The Kennedy Institute of Rheumatology v Amgen Inc - [2003] APO 55

OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 719015 in the name of THE KENNEDY INSTITUTE OF RHEUMATOLOGY

Title: Anti-TNF Antibodies and Methotrexate in the Treatment of Autoimmune Disease

Action: Application by The Kennedy Institute of Rheumatology for an extension of time under Regulation 5.10(2) to serve evidence in answer and objection thereto by Amgen Inc.

Decision: Issued 15 December 2003
Abstract

Kennedy had already been granted extensions of time for service of evidence in answer totalling 15 months. No evidence at all had been served when the application for the latest extension was made on 20 October 2003, despite Kennedy having earlier indicating its intention to complete its evidence by the end of October 2003. Amgen objected to the latest application for extension. One day before the hearing on that objection, Kennedy filed two declarations as part evidence in answer, from Dr Muirden and Mr Power. Kennedy indicated that a further declaration is still to be filed which will address a very specific issue not completely dealt with by Dr Muirden.
It was found that the Muirden declaration is highly likely to be important in determining the outcome of these opposition proceedings. Although Kennedy's explanation for the delay in serving this evidence is less than satisfactory, it was determined that Kennedy would be seriously disadvantaged if it was not able to rely on this declaration, being its main evidence in answer to the evidence in support. The Power declaration is of limited value but provides some background information and it too has already been served. As a result, an extension of time to 1 December 2003 for the service of the Muirden and Power declarations, was granted
It was determined that, while the explanation for its delay also is not satisfactory, the remaining declaration is again likely to be significant. In view of the impending Christmas break and on the understanding that the declaration would be served as soon as it is finalised, an extension of time to serve the third and final declaration was granted until 19 January 2004.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re: Patent Application No. 719015 in the name of The Kennedy Institute of Rheumatology and an application under Regulation 5.10(2) for an extension of time to serve evidence in answer and objection thereto by Amgen Inc.
BACKGROUND
Patent application 719015 (37035/97) in the name of The Kennedy Institute of Rheumatology (Kennedy) on 1 August 1997 was filed as PCT/GB97/02058 based on application US 08/690775 with an earliest priority date of 1 August 1996. The application was advertised accepted on 4 May 2000 and a notice of opposition filed by Amgen Inc.(Amgen) on 4 August 2000. The statement of grounds and particulars was served on 3 November 2000 and an amended statement of grounds and particulars served on 14 November 2001. The evidence in support was completed on 19 April 2002, after 7 extensions of time, totalling 15 months.
Kennedy applied for and was granted 5 extensions of time to serve evidence in answer, from 19 July 2002 to 19 October 2003 (15 months in total). Amgen objected to the latest of these but the objection was withdrawn prior to hearing. On 20 October 2003, Kennedy filed a further request for an extension of time to serve evidence in answer, for 3 months from 19 October 2003 to 19 January 2004. Amgen formally objected to the extension and the matter was heard in Canberra on Tuesday 2 December 2003. Kennedy was represented by phone by Ms Sophie Goddard of Counsel. Amgen did not appear at the hearing but filed written submissions by their Patent Attorney, Mr Martin O'Sullivan of Wray & Associates, Perth.
RELEVANT LAW
Regulation 5.8(2) determines that the time for serving evidence in answer is within 3 months after service of the evidence in support. Regulation 5.10(2) allows the Commissioner to extend the time for the service of evidence:
(a) on the application of a party in the approved form; and
(b) on such reasonable terms (if any) as the Commissioner specifies; and
(c) after the party has served a copy of the application on the other party.
This is to be read in conjunction with Regulation 5.10(5) which states that:
The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:
(a) if he or she proposes to grant an application by a party — is reasonably satisfied that the other party has been notified of the application; and
(b) if he or she proposes to act on his or her own motion — ensures that the parties are notified of the proposed action; and
(c) in either case:
(i) gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii) is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances.
The Federal Court has considered the requirements of regulation 5.10 in Ferocem Pty Limited v. Commissioner of Patents (1994) 28 IPR 243, A Goninan and Co Ltd v Commissioner of Patents and Another (1997) 38 IPR 213, and National Starch & Chemical Company v Commissioner of Patents (2001) 50 IPR 398. The principles arising from these decisions have been set out and followed in numerous patent office decisions relating to regulation 5.10, and were summarised by the Delegate of the Commissioner in Boral Resources (NSW) Pty Limited v BST Holdings Pty Limited [2003] APO 46 (30 October 2003) as follows:
(a)The broad discretion afforded by Regulation 5.10 cannot be reduced to insistence on imperative compliance with particular requirements;
(b)The exercise of this discretionary power requires proper, genuine and realistic consideration of all the relevant aspects that pertain to the application;
(c)The provision of a satisfactory explanation of the delay is a relevant consideration, but is not mandatory;
(d)The public interest in determining a serious opposition on its merits is a relevant consideration and must be balanced with the requirement that matters before the patent office should be dealt with in an efficient, orderly manner and not be unduly prolonged;
(e)The interests of the opponent, the applicant and any other parties are a relevant consideration.
In summary, it is clear from these decisions that the Commissioner, having given both parties the opportunity to make representations, has the discretion to grant an extension but only if she is reasonably satisfied that the extension is appropriate in all the circumstances.
DECISION
The nature and significance of the evidence
At the time of filing the application for extension of time, no evidence in answer had been served. However, on 1 December 2003, one day before the hearing, Kennedy served on Amgen part evidence in answer comprising two statutory declarations. These are a declaration by Kenneth D Muirden dated 28 November 2003, along with Exhibits KDM-1 and KDM-2, and a declaration by Paul Anthony Power (patent attorney) dated 1 December 2003.
Ms Goddard submitted at the hearing that the Muirden declaration is Kennedy's main declaration in answer to the case brought against it by Amgen. Dr Muirden is a rheumatologist and Kennedy submit that his evidence goes to objections concerning the prior art, common general knowledge and section 40 matters. Ms Goddard further stressed the importance of this declaration which she submitted addresses the evidence of Dr Portek and Professor Wakefield in evidence in support as well as the prior art publications annexed to Mr O'Sullivan's declaration. I note that the Muirden declaration clearly comments in detail on the evidence from both Dr Portek and Professor Wakefield.
Mr Power's declaration sets out the chronology of the opposition and gives some further details concerning the application for extension of time. In this declaration, Mr Power indicates that Kennedy intend to serve a further declaration in the very near future. This further declaration is said to be from a second expert witness on a limited issue, namely addressing assertions made in Amgen's evidence concerning certain statistical conclusions relating to the synergy between methotrexate and cA2. In particular Kennedy wish to address certain allegations made by Amgen's declarants that the data and examples in the opposed specification "do not support the assertion that patients on combination therapy were more likely to respond than those on mono-therapy because differences in sample groups were not statistically significant". Ms Goddard indicated that only one further declaration is to be served and that it would be served as soon as it is completed. However, because of the Christmas period, Kennedy is seeking the full extension of time requested until 19 January 2004.
It seems to me that the Muirden declaration is highly significant. It is detailed and relevant to the case Kennedy has to answer in these proceedings. It is also of considerable importance to Kennedy's case, being the main declaration in answer. Mr Power's declaration is essentially of relevance only to the application for extension of time and in foreshadowing the further declaration still to be finalised.
The impact of the third declaration is more difficult to assess. I have not been provided with a copy of the declaration from the further expert, as this is not yet ready to be served. Neither has the name of this declarant been supplied. Nevertheless, it seems to me from the information provided by Ms Goddard and Mr Power that this declaration is to be limited to answering issues concerned with whether the opposed specification has demonstrated synergy between methotrexate and cA2. I note that both Dr Portek and Professor Wakefield raise this issue in their respective declarations. It seems from Ms Goddard's submissions at the hearing that, while Dr Muirden addresses this to some extent, at some stage more recently Kennedy became aware that this point had not been fully dealt with by him.
Nevertheless, it is not clear to me what grounds of opposition will be addressed by this further declaration. I note here that utility is not a ground of opposition under section 59. However, the issue of synergy formed a significant part of the evidence in support and Kennedy should be given the chance to address this. I also accept that it is possible that this could well be relevant to certain valid grounds of opposition, such as full description or inventive step. Thus, I will conclude that the further declaration is likely to be of significance to these proceedings.
Explanation of the delay
Kennedy has already been granted 5 extensions of time, totalling 15 months, in which to serve their evidence in answer. From the application for extension dated 22 April 2003, it seems that Kennedy were already in possession of a draft declaration from its Australian expert witness at that time. The previous application for extension dated 21 July 2003 requested an extension of time of 3 months from 19 July 2003 to 19 October 2003. However, that application gives very little indication that any progress had been made in finalising the evidence and merely points to difficulties in arranging a time for a tele-conference that was suitable for all parties. Amgen filed an objection to this application which was later withdrawn, apparently on the basis of a letter from Kennedy to Amgen's Australian attorneys dated 9 September 2003. This letter conveyed Kennedy's intentions to make every effort to complete its evidence by the end of October 2003.
Nevertheless, no evidence was served within that time period and a further application for extension of time, the subject of this hearing, was filed on 20 October 2003. This gives the following reasons for the extension being required:
"We are still examining the draft declaration by our first expert witness and intend contacting our Australian attorneys shortly regarding it.
In previous correspondence with the opponent's attorneys (dated 9 September 2003) we mentioned that we would be making every effort do (sic) submit all evidence (i.e. Dr Muirden's declaration and possible other declarations) by the end of October 2003. Since this date is outside of the period of the extension already applied for, we have instructed our Australian attorneys to apply for a further extension which encompasses this date."
In Mr O'Sullivan's written submissions he strongly criticises Kennedy for not providing adequate justification for the request for extension of time. He contended that there has been undue delay in service of evidence and that no satisfactory explanation for the delay has been provided. In his view, there appears to have been no real progress made in preparing evidence in answer since Kennedy received the draft declaration more than 7 months ago. Mr O'Sullivan further submitted that the application for extension fails to provide any details to support an extension beyond the end of October 2003.
I note that the reasons given by Kennedy for the delay in serving evidence in answer seem to be merely that it took a long time to brief their expert and for him to complete his assessment and comments on Amgen's evidence. The reasons given for the latest extension are very scant indeed although Ms Goddard stated that the service of the Muirden declaration shows that Kennedy has made a serious and concerted effort to complete its evidence in answer. However, Mr Power points out in his declaration that Kennedy are located in London and all correspondence from Kennedy goes through their overseas attorneys in New York. As stated also by Ms Goddard, "this causes practical, including time-related impediments to the efficient preparation of the necessary materials".
The issue of global communication was considered by the Delegate in Eleven Lighting Pty Limited v Interium Pty Ltd [2002] APO 25 (27 June 2002):
"Mr Evans submitted that communications infrastructure globally and particularly between the USA and Australia should not hinder the presentation of evidence from a party. He particularly noted the availability of telephone, mobile telephone, electronic mail, messaging services, facsimile, mail and courier. In this respect Mr Evans referred to the Coflexip v Stolt Comex Seaway A/S decision, [1995] APO 58. In that case the hearing officer noted the availability of modern communications infrastructure of the type exemplified above to reject pleadings that the location of prospective declarants overseas justified the need for an extension of time. Mr Evans further noted that Eleven Lighting has not provided any explanation as to why such communication mechanisms were unavailable to the inventor."
In the present case, I am not convinced by Kennedy's arguments on the communication difficulties and I have not been provided with details of any unusual circumstances to explain why these should cause this long delay, when modern communication channels allow very rapid transmittal of information.
Ms Goddard further submitted that the opposed application concerns fairly complex technology which itself can justify extensions of time to serve evidence. She noted that Amgen appear to have experienced similar difficulties in preparing their evidence in support. Amgen were granted extensions of time totalling 15 months, only 3 months less than Kennedy is now requesting, and for the same sorts of reasons.
I note that the provision of a satisfactory explanation of the delay is a relevant consideration, but is not mandatory. Kennedy has provided an explanation for the delay although this explanation does not go into much detail and does not give any specific explanation as to why their evidence was not served before the end of October 2003. It would normally be expected that parties should be able to serve their evidence within this length of time, even for applications involving complex technology, unless there are exceptional circumstances. Kennedy has not brought to my attention any unforeseen or unusual circumstances that prevented its evidence being served within the time already allowed.
I note that Kennedy has now served the bulk of its evidence in answer, the Muirden and Power declarations. At some stage during the preparation of the evidence it was recognised by Kennedy that Dr Muirden's declaration did not fully address the statistical conclusions made by Amgen on the synergy issue and that a further declaration was needed. However, Ms Goddard was not able to detail when this was recognised or provide any further explanation on this point. I note however that Kennedy apparently was in possession of a draft of the Muirden declaration by April 2003.
Thus on balance, I am not convinced that Kennedy has provided a satisfactory explanation of all the circumstances surrounding the delay in service of the Muirden and Power declarations already served or the outstanding declaration from the further expert.
The interest of the parties
It is clearly in the interests of Kennedy for the extension to be granted. In my view, its case would be severely compromised if the Muirden declaration (and possibly also the further declaration) was not admitted into these proceedings. It seems that there is a serious opposition in train and Kennedy would be disadvantaged by not being able to rely on their evidence to counter the case brought against it by Amgen. On the other hand, Amgen submit that it is in its interests for the opposition to proceed in an expeditious manner. Furthermore, Kennedy gave a very strong indication in their letter of 9 September 2003 that its evidence would be finalised by the end of October. Thus, Amgen would have had that expectation. However, Amgen has not indicated any other way that the granting of this extension would unduly prejudice it and the main evidence in answer has now been served with only one declaration remaining outstanding. I also note that Amgen was itself granted 15 months extension of time to serve evidence in support.
The public interest
It is clear that the public interest lies in having a serious opposition determined on its merits. It is also in the public interest that opposition proceedings are dealt with in an orderly manner without undue delay. In the present case, I believe the public interest will be served by allowing both parties to have the opportunity to serve their evidence, provided there are no further significant delays. I do not think that it is in the public interest for the opposition to be dealt with in the absence of the evidence from Kennedy in view of the fact that the substantial part of its evidence has now been served.
CONCLUSION
I believe that the Muirden declaration is highly likely to be important in determining the outcome of these opposition proceedings. Although Kennedy's explanation for the delay in serving this evidence is less than satisfactory, I am of the view that Kennedy would be seriously disadvantaged if it was not able to rely on this declaration, being its main evidence in answer to the evidence in support. Although the public interest and the interest of Amgen lie in the opposition proceedings being dealt with in a timely manner, the evidence has already been served on Amgen and so this does not result in the opposition being unduly protracted. The Power declaration is of limited value but provides some background information and it too has already been served. As a result, I allow the extension of time to 1 December 2003 for the service of the Muirden and Power declarations, the date on which they were served on Amgen.
I have determined above that, while the explanation for its delay is not satisfactory, the remaining declaration is also likely to be significant. I understand that this declaration is primarily concerned with addressing the single issue of synergy outlined above which is raised by two of the declarants in the evidence in support. In view of the impending Christmas break and on the understanding that the declaration is to be served as soon as it is finalised, I do not believe that allowing this extension would unduly protract proceedings. Thus, I also grant an extension of time for the third and final declaration to be served until 19 January 2004.
COSTS

Both parties submitted that costs should follow the event. I see no reason to depart from this and accordingly award costs against the opponent, Amgen.
ADDENDUM
It has come to my attention that my decision dated 15 December 2003 did not accurately reflect my full consideration on the issue of costs. At paragraph 28 the decision states that "both parties submitted that costs should follow the event". However, I acknowledge that Mr O'Sullivan's written submissions requested consideration of the awarding of costs against Kennedy even in the event of the extension being granted, due to the failure of Kennedy to provide justification for the delays in preparing the evidence.
These submissions from Mr O'Sullivan were taken into account in coming to my decision on the award of costs. Although I found that Kennedy's explanation for the delay in serving its evidence was less than satisfactory, on balance I believe that it is appropriate to make an award of costs against Amgen on the basis of the other factors taken into consideration.
Dr Gillian Jenkins
Delegate of the Commissioner of Patents
15 December 2003
Patent attorneys for the applicant : Spruson & Ferguson, Sydney
Patent attorneys for the opponent : Wray & Associates, Perth