Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited
[2015] APO 32
•26 June 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited
[2015] APO 32
Patent Application: 2008322739
Title:Use of anti-bacterial compounds having an anaesthetic effect
Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited
Opponent: Sanofi-Aventis Healthcare Pty Limited
Delegate: Dr N.R. Madsen
Decision Date: 26 June 2015
Hearing Date: Written submissions completed on 3 June 2015
Catchwords: PATENTS – extension of time to file evidence in support – Regulation 5.9 – whether the opponent has made all reasonable efforts to comply with all filing requirements – whether the opponent has acted promptly and diligently at all times – extension of time granted – no award of costs
Representation: Patent applicant: Madderns Patent & Trade Mark Attorneys
Opponent:Watermark Patent and Trade Marks Attorneys
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008322739
Title:Use of anti-bacterial compounds having an anaesthetic effect
Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited
Date of Decision: 26 June 2015
DECISION
I grant an extension of the time for filing evidence in support until 11 May 2015.
For the purposes of regulation 5.8(4), this decision represents notice that all of the evidence in support has been filed. The time for filing evidence in answer is 3 months from the date of this decision.
No award of costs.
REASONS FOR DECISION
This matter relates to patent application 2008322739 in the name of Reckitt Benckiser Healthcare (UK) Limited (Reckitt). The application was advertised as accepted on 10 July 2014 and a Notice of Opposition to the grant of a patent was filed by Sanofi-Aventis Healthcare Pty Limited (Sanofi) on 10 October 2014.
Sanofi filed a Statement of Grounds and Particulars on 12 January 2015 thereby setting a due date for evidence in support of 12 April 2015 (evidence in effect being due on 13 April 2015 being the next business day). On 13 April 2015, Sanofi filed two declarations and requested an extension of the time for filing evidence in support until 12 May 2015.
A delegate of the Commissioner advised on 22 April 2015 that he not was satisfied with the reasons in support of the request, and sought further information. Sanofi responded with further information on 29 April 2015. The delegate then indicated on 4 May 2015 his intention to grant the extension. On 11 May 2015, Reckitt filed a request to be heard in regard to the extension of time. On the same day Sanofi filed complete evidence in support.
The hearing was conducted by means of written submissions.
The law
On 15 April 2013, the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) commenced. The Amendment Regulation significantly amended the Patents Regulations as they apply to patent oppositions. The law governing extensions of time to file evidence in a patent opposition depends upon the date on which the opposition commenced. As the present opposition commenced after 15 April 2013 the extension is governed by regulation 5.9 of the Regulations as in force on 15 April 2013.
Subregulation 5.9(2) states:
The Commissioner may extend the period only if the Commissioner is satisfied that:
(a) the party who intended to file evidence in the period:
(i)has made all reasonable efforts to comply with all relevant filing requirements under this Chapter; and
(ii)despite acting promptly and diligently at all times to ensure the appropriate evidence is filed within the period, is unable to do so, or
(b) there are exceptional circumstances that warrant the extension.
Exceptional circumstances are defined in subregulation (5):
In this regulation:
exceptional circumstances includes the following:
(a) a circumstance beyond the control of a party that prevents the party from complying with a filing requirement under this Chapter;
(b) an error or omission by the Commissioner that prevents a party from complying with a filing requirement under this Chapter;
(c) an order of a court, or a direction by the Commissioner, that the opposition be stayed pending the completion of a related proceeding or action under the Act.
These provisions have been considered by the Commissioner in TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 and Merial Limited v Novartis AG [2013] APO 65. The principles applied in those decisions, which I accept as correct, are that I must ask myself the following questions:
1. Has the party (and their attorney or agent) made all reasonable efforts to comply with all relevant filing requirements?
2. Was the failure to file the evidence in time despite the party (and their attorney or agent) acting promptly and diligently at all times to ensure the evidence is filed in time?
3. Were there exceptional circumstances that warrant the extension?
I can extend the time for filing evidence only if I am satisfied that the answer to questions 1 and 2 is YES, or if I am satisfied that the answer to question 3 is YES. If I am so satisfied, then I must consider whether there are any discretionary reasons why the extension should not be granted.
10. As noted in the Explanatory Statement accompanying the Amendment Regulation:
"The Commissioner will not be able to extend time periods unless one of these conditions was made out. The party seeking the extension will bear the onus of convincing the Commissioner of this. Once the conditions in subregulation 5.9(2) are met, the Commissioner still has the discretion to consider whether or not it is appropriate that an extension of time be granted. In applying the test, the Commissioner will not be required to give a direction to extend a period solely because of delays caused by a legal representative failing to act promptly or diligently, by difficulties in obtaining expert evidence that could have been anticipated and acted on or by attempts to settle the proceedings.
Where a party cannot satisfy the Commissioner that an extension is justified under the test, the Commissioner will not have the power to give a short extension to allow the filing of evidence immediately available or to validate evidence filed out of time."
11. If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extension (subregulation (3)):
The Commissioner must determine the length of the extended period having regard to what is reasonable in the circumstances.
The request for extension of time
12. Information filed by Sanofi supporting the request for an extension of time in addition to the further information provided by Sanofi in response to the delegates letter of 22 April 2015 will be identified as necessary as part of this decision. I will proceed to provide a general summary of the actions taken by Sanofi to date in the formulation of evidence in support.
13. Sanofi filed their Notice of Opposition on 10 October 2014. In the intervening period leading to the filing of a Statement of Grounds and Particulars on 12 January 2015, a range of important actions were undertaken including: a full prior art search; engagement and meeting with counsel; settlement negotiations with the applicant; identification of four experts and meetings with two of these experts. During the evidence in support period, further meetings were conducted with each of the experts with the experts being provided materials to review and tasks to perform. Sanofi provided detail of actions taken before and throughout the evidence period, particularly from 13 January to 11 March 2015, and also discussed various absences and complexity issues with the present opposition.
14. At the end of the evidence in support period, declarations were filed from two of the four experts. The extension of time sought to obtain additional time (1 month) for the filing of second declarations from these experts, and declarations from the other two experts.
Has the party made all reasonable efforts to comply with all relevant filing requirements?
15. The Innovia Security Pty Ltd v Visual Physics LLC decision, [2014] APO 15, makes the point at [18] that it is clear that the requirement in paragraph 5.9(2)(a)(i) is intended to import a consideration of the reasonableness of the relevant party’s conduct over the totality of the opposition proceedings rather than its compliance with the particular evidentiary period in question. Thus in considering the efforts of an opponent under paragraph 5.9(2)(a)(i) with particular regard to the filing of evidence in support, it is appropriate to assess the reasonableness of actions taken relating to the filing of the Notice of Opposition and Statement of Grounds and Particulars, and various actions performed before the start of the evidence period. Additionally it is relevant to assess the plan adopted by the opponent in the formulation of their evidence.
16. At the same time, it appears to be the case that an assessment of the reasonableness of a parties’ actions will equate with an assessment of whether they have been prompt and diligent. This was the case in Innovia Security Pty Ltd v Visual Physics LLC [2014] APO 15 where the Deputy Commissioner stated:
“… If I find that Innovia has been prompt and diligent in relation to the evidence in reply it will also have made all reasonable efforts…”
17. I do not consider the present case differs from that noted by the Deputy Commissioner in Innovia Security Pty Ltd v Visual Physics LLC. However for consistency with the formulation of the applicant’s submissions, I will address the submissions as they have been raised by the applicant with respect to the particular legs of subregulation 5.9(2)(a). In this regard there are a number of issues raised by the Reckitt in regard to the reasonableness of the Sanofi’s actions. I will refer to the specific facts of the case and the parties’ submissions as necessary.
Knowledge of grounds/Complex Science
18. Reckitt has identified the fact that Sanofi discussed the present opposition as being primarily focussed upon grounds of utility and manner of manufacture. On 25 September 2014, Sanofi filed a request for revocation of acceptance or re-examination citing these grounds amongst other grounds such as novelty. The Commissioner neither revoked acceptance nor decided to re-examine. Sanofi filed a Notice of Opposition on 10 October 2014. Reckitt submitted that:
“…fully aware of the nature of the evidence required at the time of filing of the Notice of Opposition, and also fully aware of the three month period allowed to prepare this evidence from the filing of the SOGAP, reasonable efforts on the part of the opponent in our submission required immediate commencement of evidence preparation activities following the filing of the Notice of Opposition. This did not occur.”
19. In the period between filing of the Notice of Opposition and the filing of the Statement of Grounds and Particulars, the request for an extension of time discusses the following actions:
· Identification and apparent engagement of four expert witnesses including meeting with the two key experts
· Engagement, briefing and meeting with legal counsel
· Full prior art search
20. At such an early stage, between filing a Notice of Opposition and filing of a Statement of Grounds and Particulars, the case to be alleged by the opponent is not yet completely formulated. In this regard, approaching this stage of evidence gathering in a strategic sense by way of identification and engagement of experts, discussions with legal counsel and subsequent formulation of the complete grounds and particulars of opposition appears entirely reasonable action in the circumstances. One might suggest that such steps enable effective and efficient evidence gathering from the point of filing the Statement of Grounds and Particulars onwards. Contrary to Reckitt’s submissions I find that the evidence preparation activities have in fact begun and have been conducted in a reasonable manner.
21. A similar submission was made by Reckitt in regard to complex scientific issues identified in the extension of time request. These submissions pointed to the fact that complexity was known to Sanofi at an early stage and that any difficulties should have been anticipated. For similar reasons as those discussed in regard to the prior knowledge of grounds of opposition this submission also fails.
Public holidays
22. In regard to public holidays occurring during the period, Reckitt submitted that:
“…given the Opponent would, or should, have been well aware of the dates of public holidays on the day the Notice of Opposition was filed, it would be expected that the Opponent would have made a reasonable effort to take this circumstance into account when preparing their evidence in order to comply with the requirement that the evidence in support be filed by the due date of 12 April 2015.
23. I disagree with Reckitt. Particularly relevant public holidays to the planned evidence gathering period included Australia day (26 January), Labour Day (9 March) and Easter (3 and 6 April). Being only four days and not falling directly upon a due date for filing evidence, I do not see any particular action in planning for these days that is required whereby failure to do so would be considered as unreasonable.
Unplanned absences
24. One of the experts from whom evidence was being gathered was a general practitioner, Dr Michael Conos. Regarding the gathering of evidence from this expert Reckitt submits the expert:
“…was unexpectedly away between 9 to 23 March 2015. However, from paragraph 11d of the Extension of Time Request, a second meeting was held on 2 February 2015, and drafting of his declaration commenced on 12 March 2015. We ask the Commissioner to consider that if reasonable efforts had been made, a declaration for which preparation commenced on 12 March 2015 should have been finalised and filed between the return of Dr Cronos on 23 March 2015 and the due date for filing evidence on 13 April 2015. The Opponent has made no attempt to explain why this declaration was not completed and filed in time. The onus is on the applicant to explain this delay.”
25. As part of their submissions for the hearing Sanofi filed information as to the specific actions taken in the period 12 March 2015 to 12 April 2015. The original request for an extension of time and the further information provided in response to the delegate’s requests was silent in regard to this information. Reckitt submitted that I should not have regard to particular aspects of this information as it is not proper for Sanofi to file further information at this stage of proceedings citing Clarus Therapeutics, Inc. v Lipocine, Inc. [2014] APO 50 at [33] and [34] where the Deputy Commissioner stated that:
“Parties seeking extensions of time are required to file comprehensive evidence at the time of their request and will at best be given one further opportunity if the delegate first considering the request identifies deficiencies that are capable of rectification.”
“… a failure to promptly provide evidence fully supporting a request for an extension of time risks refusal including on discretionary grounds.”
26. I see no basis in the Deputy Commissioner’s decision for me to have no regard to the information provided by Sanofi. The first paragraph merely refers to the Commissioner’s practice of processing requests at first instance before issuing an intention to grant or refuse. At best, a failure to fully disclose relevant information may weigh against the granting of an extension on discretionary grounds after deciding that the relevant arms of the test under regulation 5.9 are satisfied. Additionally, a failure to provide such information may result in an adverse award of costs with respect to the successful party as was the case in Fonterra Co-Operative Group Limited v Leprino Foods Company [2014] APO 89 and Arch Wood Protection Ply Ltd v Osmose New Zealand [2014] APO 82. I will have regard to all of the information filed by Sanofi in arriving at my decision.
27. Reckitt also submitted that the information is obtuse and difficult to interpret particularly due to the use of initials identifying particular experts and the fact that some information is handwritten diary notes. For example, ‘MC’ is identified in this information whereby Reckitt argues that MC could either be Dr Michael Conos or another expert, Professor Macdonald Christie. Comparing the handwritten diary notes to a typed version filed by Sanofi I am satisfied that the initials ‘MC’ refer to Dr Conos. The information relevant to the gap identified above with respect to Dr Michael Conos is provided in two separate schedules below. For reference, I identify the four experts listed in the schedules as follows:
· DA = Professor David Adams (neurophysiologist)
· Mac Christie = Professor Macdonald Christie (neuropharmacologist)
· MC = Dr Michael Conos (general practitioner)
· DF = Mr David Ford (pharmacist)
Date Activity 6/3/2015 Email MC re further questions; also DF, also DA with draft dec 22/3/2015 Review MC comments 25/3/2015 Meet with DA re dec draft 1/4/2015 Follow up DA 8/4/2015 Review evidence to date to define lodgement strategy (partic MC) 9/4/2015 Further review DA evidence re lodgement strategy 10/4/2015 Continue finalisation of first decs
Date Time Comment 8/3/2015 3-4 prepare transcript of interview with Michael Conos 9/3/2015 10-11 further prepare transcript of interview with Michael Cones 12/3/2015 11-12.30 drafting declaration 15/3/2015 11-3 preparing second transcript from meeting with Mac Christie and reviewing clinical papers 16/3/2015 11-4 revising Mac Christie's declaration, including further review of specification and clinical papers, preparation of images 17/3/2015 1-5 further work on preparing Mac Christie's declaration 24/3/2015 2-4.30 prepare transcription of talk with David Ford, internet research re post nasal drip and other non-pathogen related conditions 25/3/2015 1-2.30 prepare David Ford declaration V1 .0 26/3/2015 8.30-11.45 further revisions to Mac Christies declaration (incorporating background and other comments) 27/3/2015 9:45-10:20 receiving email from Mac, review attachments, further revisions to declaration
28. From the schedules it is clear that action was taken in regard to the Dr Conos evidence being:
· Email sent regarding further questions on 6 March 2015
· Preparation of transcripts of interviews on 8 and 9 March 2015
· Drafting of declaration commences on 12 March 2015
· Reviewed comments on 22 March 2015 (presumably addressing further questions of 6 March)
· Review of evidence to date to define lodgement strategy on 8 April 2015
29. Isolated in this manner, the course of action taken in regard to the evidence of Dr Conos appears arguably lacking. However, such information must be considered in the context of the entirety of the evidence gathering actions. In particular, it is clear that across the period in question (12 March – 12 April 2015) there has been reasonably consistent effort in the formulation of evidence from all of the four experts. Particularly, this has resulted in the finalisation and filing of first declarations from key experts Professor David Adams and Professor Macdonald Christie within the evidence period. As was made clear in Sanofi’s further information of 29 April 2015, further tasks given to the Dr Conos and Mr Ford on 6 March 2015 were a result of feedback from the other experts and a meeting with counsel. In this regard, the course of action taken for the Dr Conos declaration appears entirely reasonable as focus was clearly placed upon the filing of declarations from the key experts, Professors Adams and Christie.
30. Reckitt made similar submissions in relation to the evidence of Mr Ford:
“The pharmacist, Mr Ford, was unexpectedly busy at work from 4 February 2015 until 23 February 2015, and absent "from his workplace overseas in the period 30 March - 13 April 2015" as outlined in paragraph 8(a.) of the Opponents Further Information. We note that meetings were held with the Mr Ford on 12 January 2015 and 24 February 2015. It is unclear why drafting of Mr Ford's declaration did not commence prior to 25 March 2015. We note that the Opponent has advised of very little activity in connection with the evidence preparation in the nearly 5-week period between 24 February 2015 and 30 March 2015, when Mr Ford went overseas.”
31. It is clear that drafting of Mr Ford’s declaration did not commence prior to 25 March 2015. It follows that Reckitt identifies the period 24 February to 30 March 2015 as comprising little activity and as such, lacking reasonable effort to comply with the filing requirements. Reproduced below is a relevant extract of the further information filed by Sanofi on 29 April 2015:
a. 13 January - met and deposed Professor Christie based on his review of the science of the patent application, and later that same day provided him with a list of further tasks to undertake including the review of 4 further publications
b. 13 January - provided the general practitioner with tasks to be undertaken in relation to his understanding of pain, his practices in dealing with consumers presenting with pain and his understanding of the mechanisms of action of his recommended courses of treatment and his understanding of their efficacy
c. 16 January - provided the pharmacist with tasks to be undertaken in relation to his understanding of pain, his practices in dealing with consumers presenting with pain and his understanding of the mechanisms of action of his recommended courses of treatment and his understanding of their efficacy
d. 19 January - followed up with Professor Christie about his tasks
e. 20 January - met and deposed Professor Adams based on his review of the science of the patent application
f. 29 January - received feedback from the general practitioner and reviewed for alignment with opposition strategy
g. 2 February - met with the general practitioner to review and investigate his feedback further
h. 3 February - provided feedback to Applicant instructor and sought authority for next steps
i. 4 February - received authorisation from Applicant instructors to proceed
j. 4 February - contacted Counsel to make appointment for meeting to review evidence preparation to date and consider gaps in evidence preparation and facts to be established
k. 4 February - followed up pharmacist to ascertain degree of completion of tasks
l. 6 February - followed up Professor Christie re degree of completion of tasks
m. 11 February- reviewed notes and completed transcript of recording of Professor Christie meeting
n. 12 February- after reviewing scientific literature commenced preparation of Professor Christie's declaration
o. 13 February - continued drafting and completed review of highly relevant scientific document containing data overlapping with the patent application
p. 16 February - completed first draft statement for Professor Christie
q. 18 February - completed review of notes and transcript of Professor Adams discussions and carried out review of background documents provided by Professor Adams
r. 19 February - provided draft statement relating to material from Professor Christie's first deposition to him for review and discussion
s. 19 February- continued drafting statement for Professor Adams and reviewed contemporaneous scientific publication re a clinical study
t. 20 February - met with Professor Christie to take feedback and deposed him in connection with the tasks he was asked to undertake in the period 13 January – 20 February
u. 20 February - met with Applicant General Counsel to update and check reconfirm authority for strategy and activity
v. 24 February- met with Applicant instructor and Counsel to review evidence preparation to date and consider gaps in evidence preparation and facts to be established.
w. 6 March - provided general practitioner with further tasks to undertake regarding his understanding of pain concepts versus other physiological effects of medical treatment with lozenges in light of feedback being received from other skilled persons and meeting with Counsel
x. 6 March - provided pharmacist with further tasks to undertake regarding his understanding of pain concepts versus other physiological effects of medical treatment with lozenges in light of feedback being received from other skilled persons and meeting with Counsel
y. 6 March - provided draft statement to Professor Adams for consideration
z. 8 March - review transcript of general practitioner comments and consider relevance to strategy in light of other materials to date
aa. 11 March - received further feedback from Professor Adams.
32. Firstly I note that between 24 February and 6 March there is no record of particular action. On 24 February, the agent records a meeting with Sanofi’s instructor and counsel to review evidence and consider gaps. On 6 March tasks were performed which included the provision of further tasks to Dr Conos and Mr Ford based on feedback from other skilled persons and the meeting with counsel, and the provision of a draft statement to Professor Adams. On this basis it may be possible to infer that in this period, consideration was given to the actions performed on 6 March which resulted from the meeting of 24 March 2015. Regardless, this particular period is only 7 working days which I do not consider so significant as to render the course of action as unreasonable.
33. Regarding the remainder of the period in question being 6 March to 30 March 2015, I refer to my discussion above in regard to the Dr Conos declaration which I consider applies similarly to the action in regard to the declaration of Mr Ford. For these reasons I consider the action in regard to Mr Ford’s declaration is also reasonable.
Four experts
34. Reckitt queries the reasonableness of employing four experts for the formulation of evidence in support questioning whether it was:
“…really reasonable to have an expert in neurophysiology and an expert in neuropharmacology consider the scientific data in the application, and provide a set of two separate yet similar evidence submissions? Was it really reasonable to have a General Practitioner and a Pharmacist provide a further set of two separate yet similar evidence submissions?
Moreover, if it is reasonable for the Opponent to have four separate experts, and noting that the Notice of Opposition was filed on 10 October 2014, would it not also be reasonable to expect the Opponent would start preparing evidence in earnest much earlier in the Opposition proceedings, noting the efforts required "to prepare evidence by four skilled persons in parallel"?”
35. Regarding the first question raised by the opponent I note that while four experts may not be necessary, I see no basis to consider their use unreasonable. It is very common in opposition proceedings to have multiple experts with similar evidence. In regard to the second question raised by the opponent I refer to my discussion under the heading Knowledge of grounds/Complex science. Here I considered the actions prior to the filing of the statement of grounds and particulars reasonable. My finding is the same for the use of multiple experts.
Two-stage declarations
36. Reckitt questions whether it was reasonable for Sanofi to engage a two-stage process for experts Professor Adams and Professor Christie, citing Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2014] APO 74 at [18] where the delegate stated that:
“Where the use of a two stage process leads to the need for an extension of time, a party will need to show that it was reasonable to use such a process, and that they were prompt and diligent in the way they carried it out.”
37. In regard to the two-stage process Sanofi noted that:
“The prior art materials are those listed in the Statement of Grounds and Particulars. It was always planned that these would be considered in a secondary stage of evidence preparation”.
38. Consideration of prior art in this manner (particularly in the presence of the ground of inventive step) is common and guided by the decision of Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd [2002] FCAFC 315. I have reviewed the evidence and am satisfied that each of the first declarations of the relevant experts identifies information that was “well known” before the priority date. The subsequent declarations in part, proceed to analyse prior art. Inventive step is a ground identified in the Statement of Grounds and Particulars. It follows that I find the use of a two-stage process reasonable.
Unexpected conflict of data and unexpected volume of documents
39. In their further information provided on 29 April 2015, Sanofi discussed the fact that Professor Christie’s evidence preparation had been affected by a conflict of data that had not previously been known to the opponent. On this point, Reckitt identify the conflict and suggest that:
“… the Opponent ought reasonably to have known about this issue prior to the filing of the Notice of Opposition. Accordingly the conflict was foreseeable and the Opponent should have made reasonable efforts to plan around the conflicts to ensure that all of the evidence as filed on time.”
40. A similar submission is made by Reckitt in regard to the information provided by Sanofi discussing the fact that Professor Adams identified 17 pieces of published academic literature to support his statements, this being unexpected.
41. I do not see reason in requiring an opponent to identify every issue at the earliest possible stage, and for that matter plan for such issues. I particularly note the submission from Sanofi in regard to the conflict of data not being identified early which states:
“Simply put, we were wrong at the time”.
42. There is no lack of reasonable action in not identifying and planning for these issues. To the extent that they are relevant, consideration of such issues may be useful in shedding light upon what is prompt and diligent action in the circumstances.
Patent attorney declaration
43. On the second to last day of the proposed extension period for filing evidence in support, Sanofi filed a declaration from Ms Karen J Sinclair, patent attorney for Sanofi. The declaration simply exhibits prosecution details for the related European patent. It is clear that the declaration does not rely on identifying, engaging or deposing experts. In short, as identified by Reckitt, no reason is provided as to why this declaration was not filed by the due date for evidence in support. Reckitt submits that:
“...the filing of this Declaration on 11 May 2015 is prima facie evidence that the Opponent has not made all reasonable effort to comply with the requirement that evidence in support is to be filed by the due date… for this reason alone [the extension should be rejected]”.
44. Responding, Sanofi state:
“The simple explanation is that the Attorneys on this matter were acting, contemporaneously, as promptly and diligently as possible in respect of declarations by four other parties. It is respectfully submitted that the strategic decisions of the Opponent as to in what order or priority declarations were prepared is not at issue in these proceedings.”
45. It is particularly clear that the patent attorney declaration is a straight forward declaration (which may well be of very limited relevance to the present matter) that would not have taken a significant amount of time to produce. Ideally, all evidence should be filed as early as is possible. However, given the circumstances involving four experts whereby it does not appear to have been possible to complete the evidence by the due date, it seems reasonable that the simple task of formulating and filing this declaration be postponed until an extended deadline to allow for focus upon expert declarations.
Summary
46. I have considered all of the issues raised by Reckitt in regard to the requirement that a party must make all reasonable efforts to comply with all of the relevant filing requirements. I have also considered the entirety of the information provided by Sanofi and find no issues warranting discussion beyond those identified by Reckitt. In accordance with the discussion above I consider that Sanofi has made all reasonable efforts in compliance with subparagraph 5.9(2)(a)(i).
Was the failure to file the evidence despite acting promptly and diligently?
47. In relation to the demonstration of prompt and diligent action the delegate in TRED (supra) noted at [76] that:
“An attorney does not need to account for every minute of their day, but they must provide enough information to enable a delegate of the Commissioner to form their own opinion on whether the party has acted reasonably, promptly and diligently. The kind of information that could be provided is a brief account of actions taken (for instance, an outline of what was done, when it was done, how it was done, by whom it was done, as appropriate to the case) covering the period in question.”
48. Further guidance is present in Fugro Airborne Surveys Corp v Geotech Airborne Limited [2014] APO 23 at [20] where the delegate stated that a chronology of the steps taken is usually a good starting point to assess whether a person has acted promptly and diligently:
"A party seeking an extension of time will assist the Commissioner (and advance their own cause) if they provide information about what they did, when they did it, and how long those actions took. When considering such information, it is relevant to consider whether there have been any significant unexplained delays. The presence of significant delays without a reasonable explanation is the antithesis of acting promptly and diligently. "
49. However, it is clear that there can be no absolute measure upon how much information is required to be satisfied that a person has acted promptly and diligently. In Osmose New Zealand v Zelam Limited [2014] APO 49 at [18] and [22] respectively, the delegate noted when considering the time taken to engage an expert:
“The fact that some activities took place over several months does not automatically mean that Zelam have not been prompt and diligent.”
“While it might have been possible to carry out some activities faster, the time taken is not outside the range of prompt and diligent given the work that was involved.”
50. Reckitt initially submits that there is a general lack of narrative in regard to the activities conducted throughout the evidence period. In particular Reckitt points to issues of unplanned absences, conflict in data, 17 pieces of information provided by Professor Adams, and submits that unambiguous dates regarding these delays and steps taken to mitigate the delays are not discussed. I consider such a submission is best addressed by considering particular gaps in the timeline that are identified by Reckitt as these issues appear to be relevant to the question of what is prompt and diligent in the circumstances. There are a number of specific issues raised by the Reckitt in regard to the information provided and chronology of events which it alleges demonstrate a lack of prompt and diligent action.
20 – 29 January 2015
51. Reckitt submits that there is no explanation of any activity during this period. It is clear from the timeline provided above at [31] that prior to 20 January 2015, Professor Christie, Dr Conos and Mr Ford had been given tasks (on 13, 13 and 16 January respectively). On 19 January the agent followed up Professor Christie regarding his tasks, and on 20 January the agent met and deposed Professor Adams. The delay until 29 January is due to the agent giving three experts time to complete their tasks. It would appear reasonable to await this response before proceeding significantly with the evidence of Professor Adams. Such a delay of six working days to await expert responses does not indicate a lack of promptness and diligence.
24 February – 6 March 2015
52. Reckitt submits that there is no explanation of any activity during this period. While I agree that there is no explanation, similarly to my discussion earlier at [32], I consider a delay of 7 working days is not significant in the circumstances.
27 March – 8 April 2015
53. Reckitt identifies that the only activity recorded within this period is “follow up DA”. Taking Easter into account this period is five working days. It is Reckitt’s submission that:
“…surely more than one “follow up” should have occurred during a period of five working days, given that this five-day period ended only three working days before the due date for filing evidence…”
54. Similarly to the period 24 February to 6 March, I do not consider this period to be significant. It is reasonable to infer that at this stage, it was not possible for the evidence to be complete by the due date. Given the small amount of time in question, and the amount of work that was required to be done, the action within this period appears in the range of prompt and diligent.
Professor Christie
55. A meeting occurred with Professor Christie on 20 February and there is no mention of Professor Christie again before 15 March 2015. However within this period a range of actions were taken with other experts including: meeting with Sanofi’s instructor and counsel (24 February); provision of further task to Dr Conos and Mr Ford and draft declaration to Professor Adams (6 March); preparing a transcript and commencing the declaration of Dr Conos (8, 9, 12 March); and receiving further feedback from Professor Adams (11 March). As a whole, the actions are within the range of prompt and diligent.
Professor Adams
56. A meeting was held with Professor Adams on 20 January; however as pointed out by Reckitt, review of the meeting transcript and background documents provided by Professor Adams was not completed until 18 February, with work on a draft declaration conducted on 19 February. A draft declaration was not provided to Professor Adams until 6 March. Similarly to the actions with respect to Professor Christie, during this period tasks were ongoing regarding the other experts. In particular, between 20 January and 18 February, significant work was completed on the declaration of Professor Christie (see points l. to p. of the timeline). Other important actions are noted at points f. to k of the timeline. Between 18 February and 6 March, a draft declaration was provided to Professor Christie for review, and a range of meetings with Professor Christie, instructor and counsel were conducted. Again as a whole, the actions are within the range of prompt and diligent.
Dr Conos
57. A final meeting was held with Dr Conos on 2 February 2015 and drafting of his declaration commenced on 12 March 2015. Reckitt submitted that:
“We note that Dr Conos was away from 9-23 March 2015. It would seem that a prompt and diligent approach would have been to have Dr Conos’s draft declaration ready for his return on 23 March 2015, and this may have allowed it to be filed by the due date of 13 April 2015”.
58. It wasn’t until 6 March 2015 following meeting with opponent instructor and counsel, that Dr Conos was given further tasks which were the result of feedback from other skilled persons and meeting with counsel. Following this date, Sanofi’s agent prepared a transcript and commenced the declaration of Dr Conos (8, 9, 12 March). Focus then appears to have shifted to work on declarations of Professors Adams and Christie for the remainder of the evidence period. Given these experts appear to be particularly key experts, the course of action as a whole appears reasonable and within the range of prompt and diligent.
Mr Ford
59. Meetings were held with Mr Ford on 12 January and 24 February and drafting commenced on 25 March. Reckitt submits that it is not clear why drafting of this declaration did not occur earlier.
60. Similarly to Dr Conos, Mr Ford was given further tasks on 6 March which were the result of feedback from other skilled persons and meeting with counsel. Focus was then placed upon the evidence of Professors Adams and Christie for the remainder of the evidence period. As with Dr Conos, the course of action as a whole appears reasonable and within the range of prompt and diligent.
Summary
61. I have considered all of the issues raised by Reckitt in regard to the requirement that a party act promptly and diligently at all times. I have also considered the entirety of the information provided by Sanofi and find no issues warranting discussion beyond those identified by Reckitt. In accordance with the discussion above I consider that Sanofi acted promptly and diligently in compliance with subparagraph 5.9(2)(a)(ii).
Were there exceptional circumstances?
62. It is unnecessary to determine whether there are exceptional circumstances (to which there are no submissions from either party) under paragraph 5.9(2)(b). I have already determined the criteria of 5.9(2)(a) have been satisfied.
Should I exercise the discretionary power to refuse the request?
63. Once the mandatory requirements of paragraphs 5.9(2)(a) or 5.9(2)(b) have been met, an extension is not automatic. The Commissioner "may" extend the period for filing evidence. While I do not consider that Sanofi filed all of the necessary information to justify an extension with their request I note that the delegate did initially intend to grant. There is clearly no ill intent in the withholding of particular information. It follows that I can see no reason to exercise the discretion to refuse the requested extension of time.
Conclusion
64. I am satisfied that all reasonable efforts were made by the Sanofi and that the information provided by Sanofi demonstrates that action has been prompt and diligent. Thus, I am satisfied that an extension of time is appropriate. In accordance with subregulation 5.9(3) I need to consider what length of extension is reasonable in the circumstances. As evidence in support was filed and also completed on 11 May 2015, an extension to this day is justified.
Costs
65. It is normal for costs to follow the event. However, some of the information which established that Sanofi acted reasonably, and promptly and diligently at all times was only made in Sanofi’s submissions to the hearing rather than in their application for an extension of time where this information should have been provided. I consider that the Reckitt was justified in objecting to the extension of time. In the present circumstances following ArchWood Protection Pty Ltd v Osmose New Zealand [2014] APO 82, I think it is appropriate that the parties bear their own costs. Accordingly, I make no award of costs.
Dr N.R. Madsen
Delegate of the Commissioner of Patents
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