SmithKline Beecham Plc v Synthon B.V
[2001] APO 22
•22 May 2001
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Petty Patents : No. 713131 and 713877 in the name of SmithKline Beecham plc.
Subject: Paroxetine methanesulfonate pharmaceutical compositions.
Action: Applications for Extension of Term, notification under S.28(1) by Synthon B.V, application by the patentee for an extension of time of 3 months to serve evidence-in-response and objection thereto by the informant; hearing.
Decision: Issued .
Abstract: A reasonable case for the extension of time sought was made out. Preparation of evidence was complicated by parallel proceedings and the amount of and technical nature of the informant's evidence.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Petty Patents 713131 and 713877 in the name of SmithKline Beecham plc, applications for Extension of Term, notification under S.28(1) by Synthon B.V, application by the patentee for an extension of time of 3 months to serve evidence-in-response.
BACKGROUND
Petty Patents 713131 and 713877 were granted on 25 November and 9 December 1999 respectively, applications for extension of term for both patents were filed on 21 August 2000, and S.28(1) notices asserting that the petty patents are invalid were filed on 25 October and 9 November 2000 respectively. Synthon B.V, the S.28(1) informant, filed some evidence-in-support with its said notices and completed its evidence by 6 December 2000. The patentee was initially given three months from 13 December 2000 to file its evidence-in-response, but on 13 March 2001 requested an extension of time of three months to 13 June to file its evidence.
The reasons given for the extension of time are as follows:
"Since receiving the notification under Section 28 the patentee has conducted a detailed review of the evidence submitted by the notifier and is presently in the process of preparing evidence in relation to a number of parallel proceedings being conducted in other jurisdictions. It is intended that evidence from overseas experts that is being prepared for the parallel proceedings will be modified as necessary and presented in support of this petty patent.
Enquiries have been conducted with regard to retaining Australian experts and several potential experts have been identified. Further time is required to retain and brief Australian experts and for expert declarations to be prepared. Further time is also required to modify declarations from the overseas experts for compliance with Australian requirements and consistency with the particulars of the present matter."
On 30 March 2001 the informant notified the Commissioner and the patentee that it objected to the application for extension of time. The matter was heard in Canberra on 24 April 2001; Mr Mark Roberts, patent attorney with Davies Collison Cave, attended the hearing in person to represent the patentee, and Dr Ivan Rajkovic, patent attorney with Baldwin Shelston Waters, represented the informant by telephone. Dr Rajkovic was assisted by Mr Thai Loi.
SUBMISSIONS
The most relevant authorities referred to at the hearing were:
Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057, 28 IPR 243 (Ferocem).
In this decision Burchett J. said:
“The determination of an application for an extension of time under reg. 5.10(2) involves a balancing exercise, in which competing considerations must be taken into account. There are the interests of the persons directly concerned in the application and opposition in question. There are also public interests, which are not necessarily all ranged on the same side. They include the expeditious disposal of matters in the Patent Office, and questions of cost, of efficiency, and of insistence upon proper professional standards being maintained by those who deal with the office. But they also include, as Kitto J. pointed out in Kaiser Aluminium & Chemical Corporation v The Reynolds Metal Company (1969) 120 CLR 136 at 143, ‘the public interest that a serious opposition by a person entitled in fact to oppose the grant of a patent should be dealt with on the merits, rather than that it should be shut out in consequence of a failure in procedure, lamentable though the failure may be.’ This proposition was cited, by Bowen CJ in Vangedal-Nielsen [33 ALR 144] (at 150), where he also set out some of the considerations involved upon the application for an extension of time.”
Goninan & Co Ltd v Commissioner & Anor 38 IPR 213 (Goninan). This case related to a second application for extension of time to file evidence-in-support. A first extension had been granted, in part, applying Ferocem principles. The delegate refused the second extension because the explanation for the delay was inadequate, but the Federal Court set aside the delegate's decision because he did not take account of the importance of the evidence to be adduced and therefore did not take full account of the public interest that the opposition proceedings are determined on their merits.
Dynamic Data Systems Pty Ltd v Ingenico International (Pacific) Pty Ltd [1998] APO 60 (Dynamic Data). This case teaches that the Commissioner's discretion in determining the time for responding to a S.28(1) notice is exercised in the same way as it is under R.5.10 relating to standard opposition, and therefore the principles established in the Ferocem and Goninian decisions of the Federal Court are relevant to the present case.
The informant’s submissions are summarised as follows:
The patentee has been aware of the informant's evidence for about five months, i.e. from the filing of the latter's experts' draft declarations; this should have been sufficient time for the former to prepare its evidence-in-response.
The reasons given for the extension are generally insufficient and show a lack of diligence; there is no timetable for example; nor any reasons given as to why the patentee was not able to make further progress beyond identifying and making enquiries with regard to retaining Australian experts.
The "parallel proceedings" referred to in the reasons for the extension is not a relevant factor in the consideration of whether an extension is justified, especially for petty patents which are unique to Australia.
There is no direct evidence that overseas experts have been contacted, and the reference to "modifying" the overseas experts evidence suggests that further delays can be expected.
The DynamicData case indicates that it is in the public interest that petty patent matters especially are not unduly prolonged. See 43 IPR at 418.
Delay in the matter is a disadvantage to the informant because it delays the introduction of its product into the marketplace.
The patentee’s submissions are summarised as follows:
The properly executed versions of the declarations in the informant's evidence were not filed until the 6th December, so the patentee had not had 5 months to consider the evidence-in-support before the application for extension of time. Also, Synthon had more than 11 months from the date of sealing the petty patents to prepare its evidence.
The issues raised in Synthon's evidence are technically complex and require detailed evidence-in-response from experts, and there is a limited number of such experts in Australia.
The evidence prepared in Australia could be used in litigation overseas so it needs to be reviewed by the patentee and its advisers in other countries. Communications between all the parties are logistically difficult and time consuming.
Any delay in the proceedings will adversely affect the patentee as well as affecting the informant. Maybe even less so for the informant because, as far as the patentee is aware, Synthon is yet to receive approval for marketing of a paroxetine methanesulfonate product in Australia, so delays in the present matter are not primarily responsible for any uncertainty Synthon may have with regard to its marketing plans.
Claims of similar scope to those of the present petty patents are included in accepted application 732,211 (23,928/99), and, as it is expected that this standard patent application will be opposed, a final decision by the Patent Office relating to the allowability of such claims will not be made for some time.
The Ferocem decision suggests that the patentee should be allowed to make its case because there is clearly a serious challenge to the extension of term, and because it is in the public interest that the objections to the applications for extension of the petty patents should be resolved on their merits. Also there is no identifiable "failure in procedure" on the patentee's part.
The Goninian and other decisions indicate that a detailed explanation for delay in preparing evidence is relevant but not mandatory.
Also re Goninian, the nature of the evidence that would be excluded if the extensions of time are not granted is technically significant and will be material to the resolution of the S.28(1) matter.
DECISION
Regulation 5.10(2) enables the Commissioner to grant an extension of time in opposition proceedings. From regulation 5.10(5) I note that an extension must not be granted unless I am reasonably satisfied that the extension of time “is appropriate in all the circumstances.”
The informant has argued that the parallel proceedings overseas are not relevant in this case. I am not sympathetic with this submission; it is clear from the wording of the Act and from the Ferocem decision that I should consider all the circumstances of this case. In my view these circumstances do include the complications associated with the overseas proceedings. I note that the circumstances in the Ferocem case related to preparing evidence for both a S.59 opposition and for related proceedings in the Federal Court, so I think is appropriate to infer that such circumstances can be a valid reason for granting an extension of time.
In my prima facie view, the subject matter of the informant's evidence is technically complex, and a three month extension is not unreasonable in the light of the parallel proceedings, and the amount of and technical nature of the informant's evidence.
Re the informant's submission that petty patent matters should be treated more expeditiously than standard opposition matters. I agree with this submission; it is clearly set out in the Dynamic Data case for example. Looking closer at the circumstances in that case I note that the delegate refused to grant the extension of time requested but did grant a limited extension of time of 14 days for the patentee to serve whatever evidence was at hand. Delay was a significant factor: the patentee had been granted three previous extensions of three months each and was applying for a further two months; in all, the patentee had had more than fourteen months to respond to the informant's evidence.
In my view the present circumstances are different from those in the Dynamic Data case because the present matter relates to only a three-month extension; this is significantly different from the extended periods involved in the Dynamic Data case.
Re the issue of the reasons given for the extension of time, I note that this is the patentee's first application for an extension of time to file its evidence-in-response. In my experience with these matters it is often the practice of parties applying for such extensions to provide reasons and explanation somewhat in proportion to the total period of time extended or sought to be extended, taking into account all previous extensions. It would be appropriate for example for a third application for an extension of a typically minimal period of say three months, or for any application for an extended period of more than three months, to be accompanied by a relatively comprehensive statement of reasons, compared with a first application for a minimal extension. This is to be expected since longer extensions naturally lead to more delay in the proceedings.
However, notwithstanding the above, it is clear from the Ferocem decision that there is no requirement for a "full and frank disclosure" of all the reasons for the extension. At the hearing Mr Roberts provided some further details of progress made in the preparation of the patentee's evidence, but, although relevant, this extra information is not a factor which would determine my decision one way or the other. In the present circumstances I am satisfied that the reasons given in the patentee's application for extension are sufficient.
In the Goninian case a determination of the nature of the evidence to be adduced could have been made because at least some of the evidence had already been served in anticipation of the extension of time being allowed. In the present case the patentee has yet to file any evidence, so it is difficult for me to determine the nature of its evidence. It is of some significance however that we are at the evidence-in-response stage of the proceedings; the informant has already served its evidence and it is clear from the nature and amount of that evidence that we have a "serious opposition" ie. serious objection to the extension of term of the petty patents. (A determination of the nature of the evidence would be more significant if the matter related to evidence-in-support because at that stage no evidence has been adduced and the possibility of a frivolous opposition or objection would still exist).
Given the amount of and technical complexity of the evidence already on file, it seems likely that the patentee's evidence will be an important factor in the proceedings, so I am inclined to resolve this matter in the public interest that the matter of the validity of the petty patents be determined on its merits: ie. this is a factor in favour of allowing the extension of time.
In my view, the matter of further delay is not a particularly important issue at this stage in the present circumstances. The informant has suggested that delay in the proceedings will delay the introduction of its product into the marketplace; but it did not respond to the patentee's allegation that the main delaying factor is lack of marketing approval for its product. Also, the patentee has argued that delay will affect it at least as much as it affects the informant, there is no indication that any third parties are involved, and “expeditious disposal” of the matter by the Patent Office is hardly affected by one 3‑month extension. I conclude then that neither party is affected significantly more than the other by delay at this stage and that there is minimal public interest in this matter.
Taking all the circumstances into account, I am reasonably satisfied that the 3-month extension of time from 13 March 2001 to 13 June 2001 is appropriate. I therefore grant the extension of time.
COSTS
At the hearing Mr Rajkovic emphasised that Synthon's objection to the extension of time was based on the reasons given for the extension at the time of application, and that if I found that the extension was justified taking account of additional information brought up at the hearing then his client should not be adversely affected by any award of costs. I have considered this matter and decided, as indicated above, that the information disclosed at the hearing relating to the patentee's progress in preparing its evidence was not a determinative factor in my decision.
Therefore, following the usual practice of costs following the event, I award costs against the informant Synthon B.V.
John Welsh
Delegate of the Commissioner of Patents
Patent attorneys for the patentee: Davies Collison Cave, Melbourne.
Patent attorneys for the informant: Baldwin Shelston Waters, Sydney.
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