian Patent Office has ruled that the time limit for filing under the Budapest Treaty cannot be extended.
GloFish, LLC (“GloFish”) sought to rely on the Budapest Treaty when it sought patent protection for its transgenic Siamese fighting fish (betta splendens). Genetically modified fish, called “Bettas”, display fluorescent colors when exposed to light of certain wavelengths.
GloFish filed five provisional applications in the United States on November 13, 2018, each covering one of its red, green, orange, blue and purple Bettas. A PCT application claiming priority of provisional applications was filed on November 13, 2019.
GloFish was unable to obtain enough fish semen to meet the depository requirements of the American Type Culture Collection (ATCC), which is a recognized international depositary authority, until February 13, 2020. semen samples were deposited at the ATCC on February 20, 2020.
On August 11, 2020, GloFish amended the PCT Section 34 application to add filing details to the PCT specification.
After entering the Australian national phase, GloFish requested two extensions of time – one to include details of the filings in the patent specification, as required by Section 6(c) of the
Patents Act 1990and another for depositing biological material in accordance with sub-paragraphs (a) and (d).
Article 6 of the Patents Act 1990 stipulates that filing requirements are satisfied in respect of a micro-organism to which a specification relates if, and only if:
(a) the microorganism was, on or before the date of filing of the specification, deposited with a prescribed depositary institution in accordance with the rules relating to microorganisms; and
(b) the specification contains, on that date, the relevant information on the characteristics of the micro-organism known to the applicant; and
(c) at any time since [the publication date]specification included:
(i) the name of a prescribed depository institution from which samples of the microorganism may be obtained in accordance with the microorganism rules; and
(iii) the file, accession or registration number of the deposit given by the institution; and
(d) at any time since the date of filing of the specification, samples of the microorganism have been obtained from a prescribed depository institution as provided for in these rules.
In other words, Article 6(a) deals with the necessity that a deposit has been made before the date of filing, and Article 6(d) deals with the necessity that the deposit has been continuously available since the deposit date. Section 6(c) concerns the requirement that the repository details have been present in the specification since the specification was published.
The question posed to the delegate was whether an extension of time could be requested under Article 223 of the Patents Act 1990 to meet the requirements of section 6.
Section 223(2) provides that where, because of:
(a) an error or omission on the part of the data subject or his agent or lawyer; Where
(b) circumstances beyond the control of the data subject;
a relevant act which must be done within a certain time is not or cannot be done within that time, the Commissioner may, on application by the person concerned in accordance with the regulations, extend the time for doing the act.
To sum up, then, GloFish searched for:
- an extension of four months to deposit fish semen, in accordance with Article 6 (a) and (d).
- a three-month extension to include details of the filing in the patent specification, pursuant to Section 6(c).
The Delegate first wondered whether making a deposit is a
relevant act that must be done within a certain period of time for the purposes of section 223(2). For a request under Art. 223(2) to apply, the Delegate considered that Art. 6(a) should be interpreted so that the filing date of the patent application creates a time limit implicit for the deposit of the micro-organism, which ends on the same date. This proposition – that the act of filing creates a time limit which has already expired – would be absurd, the delegate considered. As long as the patent application has not been filed, there is no obligation to make a biological deposit and therefore no deadline to respect.
Since a Budapest Treaty filing constitutes, at least in part, the description of an invention, the Delegate observed that filing an application before a filing has been made is akin to filing of an application before the development of the invention has been completed. The delegate drew the analogy of filing a patent application for a new gene sequence before sequencing has taken place, and subsequently filing a sequence listing after sequencing is complete.
The Delegate therefore concluded that the time limit for filing a microorganism under Article 6(a) cannot be extended. Since the filing was not made before the filing date and the deadline for doing so cannot be extended, the delegate considered that it was not necessary to determine whether the deadline for including the details of the filing in the patent specification under Article 6(c) could be extended.
Although the delegate did not address the question of whether the time limit for including the details of the filing in the patent specification under Article 6(c) can be extended, the Manual of Patent Practice and Procedure indicates that such extensions are available since, contrary to the delegate’s interpretation of subsection (a), subsection (c) describes an act that must be done within a certain timenamely before the publication of the application.
Legal deadlines for biorepositories vary from jurisdiction to jurisdiction. Therefore, the ability to remedy a patent specification lacking post-publication filing details can be particularly critical for overseas applicants of Australian national phase applications. If, however, the filing itself has not been made before the filing date, it is unlikely that an extension of time will be available to make the filing. Therefore, when relying on the Budapest Treaty, applicants should ensure that deposits are made before filing a first application.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.