Arena Pharmaceuticals, Inc. v H. Lundbeck A/S
[2007] APO 36
•26 October 2007
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 777247 in the name of H.Lundbeck A/S
Title: DNA encoding SNORF25 receptor
Action: Extension of time to serve evidence in answer to an opposition by Arena Pharmaceuticals, Inc.
Decision: Issued 26 October 2007
Abstract
Extension of time granted.
The application is subject to a direction that the service of evidence in answer is deferred, subject to the requirement that “the applicant will need to obtain extensions of time (if needed) under Regulation 5.10(2) up until you are advised that leave to amend has been granted”.
The Commissioner’s power to give directions under regulation 5.10(1) is a broad power, limited only by the requirements that the direction is “not inconsistent with the Act”, and that it is for the conduct of proceedings under Chapter 5. The condition in the present direction is clearly within the Commissioner’s power. If an extension cannot be justified, then the condition of the direction will not have been met, and the direction can be withdrawn.
The extensions of time are required because of delays in finalising the amendment. Consequently, the law on extensions of time must be understood in this context. This is not to say that the applicant should be sitting on its hands with regard to the evidence in answer. The applicant should be identifying suitable witnesses, and preparing such of its evidence as can be done. The applicant is not powerless to act until the amendment is finalised.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 777247 by H.Lundbeck A/S, and an extension of time to serve evidence in answer to an opposition by Arena Pharmaceuticals, Inc
BACKGROUND
Patent application 777247 in the name of H.Lundbeck A/S was advertised accepted on 7 October 2004. The application was opposed by Arena Pharmaceuticals, Inc (hereafter referred to as Arena). Evidence in support was completed on 25 October 2006. Lundbeck proposed amendments to the specification on 26 April 2007, and these amendments are still under examination. An extension of time for serving evidence in answer until 27 October 2007 was objected to by Arena. The matter was heard in Canberra on 26 September 2007. Lundbeck were represented in person by Ian Horak of counsel, assisted by Jane Hutchinson of Davies Collison Cave. Arena appeared by phone, represented by Mark Olive of FB Rice. Patrick McManamny, David Bradfute and Deno Dialynas attended the hearing by phone but made no submissions.
The application for extension of time
The application for extension of time states:
Since the previous application for an extension of time of one month was filed on 27 August 2007 the Applicant has considered and provided instructions for responding to the Adverse Examination Report dated 12 July 2007 issued on the Amendments filed 26 April 2007. The response was filed on 21 September 2007 and it is understood that the Examiner will consider the response in due course. In the response, the Applicant proposed a further amendment to the “use” claims purely in order to clarify the construction of the use claims and thus facilitate their examination. … The Applicant is keen to progress the Amendment and has been diligent in responding to the outstanding Office Action. In the interim, the Attorney for the Applicant has contacted the previously identified expert and a meeting to discuss the questions the expert will be asked to address is now proposed for the week beginning 8 October 2007 when the expert will have returned from the United States.
Submissions by the parties
The parties made lengthy submissions, but in essence their positions are easily summarised. Arena’s chief concern seemed to be that they believed that some evidence in answer could have been filed, but to date nothing had been filed. Mr Olive pointed out that the latest amendments were trivial in nature, and questioned how long Lundbeck had taken to respond to the examination report.
Lundbeck submitted that they are actively proceeding with the opposition, by means of the amendment process. For commercial and prosecution reasons it was decided to amend the specification. The nature of the amendments as a whole is significant, and address the grounds of opposition. The delay in responding to the examination report was not excessive.
DECISION
The present matter is different to the normal extension of time in that the Commissioner has already given a direction to defer the service of evidence in answer pending the resolution of an amendment to the specification. The terms of the direction are as follows:
The time for serving evidence in answer will expire 1 month after the date the Commissioner notifies the parties of the refusal or withdrawal of the request for leave to amend filed on 26 April 2007 or notifies the parties of the allowance of the amendments which are the subject of that request.
However, as the time taken for processing the amendments is largely in the hands of the applicant, the applicant will need to obtain extensions of time (if needed) under Regulation 5.10(2) up until you are advised that leave to amend has been granted.
The proper interpretation of this direction is critical to this case. The time for serving evidence has been deferred pending finalisation of the amendment. However, the deferral is qualified by the requirement to obtain extensions. The power to give directions under regulation 5.10(1) is a broad power, limited only by the requirements that the direction is “not inconsistent with the Act”, and that it is for the conduct of proceedings under Chapter 5. The condition in the present direction is clearly within the Commissioner’s power. If an extension cannot be justified, then the condition of the direction will not have been met, and the direction can be withdrawn.
While the direction is dependent on the extensions, the extensions are also dependent on the amendment. The extensions are required because of delays in finalising the amendment. Consequently, the law on extensions of time must be understood in this context.
This is not to say that the applicant should be sitting on its hands with regard to the evidence in answer. The applicant should be identifying suitable witnesses, and preparing such of its evidence as can be done. The applicant is not powerless to act until the amendment is finalised. I would expect that the applicant would also explain what it was doing to prepare its evidence.
The law on extensions of time
The law on extensions of time have been summarised in numerous decisions of the Commissioner. The key points are that the time can be extended under regulation 5.10(2), and that 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 these prerequisites have been satisfied.
10. An extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate. In exercising this discretion the Commissioner is guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents (2001) AIPC 91-697, 50 IPR 398. These decisions establish that:
a)The power is discretionary
b)Satisfactory explanation of delay is relevant but not mandatory
c)Regard must be had to the public interest, the effect on the Patent Office and the interests of the parties
Explanation of the delay
11. The delay in the present case is occasioned by the processing of the amendment. The examination report issued on 12 July 2007. The objection related to the allowability of the inclusion of four new claims. Lundbeck have considered their response to the examination report on the amendment, and provided a further statement of amendments on 21 September 2007. The time taken to respond to the examination report was 10 weeks. While the latest amendment is relatively simple, there would have been numerous ways that the objection could be addressed. The simplicity of the response does not automatically lead to a conclusion that the time taken was unreasonable. I consider that I have been provided with a satisfactory explanation of the delay.
The public interest
12. The public interest in determining a serious opposition on its merits is assessed by considering the nature and significance of the evidence that will be served (Goninan at AIPC 39,438; IPR 225-6). Mr Horak stated that the evidence that was served in support of the opposition was technical, and the evidence in answer that is foreshadowed is equally technical. An expert has been identified for the purposes of the opposition. I am satisfied that the public interest favours allowing the extension.
Other interests
13. Lundbeck have a strong interest in the extension being allowed. No evidence has been served, and no evidence is near completion. Consequently, they would be completely shut out from properly defending the application if the extension is refused. In such a situation it is probable that an applicant would be forced to file a divisional, thus protracting the matter by years rather than months.
14. Arena would like to see partial evidence served, but it is not evident that they are suffering a disadvantage from the failure to serve any partial evidence in answer.
Conclusion
15. I am satisfied that the amendment is still being pursued appropriately. Additionally, Lundbeck have identified a witness, so the preparation of evidence is still being advanced. Lundbeck have provided a proper explanation of the delay, and their interest and the public interest strongly favour allowing the extension. While I have sympathy for Arena’s desire to see partial evidence served, this is not sufficient to offset the other considerations. Accordingly, I am satisfied that the extension of time should be granted.
16. The processing of the latest amendments is delayed due to the need to allow Arena to file comments (under regulation 10.2(7)). This time period runs until 30 October 2007. Consequently a further extension of time will probably be required in order for the examiner to report on the latest amendments.
Costs
17. It is normal practice for costs to follow the event. In the present case, Arena’s objection was without basis, and I can see no reason to depart from the normal practice. I award costs according to Schedule 8 against Arena.
Dr S.D.Barker
Delegate of the Commissioner of Patents
26 October 2007Patent attorneys for the applicant : Davies Collison Cave
Patent attorneys for the opponent : FB Rice & Co
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