GloFish, LLC
[2022] APO 52
•14 July 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
GloFish, LLC [2022] APO 52
Patent Application: 2019378844
Title:Transgenic betta
Patent Applicant: GloFish, LLC
Delegate:Felix White
Decision Date: 14 July 2022
Hearing Date: 2 May 2022, by videoconference
Catchwords: PATENTS – extension of time – Budapest Treaty deposits – request for extension of time under s223(2) to satisfy requirements of s6(a), (c) and (d) – fulfilling the requirements of s6(a) and (d) are not “relevant acts required to be done within a certain time” – extension of time to satisfy s6(c) would serve no useful purpose – request refused.
Representation: Counsel for the applicant: Benjamin Fitzpatrick
Patent attorney for the applicant: David Longmuir & Scott Whitmore, Phillips Ormonde Fitzpatrick
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2019378844
Title:Transgenic betta
Patent Applicant: GloFish, LLC
Date of Decision: 14 July 2022
DECISION
I refuse GloFish’s request for extension of time under s223(2) for satisfying the requirements of s6(a) and s6(d), because making a microorganism deposit is not a “relevant act required to be done within a certain time” within the meaning of s223. I also decline the request for extension of time for satisfying the requirements of s6(c) as it would serve no useful purpose.
REASONS FOR DECISION
This decision relates to whether the requirements for satisfying the microorganism deposit provisions of section 6 of the Patents Act 1990 (“The Act”) are amenable to the extension of time provisions of section 223 of the Act.
I will commence this decision with a short history of the Budapest Treaty and will then set out my understanding of the events in this case, before proceeding to the task of statutory construction and consideration of the applicability of s223. I will refer to GloFish’s submissions throughout the decision as appropriate.
Microorganism deposit requirements
The Budapest Treaty, concluded in 1977, provides that contracting States, which allow or require the deposit of micro-organisms for the purpose of patent protection, must recognise deposits with any “international depositary authority”. While the Treaty does not place any requirements on how the contracting states make use of deposits for their national patent law, it sets out an international framework for mutual recognition of, and access to, deposits made under the Treaty.
Australia, while not an original signatory, acceded to the treaty on 7 April 1987[1] and it entered into force some three months later. Australia had amended its national laws to reflect the provisions of the Budapest Treaty with the Patents Amendments Bill 1984 (“The 1984 Bill”). The 1984 Bill amended the Patents Act 1952 (then in force – “The 1952 Act”) to introduce the concept that disclosure requirements could be satisfied by a micro-organism deposit under the Budapest Treaty. Prior to the 1984 Bill, there had been no provision in Australian law for satisfying the description requirements in any other way than in the specification, in writing.
[1] See >
In the Explanatory Memorandum to the 1984 Bill, then Science Minister the Hon. Barry Jones set out that its intent was “to ensure that Australians can take advantage of the procedures made possible by the Budapest Treaty … Patent applicants whose invention involves a micro-organism will be enabled, and is required in certain circumstances, to make a deposit of the micro-organism in a prescribed depositary institution.”
The 1984 Bill amended s40 of the 1952 Act to, inter alia, add new subsections 40(3) and 40(4) allowing the full description requirements to be satisfied providing the deposit requirements are met, and subsection 40(5) setting out the deposit requirements.
“New sub-section 40(5) sets out deposit requirements. Apart from the need to make a deposit with a prescribed depositary institution, the specification must include the characteristics of the micro-organism and information about the deposit itself”.[2]
[2] Explanatory Memorandum to the 1984 Bill
When the 1952 Act was repealed and replaced with the current Patents Act 1990, these provisions were transposed, in unchanged form, into the current sections 41, 42 and 6 respectively.
The relevant provisions[3] of the current Act relating to deposit requirements are as follows:
[3] Other Budapest Treaty provisions not mentioned in the body of the decision: Section 41(4) provides a mechanism for recovery if the requirements of 6(c) or (d) cease to be satisfied. The remainder of section 41 deals with situations where the application involves the use of a micro-organism that is “reasonably available”, in which case a Budapest deposit is not required. Section 42 deals with the situation where subsequent Budapest deposit can remedy the situation where a micro-organism ceases to be reasonably available.
6 Deposit requirements
For the purposes of this Act, the deposit requirements are to be taken to be 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 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
(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.41 Specifications: micro‑organisms
Provisional specifications
(1A) A specification is taken to comply with subsection 40(1), so far as it requires a description of a micro‑organism, if:
(a) the micro‑organism is deposited with a prescribed depository institution in accordance with such provisions of the Budapest Treaty as are applicable; and
(b) the prescribed circumstances[4] apply.
Complete specifications
(1) To the extent that an invention is a micro‑organism, the complete specification is to be taken to comply with paragraph 40(2)(a), so far as it requires a description of the micro‑organism, if the deposit requirements are satisfied in relation to the micro‑organism.[4] The prescribed circumstances for provisional specifications mentioned in s41(1A)(b) are set out in reg 3.32 and are analogous to the requirements of Sec 6. It is apparently not in dispute that the five priority applications did not meet these criteria.
To summarise these provisions:
Section 41 gives a patent application the ability to satisfy the disclosure requirements of section 40 for micro-organisms, if the deposit requirements of section 6 are met.
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.[5]
[5] The full set of criteria for determining the prescribed period is detailed in reg 1.5 but it is apparently not in dispute that the date for the purposes of s6(c) in the present case is the publication date.
History
10.GloFish, LLC, (“Glofish” or “The Applicant”) is a producer of transgenic ornamental fish. This case concerns transgenic Siamese fighting fish (Betta splendens or “Bettas”) which have been produced to display fluorescent ornamental colours.[6]
[6] Smith #2 at 2 and 5 – these are references to declarations which appear later in the narrative.
11.According to the declaration of GloFish’s U.S. patent attorney, chromosomally integrated transgenic transformation events in fish are not reliably uniform or stable. The parental generation “F0” of transformed fish are apparently not considered to be stable until the colour producing transgene has been reliably passed to the next “F1” generation of fish.[7]
[7] Smith #2 at 7 and 10
12.This instability and unpredictability is also apparently the reason that, in order to seek patent protection for their transgenic Bettas, GloFish elected to satisfy the support and description requirements by depositing biological material of transgenic Bettas under the Budapest Treaty.[8]
[8] Smith #1 at 6, Smith #2 at 9
13.GloFish regards the production of a stable F1 generation as the trigger for display and sale of transgenic Bettas.[9]
[9] Smith #2 at 11
14.However, the American Type Culture Collection (ATCC), which is a recognised depositary institution for making patent deposits under the Budapest Treaty, apparently has different criteria for accepting fish sperm samples: according to the Applicant’s U.S. patent attorney, the ATCC was said to have required sperm samples from three generations of fish: the F0, F1 and F2 generations.[10] This was later clarified by GloFish’s Australian attorney, to the effect that his understanding was that the ATCC required 25 identical cryovials of sperm and the most practical way of generating a sufficient amount of sperm was by mixing sperm samples from the F2 generation (the earlier generations not comprising sufficient numbers of fish).[11]
[10] Smith #2 at 9
[11] Whitmore #2 at 9
15.GloFish had screened F0 (parental) fish for successful transformation with fluorescent transgenes between December 2016 and September 2017.[12] GloFish informed their U.S. patent attorney that they had begun crossing F1 transgenic fish to produce a F2 generation as early as February 2018 (Green Bettas) up to January 2019 (Orange and Pink Bettas).[13]
[12] Smith #2 at 8
[13] Smith #2 at 11
16.GloFish had filed a number of U.S. provisional patent applications on 13 November 2018 – one for each colour Betta (Green, Orange, Red, Purple and Blue).[14] Each of these priority documents state that cryopreserved testes comprising the respective colour Betta transformation have been deposited at the European Collection of Cell Cultures (ECACC) but with unspecified accession numbers (although there is no evidence that any such ECACC deposits were ever made).
[14] 62/760,480, 62/760,445, 62/760,464, 62/760,498, and 62/760,489, as listed in the priority claim of the PCT application.
17.GloFish wished to retain the priority date of these provisional applications for commercial reasons.[15]
[15] Whitmore #2 at 5
18.GloFish proceeded to file an international patent application (PCT/US2019/061155, “The PCT application”) on 13 November 2019 (12 months after the provisional applications) combining the disclosure of the provisional patent applications - i.e. stating that respective cryopreserved testes have been deposited at the ECACC but without accession numbers.
19.GloFish, although aware of the deposit requirements of the ATCC[16], was unable to obtain enough sperm sample of F2 generation Green, Orange and Pink Bettas until 13 February 2020, after the PCT application had been filed.[17]
[16] Smith #2 at 12, Whitmore #2 at 6
[17] Smith #2 at 12
20.GloFish deposited sperm of Green, Orange and Pink Bettas at the ATCC on 20 February 2020 and received a receipt for the same dated 20 March 2020.
21.An International Search Report was prepared by the Korean Intellectual Property Office and mailed to the Applicant on 13 March 2020.[18] The PCT application was published as WO2020/102333 A1 on 22 May 2020.
[18] Although I have found the s6(c) aspect is moot, the mailing date of the International Search Report would be relevant to the Applicant’s ability to introduce the deposit details into the specifiction, as a Demand for International Prelminary Examination along with amendments under PCT Article 34 can be filed at any time after the receipt of the International Search Report, up to 22 months from the priority date.
22.GloFish amended the PCT application under the provisions of PCT Article 34 on 11 August 2020[19] to change the depositary institution from ECACC to ATCC and to add the deposit details for Green, Orange and Pink (amended from Red) Bettas.
[19] 21 months from the priority datey
23.After entering the national phase in Australia,[20] GloFish sought an extension of time under s223 on 16 August 2021, to satisfy the requirements of s6(c). This was accompanied by a first declaration of GloFish’s U.S. Patent Attorney, Dr Ryan C. Smith dated 11 August 2021, (“Smith #1”) with two exhibits: RCS-1 (A copy of the Budapest Treaty deposit receipt) and RCS-2 (An extract of the PCT Chapter II demand and Article 34 amendment).
[20] On 8 June 2021
24.After a letter from the Commissioner’s delegate on 23 August 2021 requesting further information, a further extension of time request was filed on 22 October 2021, to satisfy the requirements of s6(a) and (d). This was accompanied by a declaration of GloFish’s Australian representative, Scott Anthony Whitmore, dated 22 October 2021(“Whitmore #1”), with exhibit SAW-1 which included a receipt of the PCT Chapter II demand, received by GloFish from KIPO on 11 August 2020.
25.In response to a further letter from the Commissioner’s delegate on 2 December 2021 requesting further information, GloFish filed additional submissions on 2 February 2022, accompanied by three attachments: A) Part II of the requirements for international depository authorities; B) An extract from the ATCC’s web site regarding their deposit requirements; C) A clean copy of the specification incorporating the Article 34 amendments.
26.The Commissioner’s delegate wrote to GloFish on 18 February 2022 indicating that the Commissioner intended to refuse the extension of time requests and giving GloFish an opportunity to request to be heard. The grounds for refusal were that satisfying the requirements of s6(a) and (d) are not “relevant acts” within the meaning of s223(2), the circumstances were not beyond GloFish’s control (s223(2)(b)) and no causal error or omission had been identified (s223(2)(a)). Furthermore, the delegate considered there would be no useful purpose in granting an extension for s6(c).
27.GloFish requested to be heard on the matter and the hearing duly took place by videoconference on 2 May 2022. Accompanying their written submissions prior to the hearing, GloFish submitted a second declaration from Dr Smith dated 21 April 2022 (“Smith #2”). During the hearing, I gave GloFish a two-week period to file additional written submissions relating to the effective priority date of the deposits. I also indicated that if I were to find that extension of time for s6(a) and (d) was legally possible but I was not satisfied that the failure to comply with those provisions was due to a causal error or omission, I would give GloFish the opportunity to file further evidence.
28.After the hearing, GloFish filed further evidence in the form of a second declaration of Scott Anthony Whitmore dated 16 May 2022 (“Whitmore #2”). GloFish’s cover letter of that date submitted that they did not see the priority date of the deposit as being relevant to the extension or time request.
29.To summarise:
·GloFish is requesting an extension of four months, under either s223(2)(a) or (b), from 13 November 2019[21] to 13 March 2020[22] to satisfy the requirements of s6(a) and (d).
[21] the filing date of the PCT application
[22] the ATCC deposits were made on 20 February 2020
·GloFish is requesting a separate extension of three months, under either s223(2)(a) or (b), from 22 May 2020[23] to 22 August 2020[24] to satisfy the requirements of s6(c).
[23] the publication date of the PCT application
[24] the Article 34 amendments were filed on 11 August 2020
Extensions of Time
30.The Act provides, in section 223, a mechanism that gives the Commissioner the discretionary power to extend the time for doing certain acts.
31.The subsection relied on by the Applicant in this case is 223(2) which relates to errors, omissions, or circumstances beyond the control of the person concerned.
(2) 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. (emphases added)
32.As noted above this is a discretionary power. However, before the Commissioner can choose to exercise her discretion, a number of statutory criteria must be met: [25]
[25] Cf Kimberly-Clark Ltd v. Commissioner and Minnesota Mining and Manufacturing Co (No 3) 13 IPR 569 at 697 “The material placed before the Commissioner’s delegate was in my opinion quite insufficient to permit exercise of the power conferred by s160(2)(a) in favour of the applicant.”
·The act for which the extension is sought must be a “relevant act”
·It must be one that is “required to be done”
·It must be one that is required to be done “within a certain time”; and
·The execution of the act must have been frustrated by the circumstances set out in either paragraph (a) or (b) of the subsection, i.e. there must have been a causative error, omission, or circumstance beyond control.
33.The first three criteria are questions of statutory construction which relate to whether s223(2) can apply to a given type of act. The last criterion is a factual one.
34.As will become apparent, it is only necessary for me to consider the statutory questions in this case.
Statutory construction:
35.As the Full Federal Court has recently stated[26]
[26] Commissioner of Patents v Thaler [2022] FCAFC 62 at 83. Also see Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 at 116
“The duty to resolve an issue of statutory construction is a text-based activity. However, questions of policy can inform the Court’s task of statutory construction. It is accordingly appropriate to consider policy considerations, however the surest guide to ascertaining the legislative intention is the language of the text of the legislation itself.” (Citations omitted)
36.However, there will always be situations where the text of a statute could be interpreted in multiple ways. I find the principle expressed by Justice Murphy in his dissent in APM[27] to be helpful and relevant:
[27] Australian Paper Manufacturers v CIL Inc [1981] HCA 64 (APM)
“It is a reasonable principle of interpretation that where an Act which grants monopoly rights is ambiguous, the ambiguity (whether relating to substance or procedure) should be resolved in favour of the public and against the extension of monopoly”[28]
[28] APM per Murphy J at 3
Relevant act
37.Subsection 223(11) of the Act defines a “relevant act” as:
“...an action (other than a prescribed action) in relation to a patent, a patent application, or any proceedings under this Act (other than court proceedings), and includes the making of a Convention application within the time allowed for making such applications.” (emphasis added)
38.In the hearing, GloFish’s counsel drew particular attention to the list of exclusions (“prescribed actions”) which are found in Regulation 22.11(4). Making a microorganism deposit under s6(a) is not one of them.
39.GloFish’s counsel also drew attention to the High Court decision in Alphapharm[29] which related to the definition of a “prescribed action” in Regulation 22.11(4). In Alphapharm, the High Court stated that "It may be accepted that s223(2) is remedial in nature and should therefore be given a wide operation"[30] and should have a “broadly protective and remedial operation”.
[29] Alphapharm Pty Ltd v H Lundbeck A/S (2014) 314 ALR 182
[30] Alphapharm at 115
40.The High Court in Alphapharm went on to state:
“It can be observed generally that, subject to reg 22.11, there is no reason to suppose that s223 of the Act lacks the broadly protective and remedial operation accorded to its immediate predecessor[31] by numerous courts, including this Court.
[31] Section 160 of the 1952 Act
… To focus on a single "relevant act" (or "one action") to the exclusion of time requirements, and to ask only whether that "relevant act" (or "one action") is "prescribed", as Alphapharm does, is to misapprehend the real purpose of s223(2)(a) – to confer a general remedial power to extend time – and the derivative purpose of reg 22.11(4) – to exclude a limited number of times from that general power to extend time.”[32] (applicant’s emphasis)
[32] Alphapharm at 64-65h
41.However, it must be borne in mind that the question that the High Court was answering in Alphapharm was a particularly narrow one with respect to applications for extension of patent terms under subsection 70(1). The context of this question was that the timing of term extension applications are governed by subsection 71(2) which sets two criteria: they must not only be made during the term of the patent but also within six months of the latest of three specified dates.
42.The High Court found that inclusion of the phrase “filing, during the term of a standard patent as required by subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of the term of the patent” in reg 22.11(4) did not exclude all applications under subsection 70(1) from being relevant acts. Rather, it only prevented the criterion of “made during the term of the patent” being extended under s223.
43.So, the High Court’s caution on focussing on “one action” was, in my view, simply pointing out that just because an action is mentioned in reg 22.11(4) does not mean that all instances of that action are prescribed actions.
44.Since microorganism deposits are not mentioned in reg 22.11(4) this point is somewhat moot.
45.As will be seen from my consideration, I do not consider that microorganism deposits fit the threshold definition of “relevant act”, so it is hardly surprising that they are not found in the list of exclusions.
In relation to
46.The meaning of “in relation to” has been addressed by the High Court in APM. Although that decision related to subsection 160(2) of the 1952 ct, the language of “in relation to an application or patent” is the same as found in current subsection 223(11).[33] The majority decision found that “the very first act by way of application for a patent will itself be an "act or step in relation to an application" within the meaning of s. 160 (2)”.[34]
[33] In order to remove the ambiguity identified by the dissenting Justices in APM, the definition of subsection 223(11) introduced in the 1990 Act explicitly includes the step of making an application, but the principles for interpreting “in relation to” are still sound
[34] APM per Stephen J at 6
47.In writing for the majority, Stephen J’s use of the words “very first” seems to me to be quite deliberate – in rejecting the notion that “lodging of the application must precede any act or step to which s. 160 (2) can apply”[35] he still apparently considered that acts preceding the filing of the application would be excluded.
[35] Ibid.
Required to be done
48.In Sunesis[36] at paragraph 27 the Full Federal Court provided the following comprehensive summary of the principles relating to the application of s223(2), with particular focus on the definition of “required”. I will quote the passage in full: citations have been retained from the original but the emphases are mine:
[36] Sunesis Pharmaceuticals Inc v Commissioner of Patents [2015] FCAFC 29
“Previous consideration of this section and its predecessor has led to the following principles being established:
·Section 223 is a remedial section and one of general application and should be applied where it appears to be applicable unless there is some clear indication to the contrary (Scaniainventor v Commissioner of Patents (1981) 36 ALR 101; GS Technology Pty Ltd v Commissioner of Patents (2004) 63 IPR 9 at [50]).
·The critical question is whether there is an act or step required to be done or taken within a certain time, in the sense of Australian Paper Manufacturers Ltd v CIL Inc (1981) 148 CLR 551 at 555).
·The section will relevantly apply where there is an error or omission and the applicant has failed to take a step or act within a required time in relation to a patent application, thereby losing a benefit or advantage or suffering or failing to avoid a disadvantage.
·“required” describes the nature of the link between the doing of the act and the time for the doing of it. ‘As long as the provision in question is either permissive of the doing of an act or else confers a benefit or right as a result of doing it, being in either case linked with a period within which it is to be done, “required” can aptly be used’ (Australian Paper at 557 per Stephen J, considering the predecessor section, s160 of the Patents Act 1952 (Cth) (the 1952 Act)). Before the section applies, ‘there must be an act which is required to be done or a step which is required to be taken and a time specified within which the act is to be done or the step is to be taken’ (per Brennan J at 560). 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 (per Brennan J [dissenting] at 560). ‘Required’, also used in s160(2) of the 1952 Act, means ‘requisite’ or ‘needed’ in order to secure an advantage or avoid a disadvantage (Scaniainventor at 104).
·‘Whenever the doing of some act is linked with a period within which it is to be done it can with perfect accuracy be described as being required to be done within that period… where the provision in question confers a benefit, the doing of the act within the period may be a condition of obtaining the benefit… the word ‘required’ will aptly describe the nature of the link between the doing of the act and the time for the doing of it’ (Australian Paper at 556).
·In the absence of ‘quite compelling contextual or other considerations’, the section must apply to permit or empower the granting of extensions: Australian Paper at 557; Scaniainventor at 105; Lehtovaara v Acting Deputy Commissioner of Patents (1981) 39 ALR 103.”
49.Although GloFish’s counsel drew my attention to the general beneficial applicability of the s223 provisions, I cannot help but notice the numerous caveats in the above principles:
· “should be applied where it appears to be applicable unless there is some clear indication to the contrary”
· “As long as the provision in question is either permissive of the doing of an act or else confers a benefit or right as a result of doing it”
· “In the absence of quite compelling contextual or other considerations”
50.The question at issue in Sunesis was whether the transitional provisions of the Raising the Bar Bill, which were triggered by the date at which an act (requesting examination) was done, were amenable to extension by section 223. Although Sunesis had lost a benefit as a result of failing to perform an act by a certain time, the court held that section 223 was not applicable, finding:
“This case is about the applicability of the power to extend in s223 in circumstances where the requirement to act within a certain time is said to be derived from the commencement of a legislative amendment which was not in force when the relevant act, the request for examination, was said to have been “required”.”[37]
[37] Sunesis at 30
“An extension of time in which to make the application for examination of the patent application does not back date the request for examination, it extends the time in which an application can be made. Section 223(2) of the Act cannot prevent “the Sword of Damocles” from falling on that date.”[38] (emphasis added)
[38] Sunesis at 34
Within a certain time
51.The High Court in APM also considered the meaning of “within a certain time”. I find the following paragraph, which overlaps one of the parts quoted in Sunesis, helpful because it contrasts provisions which on the one hand limit the benefit of relevant acts to a certain time with those which on the other hand prohibit the doing of an act in a certain time. Stephen J, for the majority, considered that in at least some circumstances “the concept of an affirmative requirement may be inapt”.
“Legislation may provide that an act may only be done, if at all, within some prescribed period, the doing of it later being either prohibited or being declared to be ineffective and a nullity; or again, where the provision in question confers a benefit, the doing of the act within the period may be a condition of obtaining the benefit. But in either case the word "required" will aptly describe the nature of the link between the doing of the act and the time for the doing of it. In the case of provisions of a quite different nature, prohibiting the doing of a particular act within a given time, the concept of affirmative requirement may be inapt; but so long as the provision is either permissive of the doing of an act or else confers a benefit or right as a result of doing it, being in either case linked with a period within which it is to be done, "required" can aptly be used.”[39] (emphases added)
[39] APM per Stephen J at 8
52.The meaning of “within a certain time” was also recently considered by the Commissioner’s delegate in Neurim,[40] with reference to the 1986 AAT Stibbard decision.
[40] Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd. [2022] APO 2
“Beyond the above principles, it is important to understand what precisely comprises a relevant act that is required to be done in a certain time. As is perhaps obvious from the words of s223, the time can only be extended to do acts for which there is a requirement in the Act or Regulations that the act be done in a certain time. For example, an extension of time to file a complete application where there was no earlier priority was refused in Norman Stibbard v The Commissioner of Patents 7 IPR 337 (“Stibbard”) given that there was no legislated time period to file such an application, and thereby there was no relevant act that could enliven s160(2) of the Patents Act 1952.”[41] (emphasis added)
[41] Neurim at 25
Other precedent relied on by the Applicant:
53.GloFish’s counsel drew my attention to the following passages from GS Technology.[42]
[42] GS Technology Pty Limited v Commissioner of Patents [2004] FCA 1017
“Section 223 of the Act is a remedial section designed to advance the purposes of the Act and, to that end, permitting the forgiving of error or mistake where it is appropriate to do so.”[43]
[43] GS Technology at 50
“Most errors and omissions which lead to a failure to do an act or take a step are the result of negligence or incompetence. Where such errors and omissions are made against a clearly demonstrated desire to maintain the application (and thus not have it lapse), and where attempts are made to remedy the error or omission as soon as its consequences are discovered and the existence of the error or omission learnt, as is the case here, the considerations in favour of an extension seem to me to be quite persuasive.”[44]
[44] GS Technology at 65
54.However, these passages are only in the context of determining whether the Commissioner should exercise her discretion. As will be seen from my consideration below, the question of discretion in this case is moot.
Consideration – s6(a) and 6(d)
55.Section 223 is a beneficial section and should be applied beneficially. Therefore, I have considered GloFish’s request from a number of angles: first principles based on the textual construction of section 223; comparison with existing precedent on section 223 and its predecessor; from the perspective of the policy objectives of the Budapest Treaty provisions; and from the viewpoint of what other remedies may exist in the Act for this or similar circumstances.
56.However, none of them lead me to the conclusion that s6(a) or (d) involve “relevant acts required to be done within a certain time” within the meaning of section 223. It is therefore unnecessary to consider whether any error, omission or circumstance beyond control occurred, and ipso facto the Commissioner has no discretion to exercise.
First principles
57.The threshold question is whether making a microorganism deposit is one that is actually required to be done within a certain time.
58.In order for s223 to be applicable, s6(a) would have to be interpreted such that the filing date of the application creates an implied time for doing the act (making the microorganism deposit) ending at that date.
59.However, the proposition that the act of filing, which is entirely within the applicant's control, could be said to create a time period that has already expired strikes me as absurd.
60.Until the filing is done (i.e. during the entirety of the purported implied period) there is no requirement to make any deposit, apart perhaps from a "potential" requirement to make a deposit as early as possible in order to create the possibility for a valid patent filing.
61.It seems much more appropriate to view s6(a) as a simple logical test, which makes sense given the language of s6 is "if and only if". The disclosure requirements are only satisfied if a certain state of affairs was in place at a certain time (and s6(d) confirms that this state of affairs needs to continue thereafter). There is no "within a certain time" to enliven s223.
Comparison with precedent
62.Having considered the range of cases dealing with s223, I can sort them into groups, in order to identify common principles:
Examples where an act was required to be done within a certain time:
oAlphapharm (confirming that not all instances of s70(1) requests were prescribed actions)
oNeurim (in order to satisfy the grace period requirements of s24 – the time period extended was the prescribed 12 month grace period)
oScaniainventor and APM (in order to claim the benefit of priority – the time period extended was the 12 month priority period)
Examples where an act was not required to be done within a certain time:
oStibbard (there was no period in which to file the application)
oSunesis (although the applicant could have been said to have lost a benefit by not filing an examination request by the Raising the Bar cutoff date, the transitional provisions were not extendable - they constituted a strict if/then provision)
63.I consider that the act of making a deposit (even admitting that there is an implicit requirement for this act in the Act) falls closer to Stibbard and Sunesis than it does to APM or Neurim for the following reasons:
oThere is no pre-existing time period, similar to Stibbard[45]
[45] The mere presence of a priority claim here is irrelevant as the deposits are not asserted to claim the benefit of the priority date and do not satisfy the requirements of Regulation 3.32.
oThe statutory test of section 6 is an if-and-only-if test, like in Sunesis
64.So even if the filing of the deposit could be said to be a relevant act (which is at best arguable – it may fall within the “process of obtaining patent protection”[46] even though it needs to happen by the time the “very first act” of filing the application can take place), and even if it could be said to be required to be done (the Explanatory Memorandum to the 1984 Bill does refer to “the need”) it is certainly not required to be done within a certain time.
[46] APM per Stephen J at 6
65.At this juncture I should make a couple of points about Stibbard. Although the AAT refused Mr Stibbard’s request to extend the time for lodging an application, it did not find that it was not possible to retrospectively extend a time period so as to confer an earlier priority date.[47] Rather, it declined to decide this question. It instead came to its conclusion on the basis that the filing of a standard patent without a priority claim did not have any associated time-sensitive benefits or requirements under the Act.[48]
[47] Stibbard at 10
[48] Stibbard at 11
66.The AAT in Stibbard was also concerned by the possibility of the “rude shock” of being “defeated by a less prompt inventor applying under s160(2) for an indulgence”.[49] Could GloFish’s conduct constitute an equivalently “rude shock”? On the one hand the presence of the PCT application indicating the existence of a deposit could be said to mitigate the shock. But the potential for deposits filed at an unspecified later date to augment the rights of the PCT applicant does strike me as exactly the sort of shock that the AAT was concerned to avoid.
[49] Stibbard at 14
67.So, I can admit that the requirements of section 6 could be distinguished from the situation in Stibbard in that they are associated with other actions under the Act. Furthermore, there is no apparent precedent stating that antedating priority is impossible (which is effectively what I find GloFish to be attempting). So, it could be open to me to construe sections 223 and 6 in GloFish’s favour. However, taking all the other factors into consideration, in particular Murphy J’s admonition against resolving ambiguity in favour of monopolies, I will not do so.
Policy principles – the role of the Budapest Treaty provisions
68.The purpose of the Budapest Treaty provisions is to satisfy the description requirements of the Patents Act where it is not possible to describe an invention in words. In that case, the microorganism deposit represents the disclosure of the actual technical contribution.
69.It is a clear principle of the patent bargain that the invention must be disclosed when the specification is filed. It is this which sets the date of the patent term and provides the date for assessment of patentability vis-á-vis the prior art.
70.Given that a Budapest Treaty deposit constitutes the description of a micro-organism invention, filing an application before a deposit is effected is somewhat akin to filing an application before the development of the invention has been completed.
71.In the case of an invention directed to, for example, a new gene sequence, this would be equivalent to filing the application before the sequencing had taken place and then later filing a sequence listing once the sequencing had been completed.
72.At the hearing, GloFish’s counsel proposed that the causal error or omission could have been GloFish’s failure to appreciate the time required to satisfy the ATCC deposit requirements. However, the proposition that research is time consuming and hence the Applicant took longer than it wished to satisfy the disclosure requirements seems to be drawing a very long bow from the “forgiving of error or mistake” referred to in GS Technology. Although GloFish’s counsel submitted at the hearing that there was no reason in the language of subsection 223(2) to distinguish administrative errors and omissions from technical ones, this is something that would only come into consideration when determining causation. If the requirements of s6(a) and (d) do not pass the threshold of being relevant acts required to be done within a certain time, then the causation is moot.
73.As an aside, I am not aware of any cases where s223(2) has been enlivened by a mishap that prevented the technical development of an invention. In each of APM, Scaniainventor and Neurim, where extensions of time related to filing the complete application were granted, a prior description of the invention existed. That is unlike the case here, where the description (in the form of the Budapest deposit) was only completed after the application had been filed.
Alternative legislative remedies
74.GloFish’s counsel had pointed to the lack of any mention of section 6 in the prescribed actions excluded from section 223 by reg 22.11(4). It seems to me that those prescribed actions fall within two classes: on the one hand actions that the drafters intended to be non-extendable for policy reasons (such as the need to request a term extension during the term of a patent as discussed in Alphapharm) and on the other hand actions which have an alternate remedy (such as actions regarding to oppositions, which have a separate remedial scheme in reg 5.9).
75.So, considering the presence or absence of alternative legislative remedies for section 6 and analogous situations can also, I think, be informative.
76.GloFish’s counsel suggested at the hearing that his client was being disadvantaged compared to the situation where they could have filed an additional PCT application once the Budapest deposit had been made, and then applied for a section 223 extension to the priority period. Indeed, this act is explicitly contemplated in subsection 223(11). And a regulatory scheme exists in reg 6.3(9) to mitigate the potential effect of this situation on patent term. No such scheme exists for the present situation.
77.The analogy of the sequence listing is also illuminating in terms of the remedies available in situations where an incomplete disclosure was accidentally filed – for one example, a sequence listing was inadvertently omitted from the application as filed, or for another example the wrong gene had been sequenced.
78.But when errors have caused the specification as filed to be insufficient, section 223 is not the appropriate mechanism to remedy that insufficiency. Under Australian law such errors would not be corrected by section 223 but could potentially be corrected by amendment of the application, with recourse to the “clerical error or obvious mistake” provisions of subsection 102(3). The former situation above could be corrected under s102(3) but the latter (where the wrong sample had been analysed) would not.
79.A regulatory scheme exists to confer the correct priority date on amended specifications – section 114 and reg 3.14. And conformance with s6(c) is specifically mentioned as an exception in subsection 102(3).
80.The only other remedial scheme referring to section 6 takes the form of subsection 41(4) and reg 3.30. These address the continuity requirements of s6(c) and (d). There is no apparent remedy for s6(a) (which is effectively the starting point of the s6(d) requirement).
81.The conspicuous absence of remedial provisions for s6(a) in the Act and Regulations leads me to consider that this lacuna is not a mere oversight – rather that the drafters never had the intention that the requirements of s6(a) could be extended.
Section 6(c)
82.I agree with the delegate in finding that since the deposit itself was not made before the filing date and that time cannot be extended, the second request, for extension of time to add the deposit details to the description, would not serve any useful purpose.
83.In any event, I am not particularly convinced that any error or circumstance beyond GloFish’s control led to the s6(c) date not being met. According to the available evidence, GloFish was in possession of the deposit receipt on 20 March 2020 which was before the PCT application had been published but after the International Search Report had been issued. So, it would have been possible for GloFish to file a Demand and appropriate amendments under Chapter II of the PCT immediately, which would have satisfied the s6(c) requirements. However it did not do so until close to the final date for Chapter II amendments, and there has been no reason provided for this delay.
Conclusion
84.The requirements of s6(a) and (d) do not involve relevant acts that are required to be done within a certain time. Consequently s223(2) cannot be enlivened, and there does not appear to be any advantage in providing GloFish the opportunity to file further evidence. I refuse the requests for extensions of time to satisfy the requirements of s6(a), (c) and (d).
Felix White
Delegate of the Commissioner of Patents
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