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Australian Patent Office |
2022] APO 2 
(14 January 2022)
Last Updated: 14 January 2022
IP AUSTRALIA
AUSTRALIAN PATENT
OFFICE
Generic Partners Pty Ltd v Neurim Pharmaceuticals
Ltd. [2022] APO 2
Patent Application: 2016426598
Title: Melatonin mini-tablets and method of manufacturing the same
Patent Applicant: Neurim Pharmaceuticals Ltd.
Opponent: Generic Partners Pty Ltd
Delegate: Dr W.E. Guinea
Decision Date: 14 January 2022
Hearing Date: 23 February 2021, by Video Conference
Catchwords: PATENTS – opposition pursuant to s223(6) –
extension of time under s223(2)(a) – grace period under s24(1)(b) –
whether
223 applicable to s24 – 223 considered applicable to s24 –
whether there is an error or omission – error or omission
established
– whether the error or omission is causative to frustrate an intention
– causative error or omission established
– discretion –
whether discretion should be exercised – appropriate to exercise
discretion – extension of
time granted – costs awarded against
Opponent
Representation: Counsel for the applicant: David Shavin QC
Solicitor for the applicant: Nicholas Tyacke of DLA Piper
Counsel for the opponent: Richard Cobden SC and David Larish
Solicitor for the opponent: Rob Silberstein of Silberstein &
Associates
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016426598
Title: Melatonin mini-tablets and method of manufacturing the same
Patent Applicant: Neurim Pharmaceuticals Ltd.
Date of Decision: 14 January 2022
DECISION
I am satisfied that the Applicant,
Neurim Pharmaceuticals Ltd, failed to file in time to claim the
benefit of the grace period pursuant
to s24(1)(b) and Reg 2.2D due to the
failure of Dr Nir to inform Dr Laudon about the publication of D1. The relevant
discretionary
factors weigh in favour of grant of the extension. I grant
Neurim Pharmaceuticals Ltd an extension of time of eight (8) months
pursuant
to s223(2)(a) to file the application in time to claim the benefit of
the grace period pursuant to s24(1)(b) and Reg 2.2D.
I award costs against
the Opponent, Generic Partners Pty Ltd according to Schedule 8 of
the Regulations.
Pursuant to the direction made 4 March 2020, the
evidence in reply for the opposition to this application under s59 of the
Patents Act is due two (2) weeks from the date of this decision.
REASONS FOR DECISION
Background
1. Patent application 2016426598 (the “application”) entered national phase from PCT/IB2016/057190 on 26 April 2018, in the name of Neurim Pharmaceuticals Pty Ltd (the “Applicant”). The application has a filing date of 29 November 2016, and an earliest priority date of 31 October 2016.
2. The application is also the ultimate ancestor of a family of patents or patent applications. The relationships and key dates, such as filing, grant etc. of the family is given at Annex B to this decision.
3. Expedited examination was requested at national phase entry. A first examination report issued on 6 June 2018, with the application subsequently accepted on 4 October 2018. The application was advertised as accepted on 1 November 2018.
4. The Applicant requested voluntary amendment of the application under s104 on 24 October 2018 (the “amendment”). The amendment was advertised as being allowable on 15 November 2018 and was subsequently allowed on 23 January 2019.
5. On 1 February 2019, Generic Partners Pty Ltd (the “Opponent”) filed a notice of opposition to the grant of the application under s59 of the Act (the “s59 opposition”). A statement of grounds and particulars (“s59 SGP”) was filed on 1 May 2019, with evidence in support (“EIS”) being completed on 5 August 2019.
6. Notably, for reasons that will become apparent, and while not in evidence in this matter, both the s59 SGP and EIS cited Schrier L. et al., Chapter 8: Pharmacokinetics of prolonged-release melatonin mini-tablets in children with both autism spectrum disorder and a sleep disorder, Non-invasive monitoring of pharmacokinetics and pharmacodynamics for pharmacological drug profiling in children and adolescents, Universiteit Leiden, pages 213 to 240, 15 April 2015, hereinafter “D1”. D1 was cited as prior art in the s59 opposition for the purposes of establishing lack of novelty and/or inventive step against at least some of the claims.
7. Evidence in answer (“EIA”) was completed on 6 November 2019. The Opponent flagged its intention to file an extension of time to file evidence in reply (“EIR”) on 26 November 2019, with the actual request for an extension of two months being filed on 5 December 2019. This extension was granted on 14 January 2020. However, as will be seen, while some EIR has been filed, subsequent events have overtaken this extension such that the period for filing EIR has not yet expired.
8. On 9 December 2019, the Applicant filed a request for an extension of time under s223(2)(a) and s223(2)(b) to rely upon the grace period under s24 (the “EOT”). The EOT was accompanied by several supporting declarations and written submissions as follows:
9. The EOT was for eight months, from 15 April 2016, being the last day on which the Applicant would usually be able to file the application and claim the benefit of the grace period with respect to D1 pursuant to s24(1)(b) and Reg 2.2D. Thus, it can be seen that the effect of the EOT, if it were to be granted, would be to remove D1 as prior art in the s59 opposition. Consequently, the course of the s59 opposition, and any EIR the Opponent may wish to file, will be highly dependent on the outcome of the EOT.
10. Because of this this, on 18 February 2020, a Delegate of the Commissioner wrote to the parties proposing to stay the s59 opposition until two weeks after the Commissioner advises the parties of the outcome of the EOT, at which point the EIR would also be due. After considering the positions of the parties, this stay was put in place on 4 March 2020.
11. On 13 March 2020, a Delegate of the Commissioner wrote to the Applicant regarding the EOT requesting further information and expressing the view that an extension under s223(2)(b) was not appropriate. The Applicant responded on 29 April 2020 with further submissions and several more declarations as follows:
12. The Delegate again requested further information on 24 June 2020. The Applicant responded on 9 July 2020 with submissions and a further declaration as follows:
13. At this point the Delegate was satisfied that the EOT under s223(2)(a) was allowable, and the EOT was advertised for opposition purposes on 30 July 2020. The Opponent filed a notice of opposition to the EOT on 30 September 2020 (the “opposition”).
14. The Opponent filed a statement of grounds and particulars (“SGP”) on 30 October 2020. No further evidence regarding the EOT was filed by either party.
15. The Opponent’s written submissions (the “Opponent’s written submissions”) were filed on 9 February 2021, with the Applicant’s written submissions (the “Applicant’s written submissions”) being filed on 16 February 2021. The matter was heard via video conference on 22 February 2021.
16. Both parties also referred to, and provided me with, materials, such as the evidence in support, from the s59 opposition. None of those materials, strictly speaking, are in evidence as such in this matter. It is also the case that it is not for me to determine the import of the evidence or the prior art to the application. However, it is necessary to have some reference to some of the material from the s59 material in deciding this matter. As both parties referred to such material and provided it to me, I see no injury to natural justice in having reference to material in the s59 opposition to the extent appropriate to inform my decision regarding the extension.
17. Before continuing, it is worth noting that the Opponent also sought review before the Administrative Appeals Tribunal (“AAT”) of the Commissioner’s decision to “grant” the EOT subject to opposition. The application for review was filed with the AAT on 28 September 2020, with an application for an extension of time for the review being filed on 7 October 2020. A hearing regarding the extension of time occurred on 25 November 2020, with the AAT providing oral judgement refusing the extension of time after the hearing. No appeal to the AAT decision has been filed, leaving it unquestionably open to the Commissioner to now decide the opposition.
The Opposition
18. In the SGP, the Opponent listed grounds as follows:
Further or in the alternative, the Commissioner should, in the exercise of her discretion, refuse to grant the extension of time sought because:
19. Grounds ii and vi were abandoned in the Opponent’s written submissions, and so are not considered in this decision.
The Law
20. Extensions of time are provided for under s223 of the Patents Act 1990 (the “Act”). Specifically, for current purposes s223(2) reads as follows:
“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.”
21. Section 223(11) 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.”
22. Prescribed actions are given in the Patents Regulations 1991 (the “Regulations”) at Reg 22.11(4), and include, for example, most actions under Chapter 5 of the Act. The precise list of prescribed actions is not important for the purposes of this decision, noting that the action concerned here is not one of the prescribed actions.
23. Section 223, and the equivalent provision, s160, in the Patents Act 1952, have been extensively considered in the authorities. A convenient distillation of the relevant principles was provided by the Delegate at [6] to [8] of Knauf Plasterboard Pty Ltd v CSR Building Products Limited [2018] APO 64:
“6. The following principles for applying the provisions of section 223 are derived from decided cases:
(i) The statutory provision to extend time is beneficial in nature and should be applied beneficially (Re Sanyo Electric Co Ltd and Commissioner of Patents [1996] AATA 832 at [16]; [1996] AATA 832; (1996) 36 IPR 470 at 479).
(ii) While the applicant has the burden of placing before the tribunal the circumstances it claims will justify the grant of an extension of time, that does not amount to a burden of proof and it is not appropriate that it be so described (Re Sanyo Electric Co Ltd and Commissioner of Patents [1996] AATA 832 at [16]; [1996] AATA 832; (1996) 36 IPR 470 at 479).
(iii) For section 223(2)(a) to be enlivened, it must be shown that an error or omission had contributed to cause the failure to perform the relevant act, i.e. there must be a causal connection between the error or omission and the relevant act that is required to be done within the stipulated time (Kimberly-Clark Ltd v Commissioner of Patents [1988] FCA 697 at [9] and [15]; Re Lazer Safe Pty Ltd and Commissioner of Patents [2001] AATA 967 at [11]).
(iv) The applicants for an extension of time must demonstrate that they had an intention to do the relevant act within the time prescribed, and that an error or omission on their, or their agent’s, behalf reasonably could be said to have frustrated that intention (Kimberly-Clark Ltd v Commissioner of Patents [1988] FCA 697 at [9]; Re Lazer Safe Pty Ltd and Commissioner of Patents [2001] AATA 967 at [11]). However, there will be exceptional circumstances where the relevant error precluded the formation of a specific intention. In such cases the required causal connection is satisfied if the error contributed to the failure to form the intention to perform the relevant act (Re Apotex Pty Limited and Commissioner of Patents [2008] AATA 226 at [21]).
(v) ‘In order to make out the “proper case ... justifying an extension” ... an applicant would ... have to go beyond a disclosure of the processes by which an agent’s errors came to be committed and would have to expose frankly, inter alia, all the conduct, knowledge, beliefs and mental processes of the applicant ... relevant to an understanding of the way the failure to do the act or take the step occurred, or relevant to an evaluation of the reasonableness of that conduct’ (Kimberly-Clark Ltd v Commissioner of Patents [1988] FCA 697 at [17])
7. The term ‘error or omission’ in section 223 encompasses accidental slips, inadvertences and errors caused by faulty reflection; an unexpected failure to exercise due diligence and/or a flaw in mental function in carrying out an intention; and a breakdown in procedure in effecting an intention. Accordingly, the phrase ‘error or omission’ has a broad scope.
8. In contrast, the failure to perform the relevant act cannot itself be the ‘error or omission’ by which the failure occurred and a deliberate policy or decision that leads to the failure to perform the relevant act does not constitute an ‘error or omission’.”
24. It is also perhaps helpful to note the following regarding s223(2)(a) from Sunesis Pharmaceuticals Inc v Commissioner of Patents [2015] FCAFC 29 (“Sunesis”) at [27]:
“...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...”
25. 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.
26. Conversely, and relevantly to the present matter, in Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited [2002] APO 24 (“Ashmont”), it was held that s223 was applicable to extend the time to file an application to claim the benefit of the grace period pursuant to s24(1)(b), at [22]:
“I believe that the filing of a patent application within twelve months from unauthorised disclosure of the information is a relevant act required to be done within a certain time, as required by section 223. I can see no clear indication in the legislation to exclude section 24 from the provisions of section 223. Without a specific exclusion, as is the case for the time for filing a notice of opposition or a statement of grounds and particulars, I believe that section 223 applies. As a result, I find that section 223(2) is applicable to extend the time period prescribed by section 24(1)(b) and regulation 2.3(2).”
27. I note that the principles as I have expressed them largely correspond with those put forward by the Applicant at [5] of its written submissions. Those put forward by the Opponent at [35] in its written submissions, are largely reflected in the considerations I have adopted, or reflect considerations that may be helpful in certain situations. However, they do not, to my mind, reflect those generally adopted in the authorities for considering applications under s223.
28. Finally, in terms of the standard of proof concerned, I am of the view that, while there is not a burden of proof placed on the Applicant, I still must be satisfied on the balance of probabilities that a proper case for the extension has been made out. When I asked Mr Larish about the standard of proof, he indicated that I would need to be satisfied that an error or omission had been made out. While not explicitly referring to how I could be satisfied, I take Mr Larish’s comments, particularly in terms of his comments regarding Briginshaw v Briginshaw [1938] HCA 34; 60 CLR 336 (“Briginshaw”) discussed at [78] below, to be largely congruent with my views on the matter. Mr Shavin, for his part, suggested that while I must be satisfied of matters, I should not frame that in terms of the balance of probabilities, in view of the fact that the Applicant did not bear a burden of proof and the balance of probabilities related to a civil standard of proof. It should be clear that some mechanism is required to allow me to draw facts and inferences from the evidence, and in determining whether the extension is made out. I remain of the view that the balance of probabilities is the appropriate mechanism, as it generally is in matters before the Commissioner.
29. As the putative relevant act concerns filing in time to claim the benefit of the grace period pursuant to s24(1), and the Opponent has argued that this is not a relevant act, it is pertinent to repeat that provision here:
“24(1) For the purpose of deciding whether an invention is novel or involves an inventive step or an innovative step, the person making the decision must disregard:
(a) any information made publicly available in the prescribed circumstances, by or with the consent of the nominated person or patentee, or the predecessor in title of the nominated person or patentee; and
(b) any information made publicly available without the consent of the nominated person or patentee, through any publication or use of the invention by another person who derived the information from the nominated person or patentee or from the predecessor in title of the nominated person or patentee;
but only if a complete application for the invention is made within the prescribed period.”
Relevantly to the present matter, for information made publicly available in the circumstances mentioned in paragraph 24(1)(b) of the Act, the prescribed period, pursuant to Reg 2.2D, for making a complete application for an invention is 12 months from the day the information was made publicly available, reflecting the form of s24 relevantly in operation due to amendments from the Intellectual Property Law Amendment (Raising the Bar) Act 2012.
Consideration
30. I will now consider each of the grounds ultimately pressed by the Opponent.
Alleged Act is not a relevant act for the purposes of s223(2)(a)
31. The Opponent accepts that “...the filing of a complete application is a ‘relevant act’ within the meaning of s223(11)” (Opponent’s submissions at [23]). However, the Opponent argues that “...properly characterised, the filing of a complete application is not an act that is ‘required’ to be done within a certain time’ (Opponent’s submissions at [24], emphasis in original).
32. The Opponent developed this line of reasoning in their written submissions at [25] to [27]:
“25. While s 24(1)(b) specifies a consequence that arises if the patentee does something – i.e. files a complete application within the prescribed period – it does not require a patentee to do anything.
26. The patentee does not obtain any rights or avoid any obligations by filing a complete application within 12 months – all that happens is that certain information made publicly available in certain circumstances may be excluded from considering various grounds of patentability.
27. It follows that the grace period under s 24(1)(b) cannot be extended under s 223(2)(a).” (emphasis in original)
33. At the hearing Mr Cobden argued that:
“...on its face s24 does not require that an act be done within a certain time. On its face s24 is a direction to a decision maker to disregard information that the decision maker would ordinarily take into account when determining novelty, inventive step or innovative step”.
Mr Cobden contended that what would be disregarded for the purposes of s24 is determined by the “...entirely voluntary step of filing a complete application, a step that, of course, many people who invent will simply not take”. Because of this, Mr Cobden argued that the action of filing for the purposes of s24 was quite unlike the numerous instances where s223 is applicable. Mr Cobden argued, with reference to footnote 8 from Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42; 254 CLR 247, that where s223 has been found applicable it was for “...overt occurrences within the patent system somewhere...” and were for an extension of a time fixed in the patent system or an extension of time that results from doing an act in the patent system. These were said to be overt acts that could be observed or known by anyone with an interest in the patent application concerned, as opposed to the voluntary act of making a complete application within the period prescribed by s24.
34. Mr Cobden argued that in a practical sense a publication pursuant to s24 would in fact be known only to the patent applicant as opposed to the public. This was said to support the Opponent’s construction of s223 as it was undesirable for other users of the system to be taken by surprise, which, it was argued, would be the effect of extending the period under s24. Mr Cobden also referred to Stibbard in this connection.
35. Mr Cobden urged a wholistic construction of s223, and in particular the phrase, “a relevant act that is required to be done within a certain time”. There was, Mr Cobden argued, no binding authority as to the applicability of s223 to s24, arguing that Ashmont was obiter with little proper discussion of the issue and Amicus Therapeutics did not in fact confirm Ashmont.
36. Putting aside Ashmont for the moment, I still disagree with the Opponent’s contentions. As noted above, the act concerned is not one that is prescribed for the purposes of s223(11), so the applicability of s223 is not prohibited on that basis. The construction of what constitutes a “relevant act required to be done in a certain time” has been well established in the authorities as cited earlier in this decision. Mr Cobden’s arguments about the distinction between overt acts and voluntary ones finds no remit in the words of s223 nor in the case law.
37. The arguments about being taken by surprise could equally apply to any s223 application, since, by their very nature, they result in extending the time to do something which, in the ordinary course of events, should already have been done. It should be pointed out that Stibbard involved a case where an applicant attempted to extend the time to file an application where there was no earlier priority to claim; that is, there was no legislative period that could be extended, and the “surprise” referred to by the AAT in that case was made in connection with those particular circumstances. Overall, I see no defects in, nor any reason to depart from, the established authorities in construing s223 for the purposes of determining whether s223 is applicable to extend the time to file an application to claim the benefit of the grace period.
38. On considering the established principles for s223 in the context of s24(1)(b), it is quite clear from s24(1)(b) and Reg 2.2D that, to claim the benefit of the grace period, and thereby exclude unauthorised disclosures from the prior art, an applicant must file the complete application 12 months from the day the information concerned was made publicly available. Consequently, there is an action, in the sense of s223(11), that is required to be done (filing a complete application) within a legislated time period (12 months from the day the information was made publicly available). It is indubitable that where an applicant fails to file the complete application in the period concerned, they will fail to avoid the considerable disadvantage (congruent with the language in Sunesis) of having an unauthorised disclosure held against the application as prior art. Hence, in my view, I consider that filing a complete application to claim the benefit of the grace period pursuant to s24(1)(b) comprises a relevant act for which the time to perform the act may be extended.
39. The Opponent also argued against the correctness and applicability of Ashmont at [29] to [32] of its written submissions:
“29. The applicability of s 223 to the grace period provisions was considered in Ashmont v American Home Products [2002] APO 24; (2002) 56 IPR 114. This aspect of the decision was obiter dictum because, in the result, an extension was refused.
30. Hearing Officer Jenkins considered that s 223(2) is applicable to extend the time period prescribed by s 24(1)(b) of the Patents Act, observing at [22] (emphasis added):
‘I believe the filing of a patent application within twelve months from unauthorised disclosure of the information is a relevant act required to be done within a certain time, as required by section 223. Without a specific exclusion, as is the case for the time for filing a notice of opposition or a statement of grounds and particulars, I believe that section 223 applies.’
31. The Office is not bound to follow earlier of its decisions, especially where the relevant part of the decision is obiter dictum.
32. In the present case, the Office should not follow this aspect of Ashmont. It is, with respect, wrong. The reasoning in Ashmont focused on whether s 24(1)(b) was specifically excluded from s 223, “as is the case for the time for filing a notice of opposition or a statement of grounds and particulars”. This, however, involved considering the interaction between the provisions in the wrong order. There is no need for s 24(1)(b) to have been specifically excluded from s 223 because it does not fall within its scope, for the reasons set out above.”
40. I note that at the hearing Mr Cobden clarified that the discussion at [30] of the Opponent’s written submissions was that the Delegate concluded that s223 was applicable as there was no clear indication in the legislation to exclude acts under s24 from s223. Mr Cobden suggested that the situation was balanced; if there was no reason to exclude there was no reason to include it either, thereby leading to alleged ambiguity regarding the interaction between s24(1)(b) and s223(2)(a) as discussed at [28] of the Opponent’s submissions.
41. In my opinion, it does not necessarily follow that the Delegate’s considerations regarding the applicability of s223 to filing in time to claim the benefit of the grace period, were simply obiter, because the extension was ultimately refused, even if, as I understood it from the hearing, Mr Shavin shares that view. To the contrary, it is quite clear that the determination regarding s223 and the grace period were core to the decision, in that it was a first step taken in reaching the final conclusion drawn by the Delegate. This much is apparent from Ashmont:
“However, I need to determine if this is a ‘relevant act’ as prescribed by section 223(11) and regulation 22.11(4), as otherwise section 223(2) would not apply in the present situation. The parties were not able to direct me to any previous decisions in which section 223(2) was used to extend the prescribed period in section 24(1)(b) and I am not aware of any such decisions. (at [18])...
...Nevertheless, having found that section 223(2) is applicable, I must also be satisfied that in this case there was an error or omission by the applicant or their attorney which caused patent application 707949 not to be filed within twelve months from the publication of Virbac.” (at [23], emphasis added)
42. In terms of the “correctness” of Ashmont, I also do not agree with the Opponent. While it might seem that the Delegate merely focused on whether the act was “prescribed” according to s223(11), it is also apparent that she considered whether there was a relevant act to be done in a certain time. This much is apparent when [21] and [22] of Ashmont are reproduced in full:
“21. Ms Howard submitted that this was analogous to the present situation with Ashmont seeking to antedate the filing of the patent application. However, I do not agree. In Stibbard there was no time period in the legislation which was not complied with, merely the applicant seeking to obtain an earlier priority date. Ms Howard contrasted the wording of section 94 where an applicant "may make a Convention application.....within the prescribed period" with section 24 where information may be disregarded ‘only if a patent application for the invention is made within the prescribed period’.
22. However, I do not believe that the word ‘only’ alters the fact that there is a clear reference to a prescribed period in section 24(1)(b) of the Act and it is this which Ashmont is seeking to extend. I believe that the filing of a patent application within twelve months from unauthorised disclosure of the information is a relevant act required to be done within a certain time, as required by section 223. I can see no clear indication in the legislation to exclude section 24 from the provisions of section 223. Without a specific exclusion, as is the case for the time for filing a notice of opposition or a statement of grounds and particulars, I believe that section 223 applies. As a result, I find that section 223(2) is applicable to extend the time period prescribed by section 24(1)(b) and regulation 2.3(2).” (emphasis in original)
43. Notably I do not agree with Mr Cobden’s characterisation of [22] from Ashmont. It is clear to me that the Delegate first concluded that there was “...a relevant act required to be done within a certain time” and then proceeded to consider whether that act was prescribed. It is not as though the Delegate was only considering whether the act was prescribed or not. It should also be apparent that I do not consider that there is any ambiguity in the interaction between s24(1)(b) and s223(2)(a) as suggested by the Opponent at [28] of its written submissions.
44. In any case, to the extent that the analysis in Ashmont could be said to be lacking in any way, which I do not consider is so, I have independently determined that s223 is applicable to extend the grace period under s24(1)(b).
45. Finally, for completeness, I note that at the hearing Mr Cobden referred to the collateral “windfall” of an extended grace period applying to other disclosures besides D1 as an additional pointer to the inapplicability of s223 to s24. I disagree with that contention. With reference to the discussion at [150] et seq below, the matter of the extended grace period potentially extending to other disclosures is, to my mind, one that factors into the discretion to grant an extension on a case-by-case basis, rather than the applicability of s223 to s24.
There is no Error or Omission
46. Before considering whether there has been an actual error or omission, it is necessary to outline the salient facts surrounding the putative error or omission. To assist I have created a timeline of events, based on the available evidence and relevant dates of certain actions as apparent from office records, and this is reproduced at Annex A to this decision. I have based the following on the timeline and the evidence referred to therein. Discussion of the other grounds throughout the remainder of this decision is also informed by the timeline.
47. The Applicant entered into an agreement (the “agreement”) to undertake a Pharmcokinetic Study (the “study”) with the Centre for Human Drug Research (“CHDR”) in the Netherlands on 21 August 2012. The study related to a prototype product of the application. The agreement comprised confidentiality clauses with regard to the study.
48. On or around 4 May 2015, Dr Nir, being Vice President of Clinical and Regulatory Affairs at the Applicant (Nir at [4]), received a copy of a thesis (the “thesis”) comprising a chapter (chapter 8) that comprises information included in the study – notably, chapter 8 is simply D1 as cited in the s59 opposition. Dr Nir was concerned about the publication of D1 in electronic copies of the thesis and immediately made contact with CHDR. Dr Nir spoke to CHDR on 6 May 2015, who noted that the chapter concerned was meant to be embargoed and undertook to have the situation corrected immediately. CHDR contacted Dr Nir on 7 May 2015 and informed her that the chapter concerned had been redacted from the thesis. There is further correspondence between Dr Nir and CHDR in late May 2015, regarding the apparent ongoing availability of unredacted copies of the thesis in electronic form, but this appears to have been resolved by 28 May 2015.
49. Based on the evidence Dr Nir left the matter at that and apparently did not inform Dr Laudon (Nir at [27]) about the publication of the thesis/D1, despite a belief that she did so. Dr Laudon, who is Vice President of Drug Discovery and Development at the Applicant (Laudon1 at [1]), had responsibilities and experience regarding intellectual property at the Applicant (Laudon1 at [6] to [9]). The failure of Dr Nir to inform Dr Laudon of the publication of D1 by way of the thesis is said to be the error or omission for the purposes of s223 (Applicant submissions at [15]). I will simply refer to this hereinafter as the “error”.
50. The Opponent argues that the error as asserted is not established by the evidence. The reasons for this are propounded at [43] to [61] of the Opponent’s written submissions and are premised on the evidence giving “...rise to at least the following other possibilities other than Neurim’s asserted error or omission” (at [43]). These are said to be:
I will now consider each of these arguments in turn.
51. The arguments with regard to item i. are given at [44] to [48] of the Opponent’s written submissions:
“44. First, Dr Nir did communicate the information to Dr Laudon, a matter which he no longer recalls: cf Laudon 1 [19].
45. Importantly, Dr Nir does not declare that she did not communicate the information to Dr Laudon. Rather, Dr Nir states at Nir [25] (sic [27]) (emphasis added):
‘Although the release of Neurim’s Pharmacokinetic Study Information by a third party, without Neurim’s consent was not a problem that I had encountered before in my work at Neurim, it was the sort of event that I understood that I should, and invariably would, have communicated to Dr Laudon immediately upon its occurrence... If I failed to communicate this to him, I believe that this was an error or omission on my part.’
46. Dr Nir only considers that it would be an ‘error or omission’ if she did not communicate this to Dr Laudon.
47. However, Dr Nir’s evidence is that she ‘invariably would’ have communicated this to Dr Laudon.
48. For this reason alone, the Delegate cannot make a finding on the balance of probabilities that the asserted error or omission occurred.” (emphasis in original)
52. Paragraph 19 of Laudon1 is reproduced below:
“In view of Neurim's policy that I refer to in paragraph 10 above, such an unusual and potentially problematic occurrence is the sort of event that I would have expected Dr. Nir to have promptly communicated to me at the time that it occurred, in my capacity as Director of Drug Development with involvement in developing the Mini Tablet Product and as one of Neurim's senior staff. However, I have no recollection of her advising me of the event on this occasion, or of being made aware of the unauthorised publication of D1. I believe that on this occasion either Dr Nir omitted to tell me about it, or she erroneously believed that she had passed the information on to me, when in fact I did not receive it. This omission or error was in my view one which deviated from Neurim's usual practices of clearly relaying important information about products under development between Neurim's teams.”
53. It is difficult to see how [19] of Laudon1 positively supports a conclusion that Dr Nir did in fact inform Dr Laudon about the thesis and then he simply forgot about it. It is, of course, open to speculation that this is what happened – but that is just that – speculation. On balance this paragraph is rather more suggestive that Dr Nir simply failed to inform Dr Laudon in the first place.
54. This becomes more apparent when the evidence is considered as a whole, for example the statements at [27] of Dr Nir’s declaration about being “...unable to locate any record showing that I communicated the event to him at the time that I became aware of it or made him aware of the unauthorised publication of document D1 in May 2015 (or at any subsequent time prior to May 2019)”. Indeed, it seems highly implausible that there would be no record of such communication if in fact it did take place, particularly given the understanding shown by Dr Laudon of the consequences of disclosure prior to filing (see Laudon1 at [9]). As also noted at [19]d) of the Applicant’s submissions, it is implausible that Dr Laudon would have simply forgotten “...such an unusual and potentially problematic occurrence...”. Dr Laudon deposes at [18] of Laudon1 that “I had not been aware of document D1 prior to receiving the list of documents in connection with the Opposition Proceeding”, and at [20] of Laudon1:
“At the time that I gave instructions for the filing of the US'014 patent application, and the subsequent PCT'190 patent application, I was not aware that information regarding the Pharmacokinetic Study had been released by a third party, without the consent of Neurim.”
Similar statements regarding Dr Laudon’s lack of knowledge of D1 prior to May 2019 are given at [13] of his second declaration. This is entirely consistent with Dr Laudon not being made aware of publication of the thesis by Dr Nir.
55. There is also the evidence of Dr Harston, who states at [14] of his declaration that:
“At no time between in or about May 2015 and November 2016 did I receive any instructions from Dr Laudon or any other person acting on behalf of Neurim suggesting to me that Neurim did not intend to seek patent protection for the mini tablet invention which was the subject of the three applications described by me in paragraph 10 above. Nor was I told or had otherwise become aware that any issue had arisen that might be relevant to the public disclosure of that invention.”
Notably, the Applicant had engaged with the firm Rothwell Figg in the United States to act as its agent in filing patent applications since 1994, and Dr Harston had been the Applicant’s primary contact at Rothwell Figg since 2014; see Harston at [6] and [7], Laudon2 at [9]. Hence the fact that Dr Harston was unaware of any issue relating to the public disclosure of the invention is consistent with Dr Laudon’s statements that he was unaware of D1, as it is more plausible than not, for reasons discussed later in this decision at [102] et seq, that Dr Laudon would in fact have consulted with Dr Harston if made aware of D1 soon after its publication.
56. In addition, for the Opponent’s contentions to be sustained, one must assume that in giving their evidence the declarants either:
(a) are telling the truth, but are suffering from an extraordinary and ongoing case of mass amnesia in that not one of them has yet recalled that Dr Nir did in fact (as opposed to holding a belief that they did in the case of Dr Nir as discussed further below at [57] et seq) inform Dr Laudon and other actions that the Applicant presumably would have taken in response to Dr Laudon so knowing, and despite the quite blunt reminder that filing of the s59 opposition and the extension would have provided; or
(b) the declarants are aware that Dr Nir did inform Dr Laudon but have conspired to hide the truth from the Commissioner and have deliberately misled the Commissioner in their evidence.
Either scenario is inherently implausible and has no evidence to support it. This simply highlights the speculative nature of the Opponent’s arguments.
57. The references to “if” and “invariably” in Dr Nir’s evidence do not, to my mind, reverse the above considerations. Despite Mr Larish’s arguments that the use of “invariably” in the context in which it appears in Dr Nir’s evidence at [27] means she did communicate the publication of D1 to Dr Laudon, it merely reflects Dr Nir’s musings on what she should have ideally done in terms of informing Dr Laudon. The use of “if’ is a little more problematic, in that it seemingly renders the error to be rather speculative and perhaps leaves some space for one to suggest that Dr Nir might have actually informed Dr Laudon. Reading [27] as a whole, including putting the “invariably” and “if” statements together with the rest of the paragraph, there is force to Mr Larish’s suggestion that Dr Nir believes she did communicate the matter to Dr Laudon, which was accepted by Mr Shavin at hearing. In this regard Mr Larish made statements about the alleged conflict between Dr Nir’s and Dr Laudon’s evidence, noting that there was no reason to suppose Dr Laudon’s memory was any better than Dr Nir’s.
58. In my view, Dr Nir’s evidence at [27] appears to simply reflect an honest belief that she did communicate the matter to Dr Laudon at the time and perhaps is having difficulty accepting that ultimately she failed to do so despite there being no evidence to support her belief – a tendency to deny fault or mistakes despite evidence to the contrary is as much as part of the human experience as the hindsight so extensively canvassed by the Opponent. Dr Laudon also states at [19] of Laudon1 that:
“However I have no recollection of her [Dr Nir] advising me of the event on this occasion, or of being made aware of the unauthorised publication of D1. I believe that on this occasion either Dr Nir omitted to tell me about it, or she erroneously believed that she had passed the information on to me, when in fact I did not receive it.”
This supports the above view regarding Dr Nir’s “belief”. To my mind there is no fundamental conflict between Dr Nir’s and Dr Laudon’s evidence. In any case, on balance, for the reasons discussed above, I consider it rather less plausible that Dr Nir did in fact inform Dr Laudon but Dr Laudon and Dr Nir (and likely others at the Applicant) simply forgot all about it and failed to make or keep any records of the matter and failed to take any further actions, than Dr Nir simply failing to inform Dr Laudon in the first place.
59. In summary I reject the Opponent’s assertion that Dr Nir did in fact inform Dr Laudon about publication of the thesis before May 2019.
60. The arguments with regard to item ii. are given at [49] to [52] of the Opponent’s submissions:
“49. A second possibility is that Dr Nir considered that the steps that she had taken had been successful in having D1 ‘retracted and rendered inaccessible to any member of the public’ (Nir [25]), such that there was no need to communicate with Dr Laudon.
50. This possibility is consistent with the contemporaneous emails, which suggest that Dr Nir’s focus was on preventing D1 from remaining accessible online: Nir, Annexure NR-4.
51. Dr Nir does not adequately explain whether, and if so why, she would have thought it necessary to communicate with Dr Laudon in the event that, as transpired, D1 was no longer accessible online.
It may be that Dr Nir would only have communicated with Dr Laudon if, for example, D1 could not be removed from the internet. As a matter of ordinary human experience, a person may choose not to report a ‘crisis’ if he or she considers that the crisis has been averted.”
61. The evidence does indicate, understandably, that Dr Nir was concerned to remove the public accessibility of D1. However, there is nothing in the evidence that positively suggests that Dr Nir deliberately decided to not inform Dr Laudon due to a perception that the “crisis”, as the Opponent puts it, had been averted, or for any other reason for that matter. If anything, Dr Nir’s evidence is quite emphatic to the contrary: “I certainly at no time made a decision not to communicate this matter to him, nor was it ever my intention to conceal the information from him” (at [27]).
62. The only concern I have from the evidence is the apparent lack of explanation from Dr Nir about why she failed to communicate publication of the thesis to Dr Laudon, despite stating that she “invariably would” (Nir at [27]). Mr Larish noted that if the matter was one that Dr Nir says she should have communicated the publication of the thesis to Dr Laudon, then why did she not do this? Mr Larish observed that there were no positive statements regarding an intention to inform Dr Laudon in Dr Nir’s evidence and that she forgot to do so. While it does seem, as discussed above, that Dr Nir honestly holds the mistaken belief that she did communicate the publication of D1 to Dr Laudon, it would have been helpful if Dr Nir provided further information regarding how the error and her mistaken belief came to be in her evidence.
63. This absence of explanation perhaps explains Mr Larish’s submissions at the hearing about there being a number of “triggers”, including various communications with CHDR (see TN-4) regarding redaction of the thesis, for Dr Nir to form an intention to communicate the thesis publication to Dr Laudon. Mr Larish observed that the communications with CHDR were spread over several weeks in May 2015, and therefore were ongoing across May 2015. This, it was said by Mr Larish, provided plenty of reminders to Dr Nir to communicate the matter with Dr Laudon. Mr Larish also pointed to statements at [26] of Nir, where Dr Nir states that CHDR had not advised of any limited time period after which further publication of thesis might occur, and that the matter was not a problem that she had encountered before (Nir at [27]). Arguably, these matters and the lack of explanation from Dr Nir about the error leaves some room for the Opponent’s desired inference that this was so because Dr Nir simply thought the issue had been dealt with and decided not to communicate with Dr Laudon. In response to this, Mr Shavin pointed out that if Dr Nir believed she had already told Dr Laudon, then multiple triggers would not prompt her to do something she believed she had already done. There is some force to that suggestion.
64. In any case, there remains the clear statements from Dr Nir that at no time had she made a decision not to communicate the matter to Dr Laudon. For me to accept the Opponent’s contentions requires a rejection of this evidence. It could be argued that Dr Nir is simply telling an untruth in her evidence, but that is a very serious conclusion for which I have no evidence to reach. It may be, as the Opponent discusses elsewhere, that Dr Nir’s evidence here is tainted by hindsight to insert an absence of a decision not to inform Dr Laudon that she genuinely did not hold at the time. However, it seems to me, in the circumstances concerned, that if Dr Nir inserted as a clear and unqualified statement of fact something that she was aware that she did not have a clear understanding or memory of at the time of giving evidence, then this is substantially indistinguishable from falsifying her evidence. Such a circumstance certainly does not seem congruent with [28] of her declaration: “I make this declaration conscientiously believing the statements contained in the declaration to be true and correct”. In addition, if Dr Nir’s evidence was constructed with the benefit of hindsight, whether on an honest or deceptive basis, one would expect her evidence to be rather more convenient to the Applicant. In any case, it seems to me that, given the singular nature of the matter from her perspective, and her knowledge of the confidentiality policies of the Applicant, that, even with effluxion of time, Dr Nir would recall whether she had made, in that context, the unusual and deliberate decision to not communicate publication of the thesis to Dr Laudon.
65. In summary, given Dr Nir’s evidence that the publication of the thesis was something that she should have communicated to Dr Laudon, her knowledge of the policies of the Applicant (Nir at [8] and [9]), other evidence of the existence of those policies (Laudon1 at [10]), her service with the Applicant since 1997 (Nir at [4]) and her above statements about there being no deliberate intention not to inform Dr Laudon, I am of the view that it is more likely that there was a simple failure, for unspecified reasons, of Dr Nir to communicate the thesis publication to Dr Nir, despite the matters raised by the Opponent.
66. In conclusion I reject the Opponent’s assertion that Dr Nir did not communicate the information regarding publication of the thesis because she believed that the retraction rendered it unnecessary.
67. The arguments with regard to item iii. are given at [53] of the Opponent’s submissions:
“A third possibility is that Dr Nir would not have communicated the information to Dr Laudon irrespective of whether D1 remained online because she would not have thought, or otherwise considered it necessary, to do so. Dr Nir had not encountered an event of the kind in her work at Neurim: Nir [27]. Intellectual property protection is not Dr Nir’s responsibility: Nir [9].”
68. At the hearing Mr Larish suggested that there was no explanation as to why Dr Nir “...should and invariably would, have communicated with Dr Laudon...”. Dr Larish argued that Dr Nir’s knowledge of the Applicant’s confidentiality policies does not translate into an understanding that Dr Nir should have communicated the matter to Dr Laudon if confidentiality is lost or if the situation was resolved.
69. Whilst it is true that intellectual property protection was not Dr Nir’s responsibility, the evidence does establish that Dr Nir had an awareness of the sorts of things, including the present matter, that she should bring to Dr Laudon’s attention, and of the Applicant’s confidentiality policies, as is apparent from the following passages in Nir:
“8. It is Neurim's policy to keep the key details of products which are under development highly confidential. In my role as Vice President of Clinical and Regulatory Affairs, I observe the policy and routinely take steps to avoid the disclosure of the details of products which are under development. To the extent that it is necessary to disclose some details externally of the company for the purpose of conducting clinical trials, I ensure that written agreements are signed with those external parties in order to protect Neurim’s confidential information and to prevent its unauthorized dissemination.
9. I am aware that the reason behind Neurim's policy of keeping the details of products which are under development highly confidential is in part a commercial one, but that maintaining confidentiality is also important to enable patent applications to be filed. However, obtaining intellectual property protection for Neurim's products has never been my responsibility. That is the responsibility of Neurim's upper management, and it is executed by Dr. Moshe Laudon of the Drug Discovery team.”
and
“Although the release of Neurim’s Pharmacokinetic Study Information by a third party, without Neurim’s consent was not a problem that I had encountered before in my work at Neurim, it was the sort of event that I understood that I should, and invariably would, have communicated to Dr. Laudon (in his capacity as the Director of Drug Discovery with involvement in developing the Mini Tablet Product, and as a senior staff member of Neurim) immediately upon its occurrence.” (at [27]).
70. Dr Laudon also expresses the view that the publication of thesis was something that Dr Nir should have communicated to him at [19] of his declaration:
“In view of Neurim's policy that I refer to in paragraph 10 above, such an unusual and potentially problematic occurrence is the sort of event that I would have expected Dr. Nir to have promptly communicated to me at the time that it occurred, in my capacity as Director of Drug Development with involvement in developing the Mini Tablet Product and as one of Neurim's senior staff. However, I have no recollection of her advising me of the event on this occasion, or of being made aware of the unauthorised publication of D1. I believe that on this occasion either Dr Nir omitted to tell me about it, or she erroneously believed that she had passed the information on to me, when in fact I did not receive it. This omission or error was in my view one which deviated from Neurim's usual practices of clearly relaying important information about products under development between Neurim's teams.” (emphasis added)
71. Consequently, if anything, the evidence establishes that Dr Nir had an awareness that she should bring things like the publication of the thesis to the attention of Dr Laudon and would ordinarily do so. Mr Larish’s suggestion that knowledge of the confidentially policy does not translate into an expectation that Dr Nir should have brought this to the attention to Dr Laudon seems optimistic. Where an employee is clearly aware of confidentiality policies, as Dr Nir was, it seems reasonable to me to expect that they would escalate and make known a singular and unusual breach of that policy to other relevant persons, even in the absence of specific instructions to do so or where it “seems” to be resolved as argued by Mr Larish, particularly where one may assume, given Dr Nir has a PhD and has worked for the Applicant in what appear to be quite senior positions for an extensive period of time (see Nir at [4]), that the employee is otherwise generally competent.
72. The general practice of relaying important information between the Applicant’s teams also supports this view. Mr Larish’s suggestion that the practice referred to by Dr Laudon is merely an assertion and apparently not evidence of a practice ignores the fact that Dr Laudon is giving evidence of the practice – the confidentiality arrangements in TN-1 lend force to the authenticity of Dr Laudon’s evidence on the practice. While it may have helped the Applicant’s case to have provided specific examples of the practice, particularly in the context of confidentiality matters, the absence of this does not reduce the evidence of Dr Laudon about the practice to nothing (I also refer to my comments regarding documentary evidence at [85] and [87] below). Really, what the Opponent is simply inviting me to do is to conclude that Dr Laudon has provided misleading evidence without any real basis to support such a grave assertion.
73. To the extent they are applicable here, Dr Larish’s arguments about Dr Nir having made a deliberate decision not to communicate the matter to Dr Nir have already been addressed earlier this decision at [61] et seq.
74. In summary I reject the Opponent’s assertion that Dr Nir would not have communicated publication of thesis to Dr Laudon, irrespective of whether D1 was available or not because she would not have thought or considered it necessary to do so.
75. The arguments with regard to item iv. are given at [54] of the Opponent’s written submissions:
“When the law requires the proof of any fact, the fact-finder must feel an actual persuasion of its occurrence or existence before it can be found: Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336 at 361-362. Given the possibilities outlined above, the Delegate cannot feel an actual persuasion so as to make a finding on the balance of probabilities that Neurim’s asserted ‘error or omission’ in fact occurred.”
76. In response to this the Applicant argued that the Briginshaw principle is applicable “...in civil cases only where the gravity of the matters alleged is significant” (Applicant submissions at [28]). The Applicant cited Estate of the late Shirley Joan Violet Garder; Berengo v Leaney [2019] NSWSC 1324 (“Berengo”) at [203], arguing that in Berengo “it was held that the application of the Briginshaw principle should be confined to cases involving serious allegations analogous to fraud or dishonesty. This matter does not come close to being a case of that type” (Applicant submissions at [28]).
77. However, while the Applicant has talked about the applicability of the Briginshaw principle to the present matter, it has not explicitly outlined what that is. This seems to be that in civil matters the nature and gravity of the matters in hand may factor into whether the standard of proof is met, as explained by the High Court in Neat Holdings Pty Limited v Karajan Holdings Pty Limited and Ors [1992] HCA 66, at [2]:
“The ordinary standard of proof required of a party who bears the onus in civil litigation in this country is proof on the balance of probabilities. That remains so even where the matter to be proved involves criminal conduct or fraud ((1) See, e.g., Hocking v. Bell [1945] HCA 16; (1945) 71 CLR 430, at p 500; Rejfek v. McElroy [1965] HCA 46; (1965) 112 CLR 517, at pp 519-521). On the other hand, the strength of the evidence necessary to establish a fact or facts on the balance of probabilities may vary according to the nature of what it is sought to prove. Thus, authoritative statements have often been made to the effect that clear ((2) Briginshaw v. Briginshaw [1938] HCA 34; (1938) 60 CLR 336, at p 362; Helton v. Allen [1940] HCA 20; (1940) 63 CLR 691, at p 701; Hocking v. Bell [1944] NSWStRp 31; (1944) 44 SR (N.S.W.) 468, at p 477 (affirmed in Hocking v. Bell (1945) 71 CLR, at pp 464, 500); Rejfek v. McElroy (1965) 112 CLR, at p 521; Wentworth v. Rogers (No.5) (1986) 6 NSWLR 534, at p 539 or cogent ((3) Rejfek v. McElroy (1965) 112 CLR, at p 521) or strict ((4) Jonesco v. Beard (1930) AC 298, at p 300; Briginshaw v. Briginshaw (1938) 60 CLR, at p 362; Helton v. Allen (1940) 63 CLR, at p 711; Hocking v. Bell (1944) 44 SR (N.S.W.), at p 478 (affirmed in Hocking v. Bell (1945) 71 CLR, at pp 464, 500); Wentworth v. Rogers (No.5) (1986) 6 NSWLR, at p 538) proof is necessary ‘where so serious a matter as fraud is to be found’ ((5) Rejfek v. McElroy (1965) 112 CLR, at p 521). Statements to that effect should not, however, be understood as directed to the standard of proof. Rather, they should be understood as merely reflecting a conventional perception that members of our society do not ordinarily engage in fraudulent or criminal conduct ((6) See, e.g., Motchall v. Massoud [1926] ArgusLawRp 22; (1926) VLR 273, at p 276) and a judicial approach that a court should not lightly make a finding that, on the balance of probabilities, a party to civil litigation has been guilty of such conduct. As Dixon J. commented in Briginshaw v. Briginshaw ((7) (1938) 60 CLR, at p 362; and see, also, Helton v. Allen (1940) 63 CLR, at p 711):
‘The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved ...’.”
78. At the hearing, Mr Larish confirmed that the Opponent was not urging the application of the Briginshaw principle in terms of there being a serious matter like fraud. Rather, Mr Larish argued that Briginshaw was applicable in the sense that I “...would still need to have an actual persuasion, that on the balance of probabilities, the events as our friends describe, the theory that they describe is one that you can find.” In response I noted that I was struggling to see how having an actual persuasion on the balance of probabilities differed from simply forming the view that things did happen on the balance of probabilities. Mr Larish conceded that “it might be that it adds very little to it, because you either make a finding on the balance of probabilities or you don’t and if you’re persuaded you will make the finding and if you’re not you won’t”. Consequently, I am of the view that in the present matter I need to be, as indicated earlier in this decision, satisfied on the balance of probabilities in terms of establishing facts and in whether a proper case has been made out.
79. In summary I reject the Opponent’s contention that the “possibilities” prevent me from finding that the error actually occurred.
80. The arguments with regard to item v. are given at [55] to [61] of the Opponent’s written submissions:
“55. Further and in any event, the possibility on which Neurim relies – that is, Dr Nir’s evidence that she ‘should... have communicated [with] Dr Laudon’ and, if she failed to do so, this was an ‘error or omission’ – is tainted by hindsight and therefore ought to be given little weight, if any weight at all. This is because:
(a) it is 4.5 years after the fact;
(b) it is made in the context of legal proceedings, and no doubt carefully drafted by lawyers;
(c) it is made with the benefit of having since discussed what happened with Dr Laudon and Prof Zisapel: Laudon 2 [14]; Zisapel [14];
(d) there is no evidence establishing how or why Dr Nir is said to have “understood”, in 2015, that this kind of event ought to have been reported to Dr Laudon;
(e) it is not supported by any documentary evidence, for example, demonstrating Dr Nir having reported other such disclosures to Dr Laudon since 2015. The longer the period of the extension sought, the greater the need for clear documentary evidence: e.g., Les Laboratoires Servier v GenRx Pty Ltd [2007] APO 29 at [32].
56.Even where a witness’s evidence is unchallenged and uncontradicted, it is open to a decision-maker to disbelieve evidence found to be tainted by hindsight: Gill v Ethicon Sarl (No 5) [2019] FCA 1905 at [4470], citing Ellis v Wallsend District Hospital (1989) 17 NSWLR 553 at 560 and 581 and Towns v Cross [2001] NSWCA 129 at [22].
57. Here, the Delegate need not even necessarily ‘disbelieve’ Dr Nir’s evidence.
58. Rather, it suffices if the Delegate considers it a likely plausibility that Dr Nir’s evidence was formed with the benefit of hindsight: Magnum Magnetics Corporation [2019] APO 3 at [33] (and authorities cited therein). If so, Dr Nir’s explanation will not be sufficient to constitute the requisite error or omission: Amicus Therapeutics at [34]; Mount Sinai School of Medicine, Re [2013] APO 52; (2013) 104 IPR 188 at [29]; Magnum at [33].
59. Importantly, the fact that evidence is tainted by hindsight does not mean that the witness is being dishonest. Indeed, as Rares J stated in Berry v CCL Secure Pty Ltd [2017] FCA 1546 at [24]. the recollection of honest witnesses:
‘... will be affected by the very significant lapse of time between the actual events, and the natural tendency of persons to view past events more favourably to their own position or interest than a completely objective or detached observer may at the time of giving oral (or written) evidence.’
60. And, as stated in the oft-quoted authority of Watson v Foxman (1995) 49 NSWLR 315 at 319:
‘...human memory... is fallible for a variety of reasons, and ordinarily the degree of fallibility increases with the passage of time, particularly where disputes or litigation intervene, and the processes of memory are overlaid, often subconsciously, by perceptions or self-interest as well as conscious consideration of what should have been said or could have been said. All too often what is actually remembered is little more than an impression from which plausible details are then, again often subconsciously, constructed. All this is a matter of ordinary human experience.’
61. In light of the various possibilities open on the evidence and the effect of hindsight on Neurim’s evidence, the evidence cannot lead to a finding, on the balance of probabilities, that the error or omission for which Neurim contends in fact occurred. In the absence of such a finding, the Extension Application must be dismissed.” (emphasis in original)
81. It is not clear to me that the Opponent’s contentions hold true in the present circumstances. The fact that Dr Nir is giving evidence “4.5 years after the fact” does not necessarily mean that her evidence is tainted by hindsight to the extent it must be rejected. It is indubitable that extension of time matters involve recollection of events that have occurred in the past, and to assume that this necessarily means evidence of such matters is fatally tainted by hindsight would seem to render s223 otiose. There was also the point raised by Mr Shavin at the hearing that, if the evidence was tainted by hindsight, then one would expect a “perfect story” to emerge from the evidence, which is clearly not the case here.
82. Similarly, while I do not doubt that Dr Nir’s evidence was carefully drafted with the assistance of lawyers, it is her declaratory evidence, not any other person’s. To suggest that the fact that evidence of past events has been carefully drafted with the assistance of lawyers necessarily means that evidence is tainted by hindsight seems rather incredible, and, if taken seriously, would seem to leave little role for legal professionals in the collection of evidence. It also seems odd to impugn the careful drafting of evidence, which is clearly desirable for evidence before the Commissioner or any other decision maker.
83. The fact Dr Nir had discussed the matter with Professor Zisapel (the Chief Scientific Officer and Managing Director of the Applicant (Zisapel at [1])) and Dr Laudon also does not necessarily mean her evidence is tainted by hindsight. Again, it would seem to present difficulties for the operation of s223 if parties were unable to converse with each other and jointly investigate the circumstances for the failure to perform an act for fear of any subsequent evidence being tainted by hindsight.
84. It is also not the case that “...there is no evidence establishing how or why Dr Nir is said to have ‘understood’, in 2015, that this kind of event ought to have been reported to Dr Laudon”. There is clearly the evidence of Dr Nir herself at [27]. The fact that this is her evidence of her understanding does not mean it is infected with hindsight. If anything, her awareness is consistent with the policies of the Applicant about keeping key details of products under development confidential; see Laudon1 at [10] and Nir at [8]. Notably Dr Laudon deposes that those policies had been in place for the 20 years that he had been an employee of the Applicant; see Laudon1 at [4] and [10].
85. While documentary evidence of past instances of actions Dr Nir had taken in connection to similar matters might be helpful, Dr Nir cannot provide evidence of such issues if she had never encountered them before; see Nir at [27]. Despite Dr Nir’s lengthy experience with the Applicant, it is reasonable to suppose that confidentiality breaches per se were not all that common, particularly those of the type in question. It is also illogical to expect there to be documentary evidence of the error itself, since it concerns a failure to communicate and there is no reason to suppose that Dr Nir would create a record of this failure to communicate (indeed if she did this would be rather odd without further explanation). None of this suggests that Dr Nir’s evidence was necessarily tainted by hindsight.
86. In terms of allegations of hindsight, I also refer to my discussion above at [61] et seq about Dr Nir deposing that she made no determination not to communicate the matter to Dr Laudon.
87. It is also not the case that Les Laboratoires Servier v GenRx Pty Ltd [2007] APO 29 (“Les Laboratoires”) at [32] necessarily stands for the proposition that “the longer the period of extension sought, the greater the need for clear documentary evidence”. It is perhaps helpful to reproduce [32] of Les Laboratories in full:
“Most section 223 cases involving a notice of opposition (including Geron Corporation v ES Cell International PTE [2005] APO 11 referred to by the opponent), the period of time between the prescribed deadline and filing of notice of opposition is measured in days. Because of the close timing in these cases, there is a reasonable presumption that the opponent had a real interest in opposing the case at the due deadline. This is not true in the current case where the period of extension requested is lengthy (17 months). In such cases, there is a greater need for clear documentary evidence to establish a clear intention to oppose at the relevant date.”
It is apparent from the full passage that the Delegate in Les Laboratories considered that there was a greater need for documentary evidence to establish an intent to oppose in circumstances where a considerable period of time had elapsed since the period to file an opposition. Hence [32] in Les Laboratories is quite specific to circumstances where there is an extension to file a notice of opposition and is not creating a requirement regarding the necessity or otherwise of documentary evidence for s223 in general. Indeed, in many cases of an error of omission, like the error here, it is likely that there will be no positive documentation of the error at all. It simply remains the case that there need be sufficient evidence to satisfy the Commissioner, on the balance of probabilities, that it is appropriate to grant an extension of time. What that is will clearly vary from case to case.
88. Finally, while I note the Opponent’s contentions regarding the fact that I may reject uncontradicted evidence, and the warnings of the authorities cited (more of which is discussed below) if found to be tainted by hindsight, or if it is likely plausible that the evidence was formed with the benefit of hindsight, the Opponent has simply failed to point to anything about Dr Nir’s evidence, particularly in the context of the evidence when considered as a whole, that would establish as more plausible than not that it was tainted by hindsight. All that the Opponent has done is to point to some circumstantial factors regarding Dr Nir’s evidence, as discussed above, that are said to lead to it being tainted by hindsight. As noted above, many of these circumstantial factors are applicable to almost any (if not all) extension of time applications and little can be drawn from them as such regarding whether hindsight has tainted the evidence concerned in the absence of other probative information supporting such a conclusion.
89. In summary I reject the Opponent’s assertion that Dr Nir’s evidence regarding the error is tainted by hindsight and should be given little or no weight.
90. In view of the above I conclude that the failure of Dr Nir to communicate the publication of the thesis to Dr Laudon was in fact an “error”.
No Causation
91. The putative causative chain of events regarding the error are summarised in the Opponent’s submissions at [64]:
“The ‘causative’ theory put forward by Neurim appears to be as follows:
(1) Had Dr Nir informed Dr Laudon about the publication of D1 in April 2015, Dr Laudon would have considered that its disclosure ‘might well have had the potential to impact upon, or create an obstacle to, Neurim obtaining patent protection’: Laudon 3 [9], [10].
(2) Had Dr Laudon formed this view, he would have consulted Neurim’s patent attorney, Dr Aydin Harston at Rothwell Fig (a US law firm): e.g., Laudon 2 [5]-[9].
(3) Had Dr Laudon consulted Dr Harston, Dr Harston would have recommended filing a PCT patent application within as short a time period as possible, and not longer than 12 months after the publication date of D1: Harston at [11]-[13].
(4) Had Dr Harston made this recommendation to Dr Laudon, Dr Laudon would have instructed Dr Harston to file a PCT application on behalf of Neurim within 12 months of the disclosure of D1: e.g., Laudon 2 [12].
(5) Had Neurim filed this earlier PCT application, it would have later sought patent protection in Australia based on the PCT application.”
At the hearing Mr Larish suggested, with reference to [17] of the Applicant’s written submissions, a first initial step in the causative theory, that being that Dr Nir firstly formed an intention to communicate the publication of the thesis to Dr Laudon, leading to six steps in the causative theory.
92. It is not clear to me that the initial step posed by Mr Larish in fact forms a separate part of the putative causative theory stemming from the error. The error, as accepted above, was the failure of Dr Nir to communicate publication of the thesis to Dr Laudon. The causative chain of events must proceed from this error and, therefore, what Dr Nir’s intentions might have been in terms of communicating publication of thesis to Dr Laudon precedes the error itself and thereby is irrelevant to the subsequent causative chain of events. Rather such questions of intention are more appropriately dealt with in establishing the error itself, and the question of Dr Nir’s intentions have already been canvassed in that regard. As noted above, I have some concerns about the lack of explanation by Dr Nir regarding the failure to communicate, but on balance I consider that it was an error as discussed earlier in this decision.
93. Other than this, I consider items (1) to (5) above correctly reflect the causative theory upon which the extension is based, and I note that the Applicant has not suggested that this is in any way incorrect.
94. The Opponent argues that if there was an “error” then the causative theory has problems which mean that that the error was not causative for the purposes of s223 – that is the error did not result in the failure to file on time to claim the benefit of the grace period. The Opponent outlines two problems in this regard:
I will consider each of these arguments below.
95. The Opponent’s first argument is given at [66] to [71] of its written submissions:
“66. There are two problems with this theory. First, the theory involves a chain of numerous hypothetical actions based on what, many years after the fact, Neurim’s witnesses say they ‘would have’ thought or done.
67. However, in the absence of corroborative, objective material, the authorities indicate that such evidence is to be given little weight. For example:
(a) GP repeats the authorities concerning evidence tainted by hindsight at [56]-[59] above.
(b) As Emmett AJA said in Ritchie v Woodward [2016] NSWSC 1715 at [385]:
‘Evidence of what an individual would have done had certain advice or information been provided, if the evidence is admitted, is fraught with difficulty. Such evidence is necessarily hypothetical and must inevitably be influenced by hindsight. Such evidence is of little probative value unless its reliability is confirmed by other objective material.’
(c) In Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556; (2018) 136 IPR 8 at [276], Jagot J cited authorities regarding ‘the enormous difficulty of counteracting hindsight bias’ and to the effect that ‘the true position is much more likely to be, no matter what a plaintiff may have honestly come to believe, that she cannot really say, in an absolute way, [what she would have done]...’ Having noted at [277] the caution necessary in assessing evidence about ‘asserted past hypothetical facts’, her Honour then said at [281]:
‘There are many kinds of pressures to which a person may be subject in giving evidence, whether consciously or not... When a person is being asked instead to conjecture what would have happened... [and] this is combined with the magnitude of the claims in this case it does not take much to infer that a more reliable guide to what would or might have happened is inference from available contemporaneous material and objective contemporaneous circumstances assuming rational commercial decisions rather than the evidence of witnesses speaking many years later in the context of litigation.’
68. In the context of s 223(2), in the recent case of Amicus Therapeutics, Deputy Commissioner McCaffery said at [31] that ‘statements by declarants to the extent that had they been aware of the requirements then steps would have been taken do not satisfy’ the requirement for an explanation as to how the failure occurred.
69. The evidence suffers from the vice identified in these authorities – it is multilayered, hypothetical, tainted by hindsight and is not reliable.
70. Moreover, there is no contemporaneous material – documentary or otherwise – which corroborates the witness’ evidence.
71. For example, there is no evidence that Dr Nir has ever informed Dr Laudon about any potentially worrisome disclosure. Nor is there any evidence Dr Laudon has ever consulted a patent attorney when he has had a concern about an unauthorised disclosure affecting Neurim’s ability to obtain a patent. Indeed, until May 2019 (some 4 years after publication of D1), neither Dr Laudon nor Neurim generally were aware of patent grace periods: Laudon 2 [14]; Zisapel [15].”
96. It is true that for the error to be causative, I need accept that a number of hypothetical actions need to have taken place if not for the error, despite Mr Shavin’s suggestions that the actions concerned are not hypothetical. However, this does not mean that there may not be proper causation in terms of s223. The question is undoubtedly one where one must carefully consider whether the evidence supports the hypothetical actions concerned.
97. The Opponent has cited several items of case law to support its contentions regarding causality. The Applicant argues, at [44] of their submissions, that the case law cited by the Opponent is inappropriate for an extension of time application:
“Although GP cites authorities regarding the level of evidence required to prove causation, in accordance with Div 3 of Pt 1A of the Civil Liability Act 2002, in a professional negligence case heard by the NSW Supreme Court, a more appropriate authority to inform the nature of the enquiry, and one which discusses the application of s 223 is Re Sanyo Electric Co Ltd at [16]:
‘While the applicant has the burden of placing before the tribunal the circumstances it claims will justify the grant of an extension of time, that does not amount to a burden of proof and it is not appropriate that it be so described.’”
98. The applicability of Re Sanyo Electric Co Ltd and Commissioner of Patents [1996] AATA 832 (“Sanyo Electric”) is apparent. But what of the cases cited by the Opponent? Ritchie v Woodward [2016] NSWSC 1715 (“Ritchie”) involves a professional negligence case, while Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556 (“Sigma”) concerns “claims for compensation pursuant to undertakings given as the price of the grant of interlocutory injunctions restraining infringement of a patent ultimately found to be invalid” (at [1]), although I note the authorities in Sigma referred to by the Opponent appear to all deal with negligence cases.
99. It is not clear to me that the above cases cited by the Opponent are of much assistance in 223 matters, at least to the extent desired by the Opponent. It is of some note that evidence of what a party would have hypothetically done in negligence cases, is simply inadmissible in several jurisdictions, including NSW. This is apparent from Asden Developments Pty Ltd (in liq) v Dinoris (No 3) [2016] FCA 788 at [156] (cited in Sigma supra at [276]):
“A plaintiff’s subjective evidence about what he or she would, or would not, have done if the negligent conduct in contention had not occurred is now inadmissible under the Civil Liability legislation in force in many jurisdictions in Australia: see s 5D(3)(b) of the Civil Liability Act 2002 (NSW); s 11(3)(b) of the Civil Liability Act 2003 (Qld); s 5C(3)(b) of the Civil Liability Act 2002 (WA); and s 13(3)(b) of the Civil Liability Act 2002 (Tas). The hindsight bias inherent in such evidence was one of the main reasons underpinning the introduction of these provisions. So much appears from the Final Report of the Review of the Law of Negligence (Commonwealth of Australia, Canberra, September 2002), where the authors observed (at para 7.40):
‘The enormous difficulty of counteracting hindsight bias in this context undermines the value of such testimony. In practice, the judge’s view of the plaintiff’s credibility is likely to be determinative, regardless of relevant circumstantial evidence. We therefore recommend that in determining causation, any statement by the plaintiff about what they would have done if the negligence had not occurred should be inadmissible.’ (Emphasis added)”
Hence the discussions in Ritchie and of the cases cited in Sigma about the limited value and admissibility of evidence of “hypotheticals” appears specific to negligence cases and the burden of proof in those cases (in contrast to Sanyo Electric) and is not generally warranting a prohibition of evidence of hypotheticals in all matters.
100. In that regard, it is established that an error which prevents the formation of an intention to do an act may be a causative error for s223; see Apotex Pty Limited and Commissioner of Patents and Les Laboratoires Servier (Party Joined) [2008] AATA 226 (“Apotex”) at [14] and Kimberly-Clark Ltd v Commissioner of Patents [1988] FCA 697 at [9]. Such cases necessarily comprise one or a series of hypothetical events, frequently dealing with what a party would have done if informed or advised of something, as part of establishing a chain of causality. It is trite to state that such extensions have been granted, including in Apotex, despite comprising evidence about what parties would have hypothetically done. If the principles from the negligence cases cited above were to be followed, it would seem to render otiose the ability to gain an extension in circumstances where the error or omission frustrated the formation of an intention to do the act concerned. This militates against the Opponent’s generally pejorative characterisation of hypotheticals in the context of s223.
101. At best, in the context of s223, I consider that Ritchie and Sigma, and the other cases cited by the Opponent, provide a warning about the need to carefully consider evidence about what parties hypothetically would have done where the hypothetical seems to be little more than a melange of speculation unsupported by anything else. It seems to me that where the evidence, when considered as whole, leads one to conclude that the hypotheticals were more probable than not, such that they become more than mere speculation, then one is entitled to draw an inference that the hypothetical would have occurred and thereby lead to casualty for the purposes of s223.
102. I consider that such is the case here. The fact that:
(a) the Applicant had in place policies regarding the confidentiality of products under development, with TN-1 serving as an exemplar of that policy; and
(b) Dr Laudon’s understanding of how disclosure prior to filing a patent application can compromise patent protection (Laudon1 at [9]);
indicate that, on balance, Dr Laudon would have realised that the publication of the thesis may well have an impact on obtaining future patent protection as outlined at [9] and [10] of Laudon3.
103. Similarly, Dr Laudon’s responsibilities and involvement with intellectual property matters at the Applicant, including routinely taking advice and providing instruction to legal counsel and patent attorneys (Laudon1 at [6] to [8]) lend inherent plausibility to the suggestion that he would have, on a balance, consulted Dr Harston regarding the matter (Laudon2 at [5] to [9]). Notably, the Applicant had engaged with the firm Rothwell Figg in the United States to act as its agent in filing patent applications since 1994, and Dr Harston had been the Applicant’s primary contact at Rothwell Figg since 2014; see Harston at [6] and [7], Laudon2 at [9]. In particular, Dr Harston received instructions from Dr Laudon with regard to national phase entry of the application and the filing of the US provisional and PCT/IB2016/057190 from which the application is derived; Harston at [10], Laudon2 at [7]. This all lends credence to the suggestion that Dr Laudon would have consulted with Dr Harston if made aware of the thesis soon after its publication.
104. Dr Harston deposes at [11] to [13] of his declaration that it is his usual practice, when a client informs him of a premature disclosure of information in connection with a pharmaceutical invention, to recommend to the client to file a PCT application as soon as possible (i.e. not longer than 12 months from the disclosure concerned). Dr Harston makes it clear that this was to take advantage of the grace period in those jurisdictions, including Australia, where a grace period may be available. This makes it quite clear that Dr Harston would in fact have, on balance, provided such advice to Dr Laudon if informed by Dr Laudon about publication of the thesis.
105. At the hearing, Mr Larish noted that Dr Harston, and Dr Laudon for that matter, did not depose about what troubled them about the content of D1 and seemed to be insinuating that this undermines Dr Harston’s statements about the advice he would give to Dr Laudon if Dr Laudon had been informed about publication of the thesis. This ignores the fact that Dr Laudon deposes at [21] of his first declaration that in seeking to consult a patent attorney that “I would have done this on the basis that information on the Pharmacokinetic Study might have had at least some potential relevance to aspects of the invention embodied in the Mini Tablet product that Neurim might have wanted to patent.” In any case, it is reasonable to believe that the potential impact of D1 on any future patent protection sought would be immediately manifest to Dr Laudon and Dr Harston, without any extensive analysis or explicit comments to this effect. Consequently, the precautionary approach suggested by Dr Harston is entirely plausible and, indeed, would seem in keeping with his professional obligations to his client.
106. Dr Laudon’s knowledge of the potential consequences on patent protection of early disclosure, as discussed at [9] of Laudon1, means that it is inherently plausible, unless he was suffering from a bout of unexpected irrationality, that he would have, on balance, acted on advice provided by Dr Harston in relation to filing early, as outlined in Laudon1 at [21] and Laudon3 at [10].
107. Despite this, Mr Larish suggested that the Applicant would have been unable to file in time to claim the benefit of the grace period anyway, despite Dr Laudon’s statements at [22] of his first declaration that he would still file within the grace period this even if it meant accelerating the Applicant’s processes. Notably, Dr Harston also deposes at [11] and [12] of his second declaration that:
“I understand that the unauthorised publication of document D1 occurred sometime around May 2015. At that time, there had not yet been any patent filings in relation to the Mini Tablet Product.
If I had learned about the unauthorised publication of document D1 at or about the time that it occurred, and if, at that time as a consequence of my consulting him about the possible consequences of the disclosure, Dr Harston had recommended to me the course of action set out in paragraphs 11 to 13 of Dr Harston’s Declaration, I confirm that I would have taken the advice of Dr Harston and instructed him to file a PCT patent application within 12 months of the disclosure in order to rely upon ‘grace period’ patent protection in those countries (including Australia) where it may have been available.”
108. The Applicant had until 15 April 2016 to file the application to claim the grace period with respect to D1. The priority document was filed on 31 October 2016, with the application being filed on 29 November 2016. Assuming that all the information necessary to support material in the application was in the priority document, the Applicant would have needed to reduce the time to complete everything it needed to file the provisional application by about six and a half months. If this is not the case it still means a reduction at most of a little more than seven and a half months. It does not seem to me that the shortened time requirements necessarily render an ability to file by 15 April 2016 implausible or simply impossible.
109. It seems to me that knowledge of the potential consequences of not filing on time to avoid D1 would provide a powerful incentive to undertake efforts to ensure that the filing would in fact be done on time. This, and the degree to which the time period available would be shortened, seems to me to support the proposition that it was more likely than not that the Applicant would in fact have been able to file in time to claim the benefit of the grace period, at least in the absence of positive evidence to the contrary. The Opponent’s views to the contrary are entirely speculative.
110. Dr Laudon’s evidence at [11] to [14] of his first declaration, particularly in relation to the motivation to file in Australia due to the success of a product, “CIRCADIN” (a relative to the product of the application), strongly suggests that the Applicant would in fact elect Australia on filing the PCT application and would enter national phase, if the application was filed earlier to gain the benefit of the grace period. Dr Laudon clearly deposes, at [13] of Laudon1, that “At no time has Neurim’s management decided that patent protection was not to be pursued for this product in Australia”. Notably, it is apparent from Laudon1 at [14] that Neurim did in fact decide, in 2016, to seek patent protection in connection with the application in Australia. The fact that the Applicant did enter national phase with the application corroborates all this. Indeed, the only thing against these facts and inferences from the evidence appears to be speculation by the Opponent that something would have happened to change the Applicant’s mind, such that it would not enter national phase in Australia if it had filed earlier to gain the benefit of the grace period. This seems entirely specious. On balance I consider that the Applicant would have entered national phase in Australia if the application was filed earlier to claim the benefit of the grace period.
111. In terms of “contemporaneous material” it should be apparent that I am satisfied that the evidence as it stands objectively supports the chain of causation. I also refer to my statements at [85] et seq above regarding the alleged lack of “evidence”.
112. For completeness I observe that Amicus Therapeutics, Inc. [2020] APO 4 (“Amicus”) does not assist the Opponent’s case. It is instructive to reproduce [31] of Amicus in full:
“While further consideration of the submissions made by the applicant is probably rendered moot because of this conclusion, I will make the observation that the material provided by the applicant in support of their request has been of little assistance in the present determination. Contrary to the applicant’s submissions that they have “provided a full and frank disclosure of the circumstances surrounding the need to obtain an extension of time for invoking grace provisions for the present application”, I consider the material provided in support represents little more than an invitation to infer a relevant error or omission from the general chronology of events. In this regard the request is on all fours with the statements of Jenkinson J in Kimberly-Clark v Commissioner of Patents (No 3), to the extent that the applicant has provided a chronology of the processes by which the failure to file the application in time came to occur, but little or no detail of the conduct, knowledge, beliefs and mental processes relevant to understanding how the failure occurred and to assess the reasonableness of such failure. Statements by the declarants to the extent that had they been aware of the requirements then steps would have been taken do not satisfy this requirement. The delegates sought further evidence to address the deficiencies in the supporting material, but no further detail was provided.” (emphasis in original, references to footnotes removed)
It is apparent that in Amicus, unlike the present situation, the evidence did not satisfactorily identify a relevant error or omission for the purposes of s223. The Deputy Commissioner’s statements about evidence of what the parties would have done simply indicates that hypotheticals do not overcome the fundamental fact that no error or omission was properly identified in the first place. They are not statements about the general weight or applicability to be given to evidence of hypothetical matters in s223 applications.
113. In conclusion with regard to the Opponent’s first argument, I do not see that the evidence is such that it fails to objectively support the chain of causation. Rather, on balance, I consider that the evidence leads to the chain of causation being more probable than not.
114. The Opponent’s second argument is given at [72] to [76] of its written submissions:
“72. Secondly, Neurim’s subsequent conduct is inconsistent with its causation theory.
73. In May 2019, Dr Laudon, Dr Nir and Prof Zisapel became aware that D1 formed part of the 598 Opposition: Laudon 1 [16]; Laudon 2 [14]; Nir [22]; Zisapel [13]. Shortly after, Dr Laudon became aware that information regarding the Pharmacokinetic Study had been released in April, or at least May, 2015, resulting in the publication of D1: Laudon 2 [13].
74. However, given the absence of any evidence to that effect, it may be inferred that, when the above events took place in May 2019 (4 years later):
(a) Dr Laudon did not form the view that D1 may present an obstacle to Neurim’s 598 Application. Rather, that view only appears to have been reached after review of GP’s evidence in support in around September 2019: see e.g., Tyacke [13]-[15]. (And even then, Neurim’s own evidence in the ‘598 Opposition is that D1 does not affect the novelty or inventiveness of the 598 Application.);
(b) further or in the alternative, Dr Laudon did not contact Dr Harston (or indeed Neurim’s Australian lawyers) to determine what if anything could be done about D1.
75. Both matters are inconsistent with (2) (and, to an extent, (4)) in the chain of causation at [64] above.
76. In the above circumstances, the Office is entitled to place little, if any, weight on the evidence supporting Neurim’s ‘chain of hypothetical actions’ theory. As a result, the Office cannot find on the balance of probabilities that, if there was an error or omission (which GP denies), that error or omission was causative. Rather, it is more likely that at least one of the hypothetical steps in the chain of causation would not, in fact, have occurred, and the grace period would not have been available to Neurim for any patent application filed in Australia.”
115. However, the Opponent’s contentions here do not hold up. It is quite clear from the evidence (Laudon1 at [18] and [23]; Nir at [22] to [26]; TN-5; Zisapel at [12] to [14] and Laudon3 at [9]) that the Applicant was aware of the potential problems D1 could have on their patent application soon after the s59 SGP was filed on 2 May 2019, and immediately began to investigate the circumstances surrounding the publication of the thesis.
116. I note that none of the evidence from the s59 opposition is evidence in this matter. Nevertheless, even assuming that the Applicant argued against the relevancy of D1, this does not mean that it was putatively unaware of, or putatively did not believe that there were, potential problems that D1 afforded to a future potential application; see my discussion regarding Dr Harston and Dr Laudon’s awareness of the difficulties D1 could present at [102]. Obviously neither Dr Hartson’s nor Dr Laudon’s putative understanding of what potential problems that D1 could present to a future patent application, if made aware of D1 soon after its publication, inform what arguments might be made in relation to D1 as cited in the s59 opposition. It is likely that the Applicant, understandably noting that it could not be sure of the outcome in this matter or in the s59 opposition, simply wanted to at least preserve an arguable case in the s59 opposition.
117. At the hearing Mr Larish, in view of the fact that the Applicant was arguing in the s59 opposition that D1 did not “...anticipate or render the patent obvious”, raised the spectre of sinister behaviour on behalf of the Applicant by not filing its patent earlier to avoid the patent expiring earlier. However, like ghosts in general, there is no evidence of this one’s actual existence, other than the enthusiastic, if genuinely held, speculation of those who believe in them. Reasons why the Applicant likely made arguments against D1 in the s59 opposition are provided above. The assumption of a benefit by having the patent expire later by arranging for a later filing date does not seem to follow to me. Patent applicants may well calculate that there is a perceived benefit, in terms of increased revenue, by filing on a later than an earlier date. It may also be highly desirable to file earlier to better stymie potential competitors. There is likely a whole range of other strategic factors that feature in any decision as to when to file, which may favour filing earlier or later depending on the circumstances in each case. It seems inherently unlikely that patent applicants would simply wait longer to file an application in all cases, and there is no actual evidence to suggest that that it what the Applicant did here.
118. In terms of why Dr Laudon did not contact Dr Harston or anyone else about what could be done about D1, the answer is relatively simple. The reason is that neither Dr Laudon, nor anyone else at the Applicant was aware that anything could be done about D1 in terms of the grace period until they were informed so by Mr Tyacke; see Laudon1 at [22]; Laudon2 at [14]; Zisapel at [15] to [17] and Tyacke at [14].
119. This is not necessarily inconsistent, as asserted by Mr Larish, with Dr Laudon’s evidence, that he would have promptly consulted a patent attorney if the publication of the thesis was made known to him by Dr Nir. It is perhaps helpful to reproduce the relevant passages of Laudon1:
“21. Had I known about the unauthorised publication of document D1 at the time that it occurred, I would have promptly consulted a patent attorney for advice and taken any action recommended by the patent attorney to preserve, to the fullest extent possible under the circumstances, Neurim's options for pursuing patent protection for various aspects of the Mini Tablet Product in case the content of the disclosure might adversely affect the validity of any patent applications for the invention embodied in the Mini Tablet product. I would have done this on the basis that information on the Pharmacokinetic Study might have had at least some potential relevance to aspects of the invention embodied in the Mini Tablet product that Neurim might have wanted to patent.” (emphasis added)
Clearly Dr Laudon is deposing about what he would do about D1 if he had known about it at the time of its publication. It is not evidence of what he would necessarily do if informed about it several years later. Rather Dr Laudon deposes that in May 2019 “At that time it was not apparent to me that there was any further action which could be taken to rectify the situation” (Laudon2 at [14], also see Zisapel at [15]). At the hearing Mr Larish also attempted to make something of the Applicant’s inaction in seeking the advice of a patent attorney in May 2019 in view of the observation that if Dr Laudon did not know of grace periods in May 2015, then he also did not know of them in May 2019, although presumably Dr Laudon did not know about s223 either in May 2015 or May 2019, given he was not “...an expert in patent law”; see Laudon1 at [9].
120. In a superficial sense, one might expect Dr Laudon to seek the services of a patent attorney with some alacrity regarding D1 after becoming aware, in May 2019, of its publication, as apparently urged by the Opponent. However, the elapse of several years and Dr Laudon’s and Professor Zisapel’s (see Zisapel at [15]) lack of understanding about grace period matters and patent law more generally means that it is perhaps understandable that they did not immediately seek the advice of a patent attorney about D1 in May 2019. It is trite to state that errors are generally harder to ameliorate the longer they are left to themselves, and one could infer that Dr Laudon’s statements to the effect that he believed nothing could be done in May 2019 was based on the naïvely reasonable view that the horse had bolted so far ahead that it could now never be caught, compared with what he says he would do in May 2015 when the horse had only just left the gate.
121. The comparative inaction in May 2019 is also explained by the fact that in May 2019 and for some months thereafter, as opposed to May 2015, Dr Laudon and Professor Zisapel were preoccupied by the broader s59 opposition itself and other patent litigation matters; Laudon1 at [23]; Zisapel at [20] and [21]. It is also of some note that the Applicant is a small company of only 17 employees; Zisapel at [11]. Notably, the fact that it was Mr Tyacke who initiated the phone call with Professor Zisapel to discuss the circumstances surrounding D1 and to subsequently recommend the possibility of an extension after being sent information on the matter by the Applicant (see Tyacke at [13] and [14]) reinforces the authenticity of Dr Laudon’s and Professor Zispel’s statements about believing that nothing could be done.
122. In short, the difference in circumstances between May 2015 and May 2019 and thereafter are of sufficient remit to conclude that Dr Laudon’s and Professor Zisapel’s views about what could be done about D1 in May 2019 up to the point of being informed about the possibility of an extension by Mr Tyacke (being the relevant patent attorney at that time; see Zisapel at [8] and [9] and Tyacke at [6]) were reasonable.
123. Finally, I note that Mr Larish urged me to consider the Applicant’s actions in May 2019, in terms of not consulting a patent attorney about what could be done about D1, were a better indication of what would have happened in May 2015 than the evidence provided by Dr Laudon on that point. However, as discussed above, I consider that the circumstances between May 2015 and May 2019 are sufficiently different such that the circumstances in one time period may not reliably be substituted as evidence of what would have occurred in the other time period.
124. In conclusion, with regard to the Opponent’s second argument, I do not see anything about the Applicant’s conduct that is inconsistent with the chain of causation.
125. In view of the above, on balance, I conclude that the failure of Dr Nir to communicate the publication of the thesis to Dr Laudon was in fact causative with respect to the failure to file in time to claim the benefit of the grace period. It follows that the failure of Dr Nir to communicate the publication of the thesis to Dr Laudon was a causative error for the purposes of s223 and thereby the only matter left relates to whether the Commissioner’s discretion should be exercised to grant the extension, which leads to the final grounds pressed by the Opponent.
Discretion Should not be Exercised
126. Even where a case for an extension has been made out, there is the matter of whether the Commissioner’s discretion to grant the extension should be exercised. Factors relevant to the exercise of the Commissioner’s discretion are given in Vangedal-Nielsen, Erling v Smith, Francis John [1980] FCA 190 (“Vangedal-Nielsen”) at pages 11 to 12, and are summarised as follows:
Factor ii. is not relevant to the present matter.
127. As noted in Sanyo Electric at [16], “it is ‘more important to consider the consequences of extending or refusing to extend time than to debate the reasons why the act was not done in time’ (per Davies J in Chalk’s case, at 156 [Robert Erwood Chalk v Commissioner of Superannuation [1994] FCA 1063; (1994) 50 FCR 150], with whom Chief Justice Black and Mr Justice Cooper agreed. Similar comments are to be found in Comcare v A’Hearn [1993] FCA 498; (1993) 119 ALR 85, particularly at 88)”, and that s223 is beneficial in nature and should be applied beneficially per Chalk’s case at 155.
128. The Opponent presents their arguments regarding discretion at [77] to [97] of its written submissions. These begin with a list of the discretionary factors said to be relevant, at [77]:
“If the conditions in s 223(2)(a) are made out (contrary to the above), the Delegate has a discretion as to whether the Extension Application should be allowed. The relevant factors include:
(a) whether there has been any delay: Apotex Pty Ltd and Commissioner of Patents, Re [2008] AATA 226; (2008) 101 ALD 368 at [23], Mount Sinai at [30], [38], [39]; [42]; PIHA Pty Ltd v Spiral Tube Makers Pty Ltd [2010] APO 16; (2010) 88 IPR 439 at [20(c)];
(b) the length of time for which extension is sought: cf S Cell International Pty Ltd v Geron Corp [2005] APO 11; (2005) 65 IPR 157 at [43];
(c) the nature of the disclosure made by the extension applicant. As Jenkinson J explained in Kimberly-Clark at 698 (emphasis added):
‘... an applicant would in my opinion have to go beyond a disclosure of the processes by which an agent's errors came to be committed, and would have to expose frankly, inter alia, all the conduct, knowledge, beliefs and mental processes of the applicant (or, in the case of corporation aggregate, of the relevant officers and other agents) relevant to an understanding of the way the failure to do the act or take the step occurred, or relevant to an evaluation of the reasonableness of that conduct. Whether or not the error or omission of the agent which enlivened the power occurred without moral fault on his part, the applicant's claim to the exercise of the power cannot be judged without the means of evaluating the applicant's moral claim to an indulgence which will, to some extent at least, work a prejudice to the efficient operation of what Bowen CJ in that case called “the system”, even if no prejudice to the applicant for a patent...
[The section] confers a power so conditioned that in my opinion its exercise is not lightly to be granted, and a power to be invoked only upon a prompt, frank, comprehensive and clear disclosure of all the circumstances relevant to the weighing of the discretionary considerations upon which grant or refusal of an extension of time will depend.’
(d) the patentee’s conduct during the extension process: Mount Sinai at [39];
(e) the interests of the parties and the public in refusing or granting the extension: Apotex at [23]; Langford and Commissioner of Patents, Re [2010] AATA 663 at [31].” (emphasis in original).
129. It is apparent that the Opponent’s factors do not correspond with the discretionary factors established in Vangedal-Nielsen. Despite this, it is not clear to me that where the Opponent’s factors diverge from Vangedal-Nielsen that these are “irrelevant” as seemingly suggested by the Applicant at [65] of its written submissions. Rather it seems to me that the Opponent’s factors relate to those from Vangedal-Nielsen as follows:
130. I am not sure that I agree with Mr Larish’s suggestions at the hearing that I can consider whatever I like under discretion as long as it serves the purposes and scope of the Act. Nevertheless, it seems correct to me that, where there is something that probatively informs the exercise of a discretion that is not encompassed in established principles, then that matter should still be considered. However, noting my concordance above, this is not the case here. Therefore, I will proceed to consider whether it is appropriate to exercise the Commissioner’s discretion to grant the extension of time using the factors outlined in Vangedal-Nielsen. Noting the relationship between the Opponent’s factors and those Vangedal-Nielsen, I will, however, consider the Opponent’s submissions as those relate to the factors from Vangedal-Nielsen.
Is the Commissioner satisfied that a proper case has been made out justifying an extension?
131. The Opponent makes submissions relevant to this factor at [90] to [96] of its written submissions:
“90. Thirdly, Neurim’s evidence falls well short of the standard of disclosure that is required: see Kimberly-Clark at 698, quoted at [77(c)] above.
91. Neurim’s evidence was presented in a piecemeal fashion – Neurim filed three tranches of evidence. And even then, it only did so because of deficiencies raised by the Office, which had to draw out from Neurim information that Neurim did not otherwise see fit to disclose.
92. In those circumstances, the disclosure fell well short of being comprehensive, clear or prompt: see also Mount Sinai at [37].
93. Nor was the disclosure entirely frank. For example, in Laudon 1 [23], Dr Laudon gave the following reason for the 7-month delay between his review of D1 and the filing of the Extension Application in December 2019:
‘Neurim has taken steps to investigate the circumstances around the release of information relating to the Pharmacokinetic Study without the consent of Neurim, and to investigate whether there were steps that might be taken toward reducing the harmful impact of this event. This included consideration of further documents filed in connection with the [598 Opposition], received by Neurim on 1 August 2019’
94. That implied that steps were taken for the duration of the 7-month period, whereas it subsequently emerged that Neurim did little to nothing until September 2019: see [83] above. This non-disclosure is “relevant to the weight of the discretionary considerations”, including delay.
95. Moreover, there are various lacunae in the evidence which inhibit “an understanding of the way the failure to do the act or take the step occurred” and “an evaluation of the reasonableness of that conduct”.
96. For example, there is no (let alone a comprehensive) explanation of Dr Nir’s mental processes informing her asserted ‘understanding’ that she ‘should’ have communicated with Dr Laudon: see [45] and [55(d)] above. Equally, there is no evidence of documented protocols within Neurim to manage disclosures that could give rise to concerns about patentability of inventions of commercial significance, whether in existence at the time that D1 was published or at any time thereafter.” (emphasis in original).
132. It should be apparent that I am already satisfied, for reasons given above, that a proper case has been made out, and one may refer to those reasons to refute the Opponent’s assertions. I do note that the lack of explanation by Dr Nir as to how the error came about does weaken the Applicant’s case, but, ultimately, I consider that the evidence justifies the extension. Beyond that, I will, however, say a few things in response to the Opponent’s assertions.
133. Firstly, the mere fact that an Applicant needs to file several items of evidence before the Commissioner is satisfied that an extension is allowable and may be advertised for opposition, does not necessarily mean that the evidence provided, or the case put, is inherently defective. In extension of time applications, it is relatively common for the Commissioner to require one or more further rounds of evidence before being satisfied that an extension is allowable. It is clearly desirable for a s223 applicant to provide as much relevant information as possible up front, and not wait in the expectation that the Commissioner will simply ask for more information. However, the Opponent’s position appears to reduce this to a requirement that must be met before a valid extension can be made out. Plainly, such a position is incongruent with principles of natural justice and should not be entertained.
134. Unsurprisingly, Mount Sinai School of Medicine [2013] APO 52 (“Mount Sinai”) at [37] does not support the Opponent’s cause in this regard. There the Deputy Commissioner was clearly making comments about the specific conduct of the s223 applicant in filing further information, including delays in filing the extension, delays filing further evidence and filing material immediately before the hearing. No such behaviour is apparent here. The Applicant filed the Nir and Laudon1 declarations with the initial application for an extension on 9 December 2019, and then promptly filed further declarations in response to the Commissioner’s requests for further information on 13 March 2020 and 24 June 2020, well within the time limits set each time. While the information, as Mr Larish observed, somewhat critically at the hearing, was provided over a period of “more than half a year”, the fact is that nearly five months of that time is attributable to delays in the Commissioner responding to the evidence provided by the Applicant. No late evidence or submissions were made by the Applicant.
135. Secondly, it is not clear to me that, on its own, [23] of Laudon1 cited by the Opponent says very much about what precisely happened in the seven months in question one way or the other. That is, it does not have the character of necessarily representing or misrepresenting that the Applicant was doing something for the entirety of the seven-month period concerned. In any case, it is quite clear from the evidence discussed above that the Applicant began investigations into how D1 was published very soon after 2 May 2019 – notably TN-5 is dated 14 May 2019, so it is not the case that the Applicant was doing “nothing” until September 2019. The fact that work did not begin on the extension until 10 October 2019 is readily explained by the fact that it was only at this point that the Applicant became aware that it could file such an extension.
Has there been undue delay in seeking an extension of time?
136. The Opponent makes submissions relevant to this at [79] to [89] of its written submissions:
“79. First, the Extension Application was made in December 2019 – over 4.5 years after Dr Nir became aware of the publication of D1 and over 3.5 years after the expiry of the grace period under s 24(1)(b).
80. On any view, that is an extremely long period of time. By way of comparison, in Apotex, the Tribunal considered that a ‘very long period of delay’ – there, 17 months – strongly weighed against the exercise of the s 223 discretion: [24] and [38]. Here, the delay is over twice as long as that.
81. Secondly, and relatedly, there was a 7-month delay between Neurim having become aware that D1 formed part of the SGP Opposition in May 2019 and its filing of the Extension Application. That is contrary to the requirement for promptness set out in Kimberly-Clark at 698 and the authorities at [77(a)] above.
82. Neurim did not adequately address this delay in its initial Extension Application, Laudon 1 or Nir. Rather, the delay was raised by the Office by its letter of 13 March 2020, which stated:
‘For the present case, having been well and truly aware since May 2019 of the continued existence of [D1], these was a delay of 7 months before filing the request for an extension of time. The delay between becoming aware of the existence of [D1] and the filing of the [Extension Application] is never explained by either Dr Laudon or Dr Nir. This is very concerning, particularly given the existence of the [598 Opposition] and the use that [D1] is being put to in [the 598 Opposition].’
83. The evidence subsequently filed by Neurim concerning the 7-month delay focuses on the period from September to December 2019.
84. It does not, however, explain what was done from mid-May to September 2019, a period that makes up more than half of the 7-month delay: see Tyacke [12], [13].
85. It can be inferred that nothing of substance was done in this period.
86. Where a period of delay is unexplained, a decision-maker is “unable to form a view on whether the delay was reasonable in the circumstances”: Annco Inc v Nike Innovate CV [2020] ATMO 17 at [19].
87. Even as to the period from September to December 2019, Neurim relies primarily on its general workload and employees taking time off work for non-religious reasons: Zasapil (sic) [19]-[23]. Given the extent of the delay referred to in [79] and [81], above and the nature of the indulgence sought, these matters should be given little, if any, weight: see also Mount Sinai at [39].
88. Neurim’s delay also caused prejudice to GP. During the 7-month period, GP adduced evidence in the 598 Opposition, including as to D1. The 598 Opposition was stayed after the Extension Application was filed. Had the Extension Application been made promptly, and before the deadline for GP’s evidence in support on 1 August 2019, it may be inferred that the 598 Opposition would have been stayed such that GP would not have been required to file its evidence, including as to D1.
89. Further, the delay in filing the Extension Application has necessarily resulted in a prolongation of the 598 Opposition, and thereby a delay in GP (and other persons for whom the outcome of the 598 Opposition is important, as well as the general public) knowing whether the 598 Application will be granted or not. This commercial uncertainty is a form of prejudice to be taken into account. The strain on litigants – even commercial litigants – is also a recognised species of prejudice to be taken into account: e.g, Aon Risk Services Australia Ltd v Australian National University (2009) 239 CLR 175 at [100]-[101]; Carey v Freehills [2014] FCA 788 at [66].”
137. However, the Opponent’s contentions do not bear scrutiny. Firstly, the Opponent appears to be suggesting that the time elapsed between Dr Nir’s error and/or the expiry of the relevant grace period and the filing of the extension amounts to undue delay. It is difficult to see why time prior to when the Applicant discovered the error, at least in the present circumstances, should putatively contribute to an undue delay. At most the delay between discovery of the error and filing of the extension application was a little more than seven months. Notably, the fact that the delay was at most seven months undermines the remainder of the Opponent’s case on undue delay, which is premised on a delay of at least three and a half years.
138. Secondly, the Opponent’s suggestion that nothing of substance was done from mid-May 2019 to September 2019, and that this was unexplained, is not correct. As discussed earlier in this decision, the Applicant immediately began investigating the circumstances surrounding the publication of D1. The fact nothing was done regarding an extension of time until October 2019 is logically explained by the fact that the Applicant did not think anything could be done until informed so by Mr Tyacke on 10 October 2019. It could be argued that the Applicant should have begun consultations with Mr Tyacke earlier than they did, but the delay is likely explained by the fact that the Applicant did not think anything could be done about D1, and that Mr Tyacke and others at DLA Piper were busy with patent ligation matters for the Applicant, including for the opposition under s59 to this application between May to September 2019; see Tyacke at [7] to [12]. Notably Mr Tyacke initiated the contact in September 2019 to discuss D1; see Tyacke at [13]. On balance, I do not consider that there was any undue delay in the period May to October 2019.
139. Thirdly, I do not agree with the Opponent that the explanation for the period of September to December 2019 should be given little weight. As discussed, the delay from May to October 2019 was not undue. Logically, it makes sense that work only began on the extension of time once Professor Zisapel was informed of the possibility of an extension by Mr Tyacke on 10 October 2019 and gave instructions to prepare the same on that day. This meant the Applicant prepared and filed the extension in a period of little more than two months, all the while dealing with deadlines in other patent litigation matters, other business matters and several Jewish holidays in the month of October (Zisapel at [19] to [22]; Tyacke at [16]). Mr Tyacke, Professor Zisapel and Dr Laudon all depose that nothing was done to delay filing the extension and that the Applicant proceeded with the extension as quickly as practicable; Laudon2 at [15]; Tyacke at [19] and Zisapel at [24]. I see nothing in the evidence or the behaviour of the Applicant to suggest otherwise. Mr Larish’s comments at the hearing about the length of the Nir and Laudon1 declarations (5 pages/27 paragraphs and 5 pages/25 paragraphs respectively) in comparison to the time taken to prepare and file that evidence as being inappropriate, does not bear scrutiny in view of the circumstances. On balance, considering the circumstances, there was no undue delay in the period October to December 2019.
140. In conclusion, I do not consider that there was any undue delay in filing the extension application. I will consider the Opponent’s contentions regarding the prejudice caused to it and the public by any delay in connection with the relevant factors below.
141. For completeness I note that at the hearing Mr Larish argued that the authorities did not necessarily view delay in terms of undue delay as opposed to simply delay. Mr Larish directed to me to paragraphs [24], [25], [36] and [38] of Apotex in support of this contention. However, it is not clear to me that Apotex supports the Opponent’s contentions regarding delay. Firstly, the Senior Member directly cited at [23], and therefore presumably was using, the factors regarding discretion from Vangedal-Nielsen, including undue delay. The discussion of delay at [24], to my mind, was clearly considering the issue of undue delay in that the discussion of how the seventeen-month delay came about considered the s223 applicant’s culpability in that delay. The statements at [25], while, like [24], are under the heading of “DELAY”, is not so much discussing undue delay in terms of being a factor in discretion per se as providing commentary on how extensive delays, even “...in the absence of moral fault does not detract from the desirability of certainty for patentees and the smooth and predictable operation of the system of patents registration.” It is thus simply pointing out that, even if there was no undue delay, delay per se impacts on other factors to be considered in exercise of the discretion, like the public interest and the interest of other parties, like patentees.
142. Similarly, paragraph [36] is simply discussing how the delay per se, irrespective of undue delay, impacts the public interest. It has nothing to say about the consideration of delay or undue delay as a discretionary factor per se. The same can be said for [38], which provides the Senior Member’s conclusion on discretion in view of the factors considered. Here it is apparent that the Senior Member was heavily influenced by how the absolute length of the delay (not the undue delay per se) impacted the public interest and the parties concerned in the circumstances of Apotex which involved a lengthy extension of time to file a notice of opposition.
143. It should be clear that what Apotex stands for is a consideration of the delay on the public interest and the interests of the parties. It does not stand for the proposition that delay as such should, or must, be considered as a factor on its own in place of undue delay. Indeed, if one were to simply consider the issue of delay per se, one would need to consider the import of that delay and would simply end up considering that in terms of the public and other interests anyway – it is not a matter of considering delay in the abstract. Similar reasons also apply to the wording of the Patent Manual of Practice and Procedure at 3.11.1.3.5 under the heading “Delay”, which was also cited by Mr Larish to support the Opponent’s contentions on delay.
The Interests of the Parties in Refusing or Granting an Extension
144. Obviously, the interests of the parties are opposed on this factor. The Opponent argues that it was prejudiced by the seven-month delay between discovery of the error and the filing of the extension application since, if the extension was filed earlier, the stay of the s59 opposition could have been put in place earlier and it would not have been required to file its evidence. It is true that an earlier stay may well have delayed when the Opponent would need to file evidence, but it does not seem to necessarily follow that there would be no need for evidence at all – there are other documents cited in the s59 opposition besides D1. The prejudice here to the Opponent, if the extension was allowed, includes the resources wasted in providing evidence on D1 and the fact that a document that formed part of its s59 opposition would no longer be available to it.
145. At the hearing Mr Larish suggested that even if the Applicant offered to pay the Opponent’s costs thrown away due to this, it would not overcome the prejudice to the Opponent. This is true, in that there would still be the prejudice suffered by the removal of D1from the prior art base. However, if the Applicant did pay the Opponent’s costs thrown away on evidence if the extension were granted, this would at least ameliorate the financial prejudice suffered by the Opponent. In terms of that prejudice and the costs involved, Mr Shavin stated that “now our friends say that, well a prejudice that they have suffered is that they’ve filed some evidence in relation to D1 when they wouldn’t have filed evidence in relation to D1, and we accept that, and if there was to be an order for costs thrown away by reason of that, the terms obviously have to be resolved, but as matter of principle it’s irresistible, it would be a matter of justice and fairness, we wouldn’t be resisting it. It’s a money prejudice, it’s not a substantive prejudice”. Such statements seem reasonable, and, in view of the Applicant’s acquiescence (see also [106] of the Applicant’s submissions), it seems would lead to an appropriate variation of costs in the s59 opposition, which I consider is the appropriate vehicle for such an order of costs if it were to be made.
146. There is also the matter, as noted by Mr Larish, that if the Opponent was aware that D1 might be subject to the grace period then the Opponent would have shifted emphasis to other items of prior art, particularly in view of the apparent strength of D1 as an item of prior art. I accept that this has caused prejudice to the Opponent. The Applicant suggests, at [83] of its written submissions, that there are means to allow the Opponent to file further evidence in support if the extension is granted. At the hearing Mr Larish noted that the Opponent may wish to supplement its evidence in support if the extension is granted. Mr Shavin stated that a further period to file evidence in chief would be “just and fair”. While that is a matter necessarily beyond the remit of this decision, my view, given that the period to file evidence in support under Reg 5.8(1) has expired, is that Reg 5.23 is the most appropriate vehicle for admitting further material into the s59 opposition, and that the Commissioner will consider any such Reg 5.23 request that might be made in this vein, if the extension was granted, in accordance with established principles It is reasonable to believe, based on Mr Shavin’s statements, that the Applicant would not resist any such Reg 5.23 request.
147. Conversely, the Applicant’s interest would seem to preponderantly lie with gaining the extension as this would remove an item of prior art asserted against the application in the s59 opposition.
148. Citing Apotex at [105] of its written submissions, the Applicant argues that whether the party seeking the extension “had alternative means of achieving its desired outcome of the extension was not granted” was relevant in considering the parties’ interests. The Applicant argued that it had no alternative available to it if D1 remained as prior art and therefore denying the extension will cause the Applicant prejudice that it has no means to address. In contrast, the Applicant suggested at [106] of its written submissions that the Opponent’s prejudice can be ameliorated by an appropriate costs order. Mr Shavin pointed to the fact that an Opponent can still seek to revoke, besides an opposition per se, and therefore there was no “permanent irremediable prejudice” to the Opponent.
149. However, it is not clear to me that the availability of future potential remedies is necessarily relevant to the prejudice to, or the interests of, the parties in this matter; at least not in the sense suggested by the parties. In Apotex, the extension was one for filing a notice of opposition. It thereby related to an entire action for which there were clearly further alternatives available to the opponent, such as re-examination or revocation proceedings before a relevant Court. As the present extension relates to the grace period, it does not, to my mind, lend itself to alternative remedies one way or the other. Rather it seems to simply have consequences for future actions that may be open to the parties. For example, if the extension is granted, it is open, depending on the circumstances, for the Opponent to continue with the s59 opposition, to file a future request for re-examination and to pursue revocation before a Court – but in all cases D1 would not be available prior art. In short, if the extension is granted, there is no apparent remedy for the Opponent that would necessarily allow it to take further action to alleviate any prejudice it would specifically suffer if D1 was no longer part of the prior art base. Similarly, if the extension were not granted, there appears to be no means for the Applicant to alleviate any prejudice it would suffer as a result of D1 remaining as part of the prior art.
150. Mr Larish also referred to the general benefit that would accrue to the Applicant if the extension was granted. That is, that it would provide an additional eight months of grace period that would apply to other disclosures besides D1, i.e. the extension would mean that the grace period would run from 29 March 2015 to 29 November 2016. That of course would be the case. Mr Larish referred me to a letter sent by the Opponent to the Applicant on 18 February 2021 (the “Opponent’s letter”) regarding this issue, particularly emphasising D2 and D48 of the s59 opposition, these being dated 19 May 2015 and July 2015 respectively.
151. At the hearing Mr Shavin argued that the Opponent’s contentions regarding D2 and D48 should not be accepted. Mr Shavin took me to page 3 of D2 and pointed out that this comprised a confidentiality agreement signed by various parties in May 2015. Mr Shavin asserted that D2 was not in fact published until October 2018, on the US Government Clinical Studies website, and that no evidence has been advanced by the Opponent in connection with D2. With regard to D48, Mr Shavin argued that it was not clear how this, being an information sheet for a drug called “Eudragit”, was at all relevant to the novelty or inventive step of the application. Mr Shavin also noted, with some rhetorical flourish and perhaps unintended endorsement, that D48 was “one of the fish that John West had rejected”, given that it was not referred to in the evidence in support. In terms of there potentially being other items of prior art, beyond those cited in the s59 opposition, that might be picked up by the extension, if granted, Mr Shavin argued that, given the Opponent had “dredged every barrel that can be found” and cited 61 documents in the s59 SGP, there was no basis for suggesting that there was anything beyond those cited in the opposition that could be caught up in the new grace period if the extension was granted.
152. In response Mr Larish argued that the Opponent still saw D48 as relevant, while he observed that the extended grace period would still prejudice the Opponent in the event it established an earlier publication date for D2.
153. It is not for me to assess the relevance of D2 or D48, or any other items of prior art, in this matter. However, even assuming they are of low relevance, it remains the case that the Opponent would suffer at least some, even if minimal, prejudice by having these shut out of its case and in any further action it would seek to take against the application. It is also the case that an extended grace period may catch any other disclosures that fall within the extended grace period that may be found by the Opponent, which is a further prejudice to the Opponent, even if this appears to be entirely hypothetical at this point – the Opponent has not identified any other disclosures that might be relevant to the application that would be caught up in an extended grace period. Overall, there is clearly at least some prejudice to the Opponent because of these issues.
154. The Opponent’s letter also pointed out the fact that the extended grace period may affect granted/certified or pending divisionals in the application family (hereinafter the “family members”). The Opponent’s letter sought an undertaking from the Applicant to not seek to apply the grace period to any document other than D1 that might fall within the extended term of the grace period represented by the interval 29 March 2015 to 28 November 2015 in relation to the application as granted or otherwise, or any applications or patents deriving priority from the application. The Opponent noted that the Applicant had not provided the undertaking by the requested time of 4pm on 22 February 2021. Mr Larish observed that the ability to apply the extended grace period to documents other than those connected with the error was contrary to his client’s interests and the public interest.
155. Conversely, at [107] and [108] of its written submissions, the Applicant refers to the prejudice it would suffer in terms of the family members, if the extension was not granted.
156. In terms of arguments about the effect the extension might have, if granted or not, on the family members, there is clear prejudice to either party. Obviously, if the extension were not granted, then D1 would be available for the purposes of examination, re-examination, opposition or revocation, as the case may be, in connection with the family members. Conversely if the extension were granted, D1 would not be available for the Opponent to raise, where applicable, in proceedings with regard to the family members, and it would also have to deal with an extended grace period for each of the family members due to the operation of Reg 2.3.
157. Overall, on considering the various detriments or benefits to the parties and weighing these up, I am of the view that the interests of the parties are equally balanced.
The Public Interest
158. The Opponent makes submissions regarding the public interest at [97] of its written submissions:
“Fourthly, the public interest militates against granting the Extension Application. In particular:
(a) granting the extension application would not encourage the prompt filing of applications under s 223, thereby interfering with the ‘efficient operation [of] the system’: cf Kimberly-Clark at 698;
(b) there is a public interest in minimising delay in the assessment of whether a patent ought to be granted: The Procter & Gamble Company v Kimberly-Clark Corporation [1991] APO 55; (1991) 23 IPR 45 at 51-52. Any encouragement to a patentee to file extension application during the course of an opposition procedure will lead to further delays;
(c) there is a public interest in there being relative certainty about the length of the grace period, so that entities can reach informed views about their exposure to a particular patent application (or granted patent). The 12-month grace period in s 24 has been determined by Parliament to be the appropriate length of time that represents a balancing act between the interests of patentees and the broader public. The 12-month period may also be compared with the less generous position in other jurisdictions. As WIPO states on its website (emphasis added):
‘Some national legislations allow for a grace period for processing the registration of a patent. This period is usually six months to a year, counted from the date of disclosure of the invention to the public’
(d) there is a public interest in the grant of a patent being properly assessed, and in ensuring that invalid patents do not obtain registration: Eli Lilly and Co v Pfizer Research and Development Co NV/SA [2003] FCA 988; (2003) 59 IPR 234 at [20]. GP considers that D1 will prevent the 598 Application proceeding to grant. In contrast, even if the Extension Application is refused, Neurim’s position in the 598 Opposition is that the 598 Application is novel and inventive over D1.” (emphasis in original)
159. Noting that I do not consider that there has been any undue delay in filing the application, it is difficult to see how granting the extension would encourage delays in filing s223 applications as asserted by the Opponent. While it is clearly desirable to minimise delay in resolving opposition matters, this does not mean that the ability of one party or the other to obtain extensions legally open to it is necessarily stymied or should be seen in a pejorative light as such. Much depends on the facts of each matter. It is likely that if s223 extensions were being used by one party or the other to delay an opposition, or any other matter, then the Commissioner would thereby exercise her discretion to grant, or not grant, an extension with that fact in mind.
160. Having said that, the delay introduced via the extension application here, while not undue, undoubtedly has protracted the s59 opposition by an extended period of time, which is contrary to the public interest. This delay, as far as I can see, represents the entire gamut of detriment to the orderly conduct of matters before the Commissioner as a result of the extension application. Before the extension was filed the application was proceeding as any application under opposition would do before the Commissioner.
161. As agreed by the Applicant, at [102]c) of its written submissions, it is not contested that there is a clear public interest in the grace period being clear or certain, as a general proposition. However, the same can be said for a wide variety of actions that are required to be done in a certain time under the legislation, for example filing in time to claim the benefit of an earlier priority or filing a notice of opposition. The Opponent’s criticisms, therefore, appear to be about the existence of s223 to begin with. Despite this, Parliament has seen fit to balance the desirability of public certainty surrounding the timing of certain actions with the availability of s223 to obtain extensions to do those actions. It might be said that Parliament did so to ensure that the public interest in encouraging innovation and the general availability of patent protection is not necessarily defeated in specific instances by errors or omissions by an applicant, errors or omissions by the Commissioner, force majure or despite the exercise of due care. In any case, as Parliament has seen fit to provide extensions, the issue is not so much as there being any uncertainty per se, as to the impact that uncertainty, or perhaps rather the import that granting the extension would have on potential actions that the public and other parties may have taken based on a reasonable belief of certain facts or circumstances prior to filing the extension. As noted by Mr Larish at the hearing, the delay in filing the extension factors into this consideration.
162. In that regard, the public would not have any expectations as to the grace period until the application became open to public inspection on 17 May 2018. From that date, up until the extension was filed on 9 December 2019, the public and other parties would reasonably believe that the grace period for the application ran from 29 November 2016 to 29 November 2017. While not the four-and-a-half-year delay cited by Mr Larish at the hearing, this still means the public would be, if the extension was granted, under a false impression of the grace period for a little more than 18 months. This is clearly not in the public interest per se.
163. However, it is instructive to understand what are the likely practical consequences of this false impression. As should be apparent, at no time during that 18-month period has the application proceeded to grant. This distinguishes the matter from, for example, the situation in Mount Sinai, where the extension, if granted would have significant impacts on those who, for nearly 10 years, were reasonably operating on the basis that the patent would expire on 30 November 2013 and might have been preparing to launch competing products when the extension application was made relatively close to the expiry of the patent; see Mount Sinai at [35]. Although somewhat different in nature to Mount Sinai, similar can be said regarding the significance of the practical effects of the extension on the public and others in Apotex as compared to this matter. In Apotex a putative opponent sought an extension of 17 months to file a notice of opposition, in circumstances where clearly the public and the patentee had a well-established view of the patent and what it meant for any actions they may wish to take. In effect, other than the ongoing uncertainty due to prolongation of the opposition as to when and if the application proceeds to grant, and the form the application might be in if granted, there does not seem to be any significant impacts on the public with regard to the application.
164. There is, of course, the fact that the extended grace period, if the extension is granted, will apply to the family members as well by virtue of Reg 2.3, and some understanding of how the delay and of the practical consequences this might have on actions the public might take in connection with the family members is relevant. For the family members, like the application, there may be a period, between the filing date and the filing of the extension application on 9 December 2019, where the public assumed that the grace period simply amounted to the usual period of 12 months, where granting the extension would mean that that is not the case Two of the family members were filed before 9 December 2019, by a period of a little more than 11 months in one case and less than a month for the other. The remaining case was filed after the extension application. The periods where the public believed in an erroneous grace period, if the extension was to be granted, such as they are, are contrary to the public interest, even if the duration is rather less than that for the application in one case and of a very short duration in the other.
165. In terms of actions that the public might take, two of the family members are either granted or certified (the “family patents”), while a third is yet to undergo examination. The family patents were granted/certified after the extension application, so the only effect the extension application might have on the public is to bring some doubt as to the validity of the family patents until the extension application is resolved. Of course, if the extension was granted, this would tend to solidify the validity of the family patents in the public mind, and it seems unlikely that the public would take actions, prior to resolution of the extension application, based on an assumption that the patents were invalid due to D1. That is, there seems to be little scope for a surprise of material effect with respect to the patents due to the extension application, other than those that might be caused by risky assumptions. As the third family is not yet under examination, it is difficult to see what actions could be taken by the public that would be prejudiced by the extension application. As for the application, the material effect, in terms of the prejudice there might be to actions the public might take, due to the extension application, appears to be quite low.
166. The Opponent’s comments about ensuring that invalid patents are not granted is noted. However, I note that, whether or not the extension is granted, there will still be a process that will nominally allow for the correct determination of the validity or otherwise of the application. It is just that whether D1 forms part of that determination hinges on the outcome of the extension. Obviously, this impacts on the public interest in that whether a patent is ultimately granted/revoked/amended as the case may be, may well depend on the availability of D1, and potentially other prior art that falls within an extended grace period. Similar can be said for the effect on the family members. This situation regarding the public interest, in relation to a grace period extension, was described in Canva Pty Ltd [2021] APO 35 (“Canva”) at [40]:
“Given the potential impact of the grant of this extension on the novelty and inventiveness of the claimed invention, there are serious consequences to the public. That is, grant of the extension may ultimately lead to the granting of an exclusive right which would otherwise not be granted, which could be viewed as running counter to the public interest. However, there is a broad public interest in promoting innovation (that is, by rewarding it with a monopoly) and in the proper operation of the various provisions of the Act. I consider the public interest to be a neutral consideration.”
I agree with the above statements by the Delegate in Canva regarding the impact on the public interest of the exclusion, or inclusion of D1 in the prior art base as a consequence of the extension application, with respect to both the application and the family members.
167. Overall, noting the detriment to the public interest caused by the delay in determining the s59 opposition, and the uncertainties introduced with respect to the application and the family members, I am of the view that the public interest is marginally against allowing the extension.
Conclusion on Discretion
168. It can be seen that two of the considerations, the issue of whether a proper case has been made out and undue delay, favour granting the extension, the interests of the parties are equally balanced either way, while the public interest weighs against allowing the extension. It is not, however, a matter of simply calculating how many considerations necessarily fall one way or the other, but understanding the material import of each consideration to whether the discretion should be exercised or not.
169. The public interest is against the exercise of the discretion, but it is not, to my mind heavily so. As discussed, the material impact on the public interest is not of the magnitude discussed in Mount Sinai or Apotex. Conversely the fact a proper case has been made weighs in favour, even if not overwhelming so. The lack of undue delay emphatically favours the exercise of the discretion, while the interests of the parties, to my mind, adds equally to either side of the ledger.
170. After weighing up the relevant discretionary considerations, I am of the view the detriment to the public intertest is not of sufficient warrant to outweigh those factors in favour exercise of the discretion. This is particularly so when one considers the generally beneficial nature of s223 as discussed in Sanyo Electric. On balance the considerations favour the granting of an extension of time.
CONCLUSION
171. I am satisfied that the Applicant failed to file in time to claim the benefit of the grace period pursuant to s24(1)(b) and Reg 2.2D due to the failure of Dr Nir to inform Dr Laudon about the publication of D1. The relevant discretionary factors weigh in favour of grant of the extension. I grant the Applicant an extension of time of eight (8) months pursuant to s223(2)(a) to file the application in time to claim the benefit of the grace period pursuant to s24(1)(b) and Reg 2.2D.
COSTS
172. Costs usually follow the event. I see no
reason to do otherwise here. I award costs against the Opponent according to
Schedule
8 of the Regulations.
Dr W.E. Guinea
Delegate of the Commissioner of Patents
Annex A - Timeline
|
Action/Item
|
Evidence
|
|
|
2011
|
Discussions regarding option of patent protection for the product
|
Laudon1 at [13].
|
|
21 August 2012
|
Applicant enters into an agreement with Centre for Human Drug Research
(CHDR) for research relating to a new age appropriate formulation
of Circadin
(Pharmacokinetic Study), being a prototype of the product of the application.
Agreement includes confidentiality clauses
with regard to the research.
|
Nir at [10], TN-1
|
|
26 September 2014
|
Dr Nir receives an email about CHDR wanting to submit an abstract for a
British Pharmacology Society meeting. Dr Nir rejected this
publication going
ahead.
|
Nir at [14]; TN-2.
|
|
14 April 2015
|
Earliest date of possible publication of the thesis without consent of
Applicant.
|
Nir at [21].
|
|
On or around 4 May 2015
|
Dr Nir receives a copy of a PhD thesis from CHDR. The thesis comprises a
chapter (chapter 8, being D1) with information regarding
the Pharmacokinetic
Study. This came as a surprise to Dr Nir and was without the consent of the
Applicant.
|
Nir at [15] to [18]; TN-3 and TN-4.
|
|
4 May 2015
|
Dr Nir was concerned about the publication of D1 in electronic versions of
the thesis, and immediately contacted CHDR.
|
Nir at [19]; TN-4
|
|
6 May 2015
|
Dr Nir speaks with CHDR. CHDR note that D1 was meant to be under embargo
and will seek to have this corrected immediately.
|
Nir at [19]; TN-4.
|
|
7 May 2015
|
CHDR advise Dr Nir that the mistake has been corrected and that a version
of the thesis with D1 redacted will be made available.
|
Nir at [20]; TN-4
|
|
25 May 2015
|
Dr Nir emails CHDR about links to the unredacted version of the thesis
still being available.
|
Nir at [20]; TN-4
|
|
28 May 2015
|
CHDR email Dr Nir informing her that the full version of the thesis was no
longer available.
|
Nir at [20]; TN-4.
|
|
31 October 2016
|
Filing of priority document, US 62/415014.
|
|
|
29 November 2016
|
Filing of PCT/IB2016/057190
|
|
|
26 April 2018
|
National phase entry of PCT/IB2016/057190.
|
|
|
1 February 2019
|
Notice of Opposition (s59) filed
|
|
|
2 May 2019
|
Statement of grounds and particulars in s59 opposition filed. Applicant
receives 61 documents in connection with the s59 opposition,
including
D1.
Dr Nir is surprised as D1 is the chapter of the thesis that she considered had been redacted. |
Laudon1 at [15]; Nir at [22]; Zisapel at [12] and [13]; Tyacke at
[9].
Nir at [24] and [25]. |
|
Before 14 May 2019
|
Dr Nir contacts CHDR regarding how the full version of the thesis became
publicly available.
|
Nir at [26].
|
|
14 May 2019
|
CHDR inform Dr Nir by email that the full version of the thesis had been
made available by Leiden University (rather than CHDR) as
the University only
allowed for an embargo period of a maximum of 18 months.
|
Nir at [26]; TN-5.
|
|
5 August 2019
|
Evidence in support in s59 opposition completed.
|
|
|
20 September 2019
|
Professor Zisapel discusses the circumstances surrounding the Pharmokinetic
Study of D1 with Mr Tyacke of DLA Piper, at the instigation
of Mr Tyacke.
|
Zispael at [16]; Tyacke at [13].
|
|
22 September 2019
|
The Applicant supplies DLA Piper with further information in relation to D1
and the Pharmokinetic Study.
|
Zisapel at [16]; Tyacke at [13].
|
|
10 October 2019
|
Professor Zisapel has a conversation with DLA Piper and is advised of
possibility of applying for an extension of time for filing
a complete
application. Professor Zisapel gives instructions to proceed with and prepare
the extension of time.
|
Zisapel at [17]; Tyacke at [14].
|
|
6 November 2019
|
Evidence in answer in the s59 opposition completed.
|
|
|
5 December 2019
|
Opponent requests extension to file evidence in reply in the s59
opposition.
|
|
|
9 December 2019
|
Extension of time application filed, including the Nir and Laudon1
declarations.
|
|
|
14 January 2020
|
Extension of time to file evidence in reply in s59 opposition
granted.
|
|
|
4 March 2020
|
S59 opposition stayed pending outcomes of the s223 extension.
|
|
|
13 March 2020
|
The Commissioner requests further information, within two months, in
connection with the s223 extension.
|
|
|
29 April 2020
|
Applicant files the Harston, Laudon2, Zisapel and Tyacke declarations.
|
|
|
24 June 2020
|
The Commissioner requests further information, within one months, in
connection with the s223 extension.
|
|
|
9 July 2020
|
Applicant files the Laudon3 declaration.
|
|
|
30 July 2020
|
The s223 extension is advertised in the Official Journal for opposition for
a period of two months.
|
|
|
30 September 2020
|
Opponent files notice of opposition to the s223 extension.
|
|
Annex B – Patent Family
|
Parent
|
Filing Date
|
First Examination Report Date
|
Accepted Date
|
Granted/Certified Date
|
|
|
2016426598
|
N/A
|
29 November 2016
|
6 June 2018
|
4 October 2018
|
N/A
|
|
2019200479
|
2016426598
|
24 January 2019
|
10 October 2019
|
6 October 2020
|
4 February 2021
|
|
2019101470
|
2019200479
|
28 November 2019
|
3 February 2020
|
13 December 2019
|
11 June 2020
|
|
2021200268
|
2019200479
|
18 January 2021
|
N/A
|
N/A
|
N/A
|
|
NB all share the same earlies priority date of 31 October 2016.
|
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