Apotex Pty Ltd v Les Laboratoires Servier - [2011] APO 68

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v Les Laboratoires Servier [2011] APO 68

Patent Application: 2007203451

Title: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:  30 August 2011
Hearing Date:  Written submissions filed on
Catchwords:  PATENTS – extension of time serve evidence in support – satisfactory explanation of delay provided – pubic interest favours extension – relevance of previous actions relating to allowability of amendments considered – extension allowed

Representation: Patent applicant: Allens Arthur Robinson
Opponent:Freehills

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2007203451

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

Patent Applicant: Les Laboratoires Servier
Date of Decision: 30 August 2011
DECISION
Extension of time to serve evidence in support until 2 September 2011 allowed.
Costs according to Schedule 8 awarded against Les Laboratoires Servier.
REASONS FOR DECISION

A notice of opposition to the grant of a patent was filed by Apotex Pty Ltd (the opponent) on 2 December 2010, and a statement of grounds and particulars was served on 2 March 2011. Consequently, evidence in support of the opposition was due to be served by 2 June 2011. The opponent sought an extension of time for serving evidence until 2 September 2011. The applicant for the patent (Les Laboratoires Servier) objected to the extension, and a hearing was conducted by way of written submissions.
Some background
The present application is a divisional of application 2001276418 (the parent). The applicant sought to amend the claims of the parent under section 104 in 2007. That amendment was opposed by the present opponent. The opposition was dismissed by the Commissioner(Les Laboratoires Servier v Apotex Pty Ltd [2008] APO 11), and the amendment was withdrawn during an appeal to the Administrative Appeals Tribunal. Following grant of a patent on the parent, the applicant sought to amend its claims under section 105. The Federal Court refused the amendment (Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2008] FCA 607, 83 IPR 42; appeal dismissed in Les Laboratoires Serview v Apotex Pty Ltd [2010] FCAFC 131, 89 IPR 219). The present application contains claims similar to those proposed for the parent under section 104 and 105.
Reasons for the extension of time
The reason for the extension of time was given as
“An expert has been identified and engaged to assist in relation to the evidence in support of the above opposition. An initial discussion has been had with the expert, however, it has not been possible to prepare and finalise the evidence of that expert within the current evidence period. More time is required to enable this evidence to be prepared and, accordingly, an extension of time of three months is requested.”
The patent applicant stated in its submissions
“This statement is superficial and does not discharge the burden on Apotex to show why it is appropriate for the Commissioner to exercise her discretion in…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2011] APO 68
Decision Date: 30 August 2011

CaseChat Overview and Summary

Apotex Pty Ltd opposed the grant of a patent for a pharmaceutical composition containing a crystalline form of perindopril tert-butylamine salt, filed by Les Laboratoires Servier. The dispute centered on the opponent's request for an extension of time to serve evidence in support of its opposition, which was initially due by 2 June 2011. The applicant objected to the extension, leading to a hearing conducted through written submissions. The application in question was a divisional of an earlier application, with the opponent previously opposing amendments to the claims of the parent application, which had been dismissed by the Commissioner and the Federal Court. The opponent's request for an extension of time was based on the need for more time to prepare evidence from an expert engaged for this purpose.

The court was required to determine whether the opponent had provided a satisfactory explanation for the delay in serving evidence and whether the public interest favoured granting the extension. The opponent's explanation was brief, stating only that an expert had been located but could not complete their evidence within the prescribed period. This lack of detail reduced the weight of the explanation but did not render it entirely without merit. The court considered the public interest in determining the opposition on its merits, noting that the opponent had not specified the nature of the evidence the expert would provide. However, given the grounds of opposition included lack of novelty in light of prior art, it was reasonable to conclude that the expert would address these matters.

The court assessed the interests of the parties, noting the applicant's frustration with the opponent's previous familiarity with the subject matter, which should have enabled timely preparation of evidence. The court saw the interests of the parties as largely offsetting at this stage of the opposition. Ultimately, the court was satisfied that there was an explanation for the delay, and the public interest favoured allowing the extension. The court also noted that if further extensions were required, the opponent’s case would benefit from a more detailed explanation of the delay.

The court granted the extension of time for serving evidence until 2 September 2011 and awarded costs according to Schedule 8 against Les Laboratoires Servier. This decision underscored the discretionary nature of the power to extend time and the importance of considering all relevant factors, including the reasons for the delay, the public interest, and the interests of the parties.

Orders