Norwood Immunology Ltd v Regeneus Pt Ltd - [2012] APO 132

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Norwood Immunology Ltd v Regeneus Pt Ltd [2012] APO 132

Patent Application: 2009201915

Title:Therapeutic methods

Patent Applicant:                   Regeneus Pty Ltd
Opponent:  Norwood Immunology Ltd
Delegate:  Dr S.D.Barker
Decision Date:  14 December 2012
Hearing Date:  Written submissions completed on 19 October 2012
Catchwords:  PATENTS – application to serve further evidence – nature of the evidence suggests it could be of significance – other factors of less weight – further evidence allowed

Representation: Patent applicant: Spruson & Ferguson
Opponent:FB Rice & Co

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009201915

Title:Therapeutic methods

Patent Applicant: Regeneus Pty Ltd
Date of Decision: 14 December 2012
DECISION
I allow the service of further evidence.
The applicant has three (3) months from the date of this decision to serve responding evidence.
I award costs in accordance with Schedule 8 against the opponent.
REASONS FOR DECISION

Regeneus Pty Ltd is the applicant for patent application 2009201915. Norwood Immunology Ltd is the opponent. Evidence in reply to the opposition has been completed. The applicant has applied to serve further evidence, and the opponent has objected. The parties have been heard by way of written submissions on whether the applicant should be allowed to serve further evidence.
The law
Applications for further evidence are governed by regulation 5.10. The relevant subregulations state:
(4) The Commissioner may:
(a) on the application of a party; and
(b) on such reasonable terms (if any) as the Commissioner specifies;
permit the party to serve further evidence on the other party.
(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 further evidence is appropriate in all the circumstances.
In the present case I am satisfied that the parties have been notified, and have had an opportunity to make representations (and in fact did make representations). The question that must be considered is whether I am satisfied that it is appropriate to allow the service of the further evidence. In exercising this discretion I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398 on the operation of regulation 5.10(5) in relation to extensions of time. The general principles that flow from these decisions are as follows.
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 247-8, Goninan at 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 247)
c)The public interest:                 The public interest in determining a serious opposition on its merits is a relevant consideration. (Goninan at 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 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 225)
d)The interests of the parties:     The interests of the party seeking the exercise of discretion are a relevant consideration. (Ferocem at 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 Patents Office. (Ferocem at 247, Goninan at 222)
These considerations are equally relevant to the determination of the present request for further evidence. Previous decisions of the Commissioner on further evidence illustrate different aspects of these considerations, but do not represent binding rules.
The facts
The application to serve further evidence states:
"We submit that the Opponent's Evidence in Reply, namely the Statutory Declaration of Professor Richard Lennox Boyd dated 18 April 2012 (the Boyd Declaration) and the Statutory Declaration of Dr Rodney J. Dilley dated 17 April 2012 (the Dilley Declaration), raise issues in the present opposition proceedings that have either not been addressed in the Applicant's Evidence in Answer because they are additional to the issues raised in the Opponent's Evidence in Support and or about which there is ongoing disagreement in the evidence to date and for which additional evidence is necessary for a proper determination of the matter."
The application then specifies three matters: experiments presented in the Boyd Declaration, assertions in the opponent's evidence that animal data is required, and assertions in the opponent's evidence concerning document IJR-4. The evidence that the applicant seeks to introduce are four statutory declarations by Donald Kuah, Sinead Blaber, Edmond Breen and Tony Batterham.
Explanation of delay
Evidence in reply was completed in April 2012. The application for further evidence was filed in August 2012. The applicant has contended that the evidence responds to experiments first introduced in the evidence in reply. The opponent has highlighted some aspects where this is not the case, and suggested that some of the new evidence was available while the evidence in reply was being prepared. It seems that there are parts of the new evidence that can be seen as a response to the evidence in reply, and other parts that are not. While there is probably not an explanation of the delay in terms of each specific part of the new evidence, on the whole there is an explanation of delay.
Nature and significance of the evidence
The applicant's submissions provided for the hearing address this issue as follows:
"The Opponent has through its evidence attempted to characterise the invention defined in the opposed application as of no therapeutic efficacy, including that neither the specification nor the Applicant's Evidence in Answer provides animal data which, in the Opponent's view appears to be required.
The declarations sought to be adduced in the Further Evidence directly address this point, for example by inclusion of the results of a successful animal clinical trial and the results of successful human treatments"
The opponent disagrees, saying
"What the Opponent questions is whether the claims of the opposed specification define a patentable invention when compared to the prior art in view of the common knowledge of the skilled person".
I do not believe that I need to resolve the exact nature of the opposition in order to decide the matter that is before me. The opponent's submissions in relation to the TetraQ study state:
"The submissions made by Ms Blaber and Mr Breen assert that conditioned medium obtained from culturing a combination of SVF and adipocytes has an improved therapeutic outcome, at least based on some parameters … The TetraQ study lacks a control comprising conditioned media obtained from the culture of adipocytes alone. "
I conclude that there is a dispute as to the efficacy of the treatment, and this new evidence is (at least in part) directed to that dispute. However, the evidence may not be conclusive. I note the opponent's view that the TetraQ evidence is flawed, so this new evidence can be disregarded without compromising the applicant's case. Nevertheless I feel it is safe to conclude that the evidence relates to a matter that is in dispute, and could be of relevance in the opposition.
The interests of the parties
Both parties made submissions that their interests lay in either allowing or refusing the further evidence. I accept the arguments advanced by both parties.
Balance of considerations
While it is far from certain whether the evidence will be significant in the opposition, there is enough reason to believe that the nature and significance of the evidence suggests that the further evidence should be allowed. In this case the other considerations are of lesser significance, and do not alter the balance. I am satisfied that the further evidence should be allowed.
It is appropriate to allow the opponent an opportunity to respond to the further evidence. Taking into account the Christmas period, the applicant has three (3) months from the date of this decision to serve responding evidence.
Costs
Costs normally follow the event. In this case I have decided to allow the further evidence. I see no reason to depart from the normal award.
Dr S.D.Barker
Delegate of the Commissioner of Patents