Pronova BioPharma Norge As v Naturalis S.A - [2016] APO 2

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Pronova BioPharma Norge AS v Naturalis S.A. [2016] APO 2

Patent Application: 2012364221

Title:Carrier Fluid Composition Comprising Fatty Acids Ethyl Esters and Process for Reducing the Concentration of Persistent Organic Pollutants in Fish Oil.

Patent Applicant:  Naturalis S.A.
Opponent:  Pronova BioPharma Norge AS
Delegate:  M. G. Kraefft
Decision Date:  13 January 2016
Hearing Date:  Written submissions completed on 25 November 2015

Catchwords: PATENTS – extension of time to file evidence in support – Regulation 5.9 – all reasonable efforts were made – actions were prompt and diligent at all times - exceptional circumstances not established – extension of time granted.

Representation: Patent applicant: Spruson & Ferguson.
Opponent:Ashurst Australia

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012364221

Title:Carrier Fluid Composition Comprising Fatty Acids Ethyl Esters and Process for Reducing the Concentration of Persistent Organic Pollutants in Fish Oil.

Patent Applicant: Naturalis S.A.
Date of Decision: 13 January 2016
DECISION
The opponent has met the requirements of paragraph 5.9(2)(a) of the Patent Regulations. An extension of time is appropriate.
Extension of time granted to 19 November 2015 for the opponent to complete the filing of evidence in support. Evidence in support was completed on that date.
Under sub-regulation 5.8(2), the time period for the applicant to file evidence in answer commences from the date of this decision.
REASONS FOR DECISION

This matter concerns whether an extension of time should be allowed to complete evidence in support.
BACKGROUND
Naturalis S.A. (“the applicant”) filed patent application 2012364221 on 9 October 2012. The application was advertised as accepted on 22 January 2015. Pronova BioPharma Norge AS (“the opponent”) filed a notice of opposition to the grant of a patent on 22 April 2015.
The opponent was due to complete its evidence in support by 22 October 2015. Shortly before that date the opponent made an application for an extension of time of 4 weeks up to 19 November 2015. A delegate of the Commissioner of Patents considered the request and advised of an intention to grant the extension of time. The applicant objected to the grant of the extension of time and requested to be heard. The hearing was conducted by way of written submissions.
APPLICABLE LAW
The present matter is governed by Regulation 5.9 of the Patent Regulations, which follows from the commencement of the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No. 1) (“the Amendment Regulation”).
Sub-regulation 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 sub-regulation (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 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.
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."
If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extension (sub-regulation (3)):
The Commissioner must determine the length of the extended period having regard to what is reasonable in the circumstances.
APPLICATION FOR EXTENSION OF TIME
A significant proportion of the application for the extension of time discussed the difficulty and delay in retaining independent experts, with the opponent also stating that the field of marine oils and processing of oils was relatively small, thus limiting the number of experts. The identification and pursuit of up to eleven experts to potentially provide evidence in the present opposition was detailed in the application. On the other hand, on the basis of the documentary evidence to be filed, it appeared the need for the extension of time was for one circumstance only. The opponent stated at [33] that the need for the extension of time was to enable a final report of the analysis of experimental work that replicated one example in the opposed specification to be completed, and for appropriate expert evidence to be prepared and finalised based on this report.
At this point I would note that the opponent filed evidence in support from three declarants by the due date of 22 October 2015. One of these three declarants also filed the final piece of evidence in support on 19 November 2015, the deadline for the sought after extension period.
The latter portion of the application for the extension of time focused on the processes of engaging an expert designated “K” and preparing evidence from this person, followed by the discussion regarding the experimental work undertaken and the analysis thereof. Expert K was initially approached in late August. After initially declining to assist, expert K was approached again in early September as the opponent was having difficulty engaging any other suitably qualified expert. Following approval from their employer, on 23 September expert K confirmed an availability to assist in the present proceedings.
The application for the extension of time does not make it clear whom the evidence regarding the experimental work would come from. From the application as a whole, I have presumed this evidence would come from expert K.
As will be apparent later, a crucial piece of information in the application for the extension of time was the unexpected unavailability of a senior specialist for process and development for the opponent. The senior specialist had the responsibility for overseeing the experimental work.
SUBMISSIONS
The opponent’s written submissions elaborated somewhat on its application for an extension of time, which was re-filed as an annexure to its submissions. The key points in the submissions were as follows.
The experimental evidence would be of considerable probative value as would the independent expert evidence regarding the results of the experiments. The opponent experienced considerable difficulty retaining an appropriately independent expert with sufficient time available, despite commencing enquiries in June 2015. The opponent was unable to retain an expert until late September. Finally the period of evidence preparation coincided with the 8 week European summer holiday period from mid-June to mid-August and consequently a number of key employees of the opponent were unavailable to assist.
The applicant’s written submissions mentioned the requirement of paragraph 5.9(2)(a)(i) importing 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. In respect to the opponent’s delay and difficulty in retaining experts and the claimed relatively small field of marine oils and processing, the applicant submitted that it was reasonable to expect the opponent to appreciate the possibility of such difficulties in this field and therefore commence the process of engaging experts at the earliest opportunity. The applicant noted the opponent’s first contact with a potential expert witness was almost 4 months after the filing of the notice of opposition. The applicant was also critical of the opponent citing an 8 week European summer holiday period as a reason for the delays and difficulties in engaging experts and obtaining and analysing the data related to the experimental work mentioned above. The applicant submitted that it was reasonable to expect the opponent to have appreciated the coincidence of the European summer holidays with the time for filing the statement of grounds and particulars and with the evidentiary period, and to have made reasonable efforts to mitigate the impact of possible employee absences.
The opponent’s submissions in response elaborated further on the actions taken to ensure evidence in support was filed by the due date and why, despite making all reasonable efforts and acting promptly and diligently, the opponent failed to meet the deadline. In these submissions it became clearer that the senior specialist for the opponent was the person responsible not only for the experimental work, but also the written statement and the final report of the analysis of the experimental work. The opponent’s submissions in response indicated that this material was filed in evidence on the due date. The submissions also stated that expert K was the declarant in respect to the evidence filed on 19 November after the due date. The nature of expert K’s evidence is not described in the submissions and therefore I would need to infer that evidence is the appropriate expert evidence, mentioned above, to be prepared and finalised based on the final report that related to the experimental work and for which the extension of time was sought.
The opponent further included some points on exceptional circumstances in its submissions in response. The points were the unusual number of experts that declined to assist, the unforeseen leakages in the plant used for the experimental work that required repair, and the unexpected difficulties in obtaining relevant reagents for the experimental work.
The applicant did not file any submissions in response.
SUB-REGULATION 5.9(2) REQUIREMENTS
Whether the party has made all reasonable efforts to comply with all relevant filing requirements
As in the present case, the Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited decision, [2015] APO 32, dealt with an application for an extension of time to file evidence in support. Similarly, partial evidence in support was filed by the due date in that case with an extension of time being sought to complete the filing of evidence in support. At [15] of the Sanofi decision, the delegate referred to Innovia Security Pty Ltd v Visual Physics LLC, [2014] APO 15, to state that the requirement in paragraph 5.9(2)(a)(i) was 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. The latter is addressed by the more specific requirement of paragraph 5.9(2)(a)(ii) (Merial at [16]).
Following a notice of opposition, the filing of the statement of grounds and particulars is normally the first requirement under Chapter 5 with which the opponent needs to comply. The opponent duly filed its statement of grounds and particulars in time on 22 July 2015. Prior to the present evidentiary period, one would thus conclude the opponent has made all reasonable efforts to comply with all relevant filing requirements. Further assessment of the opponent’s conduct in respect to paragraph 5.9(2)(a)(i) in the present case would appear to be coincident with an assessment of its conduct in respect to paragraph 5.9(2)(a)(ii).
Several decisions have drawn similar connections between the separate requirements under paragraph 5.9(2)(a). See for example Merial (supra) at [17], Merial Limited v Norbrook Laboratories Limited, [2015] APO 56 at [15], and Shelford Services Pty Limited v Baylor Research Institute, [2014] APO 20 at [28], albeit all in respect to the filing of evidence in answer. If a party has acted promptly and diligently in relation to the preparation and filing of evidence, it will have also made all reasonable efforts to comply. I consider it appropriate to adopt the same position in the present case. It is therefore unnecessary to further consider separately whether the opponent has made all reasonable efforts to comply with the time limit.
Whether there was a failure to file evidence despite acting promptly and diligently
In the present case, the opponent began making enquiries to identify potential expert witnesses in early June. This was approximately 6 weeks after the filing of the notice of opposition and 6 weeks before the filing of the statement of grounds and particulars. Given the grounds of opposition and the particulars in respect thereto were not yet required to be finalised and filed at that point, and given the grounds and particulars may affect the type of expert witnesses and the nature of the evidence required, I consider the opponent was proactive and applied a reasonable approach in its search for expert witnesses. This would appear to also demonstrate the opponent was cognisant of the claimed relatively small field of marine oils and processing, and the possible difficulties in engaging and retaining independent experts in such a field.
As mentioned above, the opponent filed its statement of grounds and particulars on 22 July 2015. Approximately three weeks later, from mid-August, the opponent first made actual contact with potential experts. While this may seem a gap with little direct explanation, I would not think it unusual in the present context of the opponent’s stated assessment of the suitability of identified potential experts. Such an assessment or re-assessment would appear appropriate after the statement of grounds and particulars was filed. This would appear to be also broadly consistent with the approach in Commonwealth Scientific and Industrial Research Organisation v Agriculture Victoria Services Pty Limited, [2014] APO 80 at [28], where it was considered reasonable to wait until the basis of the opposition was elucidated and the relevant prior art identified before identifying appropriate experts. In any case, as will be apparent later, this factor does not appear to have been causative of the need for the extension of time.
Despite stating in submissions in response that the opponent did not rely on the 8 week European summer holiday period as a reason per se, the opponent made much of the holiday period throughout its submissions. In the first instance, while the holiday period may be 8 weeks, I would concur with the applicant who submitted that it would be highly unlikely that employees would take 8 weeks of leave. I expect most individuals in most technology sectors would be able to take only a subset of that time off work. In any event, I would expect the opponent to have mitigated the impact of the holiday period, including the recall of key personnel from leave if necessary. In any case, I think the opponent’s submissions on the holiday period have been a distraction in the present matter. For the experimental work, some initial preparation of protocols, sourcing of appropriate materials and planning the use of relevant plant and equipment were required. The experiments themselves were conducted on only three days over only a one week period in late September. It would thus appear there was ample time to work around the European summer holiday period. As such, most of the opponent’s evidence in support was filed by the due date, including the final report of the analysis of the experimental work from the opponent’s senior specialist for process and development. The only evidence for which an extension of time would be required was the appropriate expert evidence to be prepared and finalised based on this final report.
The problems in preparing and finalising this expert evidence were as follows. The conduct of the experiments was originally planned for mid-August. This time frame is commensurate with the time of filing the statement of grounds and particulars already discussed above on another point. However unexpected circumstances arose that required the senior specialist to attend to a private matter at that time. Thus, work on the experiments could not commence until mid-September. The senior specialist had the responsibility to oversee the experiments. A junior scientist was originally scheduled to conduct the work. As a result of the delay in the starting date though, the junior scientist then became unavailable to assist. It was therefore necessary for the senior specialist to conduct the experiments personally.
In Merial, there was an adverse finding in respect to a party’s perseverance with a particular expert when there was knowledge that this person would be absent for significant periods during the relevant evidentiary stage. While it may be preferable to also have contingencies in place where other personnel could take over, I am also mindful that circumstances may exist in some cases where the availability of a particular person is crucial. In the present case, I am satisfied that the latter circumstance applied in respect to the senior specialist for the opponent. I would also note that, contrary to the situation in Merial, the unavailability of the senior specialist at a crucial time was unexpected.
As mentioned previously, the experiments were conducted on three days over a one week period in late September. Within this period, the senior specialist also had to attend an urgent business meeting overseas at short notice. To mitigate the delays caused, it is noteworthy that the senior specialist conducted the experiments over consecutive weekends. After the completion of the experimental work, the opponent provided the samples to an external analytical laboratory for analysis. The external analytical process normally takes four weeks but, given the delays and urgency, the opponent requested that the analysis be performed on an urgent basis. The opponent paid an additional fee to obtain the results of the analysis within two weeks. The results were received on 13 October 2015. I would accept that there was then insufficient time by the due date for the opponent to both prepare the final report of the analysis, and prepare and finalise appropriate expert evidence based on this report.

Expert K was retained relatively late in the evidentiary period, notably in late September. This is coincident with the time of completion of the experimental work by the senior specialist. Given that the results of the analysis were not available until 13 October, expert K’s late retention would not appear to have been causative of the opponent’s failure to file all its evidence in support by the due date. In any event, expert K reviewed a significant amount of material for this opposition outside normal working hours to manage existing concurrent work commitments.
In viewing the conduct of the opponent overall, it appears that the opponent has gone to some significant lengths to attempt to complete evidence in support by the due date. Firstly, in this case, the search for expert witnesses began relatively early, that being well before the statement of grounds and particulars was due. Secondly, personnel were engaged to work on weekends or otherwise outside normal working hours to combat the delays caused by their unexpected unavailability beforehand. Thirdly, the analytical work by the external laboratory was ordered and paid for on an urgent basis.
In the present case, I am satisfied the opponent has adequately demonstrated promptness and diligence at all times.
I conclude the opponent has satisfied the requirements of paragraph 5.9(2)(a).
Whether there were exceptional circumstances
The opponent has satisfied both of the first two conditions of sub-regulation 5.9(2) outlined above. Consequently the question of whether exceptional circumstances applied in this case is moot. Nonetheless, for the sake of completeness I will address some points.
In the TRED decision, the delegate stated at [64] that exceptional circumstances were matters outside the normal evidentiary process, and outside the control of the party, where it would be unreasonable to insist on a party filing their evidence. As mentioned earlier, the opponent submitted there were several exceptional circumstances. While the number of experts in this case that declined to assist may have been unusual, and even frustrating, and outside the control of the opponent, this circumstance is foreseeable in the normal evidentiary process. Similarly the failure of plant equipment for conducting experiments may lead to delay but is also foreseeable to occur from time to time. Similarly, the difficulty with timely supply of relevant reagents is foreseeable. Consequently I think these points, individually and collectively, are more appropriately considered in the context of whether the opponent has acted reasonably, promptly and diligently, rather than regarding them as exceptional circumstances.
I consider there have been no factors put before me, individually or collectively, that would justify a finding that there have been exceptional circumstances in this case.
CONCLUSION
I have concluded the opponent has met the requirements of paragraph 5.9(2)(a). Even so, an extension of time is not automatic. Referring to sub-regulation 5.9(2), the Commissioner “may” extend the period for filing evidence. In this case, I am satisfied that an extension of time is appropriate.
Next, I need to consider what length of extension is reasonable in the circumstances. As mentioned earlier, a crucial factor in the need for the extension of time was the unexpected unavailability of the senior specialist for the opponent. The period of this person’s absence was approximately the same as the presently sought extension period. I think the opponent’s requested period of extension is appropriate.
I grant an extension of time to 19 November 2015 for the opponent to complete the filing of evidence in support. The evidence filed on that date by the opponent is thus available to the opponent in this opposition and completes the opponent’s evidence in support.
Under sub-regulation 5.8(2), the time period for the applicant to file evidence in answer commences from the date of this decision.
COSTS
Both parties sought their costs. I see insufficient reason to depart from the normal approach that costs follow the event. I award costs in accordance with Schedule 8 against the applicant, Naturalis S.A.
M. G. Kraefft
Delegate of the Commissioner of Patents