Human Genome Sciences, Inc v Ludwig Institute for Cancer Research

[2002] APO 5

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No. 696764 in the name of HUMAN GENOME SCIENCES, INC

Title:          Vascular Endothelial Growth Factor 2

Action:          Application under Reg. 5.10(2) for an extension of time to serve evidence in reply by LUDWIG INSTITUTE FOR CANCER RESEARCH and objections thereto by HUMAN GENOME SCIENCES INC.

Decision:          Issued            .

Abstract

An extension of time was granted from 15 September to 15 December 2001 in order for Ludwig to serve evidence in reply.

The reasons provided by Ludwig on their application supported the request for an extension of time.  The public interest that the opposition be considered on its merits and the interest of Ludwig outweigh the interests of HGS in this instance.  A relevant consideration was that the evidence in question has been served in the period that Ludwig sought the extension of time for, and that the evidence appears relevant to the opposition.  In addition, the evidence was accompanied by a statement that evidence in reply is now complete.  In the awarding of costs, I took into account that although Ludwig has provided much more detail in this third application, on why the extension is needed, this application was the first to explicitly indicate that experts, other than Dr Alitalo, will be serving evidence in reply, even though it now appears the opponent has always intended to serve evidence from these experts.  Having considered all these factors, I have not made an award of costs, so each party must bear it's own costs.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 696764 by Human Genome Sciences Inc, application for an extension of time to serve evidence in reply by Ludwig Institute for Cancer Research and objection thereto by Human Genome Sciences Inc.

BACKGROUND

Patent application 73941/94 (696764) by Human Genome Sciences (HGS) was advertised as accepted on 17 September 1998.  Ludwig Institute for Cancer Research (Ludwig) filed a notice of opposition on 17 December 1998, followed by a statement of grounds and particulars on 17 March 1999.  Evidence in support and evidence in answer were each completed after a number of extensions were granted.  Ludwig Institute filed notice of intention to serve evidence in reply on 15 January 2001.  Ludwig applied for and was granted a 3 month extension of time.  When Ludwig applied for a second 3 month extension of time up to September 2001, the application was opposed by HGS.  A hearing took place before the Commissioner on 17 July 2001.  The Commissioner issued a decision allowing the requested extension of time.  On 17 September Ludwig filed an application for a further 3 month extension of time.  This was opposed by HGS and a hearing was held in Canberra on 9 November 2001.  Ludwig was represented at the hearing by Mr Chistopher Ward of counsel and by Dr Andrew Blattman of Spruson and Ferguson, Sydney.  HGS was represented by Ms Katrina Howard of counsel assisted by Mr Christian Dimitriacis also of counsel, who appeared by telephone.

THE APPLICATION FOR AN EXTENSION OF TIME

Ludwig's application provides some detail on the progress made in serving evidence in reply.  In addition, the following reasons are provided there to explain the delay in completing evidence in reply:

1. Time is needed to prepare statutory declarations by Professor Peter Rogers and Dr John Ballard which will form part of the evidence in reply.  The completion of these declarations has been delayed by the time needed to prepare the evidence of Professor Alitalo and also because Professor Rogers was on leave for the period 31 August to 10 September 2001.

1. Dr John McCann the senior Australian Patent attorney responsible for the opposition case suffered a serious and unexpected illness on 30 July 2001.  As a result of this illness, Dr McCann has been unable to assist in the preparation of evidence from that date.  Dr Andrew Blattman has needed to become sufficiently familiar with the issues of the matter to assume Dr McCann's role.

1. It is the opponent's intention to have each of the declarations reviewed and settled by counsel.  Although the declarations of Professor Rogers and Dr Ballard have progressed to an advanced stage counsel will not be available until around the middle of October due to prior commitments.

1. Preparation of the evidence in reply has been delayed by the substantial amendments proposed by the applicant for the opposed application.  There are two sets of amendments currently before the Patent Office being the applicant's third and fourth statements of proposed amendments.  The third statement of amendments was received by the opponent's attorney's on 19 July 2001.  The fourth statement of amendments was received by the opponent's attorney's on 9 August 2001.  Consideration of these proposed amendments has required time that would otherwise have been used for preparation of the evidence in reply.

1. Terrorist activities in New York on 11 September 2001 led to difficulties in maintaining contact with the US attorneys.  David Gass of the firm Marshall, Gerstein and Borun was evacuated from his Office in Chicago, immediately after the terrorist activities and advised not to return until the following day.  In addition Ludwig has a central office in New York and communications with the New York Office were disrupted by the terrorist event.

EVIDENCE FILED IN SUPPORT OF THE APPLICATION BY LUDWIG

1. Statutory Declaration dated 8 November 2001 by Dr Andrew Blattman.

1. Statutory Declaration dated 8 November 2001 by Martin O'Brien together with exhibit MOB-1.  (Exhibit MOB-1 was a transcript of the hearing on the previous application for an extension of time.)

THE EVIDENCE THAT LUDWIG SEEKS TO SERVE

The current extension of time was requested to allow the following evidence to be filed:

1. Evidence from Professor Rogers.  This evidence was subsequently served on 14 December 2001.

1. Evidence from Dr Ballard.  This evidence was subsequently served on 14 December 2001, with advice from Ludwig that the serving of this evidence completes their evidence in reply.

SUBMISSIONS

Both parties provided me with written submissions as well as making further oral submissions at the hearing. I will refer to these submissions where relevant in the body of the decision.

THE LAW ON EXTENSIONS OF TIME UNDER REGULATION 5.10

The period provided for serving evidence in reply of an opposition is three months from the date of serving evidence in answer.  An extension of time may be obtained under regulation 5.10:

(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 ... grant an application under subregulation (2) ... unless the Commissioner:
...
(c) ...
(i) gives the parties a reasonable opportunity to make representations concerning the application...; and
(ii) is reasonably satisfied that ... an extension of time or the serving of further evidence is appropriate in all the circumstances.

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 and Goldberg J in National Starch & Chemical Company v Commissioner of Patents (2001) 50 IPR 398. In all of these decisions it was stated 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) Explanations on any delays in filing evidence.
The reasons why the evidence was not served in time are a relevant consideration, but a satisfactory explanation is not a mandatory requirement.

(b) 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.

(c) The interests of the parties involved in the opposition
Disadvantages to either the applicant or opponent are relevant considerations.

DECISION

Issues relating to the conduct of Ludwig prior to this hearing

Prior to the current application, Ludwig has already had two extensions of time granted so that they could serve evidence in reply. 
The first application for an extension was granted unopposed, but the second application was opposed and a hearing was held on 17 July 2001.  HGS argued at the current hearing, that during the previous hearing, Ludwig gave the hearing officer an undertaking that they would complete evidence in reply during the requested extension of time.  In response to this allegation, Ludwig denied giving an undertaking and further argues that in any case there were unforeseen circumstances that affected the progress of evidence in reply.  Ludwig supported their argument with a transcript of the previous hearing (exhibit MOB-1) and the declaration of Dr Andrew Blattman, dated 8 November 2001 which detailed progress in filing evidence in reply.

Having read Ludwig's submissions for, and the transcript of, the earlier hearing, I cannot find any thing to suggest that Ludwig gave an undertaking to complete evidence in reply during the requested extension.  The most relevant part of the transcript appears to be a point where the hearing officer asked whether Ludwig expected to complete evidence in reply within the time they have requested.  In reply, Chris Ward, present as counsel representing Ludwig, then stated:

"My instructions are that there is, at present, nothing foreseeable that will prevent evidence in reply being filed by that date.  I simply cannot take it further than that.  That is the present intention."

I do not consider this reply to be a formal undertaking.  The decision on that hearing has already issued as Human Genome Sciences, Inc v Ludwig Institute for Cancer Research [2001] APO 38. I have read the issued decision and I observe the hearing officer does refer to an "undertaking" given by Ludwig that evidence in reply would be completed by 15 September 2001. This occurs, while summing up a section on the interests of the parties, when the hearing officer states:

"On balance, taking into account the fact that Professor Alitalo's experiment are now complete, and the undertaking made by Ludwig that evidence in reply would be completed by 15 September 2001, I believe the interests of Ludwig in having the opportunity to present evidence in reply, particularly to the criticisms of the evidence of Professor Alitalo, outweighs the interests of HGS in this instance. I am mindful that I should give due consideration to the undue delay of the substantive opposition. However, this is just one consideration, and is not, in my opinion, the overriding one in the present circumstance." (the bolding is mine)

In looking at the part of the decision that the hearing officer has summarised, I note that the word "undertaking" is not used:

"At the hearing Mr Ward also informed me that, barring unforeseen circumstances, the evidence in reply would be completed by 15 September 2001."

At the end of the decision, the hearing officer gives a summary of his reasons for granting an extension of time.  This summary covers the reasons given by Ludwig, the interests of the parties and the public interest that was taken into account in forming the decision.  After covering all these issues without referring to an undertaking being given, the hearing officer then states:

"Consequently, I am reasonably satisfied that an extension of time is appropriate in all of the circumstances. I therefore allow the extension of time for the period requested, that is, from 15 June 2001 to 15 September 2001. Furthermore, since the experiments have now been completed, I expect Ludwig to proceed expeditiously with the preparation of its evidence in reply. I also expect that, if unforeseen circumstances necessitate a further extension being requested, Ludwig will provide full reasons to justify such an extension."

Having considered the evidence before me, I find no evidence that Ludwig gave an undertaking to the hearing officer to complete evidence in answer at the hearing.  Having read the decision issued by the hearing officer, I do not consider that the decision to grant the application for an extension, was predicated on the expectation that evidence in reply would be completed during the time sought, but rather it was based on weighing up other factors.  On my reading of the decision, I consider that the word "undertaking" was used in an informal or loose sense to convey the idea that Ludwig was making serious efforts to progress the opposition and complete evidence in reply within the period of time over which the extension was sought.

In any case, I accept that unforeseen circumstances did arise, in particular the sickness of Dr McCann which occurred several weeks after the hearing, and that this led to evidence in reply not being served in time.  This is discussed in more detail, when I consider Ludwig's explanation for delays in serving their evidence.

Another issue raised by the opponent, concerns the past conduct of Ludwig in these proceedings, including during the earlier hearing,  Prior to the current application for an extension of time, Ludwig is described as, not having informed HGS, either in submissions at the hearing or in the two earlier applications for an extension of time, that there was evidence being prepared by Professor Rogers and Dr Ballard.  Yet, the current application for an extension of time plainly indicates that these experts were involved in the preparation of evidence in reply as early as February 2001.  This is confirmed in the declaration by Dr Blattman, dated 8 November 2001, in which he states:

"Pursuant to the preparation of the declarations by Professor Rogers and Dr Ballard, copies of all of the declarations and exhibits were sent to Professor Rogers and Dr Ballard on 5 February 2001.

In addition to addressing the comments of the Applicant's which are directed at the applicants earlier declarations, the Evidence in Reply declarations by Professor Rogers and Dr Ballard include substantial commentary on the results of Professor Alitalo's second series of experiments.  By necessity, therefore, the preparation of the Rogers and Ballard declarations has been delayed by the preparation of the Alitalo declaration.  In that regard, a copy of Professor Alitalo's draft declaration was forwarded to each of Professor Rogers and Dr Ballard on 13 August 2001 for their consideration."

HGS asserts that Ludwig has not provided a full and frank disclosure to the Commissioner of all reasons for the previous extension of time application.  These allegations raise questions about the conduct of Ludwig during evidence in reply and whether the Commissioner was misled by Ludwig during the previous hearing.  The past conduct of a party, is of course, a relevant consideration when assessing whether to grant an extension of time. 

The previous application does briefly refer to the fact that the evidence in answer had been sent to all the experts engaged by the opponent, although only Professor Alitalo is specifically identified:

"All of the aforementioned declarations and annexures have forwarded to the scientific experts which the opponent has engaged for assistance in this matter.  That material has been reviewed and substantial progress has been made toward the preparation of a draft response to the issues raised by the HGS evidence"

….Professor Alitalo's laboratory has designed experiments, made constructs, and made substantial progress in obtaining results which will address the criticisms raised in the Evidence in Answer.  This work is in progress.

….In the light of the above circumstances we request a three month extension of time within which to complete the experiments, assess and summarize the results, for further consideration to be given to the other issues raised by the Evidence in Answer and for the declarations that will form the Evidence in Reply to be completed, executed and served."

The experts are described as 'assisting' so it is not clear what their role is and the term "draft response" might suggest that there is only one expert is providing a substantial document for the evidence in reply.  On the other hand the declaration refers to "the declarations that will form the Evidence in Reply" and this may well indicate that experts other than Professor Alitalo will be preparing evidence in reply.

For the previous hearing on Ludwig's second application for an extension of time, Ludwig presented a declaration from Dr McCann dated 17 July 2001, that provided more detail and more up to date information on the evidence being prepared.

In this declaration, Dr McCann states:

"Copies of the evidence in Answer have been provided to three scientific experts for their review, which will assist in the preparation of Evidence in Reply.

……I also understand from Mr Gass that in addition to the experimental work conducted in the laboratory of Professor Alitalo, a substantial draft of the Evidence in Reply has been prepared.  By 14 June 2001 the draft was approximately thirty pages in length (single spaced), and the draft was being developed and revised to present the response in the context of Professor Alitalo's work and in an organised fashion.

In the event that the Delegate grants the extension of time to 15 September 2001 for which the opponent has applied, I have been advised by Mr Gass that at least part of the Evidence in reply will be served on or before that date."

Again, I do not think Dr McCann's evidence makes clear whether all three experts are presenting evidence in reply or whether one expert is preparing the draft response and the others are providing comments to assist.  However I do not interpret the documents as deliberately misleading.  The hearing officer in the earlier hearing, discusses the earlier application and the declaration of Dr McCann without referring to any experts other than Professor Alitalo, but this may simply reflect the fact that he considered the work of Dr Alitalo to be the most important for the purposes of making his decision.  I find no reasons to conclude that the delegate of the Commissioner was either deliberately or accidentally misled by Ludwig.  However I do think that there is an indication of a lack of due care in the detail provided by Ludwig and the manner in which it was presented.  I do think there was some departure from the ideal of a "full and frank disclosure" of the relevant facts in the earlier applications for an extension of time and the evidence put before the delegate of the Commissioner during the earlier hearing.  HGS has argued that insufficient disclosure by Ludwig of the reasons for delays in the evidence has led to HGS objecting to the application for an extension of time.  I do not consider the circumstances are so serious, in the manner suggested by HGS, as to have a major impact on the decision of whether to grant an extension of time, but I think they have a bearing on the issues concerning the awarding of costs.

Explanation for delay in serving evidence

This third application for an extension of time to serve evidence in reply, was for the purpose of serving evidence from Professor Rogers and Dr Ballard.  The evidence prepared by each expert, was described in the application as consisting in part of evidence that will respond to criticisms directed in the evidence in answer to the original experimental work of Professor Alitalo and in part, evidence that responds to the further experimental work of Professor Alitalo that forms part of the evidence in reply.  Because a portion of their evidence relied upon Professor Alitalo's further experimental work, Ludwig argued that the serving of the evidence of Professor Rogers and Dr Ballard was held up, "by necessity", until after they were able to obtain and consider the evidence of Professor Alitalo.

The evidence of Dr Blattman and the application for an extension of time suggests the following chronology of progress in serving evidence in reply:

5 Feb 2001Professor Rogers and Dr Ballard receive copies of the evidence in answer for the preparation of declarations as part of evidence in response

15 JuneApplication by Ludwig for a 2^nd three month extension of time to serve evidence in reply

17 July  Experimental work by Professor Alitalo completed

13-28 AugSuccessive drafts of the Alitalo declaration sent to Professor Rogers & Dr Ballard for them to review 

3 SeptAfter receipt of comments from Dr Ballard on the Alitalo declaration, a draft declaration was prepared for Dr Ballard and forwarded onto him for further consideration

30 Aug An early draft of material for Professor Rogers declaration concerning Professor Alitalo's experimental work is received by Spruson & Ferguson

31 Aug - 10 Sept        Professor Rogers was on leave and unable to progress work on his declaration

12-13 SeptProfessor Rogers provides further comments and a revised draft declaration was then prepared and forwarded onto Professor Rogers for his consideration

17 Sept  The Alitalo declaration and accompanying exhibits were served

17 Sept +Finalisation of the draft declarations of Professor Rogers and Dr Ballard delayed as Counsel unavailable from about this date until 11 October (Mr Ward) or 15 October (Mr Lyons)

17 SeptSecond extension of time expires and an application for a third extension of time to serve evidence in reply filed

HGS has put forward a number of reasons as to why I should find that there was unnecessary delay in serving some evidence.  Firstly, I need to note that a proportion of the evidence of Professor Rogers and Dr Ballard is described as being concerned with answering criticisms made during evidence in answer of their earlier evidence and the initial experimental work of Professor Alitalo performed during evidence in support.  Professor Rogers and Dr Ballard were provided with the copies of the evidence in answer in February 2001, some seven months before the expiry of the second extension.  Except for some comments about the evidence in answer being poorly organised and repetitive, there is no suggestion of any difficulties, prior to the middle of July 2001, that could be responsible for delay in progressing, finalising and serving this evidence in reply. 

In the absence of more information, I conclude that the delay probably arose, because Ludwig wished to wait until they obtained the results of the further experimental work being carried out by Professor Alitalo.  Counsel for Ludwig at the hearing argued that it would not have been appropriate to provide the evidence in a piecemeal fashion.  In the decision on Ludwig's second application for an extension to serve evidence in reply, the delegate considered a similar issue with Professor Alitalo's work.  He found that it was appropriate for Professor Alitalo to first complete the second round of experimental work and serve all evidence in the context of that work, rather than splitting the evidence, and serving evidence directed at rebutting criticisms of his earlier work at an earlier date.  I think the situation with the evidence of Dr Ballard and Professor Rogers is entirely analogous and so I think the delay is justified for the same reasons.

HGS also argued that there was inappropriate delays in the serving of that evidence from Professor Rogers and Dr Ballard that was directed at the evidence prepared and experimental work performed by Professor Alitalo during evidence in reply.  One such delay is indicated by the fact that the experimental work of Professor Alitalo was completed in 17 July 2001 but no results appear to have been forwarded on to the other experts until 13 August 2001, at which time they were sent a draft declaration of Professor Alitalo. 

Ludwig states that after completion of the experimental work, the results required analysis by Professor Alitalo.  It is therefore possible that, at 17 July 2001, the results of the experiments were not in a form so as to facilitate analysis by the other appointed experts. 
Ludwig also assert that the was a strain on their resources at around this time because on19 July 2001, Ludwig received a copy of the third statement of amendments proposed by HGS.  This may be true, but I do not think that Ludwig has provided sufficient detail to show how this caused significant delay.

On 30 July 2001, Dr McCann suffered a sudden and severe illness and could take no further part in the opposition.  Dr Blattman then had to become fully conversant with the details of the case to take over Dr McCann's role.  I have some reservations on the impact of this illness, as it might be thought that the preparation of evidence by experts, once initiated, was a basically autonomous process that needed little input from the attorney.
However I consider that, more likely than not, some active supervision was required of the progress in preparing evidence.  Dr McCann's illness would have been likely to cause delays and to hamper decision making during this period, including determining the significance of the third statement of amendments.  For all these reasons I consider that there is adequate justification for delays in filing evidence in this period.

Some days before the end of the last extension of time, the declaration of Dr Ballard and perhaps also of Professor Rogers, appear to have progressed to an advanced stage and awaited settling by counsel.  HGS argued that the declarations of Professor Rogers and Dr Ballard could have been served during the previous extension without settlement by counsel.  This may be true.  Nevertheless delay in serving evidence due to the unexpected unavailability of previously briefed legal counsel is usually viewed by the Patent Office as an appropriate delay.  In part, this is because it is desirable that experts providing evidence are advised and an effort is made to ensure that they are fully aware of their duties as an expert.  Ludwig also cites the terrorist events of September 11 as causing some delay at this time.  I think they have not provided enough information to establish, in my mind, a causal link between the events in New York and the delay in filing evidence in Australia.

HGS also argued that the defence, made my Ludwig, that failure to serve completed declarations from Professor Rogers and Dr Ballard due to Counsel being unavailable is not an appropriate justification because the evidence should have been being prepared according to a timetable that took into account when counsel would be unavailable.  I do not think counsel's availability is always predictable, as it is not infrequent for them to be involved with court cases that are unexpectedly protracted.  The preparation of evidence by Professor Rogers and Dr Ballard on the more recent experimental work of Professor Alitalo, appears to have largely occurred in the final month of the previous extension.  I think it is likely that the sickness of Dr McCann delayed the preparation of evidence and that this delay may have led to Ludwig missing the window of opportunity to have the evidence finalised by counsel.

Overall, I consider Ludwig has provided a satisfactory explanation of why evidence in reply was not completed during the last extension of time.

The public interest

It was noted by Burchett J in the Ferocem case (supra) and reiterated by Sackville J in Goninan (supra) that the public interests are not all ranged on the same side.  On the one hand is 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 (supra), viz a serious opposition should be dealt with on its merits rather than be shut out as a consequence of a failure in procedure.

HGS argued that nothing in Ludwig's application for an extension of time addresses questions about the "significance of that evidence" and that no explanation had been provided as to how such evidence could assist the Commissioner in the determination of the case.  I think this is not quite correct, the nature of the evidence is described in the application and some idea of its significance can be obtained from that.  Ludwig's application identifies the evidence being prepared by Professor Rogers and Dr Ballard as responding to the criticisms of their earlier evidence made during evidence in answer and providing a consideration of, and commentary on, the results of Professor Alitalo's second series of experiments.  The evidence from Dr Ballard is described as comprising 54 pages as of 3 September 2001 and the evidence of Professor Rogers was described as comprising 84 pages at 13 September 2001, so it appeared to be a substantial body of evidence.

HGS argued that the evidence from Dr Ballard and Professor Rogers concerning Professor Alitalo's experiments appeared not to be evidence in reply and accordingly should be given little weight in the decision on whether an extension is granted.  Counsel for Ludwig appeared to concede at the hearing that this evidence was not evidence in reply but argued that it was appropriate evidence for the Commissioner to consider.  In several recent decisions of this Office, including that of The Government of the United States of America as represented by the Secretary, Department of Human Services and Health v University of Queensland and CSL Ltd [2001] APO 51, the delegate of the Commissioner, has taken the view that the relevance of the outstanding evidence to the proceedings is the key issue and not whether it is strictly evidence in reply. This approach appears in line with the views expressed by Sackville J in Goninan (supra):

"In order for the Commissioner or his delegate to give proper, genuine and realistic consideration to the aspect of public interest I have identified, it is necessary to consider the nature of the evidence the opponent seeks to adduce and the significance of that evidence for the opposition proceedings. I do not mean to suggest that the evidence has to be scrutinised in the same way as would occur at a hearing on the merits. But unless the delegate forms a view as to the issues addressed by the proposed evidence, and whether that evidence is likely to be important in the opposition proceedings, it is difficult to see how proper consideration can be given to the public interest in having such proceedings being determined on its merits."

In this case, the evidence of Ballard and Rogers has now been served, and I can form a preliminary view of the nature of the evidence with confidence.  The majority of the declaratory evidence put forward by these experts appears concerned with refuting criticisms, made during evidence in answer, of the evidence filed during evidence in support.  This portion of the evidence appears to be clearly evidence in reply.  The bulk of the evidence is clearly properly evidence in reply and thus prima facie relevant to having the opposition determined on its merits.  A minor portion of the evidence is concerned with commenting on the results obtained and methodology used by Professor Alitalo in the experimental work performed during evidence in reply.  The significance of this latter evidence is best assessed by considering it in the light of some of the issues on which the substantive opposition is based.

I think for the purposes of discussing the relevance and potential significance of this evidence, it will suffice to consider ground 4 of the statement of grounds and particulars, which asserts that the invention is not fully described.  The issue arises because the opposed specification contains claims directed at VEGF2 polypeptides and methods of preparing them.  Key arguments from Ludwig, appear to be that VEGF2 cannot be expressed and secreted using the methods taught in the opposed application, and that the alleged VEGF2 mRNA in the opposed application is misidentified.  I have briefly looked at the evidence and I consider it appears to consider this particular issue in detail.

In the evidence in support, Professor Alitalo provided evidence of experimental work which, he claimed, showed that VEGF2 can not be expressed and secreted in the manner taught in the opposed application.  Professor Ballard and Dr Rogers commented in this work as part of the evidence in support filed in this opposition.  During evidence in answer, HGS provided evidence from experts that disagreed with the conclusions of Professor Ballard and Dr Rogers and criticised the manner in which Professor Alitalo conducted his experimental work.  In evidence in reply Professor Alitalo conducted further experimental work in an effort to obviate the criticisms made.

Professor Alitalo's initial and subsequent experimental work appears to be most relevant and potentially significant in deciding issues relating to full description.  The views of other experts such as Professor Rogers and Dr Ballard on the standing of the evidence, relating to both the early and the later experiments, would appear to be relevant and of potential significance in assessing the merits of the opposition.  Furthermore, I am aware that as Professor Rogers (at least) is an Australian based expert, while Professor Alitalo is based in Finland, Professor Rogers evidence may be important in this opposition for assessing the state of the art and the common general knowledge in Australia. 

For all these reasons, I think that there is a public interest in allowing the requested extension of time in order that the opposition can be decided on its merits.

As the evidence of Professor Rogers and Dr Ballard has now been served and evidence in reply completed within the period for which the extension is sought, it does not appear to me that the granting of this extension of time need prevent the expeditious disposal of matters in the Patent Office.

The interests of the parties

Ludwig stated that they have a legitimate interest in opposing the grant of the patent, and that they have conducted the proceedings in an expeditious and timely manner in view of the complexity and technical nature of the case.  Refusing the extension of time would prejudice them and might prevent them from having considered at the substantive opposition, evidence that is properly directed to the issues of the case.  Ludwig stated that the conduct of HGS to date reflects an awareness of the complexity and significance of the opposition, and they will not be disadvantaged by the extension.

Clearly the interests of Ludwig are in obtaining the extension in order to serve its evidence in reply.  It is my opinion that the evidence in question is relevant and of potential significance.  I think it is reasonable to conclude that Ludwig's interests would be prejudiced if I were to refuse the extension of time covering the period in which the evidence of Professor Rogers and Dr Ballard was served.

I believe the interests of HGS are clearly disadvantaged in having the extension of time granted so that the evidence can be included in the opposition.  However, while HGS say they will be disadvantaged, HGS did not provide any evidence or describe any circumstances that indicates that they would be especially disadvantaged, if the present extension were granted.  Ludwig has stated that the serving of evidence in reply has now been concluded, and I have been given no reason to assume that the granting of the requested extension will cause undue protraction in the opposition proceedings.

On balance, I believe the interests of Ludwig in having the opportunity to present the remaining evidence in reply, outweighs the interests of HGS in this instance.

CONCLUSION

I find that the reasons advanced by Ludwig, as set out in their application for an extension of time, and the declaration of Dr Blattman, make out a proper case for an extension of time.  The evidence from Professor Rogers and Dr Ballard appears relevant and significant, and it appears in both the public interest and the interest of Ludwig that the evidence be considered in the substantive opposition.  Although it is not in the interests of HGS that an extension of time be granted, it appears that their main concern was that the opposition proceedings were being protracted.  Since evidence in reply is now complete, granting of an extension of time for the inclusion of this evidence need not cause any further delay.  All though some concerns have been raised by HGS on the conduct of the opposition, in particular, the lack of prior information provided by Ludwig on the preparation of evidence in reply by Professor Rogers and Dr Ballard, I do not consider that the facts in this instance are so serious as to have a major bearing on the question of whether the current application for an extension of time be granted.

Consequently, I am reasonably satisfied that an extension of time is appropriate in all of the circumstances. I therefore allow the extension of time for the period requested, that is, from 15 September 2001 to 15 December 2001.

COSTS

The power to award costs is based on section 210 and regulation 22.8.  The normal practice is that costs should follow the event if no other circumstances require consideration.  In the hearing on the previous application for an extension of time, the delegate of the Commissioner found that a relevant issue in the question of costs was the lack of information provided by Ludwig in their application for an extension of time.  I consider that, in their current application, Ludwig provided far more detail of the evidence yet to be served, the progress being made and the reasons for the delay.  HGS was therefore much better informed on this occasion when they chose to object to the extension of time. 

Nevertheless, I also take into account, the fact that prior to this 3^rd application for an extension of time, Ludwig had not clearly indicated that experts other than Dr Alitalo were going to provide evidence and that evidence in reply may be held up for this reason. 

I do not think there is any evidence that Ludwig had the intention to mislead.  However, I think that Ludwig's past applications and submissions, indicate a lack of due care on their part, as they did not clearly disclose either HGS or the Commissioner, what expert evidence they intended to prepare and serve.  For this reason I consider that Ludwig's prior disclosures in their applications and the previous hearing have departed significantly from the ideal of a "full and frank disclosure".

The current request for an extension of time to allow the serving of evidence from Dr Ballard and Professor Rogers, does not appear to have been expected by HGS.  I think that their apparent surprise is reasonable, considering the information that Ludwig has provided to date.  Overall, having considered all these circumstances, I think that it is appropriate not to award costs to either  party.

I therefore direct that each party bear their own costs.

Delegate of the Commissioner of Patents

Patent attorneys for the applicant  : Wray & Associates, Perth

Patent attorneys for the opponent   :  Spruson & Ferguson, Sydney