Wyeth v the Kennedy Institute of Rheumatology - [2010] APO 20

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Wyeth v The Kennedy Institute of Rheumatology [2010] APO 20

Patent Application: 2003264629

Title:Anti-TNF antibodies and methotrexate in the treatment of autoimmune disease

Patent Applicant:  The Kennedy Institute of Rheumatology
Opponent:  Wyeth
Delegate:  Dr S.D.Barker
Decision Date:  21 September 2010
Hearing Date:  Written submissions filed on 11 August 2010
Catchwords:  PATENTS – extension of time to serve evidence in answer – explanation of delay considered – waiting for decision of EPO does not represent a satisfactory explanation – delay in finalising declaration of expert – evidence has been completed – extension allowed

Representation: Patent applicant: F B Rice & Co
Opponent:Jones Day

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2003264629

Title:Anti-TNF antibodies and methotrexate in the treatment of autoimmune disease

Patent Applicant: The Kennedy Institute of Rheumatology
Date of Decision: 21 September 2010
DECISION
Extension of time until 2 September 2010 allowed
The time period under regulation 5.8(4)(a) runs from the date of this decision.
Costs awarded against Wyeth.
REASONS FOR DECISION

Patent application 2003264629 in the name of The Kennedy Institute of Rheumatology (hereafter referred to as the Institute) was filed on 1 December 2003 as a divisional of 51825/00. The application was advertised accepted on 5 April 2007, and a notice of opposition was filed by Wyeth on 5 April 2007.
A statement of grounds and particulars was served on 5 October 2007. Evidence in support was completed on 5 November 2008. The time for serving evidence in answer has been extended until 5 July 2010. Partial evidence in answer was filed on 5 July 2010, along with an application to further extend the time until 5 October 2010. Wyeth formally objected to the extension, and the matter was set for hearing on the basis of written submissions. Written submissions by both parties were filed on 11 August 2010.
The reasons for the extension of time are stated to be as follows:
Applicant has today served part of the evidence in answer to the Statutory Declaration of Leslie Glen Cleland (the Cleland Declaration). The evidence served to date constitutes part of the applicant’s reply dated May 18 2007 to allegations of lack of inventive step by Wyeth in an opposition to grant of a related application in Europe i.e. EP 0914157. This includes a copy of a Statutory Declaration by Dr Paul Andrew Cope made on May 17 2007 and annexures referred to therein, and redacted submissions by the applicant dated May 18 2007 that are pertinent to the instant opposition proceedings.
Additional time is requested in which to prepare the balance of the applicant’s evidence in answer in these proceedings, pending development or resolution of the opposition by Wyeth to the grant of European Patent No EP 0914157 on similar grounds to those alleged by Wyeth in these opposition proceedings. For example, in both the European and Australian opposition proceedings, the opponent asserts lack of inventive step in the subject matter claimed by the applicant for near-identical reasons. The applicant filed their reply in the EPO on May 17 2007, and the partial evidence in support served on the opponent today adduced that part of the European evidence in reply to the Cleland Declaration. Proceeding on this basis, we submit that the outcome of the European opposition following an Oral Hearing of that matter is highly relevant and of probative value to the instant opposition proceedings before IP Australia. We also submit that it is in the public interest to await the outcome of the European opposition proceedings inter alia on the issue of inventive step of subject matter claimed. The additional time requested by the applicant in these proceedings will, if granted, provide greater efficiency and shorten the Australian proceedings relative to the time and expense incurred if the Applicant is required to settle all evidence in answer at the present time. In this respect, the parties to the European opposition proceedings filed their submissions in January this year, and are now awaiting the matter to be set down for an Oral Hearing before the EPO. It is anticipated that, since nearly six months have already elapsed since the parties finalized their evidence in Europe, the EPO will at least advise a hearing date within the period expiring October 5, 2010. Once a hearing date is set down by the EPO, it would be expected that a written decision would issue shortly thereafter. We respectfully submit that the additional time sought in these proceedings is appropriate in the circumstances, because the date on which the European opposition matter is finally heard is largely beyond the control of the applicant at this stage of those proceedings.
We also advise that Paul Andrew Cope is now available to provide original evidence in answer to the Cleland Declaration on behalf of the applicant and, if permitted, such further evidence on behalf of the applicant as necessary in these proceedings pending the decision of the EPO in the corresponding matter in Europe. The additional time requested will also permit the applicant an opportunity to prepare a Statutory Declaration by Paul Andrew Cope as original evidence in answer to the Cleland Declaration.
I note that evidence that is the subject of this dispute was completed on 2 September 2010. This evidence consists of a declaration by Mark Olive served on 11 August 2010, and a declaration of Andrew Cope served on 2 September 2010.
The law on extensions of time
The time for serving evidence can be extended under subregulation 5.10(2) of the Patents Regulation 1991 which provides that:
(2) The Commissioner may 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 5.3AA, paragraph 5.4(a), subparagraph 5.8(1)(a)(i) or regulation 5.9A):
(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.
The above provision must be read in conjunction with subregulation 5.10(5) which provides that:
(5) 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 evidence is appropriate in all the circumstances.
Consequently, it is a prerequisite to any decision that the Commissioner must ensure that the other party has been notified, and that both parties have had the opportunity to make representations. In the present case the other party has been notified, and both parties have been given the opportunity to make representations.
An extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate. In exercising this discretion, I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; (2001) AIPC 91-697, 50 IPR 398. These decisions establish that:
a)The power is discretionary: Regulation 5.10 confers a broad discretion, which cannot be reduced to imperative compliance with particular requirements. It is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem at AIPC 38, 208; IPR 247-8, Goninan at AIPC 39, 434; IPR 220)
b)Explanation of delay: The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement. (Ferocem at AIPC 38, 207-8; IPR 247)
c)The public interest: The public interest in determining a serious opposition on its merits is a relevant consideration. (Goninan at AIPC 39, 435-6; IPR 222)
·    In order to do this, it is necessary for the Commissioner to form a view as to the nature of the evidence that it is sought to adduce, and the significance of that evidence for the opposition proceedings. (Goninan at AIPC 39, 438; IPR 225-6)
·    The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself. (National Starch at [33])
·    The public interest is not protected merely because some evidence has already been served. (Goninan at AIPC 39, 438; IPR 225)
d)The interests of the parties: The interests of the party seeking the exercise of discretion are a relevant consideration. (Ferocem at AIPC 38, 208; IPR 247). It is also relevant to consider the disadvantage to the other party of delays in determining the opposition, and the effect of delays on the efficient and orderly administration of the Patent Office. (Ferocem at AIPC 38, 208; IPR 247, Goninan at AIPC 39, 436; IPR 222).
Explanation of the delay
The reasons for the delay appear to be two-fold. First, time is needed to complete the declaration of Dr Cope. Second, the applicant is waiting for a decision to issue from the EPO. Considering the first reason, it is apparent from the file that Dr Cope’s evidence was not commenced earlier because previous extensions had been achieved on the basis of the second point. Viewed in this context, the delay is understandable.
I need to say something about the second reason for the delay. I can see no reason why evidence in answer cannot be completed before the decision of the EPO issues. The decision of the EPO will not constitute evidence that is relevant to this opposition. The decision of the EPO may highlight deficiencies in the applicant’s case (or the opponent’s case), and indicate that further evidence is needed. However, that can be addressed through further evidence (by either party). There may be efficiencies to the parties in delaying the hearing of the present opposition until after the EPO has made a decision, but that is different to extending the time for service of evidence in answer. I believe that the European opposition does not represent a reason that supports the extension of time.
Wyeth’s objection largely focussed on the EPO proceedings, which I agree are not relevant. However, I am satisfied that there has been a satisfactory explanation of the delay based on the completion of the Cope declaration.
The public interest
The public interest in opposition proceedings calls for a consideration of the nature and significance of the evidence that is being prepared. In this case, the key is the Cope declaration. A copy of the Cope declaration was received by the Patent Office on 7 September 2010, so I have been able to inspect the evidence. It is apparent that he discusses the state of combination therapy for rheumatoid arthritis prior to August 1996, and the adjunctive therapy described in the present application, amongst other matters. It seems clear that this evidence could be significant in the opposition, at least with regard to the ground of inventive step. Consequently the public interest favours the extension of time.
The interests of the various parties
As is normal, the parties appear to have opposing and largely offsetting interests. Wyeth has an interest in the extension not being allowed, and the Institute has an interest in the Cope declaration being available as part of the opposition. As the evidence has now been served, there will no further delay, and thus inconvenience, to Wyeth. The interests of the Patent Office are in the orderly processing of oppositions. The present extension represents only a minor inconvenience.
Balance of Considerations
I have been provided with a satisfactory explanation of the delay, and the public interest favours allowing the extension. I note that the evidence has now been served, so no further delay will arise from allowing the extension. I am satisfied that the extension should be allowed.
Conclusion
I grant an extension of time for serving evidence in answer until 2 September 2010 to validate the evidence that has been served. The time for evidence in reply specified in regulation 5.8(4)(a) shall run from the date of this decision.
Costs
Costs normally follow the event. In the present case, The Institute has been successful. I see no reason depart from the normal approach. I award costs according to Schedule 8 against Wyeth.
Dr S.D.Barker
Delegate of the Commissioner of Patents