Apotex Pty Ltd v Les Laboratoires Servier
[2011] APO 68
•30 August 2011
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was dismissed by the Commissioner(Les Laboratoires Servier v Apotex Pty Ltd [2008] APO 11), and the amendment was withdrawn during an appeal to the Administrative Appeals Tribunal.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 its favour.
The explanation from Apotex as to why its evidence in support could not be served within the prescribed period is vague, non-specific and inadequate. For example, there is no explanation as to when the expert was engaged, what work has been carried out to date, or why it is alleged that the evidence could not be completed in time.
This omission is particularly significant when this opposition is viewed in the context of the Parent Proceedings during which Servier sought to amend the Parent Patent to introduce the Equivalent Claims, which are analogous in substance and scope to the Divisional Claims being challenged in this opposition. Apotex was a party to the Parent Proceedings and in the course of those proceedings made detailed submissions to the Patent Office in respect of the Equivalent Claims, engaged experts, filed evidence and made submissions to the Federal Court and Full Federal Court in relation to the Equivalent Claims. The Parent Proceedings are discussed in detail in Section 3.2.
Similarly, Apotex has provided no information to enable the Commissioner to form a prima facie view of the evidence. Specifically, Apotex has provided no information in relation to the nature of the evidence to be adduced, and no information has been provided to show that evidence is likely to be relevant to the substantive opposition. Apotex has failed to show that a serious opposition is even contemplated.”
The relevant law
The law applying to extensions of time under subregulation 5.10(2) of the Patents Regulation 1991 has been considered in many decisions of the Commissioner, and several decisions of the Federal Court (Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; (1994) AIPC 91-057; 28 IPR 243, A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; (1997) AIPC 91-330; 38 IPR 213 and National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; (2001) AIPC 91-697, 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 AIPC 38, 208; IPR 247-8, Goninan at AIPC 39, 434; IPR 220). Relevant considerations include:
a)The reason why the evidence was not served earlier (Ferocem at AIPC 38, 207-8; IPR 247)
b)The public interest in determining a serious opposition on its merits (Goninan at AIPC 39, 435-6; IPR 222)
c)The interests of the parties (Ferocem at AIPC 38, 208; IPR 247)
Explanation of delay
The opponent has provided a brief explanation that states little more than an expert has been located, but has been unable to complete their evidence. It would have been possible for the opponent to have stated the name of the expert, what steps were taken to prepare the evidence, what steps remain to be done and whether the expert had been involved in the previous actions relating to the parent. The failure to provide this information reduces the weight I attach to the explanation, but does not reduce it to zero.
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 AIPC 39, 438; IPR 225-6). The opponent has chosen not to specify the nature of the evidence that the expert will provide, which is unfortunate. However, as the particulars of the opposition include lack of novelty in the light of two pieces of prior art it seems reasonable to conclude that the expert will address these matters. As there is no other evidence yet served, I am satisfied that it is likely that the evidence will relate to the construction of the citations and is relevant to the ground of lack of novelty. However, it would be preferable for the opponent make this clear by stating (in broad terms) the nature of the evidence that the expert will provide.
Interests of the parties
The patent applicant appears to be frustrated by the fact that similar claims have previously been considered by the Commissioner and the Federal Court, and the opponent should be able to prepare its evidence in a timely manner. I note that the previous matters involved the issue of allowability of amendments, rather than the substantive matters in section 59. Nonetheless, the opponent’s familiarity with the subject matter should enable it to prepare its evidence in an efficient time frame. However, at this early stage in the opposition I see the interests of the parties as opposed and largely offsetting.
Overall
Overall, I am satisfied that there is an explanation of the delay, and the public interest favours allowing the extension. The extension should be allowed. I note however that if further extensions of time are required the opponent’s case would be helped by providing a more detailed explanation of the delay.
Costs
The opponent is successful, and I can see no reason to depart from the normal practice that costs should follow the event. I will award costs against the patent applicant, Les Laboratoires Servier.
Dr S.D.Barker
Delegate of the Commissioner of Patents
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