Apotex Pty Ltd v Les Laboratoires Servier - [2012] APO 91

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v Les Laboratoires Servier [2012] APO 91

Patent Applications: 2007203451

Titles:Pharmaceutical composition containing a crystalline form of perindopril tert-butylamine salt

Patent Applicant:  Les Laboratoires Servier
Opponent:  Apotex Pty Ltd
Delegate:  Dr S.D.Barker
Decision Date:  10 August 2012
Hearing Date:  27 July 2012 in Canberra

Catchwords: PATENTS – extension of time to serve evidence in reply – delay due to involvement of experts in preparing evidence in related Federal Court matter – nature and significance of evidence supports the extension – no award of costs as a consequence of the two step process of explaining the reasons for the extension

Representation: Patent applicant: Linda Govenlock and Trevor Davies of Allens Patent & Trade Mark Attorneys
Opponent:Neil Murray of counsel and Nicole Watling of Freehills Patent & Trade Mark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Applications: 2007203451

Titles:Pharmaceutical composition containing a crystalline form of perindopril tert-butylamine salt

Patent Applicant: Les Laboratoires Servier
Date of Decision: 10 August 2012
DECISION
Extension of time granted. The time for serving evidence in reply is extended to 29 August 2012.
No award of costs.
REASONS FOR DECISION

This matter relates to patent application 2007203451 in the name of Les Laboratoires Servier (the applicant), which is a divisional of application 2001276418 (the parent). The parent is presently the subject of proceedings in the Federal Court.
The present application was advertised accepted, and a notice of opposition to the grant of a patent was filed by Apotex Pty Ltd (the opponent). The opposition has progressed to the evidence in reply stage. Evidence in reply is due to be served by29 June 2012, and the opponent has requested an extension until 29 August 2012. The applicant objected to the extension, and a hearing was conducted in Canberra on 27 July 2012. The applicant was represented by Linda Govenlock and Trevor Davies of Allens Patent & Trade Mark Attorneys. The opponent was represented by Neil Murray of counsel and Nicole Watling of Freehills Patent & Trade Mark Attorneys.
Reasons for the extension of time
The reason for the extension of time was given as
“We have reviewed the evidence in answer by the patent applicant and have identified the issues we intend to address in evidence in reply. Some of these issues are similar to issues to be considered in the Federal Court proceedings relating to the parent patent (AU 2001276418). Our evidence in chief on invalidity is due in that proceeding on 11 July 2012. Two of the experts we have recently retained in the Federal Court proceedings have now also been retained to give evidence in reply in this opposition proceeding. However, due to the involvement of these experts in the evidence preparation for the Federal Court proceeding, the experts will be unable to assist in this opposition preceeding until their commitments on the Federal Court proceedings are completed. In the present circumstances, the experts have spent a significant amount of time (in addition to, and in some cases also instead of, their normal work commitments) in meetings to discuss and prepare their evidence for the Federal Court proceedings. It is thus likely that the experts will need a short period (ie, two to three weeks) between completion of their evidence for the Federal Court proceedings and the completion of evidence preparation for our evidence in reply to this opposition proceeding to attend to their normal commitments. Although there are similarities in the issues in the Federal Court proceeding, the issues are not the same and some matters to be addressed in this opposition proceedings are wholly discrete and do not arise in the Federal Court proceeding. For this reason, the experts need to undertake additional work to prepare their evidence in the opposition proceeding.
Accordingly, we request a two month extension of time to meet with the experts, draft Statutory Declarations based on discussions in these meetings, finalise the Declarations following consideration by the experts and complete our evidence in reply. We are confident that we will be able to complete our evidence in reply within the extended period as the experts will have a general familiarity with the issues to be considered. A serious opposition is being pursued as evidenced by the evidence already filed by us in the proceeding.”
These reasons have been expanded in the opponent’s submissions for the hearing at para 30 to 37:
“As stated in the request for an extension of time dated 29 June 2012, the Applicant’s evidence in answer has been reviewed and the issues intended to be addressed in the evidence in reply have been identified.
Some of these issues are similar to issues in the Federal Court proceedings relating to the Parent Patent (AU 2001276418). The Opponent’s evidence in reply will include evidence from relevant expert witnesses from the Federal Court proceeding. However, as explained further below, it has not been possible for the Opponent to finalise its evidence in reply by the due date.
In particular, the Opponent intends to rely on evidence from Dr Grant McLachlan who has prepared an affidavit in the Federal Court proceeding. His particular areas of expertise are in process development and the scale-up of the manufacture of active pharmaceutical ingredients to pilot or commercial scale. A key issue in the Opposition is whether the opposed application is novel over EP 0308341 B1 (the 341 Patent). The 341 Patent describes a pilot scale process for the preparation of perindopril tert-butylamine (or perindopril erbumine). The Opposed Application claims a particular crystalline form of perindopril tert-butylamine and it is the Opponent’s case that by following the 341 Patent, one obtains the particular crystalline form claimed in the Opposed Application.
The Applicant relies on a declaration of Professor Christopher Easton in answer to the Opposition. Dr McLachlan’s Federal Court affidavit is in chief; it does not respond to other evidence. It is necessary for the Opponent to ensure that evidence of Dr McLachlan relied upon in the Opposition is appropriately responsive to Professor Easton and the Opponent has been unable to complete this task in the time available due to conflicting demands on Dr McLachlan’s time.
Dr McLachlan is the chief executive officer of Nerprotect Pty Ltd, a Project Manager at Therapeutic Innovation Australia Pty Ltd and a consultant to Fibrotech Pty Ltd. In addition to his full-time occupation in these jobs, he recently has been heavily engaged in preparing his affidavit for the Federal Court proceeding. That affidavit comprises 106 pages, including annexures and was finalised on 11 July 2012. It required the dedication of very considerable periods of time from Dr McLachlan and the Opponent’s solicitors and counsel to prepare, review and finalise that affidavit.
The Opponent also intends to rely on evidence from Professor Michael Cima in the Opposition. Professor Cima is a Professor of Material Science and Engineering at Massachusetts Institute of Technology (MIT). … Professor Cima is a very eminent scientist with severe demands on his time.
Professor Cima’s Federal Court affidavit comprises 172 pages, including annexures. It was finalised late in the evening of 16 July 2012 and, as with Dr McLachlan’s affidavit, it required the dedication of very considerable periods of time from Professor Cima and the Opponent’s solicitors and counsel to prepare, review and finalise. Professor Cima was an expert witness in proceedings in the United Kingdom in relation to the UK equivalent of the Parent Patent and one of his reports from those proceedings is annexed as part of the Opponent’s evidence in support.
Professor Cima’s evidence is also relevant to the question of novelty and the 341 Patent. … The Opponent has arranged a time to speak to him in the week of 30 July 2012.”
The relevant law
Regulation 5.10(2) of the Patents Regulations 1991 gives the Commissioner the power to extend the time for serving evidence in reply. The Commissioner must not grant an extension unless satisfied that the parties have been notified of the application for extension (reg. 5.10(5)(b)), has given the parties a reasonable opportunity to be heard (reg. 5.10(5)(c)(i)), and is reasonably satisfied the extension is appropriate (reg. 5.10(5)(c)(ii)). In the present case the parties have been notified and have had an opportunity to be heard. The only remaining question is whether it is appropriate to extend the time.
The considerations relevant to this question have been considered several times by the Federal Court (Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243, A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 and National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398). In summary, the power to extend time is discretionary, so it is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem at 247-8, Goninan at 220). Relevant considerations include:
a)The reason why the evidence was not served earlier (Ferocem at 247)
b)The public interest in determining a serious opposition on its merits (Goninan at 222)
c)The interests of the parties (Ferocem at 247)
Explanation of delay
Taking into account the submissions made for the hearing, it is clear that the opponent has retained two experts who have been unable to work on the evidence in reply until they have completed evidence for the Federal Court and have had a couple of weeks to attend to their normal work commitments.
I note that the evidence in answer was completed on 29 March 2012, so there may have been a small window of opportunity to commence preparing the evidence in reply before the experts were overwhelmed by their affidavits for the Federal Court. Despite this fact, I am satisfied that the involvement of these experts in preparing evidence for the Federal Court is a reasonable explanation of the delay in dealing with the evidence in reply.
I am satisfied that I have been provided with a satisfactory explanation of the delay.
Public interest
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 225-6). The application for extension gives no hint as to the nature of the evidence that is to be prepared. However, the submissions for the hearing provide an explanation that the evidence relates to the 341 patent, and the issue of novelty. I am satisfied on the basis of the information now available to me that the public interest favours allowing the extension.
Interests of the parties
As is normal in such matters, the parties have differing interests. The applicant has stated that the interests are not offsetting. In this regard their submissions state: “The parties have indicated that whatever the outcome of the Opposition, the decision will be appealed to the Federal Court. In those circumstances, the interest of the public and Servier in having the Opposition concluded as soon as possible outweigh the interest of Apotex in delaying the Opposition further.”
This suggests that the opposition is irrelevant, and is merely a vehicle for the parties to access the Federal Court on appeal. Even if this is true, it does not follow that the Commissioner should take her responsibilities less seriously. The likelihood of appeal is not a reason to downplay the interests of the opponent in this opposition. I believe that the interests of the parties are largely offsetting, although not identical.
Conclusion
I am satisfied that there is an explanation of the delay, and the public interest favours allowing the extension. The opponent has discharged the onus of justifying an extension. I will allow the extension of time.
An observation
At the hearing the opponent put forward a view that the explanation of delay could be provided in a two step manner. In the first step, a broad explanation is provided when requesting the extension. In the second step, further information is provided if there is an objection to the extension or the Commissioner requests further explanation.
The Regulations do not explicitly refer to either a one step or two step approach, and the Commissioner will have regard to relevant matters, even if provided in a second step. However, it is preferable for all relevant matters to be specified at the time of making the application for extension of time because a two step approach inevitably leads to unnecessary objections to extensions, since inadequate reasons are likely to provoke an objection from the other party – objections that may well have been avoided if the full facts had been known. A two step approach is not in the public interest, or the interests of the parties.
Additionally, a two step process may be relevant to the award of costs. Where the application for extension of time as filed is inadequate, and the extension is subsequently granted on the basis of information provided at the time of the hearing, then the party objecting to the extension was justified in their objection and should not be penalised by an award of costs against them. This approach was adopted in Osmose Australia Pty Ltd v Koppers Arch Wood Protection (Aust) Pty Ltd [2009] APO 2, for instance. A party should not be surprised if costs do not follow the event.
Costs
While it is normal for costs to follow the event, that is not a rule that is applied inflexibly. In this case, the opponent has been successful on the basis of new information provided just before the hearing. The applicant was justified in objecting to the extension, and as noted above the award of costs should not penalise them. It is appropriate to make no award of costs.
Dr S.D.Barker
Delegate of the Commissioner of Patents