Merial Ltd v Eli Lilly and Company - [2012] APO 69

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Ltd v Eli Lilly and Company [2012] APO 69

Patent Applications: 2002332975, 2004210542, 2004210544

Titles:Dosage form, device and methods of treatment

Patent Applicant:                   Eli Lilly and Company
Opponent:  Merial Ltd
Delegate:  Dr S.D.Barker
Decision Date:  20 June 2012
Hearing Date:  Written submissions provided on 24 April 2012, 24 April 2012, 1 May 2012 and 1 May 2012

Catchwords: PATENTS – application to serve further evidence – satisfactory explanation of delay not provided – nature and significance of evidence supports the further evidence – further evidence allowed – no award of costs

Representation: Patent applicant: Spruson & Ferguson
Opponent:F B Rice & Co

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Applications: 2002332975, 2004210542, 2004210544

Titles:Dosage form, device and methods of treatment

Patent Applicant: Eli Lilly and Company
Date of Decision: 20 June 2012
DECISION
I allow the service of further evidence.
The opponent has three months from the date of this decision to serve evidence in response.
I make no award of costs.
REASONS FOR DECISION

Merial Ltd filed notices of opposition to patent applications 2002332975, 2004210542 and 2004210544 (all in the name of Eli Lilly and Company). The opponent completed its evidence in reply in each matter in June 2011. The applicant applied to serve further evidence on 1 March 2012. The opponent objected to the service of further evidence, and the matter was heard on the basis of written submissions.
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 John Winston Steel dated 24 June 2011, raises additional issues in the present opposition proceedings that have not been addressed in the Applicant’s Evidence in Answer.
The additional issues raised in the Opponent’s Evidence in Reply that have not been addressed in the Applicant’s Evidence in Answer include, but are not limited to:
·     the standard knowledge and experience of a person skilled in the field of formulation of veterinary dosage forms;
·     representations as to the nature of the relevant person skilled in the field of formulation of veterinary dosage forms and their interactions with other parties;
·     representations as to the nature and extent of disclosures in documents relied on by the Opponent in these proceedings; and
·     whether certain knowledge referred to in the Evidence in Reply was actually publicly available.
Furthermore, we submit that there is a serious opposition in train to which the Applicant has mounted a serious defence by way of Evidence in Answer. Accordingly, we request the exercise of discretionary power such that the Applicant is afforded the opportunity to address the additional issues raised in the Opponent’s Evidence in Reply by way of the further evidence annexed to this communication.
The proposed further evidence annexed hereto is intended to contribute to a more correct and just determination of the opposition on its merits through addressing the additional issues indicated above.
We further submit that, should the present application to lodge further evidence be allowed, the Opponent be given three months to serve evidence in reply thereto.
Favourable consideration of our application to lodge further evidence is requested.
The evidence filed with the application consists of declarations by Keith James Ellis and David Spencer Chandler.
Consideration
(i) Explanation of delay
The application for further evidence did not provide any explanation of why it had taken 8 months from the completion of evidence in reply to make the application. The written submissions by the applicant point out that there is no set period for making an application for further evidence, so “there can be no delay as such”. While it is true that there is no set period, there has been a period of eight months that elapsed. I believe that the reasons why the applicant took eight months to apply for further evidence is a relevant consideration in deciding whether to exercise the discretion in their favour.
The applicant did provide the following information in their written submissions:
“Nonetheless, regular communications with the experts involved were held, although these were hampered by absences by the experts, and the Christmas period. We submit that the preparation of the Further Evidence was pursued as diligently as possible, while taking all due care to ensure that the quality of Lilly’s defence of the three opposed applications was not compromised.”
This provides only a minimal explanation, and I do not consider that I have a satisfactory explanation of the period of eight months between the completion of evidence in reply and the application for further evidence.
(ii) The public interest
The nature of the evidence that has been prepared is described in the applicant’s written submissions as:
“The Further Evidence filed/served on 1 March 2012 addresses a number of issues raised in the Evidence in Reply. These issues include inaccuracies, ambiguities, or even what we submit are misrepresentations arising from or existing in the Evidence in Reply. The Further Evidence also provides clarification of disclosures of documents relied on by Merial, or statements made in the Evidence in Answer and/or Evidence in Reply. We submit that the nature and importance of the Further Evidence is self-evident from the declarations by Keith Ellis and David Chandler.”
This explanation is short on detail. It seems that the applicant considers the nature and significance of the evidence is “self-evident”, and does not need any explanation. In the absence of any attempt by the applicant to explain the significance of their evidence, I have inspected the declarations to form a view of its nature and significance. If the significance truly is self-evident, this should be an easy task.
The Ellis and Chandler declarations seem to be a list of the points where they disagree (or strongly disagree) with comments made by Dr Steel. While the individual points of disagreement are explained in the declarations, it is not so readily apparent what significance should be attached to this information. The Ellis and Chandler declarations contain statements such as this (at paragraph 20 of the Ellis declaration):
“A general theme throughout STEEL4 is that the technology for delivering pulses of active agents (as intended by the opposed applications) using CRCs was available well before the priority date claimed by the opposed application and/or this was straightforward and there was strong motivation towards this goal. If any of this were true, Dr Steel has not explained why this was never done before 19 October 2001.”
This is a submission and not evidence, and consequently it is of no significance. However, the Chandler declaration contains a number of Exhibits. For instance, in the discussion of D50 a number of documents are referenced to support an argument as to the nature of the Autowormer/Autoworm device. While it is not clear whether the nature of the Autowormer/Autoworm device will be important in the opposition, this information, at least, seems capable of being of significance.
I am satisfied that some of the evidence sought to be served is capable of being significant. The public interest supports the further evidence, but not strongly.
(iii) The interests of the parties
It is readily apparent that the parties have legitimate interests that lie in opposing directions.
(iv) The balance of considerations
I note that the public interest favours allowing the further evidence, but the lack of an explanation of the eight month delay lies against allowing the further evidence. The other considerations are of lesser significance and equally balanced. The balance is extremely fine. I believe there is sufficient possibility of significance of the evidence to tip the balance in favour of allowing the further evidence. However, the decision did not need to be so finely balanced – the applicant could have provided an explanation of delay and an explanation of the significance of the evidence. The applicant’s failure to do so is both surprising and regrettable.
Other matters
Where further evidence is granted, the Commissioner may impose reasonable terms (under regulation 5.10(4)(b)). Normally, the terms are to permit the other party to serve responding evidence. It is appropriate to allow the opponent three months from the date of this decision to serve evidence in response to the further evidence.
The applicant has been successful, but their case was far from “self-evident”. The applicant has only succeeded after I undertook my own investigation of their evidence. In these circumstances it is not appropriate for costs to follow the event. I will make no award of costs.
Dr S.D.Barker
Delegate of the Commissioner of Patents