Merial Ltd v Norbrook Laboratories
[2012] APO 115
•31 October 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Ltd v Norbrook Laboratories 2012 APO 115
Patent Application: 2006207326
Title:Anthelmintic composition
Patent Applicant: Norbrook Laboratories Limited
Opponent: Merial Ltd
Delegate: Dr S. D. Barker
Decision Date: 31 October 2012
Hearing Date: Written submissions completed on 5 September 2012
Catchwords: PATENTS – request for an extension of time serve evidence in support – inadequate explanation of the delay – nature and significance of evidence supports the extension – extension allowed – no award of costs
Representation: Patent applicant: Davies Collison Cave
Opponent:FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006207326
Title:Anthelmintic composition
Patent Applicant: Norbrook Laboratories Limited
Date of Decision: 31 October 2012
DECISION
I allow an extension of time until 14 October 2012 to serve evidence in support.
I make no award of costs.
I direct that the time for serving evidence in answer shall be three months from the date of this decision.
REASONS FOR DECISION
Patent application 2006207326 in the name of Norbrook Laboratories Limited (‘Norbrook’) was advertised as accepted on 14 April 2011. On 14 July 2011, Merial Ltd (‘Merial’) filed a notice of opposition to grant of a patent. The statement of grounds and particulars was served on 14 October 2011.
Following two extensions of time, evidence in support was due to be served by 14 July 2012. On 12 July 2012 Merial applied for an extension of time until 14 October 2012 to serve their evidence. Norbrook objected to the extension of time on 30 July 2012 and requested a hearing.
The parties were advised that in the circumstances an oral hearing was not required. Both parties were invited to provide written submissions on whether the extension of time should be allowed.
Written submissions were filed by Merial on 15 August 2012. On the same date Norbrook advised the Office that their submissions dated 30 July 2012 were to form the basis of their submissions. The parties then provided a response to these submissions dated 22 August 2012 (Norbrook) and 5 September 2012 (Merial).
Partial evidence in support was filed on 13 August 2012, and then the evidence in support was finalised on 12 October 2012.
Relevant law
Extensions of time are granted at the discretion of the Commissioner and the onus rests with the party requesting the Commissioner to exercise her discretion under regulation 5.10(2):
(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).
This provision must be read in conjunction with regulation 5.10(5):
(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 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, and extension of time or the serving of evidence is appropriate in all the circumstances.
I am satisfied that the Norbrook been notified of the extension request, and both parties have had an opportunity to make representations.
The extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate in all the circumstances. 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. The general principles that flow from these decisions are as follows:
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 [11], Goninan at 220).
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 [10]).
The public interest: The public interest in determining a serious opposition on its merits is a relevant consideration (Goninan at 222). It is necessary for the Commissioner to form a view as to the nature of the evidence that is sought to be adduced, 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).
The interests of the parties: The interests of the party seeking the exercise of discretion are a relevant consideration (Ferocem at [11]). 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 [11], Goninan at 222).
The application for an extension of time
10. Merial’s application for extension of time states:
“The circumstances in which, and the grounds upon which, this application is made are as follows:-
The Opponent has continued to progress the preparation of evidence in this matter. However, as a result of extensive consultation with our expert witness, further time is requested to complete the evidence.”
11. In their written submissions Merial provided a more detailed account of the circumstances leading up to the extension request. With regard to the first and second extension, it was submitted that between filing of the statement of grounds and particulars and the second extension request
“the Opponent undertook research to identify potential witnesses with expertise in the relevant field. The Opponent notes that the application is directed to veterinary formulations for the treatment of parasites in livestock animals. The veterinary field is a large and extensively broad field and as such a substantial number of potential witnesses were considered in order to identify one with the requisite expertise in veterinary formulations. After extensive consideration, a witness with the requisite expertise was identified and subsequently engaged.
In view of relatively recent Court precedents (see, for example, paragraph 45 of Minnesota Mining Manufacturing Company v Tyco Electronics Pty Ltd [2002] FCAFC 315 18 October 2002), the Opponent adopted a staged approach towards developing the evidence. Initially, the witness was asked to provide an opinion of various relevant matters relating to the veterinary field generally and more specifically to veterinary formulations. These initial considerations were made prior to the expert reviewing the opposed application.
The preliminary discussion with the witness involved a number of extensive teleconferences. These conferences had to be conducted over a number of weeks to accommodate the witness’ additional unrelated work commitments. …
Subsequent to establishing the common general knowledge in the field, the witness was provided with two prior art documents and was directed to consider how a new formulation could be developed. Upon consideration of these prior art documents, the witness described the general manner in which the development of a new formulation would be approached. This procedure is also outlined in the first declaration by Stephen W. Page.
Finally, the witness was provided with the priority document of the application a directed to consider the disclosures therein. The witness’ opinion relating to the priority document is also outlined in the first declaration by Stephen W. Page.”
12. With regard to the third extension Merial submitted:
“the Opponent is now preparing a second declaration by Stephen Page. This declaration addresses prior art document relevant to the field of veterinary formulations and specifically to the opposed application.
Whilst significant progress has been made in preparing the second declaration, the Opponent requires further time to complete the declaration and provide further substantial and significant evidence in relation to this matter.”
Explanation of the delay
13. Norbrook submitted that Merial has not provided an explanation as to why further time is required to complete their evidence. They noted that akin to the earlier requests for an extension of time to prepare their evidence, Merial only states that progress has been made, and further time is required to complete the evidence.
14. Merial’s submissions suggested that the initial discussions were to some extent delayed due to the witness’ work commitments. Considering the significant amount of time that has passed since the initial discussions with the expert witness, I consider any delays in the initial discussions to have little bearing on the present request for an extension of time.
15. Merial’s principal reason for the delay relies upon the strategy adopted to prepare their expert evidence. In view of comments made in the decision of the full Federal Court in Minnesota Mining and Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315 at [45], Merial have adopted a staged approach towards developing the evidence.
16. The Commissioner has an expectation that parties to an opposition proceeding will prepare their evidence in a diligent and timely manner. While the approach adopted by Merial to compile their evidence may be more time-consuming, and there may have been some earlier delays due to the witness’ work commitments, I consider that Merial has not described any unusual circumstances that would prevent the evidence being produced within nine months already allowed. I am therefore not satisfied that that Merial has provided an adequate explanation of the delay.
The public interest
17. When considering the public interest, it is necessary to form a view as to the nature and significance of the evidence that is being prepared (Goninan at AIPC 39, 438; IPR 225-6).
18. In their initial application for the extension of time Merial did not specify the nature of the evidence to be produced. However, in their written submissions Merial referred to the first declaration by Stephen W. Page (filed 13 August 2012) and indicated that the evidence contained therein is substantive and of high significance to the opposition proceedings. I note that the evidence concerns
· the common general knowledge with regard to anthelmintic agents, in particular combination products;
· the approach the witness would apply in the formulation of a combination pour-on product for veterinary use; and
· an analysis of the opposed application and the associated priority document.
19. I consider the nature of this evidence to be such that it could be of importance in the opposition.
20. The second declaration of Stephen W. Page was filed on 12 October 2012 (within the requested timeframe for the extension of time). The declaration addresses the relevance of four prior art documents with regard to novelty and inventive step. This evidence could be important in the opposition and could contribute to a more just and correct outcome of the opposition.
21. In view of the nature and significance of the evidence filed, the public interest favours the extension of time.
The interests of the parties
22. At this relatively early stage in the opposition proceedings I see the interests of the parties as opposed and largely offsetting.
The balance of considerations
23. Merial has not provided a satisfactory explanation of the delay. The public interest clearly supports allowing the extension, and the interests of the parties are largely offsetting. On balance, I consider it appropriate in the circumstances to grant the application for an extension of time.
24. In addition, it is necessary to consider when evidence in answer is due. Regulation 5.8(2) says that the time runs from the date that evidence in support was completed. However, due to the uncertainties created by the extension of time, this period should run from the date of this decision.
Costs
25. I note that Merial did not provide an adequate explanation of the reason for the delay, and the nature and significance of the evidence only became clearly apparent once the evidence had been filed. In view of this, Norbrook was justified in objecting to the extension of time in the first instance. As such I think it is appropriate that each party bear its own costs. Accordingly, I make no award of costs.
Dr S. D. Barker
Delegate of the Commissioner of Patents
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