Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH
[2022] APO 72
•2 November 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2022] APO 72
Patent Application: 2017245601 and
Innovation Patent: 2020102685
Title:Use of pimobendan for the reduction of heart size and/or the delay of onset of clinical symptoms in patients with asymptomatic heart failure due to mitral valve disease
Patent Applicant: Boehringer Ingelheim Vetmedica GmbH
Opponent: Zoetis Services LLC
Delegate: D. S. Triffett
Decision Date: 2 November 2022
Hearing Date: 28 June 2022, by Video Conference
Catchwords: PATENTS – evidence not considered to be properly in reply – evidence introducing new instances of prior use that should have been served in evidence in support – proposed amendments to the statements of grounds and particulars not allowed – regulation 5.23 invoked – evidence likely to be crucial to the delegate’s decision
Representation: Counsel for the applicant: Clare Cunliffe
Patent attorney for the applicant: Marcus Caulfield of FB Rice Pty Ltd
Counsel for the opponent: Patrick Flynn SC
Patent attorney for the opponent: Duncan Longstaff and Andrew Rankine of Spruson & Ferguson Lawyers
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017245601 and
Innovation Patent: 2020102685
Title:Use of pimobendan for the reduction of heart size and/or the delay of onset of clinical symptoms in patients with asymptomatic heart failure due to mitral valve disease
Patent Applicant: Boehringer Ingelheim Vetmedica GmbH
Date of Decision: 2 November 2022
DECISION
Paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Bruce William Keene’s declaration dated 13 December 2021 are not properly in reply, and the proposed amendments to the SGP are not allowed under regulation 5.16.
However, it is appropriate to invoke regulation 5.23 to consult paragraphs [31]-[85] of the Keene declaration and associated exhibits BWK-5 to BWK-12.
Boehringer Ingelheim Vetmedica GmbH is provided two (2) months from the date of this decision to file responding evidence pursuant to regulation 5.23(2).
REASONS FOR DECISION
Background
This matter relates to patent application 2017245601 (the ‘601 patent application) and Australian Innovation Patent 2020102685 (the ‘685 innovation patent) in the name of Boehringer Ingelheim Vetmedica GmbH (the applicant). The patent application was advertised as accepted on 5 November 2020. The innovation patent was advertised as certified on 7 January 2021. Zoetis Services LLC (the opponent) opposed the grant of a patent under section 59 of the Patents Act 1990 (Cth) (the Patents Act) on 4 February 2021 and opposed the certification of the innovation patent on 4 August 2021 (the oppositions).
The opponent submitted a Statement of Grounds and Particulars (SGP) for the ‘601 patent application (SGP-601) on 4 May 2021 and submitted a SGP for the ‘685 innovation patent (SGP-685) on 4 August 2021. The applicant requested further and better particulars and the opponent filed an amended SGP for the ‘601 patent application on 29 June 2021. The opponent submitted a Further Amended SGP (FASGP-601) dated 4 August 2021 which was allowed by a Delegate on 19 August 2021. The opponent submitted a Second Further Amended SGP for the ‘601 patent application (SFASGP-601) dated 30 December 2021 and submitted an amended SGP for the ‘685 innovation patent (ASGP-685) dated 30 December 2021. A Delegate of the Commissioner advised the parties they intended to refuse the amendments to the SGPs on 3 February 2022 and the opponent requested to be heard on the allowability of the amendments in the SFASGP-601 and the ASGP-685 on 17 February 2022.
The parties have filed evidence by several declarants in the oppositions. Evidence in Support (EIS) consists of declarations by Stephen Joel Ettinger (Ettinger-1) and Frazer Donald McLennan. Evidence in Answer (EIA) consists of declarations by Adrian Boswood (Boswood), Sonya G Gordon, Jens Häggström and Christoph Schummer (Schummer). Evidence in Reply (EIR) consists of declarations by Bruce William Keene (Keene), Christopher Butler and Stephen Joel Ettinger (Ettinger-2).
The applicant objected to Keene as not being properly EIR in a letter dated 20 January 2022. A Delegate of the Commissioner responded to the applicant’s letter in further correspondence dated 3 February 2022. The applicant responded in a further letter dated 17 February 2022. A Delegate of the Commissioner provided a final response in correspondence dated 24 February 2022, proposing to direct that paragraphs [31]-[85] of Keene and associated exhibits BWK-5 to BWK-12 are not properly in reply to the EIA. The opponent formally requested to be heard with regard to the proposed direction on 1 March 2022.
This decision is in relation to the proposed direction regarding the EIR and the allowability of the amendments to the SGPs. In addition, a Delegate of the Commissioner advised the parties on 24 March 2022 that whether or not any evidence in reply found not properly in reply should be consulted under regulation 5.23, would also be considered in this decision.
Summary of Invention
The application is titled “Use of Pimobendan for the Reduction of Heart Size and/or the Delay of Onset of Clinical Symptoms in Patients with Asymptomatic Heart Failure Due to Mitral Valve Disease.”
The invention is broadly summarised as “pimobendan for use in a method of reducing the heart size and/or delaying the onset of clinical symptoms in a patient suffering from asymptomatic (occult, preclinical) heart failure due to mitral valve disease (MVD), preferably asymptomatic (occult, preclinical) congestive heart failure due to mitral valve disease (MVD), more preferably asymptomatic (occult, preclinical) congestive heart failure due to myxomatous mitral valve disease (MMVD).”[1]
[1] Specification at Page 4, lines 12-16.
Evidence
As part of his EIS, Dr Ettinger described his prior use of pimobendan to treat MMVD in ACVIM Stage B2 dogs stating:
“after pimobendan was granted FDA approval during 2007, and before 6 April 2016, I routinely prescribed pimobendan when treating dogs with MMVD in ACVIM Stage B2 with clear evidence of cardiomegaly … Although the FDA approval granted in 2007 referred only to the use of pimobendan in the treatment of dogs showing clinical signs of heart failure, I and other licensed veterinarians were authorised under the applicable FDA regulations to prescribe pimobendan for use in dogs with MMVD in ACVIM Stage B2 (that is, dogs without clinical signs of heart failure) provided that we complied with certain administrative and practice requirements (so-called “off-label use”). When prescribing pimobendan “off label” for the treatment of dogs with MMVD in ACVIM Stage B2, I understood that I was obliged to, and in each instance I did, explain to the dog’s owner what drug I was prescribing (namely, pimobendan) and what treatment benefits I expected that drug to have in their dog.”[2]
[2] Ettinger-1 at [193].
As part of the EIA, Dr Boswood and Dr Schummer both questioned the fact that Dr Ettinger had no records to support his prescribing practice before 6 April 2016. For example, Dr Boswood states that Dr Ettinger provides “no evidence to support the administration of pimobendan therapy in stage B2 dogs before the results of the EPIC study were announced in June 2016”.[3] Dr Boswood further indicates that Dr Ettinger prescribing pimobendan for the treatment of dogs with stage B2 MMVD was “Dr Ettinger’s subjective opinion”[4] and that Dr Ettinger has “not provided any evidence of his practice of administering pimobendan to stage B2 dogs.”[5] Similarly, Dr Schummer states that “[s]urely Dr Ettinger would have provided case reports of dogs he had treated with pimobendan … at least from the period from 2007 approval of pimobendan in stage C dogs in the US to the preparation of the ACVIM guidelines.”[6] Dr Schummer also states that “Dr Ettinger has provided no proof that he routinely administered pimobendan to asymptomatic dogs with MMVD in stage B2.”[7] As I will elaborate on later in this decision, Dr Boswood and Dr Schummer both claim that Dr Ettinger’s prescribing practices were inconsistent with other veterinary cardiologists at the relevant time.
[3] Boswood at [277].
[4] Boswood at [337].
[5] Boswood at [338].
[6] Schummer at [45].
[7] Schummer at [161].
In the EIR, Dr Ettinger stated that he retired from clinical practice in 2020 and to the extent that any clinical records remain in existence, those records are the property of the veterinary hospitals at which he practised at the time, and he has no means of accessing those medical records.[8]
[8] Ettinger-2 at [140].
Keene was then provided as EIR which detailed, with records, that Dr Keene also undertook these prescribing practices at the time. More specifically, paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene describe the use of pimobendan in the treatment of dogs with MMVD in ACVIM Stage B2 before 6 April 2016 by Dr Keene and his colleagues at the NCSU Cardiology Service. This use of pimobendan was supported by medical records which included echocardiography reports and discharge instructions.
Challenge to the evidence in reply
The applicant submits that at least paragraphs [31] to [85] of the declaration by Keene dated 13 December 2021 and exhibits BWK-1 to BWK-12 are not properly in reply to the EIA and should not form part of the evidence in these proceedings.[9]
[9] Applicant’s Written Submissions at [13].
The law
In Merial Limited v Bayer Intellectual Property GmbH [2015] APO 16, the Delegate outlined the nature of evidence in reply at [3]:
“It is well established that evidence in reply is restricted to evidence rebutting the applicant’s evidence in answer. Evidence that merely bolsters the evidence in support or opens up new matters that should have been raised in evidence in support is not in reply (see Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft [2001] APO 13 (the ‘Sonus decision’)).”
In the Sonus decision, the Delegate said:
“Evidence in reply is clearly distinguished from evidence in support. Phipson on the Law of Evidence states that evidence in reply must be confined to rebutting the applicant’s case, and should not merely confirm the case in chief. Additionally, evidence in reply cannot raise matters that should have been raised in the evidence in support. This was emphasised by Graham J in Ernest Scragg & Sons Ltd’s Application [1972] FSR 219 (‘Scragg’) at 223:
‘To my mind it is quite wrong in these cases that there should be any sort of skirmishing in regard to evidence, and if an opponent has a case he should straight away state what his case is and should put in declarations dealing with any evidence which he thinks may be relevant to that case. The applicant can then deal with the matter in the normal way, and a lot of time is saved, and the Office can get on with deciding the case. If the opponent does not do that and waits until he sees what the applicant says, then obvious difficulties will result and oppositions will inevitably be drawn out and never finished.’…
I conclude that in general evidence in reply:
(i) is not evidence that should have been served as evidence in support
(ii) responds to some matter raised by the evidence in answer
(iii) does not merely confirm the evidence in support.”
Consideration
Should Keene have been served as evidence in support?
The applicant submits that the purpose of Keene is not to respond to the EIA, but to introduce the new alleged instances of prior art use that the opponent is now trying to rely on.[10] The applicant further submitted at the hearing that the opponent cannot “hold back their best hand” (in the form of the Keene declaration) and the opponent’s behaviour is the “evidentiary skirmishing” cautioned against in Scragg. On this issue, the parties helpfully drew my attention to a number of authorities. The first group concerned whether there is a need for corroboration in ‘prior use’ cases, and the second group related to past evidence in reply cases.
Corroboration in ‘prior use’ cases
[10] Applicant’s Written Submissions at [19].
Justice Jagot in Fieldturf Tarkett Inc v Tigerturf International Limited [2014] FCA 647 (‘FieldTurf’)[11] cited and accepted the principles set out in Old Digger Pty Ltd v Azuko Pty Ltd (2000) 88 IPR 52, where Justice Von Doussa said at [156]:
“The evidence adduced by the respondents as to the prior use of the invention is the oral evidence of witnesses to the alleged use based on their recollections of events years beforehand. The alleged use is said to have taken place in the course of trialling reverse circulation percussive hammers incorporating prototype face sampling drill bit assemblies. The particular assemblies have not been produced in evidence. Oral evidence led in these circumstances must be viewed with particular caution, partly for the reason that the memory of the witnesses is likely to have been influenced by other products seen in the meantime, and to reflect reconstruction on the basis of these later observations”
[11] FieldTurf at [16].
In Aspirating IP Ltd v Vision Systems Ltd (2010) 88 IPR 52; [2010] FCA 1061 (‘Aspirating IP’), Besanko J said at [199]-[201]:
“[199] The applicant submits that in the case of an alleged prior use, there should be corroboration from an independent witness and, preferably, the presentation of records which corroborate the alleged prior use. It is not clear to me whether the applicant goes so far as to submit that corroboration was required as a matter of law. If it does go that far then I reject the submission.
[200] The correct principle is that a prior use must be strictly proved and evidence which is not corroborated must be scrutinised with care, particularly where it is evidence of events which occurred many years ago.
…
[201] In Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 16 IPR 545 at 556–557 Gummow J said that proving an alleged anticipation by the recollection of witnesses and by drawings in catalogues and brochures is to be approached with “some caution”.”
Similarly, in Seller’s Application [1970] RPC 103, Graham J said at 106:
“In my judgement it is necessary that proof of prior use in opposition cases should be very clear. Normally, in the absence of cross-examination, this will involve corroboration of a mere statement as to recollection in a declaration, particularly where the time interval involved is considerable. Such corroboration is often best found in documents contemporary with the fact to be proved. Each case, however, must be considered on its own facts and I say expressly that I am not attempting to lay down any rule as to what is or is not sufficient in any given case.”
The applicant seeks to apply these principles to the present opposition in that as the opponent is alleging prior use based on Ettinger-1 without corroboration from another witness, this evidence must be scrutinised with care, approached with some caution and as a result, the opponent should have anticipated an attack on the evidence of Dr Ettinger (as per DAP Enterprises Pty Ltd v Roberts Designs Pty Ltd (1998) 41 IPR 192 at 200). The applicant submits that as Dr Keene kept a database of his prescribing practices, whereas Dr Ettinger’s evidence is deficient because he did not keep a database of his prescribing practices to corroborate his declaratory statements, Dr Keene’s evidence should have been led in the EIS to allow the applicant a chance to respond to it properly.
The opponent responds by noting that in Aspirating IP, cited with approval in Fieldturf, Justice Besanko held that corroboration was not required as a matter of law, and only that prior public use must be strictly proved. The opponent further submitted at the hearing that these authorities raised by the applicant do not stand for the general proposition that prior use needs to be corroborated by different witnesses.
In Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2016] FCA 236 (‘Sandvik’), Jessup J stated at [127]:
“It was submitted on [the applicants’] behalves that the respondent had failed to avail itself of an opportunity to corroborate the evidence of Messrs Geatches, Yates and Nielsen on a subject which, because of the passage of time and the absence of documentary records, would manifestly have benefited from further exposure.”
and at [128]:
“The respondent’s unexplained failure to call Mr Woolnough has given me substantial cause to pause. However, having paused, I find that the situation remains that I have the direct observation of three then workers in the industry whose evidence is credible … By limiting its evidentiary case in the way that it did, the respondent ran the risk that, for one reason or another, that case might not have crossed the bar. But the view I take is that it did cross the bar, and I would not be justified in turning away from that view by reason of what was, apparently, the respondent’s choice not to conduct a more comprehensive evidentiary case.”
The applicant submitted that in Sandvik, one witness was not called to prove prior use but three credible witnesses were, which was sufficient to prove “corroboration” within the meaning of Aspirating IP. The applicant further submitted that the opponent here should have anticipated that evidence that is not corroborated (such as that of Dr Ettinger) is likely to be the subject of attack. The opponent responds by submitting that Dr Ettinger’s evidence was comfortably sufficient to prove prior use before the attack was made on it by the applicant, and the suggestion that Keene should have been adduced in support, in advance of any knowledge of that attack, is specious.[12]
[12] Opponent’s Written Submissions at [48].
In my view, the ‘corroboration’ cases do not stand for the proposition that corroboration is required for prior use cases as a matter of law, but rather that prior use should be strictly proved and uncorroborated evidence in these cases must be scrutinised with care and weighed with a degree of caution. Given that prior use needs to be strictly proved, and the fact that Ettinger provided no evidence corroborating his prior use claim, in my view the opponent should have been aware that the evidence in support of prior use should be able to withstand scrutiny.
EIR cases
In Sonus, the Delegate cited Scragg as authority for the proposition that “evidence in reply cannot raise matters that should have been raised in support.”[13] However, in Scragg, reply evidence (of Mr Edwards) to adduce that spindle bore diameters were decreasing to rebut evidence in answer that bore diameters were tending to increase was allowed, notwithstanding that this had always been a central issue in dispute and was also the subject of the EIS. The opponent submits that there is a direct analogy between the evidence of Mr Edwards allowed in Scragg and the Keene declaration in the present case.[14] This is because the applicant in Scragg used its EIA to set up a positive case that there is no obviousness as spindle bore diameters were in fact increasing and the opponent was entitled to file EIR regarding bore diameters used at the priority date. The opponent submits that in an analogous case here, “the Keene declaration responds to a positive case set up by [the applicant’s] evidence in answer to the effect that Dr Ettinger’s prescribing practices before the Priority Date were different from those of every other veterinarian and inconsistent with the views of the veterinary cardiology community at that time.”[15]
[13] Sonus at [7].
[14] Opponent’s Written Submissions at [51].
[15] Opponent’s Written Submissions at [51].
In Optech International Ltd v Buxton Hicrarium Ltd (1993) 28 IPR 649 (‘Optech’) the opponent submitted that, because of the applicant’s assertion in the further evidence that there was no supporting evidence by the opponent regarding public disclosures, they were entitled to produce the evidence provided. However, the Delegate found that this material had been “provided in an attempt to rectify deficiencies in the opponent’s case which have been identified by the applicant, rather than to contradict the applicant’s evidence”.[16]
[16] Optech at 653.
In Optech, the Delegate further stated:
“[The three pieces of evidence] appear to have been provided in response to the applicant’s assertion that there was no supporting evidence regarding alleged public disclosures. In my view the opponent ought to have known that to establish anticipation of the invention it would be necessary to prove relevant publication in Australia. The evidence in reply to the further evidence is in my view no more than an attempt to strengthen the opponent’s case, rather than evidence to answer the evidence served in the further evidence.”[17]
[17] Optech at 654.
The applicant seeks to apply Optech submitting that in the present opposition, it was only when the applicant identified that there was no supporting evidence in the EIS on what other veterinarian cardiologists were doing at the time, that the opponent included that evidence in the form of Keene.
The opponent here seeks to distinguish Optech as in that case, the evidence adduced in support of the opponent’s lack of novelty case consisted solely of hearsay, with the first attempt by the opponent to adduce direct evidence that the claimed invention had been publicly disclosed before the priority date was made when filing EIR to certain further evidence from the applicant.[18]By contrast, the opponent’s EIS here regarding the use of pimobendan for the treatment of ACVIM Stage B2 dogs before the priority date was not limited to hearsay evidence but rather comprised direct evidence from Dr Ettinger regarding his own prescribing practices.[19] The opponent goes on to state that the evidence excluded as not properly “in reply” in Optech purported to respond to a bare assertion that the opponent had not proved its case. In the present case, the EIA is not limited to the assertion that the opponent had failed to prove its case or failed to adduce supporting evidence.[20]
[18] Opponent’s Written Submissions at [55].
[19] Opponent’s Written Submissions at [56]; See also Ettinger-1 at [189]-[193].
[20] Opponent’s Written Submissions at [58].
In Sonus, the Delegate cited Emory University v Biochem Pharma Inc (1997) 39 IPR 603 (‘Emory’) as authority for the proposition that a “matter that should have been raised in evidence in support (because it was an essential part of a ground of opposition) [is] not properly evidence in reply”.[21] The opponent seeks to distinguish Emory, as in that case although the opponent alleged lack of inventive step, its evidence failed to address critical aspects of the common general knowledge, because the opponent assumed that those matters were “a given”.[22] However, the opponent submits that there is no analogy with the present opposition as here, the opponent did not assume that the use of pimobendan to treat ACVIM Stage B2 dogs before the priority date was ‘a given’, but rather adduced direct evidence in support of those matters. As a result, the opponent submits that there were no such deficiencies in the evidence in support analogous to the deficiencies identified in Emory.[23]
[21] Sonus at 8.
[22] Opponent’s Written Submissions at [60]; Emory at 607.
[23] Opponent’s Written Submissions at [61].
I consider that the present opposition is somewhat analogous with the decision in Scragg, in that the EIA in both cases set up a positive case (Dr Ettinger’s prescribing practices were different from every other veterinarian here and that spindle bore diameters were increasing in Scragg), and the EIR in both cases filed further evidence to rebut that positive case. However, I do not consider the distinctions the opponent seeks to make between both Optech and Emory and the present oppositions are particularly helpful in determining the question of whether Keene should have been served as EIS.
Conclusion
While I consider Dr Keene’s evidence was in part rebutting a positive case made by the applicant regarding the inconsistency of Dr Ettinger’s prescribing practices with other veterinary cardiologists (discussed further below), I consider that the overall result of Keene is to introduce new alleged instances of prior art use, rather than solely responding to the attack on Dr Ettinger’s alleged prior use. Furthermore, given the ‘corroboration cases’, in my view the opponent should have been aware that the evidence of Dr Ettinger would need to be able to withstand scrutiny as this prior use was not corroborated by any evidence and prior use cases must be strictly proved. As a result, in my view, as Keene was introducing a new alleged instance of prior use, paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene should have been served as evidence in support.
Did Keene respond to matters raised by the evidence in answer?
The applicant submits that Keene does not respond to matters in the EIA but rather introduces new alleged prior art uses.[24]
[24] Applicant’s Written Submissions at [20].
In INAX Corporation v Caroma Industries Ltd [1994] APO 48 at 7-8 (‘INAX’), the Delegate observed that:
“If TAYLOR’s evidence is strictly reply evidence, one should be able to identify portions of his evidence which can be directly linked to statements or opinions expressed by OSTERLUND or KOMURA [i.e., the evidence in answer] …”
At the hearing the applicant sought to apply INAX to the present opposition, submitting that in INAX, evidence of an entirely new declarant (Mr Taylor) was not allowed at EIR stage as there were no such links between Mr Taylor’s evidence and that of the EIA. Presumably the applicant is inferring that there is also no such link between Keene and either of Boswood or Schummer (in EIA).
The opponent responds submitting that the EIA details multiple times that Dr Ettinger’s use of pimobendan to treat ACVIM Stage B2 dogs was different from the practice of every other veterinarian before the priority date. Some examples of this include:
i. “Dr Ettinger was using a treatment regime which was different to every other veterinarian in the field [emphasis added]” (Schummer at [31]).
ii. “[Dr Ettinger’s treatment with pimobendan] goes against what I believe every other cardiac veterinarian was prescribing [emphasis added]” (Schummer at [85]).
iii. “Yet before seeing Dr Ettinger’s declaration in this opposition, I had not seen any reports from him regarding his prescribing practice which was polar opposite to what every other veterinarian was doing at the time [emphasis added]” (Schummer at [95]).
iv. “it is unclear to me why Dr Ettinger appears to have been the only [emphasis added] veterinarian to have prescribed pimobendan for the treatment of dogs with MMVD in ACVIM stage B2 before the priority date.” (Schummer at [121]).
v. “Dr Ettinger may have had a subjective opinion and individual practice with regard to the use of pimobendan in dogs with stage B2 MMVD, which does not necessarily reflect standard practice of everyone in the field of veterinary cardiology [emphasis added].” (Boswood at [369]).
The applicant submitted at the hearing that Boswood at [369] does not stand for the proposition that Dr Ettinger’s use was different to “every other” veterinarian.
I consider that at least Schummer [31], [85] and [121] provide explicit references from the EIA that Dr Ettinger’s prescribing practice was different to every other veterinarian in the field. In Section D of his declaration,[25] supported by relevant medical records which form exhibits to that section, Dr Keene expressly responds to the EIA that contended that Dr Ettinger’s use of pimobendan to treat ACVIM Stage B2 dogs before the priority date was inconsistent with the practice of all other veterinarians at the time. Therefore, evidence from a veterinarian in the field (Dr Keene) filed in EIR,[26] that he was prescribing pimobendan to dogs in stage B2 of MMVD, can be “directly linked” to the above statements from Schummer. It follows that there is also the requisite connection between what the applicant has asserted in their EIA and what the opponent is claiming to be EIR to those assertions.
[25] Keene at [31]-[85].
[26] Paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene.
The opponent further submits that the EIA describes that Dr Ettinger’s use of pimobendan to treat ACVIM Stage B2 dogs was inconsistent with the views of the veterinary cardiology community before the priority date. Some examples of this include:
i. “… it was only after the 2016 EPIC publication that the veterinary cardiology community had turned to the use of pimobendan to treat dogs in stage B2 of MMVD.” (Boswood at [165]).
ii. “Before the priority date, pimobendan was only used to treat dogs with congestive heart failure in ACVIM stages C and D. Pimobendan was not used to treat asymptomatic dogs in ACVIM stage B2. It was simply never contemplated.” (Schummer at [161]).
iii. “The views of veterinary cardiologists on pimobendan therapy of preclinical MMVD remained unchanged until the results of the EPIC clinical study were published in 2016.” (Boswood at [132]).
iv. “I make the general observation that it is often stated what Dr Ettinger was doing rather than what he and other cardiologists were doing at the time. It also appears that he was not discussing his treatment practices involving pimobendan with other veterinary cardiologists.” (Boswood at [260]).
The applicant submits that Boswood at [260] is not saying that Dr Ettinger’s prescribing practice is different to the veterinarian cardiology community.
The opponent submits that the only effective manner it could respond to the EIA that Dr Ettinger’s use of pimobendan for the treatment of ACVIM Stage B2 dogs before the priority date was inconsistent with the views of the cardiology community was to adduce evidence demonstrating that other veterinarians, did in fact, prescribe pimobendan for treatment of these dogs.[27] The opponent argues this is exactly what Keene does.[28] The applicant submits that Keene’s evidence does not address what the veterinary cardiology community was doing but rather deals with what his own practice was doing and those at the NCSU Cardiology Service.
[27] Opponent’s Written Submissions at [37].
[28] Opponent’s Written Submissions at [37].
I consider that at least Boswood at [132] and [165] and Schummer at [161] provide explicit references from the EIA that only after the EPIC clinical study was published in 2016 (after the earliest priority date) did the veterinary cardiology community turn to the use of pimobendan to treat dogs in stage B2 of MMVD. In my view, Keene represents only what Dr Keene (and the NCSU Cardiology Service) was doing at the time and is not representative of what the veterinary cardiology community was doing. Therefore, in that regard Keene was not responding to the EIA. However, as indicated above, I consider that the EIA not only raises what the veterinary cardiology community was doing at the time, it also raises what all other veterinary cardiologists were doing at the time. As a result, whether there is the requisite connection between Keene and what the veterinary cardiology community was doing at the time, is a moot point.
Did Keene merely confirm the evidence in support?
The applicant submits that Keene goes further than confirming the evidence in support, it actually expands the matters on which the opponent relies in support of its opposition.[29] The opponent submits that the existing FASGP-601 makes it clear that it relies upon the use of pimobendan before the priority date by other veterinarians (i.e. not limited to Dr Ettinger) for lack of novelty, lack of inventive step and lack of innovative step.[30] Rather than expanding the matters on which it seeks to rely on in support of its opposition, the opponent submits that Keene merely “identifies further instances of the same matters on which [the opponent] has relied since the commencement of these opposition proceedings.”[31]
[29] Applicant’s Written Submissions at [21].
[30] FASGP-601, at sub-paragraphs 2(e)(i) and (ii).
[31] Opponent’s Written Submissions at [29].
While FASGP-601 may make it clear that the opponent relies upon the use of pimobendan before the priority date by other veterinarians (i.e. not limited to Dr Ettinger) for lack of novelty and lack of inventive step, the question here is whether Keene is expanding upon the EIS not whether Keene is expanding upon the grounds identified in the SGP. I consider that Keene is expanding the EIS as Keene raises a further instance of prior use that was not identified in the EIS. As a result, I consider that paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene are not merely confirming the EIS, but actually expand it, in, for example, the same way as adding new instances of documentary prior art.
Conclusion
As discussed above, I consider that while Dr Keene’s evidence was in part rebutting a positive case made by the applicant regarding the inconsistency of Dr Ettinger’s prescribing practices with other veterinary cardiologists, I consider that the overall result of Keene is to introduce new alleged instances of prior art use which expands the case the applicant has to answer.
The applicant submits that if the opponent were permitted to introduce Keene, the applicant would be seriously disadvantaged because they would not have had the opportunity to lead EIA to respond to the new factual allegations raised (for example, to cast doubt on whether the alleged uses by Dr Keene and his colleagues were public uses).[32] The applicant further submits that the opponent should not be permitted to rely on Keene now, particularly given that the opponent still has the opportunity to challenge the patents after grant if its opposition is unsuccessful.[33] The opponent responds by submitting that the applicant chose to adduce EIA to the effect that every other veterinarian prescribed different practices from those described in Ettinger-1, and therefore exposed itself to the opponent adducing evidence rebutting that proposition.[34]
[32] Applicant’s Written Submissions at [22].
[33] Applicant’s Written Submissions at [24].
[34] Opponent’s Written Submissions at [69].
After consideration of the factors identified in Sonus, I consider paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene to not be properly evidence in reply. While on the one hand, Keene was responding to the allegation made in the EIA that Dr Ettinger’s practice was inconsistent with that of all other veterinary cardiologists at the time, the result of Keene was introducing a new instance of prior use which is in effect expanding the case the applicant has to answer. As such, paragraphs [31]-[85] and exhibits BWK-5 to BWK-12 of Keene is evidence that should have been served as evidence in support, particularly given the need for prior art cases to be strictly proved.
Proposed amendments to the SGP
The opponent further seeks to amend the particulars of the ground of opposition relating to non-compliance with Section 40(2) and Section 40(3) of the Patents Act.[35] However, the applicant raises no objection to these amendments.
[35] Opponent’s Written Submissions at [70](b) and [70](c).
The opponent seeks to provide further particulars of the acts relied upon in relation to the grounds of lack of novelty and lack of inventive step (or lack of innovative step).[36] The relevant acts are identified at paragraph 2(e)(iii) of the SFASGP-601 and ASGP-685 in the following terms:
“… and including the acts of Bruce William Keene and other veterinarians described in section D of the declaration of Bruce William Keene dated 13 December 2021.”
[36] Opponent’s Written Submissions at [70](a).
However, as I have already found that the relevant parts of the Keene declaration on which these new particulars rely are not properly evidence in reply, I consider that there is no purpose in allowing such an amendment. As a result, I refuse the amendments to the SGP dated 30 December 2021.
Regulation 5.23
The law
Regulation 5.23 states:
(1) For the purposed of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition: and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner’s intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.
In Merial Limited v Bayer Intellectual Property GmbH [2015] APO 16 (‘Merial’), the Delegate posed the following test for determining whether information should be consulted under regulation 5.23:
“I conclude that a decision under regulation 5.23 must have regard to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.
If new information is not likely to change the outcome of the opposition in a significant way, there is little advantage gained by bringing it into the opposition. The procedures for evidence laid down in regulation 5.23 will introduce delay to the opposition. On the other hand, if the new information is not relied on in the opposition the Commissioner can reconsider the information at the conclusion of the opposition, and re-examine the application if any new amendments resulting from the opposition have not already addressed the issue. In other words, the new information needs to be significantly better than what is already in evidence. Where the new information is a new citation, it should be considered whether it is likely that the ground of lack of novelty or lack of inventive step in light of the citation would be made out, and whether the ground would not otherwise have been made out.”
In Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited [2017] APO 8 at [52], the Delegate identified that the following matters should be considered:
(a) The circumstances leading up to the evidence not being filed earlier;
(b) What the evidence shows;
(c) Whether the information is likely to be crucial to the delegate’s decision;
(d) The public interest in having the information considered; and
(e) The balance of convenience of the parties if the information is considered.
Consideration
The circumstances leading up to the evidence not being filed earlier
The applicant submits that the opponent has not provided an explanation as to why Keene was not filed as part of the EIS.[37] The opponent responds by submitting that it acted in good faith as Keene was raised in EIR to rebut matters raised in the applicant’s EIA.[38]
[37] Applicant’s Written Submissions at [44].
[38] Applicant’s Written Submissions at [144].
I consider that the opponent acted in good faith in raising Keene to respond to the applicant’s EIA. As the opponent was of the view that Keene was properly EIR, in my view there was no delay in filing Keene as in the mind of the opponent, they filed Keene as part of the EIR which was in the requisite evidentiary timeframes.
What the evidence shows
Keene at [31] to [85] and exhibits BWK-5 to BWK-12 include evidence showing electronic medical records created at the North Carolina State University, Veterinary Hospital, Cardiology Service during the 2015 calendar year. Exhibits BWK-5, BWK-6 and BWK-8 to BWK-12 are discharge instructions to the dog's owner and also to the dog's primary care veterinarian. The records show the attending veterinarian as being Dr Keene himself and four of his colleagues. The patients are said to be dogs with MMVD with heart enlargement but not yet diagnosed as having heart failure being prescribed pimobendan.
Whether the information is likely to be crucial to the delegate’s decision
Regarding the significance of Keene, the opponent states:
“The Keene declaration is highly significant, demonstrating uncontrovertibly (in Zoetis’s submission) that pimobendan was, in fact, prescribed and administered, at relevant dosages, for the treatment of dogs with MMVD in ACVIM Stage B2 before the Priority Date by multiple veterinarians.”[39]
[39] Opponent’s Written Submissions at [156].
As Dr Ettinger’s prescribing practices are not supported by medical records but Dr Keene’s are, I consider that Keene would likely be crucial to the delegate’s decision as Keene is rectifying a deficiency in Ettinger to that extent, rather than just providing more evidence of the same prior uses.
The public interest in having the information considered
The applicant submits that while it is in the public interest that the opposition be completed in a swift and economical manner,[40] it is not in the public interest that the allegations of public use now identified by the opponent be determined in a fashion which does not reflect the requirements of natural justice and procedural fairness.[41] The opponent submits that if Keene is not taken into account in the substantive opposition, there is “a real risk that the opposition will not be correctly decided on its merits.”[42] The opponent further submits that the public interest will not be served by a “swift and economical” outcome that results in an invalid patent being entered on the register or maintained on the register, presenting an obstacle to all interested parties including veterinarians.[43]
[40] See Genetics Institute Inc v Kirin-Amgen Inc [1999] 92 FCR 106 at [19]; F Hoffman-LaRoche AG v New England Biolabs Inc (2000) 92 FCR 106 at [47] and [66].
[41] Applicant’s Written Submissions at [36].
[42] Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited [2017] APO 8 at [64]; Opponent’s Written Submissions at [146].
[43] Opponent’s Written Submissions at [150].
I consider that it is in the public interest for this highly significant information to be considered within the existing oppositions rather than waiting for re-examination (See Merial at [22]).
The balance of convenience of the parties if the information is considered
The applicant submits that it would be severely prejudiced if Keene was considered and the opponent will not be severely prejudiced if it is not, because Keene adds new items of alleged prior use after the applicant has filed its EIA, which will severely prejudice the applicant, since it will not have the opportunity to prepare evidence to answer the case against it.[44] The opponent submits that any perceived prejudice to the applicant is capable of being cured by affording it an opportunity to file evidence responsive to Keene, should the Commissioner be persuaded that is appropriate.[45]
[44] Applicant’s Written Submissions at [28], [30] and [31].
[45] Opponent’s Written Submissions at [151].
I acknowledge that the applicant would be inconvenienced both by the delay in setting the matter for hearing and the need to prepare additional evidence.
Conclusion
I consider Keene to have substantial probative value. Keene describes multiple prior use instances of prescribing pimobendan for dogs with MMVD in ACVIM Stage B2, with each instance supported by echocardiogram reports.[46] While there is a public interest in the oppositions being completed in a swift and economical matter, I consider that the need for the oppositions to be correctly decided, taking into account all available evidence, weighs more heavily in favour of allowing Keene into evidence. I consider that any potential perceived prejudice to the applicant can be mitigated by allowing the applicant an opportunity to file evidence responsive to Keene. On balance, I consider it appropriate for the Commissioner to consult Keene at [31] to [85] and exhibits BWK-5 to BWK-12, under regulation 5.23. Pursuant to regulation 5.23(2), I further allow the applicant a period of 2 months to file evidence responsive to Keene.
[46] Keene at [34]-[84].
Costs
It is normal in matters before the Commissioner that costs should follow the event. I see no reason to depart from that approach in the present case. Although Keene was allowed under regulation 5.23, I will award costs according to Schedule 8 against the opponent as the opponent was unsuccessful in its objection to the Delegate’s direction, with the Keene declaration found to be not properly in reply and the amendments to the SGP not allowed.
D. S. Triffett
Delegate of the Commissioner of Patents
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