Alcon Research, Ltd v Sylentis S.A.U - [2012] APO 55

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Alcon Research, Ltd v Sylentis S.A.U. [2012] APO 55

Patent Application: 2005276245

Title:Treatment of eye disorders characterized by an elevated intraocular pressure by siRNAs

Patent Applicant:                   Sylentis S.A.U.
Opponent:  Alcon Research, Ltd
Delegate:  Dr S.D.Barker
Decision Date:  29 May 2012
Hearing Date:  Written submissions filed on 3 April 2012 and 10 April 2012
Catchwords:  PATENTS – extension of time to serve evidence – inadequate explanation of delay – nature of evidence uncertain, but likely to be of relevance – on balance an appropriate case has not been made out – extension refused

Representation: Patent applicant: Griffith Hack
Opponent:Phillips Ormonde Fitzpatrick

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005276245

Title:Treatment of eye disorders characterized by an elevated intraocular pressure by siRNAs

Patent Applicant: Sylentis S.A.U.
Date of Decision: 29 May 2012
DECISION
Extension of time refused.
I allow the opponent one week from the date of this decision to serve any evidence immediately to hand.
I award costs according to Schedule 8 against Alcon Research, Ltd.
REASONS FOR DECISION

The present opposition by Alcon Research, Ltd was commenced on 3 September 2010. Evidence in support was due to be served by 2 March 2011. Several extensions of time have been allowed, extending that time to 2 March 2012. A further application for an extension until 2 June 2012 has be objected to by the applicant, Sylentis S.A.U. Two declarations, forming part evidence in support, have been served. The extension of time was heard on the basis of written submissions.
The relevant law
Extensions of time are governed by regulation 5.10:
(2)The Commissioner may extend the time within which the party may take a step … :
(a)    on the application of a party in the approved form; and
(b)    on such reasonable terms (if any) as the Commissioner specifies; and
(c)    after the party has served a copy of the application on the other party.
(5)The Commissioner must not … grant an application under subregulation (2) … unless the Commissioner:
(a)if he or she proposes to grant an application by a party -- is reasonably satisfied that the other party has been notified of the application; and
(b)if he or she proposes to act on his or her own motion -- ensures that the parties are notified of the proposed action; and
(c)    in either case:
(i)gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii)is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances.
The considerations for deciding whether to grant an extension of time under regulation 5.10 have been discussed by the Federal Court in Ferocem Pty Limited v Commissioner of Patents (1994) 28 IPR 243, A Goninan and Co Ltd v Commissioner of Patents (1997) 38 IPR 213, and National Starch & Chemical Company v Commissioner of Patents (2001) 50 IPR 398. The relevant considerations arising from these decisions may be summarised as follows:
(a)   The broad discretion afforded by regulation 5.10 cannot be reduced to insistence on imperative compliance with particular requirements;
(b)   The reasons why the evidence was not served earlier is a relevant consideration, but a satisfactory explanation is not a mandatory requirement;
(c)   The public interest in determining a serious opposition on its merits is a relevant consideration and must be balanced with the requirement that matters before the Patent Office should be dealt with in an efficient, orderly manner and not be unduly prolonged;
(d)   The public interest is assessed by forming a view as to the nature of the evidence to be adduced, and the significance of that evidence for the opposition proceedings. The nature and significance of the evidence is assessed having regard to any relevant material available, not just the evidence already on file;
(e)   The interests of the opponent, the applicant and any other parties are a relevant consideration.
It is clear that an extension of time is a discretion, and a party seeking an extension needs to place before the Commissioner sufficient information to allow the Commissioner to exercise the discretion. The information should include the reason for the delay, and the nature and significance of the evidence. While the disclosure required is not of the “full and frank” type required by section 223, it is not correct to assume that extensions can be granted as a matter of course. If the party seeking the extension does not provide sufficient justification, the extension cannot be granted.
Explanation of delay
The history of this matter is not fully apparent from the various requests to extend time. The application for the present extension says:
“Further expert witnesses are required to assist in the preparation of evidence. Potential experts have been identified and further time is required to approach them to assess their suitability and ability to act and to engage their services. Once engaged, further time is required to obtain their evidence and to prepare and finalise that evidence in a suitable form.”
There is no explanation provided as to why the opponent did not identify the need for these extra witnesses at an earlier point in the opposition. The submissions provided by the opponent add the following information:
“In June 2011 research was commissioned to evaluate formulations on intraocular pressure following topical ocular (eye) administration of the formulations. During this period, experiments were performed and a report on the experiments issued. Following issue of the report, the data needed to be analysed, summarised, and interpreted. Initial draft declarations were prepared.
During the period from 2 September 2011 to 2 December 2011 further draft declarations were prepared, and finalised. From the evidence prepared, including the experimental data of the First Report, further experts were required to prepare additional evidence, and further time required.
During the period from 2 December 2011 to 2 March 2012 the finalised declarations were received by our Australian Attorneys, and these were served as Evidence in Support (in part). Furthermore, in this period, the Opponent initiated contact with the Applicant with a view to settling the opposition.
Hence it is clear from the above that the delay has substantially occurred due to the need for designing protocols from the inadequate disclosure of the patent application, the performing of experiments, and the analysis of experimental data, in addition to requiring further Experts to clarify issues in light of the experimental results.”
This explains very little. I am left with the conclusion that it has taken a long time because it has taken a long time. I also note that the opponent’s explanation of the nature of the evidence being prepared (discussed below) refers to the examination of equivalent applications in other jurisdictions, and refers to a specific citation. As far I can see, these are matters that have nothing to do with the difficulties that may have been involved in the experiments discussed above. I can see no logical reason why the preparation of evidence in relation to the citation could not have been undertaken at an earlier time, and no explanation is provided. I consider that the explanation of the delay is inadequate, and fails to inform how the preparation of evidence is progressing. Rather, the opponent appears to be deliberately keeping secret the details of the preparation of its evidence.
Nature and significance of the evidence
The opponent has been vague as to the nature of the evidence that is being prepared. In line with the decision in National Starch, I have looked widely for guidance. The statement of grounds and particulars indicates the grounds of novelty and inventive step will be argued in the light of several citations. It is possible, if not probable, that the evidence being prepared relates to this matter. If so, then the evidence could be of significance. In the submissions the opponent refers to the fact that the claims that issued on other jurisdictions are of different scope, but this does not suggest the evidence that is being prepared. The submissions go on to say that the claims lack novelty in the light of WO 2004/042024. It seems a reasonable inference that the evidence to be provided relates to this document, and perhaps other matters.
Interests of the parties
It is a normal finding in extension of time matters that the interests of the parties lie in opposite directions. This is true in the present case.
Balance of considerations
It is apparent that there is evidence being prepared that could be significant, but there is no explanation why this evidence was not prepared earlier. On the other hand, there is evidence which it is apparent could not have been prepared earlier, but there is ambiguity as to what that evidence is. The fact that there is some evidence that could be significant is not in itself a sufficient basis for an extension. In line with the Ferocem decision, it is necessary to have regard to all relevant factors. In Goninan Sackville J said:
“Like Burchett J in Ferocem, I have every sympathy with the delegate's desire to insist upon the maintenance of proper standards. I do not suggest that it was not open to the delegate to take into account Goninan's failure, not merely on one occasion, but on two occasions, to provide a satisfactory explanation for the delays in finalising its evidence. Indeed, it was open to the delegate to give considerable weight to this factor. However, he could not regard the absence of any proper explanation as being such a powerful consideration that it obviated the need to address the nature and significance of the evidence upon which Goninan wished to rely in the opposition proceedings. This is what I think the delegate did. He thereby prevented himself from giving genuine consideration to a relevant matter, namely, the public interest in opposition proceedings being determined on their merits.”
With the other considerations evenly balanced, I have given careful consideration to the balance between the nature of the evidence being prepared and the explanation of delay. While it is true that the nature of some of the evidence supports the extension, it does so to a limited extent due to the lack of precision around this point. The explanation of delay in relation to this evidence is inadequate, which is surprising given that the opponent has had the opportunity to supplement this information in its written submissions, and has failed to do so. It would be reasonable for me to give considerable weight to the failure to give proper reasons, but I have not done so in this case. I do not believe that the possible significance of the evidence is sufficient to offset the inadequacy of the explanation, so the opponent has not discharged the onus of justifying an extension of time. If I had a better understanding of the nature of the evidence I may have been able to come to a different conclusion.
In relation to the evidence for which there is a better explanation of delay but a lack of information as to the nature of the evidence, the considerations are similar. I do not believe that the explanation of delay is sufficient to offset the indeterminate nature of the evidence, so the opponent has not discharged the onus of justifying an extension of time. Again, if I had a better understanding of the nature of the evidence I may have been able to come to a different conclusion.
In line with the decision in Ferocem, it is appropriate to consider a short extension for the opponent to serve any evidence immediately to hand. Consistent with the decision in Goninan, the fact that some evidence has already been served does not justify a refusal to allow a short extension. I will allow the opponent one week from the date of this decision to serve such evidence.
However, the refusal of this extension of time does not preclude the opponent from making a further application for an extension of time (as was the case in Goninan). Any further application for an extension of time will be considered on its merits, and if a proper explanation of the reasons for the delay and the nature of the evidence is provided, the opponent may be successful. Given that these are matters that are well within the knowledge of the opponent, it should not be difficult to draft a more informative application for extension of time.
It is normal for costs to follow the event. In the present case I can see no reason to depart from this practice. Costs will be awarded against the opponent.
Dr S.D.Barker
Delegate of the Commissioner of Patents