IOWA STATE UNIVERSITY RESEARCH FOUNDATION, INC Et Al
[1998] APO 61
•30 October 1998
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 672825 in the name of Iowa State University Research Foundation, Inc et al
Title: Vaccines Inducing an Immune Response Against Viruses Causing Porcine Respiratory and Reproductive Diseases
Action: Application for an extension of time to serve evidence in answer and an application for deferral of evidence in answer by Iowa State University Research Foundation, Inc et al and opposition by Boehringer Ingelheim GMBH.
Decision: Issued.
Abstract
The applicant has not justified their application for an extension of time or their application for deferral of evidence in answer with appropriate submissions or facts relating to progress in preparation of evidence in answer. The applicant had filed two requests to amend the claims of the accepted specification. The first set of amendments appeared to be trivial. It was not clear that the second set of proposed amendments were trivial and they appeared to function to at least clarify the scope of the claims. However these amendments in themselves provided no adequate reason why these amendments should delay the preparation and serving of evidence in answer. The application for an extension of time and the application for a deferral of evidence in answer were both refused. However an extension has been granted under regulation 5.10 (2) for the serving of any evidence in answer that the applicant has in hand.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application 672825 by Iowa State University Research Foundation, Inc et al, an application for an extension of time to file evidence in answer and an application to defer evidence in answer by Iowa State University Research Foundation, inc ET AL and objection thereto by Boehringer Ingelheim Gmbh.
background
Patent application 672825 in the name of Iowa State University Research Foundation Inc and Solway Animal Health Inc (hereinafter referred to as Iowa) was advertised as accepted on 17 October 1996. Boehringer Ingelheim Gmbh (herein after referred to as Boehringer) filed a notice of opposition on 17 January 1997 and served a statement of grounds and particulars on 17 April 1997.
Boehringer completed evidence in support on 17 December 1997 after having obtained two extensions of time. An amended statement of grounds and particulars was also served on 17 December 1997.
Evidence in answer was due to be completed on 17 June 1998 after one unopposed extension of time was given to Iowa. On 27 March 1998, Iowa filed amendments under S.104 and applied to the Commissioner to issue a direction pursuant to regulation 5.10(1) of the Patents Act with the effect of postponing the date for filing evidence in answer until the outcome of the request to amend had been determined. The delegate of the Commissioner responded to the applicant on 24 June 1998 advising that a direction under regulation 5.10 (1) would be inappropriate in the circumstances.
On 17 June 1998, Iowa applied for a second extension of time ending 17 September 1998 within which to serve evidence in answer. This extension of time application was opposed by Boehringer.
On 17 September 1998, Iowa filed an application for a further extension of time for the period 17 September to 17 December within which to serve evidence in answer.
Iowa filed a second application to amend the opposed application on 6 July 1998 and indicated that they wished to apply to the Commissioner for a direction under regulation 5.10(1). Again the direction being sought was the postponement of evidence in answer until the outcome of the proposed amendments had been determined.
A hearing on both the application for an extension of time (for the period of 17 June to 17 September) and the application to defer evidence in answer took place in Canberra on 29 July 1998. Boehringer was represented by Dr Peter Stearne, patent attorney of Davies Collison Cave. Dr Peter Stearne appeared by telephone. Iowa was represented by Jill Newton of Spruson and Ferguson who did not appear in person, but sent in written submissions.
The application for extension of time
The application for the extension of time states:
"The circumstances in which, and the grounds upon which this application is made are as follows:
As foreshadowed in our application for an extension of time dated 17 March 1998, the applicant has now applied to amend the opposed application.
A request to amend the application was proposed on 26 March 1998.
Clearly the allowability of these amendments and the Commissioner's decision as to whether to permit these amendments will impact on the case to be addressed and accordingly the nature of the Evidence-in-Answer required to be filed in these opposition proceedings.
We therefore respectfully submit that it is not appropriate to file or further prepare our Evidence-in-Answer until such time as the issue concerning the amendments has been resolved."
Decision
With the application for an extension of time filed 17 June 1998 the applicant has applied to obtain the following:
(i) An extension of time of three months from 17 June to 17 September within which to serve evidence-in-answer. This application for an extension is made under reg. 5.10(2)
(ii) A deferral of the requirement to file or prepare evidence-in-answer until after the issue of the amendments has been resolved.
As the application refers both to "the allowability of these amendments and the Commissioner's decision on whether to permit these amendments" it is clear to me that the applicant is seeking a direction for a deferment of evidence in answer until after the amendments have been advertised and finally allowed. This type of direction is sometimes described informally as a direction to "stop the clock". The application for this direction is considered under reg. 5.10(1)(a).
The law on extensions of time under regulation 5.10
The time for serving evidence-in-answer of an opposition is three months from the date of serving evidence in support under regulation 5.8. This time may be extended under regulation 5.10:
(1) The Commissioner may, on his or her own motion or on the application of a party:
(a) give a direction that is not inconsistent with the Act or these Regulations for the
conduct of proceedings to which this Chapter applies; or
….
(2) 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).
Regulation 5.10(5) provides:
(5) The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) ... unless the Commissioner:
...
(c) ...(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………. is appropriate in all the circumstances.
Regulation 5.10(a) requires that any direction given by the Commissioner under this regulation is consistent with the Patents Act and Patent Regulations. The applicant, in this case, seeks a direction under regulation 5.10(1)(a) to defer the requirement to file or prepare evidence-in-answer until after the proposed amendments have been allowed or otherwise disposed of. The effect of this direction is to extend the period of evidence in answer, and so guidance on the appropriate considerations in giving such a direction can be obtained from the body of law on extensions of time. The law on extension of time provisions, and specifically the law on reg. 5.10 of the Patents Regulations 1991, 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. I consider the approach outlined in these decisions is applicable to the question of deferring the period in which to serve evidence as well as to extending the period to serve evidence. 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. Relevant aspects include:
(a)Reasons provided to justify the extension.
Relevant reasons include explanations on any delays in filing evidence to date.
The reasons why the evidence was not served in time are a relevant consideration, but a satisfactory explanation is not a mandatory requirement. However, the power to grant an extension is discretionary and so there needs to be present such facts or circumstances that will enliven the discretion.
(b) The interests of the parties involved in the opposition
Disadvantages to either the applicant or opponent are relevant considerations.
(c)The public interest
The public interest in determining a serious opposition on its merits is a relevant consideration. There is also the efficient and orderly administration of matters before the Patent Office to consider.
Reasons provided for an extension of time and for the deferral of evidence in answer
Extensions have been granted to the opponent.
The applicant submitted that the opponent had an uncontested 8 months in which to prepare and serve the whole of its evidence in support over and above the 3 months allowed for preparing its statement of grounds and particulars. The extension of time to 17 September 1998 would if granted provide the applicant with a total of 9 months (only one month in excess of that required by the opponent) in which to serve its evidence rather than the 6 months currently allowed.
I consider the fact that the opponent has successfully obtained several extensions of time to serve evidence gives a context for assessing the effect of granting a further extension of time to the applicant on the opposition process but does not otherwise provide an argument for granting an extension.
Difficulties in locating experts
The applicant also submitted that it has experienced difficulties in locating suitable experts to provide evidence in this case particularly as it appears there is no one in Australia with significant expertise to be qualified as an expert in the relevant field, namely in respect of the PRRS virus. They consider there appears to be no laboratory conducting research on the PRRS virus in Australia.
It is difficult for me to assess the anticipated role of expert witnesses in the applicant’s case and the problems arising from not locating any experts. No information has been provided about the nature of the evidence sought and the progress made trying to obtain it. It is common ground between the applicant and the opponent that the porcine respiratory and reproductive virus, on which this opposition centres, does not exist in Australia. Therefore it is not surprising that the applicant reports a dearth of Australian experts and research on this virus. This finding of fact should not have taken 6 months to discover. I do not see that any extension of time can result in Australian experts being found if none exist.
Furthermore as there is no requirement under the Australian Patents Act for any experts in an opposition case to be Australian, the applicant's submissions do not explain why overseas experts cannot provide evidence for the applicant. The evidence of overseas experts working on the same problems or in the same field as that described in the opposed patent application is generally relevant, although it may have differing import on some issues to evidence from experts in Australia. I would expect that the applicant should at the very least have ready access to the inventors on whose work this opposed application is based. Bearing in mind that no progress appears to have been made, I do not think that the submissions on difficulties in obtaining expert witnesses provide an adequate justification for an extension of time to file evidence. Nor do these reasons justify deferment of the period in which to file evidence in answer.
The effect of proposed amendments
The applicant has further submitted that more time is needed pending the outcome of amendments proposed on 27 March 1998 and 6 July 1998. The patent regulations set prescribed periods for the opponent to provide comment and for the advertised amendments to be opposed. The effect of these prescribed periods is that the amendments filed on 6 July 1998, could not be finally allowed until over 5 months after being served on the opponent. This means the outcome or resolution of the amendments cannot be known until at least several months after the three month extension sought by the applicant under regulation 5.10(2).
I therefore interpret the submissions on amendments to be largely arguing for the granting of such extensions and directions that will result in deferral of the period for filing evidence in answer. This view of the submissions is supported by the applicant's statement, made in both their application for an extension of time and in their letter accompanying the amendments filed 6 July 1998, that it is not appropriate to file or further prepare evidence in answer until such time as the issue concerning the amendments has been resolved.
I cannot agree in this case with the proposition expressed by the applicant that it is appropriate that no evidence in answer is prepared or filed until the proposed amendments to the claims are finally dealt with. I accept that such a course of action may be appropriate in some circumstances. However I do not consider the mere fact that amendments have been made invariably creates the circumstances that will enliven either the discretion under regulation 5.10(2) to extend evidence in answer or the discretion under regulation 5.10(1)(a) to issue a direction for deferment of evidence in answer. In my view this is the case, even if the amendments are not trivial.
The applicant has submitted that it is appropriate to allow deferral of evidence in answer until after the amendments have been allowed because of the possibility that the amendments may resolve the opposition. If I had reason to believe such an outcome was likely it would certainly strengthen the applicant's case for an extension of time or deferral. In this regard I note that the submissions do not suggest that the two parties are involved in negotiations on the form of the claims.
In assessing the likelihood that the amendments would resolve the opposition, it is pertinent to take into account the views expressed at the hearing by the attorney for the opponent on the amendments. These views suggest that the resolution of this opposition is unlikely to result from any amendments proposed so far. The first proposed amendments were dismissed as not limiting the scope of the claimed invention. This argument has not been seriously challenged in the submissions filed by the applicant. In a specific comment on the latest proposed amendments, the opposing attorney submitted that the meaning of the phrase "Iowa strain of PRRS" has already been objected to for being unclear and for not distinguishing the invention from the prior art. Therefore, in the attorney's view, including this term in the claims will not overcome the opposition. The attorney's observations are consistent with particulars provided in the statement of grounds and particulars. Of course, the opponent may change its views on this but at present I have no reason to consider it is likely that the proposed amendments including those that limit the viruses claimed to being of the Iowa strain will result in a resolution of the opposition.
In this case there has been no service of any evidence in answer and the applicant has not given any real indication that any efforts are being made to prepare such evidence. No submissions from the applicant provide any substantial argument on why uncertainty on whether the proposed amendments will be accepted should prevent the preparation and service of some or all of the evidence in answer. On the information provided, the applicant's lack of progress in preparing and serving evidence in answer displays a lack of due diligence in preparing to answer the opponent's case.
Overall I do not think that the applicant's submissions justify the need for an extension under regulation 5.10(2) or a direction to defer evidence in answer under regulation 5.10(1)(a).
Although an adequate justification is not a mandatory requirement when making an application under regulation 5.10(1)(a) or regulation 5.10(2) it is a factor that may be taken into account in the final decision.
The interests of the parties.
The applicant has submitted that the proposed amendments considerably narrow the scope of the claims by limiting the virus to the Iowa strain and this will severely impact on the case to be answered by the applicant. The opponent has submitted that the amendments filed on 27 March 1998 in no way limit the claims. The opponent concedes that the amendments filed 6 July 1998 effectively act to limit claims 1, 5 and 6 to the Iowa strain. However the opponent submits such amendments are trivial as the specification as accepted makes it clear that the claims as accepted related to the Iowa strain.
Although I do not wish to give the impression of prejudging the substantive opposition, I consider that I need to assess whether it is apparent that the change in scope due to the proposed amendments is likely to severely impact on the applicant's preparation of their case. From my (possibly superficial) reading of the specification, it appears to me that the amendments of 27 March do not substantially alter the scope of the claims. The amendments of 6 July, which limit the virus in the claims to the Iowa strain, are less easily assessed.
Claim 1 with proposed changes indicated by me in italics reads:
1. A biologically pure virus wherein said virus is the Iowa strain of the virus which causes porcine reproductive and respiratory syndrome (PRRS), wherein inoculation of five-week old colostrum-deprived, caesarean-derived pigs with 105 TCID50 of said virus results in lesions in at least 51.9% of lung tissue 10 days post infection.
Claim 1 as accepted, was limited to PRRS viruses that produce certain symptoms in a specific group of pigs. I am uncertain from my reading of the specification, whether it effectively teaches that only the Iowa strain of the virus would produce in these pigs the symptoms defined by the claim. Therefore I cannot conclude that an amendment, that limits the virus in the claims to the Iowa virus, has no significant impact on the scope of the claims.
On the other hand my brief reading of the specification did not convince me that the proposed amendments would result in a large change in scope of the claims or the nature of the invention. Even if I am wrong on this point, it is a relevant consideration that the applicant chose to amend. In such a circumstance I consider that it is reasonable to assume that the applicant should be prepared to make their case even if there was some uncertainty on whether the amendments proposed would be allowed.
The applicant has also submitted that a failure by the Commissioner to allow the extension and postpone the requirement for serving evidence, will mean the potential validity of claims wider in scope than now proposed, will be assessed at a hearing. Also that the hearing would be held in the absence of evidence filed on behalf of the applicant. Such a hearing would be without merit and neither in the public interest nor that of the applicant.
It is certainly possible that in the absence of a postponement for serving evidence in answer, the proposed amendments may not yet have been allowed at the time of the hearing. However that would not prevent the applicant from proposing to have considered any desired amendments at the substantive hearing. Perhaps the more serious concern being expressed is that the applicant’s interests could be adversely affected if they are unable to file any evidence in answer.
In considering the applicant's opportunity to file evidence in answer for the extension sought from 17 June 1998 to 17 September 1998 one fact that I take into account is that the period has passed without any evidence being served and filed by the applicant. I also note that the application under regulation 5.10(1)(a) to defer evidence in answer, would if granted, result in additional time to serve evidence in answer, as the proposed amendments have not yet been allowed.
I accept that the applicant’s interests could be adversely affected if they are not given more time to serve evidence in answer.
The interests of the opponent are disadvantaged if the period to serve evidence in answer is extended and even more if evidence in answer is deferred for an indefinite time while amendments are being finally allowed as it delays the substantive hearing. The opponent's entitlement to an expeditious hearing of their case was stated by Heerey J in F.A. Faulding & Company Ltd v Bristol-Myers Squibb Co., 40 IPR 511:
"someone who brings a legitimate, genuinely arguable claim to the Court is entitled to have that claim heard as soon as the Court can conveniently arrange it, consistently with the demands of other litigants"
It is thus in the opponent's interest for the opposition proceedings not to be unnecessarily extended.
The public interest
The applicant has also submitted that where there has not been undue delay on the applicant’s part, the need for an opposition to be determined on its merits outweighs all other factors to be taken into account by the Commissioner when using his discretion. Certainly the public interest must be taken very seriously but there is no imperative to put it ahead of all other considerations. The issues involved in assessing public interest were succinctly described by the hearing officer in an unreported decision on patent 675388, Nippon Steel Corp v. BHP Steel (JLA) Pty Ltd, issued 26 February 1998:
“On the issue of the public interest I am guided by the reasons of Burchett J in the Ferocem case and reiterated by Sackville J in Goninan (supra). In short, the public interests are not all ranged on the same side. On the one hand are the expeditious disposal of matters in the Patent Office, and questions of costs, of efficiency, and of insistence of standards being maintained. On the other hand are the words of Kitto J in Kaiser Aluminium & Chemical v The Reynolds Metal Company (1969) 120 CLR 136 at 143, viz a serious opposition should be dealt with on its merits rather than be shut out as a consequence of a failure in procedure.”
Avoiding unnecessary delays during opposition proceedings would certainly assist the expeditious disposal of matters in the Patent Office. The applicant has not provided any persuasive argument on why further delay in serving evidence in answer is justified. On the information before me I have no reason to consider that a deferment of evidence in answer would result in the applicant serving evidence in answer. On the other hand the applicant should be given a fair opportunity to prepare its case before the substantive opposition. Evidence from the applicant is just as important to the public interest as evidence from the opponent. At present the applicant has not served any evidence in answer. The competing concerns here are finely balanced.
CONCLUSION
Iowa has not made out a proper case for the need for direction to defer of evidence in answer.
It is not apparent from the submissions of the applicant or on the documents before me that the proposed amendments justify deferring evidence in answer. Although the amendments proposed with the application for leave to amend of 6 July 1998 may not be trivial this consideration is not enough in itself to enliven the discretion under regulation 5.10(1)(a) that any direction given "be appropriate in all circumstances".
Although Iowa has not provided submissions that justify its case, there is a public interest (as well as the applicant's interest) in the applicant having an opportunity to properly make its case. However in this case the applicant's past actions and present submissions give me no reason to expect that a deferment of evidence in answer would result in the applicant filing evidence in answer. In this regard it is a relevant consideration that the applicant appears to lack diligence in its preparation of evidence. Also it is not in the public interest to unnecessarily delay the opposition process. On balance I do not think the public interest favours deferring evidence in answer merely because there is a possibility that evidence in answer will be served.
Overall I do not think it appropriate in all the circumstances to issue a direction under regulation 5.10(1)(a) to defer evidence in answer until the amendments proposed on 27 March 1998 and 6 July 1998 have been allowed
The applicant has not provided any adequate justification as to why I should grant an extension of time from 17 June 1998 to 17 September 1998 in order to serve evidence in answer. I do not consider that the fact that amendments have been proposed provides justification in this case.
I also do not think that the submission that there is lack of Australian experts, justifies the extension when no information is provided why Australian experts are needed and virtually no details have been provided about the applicant's progress in this matter. On the basis of the information I have been provided with it appears to me that the applicant has not been diligent in their preparation of evidence in answer. This is also borne out by the fact that the period being sought under regulation 5.10(2) has passed without any evidence in answer being served. Given these circumstances and the public interest issues discussed above I refuse the application under regulation 5.10(2) for an extension of time from 17 June 1998 to 17 September 1998 to file evidence in answer.
The applicant had filed an application on 17 September 1998 for a further extension of time to lodge evidence in answer for the period 17 September 1998 to 17 December 1998 and so may have the expectation of having an additional period to serve evidence in answer. Taking this into account and the public interest that any evidence that the applicant has prepared up to this point, be made available for the substantive hearing, I think it is appropriate that the applicant has an opportunity to file any evidence it has to hand. Accordingly I will grant a short extension of time extending to two weeks from the date of issue of this decision for the applicant to serve any evidence in answer it has to hand.
DIrections
I grant an extension of time under regulation 5.10(2) up to two weeks from the date of issue of this decision, for Iowa to serve any evidence in answer it has in hand.
COSTS
In this case Iowa failed to obtain the extension of time to serve evidence in answer for the period 17 June 1998 to 17 September 1998 under regulation 5.10(2) or to obtain a direction under regulation 5.10(1)(a) to defer evidence in answer. I do not think they have been diligent in preparing their evidence in answer. I think it is appropriate to award costs against Iowa State University Research Foundation, Inc and Solway Animal Health Inc.
Ross Osborne
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Spruson and Ferguson
Patent attorneys for the opponent : Davies Collison Cave
2
0