Cook Incorporated v Endo Vascular Technologies Inc
[1999] APO 14
•24 February 1999
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 669338 in the name of COOK INCORPORATED
Title: Expandable Transluminal Graft Prosthesis for Repair of Aneurysm and Method for Implanting
Action: An application by Endo Vascular Technologies Inc. for an extension of time under Regulation 5.10(2) to serve evidence-in-reply and objection thereto by Cook Incorporated
Decision: Issued
Abstract
The opponent has encountered significant and unusual circumstances in relation to securing expert witnesses which have contributed to the delay in preparing and serving their evidence-in-reply. These circumstances arose as a consequence of the relatively small number of potential witnesses. Additionally, expert witnesses were unavailable to give evidence due to a potential conflict of interest as a result of them using or being associated with the use of technology produced by the applicant company. These are significant considerations which have directly impacted upon the opponents’ capacity to retain an expert witness in relation to the evidence-in-reply.
The opponent has made out a proper case justifying the extension. The interests of the opponent and the public both weigh heavily towards the grant of the extension.
The opponent has a draft declaration which should be served by the extended date.
Extension granted, the time for Endo Vascular Technologies Inc. to serve evidence-in-reply is extended from 12 December 1998 to 12 March 1999.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 669338 by Cook Incorporated, an application by Endo Vascular Technologies Inc. for an extension of time under Regulation 5.10(2) to serve evidence-in-reply and objection thereto by Cook Incorporated.
BACKGROUND
Patent application 27353/92 in the name of Cook Incorporated (Cook) was filed on 28 October 1992. The application was advertised accepted on 6 June 1996 as 669338.
Endo Vascular Technologies Inc. (Endo Vascular) filed a notice of opposition to the grant of the patent on 5 September 1996 followed by service of Statement of Grounds and Particulars on 5 December 1996.
Service of evidence-in-support of the opposition was completed on 12 September 1997 following the grant of three extensions totalling 7 months which were all unopposed. Service of evidence-in-answer was completed on 11 March 1998 following the grant of one extension of time which was unopposed.
On 12 June 1998 Endo Vascular made a first application for an extension of time to serve evidence-in-reply, from 12 June 1998 to 12 September 1998. The information provided in support of the extension cited difficulties in contacting Mr Michael Denton, a practising surgeon and the opponent’s principal witness, as the reason for the extension. There was also an indication that Mr Denton had telephoned the opponent’s attorney and left a message that he would not be able to provide further evidence in the matter. The extension was allowed with no objection.
Endo Vascular made a second application for an extension of time to serve evidence-in-reply on 11 September 1998 for the period 12 September 1998 to 12 December 1998. The circumstances upon which this extension application was made were: Firstly, the evidence-in-answer raised many issues to be addressed in the evidence-in-reply. Secondly, Mr Denton advised that he was no longer able to take part in the opposition owing to undertakings which he had apparently given to the applicant or companies associated with the applicant. Thirdly, there are few alternative expert witnesses available. Finally, some potential witnesses had been identified and investigations as to their suitability to give evidence-in-reply were underway. Again this extension was allowed with no objection from Cook.
On 11 December 1998, Endo Vascular made a further application for an extension of time to serve evidence-in-reply for the period 12 December 1998 to 12 March 1999. Cook filed an objection to this extension of time application on 30 December 1998 and the matter was set down for hearing on 10 February 1999 in Melbourne. Cook was not represented at the hearing as they chose to file written submissions prior to the hearing. Endo Vascular was represented by Mr Geoffrey Pryor, patent attorney of Davies Collison Cave.
THE APPLICATION FOR EXTENSION OF TIME
The application for extension of time states the circumstances in which and the grounds upon which the application is made are as follows:
“A new expert witness had been identified to give evidence-in-reply but he declined to give evidence because he had recently begun using stents which originate with the applicant herein. Accordingly it has been necessary to make still further enquiries to locate suitable witnesses. This requires a good deal of time because most of the suitable witnesses are practising medical practitioners who are normally very busy and accordingly it is difficult to make contact with them, even after they have been identified. Approaches have been made to new potential expert witnesses and we are hopeful that at least one of them will be available to provide the necessary evidence. Accordingly, more time is required to finalise the evidence-in-reply.”
SUBMISSIONS
The submissions from the applicant in support of the extension being refused can be summarised as follows:
Evidence-in-reply is intended to provide the opponent with an opportunity to rebut the evidence of the applicant and not to adduce further evidence.
The opponent does not appear to be taking steps to respond to the matter presented but appears to be on a search for a new declarant to present new evidence in the evidence-in-reply.
Consideration should be given in this case to the undue delay in the opposition proceedings.
In the present case it is apparent that the opponent does not have any evidence to hand ready to lodge. There is no necessity or desirability for the Commissioner to allow even a short extension of time for the lodgement of such evidence.
At the hearing Mr Pryor for the opponent submitted a Statutory Declaration executed by himself (dated 9 February 1999) detailing some relevant actions and enquiries he has made in relation to securing new expert witnesses.
The submissions from Mr Pryor in support of the extension being granted are summarised below:
The previous history of the opposition does not have a strong bearing on the present extension. Notwithstanding the reference by the applicants to the history of the opposition proceedings, only circumstances relevant to the current extension should be considered.
The evidence sought to be adduced and served in-reply is essential to a proper resolution of the opposition.
The opponent is not seeking to adduce further evidence but solely trying to address matters which are raised in the evidence-in-answer. Most of these matters concern facts which are disputed by Mr Hartley in the evidence-in-answer for the applicant.
Given the clear conflicts in the evidence currently on file, it is in the public interest that the extension be granted and evidence-in-reply be served, since if the opponent is shut out at this stage the hearing officer in the substantive opposition will not have a basis for properly determining the questions of disputed facts.
In the normal course of events the opponent would have turned to its principle witness Mr Denton to provide evidence-in-reply. However, Mr Denton made himself unavailable to give further evidence in the opposition because he had become involved in using Cook products. This is confirmed in a letter from Mr Denton to Mr Pryor of 1 July 1998.
The opponent then contacted another potential witness, Mr Gurry, who at an earlier time indicated a willingness to give evidence in the current opposition. But in the second instance when Mr Gurry was requested to provide evidence-in-reply he declined on the basis that he had begun using the Cook stent graft and the EVT graft, which placed him in the position of a potential conflict of interest. This is confirmed in a letter from Mr Gurry to Mr Pryor of 30 November 1998.
The two points above show a situation where two prospective witnesses, one of which was the principle witness, have been precluded from giving evidence due to a possible conflict of interest related to the use of the applicant’s technology. These are unusual circumstances which have directly contributed to the delay in preparing the evidence and which support the granting of the extension.
This is a relatively small area of technology with a limited number of people who could be called upon to give evidence. The comparatively few people practising in the area are mostly senior surgeons with administrative and/or academic responsibilities. It is difficult firstly to find suitable people and secondly to get them to commit to providing evidence.
Some people in this field don’t want to get involved in any litigation as they are far too busy while others have commitments to certain manufacturers and as a result do not wish to get involved. The actions of the applicant also restricts the number of people available. The small pool of possible witnesses is another special circumstance of this case.
As indicated in the Pryor declaration, submitted at the hearing, a suitable witness has been found, Professor John Fletcher. A draft declaration has been prepared and is expected to be forwarded to Professor Fletcher in late February for finalisation with the expectation of serving the evidence by 12 March 1999 (assuming the extension is granted).
Paragraph 8.5.3 of the Manual of Practice and Procedure Volume 3 provides a list of matters to be taken into consideration when deciding on an extension such as the one sought here, with reference to decided case law. When that part of the manual is properly considered this gives support to the case of the opponent for the granting of the extension.
DECISION
Subregulation 5.10(2) states:
“The Commissioner may:
(a) on the application of a party in the approved form; and
(b) on such reasonable terms (if any) as the Commissioner specifies;
extend the time within which the party may take a step prescribed in this chapter,
not being a step that is taken under regulation 5.3 or paragraph 5.4(1)(a).”
Subregulation 5.10(5) qualifies the operation of subregulation 5.10(2) by, inter alia, stipulating that the Commissioner must not grant an extension application under subregulation (2) unless the Commissioner:
“gives the parties a reasonable opportunity to make representations; and
is reasonably satisfied that the extension of time is appropriate in all the circumstances.”
The law on extension of time provisions, and specifically the law on Regulation 5.10, has been considered and summarised by Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) 28 IPR 243 and more recently by Sackville J in A Goninan & Co Ltd v Commissioner of Patents (1997) 38 IPR 213. Both of these decisions indicate that regulation 5.10 confers a broad discretion, which cannot be reduced to an imperative compliance with particular requirements. On the contrary, it is necessary to give proper, genuine and realistic consideration to all relevant aspects of the case.
Before allowing an extension I must consider whether the person seeking the extension has made out a proper case justifying the extension. I also have to consider the private interests of the parties concerned and also the public interest by ensuring that valid patents are not granted and that proceedings are not unreasonably protracted.
a) Has a proper case justifying the extension been made out?
From the information and submissions before me it is apparent that:
The evidence-in-answer by Mr Hartley for the applicant clearly contests matters of fact in the evidence-in-support of the current opposition;
Mr Gurry the second potential witness confirmed in November 1998 that he would be unavailable to provide evidence-in-reply in the current matter due to a possible conflict of interest with applicant company;
The field of the invention is such that the number of possible witnesses is small and that for various reasons it is difficult to contact, and/or secure the services of, potential witnesses;
The number of potential witnesses in the current matter is also made smaller by the possibility of conflicts of interest arising for the witnesses with the applicant company or for that matter with other such companies.
It is not unusual in opposition proceedings for there to be facts which are disputed between evidence-in-support and evidence-in-answer. However, in my opinion the opponent has encountered significant and unusual circumstances in relation to securing expert witnesses which have contributed to the delay in preparing and serving their evidence-in-reply. These circumstances arose as a consequence of the relatively small number of potential witnesses. The difficulties associated with contacting and securing the services of these individuals is also a relevant consideration in the present matter.
There is also the situation wherein the opponents principal witness, Mr Denton, and subsequently Mr Gurry were unavailable to give evidence-in-reply due to a potential conflict of interest as a result of them using or being associated with the use of technology produced by the applicant company. This is a particularly significant consideration which has directly impacted upon the opponents’ capacity to retain an expert witness in relation to the evidence-in-reply.
As to the notion that the opponent is seeking to adduce “new” evidence Mr Pryor emphatically submitted that the opponent is seeking to adduce evidence which solely addresses the issues raised in the evidence-in-answer and is not seeking to adduce further evidence. In the absence of information to the contrary I can only conclude that the opponent is seeking to adduce evidence which would properly be considered in-reply.
In relation to the state of preparation of evidence-in-reply, the submissions and the statutory declaration of Mr Pryor indicate that a suitable declarant has been found and that a draft declaration has been prepared with an expectation of it being served by 12 March 1999 (the date sought in the current extension).
As to submissions from the applicant, I agree that evidence-in-reply is intended to provide an opportunity to rebut the evidence-in-answer and not to adduce further evidence. However, there is nothing before me from either side to suggest that the applicant is seeking to adduce further evidence, in the sense that the term “further evidence” is used in opposition proceedings. There are matters of fact contested as between the evidence-in-support and the evidence-in-answer and from the submissions of Mr Pryor the opponent is seeking to gather evidence to deal solely with the contested issues.
Further I can see no logical connection between the applicant’s submission that the opponent is seeking a new declarant in order to present new evidence in the evidence-in-reply. I take the word “new” in the applicant’s submission to mean that the evidence is further evidence which would not properly be regarded as evidence-in-reply. However, the fact that the declarant is new does not correlate with proposition that the evidence it will provide will be “new” in the sense that it is not properly evidence-in-reply.
The opponent will clearly need to procure the services of a new declarant as Mr Denton, who provided evidence-in-support of the opposition, is now unavailable. I imagine that the evidence will be new in two respects. Firstly, in the normal course of events I would not expect the evidence to repeat that already adduced in support, although it may concur with some of the assertions of the evidence-in-support. Secondly, I expect the evidence to be new in the sense that it seeks to address issues raised in the evidence-in-answer, which as indicated by the applicant is the purpose of evidence-in-reply. Other than these two issues I can see nothing which would support the contention that the evidence sought to be adduced by the opponent is new in the sense that it is not properly evidence-in-reply.
I am mindful of the applicant’s submission that I should give due consideration to the undue delay of the opposition proceedings, however, this is one consideration and is not in my opinion the overriding one in the present matter. Given the small pool of individuals from which the opponent can possibly draw potential witnesses it would appear that the opponent has moved with reasonable diligence to secure the services of a new declarant. I will further discuss the issue of undue delay under the heading of the public interest below.
On balance, I believe that the opponent has made out a proper case to justify the granting of the extension, in all the circumstances.
b) The interests of the parties.
The interests of the applicant, Cook, are clearly in not having the opposition proceedings unduly delay the grant of the patent. I am unaware of any other special circumstances which would specifically disadvantage the applicant if the present extension were granted.
Clearly the interests of the opponent, Endo Vascular, are in obtaining the extension in order that it may have the opportunity to serve evidence-in-reply in the opposition. The facts of the case clearly indicate that the opponent’s case would be seriously prejudiced if I were to refuse the extension and preclude it from adducing evidence to address the matters contested in the evidence-in-answer.
c) The public interest.
There are disputed matters of fact as between the evidence-in-support of the opposition and the evidence-in-answer. I believe the public interest, in so far as it relates to ensuring that invalid patents are not granted, weighs heavily towards the granting of the extension sought by the opponents. This is in order that the delegate of the Commissioner in hearing the substantive opposition, with appropriate evidence-in-reply, has a more legitimate basis upon which to decide the disputed matters of fact.
On the other hand, granting the extension sought would provide some further delay in the final resolution of the current matter. However, I am mindful of the words of Kitto J in Kaiser Aluminium & Chemical v The Reynolds Metal Company (1969) 120 CLR 136 at 143 that a serious opposition should be dealt with on its merits rather than be shut out as a consequence of a failure in procedure.
The opponent has provided sufficient information explaining the delays in preparing and serving evidence-in-reply. It is also apparent to me that a serious opposition to the grant of the patent is in train. As a result, I think the need for the opposition to be properly decided in relation to the disputed facts in the current matter outweighs any prejudice to the public at large as a result of the further delay.
On balance, I believe the public interest favours the granting of the extension.
CONCLUSION
The opponent has made out a proper case justifying the extension. The interests of the opponent and the public both weigh heavily towards the grant of the extension. The opponent has a draft declaration which should be served by the extended date. I believe the extension is appropriate in all the circumstances.
I grant the opponent Endo Vascular Technologies Inc. an extension of time from 12 December 1998 to 12 March 1999 to serve its evidence-in-reply.
COSTS
In actions before the Commissioner costs normally follow the event; consequently, I award costs against the applicant, Cook Incorporated.
V. J. Portelli
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Collison & Co, Adelaide
Patent attorneys for the opponent : Davies Collison Cave, Melbourne
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